tag:blogger.com,1999:blog-3711482464050057882024-03-13T03:11:26.004-07:00Organic Chemistry - Education and IndustryOrganic chemistry is a discipline impacting every aspect of society. Examples are prevalent in the pharmaceutical and food industries, fossil and synthetic fuels, plastics, paints and textiles - to name a few. Furthermore, organic chemistry is required coursework for numerous undergraduate programs. Through this blog, ideas focused on education, industry and general organic chemistry will be discussed.Daniel E. Levyhttp://www.blogger.com/profile/05609535387028309791noreply@blogger.comBlogger43125tag:blogger.com,1999:blog-371148246405005788.post-20335889979648180922018-04-06T10:27:00.001-07:002018-04-06T10:27:45.302-07:00Data Exchange and Confidentiality Between CROs and Sponsors<div style="box-sizing: inherit; caret-color: rgb(72, 64, 84); color: #484054; font-family: raleway; font-size: 14px; margin-bottom: 1.5em;">
Data exchange is a part of the much broader issue of confidentiality when contracting R&D services. In reality, regardless of the geographic region to where services are implemented, the moment work is sent outside of the home office, confidentiality is potentially compromised.</div>
<div style="box-sizing: inherit; caret-color: rgb(72, 64, 84); color: #484054; font-family: raleway; font-size: 14px; margin-bottom: 1.5em;">
DEL BioPharma LLC works with many clients some of whom are tolerant to perceived risk and some of whom are so concerned that they will not outsource to Asia or India. From a practical point of view and regardless of the geographic region utilized for contract services, CROs and CMOs would not be in business if there were significant violations of confidentiality. That having been said, sponsor companies should always take steps to minimize any risk to their programs. Such steps, applied to chemistry research and development, include the following:</div>
<ul style="box-sizing: inherit; caret-color: rgb(72, 64, 84); color: #484054; font-family: raleway; font-size: 14px; list-style-image: initial; list-style-position: initial; margin: 0px 0px 1.5em; padding-left: 15px;">
<li style="box-sizing: inherit; padding-bottom: 10px;">For medicinal chemistry, contract labs used for the preparation of target compounds should be separate and distinct from contract labs used for the assay of target compounds. The rationale behind this strategy lies in the fact that a CRO generating target compounds does not need to know what the target compounds are used for. Similarly, contract labs providing assay services do not require the structural identity of compounds under evaluation.</li>
<li style="box-sizing: inherit; padding-bottom: 0px;">For API manufacturing, separate contract labs should be used for the regulatory starting materials and for the final drug substance. The rationale behind this strategy lies in the fact that the manufacturer of the regulatory starting materials does not require knowledge of the final drug substance. Similarly, the manufacturer of the drug substance does not require knowledge of the process utilized for production of the regulatory starting materials.</li>
</ul>
<div style="box-sizing: inherit; caret-color: rgb(72, 64, 84); color: #484054; font-family: raleway; font-size: 14px; margin-bottom: 1.5em;">
In all instances, effective communication of sensitive information (batch records, analytical data/methods, patent applications, regulatory documents, etc.) is required in order to facilitate tech transfer, troubleshooting and overall project advancement. Aside from the fact that much documentation is so large that email transmission is ineffective, unless encrypted, there is some risk associated with email. As an alternative, there are many options for encrypted cloud-based data transfer. Unless an alternate platform is required by a given client, DEL BioPharma LLC uses ShareVault as a secure and encrypted platform for all document transfer between client companies and contracted laboratories.</div>
<div style="box-sizing: inherit; caret-color: rgb(72, 64, 84); color: #484054; font-family: raleway; font-size: 14px; margin-bottom: 1.5em;">
In summary, there are many effective strategies and platforms for risk reduction associated with data exchange. The approaches described above are very effective in maintaining security and confidentiality in our current globalized pharmaceutical research and development industry.</div>
Daniel E. Levyhttp://www.blogger.com/profile/05609535387028309791noreply@blogger.com14tag:blogger.com,1999:blog-371148246405005788.post-12965965830671621942018-03-13T17:05:00.001-07:002018-03-13T17:05:52.995-07:00How to forge a successful strategic partnership with a CRO company to reach your company’s goals<div style="box-sizing: inherit; color: #484054; font-family: raleway; font-size: 14px; margin-bottom: 1.5em;">
Today’s globalized pharmaceutical industry presents many opportunities for diversifying risk in manufacturing. Part of this diversification comes from the ability to spread manufacturing activities across continents. In order to successfully develop a portfolio of relationships, each CRO or CMO engaged must be viewed as a strategic partner and those contributing to projects must feel that they are contributing to the overall development efforts. There are many contract labs available that are capable of providing quality services. However, the best services come from personal relationships and not from a business model of services and transactions. In order to forge a successful strategic partnership, the following steps are essential:</div>
<ul style="box-sizing: inherit; color: #484054; font-family: raleway; font-size: 14px; list-style-image: initial; list-style-position: initial; margin: 0px 0px 1.5em; padding-left: 15px;">
<li style="box-sizing: inherit; padding-bottom: 10px;">Know who you are working with (personal, infrastructure, capabilities/expertise and quality)</li>
<li style="box-sizing: inherit; padding-bottom: 10px;">Keep it personal (relationships first, finances/contracts second)</li>
<li style="box-sizing: inherit; padding-bottom: 0px;">Keep the CRO/CMO engaged (solicit thoughts/opinions, discuss/debate strategies, work collaboratively)</li>
</ul>
<div style="box-sizing: inherit; color: #484054; font-family: raleway; font-size: 14px; margin-bottom: 1.5em;">
From a foundation of solid relationships, costs will decrease, quality will increase and significant cooperation in dealing with problems (timeline extensions, change orders, chemistry issues, etc.) will be realized.</div>
Daniel E. Levyhttp://www.blogger.com/profile/05609535387028309791noreply@blogger.com10tag:blogger.com,1999:blog-371148246405005788.post-17586708429063381972014-11-27T23:38:00.003-08:002014-11-27T23:43:53.986-08:00GLOBAL STRATEGIES FOR SUCCESS IN DRUG DEVELOPMENTAn evening drug development seminar and wine tasting event.<br /><br />Daniel Levy will present a seminar on "Outsourcing in the Pharma Industry: Strategies for Successful Projects with Limited Budgets" during."<div>
<br />Realizing successful outcomes following engagement of CRO/CMO resources amid challenges through the adoption of key strategies that will increase efficiencies and maximize chances to attain project goals.<br /><br />Event includes a panel discussion on <b>Tricks of the Trade for Virtual Drug Development</b> led by Ken Haas, Partner at Abingworth Global Life Sciences Venture Group<br /><br />Thursday, December 4, 2014 • 5:30–9:00 p.m<br />EMBASSY SUITES<br />250 Gateway Blvd., South San Francisco, CA 94080</div>
<div>
<br />Cost: $50.00<br />Please RSVP by November 30 to akaufman@bizdevconnections.com</div>
Daniel E. Levyhttp://www.blogger.com/profile/05609535387028309791noreply@blogger.com6tag:blogger.com,1999:blog-371148246405005788.post-81032641115440496882014-08-03T17:11:00.000-07:002014-08-03T17:14:29.945-07:00Strategies for Successful Transition from Full-Time to Project-Based Employment<span style="font-family: inherit;">San Francisco American Chemical Society Meeting</span><br />
<span style="font-family: inherit;">Tuesday, August 12, 2014</span><br />
<span style="font-family: inherit;"><br /></span>
<span style="font-family: inherit;">DIVISION: SCHB: Division of Small Chemical Businesses<br />SESSION: True Stories from Entrepreneurs<br />SESSION START TIME: August 12, 2014, 8:00 am<br />PRESENTATION START TIME: August 12, 2014, 8:35 am<br />LOCATION: Moscone Center, South Bldg., Room: Esplanade Ballroom 301 </span><br />
<span style="font-family: inherit;"><br /></span>
<span style="font-family: inherit;">ABSTRACT: Many sectors, including the biotechnology and pharmaceutical industries, continue to be challenged by the current economy. With the current and ongoing trend of engaging contract laboratories for chemistry research and manufacturing, the unemployment rate among those engaged in life-sciences companies continues to be disproportionate to the national average. Through development of skills such as managing CRO activities, leveraging services for resources, networking and marketing, motivated contributors can create opportunities leading to the development of successful consulting practices.</span>Daniel E. Levyhttp://www.blogger.com/profile/05609535387028309791noreply@blogger.com5tag:blogger.com,1999:blog-371148246405005788.post-92152251026491268972014-08-03T17:07:00.005-07:002014-08-03T17:15:13.939-07:00Successful Chemistry Outsourcing for Today's Startup Companies<span style="font-family: inherit;">San Francisco American Chemical Society Meeting</span><br />
<span style="font-family: inherit;">Tuesday, August 12, 2014</span><br />
<span style="font-family: inherit;"><br />DIVISION: SCHB: Division of Small Chemical Businesses<br />SESSION: Start-Up Chemical Businesses in Drug Discovery<br />SESSION START TIME: August 12, 2014, 1:00 pm<br />PRESENTATION START TIME: 4:20 pm<br />LOCATION: Moscone Center, South Bldg., Room: Esplanade Ballroom 301</span><br />
<span style="font-family: inherit;"><br /></span>
<span style="font-family: inherit;">ABSTRACT: Chemistry outsourcing has evolved from a tool to supplement internal activities to a necessary function designed to improve efficiencies and control costs within research and development organizations. This is particularly relevant to start-up pharmaceutical and biotechnology companies. However, realizing successful outcomes following engagement of CRO/CMO resources can be challenging - especially when working across large distances and without the ability to frequently monitor day-to-day activities. Through adoption of key strategies, efficiencies with CRO/CMO resources can be increased thus maximizing chances for successful project outcomes.</span>Daniel E. Levyhttp://www.blogger.com/profile/05609535387028309791noreply@blogger.com9tag:blogger.com,1999:blog-371148246405005788.post-12723124162311515222013-06-11T17:15:00.002-07:002013-06-11T17:22:04.164-07:00Chemistry Skills for Drug Discovery<span class="Apple-style-span" style="color: #333333; font-size: 16px; font-weight: bold; line-height: 19px;">I recently came across the article summarized below. The full PDF can be downloaded </span><span class="Apple-style-span" style="color: #333333; font-size: 16px; font-weight: bold; line-height: 19px;"><a href="http://www.rsc.org/ScienceAndTechnology/Policy/Documents/chemistry-skills-for-drug-discovery.asp">here</a></span><span class="Apple-style-span" style="color: #333333; font-size: 16px; font-weight: bold; line-height: 19px;">.</span><br />
<h2 style="border-bottom-color: rgb(122, 163, 0); color: #7aa300; font-family: Arial, Helvetica, sans-serif; font-size: 1.5em; font-weight: normal; margin-bottom: 0px; margin-left: 0px; margin-right: 0px; margin-top: 3px; padding-bottom: 0px; padding-left: 0px; padding-right: 0px; padding-top: 0px;">
</h2>
<h2 style="border-bottom-color: rgb(122, 163, 0); color: #7aa300; font-family: Arial, Helvetica, sans-serif; font-size: 1.5em; font-weight: normal; margin-bottom: 0px; margin-left: 0px; margin-right: 0px; margin-top: 3px; padding-bottom: 0px; padding-left: 0px; padding-right: 0px; padding-top: 0px;">
<span class="Apple-style-span" style="color: #333333; font-family: Arial, Helvetica, sans-serif; font-size: 12px;"><h2 style="border-bottom-color: rgb(122, 163, 0); color: #7aa300; font-size: 1.5em; font-weight: normal; margin-bottom: 0px; margin-left: 0px; margin-right: 0px; margin-top: 3px; padding-bottom: 0px; padding-left: 0px; padding-right: 0px; padding-top: 0px;">
</h2>
<h2 style="border-bottom-color: rgb(122, 163, 0); color: #7aa300; font-size: 1.5em; font-weight: normal; margin-bottom: 0px; margin-left: 0px; margin-right: 0px; margin-top: 3px; padding-bottom: 0px; padding-left: 0px; padding-right: 0px; padding-top: 0px;">
Chemistry skills for drug discovery</h2>
<br /><span class="Apple-style-span" style="font-weight: normal;">11 April 2013</span><br /><br /><div style="font-size: 1em; font-weight: normal; line-height: 1.2em; margin-bottom: 0.5em; margin-left: 0px; margin-right: 0px; margin-top: 0px; padding-bottom: 0px; padding-left: 0px; padding-right: 0px; padding-top: 0px;">
Chemistry expertise is critical to technical success across the spectrum of innovative medicines R&D. </div>
<div style="font-size: 1em; font-weight: normal; line-height: 1.2em; margin-bottom: 0.5em; margin-left: 0px; margin-right: 0px; margin-top: 0px; padding-bottom: 0px; padding-left: 0px; padding-right: 0px; padding-top: 0px;">
This position paper describes the changes that have taken place in the drug discovery sector and the challenges this presents in terms of ensuring chemistry, as the key enabling science, continues to deliver the essential translation of biological opportunity into clinical application.</div>
<div style="font-size: 1em; font-weight: normal; line-height: 1.2em; margin-bottom: 0.5em; margin-left: 0px; margin-right: 0px; margin-top: 0px; padding-bottom: 0px; padding-left: 0px; padding-right: 0px; padding-top: 0px;">
It includes:</div>
<ul style="font-weight: normal; margin-bottom: 0.5em; margin-left: 2em; margin-right: 0px; margin-top: 0px; padding-bottom: 0px; padding-left: 0px; padding-right: 0px; padding-top: 0px;">
<li style="font-size: 1em; margin-bottom: 0px; margin-left: 0px; margin-right: 0px; margin-top: 0px; padding-bottom: 0px; padding-left: 0px; padding-right: 0px; padding-top: 0px;">Impact of recent developments on training capacity and mobility</li>
<li style="font-size: 1em; margin-bottom: 0px; margin-left: 0px; margin-right: 0px; margin-top: 0px; padding-bottom: 0px; padding-left: 0px; padding-right: 0px; padding-top: 0px;">Key skills and capabilities for drug discovery chemists </li>
</ul>
<div>
<span class="Apple-style-span" style="font-weight: normal;"><br /></span></div>
<div>
<span class="Apple-style-span" style="font-weight: normal;"><br /></span></div>
</span><span class="Apple-style-span" style="color: #333333; font-family: Arial, Helvetica, sans-serif; font-size: 14px; font-weight: normal;">Conclusion</span></h2>
<h2 style="border-bottom-color: rgb(122, 163, 0); color: #7aa300; font-family: Arial, Helvetica, sans-serif; font-size: 1.5em; font-weight: normal; margin-bottom: 0px; margin-left: 0px; margin-right: 0px; margin-top: 3px; padding-bottom: 0px; padding-left: 0px; padding-right: 0px; padding-top: 0px;">
<span class="Apple-style-span" style="color: #333333; font-family: Arial, Helvetica, sans-serif; font-size: 12px;"><div style="font-size: 1em; font-weight: normal; line-height: 1.2em; margin-bottom: 0.5em; margin-left: 0px; margin-right: 0px; margin-top: 0px; padding-bottom: 0px; padding-left: 0px; padding-right: 0px; padding-top: 0px;">
From target selection and compound design through to informing the design of clinical studies, chemistry has a vital role to play in driving the future success of drug discovery and, more broadly, the pharmaceutical sector as a whole.</div>
<div style="font-size: 1em; font-weight: normal; line-height: 1.2em; margin-bottom: 0.5em; margin-left: 0px; margin-right: 0px; margin-top: 0px; padding-bottom: 0px; padding-left: 0px; padding-right: 0px; padding-top: 0px;">
A major stumbling block for the industry over recent years has been unacceptably high level of Phase 2 attrition resulting from poor target selection. It is essential to embed chemistry at the earliest stages of drug discovery as well as within the clinical setting, to help develop a more thorough molecular understanding of disease pathways and to inform target selection.</div>
<div style="font-size: 1em; font-weight: normal; line-height: 1.2em; margin-bottom: 0.5em; margin-left: 0px; margin-right: 0px; margin-top: 0px; padding-bottom: 0px; padding-left: 0px; padding-right: 0px; padding-top: 0px;">
Equally important is the need to safeguard the skills, knowledge and expertise that are necessary to translate biological opportunities into safe and effective therapeutic agents. As the capacity within UK-based industry to develop these skills amongst drug discovery chemists diminishes, an alternative model for training must be established if the UK is to maintain its global competitiveness in the sector.</div>
</span></h2>
Daniel E. Levyhttp://www.blogger.com/profile/05609535387028309791noreply@blogger.com11tag:blogger.com,1999:blog-371148246405005788.post-53070032760466234572013-03-17T09:44:00.000-07:002013-03-17T09:44:50.619-07:00Strategies for Success in Virtual Drug Development - San Diego, CA<span class="Apple-style-span" style="font-family: Calibri; font-size: 18px;"><strong>Please join us for an interactive seminar and discussion focused on virtual drug development and strategies for success from discovery to clinical trials. </strong></span><br />
<div style="font-family: 'Helvetica Neue', Helvetica, Arial, sans-serif; font-size: 13px; font: normal normal normal 24px/normal Calibri; line-height: normal; margin-bottom: 0px; margin-left: 0px; margin-right: 0px; margin-top: 0px; padding-bottom: 8px; padding-left: 0px; padding-right: 0px; padding-top: 0px; text-align: center;">
<strong>April 15, 2013 </strong></div>
<div style="font-family: 'Helvetica Neue', Helvetica, Arial, sans-serif; font-size: 13px; font: normal normal normal 24px/normal Calibri; line-height: normal; margin-bottom: 0px; margin-left: 0px; margin-right: 0px; margin-top: 0px; padding-bottom: 8px; padding-left: 0px; padding-right: 0px; padding-top: 0px; text-align: center;">
<strong>5:00 – 9:00 pm</strong></div>
<div style="font-family: 'Helvetica Neue', Helvetica, Arial, sans-serif; font-size: 13px; font: normal normal normal 20px/normal Calibri; line-height: normal; margin-bottom: 0px; margin-left: 0px; margin-right: 0px; margin-top: 0px; padding-bottom: 8px; padding-left: 0px; padding-right: 0px; padding-top: 0px; text-align: center;">
<strong>Hyatt Regency Mission Bay </strong></div>
<div style="font-family: 'Helvetica Neue', Helvetica, Arial, sans-serif; font-size: 13px; font: normal normal normal 20px/normal Calibri; line-height: normal; margin-bottom: 0px; margin-left: 0px; margin-right: 0px; margin-top: 0px; padding-bottom: 8px; padding-left: 0px; padding-right: 0px; padding-top: 0px; text-align: center;">
<strong>1441 Quivira Road </strong></div>
<div style="font-family: 'Helvetica Neue', Helvetica, Arial, sans-serif; font-size: 13px; font: normal normal normal 20px/normal Calibri; line-height: normal; margin-bottom: 0px; margin-left: 0px; margin-right: 0px; margin-top: 0px; padding-bottom: 8px; padding-left: 0px; padding-right: 0px; padding-top: 0px; text-align: center;">
<strong>San Diego, CA 92109 </strong></div>
<div style="font-family: 'Helvetica Neue', Helvetica, Arial, sans-serif; font-size: 13px; font: normal normal normal 18px/normal Calibri; line-height: normal; margin-bottom: 0px; margin-left: 0px; margin-right: 0px; margin-top: 0px; padding-bottom: 8px; padding-left: 0px; padding-right: 0px; padding-top: 0px; text-align: center;">
<strong>Cost: $50.00 in advance, </strong></div>
<div style="font-family: 'Helvetica Neue', Helvetica, Arial, sans-serif; font-size: 13px; font: normal normal normal 18px/normal Calibri; line-height: normal; margin-bottom: 0px; margin-left: 0px; margin-right: 0px; margin-top: 0px; padding-bottom: 8px; padding-left: 0px; padding-right: 0px; padding-top: 0px; text-align: center;">
<strong>$60 after 12:00 p.m. April 12 and at the door. </strong></div>
<div style="font-family: 'Helvetica Neue', Helvetica, Arial, sans-serif; font-size: 13px; font: normal normal normal 18px/normal Calibri; line-height: normal; margin-bottom: 0px; margin-left: 0px; margin-right: 0px; margin-top: 0px; padding-bottom: 8px; padding-left: 0px; padding-right: 0px; padding-top: 0px;">
<b><br /></b>
<b>Register at <a href="http://successdrugdev.eventbrite.com/">http://successdrugdev.eventbrite.com/</a></b><br />
<b><br /></b></div>
<div style="font-family: 'Helvetica Neue', Helvetica, Arial, sans-serif; font-size: 13px; font: normal normal normal 18px/normal Calibri; line-height: normal; margin-bottom: 0px; margin-left: 0px; margin-right: 0px; margin-top: 0px; padding-bottom: 8px; padding-left: 0px; padding-right: 0px; padding-top: 0px; text-align: center;">
<span style="font-size: large; text-decoration: underline;"><strong>Preliminary Agenda</strong></span></div>
<div style="font-family: 'Helvetica Neue', Helvetica, Arial, sans-serif; font-size: 13px; font: normal normal normal 11.5px/normal Calibri; line-height: normal; margin-bottom: 0px; margin-left: 0px; margin-right: 0px; margin-top: 0px; padding-bottom: 8px; padding-left: 0px; padding-right: 0px; padding-top: 0px;">
<strong>5:00 – 6:00 Registration, Exhibitors, Networking, and Appetizers </strong></div>
<div style="font-family: 'Helvetica Neue', Helvetica, Arial, sans-serif; font-size: 13px; font: normal normal normal 11.5px/normal Calibri; line-height: normal; margin-bottom: 0px; margin-left: 0px; margin-right: 0px; margin-top: 0px; padding-bottom: 8px; padding-left: 0px; padding-right: 0px; padding-top: 0px;">
<strong>6:00 – 6:15 Welcome and Introduction, William Stevens, Ph.D. of Business Development Connections LLC </strong></div>
<div style="font-family: 'Helvetica Neue', Helvetica, Arial, sans-serif; font-size: 13px; font: normal normal normal 11.5px/normal Calibri; line-height: normal; margin-bottom: 0px; margin-left: 0px; margin-right: 0px; margin-top: 0px; padding-bottom: 8px; padding-left: 0px; padding-right: 0px; padding-top: 0px;">
<strong>6:15 – 6:35 “Chemistry Outsourcing – Avoiding Problems and Maximizing Benefits” </strong><strong>Presented by Daniel Levy, Ph.D. of DEL BioPharma </strong></div>
<div style="font-family: 'Helvetica Neue', Helvetica, Arial, sans-serif; font-size: 13px; font: normal normal normal 18px/normal Calibri; line-height: normal; margin-bottom: 0px; margin-left: 0px; margin-right: 0px; margin-top: 0px; padding-bottom: 8px; padding-left: 0px; padding-right: 0px; padding-top: 0px; text-align: left;">
<img alt="DanLevy" height="200" src="https://evbdn.eventbrite.com/s3-s3/eventlogos/2464635/danlevysdbdcd4.jpg" width="150" /></div>
<div style="font-family: 'Helvetica Neue', Helvetica, Arial, sans-serif; font-size: 13px; font: normal normal normal 11.5px/normal Calibri; line-height: normal; margin-bottom: 0px; margin-left: 0px; margin-right: 0px; margin-top: 0px; padding-bottom: 8px; padding-left: 0px; padding-right: 0px; padding-top: 0px;">
“Dr. Levy's presentation will focus on current chemistry outsourcing trends, challenges and strategies for success. The goal is to address issues applicable to both early stage medicinal chemistry efforts as well as scale- up and manufacturing.” </div>
<div style="font-family: 'Helvetica Neue', Helvetica, Arial, sans-serif; font-size: 13px; font: normal normal normal 11.5px/normal Calibri; line-height: normal; margin-bottom: 0px; margin-left: 0px; margin-right: 0px; margin-top: 0px; padding-bottom: 8px; padding-left: 0px; padding-right: 0px; padding-top: 0px;">
Dr. Levy is an experienced organic/medicinal chemist having led the design of novel therapeutic agents targeting cardiovascular disease, cancer and inflammatory disorders. He has broad experience in the chemistry of amino acids/peptides, sugars/carbohydrates, heterocycles, polyethylene glycols and lipids as documented in almost 30 peer reviewed publications and over 11 issued/published United States patents. Dr. Levy held positions at Glycomed, COR Therapeutics, Scios and Intradigm Corporation. As a consultant, Dr. Levy provides medicinal chemistry and manufacturing services to companies interested in small molecule drug discovery/development. Set-up and management of chemistry outsourcing is a key service supporting these sectors. In addition, he provides technical due diligence services, facilitates IP development and supports the filing of grant applications. Dr. Levy received his Ph.D. in organic chemistry from the Massachusetts Institute of Technology and his B.S. in chemistry from the University of California - Berkeley. </div>
<div style="font-family: 'Helvetica Neue', Helvetica, Arial, sans-serif; font-size: 13px; font: normal normal normal 18px/normal Calibri; line-height: normal; margin-bottom: 0px; margin-left: 0px; margin-right: 0px; margin-top: 0px; padding-bottom: 8px; padding-left: 0px; padding-right: 0px; padding-top: 0px; text-align: center;">
<a href="http://www.delbiopharma.com/" style="color: #ee6600; text-decoration: none;"><img alt="DEL BioPharma" height="120" src="https://evbdn.eventbrite.com/s3-s3/eventlogos/2464635/delbiopharmasdbdcd4.jpg" width="294" /></a></div>
<div style="font-family: 'Helvetica Neue', Helvetica, Arial, sans-serif; font-size: 13px; font: normal normal normal 18px/normal Calibri; line-height: normal; margin-bottom: 0px; margin-left: 0px; margin-right: 0px; margin-top: 0px; padding-bottom: 8px; padding-left: 0px; padding-right: 0px; padding-top: 0px; text-align: center;">
<br /></div>
<div style="font-family: 'Helvetica Neue', Helvetica, Arial, sans-serif; font-size: 13px; font: normal normal normal 11.5px/normal Calibri; line-height: normal; margin-bottom: 0px; margin-left: 0px; margin-right: 0px; margin-top: 0px; padding-bottom: 8px; padding-left: 0px; padding-right: 0px; padding-top: 0px;">
<strong>6:35 – 6:55 "<em>Regulatory & Quality Challenges of Virtual Drug Development – “Or How to Avoid Getting in Bed With the Devil” Presented by Michael A. Swit, Esq. of Duane Morris, LLP</em></strong></div>
<div style="font-family: 'Helvetica Neue', Helvetica, Arial, sans-serif; font-size: 13px; font: normal normal normal 11.5px/normal Calibri; line-height: normal; margin-bottom: 0px; margin-left: 0px; margin-right: 0px; margin-top: 0px; padding-bottom: 8px; padding-left: 0px; padding-right: 0px; padding-top: 0px;">
<img alt="MichaelSwit" height="139" src="https://evbdn.eventbrite.com/s3-s3/eventlogos/2464635/michaelswitsdbdcd4.jpg" width="115" /></div>
<div style="font-family: 'Helvetica Neue', Helvetica, Arial, sans-serif; font-size: 13px; font: normal normal normal 11.5px/normal Calibri; line-height: normal; margin-bottom: 0px; margin-left: 0px; margin-right: 0px; margin-top: 0px; padding-bottom: 8px; padding-left: 0px; padding-right: 0px; padding-top: 0px;">
Virtual drug development, while providing many key advantages, presents major challenges for the drug sponsor in selecting and overseeing the vital work that the sponsor outsources. While some issues can be addressed via contract language, savvy sponsors exercise great care in selecting and overseeing their virtual suppliers/contractors. This session will identify key FDA regulatory and quality concerns involved in virtual drug development and how to tackle those challenges to maximize the potential for success. Michael A. Swit, Esq., is a Special Counsel in the San Diego office of the international law firm, Duane Morris, LLP, where he focuses his practice on solving FDA legal challenges faced by highly-regulated pharmaceutical and medical device companies. Before joining Duane Morris in March 2012, Swit served for seven years as a vice president at The Weinberg Group Inc., a preeminent scientific and regulatory consulting firm in the Life Sciences. His expertise includes product development, compliance and enforcement, recalls and crisis management, submissions and related traditional FDA regulatory activities, labeling and advertising, and clinical research efforts for all types of life sciences companies, with a particular emphasis on drugs, biologics and therapeutic biotech products. Mr. Swit has been addressing vital FDA legal and regulatory issues since 1984, both in private practice with McKenna & Cuneo and Heller Ehrman, and as vice president, general counsel and secretary of Par Pharmaceutical, a top public generic and specialty drug firm. He also was, from 1994 to 1998, CEO of <span style="color: blue;">FDANews.com</span>, a premier publisher of regulatory newsletters and other specialty information products for FDA-regulated firms. He has taught and written on many topics relating to FDA regulation and associated commercial activities and is a past member of the Food & Drug Law Journal Editorial Board. He earned his A.B., <em>magna cum laude</em>, with high honors in history, at Bowdoin College, and his law degree at Emory University. </div>
<div style="font-family: 'Helvetica Neue', Helvetica, Arial, sans-serif; font-size: 13px; font: normal normal normal 11.5px/normal Calibri; line-height: normal; margin-bottom: 0px; margin-left: 0px; margin-right: 0px; margin-top: 0px; padding-bottom: 8px; padding-left: 0px; padding-right: 0px; padding-top: 0px; text-align: center;">
<a href="http://www.duanemorris.com/" style="color: #ee6600; text-decoration: none;"><strong><img alt="DuaneMorris" height="43" src="https://evbdn.eventbrite.com/s3-s3/eventlogos/2464635/logobdcduanemorris.jpg" width="283" /></strong></a></div>
<div style="font-family: 'Helvetica Neue', Helvetica, Arial, sans-serif; font-size: 13px; font: normal normal normal 11.5px/normal Calibri; line-height: normal; margin-bottom: 0px; margin-left: 0px; margin-right: 0px; margin-top: 0px; padding-bottom: 8px; padding-left: 0px; padding-right: 0px; padding-top: 0px;">
<strong><br /></strong></div>
<div style="font-family: 'Helvetica Neue', Helvetica, Arial, sans-serif; font-size: 13px; font: normal normal normal 11.5px/normal Calibri; line-height: normal; margin-bottom: 0px; margin-left: 0px; margin-right: 0px; margin-top: 0px; padding-bottom: 8px; padding-left: 0px; padding-right: 0px; padding-top: 0px;">
<strong>7:00 - 7:15 Break</strong></div>
<div style="font-family: 'Helvetica Neue', Helvetica, Arial, sans-serif; font-size: 13px; font: normal normal normal 11.5px/normal Calibri; line-height: normal; margin-bottom: 0px; margin-left: 0px; margin-right: 0px; margin-top: 0px; padding-bottom: 8px; padding-left: 0px; padding-right: 0px; padding-top: 0px;">
<strong><br /></strong></div>
<div style="font-family: 'Helvetica Neue', Helvetica, Arial, sans-serif; font-size: 13px; font: normal normal normal 11.5px/normal Calibri; line-height: normal; margin-bottom: 0px; margin-left: 0px; margin-right: 0px; margin-top: 0px; padding-bottom: 8px; padding-left: 0px; padding-right: 0px; padding-top: 0px;">
<strong>7:15 - 7:35 “Personalized Medicine in Clinical Development: Phenotyping, Patient Stratification and Tailored Therapy Based on Drug Pharmacology and metabolism in Target Tissue using Accellerator Mass Spectrometry” – resented by Gary Jones, M.D.; Co-Founder and Director of Clinical Development for C3 Research </strong></div>
<div style="font-family: 'Helvetica Neue', Helvetica, Arial, sans-serif; font-size: 13px; font: normal normal normal 11.5px/normal Calibri; line-height: normal; margin-bottom: 0px; margin-left: 0px; margin-right: 0px; margin-top: 0px; padding-bottom: 8px; padding-left: 0px; padding-right: 0px; padding-top: 0px;">
<img alt="GaryJones" height="174" src="https://evbdn.eventbrite.com/s3-s3/eventlogos/2464635/garyjonessdbdcd4.jpg" width="141" /></div>
<div style="font-family: 'Helvetica Neue', Helvetica, Arial, sans-serif; font-size: 13px; font: normal normal normal 11.5px/normal Calibri; line-height: normal; margin-bottom: 0px; margin-left: 0px; margin-right: 0px; margin-top: 0px; padding-bottom: 8px; padding-left: 0px; padding-right: 0px; padding-top: 0px;">
This presentation will propose a rational approach of clinical trial enrollment based on pre-trial study to evaluate drug pharmacology and uptake by target organ or tumor. Patients are administered a tracer dose of treatment drug lightly labeled with 14C to permit detection by accelerator mass spectrometry (AMS). The dose may be reduced to <100 a="" addressing="" affect="" allow="" and="" approach="" are="" as="" assessment="" based="" be="" biology="" by="" complex="" diseases="" drug="" each="" effect="" eliminate="" empirical="" enrollment="" environmental="" especially="" excluded="" from="" gene="" high="" in="" influenced="" kinetics="" larger="" longer="" low="" may="" micrograms="" modulators.="" nbsp="" networks="" of="" on="" ones="" or="" outcome="" p="" pathways="" patient="" patients="" personalized="" pharmaco-phenotyping="" pharmacologic="" pharmacology.="" pharmacology="" phase="" poor="" positive="" range="" responders="" showing="" stratified="" study.="" successful="" systems="" target="" the="" then="" this="" tissue="" to="" tracer="" trial.="" tumor="" uptake.="" uptake="" versus="" wider="" yet=""></100><br />
<div style="font-family: 'Helvetica Neue', Helvetica, Arial, sans-serif; font-size: 13px; font: normal normal normal 11.5px/normal Calibri; line-height: normal; margin-bottom: 0px; margin-left: 0px; margin-right: 0px; margin-top: 0px; padding-bottom: 8px; padding-left: 0px; padding-right: 0px; padding-top: 0px;">
As Director of Clinical Development, Gary uses his 20 years of experience and expertise, accumulated through his careers in academia, medical care, and clinical research, to enjoy direct involvement in the clinical development of both medical devices and therapeutics. He received his M.D. at the Oregon Health Sciences University had has had academic appointments at University of North Carolina and OHSU. </div>
<div style="font-family: 'Helvetica Neue', Helvetica, Arial, sans-serif; font-size: 13px; font: normal normal normal 11.5px/normal Calibri; line-height: normal; margin-bottom: 0px; margin-left: 0px; margin-right: 0px; margin-top: 0px; padding-bottom: 8px; padding-left: 0px; padding-right: 0px; padding-top: 0px;">
Especially interested in <em>“pushing the boundaries of the box” </em>of clinical development in oncology, he is directly involved in the aspects of both development and running of clinical trials, medical monitoring, interpreting results and moving aspects of data forward in a practical way to bring therapeutics to the market that help people with critical needs in any area of medicine. </div>
<div style="font-family: 'Helvetica Neue', Helvetica, Arial, sans-serif; font-size: 13px; font: normal normal normal 11.5px/normal Calibri; line-height: normal; margin-bottom: 0px; margin-left: 0px; margin-right: 0px; margin-top: 0px; padding-bottom: 8px; padding-left: 0px; padding-right: 0px; padding-top: 0px; text-align: center;">
<a href="http://www.c3-research.com/" style="color: #ee6600; text-decoration: none;"><img alt="C3Research" height="83" src="https://evbdn.eventbrite.com/s3-s3/eventlogos/2464635/c3researchsdbdcd4.jpg" width="205" /></a></div>
<div style="font-family: 'Helvetica Neue', Helvetica, Arial, sans-serif; font-size: 13px; font: normal normal normal 11.5px/normal Calibri; line-height: normal; margin-bottom: 0px; margin-left: 0px; margin-right: 0px; margin-top: 0px; padding-bottom: 8px; padding-left: 0px; padding-right: 0px; padding-top: 0px; text-align: center;">
<br /></div>
<div style="font-family: 'Helvetica Neue', Helvetica, Arial, sans-serif; font-size: 13px; font: normal normal normal 11.5px/normal Calibri; line-height: normal; margin-bottom: 0px; margin-left: 0px; margin-right: 0px; margin-top: 0px; padding-bottom: 8px; padding-left: 0px; padding-right: 0px; padding-top: 0px;">
<strong>7:35- 8:00 “Technology Transfer – Using a Gated Approach in Early and Late Stage Transfers” Presented by Laura Cribbins, MBA, PHP of the ProPharma Group </strong></div>
<div style="font-family: 'Helvetica Neue', Helvetica, Arial, sans-serif; font-size: 13px; font: normal normal normal 11.5px/normal Calibri; line-height: normal; margin-bottom: 0px; margin-left: 0px; margin-right: 0px; margin-top: 0px; padding-bottom: 8px; padding-left: 0px; padding-right: 0px; padding-top: 0px;">
<img alt="LauraCribbins" height="137" src="https://evbdn.eventbrite.com/s3-s3/eventlogos/2464635/lauracribbinssdbdcd4.jpg" width="111" /></div>
<div style="font-family: 'Helvetica Neue', Helvetica, Arial, sans-serif; font-size: 13px; font: normal normal normal 11.5px/normal Calibri; line-height: normal; margin-bottom: 0px; margin-left: 0px; margin-right: 0px; margin-top: 0px; padding-bottom: 8px; padding-left: 0px; padding-right: 0px; padding-top: 0px;">
This presentation provides detail on how to plan and conduct a successful Pharmaceutical technology transfer using a stage gate approach to the transfer. Examples of actual international transfers will be used to demonstrate the governance structure and tools used to perform a compliant transfer in a high performance team. </div>
<div style="font-family: 'Helvetica Neue', Helvetica, Arial, sans-serif; font-size: 13px; font: normal normal normal 11.5px/normal Calibri; line-height: normal; margin-bottom: 0px; margin-left: 0px; margin-right: 0px; margin-top: 0px; padding-bottom: 8px; padding-left: 0px; padding-right: 0px; padding-top: 0px;">
Laura is Director of Program Management for the ProPharma Groups. Laura is a certified Project Management Professional (PMP). She has spoken on the use of a stage gated approach to Technology Transfer at professional meetings including, DIA Annual Meeting, ISPE, BioPharmaPM, and PMI, and regularly provides training and seminars to clients on the topic of Technology Transfer and Project Management. </div>
<div style="font-family: 'Helvetica Neue', Helvetica, Arial, sans-serif; font-size: 13px; font: normal normal normal 11.5px/normal Calibri; line-height: normal; margin-bottom: 0px; margin-left: 0px; margin-right: 0px; margin-top: 0px; padding-bottom: 8px; padding-left: 0px; padding-right: 0px; padding-top: 0px;">
Laura worked as a Validation contractor where she managed a multitude of domestic and international teams. The team’s validation work was frequently reviewed during inspections by the FDA and other international government agencies. </div>
<div style="font-family: 'Helvetica Neue', Helvetica, Arial, sans-serif; font-size: 13px; font: normal normal normal 11.5px/normal Calibri; line-height: normal; margin-bottom: 0px; margin-left: 0px; margin-right: 0px; margin-top: 0px; padding-bottom: 8px; padding-left: 0px; padding-right: 0px; padding-top: 0px;">
Prior to ProPharma, she worked as an Analytical Chemist, Laura and was trained in quality and assay development. She then moved into the development and manufacturing arena as a Process Engineer. She held positions in Manufacturing in Pharmaceutical and Medical Device companies prior to her work in direct Marketing Research developing new products for manufacturing and testing materials in a GMP environment. </div>
<div style="font-family: 'Helvetica Neue', Helvetica, Arial, sans-serif; font-size: 13px; font: normal normal normal 11.5px/normal Calibri; line-height: normal; margin-bottom: 0px; margin-left: 0px; margin-right: 0px; margin-top: 0px; padding-bottom: 8px; padding-left: 0px; padding-right: 0px; padding-top: 0px; text-align: center;">
<a href="http://www.propharmagroup.com/" style="color: #ee6600; text-decoration: none;"><img alt="ProPharma" height="132" src="https://evbdn.eventbrite.com/s3-s3/eventlogos/2464635/propharmagroupsdbdcd4.jpg" width="220" /></a></div>
<div style="font-family: 'Helvetica Neue', Helvetica, Arial, sans-serif; font-size: 13px; font: normal normal normal 11.5px/normal Calibri; line-height: normal; margin-bottom: 0px; margin-left: 0px; margin-right: 0px; margin-top: 0px; padding-bottom: 8px; padding-left: 0px; padding-right: 0px; padding-top: 0px;">
<strong>8:00-9:00 Exhibitors, Networking, Wine and Cheese </strong></div>
<!--100--></div>
Daniel E. Levyhttp://www.blogger.com/profile/05609535387028309791noreply@blogger.com9tag:blogger.com,1999:blog-371148246405005788.post-74277019561870062162012-10-14T22:04:00.001-07:002012-10-14T22:04:59.326-07:00Strategies for Success in Virtual Drug Development from Discovery to Clinic
<!--[if gte mso 9]><xml>
<o:OfficeDocumentSettings>
<o:PixelsPerInch>96</o:PixelsPerInch>
<o:TargetScreenSize>800x600</o:TargetScreenSize>
</o:OfficeDocumentSettings>
</xml><![endif]-->
<!--[if gte mso 9]><xml>
<w:WordDocument>
<w:View>Normal</w:View>
<w:Zoom>0</w:Zoom>
<w:TrackMoves/>
<w:TrackFormatting/>
<w:PunctuationKerning/>
<w:ValidateAgainstSchemas/>
<w:SaveIfXMLInvalid>false</w:SaveIfXMLInvalid>
<w:IgnoreMixedContent>false</w:IgnoreMixedContent>
<w:AlwaysShowPlaceholderText>false</w:AlwaysShowPlaceholderText>
<w:DoNotPromoteQF/>
<w:LidThemeOther>EN-US</w:LidThemeOther>
<w:LidThemeAsian>JA</w:LidThemeAsian>
<w:LidThemeComplexScript>X-NONE</w:LidThemeComplexScript>
<w:Compatibility>
<w:BreakWrappedTables/>
<w:SnapToGridInCell/>
<w:WrapTextWithPunct/>
<w:UseAsianBreakRules/>
<w:DontGrowAutofit/>
<w:SplitPgBreakAndParaMark/>
<w:EnableOpenTypeKerning/>
<w:DontFlipMirrorIndents/>
<w:OverrideTableStyleHps/>
</w:Compatibility>
<m:mathPr>
<m:mathFont m:val="Cambria Math"/>
<m:brkBin m:val="before"/>
<m:brkBinSub m:val="--"/>
<m:smallFrac m:val="off"/>
<m:dispDef/>
<m:lMargin m:val="0"/>
<m:rMargin m:val="0"/>
<m:defJc m:val="centerGroup"/>
<m:wrapIndent m:val="1440"/>
<m:intLim m:val="subSup"/>
<m:naryLim m:val="undOvr"/>
</m:mathPr></w:WordDocument>
</xml><![endif]--><!--[if gte mso 9]><xml>
<w:LatentStyles DefLockedState="false" DefUnhideWhenUsed="true"
DefSemiHidden="true" DefQFormat="false" DefPriority="99"
LatentStyleCount="276">
<w:LsdException Locked="false" Priority="0" SemiHidden="false"
UnhideWhenUsed="false" QFormat="true" Name="Normal"/>
<w:LsdException Locked="false" Priority="9" SemiHidden="false"
UnhideWhenUsed="false" QFormat="true" Name="heading 1"/>
<w:LsdException Locked="false" Priority="9" QFormat="true" Name="heading 2"/>
<w:LsdException Locked="false" Priority="9" QFormat="true" Name="heading 3"/>
<w:LsdException Locked="false" Priority="9" QFormat="true" Name="heading 4"/>
<w:LsdException Locked="false" Priority="9" QFormat="true" Name="heading 5"/>
<w:LsdException Locked="false" Priority="9" QFormat="true" Name="heading 6"/>
<w:LsdException Locked="false" Priority="9" QFormat="true" Name="heading 7"/>
<w:LsdException Locked="false" Priority="9" QFormat="true" Name="heading 8"/>
<w:LsdException Locked="false" Priority="9" QFormat="true" Name="heading 9"/>
<w:LsdException Locked="false" Priority="39" Name="toc 1"/>
<w:LsdException Locked="false" Priority="39" Name="toc 2"/>
<w:LsdException Locked="false" Priority="39" Name="toc 3"/>
<w:LsdException Locked="false" Priority="39" Name="toc 4"/>
<w:LsdException Locked="false" Priority="39" Name="toc 5"/>
<w:LsdException Locked="false" Priority="39" Name="toc 6"/>
<w:LsdException Locked="false" Priority="39" Name="toc 7"/>
<w:LsdException Locked="false" Priority="39" Name="toc 8"/>
<w:LsdException Locked="false" Priority="39" Name="toc 9"/>
<w:LsdException Locked="false" Priority="35" QFormat="true" Name="caption"/>
<w:LsdException Locked="false" Priority="10" SemiHidden="false"
UnhideWhenUsed="false" QFormat="true" Name="Title"/>
<w:LsdException Locked="false" Priority="1" Name="Default Paragraph Font"/>
<w:LsdException Locked="false" Priority="11" SemiHidden="false"
UnhideWhenUsed="false" QFormat="true" Name="Subtitle"/>
<w:LsdException Locked="false" Priority="22" SemiHidden="false"
UnhideWhenUsed="false" QFormat="true" Name="Strong"/>
<w:LsdException Locked="false" Priority="20" SemiHidden="false"
UnhideWhenUsed="false" QFormat="true" Name="Emphasis"/>
<w:LsdException Locked="false" Priority="59" SemiHidden="false"
UnhideWhenUsed="false" Name="Table Grid"/>
<w:LsdException Locked="false" UnhideWhenUsed="false" Name="Placeholder Text"/>
<w:LsdException Locked="false" Priority="1" SemiHidden="false"
UnhideWhenUsed="false" QFormat="true" Name="No Spacing"/>
<w:LsdException Locked="false" Priority="60" SemiHidden="false"
UnhideWhenUsed="false" Name="Light Shading"/>
<w:LsdException Locked="false" Priority="61" SemiHidden="false"
UnhideWhenUsed="false" Name="Light List"/>
<w:LsdException Locked="false" Priority="62" SemiHidden="false"
UnhideWhenUsed="false" Name="Light Grid"/>
<w:LsdException Locked="false" Priority="63" SemiHidden="false"
UnhideWhenUsed="false" Name="Medium Shading 1"/>
<w:LsdException Locked="false" Priority="64" SemiHidden="false"
UnhideWhenUsed="false" Name="Medium Shading 2"/>
<w:LsdException Locked="false" Priority="65" SemiHidden="false"
UnhideWhenUsed="false" Name="Medium List 1"/>
<w:LsdException Locked="false" Priority="66" SemiHidden="false"
UnhideWhenUsed="false" Name="Medium List 2"/>
<w:LsdException Locked="false" Priority="67" SemiHidden="false"
UnhideWhenUsed="false" Name="Medium Grid 1"/>
<w:LsdException Locked="false" Priority="68" SemiHidden="false"
UnhideWhenUsed="false" Name="Medium Grid 2"/>
<w:LsdException Locked="false" Priority="69" SemiHidden="false"
UnhideWhenUsed="false" Name="Medium Grid 3"/>
<w:LsdException Locked="false" Priority="70" SemiHidden="false"
UnhideWhenUsed="false" Name="Dark List"/>
<w:LsdException Locked="false" Priority="71" SemiHidden="false"
UnhideWhenUsed="false" Name="Colorful Shading"/>
<w:LsdException Locked="false" Priority="72" SemiHidden="false"
UnhideWhenUsed="false" Name="Colorful List"/>
<w:LsdException Locked="false" Priority="73" SemiHidden="false"
UnhideWhenUsed="false" Name="Colorful Grid"/>
<w:LsdException Locked="false" Priority="60" SemiHidden="false"
UnhideWhenUsed="false" Name="Light Shading Accent 1"/>
<w:LsdException Locked="false" Priority="61" SemiHidden="false"
UnhideWhenUsed="false" Name="Light List Accent 1"/>
<w:LsdException Locked="false" Priority="62" SemiHidden="false"
UnhideWhenUsed="false" Name="Light Grid Accent 1"/>
<w:LsdException Locked="false" Priority="63" SemiHidden="false"
UnhideWhenUsed="false" Name="Medium Shading 1 Accent 1"/>
<w:LsdException Locked="false" Priority="64" SemiHidden="false"
UnhideWhenUsed="false" Name="Medium Shading 2 Accent 1"/>
<w:LsdException Locked="false" Priority="65" SemiHidden="false"
UnhideWhenUsed="false" Name="Medium List 1 Accent 1"/>
<w:LsdException Locked="false" UnhideWhenUsed="false" Name="Revision"/>
<w:LsdException Locked="false" Priority="34" SemiHidden="false"
UnhideWhenUsed="false" QFormat="true" Name="List Paragraph"/>
<w:LsdException Locked="false" Priority="29" SemiHidden="false"
UnhideWhenUsed="false" QFormat="true" Name="Quote"/>
<w:LsdException Locked="false" Priority="30" SemiHidden="false"
UnhideWhenUsed="false" QFormat="true" Name="Intense Quote"/>
<w:LsdException Locked="false" Priority="66" SemiHidden="false"
UnhideWhenUsed="false" Name="Medium List 2 Accent 1"/>
<w:LsdException Locked="false" Priority="67" SemiHidden="false"
UnhideWhenUsed="false" Name="Medium Grid 1 Accent 1"/>
<w:LsdException Locked="false" Priority="68" SemiHidden="false"
UnhideWhenUsed="false" Name="Medium Grid 2 Accent 1"/>
<w:LsdException Locked="false" Priority="69" SemiHidden="false"
UnhideWhenUsed="false" Name="Medium Grid 3 Accent 1"/>
<w:LsdException Locked="false" Priority="70" SemiHidden="false"
UnhideWhenUsed="false" Name="Dark List Accent 1"/>
<w:LsdException Locked="false" Priority="71" SemiHidden="false"
UnhideWhenUsed="false" Name="Colorful Shading Accent 1"/>
<w:LsdException Locked="false" Priority="72" SemiHidden="false"
UnhideWhenUsed="false" Name="Colorful List Accent 1"/>
<w:LsdException Locked="false" Priority="73" SemiHidden="false"
UnhideWhenUsed="false" Name="Colorful Grid Accent 1"/>
<w:LsdException Locked="false" Priority="60" SemiHidden="false"
UnhideWhenUsed="false" Name="Light Shading Accent 2"/>
<w:LsdException Locked="false" Priority="61" SemiHidden="false"
UnhideWhenUsed="false" Name="Light List Accent 2"/>
<w:LsdException Locked="false" Priority="62" SemiHidden="false"
UnhideWhenUsed="false" Name="Light Grid Accent 2"/>
<w:LsdException Locked="false" Priority="63" SemiHidden="false"
UnhideWhenUsed="false" Name="Medium Shading 1 Accent 2"/>
<w:LsdException Locked="false" Priority="64" SemiHidden="false"
UnhideWhenUsed="false" Name="Medium Shading 2 Accent 2"/>
<w:LsdException Locked="false" Priority="65" SemiHidden="false"
UnhideWhenUsed="false" Name="Medium List 1 Accent 2"/>
<w:LsdException Locked="false" Priority="66" SemiHidden="false"
UnhideWhenUsed="false" Name="Medium List 2 Accent 2"/>
<w:LsdException Locked="false" Priority="67" SemiHidden="false"
UnhideWhenUsed="false" Name="Medium Grid 1 Accent 2"/>
<w:LsdException Locked="false" Priority="68" SemiHidden="false"
UnhideWhenUsed="false" Name="Medium Grid 2 Accent 2"/>
<w:LsdException Locked="false" Priority="69" SemiHidden="false"
UnhideWhenUsed="false" Name="Medium Grid 3 Accent 2"/>
<w:LsdException Locked="false" Priority="70" SemiHidden="false"
UnhideWhenUsed="false" Name="Dark List Accent 2"/>
<w:LsdException Locked="false" Priority="71" SemiHidden="false"
UnhideWhenUsed="false" Name="Colorful Shading Accent 2"/>
<w:LsdException Locked="false" Priority="72" SemiHidden="false"
UnhideWhenUsed="false" Name="Colorful List Accent 2"/>
<w:LsdException Locked="false" Priority="73" SemiHidden="false"
UnhideWhenUsed="false" Name="Colorful Grid Accent 2"/>
<w:LsdException Locked="false" Priority="60" SemiHidden="false"
UnhideWhenUsed="false" Name="Light Shading Accent 3"/>
<w:LsdException Locked="false" Priority="61" SemiHidden="false"
UnhideWhenUsed="false" Name="Light List Accent 3"/>
<w:LsdException Locked="false" Priority="62" SemiHidden="false"
UnhideWhenUsed="false" Name="Light Grid Accent 3"/>
<w:LsdException Locked="false" Priority="63" SemiHidden="false"
UnhideWhenUsed="false" Name="Medium Shading 1 Accent 3"/>
<w:LsdException Locked="false" Priority="64" SemiHidden="false"
UnhideWhenUsed="false" Name="Medium Shading 2 Accent 3"/>
<w:LsdException Locked="false" Priority="65" SemiHidden="false"
UnhideWhenUsed="false" Name="Medium List 1 Accent 3"/>
<w:LsdException Locked="false" Priority="66" SemiHidden="false"
UnhideWhenUsed="false" Name="Medium List 2 Accent 3"/>
<w:LsdException Locked="false" Priority="67" SemiHidden="false"
UnhideWhenUsed="false" Name="Medium Grid 1 Accent 3"/>
<w:LsdException Locked="false" Priority="68" SemiHidden="false"
UnhideWhenUsed="false" Name="Medium Grid 2 Accent 3"/>
<w:LsdException Locked="false" Priority="69" SemiHidden="false"
UnhideWhenUsed="false" Name="Medium Grid 3 Accent 3"/>
<w:LsdException Locked="false" Priority="70" SemiHidden="false"
UnhideWhenUsed="false" Name="Dark List Accent 3"/>
<w:LsdException Locked="false" Priority="71" SemiHidden="false"
UnhideWhenUsed="false" Name="Colorful Shading Accent 3"/>
<w:LsdException Locked="false" Priority="72" SemiHidden="false"
UnhideWhenUsed="false" Name="Colorful List Accent 3"/>
<w:LsdException Locked="false" Priority="73" SemiHidden="false"
UnhideWhenUsed="false" Name="Colorful Grid Accent 3"/>
<w:LsdException Locked="false" Priority="60" SemiHidden="false"
UnhideWhenUsed="false" Name="Light Shading Accent 4"/>
<w:LsdException Locked="false" Priority="61" SemiHidden="false"
UnhideWhenUsed="false" Name="Light List Accent 4"/>
<w:LsdException Locked="false" Priority="62" SemiHidden="false"
UnhideWhenUsed="false" Name="Light Grid Accent 4"/>
<w:LsdException Locked="false" Priority="63" SemiHidden="false"
UnhideWhenUsed="false" Name="Medium Shading 1 Accent 4"/>
<w:LsdException Locked="false" Priority="64" SemiHidden="false"
UnhideWhenUsed="false" Name="Medium Shading 2 Accent 4"/>
<w:LsdException Locked="false" Priority="65" SemiHidden="false"
UnhideWhenUsed="false" Name="Medium List 1 Accent 4"/>
<w:LsdException Locked="false" Priority="66" SemiHidden="false"
UnhideWhenUsed="false" Name="Medium List 2 Accent 4"/>
<w:LsdException Locked="false" Priority="67" SemiHidden="false"
UnhideWhenUsed="false" Name="Medium Grid 1 Accent 4"/>
<w:LsdException Locked="false" Priority="68" SemiHidden="false"
UnhideWhenUsed="false" Name="Medium Grid 2 Accent 4"/>
<w:LsdException Locked="false" Priority="69" SemiHidden="false"
UnhideWhenUsed="false" Name="Medium Grid 3 Accent 4"/>
<w:LsdException Locked="false" Priority="70" SemiHidden="false"
UnhideWhenUsed="false" Name="Dark List Accent 4"/>
<w:LsdException Locked="false" Priority="71" SemiHidden="false"
UnhideWhenUsed="false" Name="Colorful Shading Accent 4"/>
<w:LsdException Locked="false" Priority="72" SemiHidden="false"
UnhideWhenUsed="false" Name="Colorful List Accent 4"/>
<w:LsdException Locked="false" Priority="73" SemiHidden="false"
UnhideWhenUsed="false" Name="Colorful Grid Accent 4"/>
<w:LsdException Locked="false" Priority="60" SemiHidden="false"
UnhideWhenUsed="false" Name="Light Shading Accent 5"/>
<w:LsdException Locked="false" Priority="61" SemiHidden="false"
UnhideWhenUsed="false" Name="Light List Accent 5"/>
<w:LsdException Locked="false" Priority="62" SemiHidden="false"
UnhideWhenUsed="false" Name="Light Grid Accent 5"/>
<w:LsdException Locked="false" Priority="63" SemiHidden="false"
UnhideWhenUsed="false" Name="Medium Shading 1 Accent 5"/>
<w:LsdException Locked="false" Priority="64" SemiHidden="false"
UnhideWhenUsed="false" Name="Medium Shading 2 Accent 5"/>
<w:LsdException Locked="false" Priority="65" SemiHidden="false"
UnhideWhenUsed="false" Name="Medium List 1 Accent 5"/>
<w:LsdException Locked="false" Priority="66" SemiHidden="false"
UnhideWhenUsed="false" Name="Medium List 2 Accent 5"/>
<w:LsdException Locked="false" Priority="67" SemiHidden="false"
UnhideWhenUsed="false" Name="Medium Grid 1 Accent 5"/>
<w:LsdException Locked="false" Priority="68" SemiHidden="false"
UnhideWhenUsed="false" Name="Medium Grid 2 Accent 5"/>
<w:LsdException Locked="false" Priority="69" SemiHidden="false"
UnhideWhenUsed="false" Name="Medium Grid 3 Accent 5"/>
<w:LsdException Locked="false" Priority="70" SemiHidden="false"
UnhideWhenUsed="false" Name="Dark List Accent 5"/>
<w:LsdException Locked="false" Priority="71" SemiHidden="false"
UnhideWhenUsed="false" Name="Colorful Shading Accent 5"/>
<w:LsdException Locked="false" Priority="72" SemiHidden="false"
UnhideWhenUsed="false" Name="Colorful List Accent 5"/>
<w:LsdException Locked="false" Priority="73" SemiHidden="false"
UnhideWhenUsed="false" Name="Colorful Grid Accent 5"/>
<w:LsdException Locked="false" Priority="60" SemiHidden="false"
UnhideWhenUsed="false" Name="Light Shading Accent 6"/>
<w:LsdException Locked="false" Priority="61" SemiHidden="false"
UnhideWhenUsed="false" Name="Light List Accent 6"/>
<w:LsdException Locked="false" Priority="62" SemiHidden="false"
UnhideWhenUsed="false" Name="Light Grid Accent 6"/>
<w:LsdException Locked="false" Priority="63" SemiHidden="false"
UnhideWhenUsed="false" Name="Medium Shading 1 Accent 6"/>
<w:LsdException Locked="false" Priority="64" SemiHidden="false"
UnhideWhenUsed="false" Name="Medium Shading 2 Accent 6"/>
<w:LsdException Locked="false" Priority="65" SemiHidden="false"
UnhideWhenUsed="false" Name="Medium List 1 Accent 6"/>
<w:LsdException Locked="false" Priority="66" SemiHidden="false"
UnhideWhenUsed="false" Name="Medium List 2 Accent 6"/>
<w:LsdException Locked="false" Priority="67" SemiHidden="false"
UnhideWhenUsed="false" Name="Medium Grid 1 Accent 6"/>
<w:LsdException Locked="false" Priority="68" SemiHidden="false"
UnhideWhenUsed="false" Name="Medium Grid 2 Accent 6"/>
<w:LsdException Locked="false" Priority="69" SemiHidden="false"
UnhideWhenUsed="false" Name="Medium Grid 3 Accent 6"/>
<w:LsdException Locked="false" Priority="70" SemiHidden="false"
UnhideWhenUsed="false" Name="Dark List Accent 6"/>
<w:LsdException Locked="false" Priority="71" SemiHidden="false"
UnhideWhenUsed="false" Name="Colorful Shading Accent 6"/>
<w:LsdException Locked="false" Priority="72" SemiHidden="false"
UnhideWhenUsed="false" Name="Colorful List Accent 6"/>
<w:LsdException Locked="false" Priority="73" SemiHidden="false"
UnhideWhenUsed="false" Name="Colorful Grid Accent 6"/>
<w:LsdException Locked="false" Priority="19" SemiHidden="false"
UnhideWhenUsed="false" QFormat="true" Name="Subtle Emphasis"/>
<w:LsdException Locked="false" Priority="21" SemiHidden="false"
UnhideWhenUsed="false" QFormat="true" Name="Intense Emphasis"/>
<w:LsdException Locked="false" Priority="31" SemiHidden="false"
UnhideWhenUsed="false" QFormat="true" Name="Subtle Reference"/>
<w:LsdException Locked="false" Priority="32" SemiHidden="false"
UnhideWhenUsed="false" QFormat="true" Name="Intense Reference"/>
<w:LsdException Locked="false" Priority="33" SemiHidden="false"
UnhideWhenUsed="false" QFormat="true" Name="Book Title"/>
<w:LsdException Locked="false" Priority="37" Name="Bibliography"/>
<w:LsdException Locked="false" Priority="39" QFormat="true" Name="TOC Heading"/>
</w:LatentStyles>
</xml><![endif]-->
<!--[if gte mso 10]>
<style>
/* Style Definitions */
table.MsoNormalTable
{mso-style-name:"Table Normal";
mso-tstyle-rowband-size:0;
mso-tstyle-colband-size:0;
mso-style-noshow:yes;
mso-style-priority:99;
mso-style-parent:"";
mso-padding-alt:0in 5.4pt 0in 5.4pt;
mso-para-margin:0in;
mso-para-margin-bottom:.0001pt;
mso-pagination:widow-orphan;
font-size:10.0pt;
font-family:Calibri;}
</style>
<![endif]-->
<!--StartFragment-->
<br />
<div align="center" class="MsoNormal" style="text-align: center;">
<b style="mso-bidi-font-weight: normal;"><i style="mso-bidi-font-style: normal;"><span style="color: #c00000; font-family: "Times New Roman"; font-size: 16.0pt; line-height: 115%;">Strategies for
Success in Virtual Drug Development from Discovery to Clinic<o:p></o:p></span></i></b></div>
<div align="center" class="MsoNormal" style="text-align: center;">
<b style="mso-bidi-font-weight: normal;"><i style="mso-bidi-font-style: normal;"><span style="color: #c00000; font-family: "Times New Roman"; font-size: 16.0pt; line-height: 115%;">Seminar &
Wine Tasting Event<o:p></o:p></span></i></b></div>
<div align="center" class="MsoNormal" style="text-align: center;">
<b style="mso-bidi-font-weight: normal;"><i style="mso-bidi-font-style: normal;"><span style="color: #c00000; font-family: "Times New Roman"; font-size: 16.0pt; line-height: 115%;"><br /></span></i></b></div>
<div align="center" class="MsoNormal" style="line-height: normal; text-align: center;">
<b style="mso-bidi-font-weight: normal;"><span style="font-family: "Times New Roman"; font-size: 12.0pt;">November 1, 2012 – 2:30 <a href="" name="_GoBack"></a>- 6:30 pm;
Westin Hotel 1 Old Bayshore Highway, Millbrae, CA <o:p></o:p></span></b></div>
<div class="smtext3" style="line-height: 12.0pt; margin-bottom: 7.5pt; mso-margin-top-alt: auto;">
<b style="mso-bidi-font-weight: normal;"><span style="color: black;"><span style="mso-spacerun: yes;"> </span>Cost: $80.00 in advance if check received by
October 15<sup>th</sup>, 2012; $95.00 at the door<o:p></o:p></span></b></div>
<div align="center" class="MsoNormal" style="text-align: center;">
<b style="mso-bidi-font-weight: normal;"><span style="font-family: "Times New Roman"; font-size: 12.0pt; line-height: 115%;">An
interactive seminar and discussion focused on virtual drug development and
strategies for success from discovery to clinical trials. <o:p></o:p></span></b></div>
<div align="center" class="MsoNormal" style="text-align: center;">
<b style="mso-bidi-font-weight: normal;"><span style="font-family: "Times New Roman"; font-size: 12.0pt; line-height: 115%;"><br /></span></b></div>
<div align="center" class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in; text-align: center;">
<b><u><span style="font-family: "Times New Roman"; font-size: 12.0pt; mso-fareast-font-family: "Times New Roman"; text-transform: uppercase;">Schedule of Events</span></u></b><span style="font-family: "Times New Roman"; font-size: 12.0pt; mso-fareast-font-family: "Times New Roman";"><o:p></o:p></span></div>
<div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<br /></div>
<div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<span style="font-family: "Times New Roman"; font-size: 12.0pt; mso-fareast-font-family: "Times New Roman";"> <b><span style="color: black; text-transform: uppercase;">2:30
Registration and networking</span></b><span style="color: black;"> </span><o:p></o:p></span></div>
<div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<b><span style="color: black; font-family: "Times New Roman"; font-size: 12.0pt; mso-fareast-font-family: "Times New Roman"; text-transform: uppercase;"> </span></b><span style="color: black; font-family: "Times New Roman"; font-size: 12.0pt; mso-fareast-font-family: "Times New Roman";"> </span><span style="font-family: "Times New Roman"; font-size: 12.0pt; mso-fareast-font-family: "Times New Roman";"><o:p></o:p></span></div>
<div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<b><span style="color: black; font-family: "Times New Roman"; font-size: 12.0pt; mso-fareast-font-family: "Times New Roman"; text-transform: uppercase;">3:00
welcome and introduction, William Stevens, Ph.D., Business Development
connections, LLC</span></b><span style="color: black; font-family: "Times New Roman"; font-size: 12.0pt; mso-fareast-font-family: "Times New Roman";"> </span><span style="font-family: "Times New Roman"; font-size: 12.0pt; mso-fareast-font-family: "Times New Roman";"><o:p></o:p></span></div>
<div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<b><span style="color: black; font-family: "Times New Roman"; font-size: 12.0pt; mso-fareast-font-family: "Times New Roman"; text-transform: uppercase;"> </span></b><span style="color: black; font-family: "Times New Roman"; font-size: 12.0pt; mso-fareast-font-family: "Times New Roman";"> </span><span style="font-family: "Times New Roman"; font-size: 12.0pt; mso-fareast-font-family: "Times New Roman";"><o:p></o:p></span></div>
<div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<b><span style="font-family: "Times New Roman"; font-size: 12.0pt; mso-fareast-font-family: "Times New Roman";">3<span style="color: black;">:15 -
3:45 "CHEMISTRY OUTSOURCING - AVOIDING PROBLEMS AND MAXIMIZING
BENEFITS" PRESENTED BY DANIEL LEVY, PH.D.</span></span></b><span style="color: black; font-family: "Times New Roman"; font-size: 12.0pt; mso-fareast-font-family: "Times New Roman";"> <o:p></o:p></span></div>
<div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<br /></div>
<div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<span style="font-family: "Times New Roman"; font-size: 12.0pt; mso-fareast-font-family: "Times New Roman";">“Dr. Levy's presentation will focus on current chemistry
outsourcing trends, challenges and strategies for success. The goal is to
address issues applicable to both early stage medicinal chemistry efforts as
well as scale-up and manufacturing.”<o:p></o:p></span></div>
<div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<span style="font-family: "Times New Roman"; font-size: 12.0pt; mso-fareast-font-family: "Times New Roman";"><br /></span></div>
<div class="MsoNormal" style="line-height: normal; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto;">
<span style="font-family: "Times New Roman"; font-size: 12.0pt; mso-fareast-font-family: "Times New Roman";">Dr. Levy is an experienced
organic/medicinal chemist having led the design of novel therapeutic agents
targeting cardiovascular disease, cancer and inflammatory disorders. He has
broad experience in the chemistry of amino acids/peptides,
sugars/carbohydrates, heterocycles, polyethylene glycols and lipids as
documented in almost 30 peer reviewed publications and over 11 issued/published
United States patents. Dr. Levy held positions at Glycomed, COR Therapeutics,
Scios and Intradigm Corporation. As a consultant, Dr. Levy provides medicinal
chemistry and manufacturing services to companies interested in small molecule
drug discovery/development. Set-up and management of chemistry outsourcing is a
key service supporting these sectors. In addition, he provides technical due
diligence services, facilitates IP development and supports the filing of grant
applications. Dr. Levy received his Ph.D. in organic chemistry from the
Massachusetts Institute of Technology and his B.S. in chemistry from the
University of California - Berkeley.<o:p></o:p></span></div>
<div class="MsoNormal" style="line-height: normal; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto;">
<span style="font-family: "Times New Roman"; font-size: 12.0pt; mso-fareast-font-family: "Times New Roman";"><br /></span></div>
<div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<b><span style="color: black; font-family: "Times New Roman"; font-size: 12.0pt; mso-fareast-font-family: "Times New Roman"; text-transform: uppercase;">3:45
- 4:15 "Assessing Compound Developability in Late Lead Opt: Making Wise
Choices Under the Gun" - presented by JeffREY Kiplinger, Ph.D.; pRESIDENT
& ceo averica discovery services, inc</span></b><span style="color: black; font-family: "Times New Roman"; font-size: 12.0pt; mso-fareast-font-family: "Times New Roman";"> </span><span style="font-family: "Times New Roman"; font-size: 12.0pt; mso-fareast-font-family: "Times New Roman";"><o:p></o:p></span></div>
<div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<br /></div>
<div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<span style="font-family: "Times New Roman"; font-size: 12.0pt; mso-fareast-font-family: "Times New Roman";">“The task faced by a medicinal chemistry-driven team in lead
optimization has expanded in recent years, and internal resources are always scarce.
Using CROs as resources in the complex job of validating and de-risking a
molecule before proceeding to a full development effort is a solution, but
management and coordination of those resources is challenging. This
presentation will discuss ways in which in house capabilities and the
decision-making process can be aligned and aimed at moving the best candidate
compound forward.”<o:p></o:p></span></div>
<div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<span style="font-family: "Times New Roman"; font-size: 12.0pt; mso-fareast-font-family: "Times New Roman";"><br /></span></div>
<div class="MsoNormal" style="line-height: normal; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto; text-align: justify;">
<span style="font-family: "Times New Roman"; font-size: 12.0pt; mso-fareast-font-family: "Times New Roman";">Dr.
Kiplinger has 25 years of experience in the pharmaceutical industry, initially
as a mass spectrometrist and analytical chemist and later as a strategic
consultant to startup discovery organizations. Presently he is CEO of
Averica Discovery Services, an analytics Contract Research Organization in
Worcester, Massachusetts. Dr. Kiplinger received his PhD at Indiana University
and carried out postdoctoral projects at the University of North Carolina and
Ohio State University. In 1988 he joined Pfizer’s drug discovery
organization, leaving in 1998 to found the Gilson CIDT technical center.
After consulting with a number of pharmaceutical companies and entrepreneurs,
he founded Averica in 2007.<o:p></o:p></span></div>
<div class="MsoNormal" style="line-height: normal; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto; text-align: justify;">
<span style="font-family: "Times New Roman"; font-size: 12.0pt; mso-fareast-font-family: "Times New Roman";"><br /></span></div>
<div class="MsoNormal" style="line-height: normal; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto; text-align: justify;">
<b><span style="font-family: "Times New Roman"; font-size: 12.0pt; mso-fareast-font-family: "Times New Roman";">4:15 -
4:30 - Break</span></b><span style="font-family: "Times New Roman"; font-size: 12.0pt; mso-fareast-font-family: "Times New Roman";"><o:p></o:p></span></div>
<div class="MsoNormal" style="line-height: normal; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto; text-align: justify;">
<b><span style="font-family: "Times New Roman"; font-size: 12.0pt; mso-fareast-font-family: "Times New Roman";"><br /></span></b></div>
<div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<b><span style="color: black; font-family: "Times New Roman"; font-size: 12.0pt; mso-fareast-font-family: "Times New Roman"; text-transform: uppercase;">4:30
- 5:00 </span></b><b><span style="color: black; font-family: "Times New Roman"; font-size: 12.0pt; mso-fareast-font-family: "Times New Roman";">"PERSONALIZED
MEDICINE IN CLINICAL DEVELOPMENT: PHENOTYPING, PATIENT STRATIFICATION AND
TAILORED THERAPY BASED ON DRUG PHARMACOLOGY AND METABOLISM IN TARGET TISSUES
USING ACCELERATOR MASS SPECTROMETRY" - PRESENTED BY GARY JONES, M.D.;
CO-FOUNDER AND DIRECTOR OF CLINICAL DEVELOPMENT FOR C3 RESEARCH</span></b><span style="color: black; font-family: "Times New Roman"; font-size: 12.0pt; mso-fareast-font-family: "Times New Roman";"> <o:p></o:p></span></div>
<div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<br /></div>
<div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<span style="color: black; font-family: "Times New Roman"; font-size: 12.0pt; mso-fareast-font-family: "Times New Roman";">"This presentation will propose a rational
approach of clinical trial enrollment based on pre-trial study to evaluate drug
pharmacology and uptake by target organ or tumor. Patients are administered a
tracer dose of treatment drug lightly labeled with 14C to permit detection
by accelerator mass spectrometry (AMS). The dose may be reduced to less than 100 micrograms
to eliminate pharmacologic effect, yet allow assessment of tracer kinetics and
target tissue or tumor uptake. Patients are then stratified as "high"
versus "low" responders, based on empirical assessment of drug
pharmacology. Patients showing poor drug pharmacology and/or target uptake may
be excluded from the longer phase of the study. Enrollment based on positive
pharmacology may affect successful outcome in the larger trial. This systems
biology approach of "pharmaco-phenotyping" personalized to each patient
may allow addressing a wider range of diseases, especially ones influenced by
complex gene networks, pathways, and environmental modulators."</span><span style="font-family: "Times New Roman"; font-size: 12.0pt; mso-fareast-font-family: "Times New Roman";"><o:p></o:p></span></div>
<div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<span style="color: black; font-family: "Times New Roman"; font-size: 12.0pt; mso-fareast-font-family: "Times New Roman";"><br /></span></div>
<div class="MsoNormal" style="mso-layout-grid-align: none; mso-margin-top-alt: auto; mso-pagination: none; text-autospace: none;">
<b><span style="font-family: "Times New Roman"; font-size: 12.0pt; line-height: 115%;">Gary Jones, MD, </span></b><b><span style="font-family: "MS Mincho"; font-size: 12.0pt; line-height: 115%; mso-ascii-font-family: "Times New Roman";"> </span></b><b><span style="font-family: "Times New Roman"; font-size: 12.0pt; line-height: 115%;">Director of Clinical Development – C3
Research. </span></b><span class="apple-style-span"><span style="font-family: "Times New Roman"; font-size: 12.0pt; line-height: 115%;">As
Director of Clinical Development, Gary uses his 20 years of experience and
expertise, accumulated through his careers in academia, medical care, and
clinical research, to enjoy direct involvement in the clinical development of
both medical devices and therapeutics. He received his M.D. at the Oregon
Health Sciences University had has had academic appointments at University of
North Carolina and OHSU</span></span><span style="font-family: "Times New Roman"; font-size: 12.0pt; line-height: 115%;">.<span style="mso-spacerun: yes;"> </span></span><span class="Apple-style-span" style="font-family: 'Times New Roman'; font-size: 16px; line-height: 18px;">Especially interested in<i> “pushing
the boundaries of the box”</i> of clinical development in oncology, he is
directly involved in the aspects of both development and running of clinical
trials, medical monitoring, interpreting results and moving aspects of data
forward in a practical way to bring therapeutics to the market that help people
with critical needs in any area of medicine.</span></div>
<div class="MsoNormal" style="line-height: normal; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto;">
<br /></div>
<div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<b><span style="font-family: "Times New Roman"; font-size: 12.0pt; mso-fareast-font-family: "Times New Roman";">5:00<span style="color: black;"> -
5:30 <span style="text-transform: uppercase;">"Preclinical DMPK without a
lab: A study in CRO partnering" - presented by Roderic Cole, Ph.D.</span></span></span></b><span style="color: black; font-family: "Times New Roman"; font-size: 12.0pt; mso-fareast-font-family: "Times New Roman";"> </span><span style="font-family: "Times New Roman"; font-size: 12.0pt; mso-fareast-font-family: "Times New Roman";"><o:p></o:p></span></div>
<div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<b><span style="font-family: "Times New Roman"; font-size: 12.0pt; mso-fareast-font-family: "Times New Roman";"><span style="color: black;"><span style="text-transform: uppercase;"><br /></span></span></span></b></div>
<div class="MsoNormal" style="line-height: normal; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto;">
<span style="font-family: "Times New Roman"; font-size: 12.0pt; mso-fareast-font-family: "Times New Roman";">"As the pharmaceutical industry
moves toward increasingly heavy reliance on external resources, effective
management of CRO relationships has become critical. In many situations,
researchers manage several programs in multiple organizations. Interactions
become transactional, with little/no opportunity to anticipate problems or to
arrive at creative solutions. Key missing elements are the researcher and
project team interactions which are typical in classical organizations.
This talk will look at strategies to optimize working relationships between
sponsor and CRO staff to maximize the value of the outsourcing dollar."<o:p></o:p></span></div>
<div class="MsoNormal" style="line-height: normal; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto;">
<span style="font-family: "Times New Roman"; font-size: 12.0pt; mso-fareast-font-family: "Times New Roman";"><br /></span></div>
<div class="MsoNormal" style="line-height: normal; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto;">
<span style="font-family: "Times New Roman"; font-size: 12.0pt; mso-fareast-font-family: "Times New Roman";">Rod is currently Director,
Analytical Sciences at Cerulean Pharma in Cambridge, MA where he oversees
analytical, bioanalytical and is involved with preclinical DMPK. He has
broad experience in the pharmaceutical industry where he has worked for Pfizer,
AstraZeneca, Abbott, and Millennium in various roles. His early work
focused on analytical and bioanalytical chemistry in a discovery setting.
Over the last 6 years, he has focused on development and applications of high
throughput ADME and pharmacokinetic techniques to support drug discovery and
development programs. Rod attended University of Tennessee, Knoxville
where he earned a PhD in Chemistry.<o:p></o:p></span></div>
<div class="MsoNormal" style="line-height: normal; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto;">
<span style="font-family: "Times New Roman"; font-size: 12.0pt; mso-fareast-font-family: "Times New Roman";"><br /></span></div>
<div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<b><span style="font-family: "Times New Roman"; font-size: 12.0pt; mso-fareast-font-family: "Times New Roman";">5:30<span style="color: black;"> -
6:30</span></span></b><span style="color: black; font-family: "Times New Roman"; font-size: 12.0pt; mso-fareast-font-family: "Times New Roman";"> <b>-</b> <b>Networking,
Winemaker Talk and Wine Tasting, Light Appetizers hosted by Business
Development Connections, LLC and Vintner Jeff Hall of Williamson Wines </b></span><span style="font-family: "Times New Roman"; font-size: 12.0pt; mso-fareast-font-family: "Times New Roman";"><o:p></o:p></span></div>
<div class="MsoNormal" style="line-height: normal; margin-bottom: .0001pt; margin-bottom: 0in;">
<br /></div>
<div class="MsoNormal">
<b style="mso-bidi-font-weight: normal;"><span style="font-family: "Times New Roman"; font-size: 12.0pt; line-height: 115%;">Sponsored
By:<o:p></o:p></span></b></div>
<div class="MsoNormal">
<b style="mso-bidi-font-weight: normal;"><span style="font-family: "Times New Roman"; font-size: 12.0pt; line-height: 115%;">Business
Development Connections, LLC<o:p></o:p></span></b></div>
<div class="MsoNormal">
<b style="mso-bidi-font-weight: normal;"><span style="font-family: "Times New Roman"; font-size: 12.0pt; line-height: 115%;">C3
Research and Associates<o:p></o:p></span></b></div>
<div class="MsoNormal">
<b style="mso-bidi-font-weight: normal;"><span style="font-family: "Times New Roman"; font-size: 12.0pt; line-height: 115%;">Agilux
Laboratories<o:p></o:p></span></b></div>
<div class="MsoNormal">
<b style="mso-bidi-font-weight: normal;"><span style="font-family: "Times New Roman"; font-size: 12.0pt; line-height: 115%;">Averica
Discovery Services, Inc.<o:p></o:p></span></b></div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
<b style="mso-bidi-font-weight: normal;"><span style="font-family: "Times New Roman"; font-size: 12.0pt; line-height: 115%;">Please
mail checks to: Business Development Connections<o:p></o:p></span></b></div>
<div class="MsoNormal">
<b style="mso-bidi-font-weight: normal;"><span style="font-family: "Times New Roman"; font-size: 12.0pt; line-height: 115%;"><span style="mso-tab-count: 3;"> </span><span style="mso-spacerun: yes;"> </span>336 Bon Air Center, # 228<o:p></o:p></span></b></div>
<div class="MsoNormal">
<b style="mso-bidi-font-weight: normal;"><span style="font-family: "Times New Roman"; font-size: 12.0pt; line-height: 115%;"><span style="mso-tab-count: 3;"> </span><span style="mso-spacerun: yes;"> </span>Greenbrae, CA 94904<o:p></o:p></span></b></div>
<div class="MsoNormal">
<b style="mso-bidi-font-weight: normal;"><span style="font-family: "Times New Roman"; font-size: 12.0pt; line-height: 115%;"><span style="mso-tab-count: 4;"> </span><o:p></o:p></span></b></div>
<!--EndFragment-->Daniel E. Levyhttp://www.blogger.com/profile/05609535387028309791noreply@blogger.com5tag:blogger.com,1999:blog-371148246405005788.post-64227116951203001042012-10-09T14:02:00.002-07:002012-10-09T14:02:45.990-07:00A Letter to Gray DavisOn February 23, 2011, I attended a symposium where both Gavin Newsom and Gray Davis were speaking. Following the program, I had separate brief discussions with each. These discussions were focused on the current state of the biotech/pharma industries - specifically related to continued trends in mergers, acquisitions, layoffs and site closures. As both individuals spoke about their contributions to and support for the biotech/pharma industries in California, I was happy to have had those interactions.<br />
<br />
In response to our conversation, Gray Davis asked me to send him an email regarding what is happening to scientists who were displaced by the ongoing industry contraction. Below is the text of that email.<br />
<br />
<span class="Apple-style-span" style="border-collapse: collapse;">
<!--StartFragment--><span style="font-family: Verdana, Helvetica, Arial;"><span style="font-size: 12.0px;">Dear Governor Davis,<br />
<br />
It was a pleasure to meet you yesterday afternoon. I enjoyed your talk and truly appreciate all you have done to build QB3 and related organizations. Having served the biopharmaceutical industry for over 18 years, I can tell you with complete certainty that these efforts are making a difference in fostering the abilities of innovative scientists to create truly novel and beneficial technologies. In following up with our discussion, I want to describe my perspective of the biopharmaceutical industry as it relates to mergers/acquisitions and employees.<br />
<br />
Since receiving my PhD from MIT in 1992, I worked for four companies. The first company, Glycomed, was purchased by Ligand Pharmaceuticals in a stock/stock transaction. During the year following the merger, we experienced several rounds of layoffs followed by the complete closure of Glycomed in 1997. In April of 1998, I joined COR Therapeutics. Like Glycomed, COR merged with Millennium Pharmaceuticals and was subsequently closed in 2003. As the pattern of corporate activities were similar in the Glycomed and COR mergers, I felt I knew what to look for in times of transition. So when Scios, my next employer, was purchased by Johnson & Johnson in 2003 in an all-cash transaction, I felt that this merger would be productive. Unfortunately, in 2006, Johnson & Johnson elected to close Scios and lay off all of the 600 employees. Following a ten month period of consulting, I joined Intradigm Corporation as the Director of Synthetic Chemistry. Yet again, this company was merged with another and subsequently shut down.<br />
<br />
Governor Davis, it is clear that business decisions are driven by the needs of investors and shareholders. However, in the currently contracting economy, there are not enough new companies forming to absorb the number of talented scientists left without work. While many corporate recruiters are suggesting that the job climate is improving, in January of this year, layoffs were announced at Elan, Genentech, Kai and Exelixis. These local events are in addition to many more in both biotech and large pharma that are almost regularly being announced.<br />
<br />
Yesterday afternoon, you asked me to write to you regarding what happens to those impacted by corporate downsizings. Sadly, while some move on to new companies, others remain unemployed for longer periods of time. Still others choose to leave their professions in favor of alternatives leading to employment. In the area of chemistry, Chemical and Engineering News recently stated that the unemployment rate for medicinal chemists is higher than any other chemistry discipline - a problem that cannot solely be blamed on outsourcing. The amount of unutilized talent applicable to drug discovery and development is now truly staggering.<br />
<br />
While investors are pushing for returns, big pharma and biotech companies are now trending towards increased development activities and de-emphasizing research. The long-term results of this trend will include fewer new medications being approved. The peak of this problem will begin to manifest itself in approximately 10-15 years - the end of the discovery/development cycle timeline for new projects initiated today. As our population continues to age, significant markets are already established for which there are unmet medical needs.<br />
<br />
Regarding the next generation, the current climate is having a significant impact on decisions to pursue education in the life sciences. After all, if student do not see a future in this industry, what is their motivation? Furthermore, the current climate is disruptive to families. One specific example involves a friend of mine who was relocated by Roche, with his family, from California to New Jersey following the closure of Roche Palo Alto. After only one year, Roche executed a corporate downsizing effectively stranding my friend and his family in an unfamiliar state with no income.<br />
<br />
While the current economy is challenging, there is reason to be optimistic. Advances in genetic sequencing are creating new opportunities likely to impact the future of healthcare. One area in particular involves new paradigms bringing together novel therapeutic agents and companion diagnostics. This approach of personalized medicine has the potential to determine which patient populations will respond to specific therapeutics. While patient population sizes will be smaller, this paradigm opens the possibility for many more markets targeted to specific sub-populations. Therapeutics will be more effective and non-responders will be minimized.<br />
<br />
While I cannot provide all of the answers in this email, I want to reiterate my interest in joining task forces where I can contribute to finding solutions for these difficult problems. Please contact me at your convenience so that we can discuss this in greater detail.<br />
<br />
Best wishes,<br />
<br />
Dan</span></span>
<!--EndFragment-->
</span><br />
<span class="Apple-style-span" style="border-collapse: collapse;"><span style="font-family: Verdana, Helvetica, Arial;"><span style="font-size: 12.0px;"><br /></span></span></span>
While political activities and policy development tend to take time to evolve, it has been over a year and a half since this letter was written. To date, I have not received a response (or even an acknowledgement of receipt) from Governor Davis' office. From Gavin Newsom's office, I was asked to review a new biotechnology policy platform scheduled to be rolled out during the summer of 2011. Even with my follow-up, I have yet to see any information regarding this new policy - even one year later.<br />
<br />
To both Gray Davis and Gavin Newsom, biotechnology is a cornerstone industry in California. It delivers hope to those suffering from ailments for which no cures exist. It also continues to provide novel therapeutics effectively improving the quality of life for multitudes who, without this industry, would continue to suffer.<br />
<br />
Biotechnology and pharmaceuticals are industries in transition. Opportunities now exist to influence the shape of new paradigms which will be applied to these industries. Let's hope that the politicians at the center of this transition utilize the insight and experience of those who actively contribute to these industries. As for me, I will be very happy to help.Daniel E. Levyhttp://www.blogger.com/profile/05609535387028309791noreply@blogger.com4tag:blogger.com,1999:blog-371148246405005788.post-76750375275833164112012-08-22T21:09:00.000-07:002012-08-22T21:12:26.290-07:00Creating Opportunities in the Life Sciences<span class="Apple-style-span" style="font-family: Arial, Helvetica, sans-serif;">This coming Tuesday, I will be speaking on "Creating Opportunities in the Life Sciences - Maintaining Self Employment in a Difficult Job Climate."</span><br />
<span class="Apple-style-span" style="font-family: Arial, Helvetica, sans-serif;"><br />
Date: Tuesday, August 28</span><br />
<span class="Apple-style-span" style="font-family: Arial, Helvetica, sans-serif;">Time: 8:30am</span><br />
<span class="Apple-style-span" style="font-family: Arial, Helvetica, sans-serif;">Location: Sunnyvale City Council Chambers, 456 West Olive Ave., Sunnyale, CA</span><br />
<span class="Apple-style-span" style="font-family: Arial, Helvetica, sans-serif;"><br />
<span class="Apple-style-span" style="line-height: 19px;">Abstract: In today's difficult economy, many sectors have been impacted. Among the hardest hit are the biotechnology and pharmaceutical industries. With almost twice the unemployment rate compared to the national average, these sectors present significant challenges to those wishing to contribute to the development of innovative solutions to healthcare problems. As a 20 year veteran of biopharma, Dr. Daniel E. Levy will share his experiences transitioning from full time employment to consultant. Topics will include challenges in managing CROs, leveraging services for resources, networking and marketing. In this tough economy, there are plenty of reasons for not getting paid. However, there are no excuses for not working. Learn how to create opportunities.</span></span><br />
<span class="Apple-style-span" style="font-family: Arial, Helvetica, sans-serif;"><span class="Apple-style-span" style="line-height: 19px;"><br /></span>This talk is designed to provide insight and encouragement to those taking on the currently challenging job market. More information can be found at the <a href="http://www.bio2devicegroup.org/content/creating-opportunities-life-sciences-maintaining-self-employment-difficult-job-climate-danie">Bio2Device Group</a> website.</span><br />
<br />
<span class="Apple-style-span" style="font-family: Times, 'Times New Roman', serif;"><span class="Apple-style-span" style="line-height: 19px;"><br /></span></span>Daniel E. Levyhttp://www.blogger.com/profile/05609535387028309791noreply@blogger.com1tag:blogger.com,1999:blog-371148246405005788.post-49739275084017735232012-04-22T13:24:00.000-07:002012-04-22T13:24:59.445-07:00Are there any jobs in Medicinal Chemistry? And how can I get one?Through my efforts to provide encouraging information and strategies for those interested in life sciences careers, I will occationally invite guest bloggers to provide their thoughts. My first guest blogger is Connie Hampton - founder of Hampton Associates and provider of scientific and executive search services. Connie's blog is highlited in my blog list. More information regarding her background and services can be found on her website (www.hamptonexecutivesearch.com).<br />
<div>
<br /></div>
<div>
<div class="MsoNormal">
<b>Are there any jobs in Medicinal Chemistry? And how can I get
one?</b><o:p></o:p></div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
There are over <a href="http://www.simplyhired.com/a/jobs/list/q-iphone+developer">7,000 IPhone
developer jobs</a> today on <a href="http://www.simplyhired.com/">SimplyHired.com</a>
and only <a href="http://www.simplyhired.com/a/jobs/list/q-medicinal+chemistry/pn-2">500
Medicinal Chemistry positions</a>. This
is only 1/5 of the total jobs, but the other 4/5ths are filled before they are
posted. Obviously it is much harder to
get a job in Medicinal Chemistry than IPhone development. These jobs are all over the world, from
summer (unpaid) intern to Principal Scientist and Professor. If you are one of the many students of
medicinal chemistry about to graduate, how are you going to compete? <o:p></o:p></div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
Job Search is Tough and You were Never Taught How <o:p></o:p></div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
Today’s economy is especially tough on small therapeutics
companies. Seed money is hard to find
and further financing is even harder to get.
Since it takes 100 ideas and at least 10 years from proof-of-concept to
marketed drug, the venture capitalists are putting their money into IPhone
development in order to spend less than a year to get 4+ times their
investment. Medicinal chemistry is
necessary in both large and small molecule drugs, but there are fewer companies
and simply fewer positions than there used to be.<o:p></o:p></div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
The solution to finding a job under these circumstances is
to take on the task of finding a job as a job, to “hunt your own head” and
become your own “job fairy”.<o:p></o:p></div>
<div class="MsoListParagraphCxSpFirst" style="mso-list: l0 level1 lfo1; text-indent: -.25in;">
</div>
<ol>
<li>Put in no fewer than 20 hours/week and
preferably 30-40.</li>
<li>Write, for your own use as a pool of phrases,
what you bring to the table in the way of skills and cutting-edge knowledge</li>
<li>Write your approximate overall career goal.</li>
<li>Decide, geographically, where you want to
work. Will you move or will you commute?</li>
<li>Start a database of all the companies within
your commute distance which use the skills you have and can provide you with
the next step in moving you closer to your goal.</li>
<li>Start a database of the people you know, where
they work and how to get in touch with them.</li>
<li>Sync these two databases with each other. Which companies do you already have a
personal connection in? Which do you
need to get (at least) one?</li>
<li>Start networking! Up to 80% of jobs are filled by networking
and only 20% by job boards</li>
</ol>
This is just the homework part of job search. The next step is getting out there and meeting people to find out who has a problem you can solve. Do you know how to network?<br /><div class="MsoNormal">
<o:p></o:p></div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
Networking is when you give something of value to the other person
(that does not cost you much) and get something that you value (that doesn’t
cost them much). You give time,
attention, information and you get time, attention and information. <o:p></o:p></div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
The first person you want to network with in a company that
you are interested in should be someone who is NOT the hiring manager and NOT a
person in the department that you want.
You need to know if the company is financially stable, a good place to
work and fits with your idea of a good company.
Who of your connections is able to tell you these things? You need to give them the gift of your
attention. Ask: “how do you like your
job?” and “what is it like to work
there?” and “are they hiring or laying off?”<o:p></o:p></div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
If the company sounds good, THEN you want to be introduced
to someone in your preferred department.
You need to find out if they are working on any problems that you could
help solve and present yourself as someone who could do so. If they have a problem that is NOT one that
you want to solve, then ask the same questions as above and move on. But if they are working on something that
appeals to you, have a very “geeky” conversation – ask really good questions,
display your understanding of the issues.
At the end of the conversation, do NOT beg for a job. Do NOT hand them
your resume. Instead say, “What an
interesting problem! You must be having
so much fun!” even if you know that it is not being fun for them. <o:p></o:p></div>
<div class="MsoNormal">
Then go home and put the person and company in your Gist.com
database. This site will sweep the
internet for any mention of the person or company and look in Twitter, Facebook
and blogs to find them. This will allow
you to email this person once a week with “saw this and thought of you” emails
and therefore stay on the top of their minds.
When their boss and hiring manager realizes that the problem is not
getting solved with the people he is already paying, the first thing he will
ask is “Who do we know?” Your name will
be the one that comes up.<o:p></o:p></div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
Stay in touch with your contacts in the departments of the companies
you want to work for.<o:p></o:p></div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
Keep checking their websites in case your job gets posted.<o:p></o:p></div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
Stay alert to other ways that the company may be looking for
you.<o:p></o:p></div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
But keep on networking your way through the list of
companies that hire people with your talents.<o:p></o:p></div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
This is your career network and it will last you for the
rest of your career. You will help these
people find jobs and they will help you.<o:p></o:p></div>
<div class="MsoNormal">
<br /></div>
<div class="MsoNormal">
<img src="webkit-fake-url://3E163522-59F0-4C93-834A-DEA66C5F053F/application.pdf" /></div>
<div class="MsoNormal" style="line-height: normal; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto;">
<span style="font-family: 'Times New Roman'; font-size: 12pt;">Connie
is a scientific and executive search consultant and a purple squirrel hunter –
after a company has exhausted their network, posted the job and not found the
right person, they turn to her to find that hard-to-find MD or PhD or MBA.<o:p></o:p></span><br />
<span style="font-family: 'Times New Roman'; font-size: 12pt;"><br /></span></div>
<div class="MsoNormal" style="line-height: normal; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto;">
<span style="font-family: 'Times New Roman'; font-size: 12pt;">She
started recruiting early in the history of the worldwide web. While she
does not restrict herself to just the web, she stays on the cutting edge of
social media and makes full use of it in finding the right people for her
clients.<o:p></o:p></span></div>
<div class="MsoNormal" style="line-height: normal; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto;">
<a href="http://www.hamptonexecutivesearch.com/"><span style="font-family: 'Times New Roman'; font-size: 12pt;">www.hamptonexecutivesearch.com</span></a><span style="font-family: 'Times New Roman'; font-size: 12pt;"><o:p></o:p></span></div>
<div class="MsoNormal" style="line-height: normal; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto;">
<a href="http://www.networkpolishkit.wordpress.com/"><span style="font-family: 'Times New Roman'; font-size: 12pt;">www.networkpolishkit.wordpress.com</span></a><span style="font-family: 'Times New Roman'; font-size: 12pt;"><o:p></o:p></span></div>
</div>Daniel E. Levyhttp://www.blogger.com/profile/05609535387028309791noreply@blogger.com7tag:blogger.com,1999:blog-371148246405005788.post-32009851583098426522012-04-02T22:50:00.000-07:002012-04-02T22:50:35.885-07:00Biotechnology and the Dot-Com EraEarlier this month, I attended the CalBio2012 conference in San Francisco. Among the attendees were venture capitalists and executives from biotech and pharma companies around the world. The two days of panel discussions and keynote addresses focused on all aspects of these industries from financing strategies to reimbursement issues. As a networking event and major local conference, I found the topics highly relevant. However, of all the sessions, I found the lunch keynote speeches to be the most inspiring.<br />
<br />
The keynote address on day one of the conference was particularly noteworthy. The speaker was John Crowley. To those of you who don't know, this is the man who risked his career to head up a company focused on finding a treatment for Pompe Disease – a terminal illness affecting his two children.<br />
<br />
Pompe disease is a condition where glycogen is not cleared from cells. This leads to cell death, organ failure, paralysis and death. While the story of how the treatment was ultimately found and developed is truly an inspiring example of the hope and promise that biotechnology brings to this world, this story is not the focus of this post. For an excellent interpretation of the Pompe disease story, I highly recommend the Harrison Ford movie "Extraordinary Measure" which focuses on the Crowley family and their journey.<br />
<br />
Instead of focusing on Pompe Disease, I thought it would be relevant, especially in today's economy, to comment on a small part of Crowley's speech describing previous attitudes towards investments in biotechnology. As you all know, investments in early stage biotechnology companies are considered highly risky. This is largely due to the roughly 15 year timeline from concept to market coupled with the 6% success rate for small molecule drug candidates completing clinical trials and becoming marketed therapeutic agents.<br />
<br />
In the 1980s, VC financing and IPO interest in biotechnology companies were abundant. It seemed that any company incorporating the letters G, E and N in its name was likely to obtain needed funds. Examples include Genentech, Biogen, Genencor, Gensia, Amgen and many more. It will also be no surprise that all of these companies were running operating losses during their initial financing periods. Relevant to the Crowley keynote speech is his description of interactions he had with a venture capitalist while serving as CEO for a biotech company. Paraphrasing Crowley's narrative, the dialog went something like this:<br />
<br />
<b> VC: </b> So, how are your sales?<br />
<b> Crowley: </b> Well, we currently don't have any sales.<br />
<b> VC: </b> I see. How strong are your revenues?<br />
<b> Crowley: </b>Actually, we presently don't have any source of income.<br />
<b> VC: </b>Interesting. When will your product be ready for market?<br />
<b> Crowley: </b>Uncertain. There can be no guarantee that our product will ever be ready for market.<br />
<br />
The above dialog summarizes the reality of the biotechnology industry from its inception to the present. The only driving force behind the ability to finance companies with long term operating losses and no guarantee of success was the hope and promise of a better future. For a long time, this was enough. Investors were interested and biotechnology was the only industry that could justifiably operate under this business model.<br />
<br />
Let's now move ahead to the 1990s. In this period, a new industry emerged - the internet. With the evolution of the internet came may entrepreneurs eager to capitalize on the promise of e-commerce. Whether selling products or focusing on business-to-business services, investors were jumping into this new sector with hopes of making large profits and quick exits. While some of these dot-com companies had solid business models, most eventually came and went. That did not stop the massive ballooning of the IPO market. While some people did, in fact, realize significant returns on their investments, most did not. So, when the investing community had had enough, the dot-com bubble burst and the NASDAQ plummeted from its "irrationally exuberant" highs. Ultimately, much of this downturn rests on the dot-com companies attempting to adopt the biotechnology model of selling shares while operating at a loss.<br />
<br />
Recognizing that the dot-com bubble had collapsed, investors next turned to the smaller "biotech bubble". While the dot-com IPO boom did have an impact on biotech, the size of this bubble was far less significant than that related to the internet. After all, it is the internet-based industries that are better understood by the investing public. Nevertheless, following the dot-com bust, biotech stocks fell. The investment community had had enough of high-risk markets and money dried up.<br />
<br />
When I hear people tell me that the biotechnology business model is broken, I point out that the model never changed. It is today, what it was in the 80s - highly speculative and full of promise. What has changed, however, is the risk-tolerance of investors. Where biotech companies used to be able to obtain financing at research stages, they now find themselves lucky if they can attract financing when achieving positive results in phase II clinical trials.<br />
<br />
While the biotechnology business model is not broken, it is obsolete. Clearly, investors want less risk and the future of innovative drug-discovery efforts depends upon the industry's ability to adapt during these challenging times. Unfortunately, no amount of adapting can fully bridge the divide from identification of development candidates to entry into clinical trials. The expenses are simply too high.<br />
<br />
The interplay between innovation and venture financing has always been a partnership. Extending partnerships requires effort and compromise on both sides. While I routinely work with early stage companies to find cost-effective ways to advance their programs, the investment community must also come to the plate. This country was built on taking risks. Continuing our leadership in innovation requires continually taking risks. Ask the Crowley family. I am sure they would agree.Daniel E. Levyhttp://www.blogger.com/profile/05609535387028309791noreply@blogger.com4tag:blogger.com,1999:blog-371148246405005788.post-64381799611874562202012-02-27T23:11:00.000-08:002012-02-27T23:11:39.028-08:00Life Science Careers - Questions from Soon-To-Be GraduatesTwo years ago, I was invited to participate as a career mentor at the California State University Biotechnology Symposium. At that time, I addressed questions asked by students contemplating careers in the life sciences - specifically relating to medicinal chemistry and drug discovery. I had a great time meeting with the students and listening to their interests and concerns. So, when I was asked to participate at this year's event, I readily accepted the opportunity.<br />
<br />
At the time of my participation two years ago, the economy was at a very low point. Pharmaceutical and biotechnology companies were routinely downsizing and outsourcing of chemistry was the rule rather than the exception. However, the questions asked by the participating students were not focused on the economy. Instead, the questions clustered into four distinct groups:<br />
<ul><li>Questions about medicinal chemistry</li>
<li>Questions about career paths</li>
<li>Questions about employment opportunities</li>
<li>Questions about relevant knowledge and experience</li>
</ul>What was remarkable about the questions coming from this years session was that the interests and concerns of the students were completely different compared to two years ago. In this post, I present the questions raised by participating students. Over the next few months, I will address each question in detail. As I work through this exercise, I encourage all readers of this blog to ask additional related questions.<br />
<br />
<b>Questions Asked by Life Science Students</b><br />
<br />
As in 2010, I was truly impressed with the questions asked at the mentoring session. These questions, paraphrased below, reflect the evolving discussions encompassed by this blog. The questions raised, organized by topic, are:<br />
<br />
<b>Questions About Education and Employment</b><br />
<ul><li>In what ways can I be valuable to companies?</li>
<li>What are the differences between workforce personnel with undergraduate degrees vs graduate degrees?</li>
<li>How can practical experience be built favoring employment in medicinal chemistry?</li>
<li>What opportunities/career paths are available for foreign job applicants?</li>
<li>Does the quality of an educational institution carry any weight?</li>
<li>What perceptions exist relative to job applicants with degrees from foreign countries?</li>
<li>What are the financial benefits for PhD employees compared to BS/MS employees right out of school?</li>
</ul><b>Questions About Roles and Opportunities in Drug Discovery Organizations</b><br />
<ul><li>Are there interdisciplinary opportunities available for medicinal chemists in other functional areas related to drug discovery?</li>
<li>Is a PhD required to lead a project?</li>
<li>How do organic chemists interact with biologists?</li>
<li>Can a biologist become a medicinal chemist?</li>
<li>Is computational chemistry important to medicinal chemistry?</li>
<li>How does a molecular biologist fit into a drug discovery organization?</li>
<li>Is medicinal chemistry only relevant to drug discovery?</li>
</ul><b>Questions About Medicinal Chemistry and the Drug Discovery Process</b><br />
<ul><li>How does the drug discovery process begin?</li>
<li>What is involved in drug discovery from concept to market?</li>
<li>Is medicinal chemistry used in veterinary medicine?</li>
<li>Are animal models still used in drug discovery?</li>
<li>What is the transition point from animal models to human clinical trials?</li>
<li>How much medicinal chemistry is dedicated to making small quantities of many compounds vs large quantities of fewer compounds?</li>
<li>What is the importance of making derivatives of natural products?</li>
<li>Do medicinal chemists collaborate with physicians?</li>
<li>Do medicinal chemists collaborate with biochemists?</li>
</ul><div style="margin-bottom: 0px; margin-left: 0px; margin-right: 0px; margin-top: 0px;"></div><div style="margin-bottom: 0px; margin-left: 0px; margin-right: 0px; margin-top: 0px;"></div><div style="margin-bottom: 0px; margin-left: 0px; margin-right: 0px; margin-top: 0px;"></div><div style="margin-bottom: 0px; margin-left: 0px; margin-right: 0px; margin-top: 0px;"><b>Questions About Business Strategies</b></div><ul><li>Is there pressure to get new products out the door?</li>
<li>Can old drugs be used for new indications?</li>
</ul>As with my previous series, it is my hope that those of you following this blog will add your voices and opinions to mine thus enhancing the breadth of insight provided to the next generation of students entering the life sciences workforce.Daniel E. Levyhttp://www.blogger.com/profile/05609535387028309791noreply@blogger.com6tag:blogger.com,1999:blog-371148246405005788.post-72367655861723885652012-02-01T21:29:00.001-08:002012-03-11T16:03:42.391-07:00Recent Activities and Future Plans - I'm Still Here!!!My apologies for the long delay since my last post. Since beginning this blog, I strive to post at least once per month. Unfortunately, due to a very busy end-of-the-year, blogging slipped.<br />
<br />
As you are aware from the content of my posts and from my personal website (<a href="http://www.DELbiopharma.com/">www.DELbiopharma.com</a>), I am a consultant providing the following services:<br />
<ul><li>design and implementation of medicinal chemistry programs</li>
<li>chemistry outsourcing management</li>
<li>technical due diligence</li>
</ul>As a consultant, it is absolutely essential for me to continually network and market my services. Time for these activities must be allotted in addition to the time that I spend working with my clients. From all aspects, the combination of scientific engagement and personal interactions is unparalleled to any employment situation I experienced prior to becoming a consultant. That being said, I would like to focus this post on both highlights of the past 6 months and events planned for the near future.<br />
<br />
<b>Recent Activities</b><br />
<br />
During the second half of the summer, I had a full load of clients - all with unique needs. One in particular required the synthesis of several compounds within an extremely aggressive timeline. After contacting seven different contract research organizations (CROs), I was able to identify one that was willing to take on this project within the parameters of the required timeline. I am happy to say that this project, arguably the most difficult assignment I took on, was completed on time with all objectives met.<br />
<br />
As indicated above, networking is critical to the establishment of a contract pipeline. As such, I regularly go to local networking events and conferences. The following is a list of groups I find particularly interesting in the San Francisco area:<br />
<ul><li>BioScience Forum (<a href="http://www.biosf.org/">www.biosf.org</a>)</li>
<li>Bio2Device Group (<a href="http://www.bio2devicegroup.org/">www.bio2devicegroup.org</a>)</li>
<li>Bay Area Biomedical Consultants Network (<a href="http://babcn.net/">babcn.net</a>)</li>
<li>CACO-PBS (<a href="http://caco-ca.org/">caco-ca.org</a>)</li>
<li>BioE2E (<a href="http://www.bioe2e.org/">www.bioe2e.org</a>)</li>
<li>QB3 (<a href="http://qb3.org/">qb3.org</a>)</li>
</ul>In August, I was asked to present a talk at a BABCN event entitled "Creating Opportunities - Generating Consulting Income in a Hostile Market." This talk was well attended and I received a great deal of positive feedback.<br />
<br />
In January, I participated in the CSU Biotechnology Symposium as a career mentor. The following week, I attended the JP Morgan Healthcare Conference. One week later, I attended the Personalized Medicine World Conference.<br />
<br />
As a follow-up to my BABCN presentation in August, I was invited to write a guest blog covering a key component of my consulting activities - identifying, engaging and managing CROs. This blog was posted on January 31 and can be found at <a href="http://hamptonexecutivesearch.com/?p=1497">http://hamptonexecutivesearch.com/?p=1497</a>.<br />
<br />
<b>Future Activities</b><br />
<br />
Having brought you up to date from the past 6 months, the following is a list of plans for the near term.<br />
<br />
As networking is essential to my ongoing consulting activities, I plan to attend the following conferences:<br />
<ul><li>InformexUSA 2012 (<a href="http://www.informex.com/">www.informex.com</a>)</li>
<li>Molecular Medicine Tri-Conference (<a href="http://www.triconference.com/">www.triconference.com</a>)</li>
<li>American Chemical Society National Meeting (<a href="http://www.acs.org/">www.acs.org</a>)</li>
</ul>During the American Chemical Society meeting, I will be speaking as part of a symposium discussing chemistry careers outside of the laboratory.<br />
<br />
Finally, as a follow-up to the CSU Biotechnology Symposium in January, I will be posting blogs addressing all of the questions raised at my table during the career mentoring session. These posts will begin in February and continue until all questions are answered.<br />
<br />
As always, I encourage you to bring up any topics you would like discussed in this forum.Daniel E. Levyhttp://www.blogger.com/profile/05609535387028309791noreply@blogger.com3tag:blogger.com,1999:blog-371148246405005788.post-5048006024248844192011-07-05T23:19:00.000-07:002011-07-05T23:19:44.747-07:00Unnerving Trends in the Pharmaceutical Industry"Houston, we have a problem." This phrase, credited to the crew of the Apollo 13 lunar mission, has been used in many contexts (both seriously and comically) to describe difficult situations. In worst-case scenarios, like Apollo 13, profound and life-changing (challenging) consequences may emerge. In today's economy, one may paraphrase this to "ACS, we have a problem."<br />
<br />
ACS (the American Chemical Society) is an organization dedicated to the promotion of the chemical sciences through educational programs, industry support and government lobbying. Twice a year, it brings together thousands of chemists to exchange thoughts on the future of science, the status of academia/industry and government policy. Additionally, career resources are continually provided to aid ACS members in advancing their careers or identifying opportunities to regain or maintain employment. Such resources are extremely valuable in these days of continued downsizing and outsourcing. However, even the ACS cannot create jobs where few exist. In previous years, the back of Chemical & Engineering News was full of job advertisements for chemists. Furthermore, the ACS sponsored career fairs were supported by hundreds of potential employers with jobs spanning all levels of experience. I am sad to say that these advertisements are sharply diminished compared to previous years. It is no secret that among sectors, the pharmaceutical industry is among the hardest hit.<br />
<br />
Fully recognizing that these trends are industry-related and not the fault of the ACS, the question is now "what can be done to restore growth to the pharmaceutical industry?" In order to answer this question, it is important to understand the causes of the present multi-year downturn. These causes can be traced back to the marketing of "blockbuster" drugs and the resulting year-over-year double digit returns to investors. As patent protection for the existing inventory of "blockbuster" drugs expires, the pharmaceutical industry is forced to look at lower revenues and increased competition from generics. At the same time, the existing drug development pipeline is deficient in new "blockbuster" products to replace those going off patent. Lower revenues coupled with continued demands from investors for high returns forces corporate downsizings. Such downsizings are typically at the expense of research - the efforts generating long-term revenues. With research departments minimized or eliminated, there are fewer quality products entering development - the efforts generating short-term revenues. With fewer and/or premature compounds entering development, the likelihood of late-stage clinical failure is increased. This trend directly results in decreased investor confidence. With decreased investor confidence, there is less money available for investment in the pharmaceutical industry. Less money means fewer jobs and fewer products advancing into the clinic. IT IS THIS CYCLE THAT MUST BE BROKEN IN ORDER FOR THE PHARMACEUTICAL INDUSTRY TO RECOVER!!!<br />
<br />
<b>Emerging Trends in the Pharmaceutical Industry</b><br />
<br />
Understanding the cycle leading to poor investor confidence is only the beginning. In order to reverse the pharmaceutical industry's downward spiral, we must implement new paradigms and develop them to their full potential. Such paradigms include:<br />
<ul><li>personalized medicine - novel therapeutics with companion diagnostics</li>
<li>efficient use of both in-house and outsourced activities</li>
<li>streamlined processes enabling the "forced failure" of programs more likely to fail so efforts can be focused on programs most likely to succeed.</li>
</ul>Regarding personalized medicine, I posted two articles on this subject (see postings on November 12, 2010 and February 27, 2011). Furthermore, the potential that can be realized through the ability to screen likely patients in order to assess their likelihood of responding to an experimental therapeutic is dramatic. To cite data presented by James Sabry (Vice President of Genentech Partnering) at a recent networking event, 4000 drugs were tracked from clinical trial to market from 2004-2010. Of this set of drug candidates, only 9% achieved FDA approval. Broken down to the clinical stages, 63% advanced through phase I clinical trials. Of the 63%, only 33% advanced through phase II clinical trials. Of that 33%, 55% advanced through phase III clinical trials. Finally, 80% of those advancing through phase III received approval. In order to restore investor confidence and rebuild our industry, these percentages must rise. Through exclusion of clinical trial participants lacking necessary biomarkers, these percentages will increase.<br />
<br />
Regarding the combined use of in-house and outsourced activities, I continually comment on industry trends, employment challenges and novel career opportunities. Two postings on these topics (see postings on August 21, 2009 and October 25, 2009) go into great detail regarding current and emerging trends. The reality is, outsourcing is here to stay. Once accepting this reality, potential new opportunities come to light. In the May 9, 2011 issue of Chemical & Engineering News (pg 48-51), I was quoted regarding trends and opportunities in "Managing Outsourcing." Specifically, as organizations continue to view synthetic chemistry as "outsourceable," these same organizations recognize that management of these activities requires one both skilled and knowledgeable in the science of organic/medicinal chemistry. Problems always arise when working with CROs. Success is dependent upon how efficiently these problems can be addressed. Furthermore, simply being able to prepare compounds is not a replacement for the ability to design the right compounds to prepare. In my experience, the most efficient combination of in-house and external resources utilizes a small internal infrastructure for development of robust synthetic methodologies in concert with the technical talents of CROs for the synthesis of targeted compound series dependent upon these methodologies.<br />
<br />
Regarding streamlined processes, early drug discovery efforts were somewhat linear with compounds advancing through one assay at a time. By utilizing batteries of assays to evaluate structural classes, early indications regarding pharmacokinetics, metabolism and toxicity can be established. Structural series failing to demonstrate early acceptable properties can be terminated in favor of those showing promise. Through "forced failure," more money is spent earlier to save even greater amounts by not advancing sub-optimal compounds into development. Finally, referring to the percentage of drug candidates advancing through phase I clinical trials mentioned above, the "forced failure" paradigm holds the potential to positively impact this statistic.<br />
<br />
<b>The Future of Employment in the Pharmaceutical Industry</b><br />
<br />
While the above describes trends likely to result in greater success and return on investment, it does little to address the current state of employment in this industry. While the <a href="http://www.bls.gov/cps/">unemployment rate in the United States is around 9.1%</a>, the unemployment rate in the pharmaceutical industry (including biotechnology) is almost twice that. While disheartening, I continually post on strategies for maintaining employability as well as what types of opportunities are available for those displaced in a shrinking job market. Additionally, in the April 18, 2011 issue of Chemical & Engineering News (pg 49-51), I was quoted in an article focused on "Survival Skills." The lessons are more relevant now than ever - those currently unemployed must find ways to stay active in this industry or risk not finding employment as conditions improve. In today's economy, there are plenty of reasons for not getting paid. However, there are no excuses for not working.<br />
<br />
Even with the unemployment trends, there are those who have the potential to influence policy and, at least partially, restore growth to this industry. These individuals are our congressional leaders and big-pharma executives. <br />
<br />
In the current state of the pharmaceutical industry, large companies have turned to small biotechnology companies to enhance their development pipelines. However, these deals, especially for earlier stage compounds, come with high milestone payments. Consequently, deals between large and small companies are dissolving in attempts to minimize these payments. The unfortunate result is small companies being forced to develop their products without the backing of larger organizations. The increased corporate expenses related to clinical development often result in significant corporate downsizings - thus compounding the current employment climate (Chemical & Engineering News, June 20, 2011, pg 15-20). In an industry where high risk yields high reward, the current risk adverse nature of those influencing the pharmaceutical industry continues to result in downward pressure on the economy. Downstream, these trends will inevitably be reflected in fewer new products and continued medical indications with no available effective treatments. <br />
<br />
With the number of highly innovative scientists displaced due to mergers, outsourcing and downsizing, the talent pools in both local industry hotspots and nationwide are unprecedented. Even so, <a href="http://www.bloomberg.com/news/2011-06-23/lilly-ceo-blames-immigration-and-tax-laws-for-slower-innovation.html">John Lechleiter (CEO of Eli Lilly & Co.) is lobbying for US immigration officials to issue more green cards for highly skilled immigrants</a>. While I am all for opening up opportunities for the most qualified individuals, isn't it incumbent upon us to first look after those who, through no fault of their own, found themselves unemployed?<br />
<br />
Regarding the rich pool of available talent, the trends and paradigms discussed in this posting should generate a great deal of optimism. Once the dust settles and new business models emerge, growth will return. Furthermore, with appropriate financial resources, the available talent pools will inevitably give rise to a new generation of start-up companies creating new opportunities for innovation. As Apollo 13 began with a problem and returned safely home, so too will the pharmaceutical industry. After all, we are a growing and aging population. We will always need to eat, we will always generate garbage and we will always require medication.Daniel E. Levyhttp://www.blogger.com/profile/05609535387028309791noreply@blogger.com4tag:blogger.com,1999:blog-371148246405005788.post-48921597647780095312011-03-29T22:28:00.000-07:002011-03-29T22:28:40.402-07:00Organic Chemistry Degrees - Training in Thinking vs Training in DoingA recent editorial in Chemical & Engineering News, along with an accompanying article, has had me thinking about the future and quality of our educational programs. The editorial entitled "Too Many Ph.D.s?" and the article "Doctoral Dilemma" both appeared in the January 31 issue and, not surprising, have received significant interest and responses. Presently, I am attending the Anaheim ACS meeting and, in light of the high caliber of science being presented around me, I feel a need to add my thoughts to this discussion.<br />
<br />
I received my PhD under the supervision of Professor Satoru Masamune at the Massachusetts Institute of Technology. As part of my graduate studies, I was responsible for the design and execution of synthetic strategies leading to the total synthesis of Calyculin A. Those of you who may be familiar with this natural product will recall that it is a highly structurally diverse molecule with an aminosugar unit, a heterocycle, a spiroketal and a tetraene. The two fragments I worked on were the aminosugar and the tetraene. In addition, I designed a novel approach for the introduction of necessary chirality adjacent to the heterocycle. In all cases, my efforts began with an exhaustive study of the target structures as matched with the structures of available starting materials and availability of key reagents. At no time did I receive instructions as to how I was to approach my assigned tasks. Instead, I was given the freedom to execute on my ideas and drive these efforts as far as they could go based upon the available technology. I would not be honest if I suggested that each attempt worked as planned. However, each strategy, successful or not, allowed me opportunities to ask questions, find answers and evaluate results. My technical experience was a byproduct of the extensive chemical studies I pursued. After all, how could I answer questions without doing the experiments.<br />
<br />
My undergraduate research activities, in contrast to those in graduate school, fell under the tutelage of Professor Henry Rapoport. In his labs, I was assigned specific tasks with generally understood protocols. My role was initially to support the efforts of a post doc. Later, I was assigned more independent studies allowing me to begin thinking about chemistry rather than simply following instructions. So, when comparing my undergraduate experiences to my graduate studies, Rapoport taught me how to do chemistry and Masamune provided me the opportunity to teach myself how to think about chemistry. Both experiences were essential to my academic and professional development.<br />
<br />
<b>Current Educational Programs - Are We Training Too Many Ph.D.s?</b><br />
<br />
<b></b>In the present job climate, there is no question that medicinal chemists have endured more than their fair share of problems. With the continuing trend of corporate takeovers and subsequent shutdowns, there is plenty of available talent with nowhere near enough new jobs being formed to absorb the unemployed. At the same time, graduate programs continue to produce a new generation of chemists eager to enter the workforce. In anticipation of the extremely high level of competition for any available position, I have heard it argued that some graduate student mentors are tailoring their programs to meet specific needs of companies. If true, this type of "apprenticeship" risks compromising the quality of the PhD degree in favor of the short term benefit of "grooming" students for entry into chosen professions.<br />
<br />
As I discussed in the first section of this post, a complete education involves a combination of technical and intellectual training. Without a firmly established ability to generate and test independent hypotheses, an advanced education would be incomplete. After all, as "PhD" stands for "doctor of philosophy," is it an unfair expectation that those holding such a degree should be capable of generating and testing their philosophies - even when they differ from more conventional thinking? Without new thoughts and ideas, progress will come to a complete standstill. That having been said, I have not been in the academic setting for many years and cannot evaluate the current trends beyond what is reported. I can only hope that the quality of advanced education today remains as high as it was when I received my PhD.<br />
<br />
Returning to the question of whether we are training too many PhDs, the ability to think is not restricted to an individual field of thought. If one is capable of imagining, endless possibilities become available. This applies not only to the advancement of technology, but also to professional development. Yes, the job market is unstable. Yes, there are few available jobs. Yes, there are many unemployed chemists. However, there are numerous areas where creativity can lead to exciting career options - even if not along envisioned paths. As I have communicated throughout this blog, the key to success is not along one path. Today, it is essential to continually learn new skills, reinvent oneself and be adaptable to opportunities presented. From this philosophy, it is not the number of PhDs that we need be concerned about, but rather what we are preparing our PhDs to do. If we train PhDs to think creatively, as I believe we do, there is no limit to what can be accomplished.Daniel E. Levyhttp://www.blogger.com/profile/05609535387028309791noreply@blogger.com3tag:blogger.com,1999:blog-371148246405005788.post-61757431256575263052011-02-27T00:30:00.000-08:002011-02-27T00:30:03.682-08:00Personalized Medicine - Additional ThoughtsSince my posting on personalized medicine (November 12, 2010), I had many discussions with my colleagues and peers regarding the true utility of genetic screening and the utility of biomarkers in establishing appropriate therapeutic regimens. While many agree with me regarding the promise of this approach, there are some dissenting opinions - most of which limit the reach of personalized medicine to cancer and bacterial infections. Regardless of opinion, a recent presentation by James Sabry (February 17, 2011 - www.growbold.com) would have been of great interest to all camps.<br />
<br />
In his discussion, Sabry argued that the success rate for new drug approvals suffers, in part, from heterogeneous patient populations. Specifically, these patient populations include groups that are genetically pre-disposed to be non-responders. If we could screen out these non-responders from any clinical trial, drug response rates are likely to improve and more clinical endpoints will be met. The result, while relevant to smaller patient populations, will be better therapeutic agents. The key to all of this lies with the development of diagnostic tests for pre-screening patients prior to prescribing medications. In the cancer arena, Genentech is taking a lead position with the development of disease-specific antibodies tethered to chemotherapeutic agents. While, at present, this will not address all forms of cancer, I believe that this strategy is moving in the right direction.<br />
<br />
<b>The Rx/Dx Model - What it Means for Big Pharma</b><br />
<br />
One of the challenges facing the pharmaceutical industry relates to the market potential of any given product. After all, the drug industry, like any other, is a money-making enterprise with financial responsibilities to investors. As such, the larger the market potential of a given product, the more attractive the program to large companies. To put this in another perspective, it is far easier for a company to earn one billion dollars per year from a single product than it is to earn the same amount from ten products with markets of one hundred million dollars per year. Aside from the reduced number of programs to manage, fewer dedicated personnel are required in areas such as sales/marketing, QA/QC and manufacturing.<br />
<br />
In order to obtain blockbuster status, therapeutic agents must target the largest potential patient populations. However, these patient populations are heterogeneous and include various sub-populations - many of which will not respond. From an economic standpoint, this does not matter to business as long as the therapeutic does no harm. However, the waste associated with the money spent on products not benefiting patients is significant. Introduction of companion diagnostics, while beneficial to patients, will likely reduce the potential market size of therapeutic agents resulting in lower profits for drug companies. I FIRMLY BELIEVE THAT THIS SHOULD NOT BE A CONSIDERATION FOR DRUG COMPANIES! After all, if a patient will not respond to a given drug, that drug should not be sold to that patient. In further support of this assertion, Sabry, in his February 17 talk, argued that pharmaceuticals should only be paid for if they work. While such business models don't currently exist, there is a great deal of merit to this argument that can only result in better products.<br />
<br />
Regarding the potential reduced markets for diagnostic-coupled therapeutics, this should not be a deterrent to the pharma industry. To the contrary, this paradigm has great potential. If diagnostics can differentiate large populations into smaller responsive populations, they can also define additional patient populations suffering from conditions with unmet medical needs. Furthermore, additional revenue will be realized from the diagnostics which, as a screening tool, will be used on all patients seeking treatment for ailments with established biomarkers. While the number of blockbuster drugs is likely to decline, the Rx/Dx paradigm is a potential gold mine of opportunities poised to improve the efficiency of drug discovery and the overall quality of healthcare to the general population.Daniel E. Levyhttp://www.blogger.com/profile/05609535387028309791noreply@blogger.com2tag:blogger.com,1999:blog-371148246405005788.post-79431154117459189082011-01-27T20:11:00.000-08:002011-01-27T20:12:12.258-08:00Staying Employed, Maintaining Employability and Finding WorkMy apologies for the delay since my last post. Between the holidays and some major networking opportunities, my time has been very scarce.<br />
<br />
In my last post, I reached out to you to learn what topics you wanted me to address. Among them was a series of questions focused on developing skills that are not "outsourcable" in today's global market. To directly address this question, I believe that all skills are essentially "outsourcable." However, that does not mean that all skills will be outsourced. There are a tremendous number of activities, necessary to the operation of a successful business, that are more efficient (based on time, money and logistics) when not outsourced. Among these is the ability to efficiently manage, maintain and troubleshoot projects from remote locations. Certainly, when faced with outsourcing problems, the ability to assess and correct without having to be on site is marketable.<br />
<br />
While managing outsourced activities is a useful skill, this does not help undergraduates as they are not typically in positions requiring management of outsourced chemistry. Instead, I refer back to my assertions in previous posts that, at least in the drug discovery arena, the broadest knowledge/skills in organic synthesis are essential. Such skills, however, cannot be obtained through the requisite course material. Undergraduates seeking to expand their organic chemistry skills have to seek additional educational resources such as undergraduate research and industry-relevant summer internships.<br />
<br />
While summer internships may introduce young chemists to industrial environments, they actually do little to provide broad educational experiences. However, finding a mentor via undergraduate research programs will. This is, in fact, how I prepared myself for graduate school. When I realized that I wanted to specialize in organic chemistry, I approached Professor Henry Rapoport. He was highly receptive to my joining his group. Through that experience, I began studying heterocyclic chemistry and explored the conversion of amino acids to 4-amino-4-deoxy sugars. Additionally, I was introduced to my first medicinal chemistry project - preparing rigid analogs of the glaucoma drug pilocarpine.<br />
<br />
While there are many valuable skill sets, trends in outsourcing will continue to advance and decline - based on corporate needs, perspectives and strategies. However, the underlying knowledge required to navigate this "employment at will" environment will always be rooted in the foundation and breadth of acquired education.<br />
<br />
<b>Maintaining Employability through Networking - A Self-Taught Skill</b><br />
<br />
While the preceding paragraphs emphasized the value of a strong education, they did not focus on skills important to finding and maintaining employment. Among the most important is networking. Sure, while social groups such as Facebook, Linked-in and Twitter can provide some resources, the greatest networking activities involve face-to-face introductions/conversations. These must also be accompanied by diligent follow-up.<br />
<br />
For me, the first two weeks of January were packed with networking opportunities. The first was the JP Morgan Healthcare Investor Conference. This annual event, bringing together executives and venture capitalists from around the world, is the largest of its kind and conveniently takes place in San Francisco. Following JP Morgan was the New Paradigms for Biotechnology Funding and Development conference. Finally, during the following week, I attended the Personalized Medicine World Conference. Overall, these conferences allowed me to meet numerous individuals including executive recruiters, consultants, executives and industry analysts.<br />
<br />
While major networking events, like those just described, present valuable opportunities to expand networks, one must not discount the smaller networking groups which usually meet monthly. The groups I frequently attend include BioSF, Bio2Device Group, BioE2E and BABCN. All of these groups have websites with valuable industry information.<br />
<br />
In closing, most of one's success will always depend upon a strong knowledge and skill base. However, There is always a component that directly relates to who one knows and what opportunities are available at any given time. The value of networking will not always be immediately recognized - but when it pays off, the dividends are usually significant.Daniel E. Levyhttp://www.blogger.com/profile/05609535387028309791noreply@blogger.com3tag:blogger.com,1999:blog-371148246405005788.post-44499347576023307172010-12-05T23:06:00.000-08:002010-12-05T23:06:16.949-08:00Organic Chemistry - What Do You Want to Hear About?Dear Readers,<div><br />
</div><div>For over a year, I have been posting my thoughts on organic chemistry issues from both academic and industrial perspectives. While the press emerging from many news agencies tends to be negative, I choose to view the chemical industries from a broader and more optimistic perspective. I view these philosophies as both realistic and necessary. After all, if chemistry touches almost every aspect of daily life, it seems illogical that this industry, while suffering in the current economy, will disappear. Furthermore, negative press may tend to dissuade younger individuals from pursuing careers in the life sciences. Through my efforts, I endeavor to convince students that the future will present many new and exciting opportunities.</div><div><br />
</div><div>While this blog generally reflects my thoughts and opinions on subjects I choose to address, I also want to speak to issues important to others. In this vein, I ask you to send me questions and/or concerns relevant to the scope of this blog. I look forward to your queries and the discussions that will follow.</div><div><br />
</div><div><br />
</div>Daniel E. Levyhttp://www.blogger.com/profile/05609535387028309791noreply@blogger.com3tag:blogger.com,1999:blog-371148246405005788.post-31691540913096210842010-11-17T21:22:00.000-08:002010-11-17T21:22:27.363-08:00Chemistry and the Teenage MindToday, I had the unique experience of visiting my son's middle school science class. The teacher, as part of the curriculum, is bringing in guests to teach his class about real-world science. I was the first.<br />
<br />
In preparation for this class, I thought about how I could impress upon the students the importance of chemistry. Initially, I thought about discussing anecdotes from my childhood that reflected my interest in science. However, realizing that some of my "experiments" were extremely dangerous and certainly not executed under adult (or parental) supervision, I opted to omit details in this area. After all, I did not want to give ideas to these young and impressionable (and somewhat unpredictable) teenagers. After some thought, I decided that a two-part discussion was appropriate. The first part was to focus on how chemistry impacts everyday life and the second part was to be a brief presentation based on one of the drug discovery projects I worked on.<br />
<br />
When I was introduced to the class, I initially took questions from the students. These generally related to what my area of expertise is and what are the steps involved in the discovery of new medicines. These questions, as they related directly to my slide presentation, were tabled until the second half of the class.<br />
<br />
The second half of class was uneventful. I described the drug discovery paradigms of past and current years along with exploratory research relating matrix metalloproteinase inhibitors to inhibitors of endothelin converting enzyme. The students were engaged and sufficiently grossed out when I discussed studying urine and feces for drug-related metabolites. While this discussion gave them a flavor for the exciting opportunities available to those pursuing careers in the life sciences, the students seemed much more enthusiastic about the chemistry in everyday life challenge presented in the first part of my visit.<br />
<br />
Teenagers, by nature, take a great deal for granted. They are quite reliable in their abilities to not think about where things come from. For example, money comes from parents, toilet paper comes from Costco, gasoline comes from gas stations and food/medicine comes from stores. So, when I presented the possibility that chemistry was everywhere, the students actually thought about this idea. As a follow-up, I went around the class asking each student to name something that they felt was not related to chemistry. Interestingly, at least one fourth of the class felt that chemistry was everywhere. The other students managed to come up with rather creative questions. Such questions tended to involve biological processes (vision and movement of limbs) rather than materials. Still, realizing that biology involves numerous biochemical reactions, these questions were relevant.<br />
<br />
Towards the end of this discussion, I directed the students to consider materials. A door, for example, is made of wood. The wood is held together by glue, laminated with a coating and stained to a desired color. While the wood may be from a natural source, agriculture plays an important role in obtaining such products. Thus, the finished door was the direct result of chemical substances including:<br />
<ul><li>adhesives (glue)</li>
<li>pigments (stain)</li>
<li>polymers (laminate)</li>
<li>pesticides </li>
</ul>As a direct result of this conversation, the class understood that chemistry does, in fact, impact practically every part of our daily activities including, but not limited to:<br />
<ul><li>clothing (polymers, pigments)</li>
<li>toothpaste/soap/shampoo</li>
<li>food (pesticides, ingredients, preservatives, packaging)</li>
<li>water</li>
<li>medicine</li>
<li>building materials</li>
<li>cars</li>
<li>roads</li>
</ul>Regarding the roads, one student suggested that if a road was made by hand using only gravel found on the adjacent hillside, and the road was only used by people walking barefoot and naked then there would be no chemistry involved. No chemistry, that is, except for the natural mineral composition of the gravel.<br />
<br />
So, chemistry is truly everywhere.Daniel E. Levyhttp://www.blogger.com/profile/05609535387028309791noreply@blogger.com5tag:blogger.com,1999:blog-371148246405005788.post-68001381116344868852010-11-12T09:03:00.000-08:002010-11-12T09:04:51.338-08:00Personalized Medicine - Treating the Patient vs Treating the DiseaseThrough the evolution of the drug development process, many factors have been changed and policies adjusted to improve safety, to assure quality and to prove efficacy. Much work in this area was driven by a core philosophy, enforced by the FDA, that in order to protect patients, medications must be proven both safe and efficacious. In order to prove these claims, drug candidates are subjected to rigorous assays designed to assess the following responses in various patient populations:<br />
<ul><li>maximum tolerated dosages</li>
<li>potential adverse effects (both chronic and acute)</li>
<li>disease/disorder/symptom response</li>
</ul>Throughout this process, certain parameters must be standardized in order to design feasible animal and human protocols because the physical traits among animal and human populations are heterogeneous. Examples of such traits include metabolism and body weight.<br />
<br />
Metabolism relates to the speed at which a therapeutic agent, once introduced into the body, is eliminated. Based on an individual's dietary habits and genetic profile, metabolic rates can range from rapid to slow. Such variances are often reflected in body weight where individuals with rapid metabolism may weigh less than those with slow metabolism. Where pharmaceutically active substances are concerned, patients with high metabolic rates will eliminate these agents more rapidly than those with slow metabolic rates. <br />
<br />
Body weight is not necessarily a result of dietary habits. It is, in many cases, dependent upon an individual's genetic profile. While body weight is not necessarily an indication of one's health, it does impact how one will respond to pharmaceutically active substances. For example, a heavy person will generally be able to tolerate more alcohol consumption than a leaner companion. This effect easily translates to medications where a given dosage will induce a stronger pharmacological response in a leaner individual than in a heavier person.<br />
<br />
Thus, from the simple perspectives of weight and metabolism, it is easy to see that all patients are not the same - even if they present with similar symptoms. If this is the case, why does the pharmaceutical industry market medications in a one-dose-fits-all paradigm? The answer is very simple. It is not practical to produce an individual dosage for an individual person based on the biological variables within our heterogeneous population. Medications must be standardized based upon the maximum tolerated dosages and then recommended for patients presenting with symptoms classifying them as suffering from a common disease/disorder. In this manner, the pharmaceutical industry has historically targeted the disease and not the patient. With advancements in personalized medicine, all that is changing.<br />
<br />
<b>Genetics - Links Between Patient Populations and Drug Efficacy</b><br />
<br />
While weight and metabolism may explain the extent of a patient's response to a given medication, these factors provide little information as to why one patient with a given set of symptoms responds to a given therapeutic while another patient with a similar set of symptoms shows no response to the same treatment. In many cases, the cause of such variances in response rates lies within an individual's genetic code. Thus, in order to truly treat the patient, an understanding of genetics is essential.<br />
<br />
Today, there are few examples of truly personalized medicine. One notable exception applies to breast cancer. While breast cancer is commonly classified as a single disease, it is actually a family of diseases - all affecting breast tissue. Because different types of breast cancer have different genetic profiles, specific biological markers have been identified which help to determine appropriate therapeutic regimens. One potential component of such regimens is the drug herceptin.<br />
<br />
Herceptin is a monoclonal antibody targeting HER2 proteins. When a breast cancer cell line overproduces HER2, introduction of herceptin to the chemotherapeutic regimen increases both survival time and response rate compared to chemotherapy without herceptin. Furthermore, when the cancer is not HER2 positive, there is no significant therapeutic benefit to the use of herceptin. Thus, herceptin represents an example of a medication useful for a specific form of breast cancer in a specific population of patients.<br />
<br />
While most new medications are still targeting the diseases, the concept/philosophy of personalized medicine is the driving force behind a new wave of interest in the biopharmaceutical industry. Since the first sequencing of the human genome, the time required for a complete human genetic profile has been reduced from years to days. Furthermore, the costs associated with genetic sequencing have been proportionately reduced. One leader in these endeavors is Pacific Biosciences - a company dedicated to the development of real-time genetic sequencing. <br />
<br />
One problem slowing the realization of truly personalized medicine is the lack of information on genetic variations throughout human populations. In this area, efforts are underway to catalog genetic diversity amongst thousands of individuals. Pilot data has already revealed more than 15 million genetic differences in a population of only 179 people from various populations (C&EN Nov. 1, 2010, pg 8). Furthermore, each individual was found to average from 250-300 genetic mutations preventing normal gene function and 50-100 gene variants implicated in congenital disorders. <br />
<br />
While true personalized medicine is still on the horizon, adoption of this philosophy to the life sciences is creating new opportunities in fields including:<br />
<ul><li>cell biology</li>
<li>genetics</li>
<li>drug discovery</li>
<li>diagnostics</li>
</ul>Through personalized medicine, our understanding of diseases will be improved, patients will receive appropriate medications and side effects will be reduced - resulting in better healthcare for all.Daniel E. Levyhttp://www.blogger.com/profile/05609535387028309791noreply@blogger.com1tag:blogger.com,1999:blog-371148246405005788.post-10790470780210293002010-10-19T15:45:00.000-07:002010-10-19T15:45:54.788-07:00Consulting in BiopharmaJust a quick note today. I was recently asked to describe my experiences as a consultant. <a href="http://chemjobber.blogspot.com/2010/10/interview-dr-daniel-levy-talks-about.html">Part 1</a> and <a href="http://chemjobber.blogspot.com/2010/10/interview-dr-daniel-levy-talks-about_19.html">part 2</a> of the resulting interview are posted on the <a href="http://chemjobber.blogspot.com/">Chemjobber </a>blog.Daniel E. Levyhttp://www.blogger.com/profile/05609535387028309791noreply@blogger.com0tag:blogger.com,1999:blog-371148246405005788.post-9664228216055233032010-10-15T16:08:00.000-07:002010-10-15T16:08:25.750-07:00New Paradigms in Drug DiscoveryWith ongoing uncertainty in the economy, two issues impacting potential rebounds in industry are:<br />
<div><ul><li>the lack of new funds available for investment, and</li>
<li>the need to deliver a rapid return on investment capital.</li>
</ul></div><div><div>There is perhaps no sector impacted more by these two issues than pharmaceuticals. The reasons are in fact quite plain. Products cannot be advanced from research through the clinic without appropriate funding. Furthermore, the drug discovery process is inherently slow requiring up to 15 years for successful programs to reach market. As I have discussed in various postings, these issues, while formidable, can be addressed through creative business models. In this vein, at the ACS meeting in Boston, I learned of Lilly's PD2 program. This effort, effectively recruits small companies and academic laboratories by offering free and confidential compound screening with the intention of mining this chemical space for potential products to develop and/or potential collaborative relationships. </div></div><div><br />
</div><div>The PD2 program is innovative in that it utilizes the broad capabilities and chemical space provided by a broad network of settings for the purpose of advancing its drug discovery pipeline. Within the parameters of this program, </div><div><ul><li>potential collaborators submit compound structures to a confidential on-line evaluation tool</li>
<li>following evaluation of submitted structures, those deemed interesting to Lilly's programs are selected for screening</li>
<li>following screening of interesting structures, those with promising activity profiles become subjects for collaborative development activities</li>
</ul></div><div>If you are a small company or an academic group with limited screening capabilities, how can you lose? This is especially important regarding compounds that are not of interest to Lilly - companies/academics retain all IP rights. In the end, small companies/labs with limited resources identify potential development partners and Lilly gets to enhance its research/development pipelines. From the corporate perspective, this is truly a win-win scenario providing a new dimension to the paradigm shift impacting today's pharma/biotech sector.</div><div><br />
</div><div><b>Corporate Win-Win Scenarios - Where do Employees Fit In?</b></div><div><br />
</div><div>Looking at PD2 from inside of Lilly's corporate headquarters or from within the labs of a potential small company collaborator, compounds are changing hands and the no-cost synergistic resources available are enough to entice business personnel from both entities to enter into mutually beneficial contractual relationships. However, if viewed from above, one can see a slightly different scenario. On one side, small company scientists engaged in drug discovery activities find a sense of security through potential interest from big-pharma. On the other side, the potential influx of developable compounds might induce Lilly's drug discovery infrastructure to question its long-term importance to the company. After all, if Lilly can obtain drug discovery services for free, why should it employ its own efforts?<br />
<br />
The above argument, while presenting a black-and-white picture, does illustrate a trend towards new paradigms in the pharmaceutical industry. Such paradigms clearly depend upon research activities. However, such research activities are executed through peripheral organizations and not within the infrastructure of parent companies. Nobody disputes the fact that without research, there can be no development pipelines. The only real questions are:<br />
<ul><li>Who does the research?</li>
<li>Where will research activities be located?</li>
</ul>While research activities will always require the talents of skilled and knowledgeable scientists, the location of such activities is still a point of discussion. As I mentioned in previous posts, research infrastructure is very expensive to maintain - especially when priorities shift to development. On the other hand, the ability to draw on research infrastructures without the umbrella of long-term commitments provides an attractive option to parent organizations invested in the success of drug development activities. Through decentralized research models such as PD2, scientists will be able to continue producing cutting-edge research and, at the same time, feed the development pipelines of companies possessing the financial resources capable of bringing new therapeutics to market.<br />
<br />
</div>Daniel E. Levyhttp://www.blogger.com/profile/05609535387028309791noreply@blogger.com3tag:blogger.com,1999:blog-371148246405005788.post-88689294811848634042010-09-16T09:54:00.000-07:002010-09-16T09:55:39.573-07:00The Pharmaceutical Industry - The Economy and The PressOver the past several months, articles appear in the news describing the bleak state of various industries contributing to the overall economic and employment situation facing both future graduates and workers of today. One such article, "<a href="http://finance.yahoo.com/banking-budgeting/article/110592/the-10-american-industries-that-will-never-recover">The 10 American Industries That May Never Recover</a>," was on Yahoo this morning. In this article, the pharmaceutical industry was listed as number 5. The bleak outlook presented read as follows:<br />
<br />
"<span class="Apple-style-span" style="font-family: arial, helvetica, clean, sans-serif; font-size: 13px; line-height: 15px;">This industry has bled workers for three years, and that trend is likely to continue. The largest companies in the sector, such as Pfizer and Merck, have a number of blockbuster drugs that have lost their patent protection in the last decade. They have other pharmaceuticals that will lose that protection in the next decade. Sales of most of these drugs will move to generic companies that will sell them for far less, and erode critical revenue sources for the huge pharma firms. Most companies in the industry admit that they cannot replace the drugs that go off patent fast enough to keep their revenue high. The other reason employment in the sector will stay down and may drop further is that big drug companies are merging to save costs, and most of those costs are people. Pfizer has cut 30,000 people since the start of the recession. Merck has cut 25,000, and these companies and their peers expect that they will have to bring down costs even more.</span>"<br />
<br />
While there is first amendment protection regarding freedom of speech and press, such abbreviated analyses of the present situation provide a far gloomier picture than what can be obtained by applying just a little rational thought. After all, among all of my colleagues and connections, no one is suggesting that the pharmaceutical industry will collapse altogether. Furthermore, there remains considerable need for the discovery of new and better therapeutics addressing indications for which there is an unmet medical need. As long as there is a need, there will be a market.<br />
<br />
In looking at the above analysis of the pharmaceutical industry, the author is correct regarding the downsizing trend affecting this sector. Furthermore, with major products subject to patent expiration, this trend is likely to continue - at least in the short term. However, a greater understanding of the industry should provide hope. With products losing patent protection and becoming generic, one of the first casualties is sales and marketing. Employment in these areas is dependant upon two areas - currently marketed drugs and drugs soon-to-be marketed. With research pipelines being downsized to focus on development, the development pipeline has a limited lifetime. This trend would lead to the conclusion that employment in drug development may suffer. However, without research, there will be no new products to develop or market.<br />
<br />
While research has been a primary casualty over the past 3-5 years, many experts (professionals and recruiters) are beginning to see a change in the market. This should bring some hope to those preparing to enter the workforce. To those graduating with BS/MS degrees, jobs have always been more abundant. To those completing PhD work, a little more time may be necessary before reasonable opportunities present themselves. In today's economy, pursuit of postdoctoral research activities may provide the necessary time and additional experience necessary to enter the workforce from the most competitive perspective.<br />
<br />
<b>The Pharma Industry Casualties - WHAT IS THERE TO DO?</b><br />
<br />
The above discussion, while providing hope to those entering the workforce, does not really address the problem faced by the thousands of scientists who have lost their jobs due to downsizing, outsourcing and company closures. To this sector, I refer to the many previous posts I have published regarding maintaining up-to-date and diverse skill sets. There is work out there and one must be creative in order to identify the appropriate opportunities. Do not be hesitant to try your hand at consulting or applying your skills to related industries. Such industries include:<br />
<ul><li>agrochemical</li>
<li>food</li>
<li>textiles</li>
<li>polymers</li>
<li>biofuels</li>
<li>medical devices</li>
<li>patent law</li>
<li>contract research organizations</li>
</ul>While it may take some time to adapt to different industries, or to build a consulting practice, the payoff will be recognized in the diversity of new skill sets. Most importantly, it is critical to maintain a level of visible activity within your chosen sector. Potential employers will recognize continued efforts and creative thought. Remember, in today's economy, there are plenty of reasons for not getting paid. However, there is no excuse for not working.Daniel E. Levyhttp://www.blogger.com/profile/05609535387028309791noreply@blogger.com2tag:blogger.com,1999:blog-371148246405005788.post-10551474706539378662010-09-14T15:50:00.000-07:002010-09-14T15:50:51.314-07:00Pharmaceuticals and Food Products - Regulation and MarketingOver the past few days, news has emerged focused on two areas of high importance to consumers - pharmaceuticals and food products. From the pharmaceutical side, attention focused on Genentech's Avastin and its potential as a cancer therapy. While approved for the treatment of lung and colon cancer, Avastin was also being marketed for the treatment of breast cancer - an indication not supported by clinical trials. This issue, covered in detail by Ed Silverman (see "<a href="http://www.pharmalot.com/2010/09/bcas-brenner-avastin-and-fda-approval-standards/#more-26213">BCA's Brenner: Avastin and FDA Approval Standards</a>", Pharmalot, 9/14/10), goes hand-in-hand with a post by Derek Lowe (see "<a href="http://pipeline.corante.com/archives/2010/09/14/a_new_way_to_approve_drugs.php">A New Way to Approve Drugs</a>", In the Pipeline, 9/14/10) focused on new paradigms for accelerated drug approval through the combined use of biomarkers, conditional approval and adaptive clinical trials. I will not comment further on these areas, instead referring to the referenced posts, except to say that there still remains significant issues regarding pressure leading to premature drug approval and marketing to consumers.<br />
<br />
From the food product side, recent news indicating that manufacturers of high fructose corn syrup are petitioning the FDA to rename the product "corn sugar" have emerged. Particularly appalling is the <a href="http://news.yahoo.com/s/ap/20100914/ap_on_bi_ge/us_corn_syrup_image">report</a> that "two new commercials try to alleviate shopper confusion, showing people who say they now understand that whether it's corn sugar or cane sugar, your body can't tell the difference. Sugar is sugar." Let me make my perspective absolutely clear - THIS IS A COMPLETE DECEPTION! To back up this statement, the term "sugar" is loosely used to describe the class of organic molecules known as simple carbohydrates. More commonly, the term "sugar" relates to table sugar (sucrose, produced from sugar cane or sugar beets). <a href="http://en.wikipedia.org/wiki/Sucrose">Sucrose</a> is one example from a class of molecules known as disaccharides (chemically joined combinations of two monosaccharide units). The monosaccharide (simple sugar) units making up sucrose are glucose and fructose.<br />
<br />
<a href="http://en.wikipedia.org/wiki/High-fructose_corn_syrup">High fructose corn syrup</a>, obtained from corn starch, begins primarily as glucose. Enzymes are then added to convert the glucose into fructose. The resulting product is a mixture of two separate monosaccharides - glucose and fructose. This mixture is different from sucrose because the glucose and fructose molecules are not chemically bound to one another. It is interesting to note that fructose is not even the major sugar component isolated from corn - its presence in corn syrup is ENHANCED THROUGH ARTIFICIAL MEANS.<br />
<br />
Reasons for wanting to include fructose in food products include cost of production and sweetness. High fructose corn syrup is cheaper to produce than sucrose due, in part, to <a href="http://michaelpollan.com/articles-archive/the-way-we-live-now-the-agricultural-contradictions-of-obesity/">corn subsidies</a>. Regarding relative <a href="http://en.wikipedia.org/wiki/Fructose">sweetness</a><a href="http://en.wikipedia.org/wiki/Fructose"> compared to sucrose</a>, glucose is less sweet and fructose is almost twice as sweet.<br />
<br />
In biology, <a href="http://en.wikipedia.org/wiki/Glucose">glucose</a> plays important roles in energy and metabolism. In fact, it is critical to the production of proteins and lipids and is a precursor to the production of vitamin C. <a href="http://en.wikipedia.org/wiki/Glucose">Fructose</a> has no such biological roles. Additionally, while fructose is introduced into our bodies through consumption of sucrose, this introduction is the result of natural sucrose metabolism. Consumption of high fructose corn syrup essentially results in flooding our bodies with a non-essential and non-nutritive sweetener. DOES THIS MAKE SENSE? DO WE REALLY WANT TO FEED THIS CONCOCTION TO OUR CHILDREN? The food, candy and soft drink industries were doing just fine before high fructose corn syrup. Certainly, we can do without it today.<br />
<br />
<b>Science and Ethics - CAN WE DO IT? vs SHOULD WE DO IT?</b><br />
<br />
At the Boston ACS meeting, I had the pleasure of speaking with Professor <a href="http://en.wikipedia.org/wiki/Roald_Hoffmann">Roald Hoffmann</a>. Our conversation centered around the principle tenants of his lecture that morning entitled "Science and Ethics: A Marriage of Necessity and Choice for the Millennium." During his speech, Professor Hoffmann focused on public suspicion of science relating to ecological, environmental and ethical/moral issues. Of these three areas, I would like to focus on ethical/moral considerations.<br />
<br />
In his lecture, Professor Hoffmann stated that "The invention or implementation of a tool without consideration of the consequences of its use is deeply incomplete. Science is not ethically neutral." He went on to say that "we must consider potential abuses of our well intended work." While both of these statements are absolutely true, scientists are also humans and subject to the same human flaws as the rest of society. This is never more apparent than when we make plans for selfish purposes or simply because there is a high likelihood that such plans can be successfully executed. From this philosophy, consider the following:<br />
<ul><li>We can plagiarize or falsify data, but we shouldn't.</li>
<li>We can generate harmful chemical or biological warfare agents, but we shouldn't.</li>
<li>We can withhold negative clinical data from regulatory agencies, but we shouldn't.</li>
<li>We can promote pharmaceuticals for unproven off-label use, but we shouldn't.</li>
<li>We can promote herbal remedies and dietary supplements for unproven health benefits, but we shouldn't.</li>
<li>We can argue the equivalence between natural substances and manufactured alternatives, but we shouldn't.</li>
</ul>For all of the above, there are examples highlighted by the press. Certainly, such examples are exceptions rather than common practice. However, such exceptions, when impacting high profile topics such as food and medicine, have the potential to make big headlines. As alternatives to the above, consider the following - all of which are standard practices:<br />
<ul><li>We can maintain high ethical standards in all publications, and we should.</li>
<li>We can generate useful chemical and biological agents for the benefit of society, and we should.</li>
<li>We can fully disclose all clinical data to regulatory agencies, and we should.</li>
<li>We can promote pharmaceuticals, herbal remedies and dietary supplements for proven health benefits, and we should.</li>
<li>We can anticipate the potential for abuse of pharmaceutical and biological agents, and we should.</li>
<li>We can focus our efforts on commercialization of products for constructive uses and not simply because we can make money, and we should.</li>
</ul>Whether arguing for Avastin as a treatment for breast cancer or that high fructose corn syrup is the same as table sugar, such examples do nothing more than degrade the trust that is essential between the public and the scientific community.Daniel E. Levyhttp://www.blogger.com/profile/05609535387028309791noreply@blogger.com4