Session 3: June 15-18, 2009 (San Francisco, CA)

Learning and Confirming Trials: Finding and Confirming the Right Dose

Session Co-Leaders: Diane K. Jorkasky, MD, FACP, Independent Consultant; and Robert Powell, PharmD, Food and Drug Administration

Session Chairs: Sandra RB Allerheiligen, PhD, Eli Lilly; Diane K. Jorkasky, MD, FACP, Independent Consultant; Robert Powell, PharmD, Food and Drug Administration; and Stephen A. Williams, MD, PhD, Decisionability LLC

The planning, the choice of different trial designs, the randomization modes and the choice of endpoints are discussed. The different aspects of the conduct of a trial, i.e. study monitoring, principles of good clinical practice (GCP), adverse event monitoring (risk/benefit assessment) and data management are demonstrated.

Frontiers in Drug Development and Regulatory Science Series: Special Populations, New Challenges and the Future on June 18.

Lectures

• The Art and Science of Choosing Doses for First in Human Studies.
• Developing Drugs from First in Human Dosing to Understanding Dose-response in Patients
• Proof of Concept Trials
• Learn-Apply Paradigm to Drug Development
• Adaptive Trial Designs for Dose Response, Safety and Proof of Concept
• Does-response Evaluation Based on Pharmacokinetic and Pharmacodynamic Principles
• Considerations for the Development of Vaccines
• Fast Data, Fast Results, Fast Decisions
• Overview of Issues with Measuring Efficacy and Safety in Clinical Trials
• Promise and Pitfalls of Imaging in Arthritis
• Measurement of Efficacy and Safety in Clinical Trials: An Overview of Issues
• The Business of Biomarkers: From Clinical Trials to Clinical Practice
• Implications of Pharmacogenomics and Personalized Medicine on Dose-response
• Bionformatics Development at FDA/CDER and Beyond
• Dose-response from an FDA Perspective
• Leveraging Prior Knowledge to Drive Drug Development Decisions: FDA
• Dose–ranging in Patients in Phase 2 and 3
• Regulatory NDA Analysis for Effectiveness and Safety
• Individualizing the Dose: Right Dose, Right Patient, Right Time
  
  Frontiers Workshop
• Overview of Special Populations: Issues to Consider and a Case Example: Midazolam and the Elderly
• Special Populations: Age from 0-120 Years
• End Organ Dysfunction: Focus on Renal Impairment
• Understanding the Impact of Potential Drug - Drug Interactions: Not just a Bioequivalence Exercise
• Nanostructured Interfaces for Therapeutic Delivery
• BioMEMS/Lab on a Chip and Biosensors
• Panel discussion on Developing New Technologies Safely and Efficiently

Case Studies

• Antibody X (Part II)
• Developing an Efficacy Biomarker

Teaching Faculty
Sandra RB Allerheiligen, PhD, Eli Lilly
Donald Berry, PhD, MD Anderson Cancer Center
Andrew T. Chow, PhD, Amgen
Tejal Desai, PhD, University of California, San Francisco
Joga Gobburu, PhD, Food and Drug Administration
Mark Hovde, MBA, Pharsight Corporation
Pravin Jadhav, PhD, Food and Drug Administration
Katherin U. Jansen, MD, Wyeth
Diane K. Jorkasky, MD, FACP, Independent Consultant
George Mills, MD, MBA, Perspective Informatics
Richard L. Lalonde, PharmD, Pfizer
Jeffrey Murray, MD, Food and Drug Administration
Carl Peck, MD, University of California, San Francisco
Marc Pfister, MD, FCP, Bristol-Myers Squibb
Robert Powell, PhD, Food and Drug Administration
Aidan C. Power, MB BCh MRCPsych, Pfizer
Shuvo Roy, PhD, University of California, San Francisco
Kellie Schoolar Reynolds, PhD, Food and Drug Administration
Brian Smith, PhD, Amgen
Dominic G. Spinella, PhD, Pfizer
Gervais Tougas, MD, Novartis
Yaning Wang, PhD, Food and Drug Administration
Stephen A. Williams, MD, PhD, Decisionability LLC

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