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