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
- Trade associations
- 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.
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 [...]
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 [...]
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 [...]
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 [...]
Catalyst to Speak on FDA & Innovation, Market Trends Affecting the Future of Health Care, and RWE in Drug Development
Catalyst Healthcare Consulting will be speaking at a number of events this spring and summer. Come join us as we explore some of the key issues [...]
Come and join us on Jan. 8 as Catalyst President Nancy Bradish Myers speaks as part of a panel on “The impact of new leadership and [...]
Join us on Jan. 9 as Catalyst President Nancy Bradish Myers speaks as part of a panel entitled “Once the train has left the station, is [...]
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 [...]
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 [...]
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 [...]
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 [...]