______________________________Arrow-Pushing in Organic Chemistry: An Easy Approach to Understanding Reaction Mechanisms, 2nd Edition (111899132X) cover image

Sunday, October 14, 2012

Strategies for Success in Virtual Drug Development from Discovery to Clinic

Strategies for Success in Virtual Drug Development from Discovery to Clinic
Seminar & Wine Tasting Event

November 1, 2012 – 2:30 - 6:30 pm; Westin Hotel 1 Old Bayshore Highway, Millbrae, CA
 Cost: $80.00 in advance if check received by October 15th, 2012; $95.00 at the door
An interactive seminar and discussion focused on virtual drug development and strategies for success from discovery to clinical trials.

Schedule of Events

 2:30  Registration and networking
3:00  welcome and introduction, William Stevens, Ph.D., Business Development connections, LLC

“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.”

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.

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

“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.”

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.

4:15 - 4:30 - Break


"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."

Gary Jones, MD, Director of Clinical Development – C3 Research. 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. Especially interested in “pushing the boundaries of the box” 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.

5:00 - 5:30 "Preclinical DMPK without a lab:  A study in CRO partnering" - presented by Roderic Cole, Ph.D.

"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."

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.

5:30 - 6:30 - Networking, Winemaker Talk and Wine Tasting, Light Appetizers hosted by Business Development Connections, LLC and Vintner Jeff Hall of Williamson Wines

Sponsored By:
Business Development Connections, LLC
C3 Research and Associates
Agilux Laboratories
Averica Discovery Services, Inc.

Please mail checks to: Business Development Connections
                                       336 Bon Air Center, # 228
                                        Greenbrae, CA 94904

Tuesday, October 9, 2012

A Letter to Gray Davis

On 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.

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.

Dear Governor Davis,

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.

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.

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.

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.

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.

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.

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.

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.

Best wishes,


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.

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.

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.