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#272: Towards Instantaneous Regulatory Decisions and Better Predictability
Tuesday June 17, 2025 4:00pm - 5:00pm EDT
145AB
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-25-604-L04-P; CME 1.00; RN 1.00

An interactive sesion to reimagine regulatory frameworks and streamline product approvals globally. This session will focus on focus on data transparency, collaboration, process optimization and technology to accelerate medicine development and patient access.

Learning Objectives

Recognize the power of data to accelerate submissions; Initiate pilot projects aiming at sharing data, not documents, and lay the groundwork for dynamic reviews; Create better pre-competitive collaborations to share more safety data and endpoints.

Chair

Dominique Lagrave, PharmD

Speaker

Panelist
Debra Yeskey

Panelist
Len Rosenberg, PhD, RPh

Panelist
Tony Fantana, PhD

Panelist
Tala Fakhouri, PhD, MPH


Speakers
avatar for Tala Fakhouri

Tala Fakhouri

Associate Director for Data Science and Artificial Intelligence, CDER, FDA, United States
Tala H. Fakhouri PhD MPH is the Associate Director for Data Science and Artificial Intelligence in the Office of Medical Policy, Center for Drug Evaluation and Research at Food and Drug Administration. Dr. Fakhouri manages a team tasked with developing, coordinating, and implementing... Read More →
avatar for Tony Fantana

Tony Fantana

Sr. Dir, Eli Lilly, United States
Tony Fantana is the Global Regulatory Affairs Innovation and Technology Lead at Eli Lilly. He is passionate about creatively solving unmet medical needs through innovative technology solutions. Trained at Harvard Medical School, Tony held roles of increasing responsibility driving... Read More →
avatar for Dominique Lagrave

Dominique Lagrave

Senior Vice President of Regulatory Innovation, Accumulus Synergy, United States
Dominique has over 25 years of International Regulatory Affairs experience with the last 20 years spent in Global Regulatory Operations leadership role. Past experiences include work at Galderma, Novo Nordisk, Liquent-Parexel and Dendreon. Dominique joined Accumulus as SVP of Regulatory... Read More →
avatar for Len Rosenberg

Len Rosenberg

Head of Clinical Operations, Beat AML, a division of The Leukemia and Lymphoma Society, United States
Len Rosenberg is an executive with proven experience in driving operational excellence at all levels within the pharmaceutical, biotechnology, CRO and eClinical sectors - diverse background includes executive management, clinical and regulatory operations, business development and... Read More →
avatar for Debra Yeskey

Debra Yeskey

Head of Regulatory Policy and Intelligence, CEPI, United States
Debra Yeskey, Pharm.D., is the Head of Regulatory Policy and Intelligence for the Coalition for Epidemic Preparedness Innovations (CEPI). She has been with CEPI since December 2018, and was instrumental in the creation of the Regulatory Affairs Group under COVAX that is co-led by... Read More →
Tuesday June 17, 2025 4:00pm - 5:00pm EDT
145AB Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  09: Regulatory, Session

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