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, management 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 and diagnostics 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

Former FDA Chief Counsel Elizabeth Dickinson Hailed For Her Expertise, Warmth and Mentorship

October 6th, 2022|Comments Off on Former FDA Chief Counsel Elizabeth Dickinson Hailed For Her Expertise, Warmth and Mentorship

The Pink Sheet - September 27, 2022 In an article on the legacy of retiring FDA Chief Counsel/Deputy Chief Counsel Elizabeth Dickinson, Catalyst’s Nancy Bradish Myers comments that Dickinson’s management style won her internal accolades. [...]

FDAnews Webinar: On Challenges Facing the New FDA Commissioner

January 21st, 2022|Comments Off on FDAnews Webinar: On Challenges Facing the New FDA Commissioner

During her panel for FDAnews, Nancy Myers highlighted impending challenges looming over FDA’s commissioner hopeful, Robert Califf. If confirmed, Califf would enter the FDA at a time crucial to rebuilding public trust in the Agency [...]

Accelerated Approval Standards: Application to Gene Therapy

September 25th, 2021|Comments Off on Accelerated Approval Standards: Application to Gene Therapy

At the ASGCT Policy Summit 2021, Nancy Bradish Myers shared these slides to help participants understand FDA’s accelerated approval standards and how they specifically apply to gene therapies.  In addition, she highlighted the ongoing debate [...]

  • medicaid

Ruling Blocks Okla. MCO Program, But Fight May Not Be Over

June 25th, 2021|Comments Off on Ruling Blocks Okla. MCO Program, But Fight May Not Be Over

AISHealth.com — June 25, 2021 Jeff Myers, Catalyst’s Senior Vice President, Market Access & Reimbursement Strategies, discusses the legal technicalities which tripped up Oklahoma as the health providers win their lawsuit against Republican Gov. Kevin [...]

Events

Blog Posts

FDA User Fee Programs Reauthorized: FDA’s CBER Is A Clear Winner

October 6th, 2022|Comments Off on FDA User Fee Programs Reauthorized: FDA’s CBER Is A Clear Winner

Pharmaceutical Online/Cell & Gene/Bioprocess Online – October 6, 2022 PDUFA VII, CBER and the new gene & cell therapy Super Office: Catalyst’s Nancy Bradish Myers shares her insights on the cleanest user fee reauthorization in [...]

Marks Took On FDA Vaccine Leadership Position What Happens Now?

November 1st, 2021|Comments Off on Marks Took On FDA Vaccine Leadership Position What Happens Now?

Outsourced PharmaOnline / PharmaceutialOnline — November, 1 2021 Nancy Bradish Myers shares views on Dr Peter Marks’ decision to step into an Acting Director role at the CBER Office of Vaccines (OVRR) and identifies cautionary [...]

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 [...]