French BioBeach Fireside Chat
About this Event
Faster to the clinic: what FDA Operation TrialBlazer means for early-stage biotech
Rethinking the Path from Discovery to First-in-Human
Join French BioBeach at the La Jolla Institute for Immunology for a fireside chat exploring new FDA initiatives aimed at accelerating first-in-human clinical trials.
Launched by HHS in June 2026, Operation TrialBlazer brings phase-appropriate CMC expectations, new nonclinical and dose-selection guidance, and an Expedited IND pilot whose first cohort the FDA names in December. The FDA estimates the changes could save sponsors 6 to 12 months.
On the manufacturing side, GBI Bio reports its stable-pool platform can take a biologic from gene to GMP vial in about 8 months instead of 12–15, for roughly $2M instead of $7–10M.
Our panelists, bringing expertise in biomanufacturing, regulatory affairs, and early-stage drug development, will discuss:
- What TrialBlazer changes for early-stage companies
- How much time and money phase-appropriate CMC can really save
- What still slows down clinical development: pre-IND preparation, IRB review, and clinical site activation
- What companies can do now, whether or not they participate in the FDA's pilot program
- How more efficient development strategies could impact clinical milestones, financial runway, and funding decisions
Meet Our Panelists & Moderator
We are delighted to welcome three experts bringing complementary perspectives on biomanufacturing, regulatory affairs, and early-stage drug development.
, CEO of
With over 20 years of leadership in biologics development and GMP manufacturing, Jesse will share his insights on innovative manufacturing strategies and accelerating the transition to clinical trials.
, Sr. VP, Regulatory Affairs and Quality at
John will bring his regulatory expertise to the discussion, exploring evolving FDA expectations and strategies for navigating the path to first-in-human clinical trials.
, Sr. Director, Early Development at
With extensive experience in preclinical drug development, Jessica will share her insights on IND-enabling studies, FDA interactions, and the challenges of advancing innovative therapies from discovery into clinical trials.
Moderator: , CEO of
Kelly will lead the discussion, drawing on his experience in clinical development and biotech innovation to explore the opportunities, challenges, and practical implications of the FDA's new initiatives.
Proudly sponsored by .
Whether you're a biotech founder, scientist, investor, or industry professional, join us for a practical, experience-driven conversation about the future of early-stage drug development, followed by champagne and networking with the San Diego life sciences community.
Agenda
4:30 – 5:00 PM — Networking / Registration
5:00 – 6:00 PM — Fireside Chat
6:00 – 7:00 PM — Networking Happy Hour
With thanks to our host, , and our sponsor, .
🅿️ Free parking available in front of LJI and in the SRP781 Lot
Agenda
🕑: 04:30 PM - 05:00 PM
Networking / Registration
🕑: 05:00 PM - 06:00 PM
Fireside Chat
🕑: 06:00 PM - 07:00 PM
Networking Happy Hour
Where is it happening?
Event Location & Nearby Stays:
USD 0.00 to USD 17.35
