New York/New Jersey Area Chapter Virtual Event: Maximizing the Impact of Patient-centric Data: Meani

Patient Focused Drug Development (PFDD) has gained growing support from patients, regulators, health technology assessment (HTA) bodies and industry who are seeking to systematically incorporate patient perspectives into drug development, regulatory decisions and value assessments.

To maximize the impact of this patient-centric data, it is critical that Sponsors and FDA collaborate and align early in the development process to ensure that the Sponsor’s program will deliver data that is fit for purpose to inform the specific regulatory decision(s) being targeted. Because patient experience data (PED) as a source of evidence in regulatory decision making is important, both regulators and industry benefit from interactions throughout the process of PED development when PED is intended to support a regulatory decision.

This session will incorporate FDA, EMA, and industry perspectives and experience to help support meaningful FDA-Sponsor interactions, specific to the design, collection, and analysis of PED, while balancing needs of both parties. The session will feature a series of brief presentations that will provide an introduction to PED and its potential use as evidence in regulatory decisions, discuss examples that demonstrate key elements that resulted in a successful Regulator-Sponsor interaction. The session will highlight learnings and opportunities where a modified approach to Regulator-Sponsor interactions could be even more beneficial.

Lastly, a panel discussion will focus on how Regulators and Sponsors can align and work collaboratively on next steps that will have the greatest impact on increasing the efficiency and productivity of interactions and use of the resulting PED to inform regulatory decisions.

Registration Fees & Deadlines

Member $0 | Nonmember $25 

Speakers

Joshua Coulter
Director, Preference Elicitation, Pfizer

Nicholas Langevin
Senior Director, Regulatory Affairs, Sumitomo Pharma America, Inc.

Cancellations and Refunds

RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. All cancellation requests must be submitted in writing to support@raps.org. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.

Substitutions

Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email support@raps.org with the event title, name of the original registrant and the contact information for the new attendee.

Proof of Attendance

A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.

Questions