June 5, 2019

FierceBiotech Executive Breakfast
Getting Real: The Changing Tide on Real-World Evidence in Drug Development

Philadelphia Marriott / Liberty Ballroom / 1201 Market Street

About

Getting Real: The Changing Tide on Real-World Evidence in Drug Development

FDA is opening up to data gathered outside the hermetically sealed clinical trial setting as regulators recognize the need for a more flexible framework for evaluating treatments, helped along by the 21st Century Cures Act. This move is coinciding with growing expertise among technology providers to tap real-world data sources and analyze them using everything from the latest data-crunching technologies to natural language processing and artificial intelligence.

Real-world evidence teams are cropping up across biopharma as the industry invests in talent and infrastructure to deploy this sort of data in their R&D efforts. They’re using RWE to identify biomarkers that can be used to select clinical trial patients and tapping patient records to help design and optimize trial protocols, plus help identify optimal trial sites. Real-world evidence could also serve as a control arm in certain studies—for instance, rare cancers—to reduce trial duration, allow for a smaller number of participants and save money.

And on the other side of the approval divide, drugmakers are running real-world studies to find and tap new marketing and payer insights, including long-term safety and outcomes.

As a new approach that requires significant investment, real-world evidence requires the right talent and technology. Where to find that talent and technology, and how to deploy it internally or with partners, are some of the questions companies face. We’ll address these questions and more with the help of current experts and practitioners in the field.

Speakers

Jennifer Graff, PharmD

Vice President of Comparative Effectiveness Research
NATIONAL PHARMACEUTICAL COUNCIL
Jennifer Graff, PharmD, is vice president of comparative effectiveness research at the National Pharmaceutical Council (NPC). Since joining NPC in 2009, she has lead research and policy initiatives to advance the use of high-quality evidence to inform health care decision-making.

Prior to joining NPC, Dr. Graff led strategic health economic research activities at MedImmune and Pfizer Pharmaceuticals. Dr. Graff holds a Doctorate of Pharmacy from the University of Nebraska Medical Center, and completed a fellowship at the University of Michigan.

Jack Sheehan, RPh, MBA, PhD

Director, Real-World Value and Evidence, Neuroscience, JANSSEN SCIENTIFIC AFFAIRS (JSA)
Jack Sheehan, RPh, MBA, PhD, is a Director, Real-World Value and Evidence, Neuroscience, Janssen Scientific Affairs (JSA).
Jack has more than 10 years of industry experience in psychiatry, metabolics, neurology, and anti-infectives therapeutic areas.
He holds a PhD in Molecular Pharmacology from SUNY Stony Brook and a BS in Pharmacy from Rutgers. He also completed post-doctoral training in Pathophysiology at the University of Pennsylvania and an MBA specialized in economics at New York University.

FirstName LastName

Job Title
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FirstName LastName

Job Title
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Danny Wiederkehr

Senior Director, Global Health Economics and Outcomes Research Team Lead, PFIZER
Danny Wiederkehr is the Global Lead for the Health Economics and Outcomes Research supporting cardiovascular medicine at Pfizer. Danny believes we have only slightly tapped the potential of real-world evidence to drive better decision making in healthcare, improve the efficiency of care delivery and improve patient outcomes. He holds an undergraduate degree in Mathematics and Gender Studies from the University of Notre Dame and an MPH in Health Policy and Management from Columbia University.

Bio coming soon!

Carly Helfand (Moderator)

Senior Editor, FIERCEPHARMA
Carly Helfand is a news editor with FierceMarkets' Life Sciences group, writing for FierceVaccines, FiercePharma and FiercePharmaMarketing. Carly got her start covering pharma while earning her master's at Northwestern University's Medill School of Journalism, where she concentrated in business reporting. She has completed journalism projects on four continents, and her work has appeared in various outlets such as The Boston Globe, The Washington Post's Wonkblog and Cape Town's Weekend Argus. Carly prefers watching pro hockey to nearly everything. She also plays the Irish fiddle. You can contact her at [email protected].

schedule

6:45 AM - 7:15 AM: Check-in, Networking, and Breakfast Buffet
7:15 AM - 8:30 AM: Panel Discussion

Pricing

Attendee Rate

$139 per person

location

FAQ

Parking is available at the Marriott for a fee.

Yes, a full breakfast buffet will be served from 6:45 AM - 8:30 AM

Attendee substitutions may be made on or before May 31, 2019. Please submit a written request by email to Ashley Secondini at [email protected].

Due to the nature of this event, we are unable to provide refunds. Attendee substitutions may be made on or before May 31, 2019. Please submit a written request by email to Ashley Secondini at [email protected].