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© 2000-2021. Parexel International Corporation.
Relentlessly identifying every action possible to help reduce the patients’ wait for your therapy.
Our 1000+ strong consulting team includes ~100 former regulators/HTA assessors, alongside industry luminaries, who know exactly how to help you navigate regulatory and access hurdles to reach patients sooner.
Strategies for cell and gene therapies
The cell and gene therapy (CGT) era promises to make life-changing drugs more accessible to patients worldwide. Yet, only a few have gained approval to date. Parexel’s consulting experts, including former regulators provide unique insight into the four most significant challenges companies need to address to accelerate product development.
- Avoiding regulatory and CMC pitfalls
- Understanding patient needs
- Communicating about clinical trials
- Demonstrating value
Expert insights
Podcast
Pandemic preparedness: Investing in the future of infectious disease vaccine development
Video
What you need to know about accelerated pathways
Video
The evolving role of real-world evidence (RWE)
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Real-World Evidence: The Feedback Loop
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Accelerated Pathways – Alberto Grignolo
Regulatory & Access Content
Three ways to improve your chances that insurers will pay for a new CGT
Ned Wydysh, Ph.D
Vice President, Health Advances
Access: full bio
Three ways to reap the benefits (and mitigate the risks) of adaptive trial design
Adaptive trials can facilitate faster and smarter development decisions, yet they remain underutilized by sponsors. This article looks at strategies to minimize their risks while adopting these innovative trial designs.
We need faster endpoints for targeted cancer drugs, and there is one
Jorge Camarero
Technical Vice President, Clinical
Access: full bio
Passionately guiding you through a regulatory and access environment they helped shape.
"With unrivaled real-world experience and a collective resume unlike any other team in the industry, our elite group can help you identify and navigate the requirements of regulators, providers, payers and patients holistically, and early. So you can get your innovation from the lab to the people who need it most, faster – with heart."
Paul Bridges
Senior Vice President and Worldwide Head of Regulatory & Access, Parexel
Unrivaled real-world expertise includes:
- 1000+ strong consulting team with ~100 former regulators and HTA assessors
- Localized knowledge covering 110 countries
- Therapeutic experts with deep technical expertise
- Market access specialists with proven health technology assessment (HTA) success
Learn more about Parexel Regulatory & Access Consulting services