Phase I Trials: Establishing Proof of Concept

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October 16 - 18, 2007 | Hyatt Regency Cambridge, Cambridge, MA

Thursday, October 18, 2007

8:15	Morning Coffee
8:30	Chair'sWelcoming Remarks Paul A. Frohna,MD, PhD, PharmD, Senior Director, Clinical Development, Head, Clinical Pharmacology and Drug Safety, FIBROGEN, INC.
Regulations, Logistics & Operations
8:45	Using Efftox to Find a Safe and Effective Dose in a Single Trial John D. Cook, Head of Software Development, Division of Quantitative Sciences, M.D.ANDERSON CANCER CENTER
9:30	Comparing Regulatory Procedures between US, Europe & Canada John Warren, MD, Medical Assessor, MHRA Norman Viner, MD, Chief, Clinical Trials Division, HEALTH CANADA (Invited)
10:15	Networking Break
10:45	Current Technologies that are Helping Phase I Candidates Get to Proof of Concept Jeanne Mendell, Director, Clinical Pharmacology, ONO PHARMA USA, INC.
11:30	Panel Discussion: Ethical Considerations in Volunteers versus Patients on Site Moderator: Malcolm Mitchell, MD, Director Clinical Pharmacology, ELI LILLY AND COMPANY Panelists: Randall R. Stoltz, MD, CPI, Medical Director, COVANCE CLINICAL PHARMACOLOGY Samuel Holtzman, PhD, CEO, ROSA PHARMACEUTICALS, INC.
12:15	Luncheon
1:30	Concurrent Tracks Begin

	Track D: Phase I Trials Abroad Track Chair: Malcolm Mitchell, MD, ELI LILLY AND COMPANY	Track E: Outsourcing, Site Management & Safety Track Chair: Sameer Tandon, NOVARTIS PHARMACEUTICALS CORPORATION
1:45	Phase I Clinical Trials in Europe: Current Challenges and Developments Francis P. Crawley, Executive Director, GOOD CLINICAL PRACTICE ALLIANCE – EUROPE	Optimizing your Outsourcing Relationships Colleen Hoke, Director of Business Operations, CHARLES RIVER LABORATORIES, CLINICAL SERVICES NORTHWEST
2:30	Case Study: Running a Phase I Study in Singapore Malcolm Mitchell, MD, Director Clinical Pharmacology, ELI LILLY AND COMPANY	How to Work Successfully With Your Sites and Strategies to Help Initiate PoC Studies Sameer Tandon, Outsourcing Manager, NOVARTIS PHARMACEUTICALS CORPORATION
3:15	Networking Break
3:30	Integrating Asia into Global Development Dr. Kenneth Kim, CEO & President, West Coast Clinical Trials, LLC	Phase I Trials: An IRB's Perspective Cami Gearhart, JD, Chief Executive Officer, QUORUM REVIEW, INC
4:15	Conference Concludes