Regenerative Medicine

Putting our hearts into every cell.

Regenerative Medicine is defined by treatment modalities that assist, stimulate or replace the body’s own reparative properties using cell, gene therapy or tissue engineering approaches. According to Food and Drug Administration’s (FDA) commissioner, the FDA anticipates receiving more than 200 new cell and gene therapy INDs in 2019 alone.

Source: https://everylifefoundation.org/wp-content/uploads/2018/09/Gene-Therapies-Wilson-Bryan-FDA.pdf

Parexel’s Global Cell and Gene Therapy team has been formed to provide a complete suite of solutions to support the needs of our clients in the regulatory and technical space including:

  • CMC
  • Non-clinical and clinical development,
  • Facility design and commissioning,
  • GTP, GMP and GCP (GXP) compliance
  • Strategic regulatory consulting

Expertise ready to facilitate your success

We have 1000+ regulatory consultants on staff, including three which are Ex-FDA from the Office of Tissues and Advance Therapies (OTAT) in CBER and Ex-EMA and EU authorities. In addition, we have 30+ cross-functional experts with relevant experience, including CAR-T and gene therapies. They understand the complex regulatory challenges and are ready to help you develop practical, tailored plans that align quality and business strategy.

Broad expertise of novel regulatory pathways

Parexel experts have experiential working knowledge of various expedited programs at FDA including fast track, RMAT and breakthrough designations, accelerated approval and priority review and other programs which can help our clients to navigate the regulatory pathways toward commercialization.

Experience in Regenerative Medicine*

  • Supported 60+ projects over three years
  • 30+ cross-functional experts including Car-T and gene therapies
  • 6+ ex-Heath Authorities including Office of Tissues and Advance Therapies

*Parexel data as of March 2019

 

We are always available for a conversation.

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