Talks
Speaking, in rooms with stakes
Conferences, panels, and the occasional workshop. I speak to regulators, founders, clinicians, and AI engineers who all somehow ended up in the same room.
Featured Milestone
Two Nasdaq Closing Bells, two regulatory teams I led through their IPOs
Sigilon Therapeutics (Nasdaq SGTX, December 2020) and Roivant Sciences (Nasdaq ROIV, October 2021). Two bell-ringings between them, four Times Square Nasdaq MarketSite billboard appearances (three with Sigilon, one with Roivant), and an honored celebration visit to the NYSE trading floor on Wall Street. The rare regulatory wins that come with confetti.
2026
-
AI Agents Are Ready for Healthcare and Medtech. Is It Ready for Them?
AI Agent Conference 2026 · Manhattan, NY · April 5, 2026 panel
Panel on agentic AI deployment in regulated healthcare contexts. Covered the gap between generative and procedural AI, threat modeling for prompt injection and tool misuse, and the regulatory playbook still to be written for systems that plan, retry, and self-correct.
2025
-
Global Pharmaceutical Regulatory Keynote — Cytiva China Set Sail Initiative
Cytiva China Set Sail Initiative · China · April 2025 keynote
Keynote on global pharmaceutical regulatory strategy at Cytiva's China Set Sail Initiative, an industry program supporting Chinese biopharma companies expanding into global markets. Covered the regulatory pathways from China-domestic NMPA approval through FDA, EMA, and Asia-Pacific filings.
-
Regulatory Acceleration & Innovation: Leveraging New Policies for a Smarter Biopharma Go-to-Market Strategy
BIO International Convention · Boston, MA · June 16, 2025 panel
Panel on FDA acceleration pathways (AMT, breakthrough, RMAT) and how biopharma should structure go-to-market strategy around recent policy shifts.
2024
-
Comparative Analysis of Sterile Grade Filters in Adeno-Associated Virus Manufacturing
ASGCT 27th Annual Meeting · May 2024 invited talk
Oral CMC presentation on AAV manufacturing filtration optimization for gene therapy products.
-
Comparative Interrater Analysis of Regulatory Challenges in Recently Approved Gene Therapies for Sickle Cell Disease
ASGCT 27th Annual Meeting · May 2024 poster
Analysis of regulatory pathway divergences across recent SCD gene therapy approvals.
-
Accelerating Novel Platforms into the Clinic: Early Experiences with FDA's Advanced Manufacturing Technology (AMT) Designation and Global Perspectives
RAPS Annual Convergence · Salt Lake City, UT · September 18, 2024 invited talk
First-look industry experience with FDA's AMT designation pathway, including early sponsor learnings and parallel pathways in EU and APAC.
2023
-
Strategies and Technologies for Advanced CMC
International Society for Cell & Gene Therapy (ISCT) Annual Meeting · May 2023 invited talk
Oral presentation on next-generation CMC strategies for cell and gene therapy products.
-
Quantifying Challenges to Development of Generics and Biosimilars in Non-Hodgkin's Lymphoma Therapeutics
ASH 65th Annual Meeting (American Society of Hematology) · San Diego, CA · December 2023 poster
Poster presentation of mixed-methods analysis on barriers to biosimilar and generic entry across non-Hodgkin's lymphoma therapeutic classes. Published as Blood 142(Suppl 1), Abstract 5148. Co-authors Fulgoni A, Wang L, et al.
2021
-
Optimizing Regulatory Strategy for Gene Therapies
Gene Therapy for Rare Blood Disorders Conference · Boston, MA · March 2021 invited talk
Current trends, guidance, and industry milestones in gene therapy regulatory strategy.
2019
-
Introducing Agile in Regulated Industries: Leading Agile in MedTech
TriAgile · Raleigh, NC · March 2019 invited talk
Practitioner talk on applying agile methodology within FDA-regulated medical device development.
2018
-
Human Gene Editing and Advanced Therapies: How Will FDA, EMA, and Gene Therapy Mix?
RAPS Convergence · Vancouver, BC · March 2018 invited talk
Invited co-presentation with Rachael Anatol, PhD (then Deputy Director, Office of Tissues and Advanced Therapies, FDA CBER). Direct industry-and-FDA collaboration analyzing how the agency, EMA, and the broader regulatory landscape would converge on gene editing and advanced therapy pathways. One of the early cross-jurisdictional sessions held jointly by industry and FDA before the framework reorganization that produced today's Office of Therapeutic Products.
2017
-
From Additive to Algorithm
RAPS Convergence (Medical Device Session) · Washington, DC · April 2017 invited talk
Co-presented on regulatory pathways spanning 3D-printed devices through algorithm-driven Software as a Medical Device.
Interested in booking a talk? See the press kit for topic areas and contact.