Agenda: 1/2 day workshop (9am to 2:30pm)

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

  • 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 (1 hr)

  • 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 (10 mins)

• Guest Expert Session — Real-World Regulatory & Clinical Insights (1 hr)

  • 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

• Lunch Break (30 mins)

• Session 3 — Building Your Regulatory & Clinical Milestone Roadmap (45 mins)

  • 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

• Session 4 — Founder Workshop: Evidence & Risk Planning (30 mins)

  • Drafting your personal evidence plan

  • Identifying regulatory/clinical risks and mitigation strategies

  • Prioritizing next steps for the next 30–90 days

  • Template: Evidence & Risk Planning Worksheet

• Wrap-Up & Next Steps (10 mins)