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Key Sessions

Scott Gottlieb, MD

Opening Keynote Address

The Food and Drug Administration (FDA)

Janet Woodcock, MD

Keynote Address: The Center for Drug Evaluation and Research in 2017 and the Year Ahead

U.S. Food and Drug Administration (FDA)

Matthew Might, PhD

Keynote Fireside Chat : The Future of Precision Medicine

University of Alabama at Birmingham

Dec 05
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7:15am - 8:00am 45 mins
Registration
8:00am - 8:45am 45 mins
Informal Breakfast Roundtable Discussion
  • Panelist Matthew Might, PhD - Director, Hugh Kaul Precision Medicine Institute, University of Alabama at Birmingham
  • Panelist Sarfaraz Niazi, PhD - Adjunct Professor, Department of Biopharmaceutical Sciences, UIC College of Pharmacy
  • Panelist Janet Woodcock, MD - Director, Center for Drug Evaluation & Research (CDER), U.S. Food and Drug Administration (FDA)
more
8:45am - 9:00am 15 mins
Chairman’s Opening Remarks
  • Chairman Nielsen Hobbs - Editor, The Pink Sheet
more
9:00am - 9:30am 30 mins
Keynote Addresses
Opening Keynote Address
  • Keynote Speaker Scott Gottlieb, MD - Commissioner of Food and Drugs, The Food and Drug Administration (FDA)
more
9:30am - 10:00am 30 mins
Keynote Addresses
Keynote Address: The Center for Drug Evaluation and Research in 2017 and the Year Ahead
  • Keynote Speaker Janet Woodcock, MD - Director, Center for Drug Evaluation & Research (CDER), U.S. Food and Drug Administration (FDA)
more

Here an update from CDER on current initiatives, challenges and accomplishments of 2017 and what’s in store for the year ahead

10:00am - 10:30am 30 mins
CDER Office of New Drug Update
  • Patrick Frey - Senior Advisor to the Director, Office of New Drugs CDER, Food & Drug Administration
more

Here an update on developments in OND and what is currently in the pipeline for 2018.


10:30am - 11:00am 30 mins
Networking Refreshment Break
11:00am - 11:30am 30 mins
Update on Drug Safety and Post Market Surveillance
  • Gerald Dal Pan, MD, MHS - Director, Office of Surveillance and Epidemiology, U.S. Food and Drug Administration (FDA)
more

Here an update from the director on the latest developments from the office of Surveillance and Epidemiology.

11:30am - 12:30pm 60 mins
Keynote Panel: Industry Follow up on Morning Keynotes, Office of New Drug Updates
  • Moderator Meg Tirrell - Biotech and Pharma Reporter, CNBC
  • Panelist Karen Hauda - Senior Director; Clinical, Medical and Regulatory Affairs, Novo Nordisk Inc.
  • Panelist John Maraganore, PhD - CEO, Alnylam Pharmaceuticals, Inc
  • Panelist Peter Honig - Senior Vice President, Worldwide Safety and Regulatory, Pfizer
more

Sit in on a panel discussion in follow up to the morning’s keynotes and updates. What are the current trends and developments affecting the industry, key industry implications of regulatory policies and updates, as well as industry insight on what is anticipated for the year ahead.  

 

12:30pm - 1:30pm 60 mins
Networking Lunch
1:30pm - 2:15pm 45 mins
Understanding the Emerging Role of Patient Reported Outcomes (PRO) and FDA Use in Drug Programs
  • Panelist Cynthia Grossman, PhD - Associate Director, Science of Patient Input, FasterCures Milken Institute
  • Panelist Christine McSherry - Executive Director, Jett Foundation
  • Panelist Carmen Bozic, MD - Vice President, Global Development, Biogen
  • Moderator Kay Holcombe - Senior Vice President, Science Policy, Biotechnology Innovation Organization (BIO) (retd.)
more

Patient reporting has not historically held much sway in FDA considerations, but the tide has been turning. As the FDA more seriously considers including patient-reported outcomes (PRO) as part of its approval processes, examine the potential impact on drug manufacturers as well as what this will mean for the approval process moving forward and current developments and considerations for individual diseases and treatments.

2:15pm - 2:45pm 30 mins
Update: Current Political and Regulatory Proposals and Developments Impacting Pharma and Healthcare
  • Hector De La Torre - Executive Director, Transamerica Center for Health Studies
more

 Discuss the latest DC developments, what is coming down the pipeline? Identify and examine current proposals that are circulating the Hill which would impact the Bio/Pharma and healthcare industries.  

2:45pm - 3:15pm 30 mins
Networking Refreshment Break
3:15pm - 4:00pm 45 mins
The Opportunities and Challenges of Expanded Access
  • Panelist Beth Roxland, J.D., M.Bioethics - Senior Consultant on Law, Policy and Ethics, Independent
  • Moderator Jess Rabourn - Managing Director, Wide Trial
  • Panelist Jonathan Jarow - Senior Medical Advisor, Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA)
  • Panelist Martin Naley - General Manager, My Tomorrows
more

This session examines best practices and modern approaches to integrating well-designed large group access programs into the drug development process. 

  • Examine the current requirements of all expanded access uses and its evolution, as well as those specifically for investigational drugs and biologics 

  • What are the practical, ethical and legal issues to be considered? 

  • Discuss the drivers of commercial feasibility including cost recovery, regulatory considerations, and pragmatic design.  

 

4:00pm - 5:00pm 60 mins
Keynote Fireside Chat : The Future of Precision Medicine
  • Keynote Speaker Matthew Might, PhD - Director, Hugh Kaul Precision Medicine Institute, University of Alabama at Birmingham
  • Moderator Nicole Fisher - Contributor; Founder & CEO, Forbes Magazine; HHR Strategies
more

Sit in on a discussion on the intersection of ethics, innovation and precision medicine, from patient to pill.

Matthew Might, Ph.D., a strategic leader appointed to the White House Precision Medicine Initiative by former President Barack Obama, has been named the inaugural director of the Hugh Kaul Personalized Medicine Institute at the University of Alabama at Birmingham School of Medicine.Might comes to UAB from the University of Utah, where he is a Presidential Scholar and an associate professor in both computer science and pharmaceutical chemistry, and from Harvard Medical School, where he is a visiting professor of biomedical informatics. Might’s research interests focus on the intersection of computation and medicine to advance precision medicine through personalized therapeutics.

5:00pm - 6:00pm 60 mins
Cocktail Reception