Company: 

Adaptimmune

Adaptimmune

NST provided quality review for a broad range of regulatory documents, including:

  • Investigator’s Brochures;
  • Development Safety Update Reports;
  • Clinical Study Reports;
  • Patient safety and efficacy narratives.

We were also contracted to provide medical writing and editorial support as well as general QX function for all regulatory submission documents.

What our client said

"“I cannot praise the Niche team highly enough, having been a huge support from the outset – we quickly built up a great relationship, they are very supportive, responsive to all my emails and incredibly approachable and friendly. They have made it clear that they are always there when we need them."

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Dr Sarah Loftus, Associate Director, Medical Writing

Adaptimmune




Project background
Founded in 2008, Adaptimmune specialises in developing novel therapies for the treatment of resistant tumour types, exploiting their proprietary cell therapy platform which harnesses a patient's own cells. Adaptimmune engineers the patient’s T-cell receptors (TCRs) so that they identify cancer proteins for target therapy. The company received US FDA approval for TECELRA® in 2024, becoming the first engineered cell therapy for solid tumour cancers. The company has since been researching multiple novel therapies for a variety of cancer types.
Delivery

NST began work with Adaptimmune in 2024, conducting a QC review of an IB update for uzatresgene autoleucel, one of Adaptimmune’s TCR-based therapies. NST went onto play a pivotal role with the team responsible for the delivery of Adaptimmune’s regulatory documents. Adaptimmune appreciated NST’s flexibility and range of skills, meaning assistance could be scaled to address any of their medical writing needs across a broad range of regulatory documents for their various development assets.

NST established clear lines of communication with the Adaptimmune team to enable close tracking of multiple documents across a variety of projects with ambitious timelines. All documents were delivered to the highest quality and according to the agreed timelines.

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