Consulting Services for Cell & Gene Therapy Sponsors

We bring 35+ years of expertise in cell therapy to help advance the development of cell therapy clinical trials.

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Consulting Services for Cell & Gene Therapy Sponsors

We bring 35+ years of expertise in cell therapy to help advance the development of cell therapy clinical trials.

Expertise to effectively plan for cell therapy clinical trials and beyond

Three open and friendly doctors in lab coats on one side of a table.

Finding the best way to design, optimize and execute the clinical trial for an allogeneic or autologous cell therapy can be challenging. Additional obstacles, such as building an allogeneic cell bank that meets the needs of a target population or meeting regulatory requirements in different countries, introduce even more complexity to the clinical trial process.

We have unique experience and knowledge of managing the cell therapy supply chain and the clinical aspects of cell therapies, developed over our long history. Importantly, we have physicians on staff with the cell therapy expertise sponsors need.

Cell and gene therapy insights

With an experienced consulting team, we offer support and guidance for a variety of cell therapy development challenges that sponsors may face, including:

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Immunogenetics and bioinformatics

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Clinical research including biorepository capabilities, pre-clinical and clinical trial design and support, and data analysis

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Quality and regulatory compliance

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Physicians with direct experience in designing and executing clinical trials in the field of cell therapy

Access to extensive resources

Our immunogenetics and bioinformatics team utilizes the CIBMTR Bioinformatics Research Program, as an invaluable resource to advance the field of immunogenetics and cellular therapy genomics.

Additionally, through the CIBMTR, we conduct research and help cell and gene therapy sponsors design and execute protocols. The CIBMTR has infrastructure in place for multicenter prospective Phase I-III trials and observational studies requiring statistical and/or logistical support. It also offers resources for cell and gene therapy sponsors with commercial therapies, as well as investigators conducting prospective and retrospective clinical studies.

CIBMTR Research Activity

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publications
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centers participating in research
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ongoing studies and clinical trials
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A global understanding of regulatory compliance

Our regulatory specialists work with clients to help them overcome domestic and/or international regulatory challenges. They advise clients on developing de novo collection protocols that meet both FDA and international regulatory requirements. The team is well-versed in the U.S. regulatory requirements for cellular therapy starting material, as well as international starting material requirements in regions including the European Union, Australia, Canada, and Japan.

Our quality and regulatory specialists support the advancement of cell therapies by:

  • Understanding unique product requirements and supply chain
  • Identifying applicable U.S. and/or global regulatory requirements
  • Consulting with clients to develop cell collection specifications that meet regulatory requirements
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