Cell and Gene Therapies

Leveraging the expertise and insights of former regulators

For biopharmaceutical companies, the heterogeneity of cell and gene therapies presents unprecedented technical, logistical, and strategic challenges. To help our customers navigate this complexity, Parexel brings expertise from former regulators – experts who leverage their first-hand experience of how regulators think to help our customers proceed with confidence. Our team of 80+ former regulators includes 6 from the FDA Office of Tissues and Advanced Therapies (OTAT) in CBER – including the supervisory medical reviewer from one of the first approved CAR-T cell therapies. The team also includes CMC Regulatory experts from EMA and MHRA.

Our global Cell and Gene therapies working group was formed in 2016 to provide a complete suite of solutions to support the needs of our customers, aggregating best practices from medical, regulatory, feasibility, clinical operations, logistics, value and access and commercial strategy.

Parexel has experience with multiple cell and gene therapies, including therapies for neurology and metabolic indications as well as oncology.
 

Our services include:

Non-clinical and clinical development strategy.

  • Full-service and FSP clinical operations with distinct, custom operating models for cell or gene therapy trials.
  • An established network of over 365 fully accredited sites with full CGT capability.
  • Patient recruitment and retention strategies delivered in partnership with our Patient Innovation Center and patient-focused protocol optimization teams to overcome challenges with low and hard-to-find patient populations.
  • Genomics research, methods, and resources.
  • In-house Clinical Trial Supply & Logistics services to support complex requirements, import/export, and in-country capabilities to distribute temperature-controlled products, including CAR-T trial requirements.
  • Regulatory and CMC consulting.
  • GTP, GMP and GCP (GXP) compliance.
  • Market access strategy and value communications.

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Over the last 5 years, Parexel’s Cell and Gene therapy experience included:
Cell_Gene_Therapy_Infographic (3).jpg

We are always available for a conversation.

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