Clinical operations

We are the only full service clinical operations group focussed purely on cell and gene therapies in the UK and Europe. Our unique offering is a combination of our scientific expertise and our experience in clinical trial delivery specifically for cell and gene therapies.

Cell and gene therapies offer unique challenges over and above that seen with small molecules and biologics when it comes to clinical operations. Our combined expertise in clinical trials spans across the majority of disease indications with clinical backgrounds from large pharma, biotech, academic, consultancy and clinical research organisations, bringing together a wealth of specialist knowledge.

We are the only full service clinical operations group focussed purely on cell and genetherapies in the UK and Europe and believe we are the leaders in this particular type of therapy.

Our unique offering is our combination of scientific expertise and our experience in clinical trial delivery specifically for cell and gene therapies:

  • Get the right data in the most efficient way to demonstrate efficacy and safety to UK and European regulators and payers
  • Use our specialised network in the UK to match your clinical design with clinical unitsthat are the best fit for your therapy
  • Achieve efficiencies in scale, cost and time by using our understanding of the challengesand requirements for cell and gene therapies to achieve market access

 

Our cinical operations flexible model for your trial:

 

Our combined expertise in clinical trials spans across the majority of disease indications with a range of clinical backgrounds. We have close links with key players in the clinical field in the UK due to the depth and breadth of our experience. Our team works strategically with key partners from the Department of Health and NIHR to further optimise the set-up and conduct of regenerative medicine clinical development in the UK.

Each year the clinical operations team compile pre clinical and clinical trials databases covering cell and gene therapy clinical trial activity. Search these databases and read our commentary on trends here.

Case studies:

  Oncology programme Tissue engineered trachea ARDS trial
Aim

Development and commercialisation of gene modified Tcells over expressing a specific antigen in haematological conditions, e.g. AML, MDS.

Optimise the manufacturing process and conduct a Phase I/II clinical trial of a tissue engineered tracheal replacement product that has, to date, been used clinically in a small number of compassionate cases.

Support a Phase I/II clinical study evaluating the administration of an MAPC’s therapy to Acute Respiratory Distress Syndrome patients.

Involvement

Set up to capture intellectual propertyand know-how from UCL Band Imperial Innovations
along with core investment
from Cell and Gene Therapy Catapulttoprovide:

  • Phase I/IIa clinical trials
  • Process development

  • Commercialisation strategy

Cell and Gene Therapy Catapult is responsible for pre-clinicalinvivoassessment
regulatory strategy and filings,clinical plan and clinical trial sponsorship including design and conduct.

  • Clinical site selection
  • Trial execution
Outcome

Advanced speed to the clinic, expanded the trial to Europe andcreated an investable proposition.

Full case study here

SME and academic partners enabled to develop the clinical programme and to raise further funds.

Full case study here.

Enables trial to be conducted in UK sites.

 

Contact us to find out more about our clinical operations capabilities. 

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