Latest Events

Where has Catalyst spoken recently?

On Thursday, June 13th, Catalyst’s regulatory policy expert Betsy Foss-Campbell presented at an expanded webinar hosted by FDAnews from 1:30-4:30pm ET. She discussed Cell & Gene Therapy and FDA funding as part of an examination of the issues FDA is facing in 2024 and what to expect as we head into 2025.

Nancy moderated a panel discussion with Women’s Health experts at this year’s annual DIA Meeting from June 16-20 in San Diego. The panel was held on Wednesday, June 19th from 8-9am in Room 5AB and focused on policy solutions aimed to advance Women’s Health innovation and research.

Catalyst’s Nancy Myers interviewed Kimberlee Trzeciak, FDA’s Deputy Commissioner for Policy, Legislation, and International Affairs during a webinar hosted by the Alliance for a Stronger FDA, sparking a lively discussion about FDA’s strategic policy roadmap.

Catalyst’s Nancy Myers co-moderated a “fireside chat” interview featuring FDA Commissioner Robert Califf on Aug. 16. The webinar, hosted by the Alliance for a Stronger FDA. Califf talked about his priorities for FDA in 2024.

Catalyst’s Nancy Myers moderated a panel at the DIA annual meeting in Boston on June 27 exploring: “Is Mark Cuban Really Solving the Drug Pricing Problem?” Topics for discussion included whether new models for selling low-cost drugs are sustainable for the long term and scalable to help more patients and bring down drug prices. Panelists included Craig Burton, Senior Vice President of Policy and Strategic Alliances, Association for Accessible Medicines and Executive Director, Biosimilars Council; Vinod Mitta, Medical Officer, Center for Medicare and Medicaid Innovation’s (CMS Innovation Center) Seamless Care Models Group; and Josie Cooper, Executive Director, Alliance for Patient Access.

Catalyst’s Nancy Myers will spoke as part of a panel at a webinar hosted by FDA News on “Califf’s FDA, 2023 and Beyond: Key Developments, Insights & Analysis” on April 27. The panel analyzed the latest developments at FDA under Commissioner Califf and what the future may hold for the agency, including reforms to the product development process, greater reliance on real-world data, more emphasis on orphan drugs and devices, new requirements for accelerated approval drugs, PDUFA VII implementation, and potential changes to the use of advisory committees. Myers and her fellow presenters – Wayne Pines, president of healthcare at APCO Worldwide, Steven Grossman, President, HPS Group, Lowell Zeta, Partner, Hogan Lovells and Cathy Burgess, Partner, Alston & Bird – discussed new initiatives on the horizon and how stakeholders may be able to influence them.

Catalyst’s Nancy Myers co-moderated a webinar hosted by the Alliance for a Stronger FDA on Jan. 13, along with Emily Holubowich, National Senior Vice President, Federal Advocacy, American Heart Association. The webinar featured Andi Fristedt, FDA’s Deputy Commissioner for Policy, Legislation and International Affairs.

Catalyst’s Jeff Myers spoke on the impact of the IRA on innovation during JP Morgan’s Biotech Showcase on Jan. 10 in San Francisco. Mr. Myers participated on a panel entitled “The Inflation Reduction Act (IRA): The Dawn of a New Era – What Will it Mean for Innovation?” moderated by Simone Fishburn, VP & Editor in Chief, BioCentury. Fellow panelists included: Alex Harding, Head of Business Development, CRISPR Therapeutics; Paul Hastings, President & CEO, Nkarta Therapeutics; Peter Rubin, Executive Director, No Patient Left Behind; and Alice Valder Curran, Partner, Hogan Lovells.

Catalyst’s Nancy Bradish Myers co-moderated a webinar on “Digital Health and Cyber Security” on October 20, 2022. This online event, hosted by the Alliance for a Stronger FDA, featured a discussion with CDRH’s Dr. Suzanne Schwartz, Director, Office of Strategic Partnerships & Technology Innovation (OST). The OST is responsible for leading digital collaborations with stakeholders, addressing unmet medical needs with emerging technology, and managing CDRH’s medical device cybersecurity, software, and digital health standards.

Nancy Bradish Myers presented a talk, Accelerated Approval Standards: Application Gene Therapy, as part of a panel entitled From Accelerated Approval to Reimbursement at the American Society for Gene and Cell Therapy Policy Summit September 22-24, 2021. She also served on a panel with: Renu Vaish, Kite Pharma, Ani Khachatourian, PharmD, Highmark Blue Cross Blue Shield, Richard White, National Organization for Rare Disorders (NORD) and Moderator: Jocelyn Ulrich, Pharmaceutical Research and Manufacturers of America (PhRMA).

“Improving Access to Medicines: Exploring New Regulatory Frameworks for Letting Data Lead the Way to Increased Drug Options”
Moderator: Nancy Bradish Myers
March 18, 2021 — DIA Europe 2021, virtual

“What’s Next for the FDA in the Biden Administration?”
Presenter: Nancy Bradish Myers
December 16, 2020 — Rising Leaders Conference, virtual

Catalyst Moderated a Panel at the American Society of Gene & Cell Therapy Policy Summit
Catalyst Founder and CEO, Nancy Myers, moderated a panel on Thursday, September 24th, 2020 at the (virtual) ASGCT Policy Summit. The panel was on “Overcoming Regulatory Challenges in Gene Therapy Development.”

Informa Pharma Intelligence
COVID-19 24-hour Webinar Series Event: Lessons Learned and a Path Forward
Presenter, Nancy Bradish Myers – Washington, DC
July 21, 2020

“Gene Therapy Manufacturing: How Can Innovation Help Overcome This Anticipated Hurdle?”
Moderator, Nancy Bradish Myers — Washington, DC
June 15, 2020 — DIA Annual Meeting

“Drug Pricing and Transparency: Upcoming Issues in Medicaid”
Presenter, Jeff M. Myers — Alexandria
February 28th — Medicaid Managed Care Summit

Catalyst and The Pink Sheet Explore the Impact of Past, Present and Future FDA Commissioners
Presenter, Nancy Bradish Myers – Washington, DC
Oct. 22, 2019

“Hot Topics in Digital Health: How is FDA’s Approach Evolving, and What Do Industry and Patients Need to Know?”
Moderator, Nancy Bradish Myers – San Diego
June 2019 – DIA Annual Meeting

“FDA in the Post-Gottlieb Era”
Presenter, Nancy Bradish Myers – Washington, DC
May 2019 – Rising Leaders Conference on Healthcare Policy

“FDA Basics: Structure, Authorities & Hot Topics”
Presenter, Nancy Bradish Myers – Washington, DC
April 12, 2019 — University of Tennessee: Executive MBA Program (The Washington Campus)

“Changes in the Political Landscape Impacting Pharma and Bio Regulations”
Panelist, Nancy Bradish Myers – Washington, DC
December 2018 – FDA/CMS Summit

“2018 Policy Mash-Up: New Shifts in the Healthcare Market and What They May Mean for Patients and the Biopharma Industry”
Moderator, Nancy Bradish Myers – Boston
June 2018 – DIA 2018 Annual Meeting

“Real-World Evidence (RWE) in drug development”
Panelist, Nancy Bradish Myers – Beijing, China
May 2018 – 10th DIA China Annual Meeting

“The impact of new leadership and new initiatives at FDA”
Panelist, Nancy Bradish Myers — San Francisco
January 2018 — Biotech Showcase

“Regulating the Digital Health Revolution: When does it help or hinder innovation?”
Panelist, Nancy Bradish Myers — San Francisco
January 2018 — Digital Medicine & Medtech Showcase

“CRISPR – Regulatory Challenges in the Gene Editing Revolution”
Moderator/presenter Nancy Bradish Myers (panel) — Chicago
June 2017 — DIA 2017 annual meeting

 “Regulatory Frameworks: How Can Regulators Facilitate Disruptive Innovation?”
Moderator/presenter Nancy Bradish Myers (panel) — Chicago
June 2017 — DIA 2017 annual meeting

Keynote speech on FDA and the Trump Administration
Nancy Bradish Myers, Florham Park, NJ
May 2017: RxAdherence 2017, Strategies to Improve Outcomes conference

 “The Trump Administration – What to Expect From the FDA”
Panelist, Nancy Bradish Myers — San Francisco
January 2017: Biotech Showcase annual meeting

 “The Future of Big Data”
Moderator/presenter, Nancy Bradish Myers — Philadelphia
June 2016: DIA 2016 annual meeting — Panel, DIAmond Session