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Phase I Trials: Establishing Proof of Concept

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

Online Documentation

Online Documentation

This page will be used to provide paid delegates of the conference with access to any presentations that were not included in the conference documentation. Only paid conference delegates have permission to access IIR online documentation.

While these presentations were not available to be included in your conference documentation, IIR is pleased to make them available to all conference delegates through this web site.

You will need the freely available Adobe Acrobat Reader, which is available by clicking here. To access the presentations:

  • Click the title of the session
  • You can choose to view the file online or save the file to your computer
  • You can print the files and add them to your other conference material

10/16/2007

PM Pre-Conference Workshop B2:
Strategic Planning for Patient Recruitment in Phase I: Healthy Volunteers versus Disease Populations
Nathan Messinger, Executive Vice President of Sales and Marketing, INCLINIX, INC.

AM Pre-Conference Workshop B1:
Biomarker Validation versus Biological Effects – Is your Drug Really having an Effect?
J. Margaretha Oortgiesen, Director, Integrated Drug Development, CATO RESEARCH

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10/17/2007

1.45pm: What is Needed to Bring a Product to Phase I?
Stephen Freestone, MD, Medical Director, CHARLES RIVER CLINICAL SERVICES

10.15am: Part II: How can Working with Patients Earlier in Phase I will get you to Proof of Concept Faster?
Paul A. Frohna,MD, PhD, PharmD, Senior Director, Clinical Development, Head, Clinical Pharmacology and Drug Safety, FIBROGEN, INC.
Lawrence Brownstein, Chief Administrative Officer, CRI WORLDWIDE

11.30 am: Part III: How to Choose the Most Viable Candidate to Invest In? Optimizing Economics
Sam Holtzman, PhD, CEO, ROSA PHARMACEUTICALS, INC.


10/18/2007

1.45pm: Phase I Clinical Trials in Europe: Current Challenges and Developments
Francis P. Crawley, Executive Director, GOOD CLINICAL PRACTICE ALLIANCE – EUROPE

2.45pm: How to Work Successfully With Your Sites and Strategies to Help Initiate PoC Studies
Sameer Tandon, Outsourcing Manager, NOVARTIS PHARMACEUTICALS CORPORATION

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