Welcome to Catalyst Healthcare Consulting, Inc.
Catalyst Healthcare is a dynamic, hands-on regulatory affairs strategy partner to global innovators, thought leaders, advocates, investors 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 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 and policy and identifying opportunities for clients through regulatory 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, 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.
The Pink Sheet- “How is FDA doing under Commissioner Scott Gottlieb?” is a question that, as a regulatory policy and strategy consultant, I am asked regularly. With amazing frequency, the questioner follows up with a [...]
Med Device Online – In this “Insider’s View” column, Catalyst President Nancy Bradish Myers examines the coming wave of digital health, what FDA is signaling through its recent moves in the digital health space, and [...]
The Pink Sheet- This article looks at the impact of the recent government shutdown on FDA and includes Catalyst’s perspectives the challenges involved; Catalyst President Nancy Myers notes that timelines for a number of FDA [...]
In this article, Catalyst’s Jill Hartzler Warner provides context for a potential future government shutdown, based on her experience at FDA. The article explores the potential impact of a federal government shutdown across a range [...]
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 [...]
Latest Blog Posts
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 [...]