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

  • Cavazzoni and Woodcock

Wall Street Sees Woodcock Commissionership As Positive for Aducanumab, But Eyes Should Be On Cavazzoni

February 1st, 2021|Comments Off on Wall Street Sees Woodcock Commissionership As Positive for Aducanumab, But Eyes Should Be On Cavazzoni

Pink Sheet: Informa Pharma Intelligence – January 29, 2020 Nancy Bradish Myers shares views with Sarah Karlin-Smith that approval watchers’ eyes should more appropriately be on what CDER’s Cavazzoni is thinking around the aducanumab Alzheimer’s [...]

  • Janet Woodcock

Woodcock Faces Maze Of Rules To Become Commissioner Nominee

January 25th, 2021|Comments Off on Woodcock Faces Maze Of Rules To Become Commissioner Nominee

Pink Sheet: Informa Pharma Intelligence – January 21, 2020 Nancy Bradish Myers is quoted by the Pink Sheet explaining the potential value of nominating a former Center Director to be a Commissioner. It may be [...]

  • Joe Biden

Biden’s FDA Commissioner Playbook: Build On COVID Innovations To Modernize Agency

January 7th, 2021|Comments Off on Biden’s FDA Commissioner Playbook: Build On COVID Innovations To Modernize Agency

Pink Sheet: Informa Pharma Intelligence – January 6, 2020 Nancy Bradish Myers, President & CEO at Catalyst Healthcare Consulting, explores how the Biden Administration FDA Commissioner pick will determine how significant agency reforms will be [...]

Recently Approved Evrysdi May Have Big Impact on SMA Class

October 13th, 2020|Comments Off on Recently Approved Evrysdi May Have Big Impact on SMA Class

AIS Health Daily- September 1, 2020 Jeff Myers, Senior VP of Market Access and Reimbursement Strategies at Catalyst Healthcare Consulting Inc., examines potential prior authorization requirements and payor thinking around the recent FDA approval of [...]

Events

Catalyst to Moderate a Panel at the American Society of Gene & Cell Therapy Policy Summit

Comments Off on Catalyst to Moderate a Panel at the American Society of Gene & Cell Therapy Policy Summit

Catalyst Founder and President, Nancy Myers, will be moderating a panel on Thursday September 24th, 2020 at the (virtual) ASGCT Policy Summit. The panel will be on "Overcoming Regulatory Challenges in Gene Therapy Development." [...]

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 [...]