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Agenda
General Format
The International Conference on Drug Development (ICD2) utilizes an interactive format that allows for the brief presentations of key perspectives under specific topics followed by round table open discussions where speakers and participants can debate, discuss, and ask questions of all topic presenters and other participants.
2014 Agenda will be available in early fall 2013.
2013 CONFERENCE THEME: At the Intersection of Global Policy, Regulation, Innovation and Economics
SUBTHEMES:
Downloadable Detailed Agenda*
2013 ICD2 Agenda PDF
2013 ICD2 Tentative Agenda
All meeting sessions will take place in the Forum unless otherwise specified
MONDAY, FEBRUARY 25, 2013: 2:00PM - 8:00PM*
Welcome & Opening Remarks
Opening
Salomon Stavchansky, Ph.D. • ICD2 Conference Scientific Chair
The University of Texas at Austin College of Pharmacy
Welcome
Dean M. Lynn Crismon, Pharm.D., FCCP, BCCP
The University of Texas at Austin College of Pharmacy
Theme: At the intersection of Global Policy, Regulation & Innovation
Moderator: Samuel D. Maldonado, M.D., MPH, FAAP
FDA/CDER Update
Janet Woodcock, M.D. • FDA
Subtheme: Impact of FDA Proactive Approach to Transparency on Innovation and Drug Development
Moderators: John M. Engle, J.D. • Engel & Novitt, LLP; and Andrea Masciale, J.D. • Johnson & Johnson
Transparency: European Perspective • Case Study
Thomas Lönngren • Former Executive Director of EMA
Transparency: Industry & Legal Perspective
James J. Kelly • Eli Lilly Company
Transparency: FDA Perspective
Steven Kozlowski, M.D. • FDA
Round Table Discussion
Panel & Participants
Welcome Dinner - Canyons Dinnign Room - 6:00PM CT
Remaining evening program will take place in the Canyons Dinning Room
Theme: Patient’s Perspective in Drug Development
Moderator: Kay Holcombe
• Genzyme
Factoring Patient Benefit and Risk into FDA Decision-making
Dr. Charles Johnson • Vertex Global Head of Medical Affairs
Robert J. Beall, Ph.D. • Cystic Fibrosis Foundation
Round Table Discussion
Panel & Participants
TUESDAY, FEBRUARY 26, 2013: 7:30 AM - 9:30 PM*
Continental Breakfast - Outside Forum -7:30 AM CT
Theme: Globalization of R&D – Evolving Role of The United States in the Globalization of Research and Development
Subtheme: Clinical Perspective
Moderator: Joanne Waldstreicher, M.D. • Johnson & Johnson
Globalization of R&D: Introduction
Joanne Waldstreicher, M.D. • Johnson & Johnson
Globalization of R&D: FDA Perspective
Janet Woodcock, M.D. • FDA
Globalization of R&D: Industry Perspective
Rob Kowalski, Pharm.D. • Novartis
New Initiatives of the Office of Generic Drugs – Challenges and Opportunities offered by GDUFA
Gregory Geba, M.D., M.P.H. • FDA
Challenges and Opportunities by GDUFA-GphA Perspective
David Gaugh • GPhA
Moderator: Volker Fischer, Ph.D. • Abbott Laboratories
Globalization of R&D: Academic Clinical Perspective
David E. Gerber, M.D. • UT Southwest Medical Center
Globalization of R&D: CRO Clinical Perspective
Kenneth Somberg, M.D., M.B.A. • Covance, Inc.
Round Table Discussion
Moderator: Kenneth I Kaitin, Ph.D. • Tufts University
Panel & Participants
Lunch - Hill Country Dinning Room - 12:10-1:30 PM CT
Theme Continued: Globalization of R&D – Evolving Role of The United States in the Globalization of Research and Development
Subtheme: Chemistry, Manufacturing and Controls (CMC) Perspective
Moderator: Charles P. Hoiberg, Ph.D. • Pfizer Pharmaceuticals
Globalization of R&D: CMC FDA Perspective
Christine M. V. Moore, Ph.D. • ONDQA / CDER / FDA
Globalization of R&D: CMC Industry Perspective
Roger Nosal • Pfizer, Inc.
Globalization of R&D: CMC Industry Perspective
Christopher Sinko, Ph.D. • Bristol-Myers Squibb
Round Table Discussion
Moderator: Mehul Mehta, Ph.D. • FDA
Panel & Participants
Theme: Impact of Heath Technical Assessments and Drug Reimbursements Models on Drug Development
Moderator: Dr. Susan Lognman • Novartis
Introduction: European Model for Drug Reimbursement - Lessons Learned
Thomas Lönngren, M. D. • Former Executive Director of EMA
General Analysis of Drug Reimbursement Models
Joshua Cohen, Ph.D. • Tufts University School of Medicine
Cost-effectiveness Analysis of Differential Pricing of Drugs for Access
Adrian Thomas, M.D., FRACP • Janssen Global Services, LLC
Round Table Discussion
Panel & Participants
Dinner - The Pavilion - 6:40 PM CT
Remaining evening program will take place in the Pavilion
Subtheme: Pathway to Global Product Quality and Safety
Moderator: Robert Meyer, M.D. • Merck & Co., Inc.
Update on the Initiatives of the Pathway to Global Product Safety and Quality
Deborah M. Autor, Esq • FDA
FDA Panel Discussion
Moderator: Gerald J. Yakatan, Ph.D. • IrisSys Inc.<
FDA Panelists
Janet Woodcock, M.D.
Director CDER
Deborah M. Autor, Esq.
Deputy Commissioner for Global Regulatory Operations and Policy
Greg Geba, MD, MPH
Director of the Office of Generic Drugs
Steven Kozlowski
Director, Office of Biotechnology Products
Mehul Mehta, Ph.D.
Director, Division of Clinical Pharmacology I
OTS/CDER/FDA
Christine M. V. Moore, Ph.D.
Acting Director, ONDQA/CDER/FDA
Terrance W. Ocheltree, Ph.D.
Director, Division of New Drug Quality Assessment II
ONDQA/OPS/CDER/FDA
Adjourn
* Agenda order and arrangement subject to change
Designed for Value
The agenda includes 20+ presenters and panelists in two full days. Participants should understand that programs run though dinner and early evening hours on both nights. The agenda is tight, which was created to provide busy executives valuable content in a timeframe that allows participants time for travel and returning to their work.
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