Exploratory Clinical Development World Americas

Day 1 Programme, 21-Oct-2009

Summary : The first day of the conference will be having 2 streams & drug development in different areas issue will be discussed on a wide platform.

09:00 AM  -  0:0 AM
How should we be developing drugs in the 21st century?
Dr. Giora Feuerstein, Assistant Vice President, Head of Discovery Translational Medicine, Wyeth Research

09:30 AM  -  0:0 AM
Implementing early proof of concept, readdressing the traditional development model
Dr. Irina Antonijevic, Director, Translational Research, Lundbeck Research USA, Inc.

10:00 AM  -  0:0 AM
Global Strategies for Early Clinical Drug Development
Dr. John Lambert, Chief Medical Officer, Early Phase Services, PAREXEL International

11:30 AM  -  0:0 AM
Life along the critical Path (Initiative): how the PSCT is changing exploratory drug development
Dr. William Matttes, Director of Toxicology, The Critical Path Institute, William B. Mattes is the Director of Toxicology at The Critical Path Institute. Previously, he was senior scientific director of Toxicogenomics at Gene Logic, associate director of toxicogenomics at Pharmacia Corp, Kalamazoo, MI.

12:00 PM  -  0:0 AM
New Approaches in Early Clinical Development
Dr. Dongzhou (Jeffery) Liu, Assistant Director, New Products Research and Development, GlaxoSmithKline, Dr. Liu currently working as Assistant Director in New Products R&D at GlaxoSmithKline. Earlier, he worked at Wyeth and Forest Labs from 1998 to 2007. He has also authored couple of FDA/EMEA-accepted BA/BE Biowaiver applications.

14:00 PM  -  0:0 AM
Using Exploratory Clinical Trials (eCTAs, eINDs) in Pharmaceutical Discovery: Planning for Fail, or to WIN?
Dr. Lewis Kinter, Senior Director Safety Assessment, AstraZeneca, Dr. Kinter is a Senior Director at AstraZeneca Pharmaceuticals. He is an expert in the area of cardiovascular-renal function assessments in animals & currently Chair of the PhRMA Preclinical Safety Leadership Committee (formerly DruSafe).

14:30 PM  -  0:0 AM
Gaining accreditation for protecting human rights of subjects enrolled in early stage clinical trials
Dr. Howard Uderman, Medical Director, New Haven Clinical research Unit, Pfizer

15:25 PM  -  0:0 AM
Opening remarks from the chair
Jochen Theis, Pharmaceutical Physician & Principle Consultant, InHeCon, Jochen Theis is the founder and principle consultant of InHeCon. He is also a physician with clinical training in paediatrics and board certification in clinical pharmacology. Earlier, he was the Global Head of Biomarkers and Experimental Medicine.

15:30 PM  -  0:0 AM
Biomarkers in early development - value and pitfalls
Dr. Michael Burczynski, Associate Director, Biomarker Laboratory, Clinical Translational Medicine, Wyeth Research, Dr. Michael E. Burczynski is Associate Director of the Biomarker Laboratory in the Dept. of Clinical Translational Medicine at Wyeth Research. He is also an adjunct assistant professor at the University of Pennsylvania School of Medicine.

16:00 PM  -  0:0 AM
Regulatory review: biomarkers and the development of personalized medicine
Dr. Francis Kalush, Network Leader, Diagnostics, Officer of centre Director, Centre for Devices & Radiological Health, Food and Drug Administration, Dr Francis Kalush is the Diagnostics Network Leader at FDA. Previously, she was the Director, Pharmacogenomics in the Celera On line Business & Post Doctoral Fellow at the Weizmann Institute of Science in the Human Genome Center in Israel.

16:30 PM  -  0:0 AM
Personalized Healthcare biomarkers in exploratory clinical development
Dr. Ruth March, Head of Personalized Healthcare Team, AstraZeneca

17:00 PM  -  0:0 AM
What potential can imaging biomarkers offer in early clinical development?
Dr. David Geho, Director of Imaging, Merck & Co.

15:30 PM  -  0:0 AM
Maximizing Predictive Preclinical Cardiac Safety Data
Dr. Gary Gintant, Senior Group Leader, Department Integrative Pharmacology, Abbot Laboratories, Gary Gintant is Senior Group Leader in the Dept. of Integrative Pharmacology at Abbott Laboratories. He is also involved in various cardiac risk assessment / QT interval committees and has served on various NIH study sections.

16:00 PM  -  0:0 AM
Advanced Cardiac Safety: De-Risking Drug Candidates in Early Clinical Development
Dr. Anthony Fossa, Vice President, Cardiovascular Safety, iCardiac, Dr. Fossa is currently Vice President, Cardiovascular Safety at iCardiac. He spent 25 years in the pharmaceutical industry, including 22 years at Pfizer where he was a Research Fellow & helped to form the companys General Pharmacology group in 1988.

16:30 PM  -  0:0 AM
Challenges, regulatory expectations, and potential strategies for assessing key aspects of cardiac safety during early development using a risk management approach
Dr. Andrew Erdman, Senior Drug Safety Scientist, Genentech Inc.

17:00 PM  -  0:0 AM
Pharmacology studies for early selection of drug candidates with regard to CV risk
Dr. Malcolm Mitchell, Medicinal Director, Product Phase EPM, Eli Lilly & Co., Dr. Malcolm Mitchell is currently Global Medical Director for late phase clinical pharmacology assets of Eli Lilly. He is a member of Lilly Cardiovascular safety committee for about 10 years, which overviews all molecules in development.

Day 2 Programme, 22-Oct-2009

Summary : The second day of the conference will focus on strategies to revolutionize research and development & predictive value of preclinical animal models etc.

09:00 AM  -  0:0 AM
Innovating strategies to revolutionize research and development
Dr. David Nicolson, Senior Vice President, Global Product Management, Schering Plough

09:30 AM  -  0:0 AM
Predictive value of preclinical animal models
Dr. Carl Alden, Vice President, Toxicology, Millennium: The Takeda Oncology Company

10:00 AM  -  0:0 AM
Application of Preclinical PK-PD Modeling in Late Stage Research and Early Development
Dr. Harvey Wong, Drug Metabolism and Pharmacokinetics, Genentech Inc., Harvey Wong is a Senior Scientist in the Department of Drug Metabolism and Pharmacokinetics at Genentech, Inc. He graduated from the University of British Columbia with a Ph.D. in Pharmacokinetics and Biopharmaceutics.

11:00 AM  -  0:0 AM
Translational Pharmaceutics: interactive pharmaceutical and clinical development to enable rapid formulation optimization during early clinical and proof of concept studies in drug development
Dr. Lloyd Stevens, Senior Research Fellow, Quotient Clinical, Having 30 years of experience in big pharma big Pharma (Hoechst, Glaxo Pharma, UK) & Phase I/II CRO (Covance, Leeds UK; Quintiles), Lloyd Stevens is Principal Scientist at Quotient Clinical (Pharmaceutical Profiles) at present.

11:30 AM  -  0:0 AM
Considerations for FIM trials
Dr. Jonathan Jaffe, Translational Medicine-Respiratory, Novartis Pharmaceutical Corporation, Since 2007, Dr Jaffe has been the Translational Medicine-Respiratory at Novartis Pharmaceutical Corporation. He has also worked in development programs in transplantation, rheumatology, asthma and COPD in 1996 when he joined industry.

12:00 PM  -  0:0 AM
Challenges and innovative solutions to safety testing of drug metabolites
Dr. Larry Tremaine, Senior Director, Pharmacokinetics, Dynamics & Metabolism, Pfizer, Larry M. Tremaine is working as a Senior Director in Pharmacokinetics, Dynamics and Metabolism (PDM), Groton Research Laboratories, Pfizer Global R&D which he joined in 1983 after receiving Ph.D. in Pharmacology from the University of Minnesota.

14:00 PM  -  0:0 AM
Potential of using adaptive clinical trial design in early development
Dr. Sergei Leonov, Director, Research Statistics, GlaxoSmithKline

16:00 PM  -  0:0 AM
Outsourcing in phase I; a sponsor's perspective
Dr. Gavin Choy, ice President, Clinical Research Operations, SuperGen, Inc.

16:30 PM  -  0:0 AM
Outsourcing Phase I trials to Asia
Dr. Gangadhar Sunkara, Associate Director, Translational Science, Lead Coordinator, TS India Business Strategy, Novartis