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 15^th, 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