New Medicines, Novel Insights:
Cell and gene therapies offer extraordinary hope to patients with advanced cancers and genetic diseases but pose unprecedented challenges for sponsors. In this report, Parexel experts share insights that can bring these complex treatments to market faster and more efficiently.
Chris Learn, PhD, PMP
In this report
The Patients' Perspective
Go to section
Effective Regulatory Strategies
Go to section
Clinical Development Approaches
Go to section
Market Access and Value Propositions
Go to section
To gain a deeper understanding of journeys before, during, and after CAR-therapy for hematological malignancy, we gathered insights and feedback from patients, caregivers and healthcare professionals (HCPs).
Kristina Reeder
Cancer patients’ lived experiences on their pathway to CAR-T cell trial participation
View
Cell and gene therapies do not fit existing frameworks for valuing, pricing, and reimbursing pharmaceuticals, but there is an opportunity to change the narrative. With a focus on communicating value, and aligning regulatory, clinical and market access strategies earlier and simultaneously, hear from Parexel’s experts on the trends that could impact patient access and market success.
Chris Learn, PhD
Vice President,
Cell and Gene Therapy Center of Excellence, Parexel International
With over 20 years of experience, Chris is personally committed to and passionate about advancing the clinical development of cell and gene therapies by addressing the unique challenges associated with phasing, dosing, routes of administration and delivery of these most innovative trials. He has overseen the clinical development programs of more than 20 cell and gene therapy programs in rare diseases, neuroscience, pediatrics, and oncology and was team leader for the registrational buildout, agency submission, and regulatory approval of five separate and unique marketed products: YONDELIS®, IMBRUVICA®, KEYTRUDA®, BREYANZI®, and ABECMA®. A published author and architect of numerous clinical trial protocols, he is also a former project leader at Duke University, Merck & Co, and Istari Oncology.
Partnerships in the Cell and Gene Therapy Ecosystem
Accelerating development of cell and gene therapies
Vice President,
Cell and Gene Therapy Center of Excellence,
Parexel International
Amy McKee
Self-reliant therapy developers can help over-stretched regulators expedite reviews
View
Multiple Contributors
Five regulatory pitfalls for cell and gene therapies in the US, EU, and China, and how to avoid them
View
FDA
FDA approvals data, from 2017 -2022
View
00 read
Kathy Scott
The clinical trial infrastructure for cell and gene therapies is overloaded. How can we strengthen it?
View
0 min listen
Noha Rayad, PhD
Supporting approval of a first-in-class one-time gene therapy
View
Wyatt Gotbetter
Three trends that could position CAGTs for greater patient access and market success
View
Multiple Contributors
CAGTs: Evolving marketing dynamics and future potential
View
Watch video
With a growing global CAGT pipeline, sponsors should develop data-informed development paths to support their product applications. Prepared therapy developers set themselves up for the best chance of success for expedited regulatory review, to bring products to patients – quicker. In this section, Parexel experts and former regulators share their insights.
Current research processes and infrastructure can’t fully support the requirements of cell and gene therapy protocol development and delivery. Now is the time for new approaches, to futureproof clinical development as the product pipeline continues to grow. This section sets out the perspectives and insight to build partnerships throughout the cell and gene therapy ecosystem, to accelerate innovation and therapy delivery.
Share
The Patient's Perspective
Go to section
Effective regulatory strategies
Go to section
Clinical development approaches
Go to section
Market Access and Value Propositions
Go to section
Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory, and therapeutic expertise, our team of more than 21,000 global professionals is doing everything humanly possible to design and deliver clinical trials with patients in mind, increasing access and participation and making every phase of the clinical trial process more efficient. We work With Heart™ every day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. For more information, visit us at www.parexel.com.
© 2000-2023. Parexel International (MA) Corporation. All Rights Reserved. • Privacy Policy • Terms of Service • Modern Slavery Statement Act
Download the Executive Summary
