Panel: Advancing Clinical Trial Innovation through Strategic Regulatory and Statistics Collaboration
Biotech companies face critical trade-offs in trial design—balancing speed and cost advantages with regulatory risks. Join the RAPS Boston chapter at Ketryx for a practical discussion moderated by April Nguyen (RAPS Volunteer and Regulatory Strategy, MMS) on how early cross-functional collaboration provides a competitive internal and regulatory advantage for programs to maximize the probability of therapeutic and submission success. Our speakers, Aiden Flynn (Strategic Statistical Services, MMS) and Ben Kaspar (Regulatory Strategy, MMS) will also share case studies on how leveraging statistical simulations, real-world data, and regulatory engagement strategies to accelerate development and improve outcomes for patients. By understanding historical precedent as the foundation of innovative study designs, sponsors can apply underutilized tools to make evidence-based decisions with greater confidence.
RAPS-Boston Learning Objectives:
- Understand how early alignment between statistical and regulatory teams leads to more efficient and accepted trial and development program strategies.
- Learn how innovative trial designs, statistical simulations, and health agency interactions can improve the predictive value of Ph2b studies.
- Identify regulatory best practices and risk mitigation approaches to optimize clinical program development and agency engagement.
- Understand when and how to use study design technologies to reduce patient burden and support regulatory engagement.
- Discuss optimizing existing expedited pathways and the Commissioner’s National Priority Voucher (CNPV) in advance of the FDA's pilot program public hearing.
Executive Chat: From Molecule to Market—Regulatory Leadership at Biogen
Join RAPS Boston for an in-person Executive Chat with Diane Rocco, SVP, Global Regulatory Affairs at Biogen, moderated by Ami Mehr. This conversation will explore how regulatory leadership shapes critical decisions across the drug development lifecycle—from early clinical strategy through post-market execution in complex therapeutic areas.
Drawing on her experience at Biogen and Pfizer, Diane will share how regulatory strategy drives cross-functional alignment, enables innovation, and supports execution in a high-science, high-uncertainty environment. Ami will guide a practical discussion on the evolving role of regulatory affairs as a strategic partner in advancing breakthrough therapies—while balancing speed, rigor, and compliance.
Location
Ketryx1 Main St
Cambridge, MA 02142
Agenda
5:00 – 5:30 pm Welcome reception and networking
5:30 – 6:15 pm Panel: Advancing Clinical Trial Innovation through Strategic Regulatory and Statistics Collaboration
6:15 – 7:00 pm Executive Chat: Diane Rocco MSc, MBA
7:00 – 8:00 pm Open networking with light appetizers and drinks
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 [email protected]. 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 [email protected] 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
Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email [email protected].
Speaker
Diane G. Rocco
Panelists
Aiden Flynn
Ben Kaspar
Moderators
April Nguyen
Ben Kaspar
Sponsors
