FDA Regulatory Strategy Institute

The FDA RSI curriculum is organized around five core topic areas that address the scientific, regulatory, intellectual property, commercialization, and clinical development considerations that influence successful product translation. The week will include presentations, panel discussions, and case studies, with Penn innovators, regulatory experts with extensive FDA experience, and intellectual property and commercialization professionals. A draft syllabus is coming soon.

• FDA and Regulatory Foundations
  • Facilitators: Peter Marks, MD, PhD and Emma Meagher, MD
  • Explore FDA regulatory pathways for drugs, biologics, and medical devices, including product classification, regulatory submissions, and evidence requirements. Participants will gain an understanding of how FDA expectations differ from traditional academic research and how regulatory considerations influence product development decisions.
• From Discovery to Impact: Innovation and Commercialization Essentials for Academics
  • Facilitators: Katherine Reuther, PhD, MPH and Kultaran Chohan, PhD
  • Explore how academic discoveries advance from the laboratory toward clinical and commercial application. Participants will examine innovation and commercialization frameworks, intellectual property strategies, funding pathways, and approaches for communicating the value of a technology to investors, collaborators, and industry partners.
• Chemistry, Manufacturing, & Controls (CMC)
  • Facilitator: Bruce Levine, PhD and Andrew Fesnak, MD, MHCI
  • Examine the manufacturing, quality, and product characterization considerations necessary to support regulatory submissions and product development. Participants will gain an appreciation for how CMC requirements influence product readiness and long-term development strategy.
• Medical Device Development and the FDA
  • Facilitators: Katherine Reuther, PhD, MPH and Brian Litt, MD
  • Learn how medical devices move from concept to clinical investigation. Topics include device classification, regulatory pathways, product development considerations, and interactions with the FDA throughout the development lifecycle.
• IND Enabling Studies and Clinical Protocol Design
  • Facilitator: Emma Meagher, MD
  • Explore the nonclinical studies, evidence-generation strategies, and clinical protocol considerations required to support first-in-human research and regulatory submissions.
  • Prerequisite: Participants without a background in pharmacology will be asked to review a 45-minute foundational video to ensure a common foundation for discussion.

Additional speakers and panelists will be announced at a later date.

By the end of the program, participants will be able to:

1. Classify biomedical innovations as drugs, devices, or combination products and recognize how product classification influences regulatory pathways.
2. Describe the structure and role of the FDA (including the centers and types of products they regulate).
3. Distinguish between academic exploratory research and FDA evidence for risk-benefit.
4. Identify key sources of FDA regulatory guidance.
5. Recognize critical data and quality standards for FDA-regulated or product-enabling research.
6. Articulate when and why to engage with the FDA.
7. Apply basic commercialization and innovation frameworks to evaluate product opportunities, value propositions, and development priorities.
8. Recognize institutional resources available to support translational product development.

• Have an MD and/or PhD.
• Currently a faculty, physician-scientist, researcher, engineer, and/or academic innovator who is actively advancing therapeutics, biologics, cell & gene therapies, medical devices, diagnostics, digital health technologies, radiopharmaceuticals, and/or combination products.
• Participants may be from Penn, CHOP, or external organizations.
• Participants must commit to full attendance throughout the week of May 24-27, 2027.

To be considered for admission, applicants must:

• Submit the online application form; and
• Meet the program eligibility requirements.

Application Fee: None

Program Fee: $1,000 per participant will be charged after an admitted applicant accepts their offer of admission to the institute.

*Note: This is a non-credit institute.

Applications are due March 1, 2027. The Leadership Team will review applications and release decisions by March 29, 2027. Decisions are due by April 9, 2027 for participants enrolling in the May 24-27, 2027 institute.