Session 3: May 12-15, 2008
Learning and Confirming Trials: Finding and Confirming the Right Dose
Session Co-Leaders: Gilbert Burckart, PharmD, University of Southern California and Robert Powell, PhD, Food and Drug Administration
Session Chairs: Joga Gobburu, PhD, Food and Drug Administration; Diane K. Jorkasky, Pfizer, MD, Lawrence Lesko, PhD, Food and Drug Administration; Michael Krams, Wyeth, MD; and Brian Smith, PhD, Amgen; and Stephen 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. A basic introduction to biostatistics is given.
Frontiers in Drug Development and Regulatory Science Series: Special Populations and Situations on May 15.
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
- Re-Designing Clinical Development According to a Learn-Confirm Paradigm
- Proof of Concept Trials
- Considerations for Vaccines and Biologics
- Fast Data, Fast Results, Fast Decisions
- Overview of Issues with Measuring Efficacy and Safety in Clinical Trials
- Promise and Pitfalls of Imaging in Arthritis
- Measuring Tumor Response and Predicting Outcome
- Statistical Issues with Current Liver Enzyme Testing and the Potential Impact of Multidimensional Analysis
- Pharmacogenomics and Personalized Medicine
- Learn, Apply Paradigm: Basis for More Efficient Decisions
- Clinical PK/PD Dose-response Principles and Examples
- Leveraging Prior Knowledge to Drive Drug Development Decisions: Food and Drug Administration
- Dose–ranging in Patients in Phase 2 and 3
- Regulatory NDA Analysis for Effectiveness and Safety
Frontiers Workshop - Overview of Special Populations: Issues to Consider and a Case Example: Midazolam and the Elderly
- Special Populations: Pediatric Patients
- Special Populations: Geriatric Patients/Aging
- Special Populations: End - Organ Dysfunction
- Understanding the Impact of Potential Drug - Drug Interactions: Not just a Bioequivalence Exercise
- Individualizing the Dose: Right Dose, Right Patient, Right Time
Teaching Faculty
Sandra RB Allerheiligen, PhD, Eli Lilly
Jeffrey Barrett, PhD, FCP, Children’s Hospital of Philadelphia
Gilbert Burckart, PharmD, University of Southern California
Jerry M. Collins, PhD, National Cancer Institute
Hartmut Derendorf, PhD, University of Florida
Emilio Emini, MD, Wyeth
Felix Frueh, PhD, Food and Drug Administration
Joga Gobburu, PhD, Food and Drug Administration
Pravin Jadhav, PhD, Food and Drug Administration
Diane Jorkasky, MD, Pfizer
Michael Krams, MD, Wyeth
Richard L. Lalonde, PharmD, Pfizer
Laurence Lesko, PhD, Food and Drug Administration
Trevor Mundel, MD, PhD, Novartis Institutes for BioMedical Research
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
Kellie Schoolar Reynolds, PhD, Food and Drug Administration
Brian Smith, PhD, Amgen
Donald Stanski, MD, PhD, Novartis
Christoffer Tornoe, PhD, Food and Drug Administration
Donald C. Trost, MD, PhD, Independent Consultant
Yaning Wang, PhD, Food and Drug Administration
Dan Weiner, PhD, Pharsight Corporation
Stephen Williams, MD, PhD, Decisionability LLC
James Witter, MD, Food and Drug Administration
