Agenda: 1/2 day workshop (11am-3pm EDT)

• Session 1: FDA Pathways Made Simple — What Founders Need to Know

  • FDA structure and regulatory categories (drugs, devices, biologics, digital health)

  • How to determine your correct pathway (510(k), PMA, De Novo, IND/NDA, EUA)

  • Preparing for FDA interactions: pre-subs, Q-subs, and early communication

  • Common founder mistakes and delays—and how to avoid them

  • Aligning regulatory strategy with business milestones and investor expectations

  • Template: FDA Pathway Selector Worksheet

• Session 2 — Clinical Trial Landscape & Lean Evidence Strategy

  • Clinical trial phases and study types across drugs, biologics, devices

  • Designing a clinical evidence strategy that fits regulatory and investor needs

  • IRB submissions, site selection, recruitment, budgeting

  • Overcoming early-stage barriers with limited resources

  • When to engage CROs, advisors, and academic partners

  • Template: Clinical Evidence Planning Sheet

• Break/ Networking

• Guest Expert Session — Real-World Regulatory & Clinical Insights

  • Case studies from FDA submissions and real startup trials

  • What regulators and clinical leaders look for

  • Pitfalls and accelerators in early evidence generation

  • Group discussion/ Q&A

• Session 3 — Building Your Regulatory & Clinical Milestone Roadmap

  • Integrating regulatory, clinical, and business strategy

  • Sequencing milestones to align with fundraising and go-to-market timelines

  • Identifying long-lead tasks and dependencies

  • Template: Regulatory & Clinical Milestone Roadmap

• Wrap-Up & Next Steps