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.
Catalyst News
Califf: FDA will be a ‘more activist’ agency
Regulatory Focus - Aug. 24, 2023 Note: This article describes an interview co-moderated by Catalyst CEO Nancy Myers, along with Tom Kraus, VP- Government Relations, American Society for Health-System Pharmacists. The webinar interview was sponsored by [...]
Telework helps FDA compete for scientists. What if it’s no longer an option?
STAT+ May 11, 2023 Catalyst CEO and Founder Nancy Bradish Myers provided her perspective on FDA hybrid/telework policies and the impact of any potential changes in the future. With over 2,000 vacancies at the agency, [...]
HHS Floats Trio of Drug Pricing Models, Some More Ambitious Than Others
AISHealth.com - February 23, 2023 Jeff Myers, Catalyst’s Senior Vice President, Market Access & Reimbursement Strategies, comments on the pricing models recently announced by CMS. Mr. Myers "says cell and gene therapy manufacturers may be skeptical [...]
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. [...]
Events
Catalyst’s Nancy Myers will moderate a panel at the DIA annual meeting in Boston on June 27 exploring: “Is Mark Cuban Really Solving the Drug Pricing Problem?”
Blog Posts
The launch of a patient-focused nonprofit: Catalyst Healthcare Consulting lends a hand
Two integral parts of Catalyst’s corporate mission are to 1) surf ahead of regulatory trends and anticipate environmental needs and 2) be good and do good. In the spirit of these objectives, we wanted to [...]
FDA Office of the Ombudsman: Focusing on Communication and Ensuring All Voices Are Heard
During an interview with the Alliance for a Stronger FDA on Aug. 30, 2023, Laurie Lenkel, JD, Director, FDA Office of the Ombudsman, provided an overview of the functions of the office, how it interacts [...]
Rare Disease Week: Marking the 40th anniversary of the Orphan Drug Act
By Anne McNickle, VP - Research & Communications, Catalyst Can you believe 2023 is the 40th anniversary of the Orphan Drug Act (ODA)? That is some time lapse! In this blog, we want to highlight [...]
CMS sends roses to Sickle Cell Patients; but will the rest of Cell and Gene Therapy get the thorns?
By Jeff Myers, Senior Vice President, Reimbursement Strategy and Market Access, Catalyst. On February 14th, CMS released its answer to President Biden’s Executive Order to “do something” to lower drug prices in the public payor programs. [...]