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.
Catalyst News
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 [...]
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 [...]
Not A Time For Novices: FDA Needs A Leader With Deep Agency Roots And Expertise
Clinical Leader Online – May 5, 2021 Nancy Bradish Myers encourages the Administration Senate to move quickly to choose an FDA Commissioner and highlights the challenges the next FDA leader will face. She points out [...]
Wall Street Sees Woodcock Commissionership As Positive for Aducanumab, But Eyes Should Be On Cavazzoni
Pink Sheet: Informa Pharma Intelligence – January 29, 2021 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 [...]
Events
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
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
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
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 Health: New Law Encourages Telehealth Services For Medicare Patients
By Nancy Bradish Myers As Congress moved to keep the doors open for the federal government, it also swept in changes to advance the use of telemedicine for Medicare patients. These are exciting changes that [...]