Informa Life Sciences is part of the Knowledge and Networking Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 3099067.

Informa
Key Sessions

Scott Gottlieb, MD

Opening Keynote Address: Scott Gottlieb, FDA Commissioner

The Food and Drug Administration (FDA)

Janet Woodcock, MD

CDER Keynote Address: 2018 and the year ahead

U.S. Food and Drug Administration (FDA)

Dec 11
Show Filter
8:00am - 8:45am

Morning Coffee & Registration

More
8:45am - 9:00am

Chairman’s Opening Remarks

More
Showing of Streams
Showing of Streams
1:00pm - 2:00pm

Networking Lunch

More
Showing of Streams
4:45pm - 5:00pm

Closing Remarks

More
5:00pm - 6:00pm

Cocktail Reception

More
8:00am - 8:45am 45 mins
Morning Coffee & Registration
8:45am - 9:00am 15 mins
Chairman’s Opening Remarks
9:00am - 9:30am 30 mins
Keynote Addresses
Opening Keynote Address: Scott Gottlieb, FDA Commissioner
  • Scott Gottlieb, MD - Commissioner of Food and Drugs, The Food and Drug Administration (FDA)
9:30am - 10:15am 45 mins
Info
Keynote Addresses
CDER Keynote Address: 2018 and the year ahead
  • Keynote Speaker Janet Woodcock, MD - Director, Center for Drug Evaluation & Research (CDER), U.S. Food and Drug Administration (FDA)

Hear an update from CDER on current initiatives, challenges, and accomplishments of 2018, and what the future holds with the ongoing changes within FDA structure, initiatives, and priorities.

10:15am - 11:00am 45 mins
Panel: Changes in the Political Landscape Impacting Pharma and Bio Regulations
  • Panelist Karen Hauda - Senior Director; Clinical, Medical and Regulatory Affairs, Novo Nordisk Inc.
  • Panelist Ipsita Smolinski - Managing Director, Capitol Street
  • Panelist Nancy Myers - President & Founder, Catalyst Healthcare Consulting
  • Moderator Nielsen Hobbs - Editor, The Pink Sheet
11:00am - 11:30am 30 mins
Networking Refreshment Break
11:30am - 12:15pm 45 mins
Info
Safety, Efficacy and Post Market Surveillance
  • Gerald Dal Pan, MD, MHS - Director, Office of Surveillance and Epidemiology, U.S. Food and Drug Administration (FDA)

Hear an update from the director on the latest developments from the Office of Surveillance and Epidemiology. 

12:15pm - 1:00pm 45 mins
The Role of Value Based Reimbursement and Value Based Outcomes in Pharma
  • Leslie Isenegger - Reputation and Risk Management Practice, Syneos Health
  • Susan Cantrell - CEO, Academy of Managed Care Pharmacy
  • Jonathan Blum - Managing Principal, Health Management
  • Michelle Drozd - Deputy Vice President, PhRMA
  • Paul Radensky - Partner, McDermott, Will & Emery
1:00pm - 2:00pm 60 mins
Networking Lunch
2:00pm - 2:45pm 45 mins
Info
Track A: The New Wave of Biosimilars, PROs, and Office of New Drugs
Rare Disease Pathways to Accelerated Approval
  • Lucas Kempf - Associate Director Rare Diseases Program, Food and Drug Administration
  • Meg Alexander - Head, Reputation & Risk Management Practice, Syneos Health
  • Ron Cooper - President and CEO, Albireo Pharma

The FDA is approving treatments for orphan diseases at an unprecedented rate. Which in itself is great for rare disease patients who have been waiting for a treatment. However, FDA approval does not equal access, as the reimbursement community is demanding demonstration of value to justify the high cost. Absence of strong confirmatory evidence means no access for some patients. Many times, coverage policies are limiting access based on arbitrary requirements, misunderstanding of the accelerated approval pathway, or worse, no understanding of the disease intended to treat. This process results in sick patients seeking treatment only getting sicker and costing more to treat and provide care. Creative solutions should be discussed and explored to this critical issue.


2:00pm - 2:45pm 45 mins
Track B- Med Device and Tech Perspectives Powered by Medtech Insight: Costs, Reimbursement, and Speed to Coverage
Panel: Burden of Proof: Building a Value Framework for Regulatory and Payer Approval
  • Panelist Bruce Robertson - Managing Director, H.I.G. Capital
  • Panelist Ryan Shelton, Ph.D. - CEO and Co-founder, PhotoniCare, Inc.
  • Don May - Executive Vice President, Payment and Health Care Delivery, AdvaMed
2:45pm - 3:30pm 45 mins
Info
Track A: The New Wave of Biosimilars, PROs, and Office of New Drugs
CDER New Drugs Program: 2018 update at the FDA/CMS
  • Khushboo Sharma - Chief of Staff (Acting), Office of New Drugs, CDER

Hear an update on the restructuring of the OND, what is currently in the pipeline for the year ahead, and what is in store leading up to 2020.

2:45pm - 3:30pm 45 mins
Info
Track B- Med Device and Tech Perspectives Powered by Medtech Insight: Costs, Reimbursement, and Speed to Coverage
Case Study: Speeding the Pathway to Coverage
  • Ken Skodacek - Deputy Ombudsman, CDRH, FDA

Learn from a recently approved Medical Device or Technology on their expedited path to both FDA approval and Payer coverage. Hear insights on their value framework and communication process with the approving bodies.

3:30pm - 4:00pm 30 mins
Track A: The New Wave of Biosimilars, PROs, and Office of New Drugs
Networking Refreshment Break
3:30pm - 4:00pm 30 mins
Track B- Med Device and Tech Perspectives Powered by Medtech Insight: Costs, Reimbursement, and Speed to Coverage
Networking Refreshment Break
4:00pm - 4:45pm 45 mins
Info
Track A: The New Wave of Biosimilars, PROs, and Office of New Drugs
RWE in the Drug Approval Process: Keys to the Future of Healthcare
  • Panelist Christine McSherry - Executive Director, Jett Foundation

The availability of information and improvements in healthcare related technology have made it possible for consumers to be better informed about their healthcare and to make better decisions as a result. Offsetting this is the fact that patients are being asked to pay a larger percentage of their household income to maintain their health. The challenge this poses to everyone involved in the healthcare system (including companies developing new products, whether they be drugs, devices, new apps, etc.) is being able to communicate a rationale as to why a specific action or particular product represents good value for money.

Patient reported outcomes reflect how a patient feels or functions. With all people wanting to live better, longer, utilizing PROs in clinical trials as support for the claims a product makes and the value it brings to consumers and patients are key to having people take action, which may include spending limited amounts of money on new products or technology to improve their health.

Identifying the right PROs for any product and measuring its value in terms of improvement in life quality vs a current standard of behavior is key to the future success of any new product or healthcare initiative. Too often, however, PROs are treated as secondary endpoints rather than the primary focus they deserve to be.

This talk will focus on the evolving role of PROs and their value and importance in improving the health of people in the US.

4:00pm - 4:45pm 45 mins
Track B- Med Device and Tech Perspectives Powered by Medtech Insight: Costs, Reimbursement, and Speed to Coverage
Use of Patient-Driven Biology and Bayesian AI to engineer a more efficient drug development paradigm
  • Niven Narain - Co-Founder, President & CEO, Berg LLC
4:45pm - 5:00pm 15 mins
Closing Remarks
5:00pm - 6:00pm 60 mins
Cocktail Reception