Emerging therapeutic and pharmaceutical companies—whether developing innovative drugs, biologics, cell and gene therapies, digital health–integrated products, or other novel modalities—face a uniquely complex regulatory landscape. Limited resources, accelerated timelines, and evolving global expectations demand a strategic, proactive approach to regulatory planning. This panel brings together seasoned regulatory leaders, innovators, and industry strategists to explore how early‑stage companies can build the right foundations for long‑term success.
Through real‑world case studies and candid discussion, panelists will unpack the essential elements of regulatory excellence: designing smart development pathways, leveraging expedited programs, building scalable governance systems, navigating global convergence, and communicating science with clarity and credibility. Attendees will walk away with practical frameworks they can apply immediately—whether preparing for their first FDA meeting, planning pivotal studies, or scaling toward commercialization.
Learning Objectives
- Understand how to design strategic, phase appropriate regulatory pathways
Participants will learn to anticipate data needs, identify risks early, and align development plans with evolving global regulatory expectations—ensuring the selection of appropriate regulatory pathways and enabling smarter, more efficient decision‑making from preclinical through pivotal studies. - Learn how to effectively leverage expedited programs and early agency engagement
Attendees will gain practical insight into when and how to pursue designations such as Fast Track, Breakthrough Therapy, RMAT, and PRIME, and how to prepare for high impact regulatory interactions, including first in human and pre IND/Scientific Advice meetings. - Acquire frameworks for building scalable governance, documentation, and communication systems
Participants will explore real world models for establishing right sized regulatory operations, cross functional alignment, and science forward communication practices that support growth, due diligence readiness, and successful commercialization.
Agenda
5:00-5:30 pm Check-in/Networking
5:30-5:45 pm RAPS-SF Welcome & Introduction
5:45-6:00 pm Bakar Bio Labs Welcome
6:00-6:15 pm Sponsor presentation
6:15-7:15 pm Panel discussion
7:20-8:00 pm Tour of the facility
8:00-8:30 pm Networking & Wrap up
*Appetizers and beverages will be provided.
Location
Bakar Bio Labs
2625 Durant Ave
Berkeley, CA 94720
Public Transit Options Bay Area Rapid Transit (BART) The Downtown Berkeley (2160 Shattuck Avenue, Berkeley, CA 94704) BART stop is one block from the west side of UC Berkeley Campus and a 17 min walk from Bakar Labs.
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].
Speakers
Lynne Krummen
Barbara Troupin
Kevin Tate
Jenny Chaplin
Tuan Nguyen
Sulatha Dwarakanath
Gino Serge
Kamana Singh
Brandy Amarillas
Sponsor
