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.

Stay tuned for speaker announcements in the coming weeks!

Speakers

Sandy Leonard

VP, Medical Evidence and Observational Research, ASTRAZENECA
Sandy Leonard is Vice President, Medical Evidence and Observational Research at AstraZeneca who leads a team of RWE scientists and study delivery professionals who together deliver impactful evidence for the entirety of the AstraZeneca portfolio.
Sandy believes the value of evidence is linked inextricably to the ability to improve the lives of patients. She challenges her to team to deliver scientific insight, seek strategic collaboration and ultimately drive innovative, impactful and efficient medical and payer evidence generation.
Throughout her career, Sandy has developed and implemented key corporate strategies focused on the development and application of evidence throughout the healthcare system, including the evolution of AstraZeneca’s evidence generation capabilities, establishing AstraZeneca’s RWE strategy and collaboration initiatives, as well as leading AstraZeneca’s US government reimbursement team during the implementation of the Medicare drug benefit.
Sandy holds an undergraduate degree in Psychology from the University of Wisconsin – Madison and has a Masters in Public Health, from the University of Tennessee – Knoxville.

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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

Early Bird Rate
(Ends May 3)

$119 per person

Onsite Rate (May 4 - June 5): $139
Register now!

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].