Health Network Communications, Cambridge
19th-22nd October 2010
Day One: Wednesday 20th October2010
8:50 Opening remarks from the chair 9:00 Innovating management strategies to revolutionize early phase R&D
Eyas Abu-Raddad, PhD, Research Advisor, Head, PK/PD and Clinical Trial Simulations, Chorus, Eli Lilly
9:30 Development approaches used to achieve success with personalized medicine and targeted drugs
Nadine Cohen, Head of Pharmacogenomics, Johnson & Johnson
TRANSLATIONAL MEDICINE
10:00 The case for early failure studies
Doina Roman, MD, Senior Medical Director, Translational Medicine, Takeda Global Research & Development Center, Inc.
10:30 Speed Networking and morning coffee
11:15 Enriched patient tools to fast track POM and POC
Jeffrey Paul, PhD, Assistant Vice President, Early Development and Clinical Pharmacology- Neuroscience, Pfizer
11:45 How to fail faster: Getting all the answers in phase I
Howard Goodall, Clinical Research Physician – Phase I, Quotient Bioresearch, Clinical Services 12:15 The role of experimental medicine and translational medicine to reach go/no go decisions fasterDr Sandeep Athalye, Clinical Franchise Lead (Resp/NSO),Novartis Pharmaceutical Corporation
12:45 Realizing the Promise of Experimental Medicine in Early Clinical Development
Dr Samuel C. Blackman, Associate Director, Experimental Medicine / Oncology, Merck Research Laboratories
13:15 Lunch STREAM ONE
CLINICAL TRIAL DESIGN
14:10 Opening remarks from the chair
14:15 Quantitative knowledge integration to inform dose selection in early clinical development
Alaa Ahmad, Ph.D., Associate Director, Clinical Pharmacology, M&S, Bristol-Myers Squibb
14:45 Statistical and strategic approaches for early phase clinical trials
Yili L. Pritchett, Ph.D., Research Fellow, Director, Clinical Statistics, Abbott Laboratories
15:15 Afternoon coffee
15:45 The fast track way to PoC – Adaptive design used in a creative way
Willem Jan Drijfhout, Senior Vice President Early Development Services, PRA International
16:15 Patients vs. health volunteers in early phase trials
Speaker TBC
16:45 Closing remarks from the chair
OR
STREAM TWO - SAFETY PHARMACOLOGY & QT
14:10 Opening remarks from Dr Philip Sager, Vice President and Head Cardio pulmonary and Metabolic Clinical Deveopment, Gilead
14:15 Drug safety strategy in early development
Dr Jonathan Deutsch, Safety Science Leader, Director, Pharma Development Safety, Licensing and Early Development, Hoffmann-La Roche Inc. 14:45 Preclinical cardiovascular safety which would of course include QT testingMartin Sanders, Research Director, Safety Pharmacology, Hoffmann-La Roche
15:15 Afternoon coffee
15:45 “Right-sized” assessment of cardiovascular safety in early clinical development
Sasha Latypova, Executive Vice President, iCardiac Technologies, Inc. 16:15 Safety pharmacology best practices
Dr Philip Sager, Vice President and Head Cardio pulmonary and Metabolic Clinical Development, Gilead
16:45 Closing remarks from the chair
17:00 End of day one and networking drinks reception Day Two - Thursday 21 October 2010
8:50 Opening remarks from the chair
9:00 The changing R&D process: The need to move from a linearmodel to highly interactive drug discovery and development
Johan Luthman, Vice President Neuroscience &Ophthalmology R&D, Franchise Integrator, Merck & Co Inc
9:30 Opportunities and challenges to clinical pharmacologist inoptimal drug development
Dr Alan Xiao, Director Clinical Pharmacology, AstraZeneca
10:00 A first look at efficacy: special populations in phase I/IIStudies
Bradley Vince D.O., President & Medical Director, Vince and Associates Clinical Research
10:30 Morning coffee
11:00 Understanding the importance of preclinical studies forclinical success
11:30 Challenges and solutions to safety testing of drug metabolites
Larry J. Jolivette, Ph.D., Director DMPK, GlaxoSmithKline
12:00 Modeling in early development
Suhasini Iyer, Group Leader, Genentech
12:30 LunchAPPLICATION OF BIOMARKERS IN EARLY DEVELOPMENT
13:30 Practical considerations when implementing a fit-for-purpose biomarker assay development paradigm
Dr Russell Weiner, Group Director, Bristol-Myers Squibb
14:00 Values and challenges in applications of biomarkers for clinical development
Zhaosheng Lin, Head of Biomarkers, Pfizer
14:30 Biomarkers and clinical translational approaches in early development
Mark Day, Associate Director, Head of Translational Neuroscience and Immunology Imaging, Abbott Laboratories
15:00 Afternoon coffee
15:30 How imaging in can aid decision making in early clinicaldevelopment
Terri Binder, Director Imaging, Eisai
16:00 Validating biomarkers for effective clinical development
Mike Hale, Head Global Medical Science, Biostatistics Group, Amgen
16:30 Closing remark from the chair
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Invited Speakers:
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Zhaosheng Lin, Head of Biomarkers, Pfizer
Nadine Cohen, Head of Pharmacogenomics, Johnson & Johnson
Mitchell B. Friedman, Director of Toxicology, Takeda Global R&D
Malcolm Mitchell, Medical Director, Clinical Pharmacology, Eli Lilly
Dr Alan Xiao, Director Clinical, Pharmacology, AstraZeneca
Dr Russell Weiner, Group Director, Bristol-Myers Squibb
Yili L. Pritchett, Ph.D., Research Fellow, Director, Clinical Statistics, Abbott Laboratories
Terri Binder, Director Imaging, Eisai
Dr Philip Sager, Vice President and Head Cardio pulmonary and Metabolic Clinical Development, Gilead
Samuel C. Blackman, MD, PhD Associate Director, Experimental Medicine/Oncology, Merck Research Laboratories
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