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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)

7:00am 8:00am (60 mins)

Main agenda

Registration

8:00am 8:45am (45 mins)

Main agenda

Informal Breakfast Roundtable Discussion with Regulatory and Industry Leaders

  • Janet Woodcock, MD - Director, Center for Drug Evaluation & Research (CDER), U.S. Food and Drug Administration (FDA)
  • Matthew Might, PhD - Director, Hugh Kaul Precision Medicine Institute, University of Alabama at Birmingham
  • Sarfaraz Niazi, PhD - Adjunct Professor, Department of Biopharmaceutical Sciences, UIC College of Pharmacy

8:45am 9:00am (15 mins)

Main agenda

Chairman’s Opening Remarks

  • Nielsen Hobbs - Editor, The Pink Sheet

9:00am 9:30am (30 mins)

Main agenda

Opening Keynote Address

  • Scott Gottlieb, MD - Commissioner of Food and Drugs, The Food and Drug Administration (FDA)

9:30am 10:10am (40 mins)

Main agenda

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

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

  • Janet Woodcock, MD - Director, Center for Drug Evaluation & Research (CDER), U.S. Food and Drug Administration (FDA)

10:00am 10:30am (30 mins)

Main agenda

Networking Refreshment Break

10:30am 11:00am (30 mins)

Main agenda

CDER Office of New Drug Update

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


  • Patrick Frey - Senior Advisor to the Director, Office of New Drugs CDER, Food & Drug Administration

11:00am 11:30am (30 mins)

Main agenda

Update on Drug Safety and Post Market Surveillance

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

  • Gerald Dal Pan, MD, MHS - Director, Office of Surveillance and Epidemiology, U.S. Food and Drug Administration (FDA)

11:30am 12:15pm (45 mins)

Main agenda

Industry Panel Follow up on Office of New Drug Update

Participate in an industry panel discussion in follow up to the morning’s keynotes and updates. What are the current trends and developments affecting the industry, and hear the perspective of stakeholders on the past year, and what’s anticipated for 2018

  • Moderator Meg Tirrell - Biotech and Pharma Reporter, CNBC
  • Panelist Karen Hauda - Senior Director; Clinical, Medical and Regulatory Affairs, Novo Nordisk Inc.
  • Panelist Kay Holcombe - Senior Vice President for Science Policy, Biotechnology Innovation Organization
  • Panelist John Maraganore, PhD - CEO, Alnylam Pharmaceuticals, Inc
  • Panelist Peter Honig - SVP, Worldwide Safety and Regulatory, Pfizer

12:30pm 1:30pm (60 mins)

Main agenda

Networking Lunch

1:30pm 2:15pm (45 mins)

Main agenda

Understanding the Emerging Role of Patient Reported Outcomes (PRO) and FDA Use in Drug Programs

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.

  • Panelist Carmen Bozic MD - Vice President Global Development, Biogen
  • Panelist Cynthia Grossman PhD - Associate Director, Science of Patient Input, FasterCures Milken Institute
  • Panelist Christine McSherry - Executive Director, Jett Foundation

2:15pm 2:45pm (30 mins)

Main agenda

Update: Current Political and Regulatory Proposals and Developments Impacting Pharma and Healthcare

 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.  

  • Hector De La Torre - Executive Director, Transamerica Center for Health Studies

2:45pm 3:15pm (30 mins)

Main agenda

Networking Refreshment Break

3:15pm 4:00pm (45 mins)

Main agenda

The Opportunities and Challenges of Expanded Access

This session examines best practices and modern approaches to integrating well-designed large-group access programs into the drug development process. Expert panelists will discuss the drivers of commercial feasibility, including cost recovery, regulatory considerations, and pragmatic design.

 

  • Moderator Jess Rabourn - Managing Director, Wide Trial
  • Panelist Beth Roxland JD - Senior Consultant on Law, Ethics and Policy Associate,, NYU Langone Medical School

4:00pm 4:45pm (45 mins)

Main agenda

Keynote Fireside Chat : The Future of Precision Medicine

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.

  • Matthew Might, PhD - Director, Hugh Kaul Precision Medicine Institute, University of Alabama at Birmingham
  • Moderator Nicole Fisher - Contributor, Forbes Magazine; Founder & CEO, HHR Strategies

5:00pm 6:00pm (60 mins)

Main agenda

Cocktail Reception