From Lab to GMP: Building a Clinical-Ready Biotech
How early-stage teams avoid rework, delays, regulatory missteps — and the loss of investor confidence
PLUS - A BioBuzz Philly Startup Showcase
This event is part of BioBuzz’s Insights to Impact Series, a curated program designed exclusively for life sciences industry leaders and ecosystem builders. Our guest list is intentionally built to foster a high-quality, peer-driven experience.
Overview
The hardest part of building a biotech company isn’t discovery — it’s translation.
Moving from promising preclinical data to a clinically viable program requires more than strong science. It demands early decisions across CMC, manufacturing, regulatory strategy, and quality — often before teams are fully built or funded.
At the same time, expectations are shifting. Investors and regulators now expect a clear path to IND, including GMP readiness, scalable processes, and aligned quality systems — much earlier than most teams anticipate.
So where do teams get it wrong?
This session brings together operators who have navigated that transition to unpack what happens between “it works in the lab” and clinical readiness.
You’ll learn:
Where process development and CMC strategies break down
How rework, delays, and budget overruns actually happen
What investors and regulators expect earlier than you think
How to build GMP and quality systems without slowing innovation
This is a practical look at what it really takes to reach IND — without delays, missteps, or lost investor confidence.
Agenda
4:30 PM Check-In + Networking
5:00 PM Welcome + Opening Remarks
5:05PM Fireside Chat #1: Building Therapies That Make It: Integrating Science, Scale, and Strategy from Day One
5:35 PM Fireside Chat #2: Scaling with Discipline: Operations, Quality, & GMP Execution
Nathan Roman - Founder & Principal, VMS
Abhimanyu Patwa - Sr Manager Engineering, Minaris
6:05pm Networking + STARTUP SHOWCASE
Advent Therapeutics, Inc. - advent-therapeutics.com
Diagnostics (Dx) Your Way - dxyourway.com
Airalux Medical - airalux.com
MyMonitor.ai - MyMonitor.ai
BlueWhale Bio - BlueWhale.bio
BioLattice Ophthalmics - biolatticetech.com
Venue
uCity Square
uCity Square exists at the intersection of world-class universities, research institutions, academic medical centers, and dynamic neighborhoods. Our mission is to facilitate collaboration that stimulates breakthroughs, drives inclusive economic growth, and expands our diverse and vibrant community.
Learn more at ucitysquare.com
Partners
This event is made possible by the support of our sponsors:
Conner Strong & Buckelew (connerstrong.com)
Heffron (heffroncompany.com)
Kymanox (kymanox.com)
Minaris (minaris.com)
Workforce Genetics (workforcegenetics.com)
Important Information
We encourage you to share this with those in your network who are passionate about strengthening the Philadelphia Region’s biotech ecosystem and would benefit from attending.
NOTE TO VENDORS + SERVICE PROVIDERS
Vendor and Service Provider attendance is limited to ensure a high-quality, peer-driven industry experience. A select number of Vendor / Service Provider tickets ($75) are available using access code VENDOR.
Vendors and Service Providers operating in the same category as any of our sponsors will require pre-authorization from the associated sponsor. BioBuzz reserves the right to restrict registration and entry as necessary. Refunds will be provided when tickets cannot be honored.