Catalyst Healthcare Consulting
Catalyst Healthcare Consulting is a dynamic, hands-on regulatory policy and regulatory affairs partner dedicated to helping clients advance innovative healthcare solutions that benefit patients. They build fit-for-purpose solutions to accelerate product development, advance policy objectives, and improve the regulatory environment, serving a diverse client base including global innovators, start-ups, agencies, patient advocates, investors, universities, non-profits, and trade associations. With over 20 years of experience, they leverage a broad view of the healthcare ecosystem to craft bold solutions to complex challenges, supporting clients across the entire development spectrum.
Industries
Nr. of Employees
small (1-50)
Catalyst Healthcare Consulting
Mclean, Virginia, United States, North America
Products
Emerging technologies horizon scan (white paper)
A commissioned industry horizon scan summarizing scientific background, innovations, and regulatory considerations for top emerging cell and gene therapy technologies over a 3–10 year horizon.
Emerging technologies horizon scan (white paper)
A commissioned industry horizon scan summarizing scientific background, innovations, and regulatory considerations for top emerging cell and gene therapy technologies over a 3–10 year horizon.
Services
Advisory services to develop regulatory policy positions, advocate before federal agencies, and shape public policy to support product development and patient access.
Ongoing monitoring and reporting on emerging scientific and regulatory trends with actionable guidance for clients; includes white papers and briefs.
Design and execution of convenings and multi-stakeholder processes to build consensus across regulators, industry, patient advocates, and payers.
Development of payer engagement strategies, reimbursement planning, and market-access pathways to support commercialization.
Advisory on trial design options for cell and gene therapies and rare diseases, including master protocol frameworks and innovative trial constructs.
Creation and delivery of presentations and training series that translate complex science for regulatory reviewers and cross-disciplinary audiences.
Advisory services to develop regulatory policy positions, advocate before federal agencies, and shape public policy to support product development and patient access.
Ongoing monitoring and reporting on emerging scientific and regulatory trends with actionable guidance for clients; includes white papers and briefs.
Design and execution of convenings and multi-stakeholder processes to build consensus across regulators, industry, patient advocates, and payers.
Development of payer engagement strategies, reimbursement planning, and market-access pathways to support commercialization.
Advisory on trial design options for cell and gene therapies and rare diseases, including master protocol frameworks and innovative trial constructs.
Creation and delivery of presentations and training series that translate complex science for regulatory reviewers and cross-disciplinary audiences.
Expertise Areas
- Regulatory policy strategy
- Regulatory intelligence and horizon scanning
- Stakeholder engagement and consensus building
- Reimbursement strategy and market access
Key Technologies
- Cell and gene therapy methods
- CAR T‑cell therapy (therapy class)
- Master protocol trial designs
- Real-world evidence (RWE) analysis
News & Updates
Catalyst to attend the FDLI 2025 Annual Conference, engaging with leaders in food and drug law.
Catalyst to moderate a panel on enhancing innovation in CGT clinical trials for rare diseases at DIA 2025.
FDA Commissioner Robert Califf discusses the agency’s future priorities including real-world evidence and misinformation combat.
Scientific innovation in Cell & Gene Therapy (C>) is advancing rapidly, sparking hope for patients with rare diseases, cancer, and other debilitating conditions.
Catalyst team demonstrates support and highlights the importance of rare diseases and the impact of rare talents and personalities.
Catalyst to attend the FDLI 2025 Annual Conference, engaging with leaders in food and drug law.
Catalyst to moderate a panel on enhancing innovation in CGT clinical trials for rare diseases at DIA 2025.
FDA Commissioner Robert Califf discusses the agency’s future priorities including real-world evidence and misinformation combat.
Scientific innovation in Cell & Gene Therapy (C>) is advancing rapidly, sparking hope for patients with rare diseases, cancer, and other debilitating conditions.
Catalyst team demonstrates support and highlights the importance of rare diseases and the impact of rare talents and personalities.