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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 Conference Theme

Transformation of Drug Development – Challenges and Opportunities
Advancing Innovative Solutions to Meet Patient’s Medical Needs of Serious Conditions and Rare Diseases

Downloadable 2014 Agenda: Click here for PFD of 2014 Agenda

2014 International Conference on Drug Development
Agenda at a Glance

Monday, February 24, 2014 • Barton Creek Omni
2:15
Welcome and Opening

Salomon Stavchansky, Ph.D.
ICD2 Conference Scientific Chair
Alcon Centennial Professor of Pharmaceutics
The University of Texas at Austin College of Pharmacy

3:00

FDA/CDER Update
Improving Drug Access to Patients – Expediting Drug Development - Risks and Rewards

Janet Woodcock, M.D.
Director • Center for Drug Evaluation & Research
CDER, FDA

Moderator: Joe Lamendola, Ph.D.
Vice President
Global Regulatory Sciences, US and Regulatory Policy
Bristol-Myers Squibb Company

3:45

Round Table Sessions on Transforming and Expediting Drug Development

Moderator:
Linda S. Carter
Senior Advisor
Greenleaf Health LLC

FDA Challenges Expediting Drug Development – Scientific, Clinical and Regulatory Considerations of Breakthrough Therapies and Accelerated Approvals.  

Janet Woodcock, M.D.
Director • Center for Drug Evaluation & Research
CDER, FDA

Market Access and Innovative Industry Therapies

Ray Sacchetti
Senior Vice President, US Virology & Transplant
Bristol-Myers Squibb

Payers Perspective of Expediting Drug Development –Integrated Health Care Benefits to Accelerate Breakthrough Therapies to Patients.  Innovative Partnerships for Better Clinical Outcomes and Care at a Lower Cost

Tracy Mayne, Ph.D.
Vice President, Global Health Economics and Outcomes Research
Covance

Patient Perspective of Expediting Drug Development – Patient Role in Knowledge Generation

J. Russell Teagarden, RPh., M.A.
Senior Vice President, Medical & Scientific Affairs
National Organization for Rare Disorders (NORD)

Oncologist Perspective – Towards Patient Drug Development  – Better Communication of Risk, Benefit and Medical Evidence

Ethan Basch, M.D.
Director, Cancer Outcomes Research
Associate Professor
Medicine and Public Health
Lineberger Comprehensive Cancer Center 
University of North Carolina-Chapel Hill

5:00
Round Table Discussion with Afternoon Speakers joined by Isaam Zineh, PharmD of CDER, FDA

Moderator:
Maria Rivas, M.D.
Vice President
Global Medical Affairs, R & D
Abbvie Pharmaceutical

6:00
Dean's Welcome

M. Lynn Crismon, Pharm.D., FCCP, BCCP
Dean
The University of Texas at Austin College of Pharmacy

6:15

Reception

7:00

Dinner

Robert Messing, M.D.
Vice Provost, Biomedical Sciences
The University of Texas at Austin

Tuesday, February 25, 2014 • Barton Creek Omni
7:30
Breakfast
8:30

Expedited FDA Programs Initiatives –– Drugs and Biologics Building the Science (Clinical and Non Clinical) to Expedite Drug Development

Janet Woodcock, M.D.
Director • Center for Drug Evaluation & Research
CDER, FDA

Moderator: Joanne Palmisano, M.D., FACP
Vice President • Drug Regulatory Affairs
Boehringer Ingelheim Pharmaceuticals, Inc.

9:15

Round Table Sessions on a Vision for Expedited Drug Development in the XXI Century

Moderator: Lisa A. Shipley, Ph.D.
Vice President & Global Head
Pharmacokinetics,
Pharmacodynamics & Drug Metabolism
Merck & Co., Inc.
Clinical Perspective – Innovation in the design of Clinical Studies  

Donald A. Berry, Ph.D.
Professor, Department of Biostatistics
The University of Texas MD Anderson Cancer Center

Pharmaceutical Industry Perspective - Innovation in Clinical Drug Development

Paula Rinaldi
North America Head, Drug Regulatory Affairs
Novartis Pharmaceuticals

Risks and Opportunities for Acceleration of Drug Development in Rare Diseases

Carlo Russo, M.D.
Senior Vice President, Alternative Development Program
Head, Alternative Discovery & Development
Interim Head, Rare Disease Development
GlaxoSmithKline

BIO Perspective - Innovation in Clinical Safety and Effectiveness

Lisa Bell, Ph.D.
Vice President, Regulatory Affairs and Pharmacovigilance
BioMarin

Expediting Drug Development:  Integrating Knowledge, Enabling Decisions and Submissions

Sandy Allerheiligen, Ph.D.
Vice President Quantitative Pharmacology and Pharmacometrics
Merck Research Laboratories

11:00
Round Table Discussion with Morning Speakers joined by Janet Woodcock, MD, FDA/CDER

Moderator: Jonathan Seltzer, M.D.
President ACI Clinical
Director of Clinical Research Lankenau Heart Institute

12:00
Lunch
1:30

Round Table Sessions on Finding Solutions to Quality and Safety Challenges of Breakthrough Therapies – Building data to Minimize Risk and Systems to Maximize Lifecycle Quality

Moderator: Terrance Ocheltree, Ph.D., R.Ph.
Sr Director Regulatory Affairs, CMC
Abbvie Pharmaceutical
FDA Challenges and Perspectives

Steven Lynn, M.S.
Director, Office of Manufacturing and Product Quality (OMPQ)
OC, CDER, FDA

Industry Challenges and Perspectives

Roger Nosal
Vice President, Global CMC
Pfizer, Inc.

Clinical Safety Considerations for Expedited Approvals – FDA Perspective

Mwango Kashoki, M.D.
Medical Officer, Office of New Drugs
CDER, FDA

Companion Diagnostics and Breakthrough Therapies – Personalized Therapeutics

Debra J Rasmussen, MBA, RAC
Senior Director Global Regulatory Affairs
Janssen Pharmaceuticals

3:00
Round Table Discussion with Afternoon Speakers joined by Moheb M. Nasr, Ph.D. of GlaxoSmithKline

Moderator: Charles Hoiberg, Ph.D.
Executive Director
Pfizer, Inc

6:30
Dinner
8:00

FDA PANEL

Steven Lynn, M.S.
Director, Office of Manufacturing and Product Quality (OMPQ)
OC, CDER, FDA

Mehul Mehta, Ph.D.
Director, Division of Clinical Pharmacology I
Office of Clinical Pharmacology
OTS, CDER, FDA

Sarah Pope Miksinski
Division Director (Acting)
FDA, CDER, OPS, ONDQA, DNDQA 2

Isaam Zineh, PharmD, MPH, FCP, FCCP
Director, Office of Clinical Pharmacology Office of Translational Sciences
CDER, FDA

Janet Woodcock, M.D.
Director • Center for Drug Evaluation & Research
FDA

Moderator:
Gerald J. Yakatan, Ph.D.
Founder & Chairman
IriSys, Inc.

 


Past Conferences:

2013 Theme: At the Intersection of Global Policy, Regulation, Innovation and Economics
Downloadable 2013 Agenda: 2013 ICD2 Agenda PDF

2012 Theme: Fostering Innovation and Translational Research in Support of Public Health and Economic Growth
Downloadable 2012 Agenda: 2012 ICD2 Agenda PDF


 

Designed for Value
The agenda includes 15+ 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.   

Last Reviewed: February 24, 2014

ACPE The University of Texas at Austin College of Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.
Comments to: UTPharmacyCE@austin.utexas.edu
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