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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

How a Rapid and Well Messaged FDA Offense Is Driving Spectators to Their Feet and Twitter Accounts

August 21st, 2018|Comments Off on How a Rapid and Well Messaged FDA Offense Is Driving Spectators to Their Feet and Twitter Accounts

The Pink Sheet- “How is FDA doing under Commissioner Scott Gottlieb?” is a question that, as a regulatory policy and strategy consultant, I am asked regularly. With amazing frequency, the questioner follows up with a [...]

  • Executive Insights. Insider's view. Nancy Bradish Myers

The Digital Health Tsunami Is Here. How Is FDA Gearing Up?

April 20th, 2018|Comments Off on The Digital Health Tsunami Is Here. How Is FDA Gearing Up?

Med Device Online – In this “Insider’s View” column, Catalyst President Nancy Bradish Myers examines the coming wave of digital health, what FDA is signaling through its recent moves in the digital health space, and [...]

  • Shutdown

Shutdown Winds Down: Short ‘Lapse Period’ Likely Means Few Disruptions At US FDA

January 22nd, 2018|Comments Off on Shutdown Winds Down: Short ‘Lapse Period’ Likely Means Few Disruptions At US FDA

The Pink Sheet- This article looks at the impact of the recent government shutdown on FDA and includes Catalyst’s perspectives the challenges involved; Catalyst President Nancy Myers notes that timelines for a number of FDA [...]

  • Shutdown

How a government shutdown could affect drug safety, flu response, and more

January 17th, 2018|Comments Off on How a government shutdown could affect drug safety, flu response, and more

In this article, Catalyst’s Jill Hartzler Warner provides context for a potential future government shutdown, based on her experience at FDA. The article explores the potential impact of a federal government shutdown across a range [...]

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 [...]