NEW MEDICINES, NOVEL INSIGHTS
Accelerating development of cell and gene therapies
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Chris Learn, Ph.D., P.M.P.
Senior Vice President, Head of the Cell and Gene Center of Excellence
Cell and gene therapies (CAGTs) 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.
IN THIS REPORT
SECTION 1
Cancer patients' lived experiences on their pathway to CAR-T cell trial participation
To gain a deeper understanding of journeys before, during, and after CAR-T therapy for hematological malignancy, we gathered insights and feedback from patients, caregivers and healthcare professionals (HCPs).
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SECTION 2
Effective regulatory strategies
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.
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SECTION 3
Clinical development approaches
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.
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SECTION 4
Market access and value propositions
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.
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Contributing Experts
Alicia Shields, Ph.D.
Strategy Consultant, Cell and Gene Therapy Practice, Health Advances
Angela Hirst
Director, Site Alliance, Therapeutic Networks, Oncology
Chris Learn, Ph.D., PMP
VP, Head of the Cell and Gene Center of Excellence
Christiane Niederlander
VP, Technical - Regulatory Strategy
Gwyn Bebb, M.D., BM, BCh, Ph.D.
Senior Vice President, Global Therapeutic Area Head – Oncology
Kathy Scott
Associate Site Alliance Director
Kristina Reeder
Director, Patient Engagement
Mingping Zhang （张明平）
Vice President, Technical - Regulatory Strategy
Ned Wydysh
Vice President, Oncology and Cell and Gene Therapy Practices, Health Advances
Pengfei Song, Ph.D.
VP, Regulatory Strategy
Rajiv Gangurde, Ph.D.
VP, Technical Operations, Cell and Gene Therapy
Siegfried Schmitt
Vice President, Technical PC
Sinan Sirac, MD, Ph.D., MSc
VP, Technical - Regulatory Strategy
Steve Winitsky
VP, Technical - Regulatory Strategy
Vivek Mittal, Ph.D.
Partner and Managing Director, Head of Biopharma, Health Advances
Xoli Belgrave
Senior Director, Head of Clinical Trial Diversity and Inclusion
Contributing Experts
Alicia Shields, Ph.D.
Strategy Consultant, Cell and Gene Therapy Practice, Health Advances
Angela Hirst
Director, Site Alliance, Therapeutic Networks, Oncology
Chris Learn, Ph.D., PMP
VP, Head of the Cell and Gene Center of Excellence
Christiane Niederlander
VP, Technical - Regulatory Strategy
Gwyn Bebb, M.D., BM, BCh, Ph.D.
Senior Vice President, Global Therapeutic Area Head – Oncology
Kathy Scott
Associate Site Alliance Director
Kristina Reeder
Director, Patient Engagement
Mingping Zhang （张明平）
Vice President, Technical - Regulatory Strategy
Ned Wydysh
Vice President, Oncology and Cell and Gene Therapy Practices, Health Advances
Pengfei Song, Ph.D.
VP, Regulatory Strategy
Rajiv Gangurde, Ph.D.
VP, Technical Operations, Cell and Gene Therapy
Siegfried Schmitt
Vice President, Technical PC
Sinan Sirac, MD, Ph.D., MSc
VP, Technical - Regulatory Strategy
Steve Winitsky
VP, Technical - Regulatory Strategy
Vivek Mittal, Ph.D.
Partner and Managing Director, Head of Biopharma, Health Advances
Xoli Belgrave
Senior Director, Head of Clinical Trial Diversity and Inclusion