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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.

2015 Theme

Risks to Drug Development and Biomedical Innovation – The 21st Century Challenge!


2015 Agenda: Click here for downloadable PDF version of the agenda

International Conference on Drug Development (ICD2) • Day IMonday, February 23, 2015
12:00

Lunch

 
6:15

Welcome

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

2:30

Opening Remarks

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
The Safety Risks of Biomedical Innovation? - How to Define Clinical Value

Richard A. Moscicki, M.D..
Deputy Center Director for Clinical Science
FDA/CDER

Speaking on behalf of Janet Woodcock, M.D.

3:40

Round Table Presentations:Risk Reduction in Drug Development and Biomedical Innovation in the XXI Century – A Path to New Cures

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

Bio Update and Perspectives

The Honorable James C. Greenwood
President and CEO
Biotechnology Industry Association (BIO)

PhRMA Update and Perspectives

John J. Castellani
President and CEO
Pharmaceuticial Research and Manufacturers of America (PhRMA)

Integration of CMS Perspectives in Biomedical Innovation and Market Access – Risk-Benefit Assessment

Joel Brill, M.D.
Medical Director
FAIR Health, Inc.

Legal Perspectives – A Path to 21st Cures Initiative

John M. Engel, Esq.
Founding Partner & Manager
Engel & Novitt, LLP

5:15

Round Table Discussion: Risk Reduction in Drug Development and Biomedical Innovation in the XXI Century – A Path to New Cures

Panel of Afternoon Speakers joined by Paul Huckle, Chief Regulatory Officer, GlaxoSmithKline

6:15

Reception

 
7:00

Dinner

 
8:00

Transparency of Clinical Trial Data - The Right of the Clinical Scientist and the Patient to Know

Joanne Wadestricher, M.D.
Chief Medical Officer
Johnson and Johnson

 

International Conference on Drug Development (ICD2) • Day II Tuesday February 24, 2015
7:30

Breakfast

 
8:30

Round Table Presentations: A Vision for Clinical Development in the XXI Century – The Right Targets for the Next Generation of Drug Development and Effective Therapeutics- Use of Real World Data

Moderated by:
Jonathan Seltzer, M.D., MBA, M.A., F.A.C.C
President, ACI Clinical
Director, Clinical Research, Lankenau Heart Institute

Challenges and Opportunities of Fewer Patients Outcome Clinical Studies in the XXI Century

Richard A. Moscicki, M.D..
Deputy Center Director for Clinical Science
FDA/CDER

Speaking on behalf of Robert Temple, M.D.

Approach to the Acquisition and Use of Real World Clinical Data – Challenges and Predictive Tools

Marc Berger
VP Real World Data and Analytics
GH&V Real World Data Lead
Pfizer, Inc.

Big Data Analysis to Accelerate Biomedical Innovation and Product Development

Jesse Berlin, Sc.D.
Vice-President, Pharmacoepidimiology
Pharmaceutical Research and Development
Johnson &Johnson

Patient-Focused Drug Development - The Time is Now

Paula E. Rinaldi, RPh, MPH
US Head DRA
Novartis Pharmaceuticals

Personalized Medicine and Novel Trial Design in Drug Development and Biomedical Innovation – Patient's Role

Jane Perlmutter, Ph.D., M.B.A.
President and Founder of
Gemini Group

Expanded Access Programs for Drugs and Biologics: Concepts, Controversies, and Clinical Implications

Martha B. Donoghue, M.D.
Medical Officer
FDA/CDER/OND/OHOP

Impact of Social Media on Drug, Biologics and Biomedical Innovation - Managing life changing illness

Ben Heywood
Co-Founder, President
PatientsLikeMe

Doing More with Less in Clinical Development in the XXI Century – How to?

Lynn Marks, M.D.
Senior VP of Projects Clinical Platform and Science
GlaxoSmithKliine
11:45

Round Table Discussion: A Vision for Clinical Development in the XXI Century – The Right Targets for the Next Generation of Drug Development and Effective Therapeutics- Use of Real World Data

Panel of Morning Speakers, joined by Issam Zineh, Pharm.D., M.P.H., F.C.C.P, Clinical Pharmacology at CDER/FDA
12:30

Lunch

 
2:15

Round Table Presentations: Finding Solutions to Quality and Safety Challenges in Drug and Biologics Innovation and Development in the XXI Century

Moderated by:
Sarah Pope Miksinski, Ph.D.
Director (Acting)
Office of New Drug Quality Assessment 
FDA, CDER, OPS

Breakthrough Therapies and Manufacturing Challenges

Sarah Pope Miksinski, Ph.D.

Innovation of Manufacturing and Emerging Technology – Integration of Review, Inspections and Monitoring

Lawrence Yu, Ph.D.
Deputy Director (Acting) Office of Pharmaceutical Science
FDA, CDER

Emerging Technologies and Manufacturing Efficiencies – Noncell-based production technologies

Joseph Tarnowski, Ph.D.
Senior Vice President of Chemistry, Manufacturing and Controls Biopharm R&D
GlaxoSmithKline

Integrating Biomedical Innovations in The Transformation of Pharmaceutical Manufacturing in the XXI Century – Challenges and Opportunities 

Charles Hoiberg, Ph.D.
Executive Director
Pfizer, Inc
4:00

Round Table Discussion:

Panel of Afternoon Speakers
5:30

Reception

 
6:00

Dinner

 
8:00

FDA Panel Discussion and Q&A with Attendees

FDA Panel Proposed Topics:

  • Biosimilars Risk Assessment – Harmonization initiatives: EU-Japan and USA
  • Changes in Import and Export Requirements – Why now?
  • User Fees and GDUFA challenges
  • Lessons Learned from FDA Compliance Initiatives - Data Integrity
  • Product Quality Attributes and Clinical Outcomes

Martha B. Donoghue, M.D.
Medical Officer, Neuro-Oncology, Pediatric Oncology, and Rare Tumors Group
FDA, CDER, OND, OHOP

Sarah Pope Miksinski
Director (Acting)
Office of New Drug Quality Assessment 
FDA, CDER, OPS

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

Paul Seo, Ph.D.
Lead (Acting), Biopharmaceutics Staff
Office of New Drug Quality Assessment
FDA/OMPT/CDER/OPS/

Lawrence Yu, Ph.D.
Deputy Director (Acting)
Office of Pharmaceutical Science
FDA, CDER

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

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

Conference Theme:
Risks to Drug Development and Biomedical Innovation – The 21st Century Challenge!

The complex global economic recovery that we are witnessing has definitely impacted the funding of the scientific enterprise, but it has not stopped researcher’s creativity to develop critical technological advances to understand the causes of disease. Despite tough economic times science will always continue its journey to understand the dynamics changes of our universe, the causes of disease, human behavior, human longevity, and the human origin.   

In the last five years, researchers have developed new tools in genetics, proteomics, metabolomics, bioanalytical methodologies, innovative molecular imaging techniques, and “big data” analysis algorithms  with the purpose of finding and validating new disease targets, to further our understanding of  gene changes and the rate at which these changes take place  with the purpose of defining the root causes of diseases to enable researchers to develop the next generation of drugs and treatment modalities to cure disease.

Equally important, these technological advances will help the biopharmaceutical industry to reduce the risk early on during the drug development process.  This is the challenge that we face in the 21st century.   Recently, The Accelerating Medicines Partnerships was made public.  It is an unprecedented 230 million over five years initiative between NIH, ten biopharmaceutical companies, the Foundation for the NIH, FDA, several patient organizations, and others with the purpose of reducing the risk of drug development for Alzheimer’s, type-2 diabetes, autoimmune diseases (arthritis, lupus), and Parkinson’s disease by identifying and validating the best disease targets for drug development to bring new drugs and treatment modalities faster to patients.

Reducing the risk of biomedical innovation requires that we continuously assess the drug development process.  It requires that we continuously ask if there is a better way to increase the prediction ability of non-clinical and clinical experimentation to prevent failures during the late phases of the drug development process.  Researchers have been aware for a long time that the rate of failure during phase-3 is unacceptable.  This raises an interesting question: Why is that phase-2 does not predict the high failure rate of phase-3?    Involvement of patients early on in the drug development process will help us ask the right questions to accelerate, and reduce the risk of the drug development process. 

The transformation of the drug development is imperative and should not be delayed.  We need to take risks to reduce the risk of failure.  Uncertainty is an important component of bringing new biomedical innovations to patients.  Detailed risk assessment is essential, and frankly, a matter of life or death, to the pharmaceutical and biomedical industry.  Innovative clinical protocols need to continuously be developed using fewer number of patients, but measuring more biomarkers that will allow the testing of more than one hypothesis, and facilitate the detection of more complex interactions.   Dr. Woodcock stated during the first committee’s meeting of the 21st Century Cures Initiative “…. I think number one, the clinical trials system that we have is not a system.  It takes years; it exhausts the investigators and involves much paperwork and often many lawyers”.  There is a need to explore the efficient use of clinical networks to accelerate drug development.

Emerging technologies requires a transformation of manufacturing and more efficient regulatory initiatives to ensure the quality, safety and efficacy of the products reaching the patients.  For example, transforming manufacturing to meet the needs of cell therapies and personalized medicine.  There is a need to develop new dosage forms; we need to challenge formulators to develop more acceptable dosage forms for pediatrics, geriatrics, and other special populations.

The transformation of manufacturing may include moving offshore.  This move raises important questions: What is the impact on biomedical innovation?  What is the impact on intellectual property protection? What is the impact on national emergency needs?

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 challenge of biomedical innovation.

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



Past Conferences

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

Downloable 2014 Agenda: 2014 ICD2 Agenda

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


Last Reviewed: February 19, 2015

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