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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.

2016 Agenda

The 2016 Agenda is currently under development. Presenters updated as confirmed.

CONFERENCE THEME:
Safety, Efficacy and Affordability of Medicines for all Patients– The 21st Century Challenge!

International Conference on Drug Development (ICD2)
Day I
Monday, February 22, 2016
12:00

Lunch

 

1:30

Welcome

M. Lynn Crismon, PharmD., FCCP, BCCP
Dean & Professor
The University of Texas College of Pharmacy

1:45

Opening Remarks

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

Legislative Update

The Honorable Michael C. Burgess, M.D.
United States House of Representatives

FDA/CDER Update
Principles for Regulation and Oversight of Precision Medicine and Emerging Technologies - FDA Initiatives and Affordability of Precision Medicine

Jonathan P. Jarow, MD
Senior Medical Officer to the Director
Center for Drug Evaluation and Research
US Food and Drug Administration

Delivering Janet Woodcock's Update

3:40

Round Table Presentations:
Precision Medicine, Emerging Technologies, and Breakthrough Therapies

Moderator:
Robert Meyer, M.D.
Director of the Virginia Center for Translational and Regulatory Sciences
University of Virginia School of Medicine

A Panoramic View of Precision Medicine , Emerging Technologies and Breakthrough Therapies

Kenneth I. Kaitin, Ph.D.
Director
Tuft's Center for the Study of Drug Development
Professor, Tufts University School of Medicine

The Promise and Potential of Personalized Medicine

Anne McDonald Pritchett, Ph.D.
Vice-President
Policy and Research
PhRMA

Advancing Precision Medicine and Extension of Life

Ellen V. Sigal, Ph.D.
Chairperson and Founder
Friends of Cancer Research

Payers' Perspective on Precision Medicine – Clinical Assessment of Risk - Provider Behavior and Accountability

Matthew C. Fontana, M.D.
Vice President and Chief Medical Officer, Pharmacy
Health Care Service Corporation

Payers' Perspective on Precision Medicine –Assessment of Risk - Provider Behavior and Accountability

Kara M. Morgan, Ph.D.
Research Leader, Health and Analytics
Battelle Memorial Institute

5:20

Round Table Discussion:
Precision Medicine, Emerging Technologies, and Breakthrough Therapies

Panel of Afternoon Speakers joined by:
John M. Engel, Esq.
Founding Partner & Manager
Engel & Novitt, LLP

Kay Holcombe
Senior Vice President of Science Policy
Biotechnology Industry Organization (BIO)

Ann D. Kwong, Ph.D.
Founder and CEO
TREK Therapeutics, PBC

6:15

Reception

 

7:00

Dinner

 

8:00

Keynote
Proactive Initiatives in the Life Sciences – Robotics – “Smart Lens” Technology  for Ocular Medical Uses and New Approaches for Cancer, Parkinson’s and Alzheimer’s Diseases

Brian Otis, Ph.D.
Director
Google Life Sciences
Research Associate Professor
University of Washington

 

International Conference on Drug Development (ICD2)
Day II
Tuesday February 23, 2016
7:30

Breakfast

 

8:15

Round Table Presentations:
Linking Critical Product Quality Attributes and Critical Process Parameters to Clinical Product Performance of Single and Combination Drug-Device Products

Opening Remarks and Moderated by:
Sarah Pope Miksinski, Ph.D.
Acting Director
Office of New Drug Products
Center for Drug Evaluation and Research
US Food and Drug Administration

TBA

Paul Seo, Ph.D.
Lead (Acting), Biopharmaceutics Staff
Office of New Drug Quality Assessment
Center for Drug Evaluation and Research
US Food and Drug Administration

“Biosimilars, Regulatory Innovation and Evolution – Linking Quality Product Attributes and Critical Process Parameters to Product Clinical Performance – Global Lessons Learned”

Mark McCamish, M.D., Ph.D.
Head Global Biopharmaceutical Development
Sandoz

Disruptive Innovation - Quality Product Attributes and Manufacturing Changes of Macromolecules and Vaccines – Molecular Structure & Function

John Baldoni, Ph.D.
Senior Vice President
Platform Technology & Science
GlaxoSmithKline

Defining Meaningful Critical Quality Product Attributes and Critical Process Parameters to Clinical Product Performance of Small Molecules

Roger Nosal
Vice President, Global CMC
Pfizer, Inc.

Industry Perspective –  Linking Drug-Device Quality Product Attributes and Critical Process Parameters to Product Clinical Performance. A Hypothetical Scenario

Manfred Maeder, Ph.D.
Head of Group Compliance & Audit for Devices and Combination Products
Novartis

Industry Perspective – Risk-based Approaches to Drug-Device Combination Product Development

Karen Weiss, M.D.
Vice President
Global Regulatory Policy and Intelligence
Janssen Pharmaceutical Companies of Johnson & Johnson

FDA Perspective. Assuring Lifecycle Quality Performance for Traditional Drugs and Combination Products. Lessons Learned

Rick Friedman, Ph.D.
Deputy Director
Science & Regulatory Policy

Center for Drug Evaluation and Research
US Food and Drug Administration

11:45

Round Table Discussion:
Linking Critical Product Quality Attributes and Critical Process Parameters to Clinical Product Performance of Single and Combination Drug-Device Products

Panel of Morning Speakers, joined by:
Jonathan P. Jarow, MD
Senior Medical Officer to the Director
Center for Drug Evaluation and Research
US Food and Drug Administration

(Representing Janet Woodcock)

Isaam Zineh, PharmD, MPH, FCP, FCCP
Director, Office of Clinical Pharmacology
Office of Translational Sciences
Center for Drug Evaluation and Research
US Food and Drug Administration

12:30

Lunch

 

2:15

Round Table Presentations:
Advancing Regulatory Clinical Pharmacology and Clinical Research in Assessing Safety and Efficacy of Medicines and Emerging Technologies.  Lessons Learned and Disruptive Innovation.

Opening Remarks and Moderated by:
Mehul Mehta, Ph.D.
Director, Division of Clinical Pharmacology I Office of Clinical Pharmacology
Center for Drug Evaluation and Research
US Food and Drug Administration

Regulatory Perspective:  Disruptive Innovation and Proactive Initiatives in Clinical Pharmacology and Clinical Research to Advance the Assessment of Safety and Efficacy of Emerging Technologies and Medicines.  Case Studies

Robert Temple, M.D.
Deputy Center Director for Clinical Science
Acting Deputy Director of the Office of Drug Evaluation I (ODE-1)
Center for Drug Evaluation and Research
US Food and Drug Administration

Academic Perspective: Effectiveness of Quantitative Disease Models to Advance Precision Medicine and the Safety and Efficacy of Emerging Technologies – Case Studies

Jogarao Gobburu, Ph.D.
Professor, Executive Director
Center for Translational Medicine
Schools of Pharmacy & Medicine
University of Maryland

Clinical Pharmacology: De-Risking the Critical Path to Informed Decisions

Issam Zineh, PharmD, MPH, FCP, FCCP
Director, Office of Clinical Pharmacology
Office of Translational Sciences
Center for Drug Evaluation and Research
US Food and Drug Administration

The Role of Statistics in Advancing Clinical Pharmacology and Translational Tools – Predictable Uncertainties?

Lisa LaVange, Ph.D.
Director
Office of Biostatistics Organization
Center for Drug Evaluation and Research
US Food and Drug Administration

Industry Perspective: What Role Can Clinical Pharmacology Play in Leveraging Disruptive Technologies in Drug Development?

Prajakti Kothare, Ph.D.
Director
Global Preclinical ADME
Merck

Disruptive Innovation in the Industry –Expanding role of Clinical Pharmacology in Drug Development Decision making and Optimal Synthesis of Efficacy and Safety to Support Registration and Reimbursement. Case Studies

Sriram Krishnaswami, Ph.D.
Senior Director
Clinical Pharmacology
Pfizer

4:00

Round Table Discussion:
Advancing Regulatory Clinical Pharmacology and Clinical Research in Assessing Safety and Efficacy of Medicines and Emerging Technologies.  Lessons Learned and Disruptive Innovation.

Panel of Afternoon Speakers

5:30

Reception

 

6:00

Dinner

 

8:00

FDA Panel Discussion and Q&A with Attendees

FDA Panel Proposed Topics:

  • Product Quality Attributes and Clinical Outcomes
  • Emerging Technologies – e.g., CRISPR, Synthetic Biology, Stem Cell Therapies, gene therapy, and others.

Moderated by
Gerald J. Yakatan, Ph.D.
Founder & Chairman
IriSys, Inc

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Robert Temple, M.D.
Deputy Center Director for Clinical Science
Acting Deputy Director of the Office of Drug Evaluation I (ODE-1)
Center for Drug Evaluation and Research
US Food and Drug Administration

Rick Friedman, Ph.D.
Deputy Director
Science & Regulatory Policy
Center for Drug Evaluation and Research
US Food and Drug Administration

Jonathan P. Jarow, MD
Senior Medical Officer to the Director
Center for Drug Evaluation and Research
US Food and Drug Administration

Lisa LaVange, Ph.D.
Director
Office of Biostatistics Organization
Center for Drug Evaluation and Research
US Food and Drug Administration

Mehul Mehta, Ph.D.
Director, Division of Clinical Pharmacology I Office of Clinical Pharmacology
Center for Drug Evaluation and Research
US Food and Drug Administration

Sarah Pope Miksinski, Ph.D.
Acting Director
Office of New Drug Products
Center for Drug Evaluation and Research
US Food and Drug Administration

Paul Seo, Ph.D.
Lead (Acting), Biopharmaceutics Staff
Office of New Drug Quality Assessment
Center for Drug Evaluation and Research
US Food and Drug Administration

Issam Zineh, PharmD, MPH, FCP, FCCP
Director, Office of Clinical Pharmacology
Office of Translational Sciences
Center for Drug Evaluation and Research
US Food and Drug Administration

CONFERENCE THEME:  Safety, Efficacy and Affordability of Medicines for all Patients– The 21st Century Challenge!

Enormous opportunities for the Pharmaceutical and Biotechnology Industry continue to exist because of a growing number of patients because of better diagnosis and improved understanding of pathogenesis of disease, an aging global population and technological advances that promise to improve the quality of treatments and reduce cost.    The President’s Precision Medicine Initiative, provisions of the 21st Century Cure Act and provisions being developed by the U.S. Senate, aim to  take advantage advances in the fields of molecular guided diagnostics, genomics, metabolomics, “big data” management (including electronic medical records and patient databases) and other are fundamental for advancing the development of precision therapeutics, and for identifying prevention strategies.  Most importantly, precision medicine will help patients.  As a bonus, the development of targeted therapies and the identification of smaller patient population more likely to benefit from certain medicines, or less likely to experience serious adverse effects, will also help the biopharmaceutical industry by making the development process more predictable and less time-consuming, and by improving the safety and efficacy  of medicines for all patients. Some important challenges in the 21st Century include the translation of clinical observations, and unique challenges of designing clinical trials and employing statistical analyses that are appropriate for the smaller populations who would participate in clinical trials for precision therapeutics.

Emerging technologies such as nanotechnology, synthetic biology, stem cell therapies, tissue regeneration, gene therapy, gene editing (CRISPR) and drug device combinations are among the emerging and burgeoning areas at the heart of precision medicine.  Experience suggests that technology emerges faster than the regulatory system can adapt. Perhaps, it would be valuable to consider whether and to what extent the commitment by sponsors to conduct pot-market studies can expedite the pre-market evaluation, or how certain products could be made available to patients prior to their full approval.  The latter, of course, raises the question of whether such yet-to-be approved products would be covered by insurance; insurance reforms are needed to assure that this happens in appropriate circumstances.  The circumstances under which greater flexibility to market emerging technologies are important to define.  In addition, new models for risk-benefit analysis need to be developed that take into account of a more flexible regulatory paradigm.  Uncertainty is an inevitable component bridging medical innovation to market.  When uncertainty increases, there may be greater risk, but the rewards to patients are also greater.  Perhaps, networks of excellence should be developed across the United States and globally to facilitate access to emerging technologies by patients of all ages with particular emphasis on infants and the global pediatric population.

The success of available and emerging medicines requires new tools or modification of existing tools to link quality attributes of a drug product to its clinical performance.  This is particularly more important if reimbursement to hospitals, industry and physicians will be based on the performance of the product.

ICDD is dedicated to advance scientific and regulatory solutions to expedite drug development to meet patient’s medical needs without compromising quality, safety, and efficacy of drugs, biologics and devices.  ICDD offers an informal forum to exchange ideas to find solutions to the constant challenges facing biomedical innovation. 


Past Conferences

2015 Theme: Risks to Drug Development and Biomedical Innovation – The 21st Century Challenge!
Downloadable Agenda: 2015 ICD2 Agenda PDF

2014 Theme: Transformation of Drug Development – Challenges and Opportunities
Advancing Innovative Solutions to Meet Patient’s Medical Needs of Serious Conditions and Rare Diseases

Downloadable Agenda: 2014 ICD2 Agenda PDF

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

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


Last Reviewed: February 4, 2016

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