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Welcome to Catalyst Healthcare Consulting, Inc.

Catalyst Healthcare is a dynamic, hands-on regulatory affairs strategy partner to global innovators, thought leaders, advocates, investors and trade groups, helping to speed innovative health care solutions to market in order to improve lives; patients are at the center of our work.

With strategic vision, expertise and energy, we work side-by-side with clients to generate and advance meaningful policy, engagement and regulatory strategies in order to create opportunities and solutions, while side-stepping unnecessary challenges. Serving as a Catalyst is what we do best.

We thrive on surfing and anticipating upcoming trends in science and policy and identifying opportunities for clients through regulatory intelligence gathering and working with thought leaders.

We take the time to understand our clients’ current needs and their vision of the future, working within the bounds of their risk tolerance and the resources at hand.

We are experts in the fields of translating FDA, influencing and interpreting regulatory policy and strategic pathways.  In addition, our service offerings include: strategic business advice, strategic positioning and counsel, and regulatory intelligence gathering and environmental scans.

Our team prides itself on being nimble, ahead of the curve and well-networked in DC healthcare policy circles.

We love to with firms of all sizes and stages, from start-ups to the largest global biopharma companies.

Our US-based and global clients include:

  • Biopharma companies
  • Medical device firms
  • Combination product developers (whose products cross regulatory silos)
  • Digital health companies
  • Cell and gene therapy companies
  • Genomics companies
  • Patient advocacy organizations
  • Nonprofits
  • Trade associations
  • Venture capitalists launching and investing in new companies

We specialize in helping innovators advance important agendas in the most effective way, with an eye to the future and a goal of building long-term trust.

Click here to learn more about our leadership team.

Catalyst News

  • Ned Sharpless, Scott Gottlieb

FDA After Gottlieb –Catalyst Presentation on the Future of FDA

May 24th, 2019|Comments Off on FDA After Gottlieb –Catalyst Presentation on the Future of FDA

Healio and MM&M May 22, 2019 What lies ahead for FDA under Acting Commissioner Ned Sharpless? This article in Healio covers a presentation by Catalyst President Nancy Bradish Myers at the May 22 Coalition for [...]

  • FDA Commissioner Gottlieb

Raising the Bar: The Silver Lining of FDA Commissioner Gottlieb’s Exit

March 7th, 2019|Comments Off on Raising the Bar: The Silver Lining of FDA Commissioner Gottlieb’s Exit

Pharmaceutical Online Scott Gottlieb was unusually effective as a commissioner, and future commissioners would do well to learn from his playbook, Catalyst President Nancy Bradish Myers writes in a guest column published in Pharmaceutical Online. [...]

  • Pink Sheet Pharma Intelligence

Gottlieb’s Short Tenure Will Be Felt Long After He Leaves US FDA

March 6th, 2019|Comments Off on Gottlieb’s Short Tenure Will Be Felt Long After He Leaves US FDA

The Pink Sheet- Commenting on FDA Commissioner Gottlieb’s resignation, Catalyst President Nancy Bradish Myers says that “Gottlieb was pro-patient, pro-industry and pro-safety at the same time, which is difficult. He also used the office in [...]

Latest Events

Latest Blog Posts

RWE at the Tipping Point: From Registries to Artificial Intelligence, RWE is Poised to Accelerate Medical Product Development

May 24th, 2018|Comments Off on RWE at the Tipping Point: From Registries to Artificial Intelligence, RWE is Poised to Accelerate Medical Product Development

By Anne McNickle This is an exciting time for those of us interested in RWE development. Digital technologies and advanced computing capabilities are enabling the generation of RWE continuously, and from sources that have traditionally [...]

Artificial Intelligence (AI): Coming to a Policymaker Near You

April 2nd, 2018|Comments Off on Artificial Intelligence (AI): Coming to a Policymaker Near You

By Nancy Bradish Myers It’s as if Artificial Intelligence just reached the DC area and policy makers need to think about it. Software companies, academic institutions and innovative companies hoping to develop and harness the [...]

Digital Medicine is Here: Why the Combination of Abilify and Proteus’ Ingestible Sensor is “Sweet”!

November 14th, 2017|Comments Off on Digital Medicine is Here: Why the Combination of Abilify and Proteus’ Ingestible Sensor is “Sweet”!

By Nancy Bradish Myers Yahooooo! What a thrill it is to finally have the first digital medicine approved by the FDA: Abilify Mycite (aripiprazole + Ingestible Event Marker). When I visualize it, it’s like the [...]