Welcome to Catalyst Healthcare Consulting, Inc.

Catalyst Healthcare is a dynamic, hands-on regulatory affairs and reimbursement and coverage strategy partner to global innovators, thought leaders, advocates, investors, payors, providers states 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, communications 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, policy, reimbursement, coverage and identifying opportunities for clients through regulatory and market 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, CMS, State Medicaid programs, 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
  • Payors
  • 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

Gene Therapy CMC Constriction Points and Ideas for Solutions – A Catalyst Moderated Panel at the DIA 2020 Annual Meeting

June 26th, 2020|Comments Off on Gene Therapy CMC Constriction Points and Ideas for Solutions – A Catalyst Moderated Panel at the DIA 2020 Annual Meeting

On June 15th at the DIA (Virtual) Annual Meeting, Catalyst’s Nancy Myers moderated a panel titled “Gene Therapy Manufacturing: How Can Innovation Help Overcome This Anticipated Hurdle?” The esteemed panelists were Peter Marks, Director of [...]

Hahn Pledges FDA Independence While Maintaining Role On Warp Speed

June 8th, 2020|Comments Off on Hahn Pledges FDA Independence While Maintaining Role On Warp Speed

In the Pink Sheet, Catalyst's Nancy Myers discusses the Administration's Operation Warp Speed and conflicts of interest. Though "the commissioner doesn't approve drugs or vaccines. That is really left up the center directors and the [...]

Woodcock, Marks Recusals From COVID-19 Product Reviews ‘Protect FDA’s Reputation’

May 20th, 2020|Comments Off on Woodcock, Marks Recusals From COVID-19 Product Reviews ‘Protect FDA’s Reputation’

In the Pink Sheet, Catalyst’s Nancy Myers commends how "Marks and Woodcock recognize they can't be both referee and player" as they recuse themselves from reviewing COVID-19 products while working on Operation Warp Speed. She [...]

Health Insurers Hail SCOTUS Ruling in Risk Corridors Case

May 4th, 2020|Comments Off on Health Insurers Hail SCOTUS Ruling in Risk Corridors Case

AIS Health Catalyst’s Jeff Myers weighs in on the SCOTUS 8-1 ruling of CMS owing billions to health insurers in risk corridor funding, discussing while it’s mandated by law, the risk corridor program isn’t well [...]

Events

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 [...]