Angela N. Johnson

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.

Angela Johnson at the Nasdaq Closing Bell ceremony, Sigilon and Roivant IPOs

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

  • Angela Johnson speaking at the AI Agent Conference 2026 in Manhattan

    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

  • Angela Johnson delivering the global pharmaceutical regulatory keynote at the Cytiva China Set Sail Initiative, April 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.

  • Angela Johnson on regulatory acceleration panel at BIO International Convention 2025

    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

  • Angela Johnson presenting on AAV filtration at ASGCT 27th Annual Meeting, May 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.

  • Angela Johnson at the ASGCT 27th Annual Meeting, May 2024

    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.

  • Angela Johnson presenting on FDA AMT designation at RAPS Convergence 2024 in Salt Lake City

    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

  • Angela Johnson at the ISCT Annual Meeting on advanced CMC strategies, May 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.

  • Angela Johnson with her ASH 2023 poster on generics and biosimilars in non-Hodgkin's lymphoma therapeutics

    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

  • Angela Johnson at the Gene Therapy for Rare Blood Disorders Conference, Boston, March 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

  • Angela Johnson presenting on agile in medtech at TriAgile, Raleigh NC, March 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

  • RAPS Convergence 2018 program listing for the human gene editing session co-presented by Angela Johnson and Rachael Anatol of FDA CBER

    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

  • RAPS Convergence 2017 Medical Device Session in Washington DC, From Additive to Algorithm presentation

    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.


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