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Nov. 8-10 2010 Course - Videos, Slides, Transcripts


November 8, 2010

Session 1: FDA and the Regulation of Clinical Trials
A video of Session 1 can be viewed by accessing these links:
Dr. Throckmorton through Dr. Midthun
Dr. Lumpkin through Dr. Nambiar

Slides from Session 1 can be viewed by clicking the links below: 

Overview and Introduction to Drug Regulation – Douglas Throckmorton, M.D. (CDER)
FDA Structure and Device Role – William Maisel, M.D. (CDRH)
A Vision for the Future of Clinical Investigators in a New World of IT, Biological Science and Communications – Karen Midthun, M.D. (CBER)
FDA Perspective on International Studies – Murray Lumpkin, M.D. (OC)
Investigator Responsibilities with Regulation and Clinical Trials – Leslie Ball, M.D. (CDER)
Informed Consent and Ethical Considerations in Clinical Trials – Dale Hammerschmidt, M.D. (University of Minnesota)
Overview of Phase 1 Studies: Purpose, Guidance, Design – Sumathi Nambiar, M.D. (CDER) 


Session 2: Understanding the Investigator Brochure -
 Non-clinical and Phase 1 Studies
A video of Session 2 can be viewed by accessing this link:
Dr. Duffy through Dr. Reynolds
Slides from Session 2 can be viewed by clicking the links below:

CMC and the Investigator Brochure (Drugs): Ensuring the Quality of a Drug Being Used in a Clinical Trial – Eric Duffy, Ph.D. (CDER)
CMC and the Investigator’s Brochure (Biologics) – Steven Kozlowski, M.D. (CDER)
Pharmacotoxicology in the Investigator Brochure – Haleh Saber, Ph.D. (CDER)
Clinical Pharmacology 1: What to Look for in Drugs Being Studied in Phase 1 Studies and Early Drug Development – Sarah Robertson, Pharm. D. (CDER)
Clinical Pharmacology 2: Phase 2 and Beyond – Kellie Reynolds, Pharm.D. (CDER) 

November 9, 2010
Session 3: The Clinical Trial Protocol
 A video of Session 3 can be viewed by accessing these links:
Dr. McMaster through Dr. Toth-Allen
Dr. Sullivan through Q/A Session

• Review of ‘Phase 1’ Case Studies – Owen McMaster, Ph.D. (CDER) and Barbara Rellahan, Ph.D. (CBER)
• The design of clinical trials (Part I) – Robert Temple, M.D. (CDER)
• The design of clinical trials (Part II) – Robert Temple, M.D. (CDER)
• Issues in Clinical Trial Designs for Devices – Bram Zuckerman, M.D. (CDRH)
• Good Clinical Practice, New Regulations for Expanded Access and Compensation – Jean Toth-Allen, Ph.D. (OC)
• Clinical Trial Endpoints – Eugene Sullivan, M.D. (United Therapeutics)
• Issues in Clinical Trial Designs for Diagnostics and Combination Products – Sally Hojvat, Ph.D. (CDRH)
• The analysis of investigator data, sources of bias and error – David DeMets, Ph.D. (University of Wisconsin)
• Discussion/Questions – Session 3 Afternoon Presenters Panel


 Session 4: Safety of Clinical Trials and Special Populations


 A video of Session 4 can be viewed by accessing these links:

Dr. Villalba begins at 1 hour 58 minutes into this recording
Dr. Kweder through Q/A

• General issues in the Safety of Clinical Trials – Maria Lourdes Villalba, M.D. (CDER)
• Special populations and special considerations in Clinical Trials: Children, Elderly, Pregnant Women – Sandra Kweder, M.D. (CDER)
• Discussion/Questions Discuss and Distribute Case Study Assignments/Adjourn – Session 4 Presenters Panel


November 10, 2010



 Session 4: Safety of Clinical Trials and Special Populations (cont)

  A video of Session 4 can be viewed by accessing these links:

Dr. Buch
Dr. Grant through Dr. Senior and Q/A
Jane Reese-Coulbourne through the Roundtable discussion
How to Put Together an Application through Ensuring the Safety of Clinical Trials

• Review of Case Studies – Barbara Buch, M.D. (CDRH) and Stephen Grant, M.D. (CDER)
• Special safety concerns: CV safety issues: QT prolongation and valvulopathy – Shari Targum, M.D. (CDER)
• Special safety concerns: hepatotoxicity and life cycle safety analysis (including hepatic biomarkers) – John Senior, M.D. (CDER)
• Questions/Discussion – Session 4 Morning Presenters Panel
• A Patient Advocate’s Perspective on Clinical Trials – Jane Reese-Coulbourne (Reagan-Udall Foundation)
• Roundtable: A Pharmaceutical Industry Perspective on the Clinical Investigator’s Role in Drug Development – Industry Representatives; Briggs Morrison (Pfizer), Craig Wozniak (GSK), Adam Chasse (Quintiles), and Yvonne McCracken (Carolinas Medical Research)
• How to Put Together an Application – Judit Milstein (CDER), Michael Marcarelli, Pharm. D. (CDRH), Donald Fink, Ph.D. (CBER), Patrick Au, Ph.D., (CBER), andRachel Witten, M.D. (CBER)
• Ensuring the Safety of Clinical Trials: AE reporting, DSMBs, IRBs – Joseph Salewski (CDER), Jonathan Helfgott (CDRH), and Patricia Holobaugh (CBER)