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