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Thursday, November 27, 2014

GLOBAL STRATEGIES FOR SUCCESS IN DRUG DEVELOPMENT

An evening drug development seminar and wine tasting event.

Daniel Levy will present a seminar on "Outsourcing in the Pharma Industry: Strategies for Successful Projects with Limited Budgets" during."

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.

Event includes a panel discussion on Tricks of the Trade for Virtual Drug Development led by Ken Haas, Partner at Abingworth Global Life Sciences Venture Group

Thursday, December 4, 2014 • 5:30–9:00 p.m
EMBASSY SUITES
250 Gateway Blvd., South San Francisco, CA 94080

Cost: $50.00
Please RSVP by November 30 to akaufman@bizdevconnections.com

Sunday, August 3, 2014

Strategies for Successful Transition from Full-Time to Project-Based Employment

San Francisco American Chemical Society Meeting
Tuesday, August 12, 2014

DIVISION: SCHB: Division of Small Chemical Businesses
SESSION: True Stories from Entrepreneurs
SESSION START TIME: August 12, 2014, 8:00 am
PRESENTATION START TIME: August 12, 2014, 8:35 am
LOCATION: Moscone Center, South Bldg., Room: Esplanade Ballroom 301 


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.

Successful Chemistry Outsourcing for Today's Startup Companies

San Francisco American Chemical Society Meeting
Tuesday, August 12, 2014

DIVISION: SCHB: Division of Small Chemical Businesses
SESSION: Start-Up Chemical Businesses in Drug Discovery
SESSION START TIME: August 12, 2014, 1:00 pm
PRESENTATION START TIME: 4:20 pm
LOCATION: Moscone Center, South Bldg., Room: Esplanade Ballroom 301


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.

Tuesday, June 11, 2013

Chemistry Skills for Drug Discovery

I recently came across the article summarized below. The full PDF can be downloaded here.

Chemistry skills for drug discovery


11 April 2013

Chemistry expertise is critical to technical success across the spectrum of innovative medicines R&D. 
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.
It includes:
  • Impact of recent developments on training capacity and mobility
  • Key skills and capabilities for drug discovery chemists 


Conclusion

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.
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.
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.

Sunday, March 17, 2013

Strategies for Success in Virtual Drug Development - San Diego, CA

Please join us for an interactive seminar and discussion focused on virtual drug development and strategies for success from discovery to clinical trials. 
April 15, 2013 
5:00 – 9:00 pm
Hyatt Regency Mission Bay 
1441 Quivira Road 
San Diego, CA 92109 
Cost: $50.00 in advance, 
$60 after 12:00 p.m. April 12 and at the door. 
Preliminary Agenda
5:00 – 6:00 Registration, Exhibitors, Networking, and Appetizers 
6:00 – 6:15 Welcome and Introduction, William Stevens, Ph.D. of Business Development Connections LLC 
6:15 – 6:35 “Chemistry Outsourcing – Avoiding Problems and Maximizing Benefits” Presented by Daniel Levy, Ph.D. of DEL BioPharma 
DanLevy
“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. 
DEL BioPharma

6:35 – 6:55 "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
MichaelSwit
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 FDANews.com, 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., magna cum laude, with high honors in history, at Bowdoin College, and his law degree at Emory University. 
DuaneMorris

7:00 - 7:15 Break

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 
GaryJones
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="">
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. 
C3Research

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 
LauraCribbins
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. 
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. 
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. 
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. 
ProPharma
8:00-9:00 Exhibitors, Networking, Wine and Cheese 

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
 
3:15 - 3:45 "CHEMISTRY OUTSOURCING - AVOIDING PROBLEMS AND MAXIMIZING BENEFITS" PRESENTED BY DANIEL LEVY, PH.D.

“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

4:30 - 5:00 "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

"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,

Dan


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.