Scaling into Clinical
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 life sciences industry is bursting with innovation. Novel therapies, technologies, and delivery models are emerging constantly, promising better patient outcomes and new commercial opportunities.
What often limits their impact is not the quality of the science, but the ability to move discoveries methodically into the clinic. Companies frequently face challenges navigating regulatory pathways, designing efficient trials, securing funding, and building the operational infrastructure needed to scale safely and effectively.
This session tackles these challenges head-on, spotlighting Maryland-based startups with national impact that have successfully advanced innovations into clinical trials. Through data-driven strategies, partnerships, and practical lessons—including applications of AI and analytics—attendees will gain actionable insights to accelerate clinical programs, mitigate risk, and build sustainable impact.
Participants will leave with guidance on:
Aligning cross-sector resources and teams for clinical execution
Building operational infrastructure that supports safe and scalable growth
Understanding regulatory, quality, and manufacturing considerations critical to success
By emphasizing both opportunity and operational reality, this session highlights Maryland as a hub for clinically-ready, ecosystem-aligned life sciences innovation.
Agenda
4:00 PM Check-In + Networking
5:00 PM Welcome + Opening Remarks
5:05 PM Fireside Chat #1: From Discovery to IND: De-Risking your First-in-human studies
Advancing from discovery to an IND-ready asset requires more than promising data—it demands disciplined development strategy.
In this fireside chat, we’ll explore how companies structure pre-clinical programs, design toxicology packages, and align translational data with regulatory expectations. Drawing on deep experience across drug discovery and early development, the conversation will focus on the critical decisions that reduce downstream risk and strengthen clinical positioning.
5:25 PM Fireside Chat #2: Making Medicine: Process Development & Manufacturing for Clinical Readiness
Advancing from discovery to an IND-ready asset requires more than promising data—it demands disciplined scale-up and cGMP strategy for your manufacturing and CMC.
In this fireside chat, Pharmaron will explore how companies structure pre-clinical programs, design toxicology packages, and align translational data with regulatory expectations. Drawing on deep experience across drug discovery and early development, the conversation will focus on the critical decisions that reduce downstream risk and strengthen clinical positioning.
5:45 PM Fireside Chat #3: Scaling with Discipline: Operations, Quality, & GMP Execution
Clinical readiness is not a single milestone—it is the result of integrated strategy across quality systems, facilities, manufacturing, and regulatory execution.
In this fireside chat, we’ll explore how companies align development, engineering, quality compliance, and manufacturing operations to support successful clinical advancement. Drawing from experience across device development, combination products, biologics, advanced therapies, and GMP facilities, the discussion will examine how infrastructure decisions made early can accelerate—or jeopardize—clinical timelines.
From regulatory submissions and quality system implementation to facility readiness and manufacturing scale-up, this session highlights the operational discipline required to move efficiently into first-in-human studies and beyond.
6:00pm Networking + Startup Showcase
Confirmations forthcoming...
Venue
Propel Labs
Propel Labs is a purpose-built innovation hub designed to accelerate the growth of emerging life sciences and tech companies. Developed by Minkoff Development Corporation, it offers flexible lab and light manufacturing spaces tailored to early- and growth-stage tenants seeking to scale efficiently. Located in Montgomery County’s I-270 biotech corridor, Propel Labs provides direct access to a world-class ecosystem of research institutions, federal agencies, and industry leaders – creating an ideal environment for companies to innovate, collaborate, and commercialize.
Learn more at propellabsmd.com.
Partners
This event is made possible by the support of our sponsors:
Conner Strong & Buckelew (connerstrong.com)
Fulton Bank (fultonbank.com)
Heffron Company (heffroncompany.com)
Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc. (HJF) (hjf.org)
Kymanox (kymanox.com)
QIAGEN (qiagen.com)
TEDCO (tedcomd.com)
Workforce Genetics (workforcegenetics.com)
Xcellon Biologics (xcellon.bio)
Important Information
We encourage you to share this with those in your network who are passionate about strengthening the BioHealth Capital 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.