Clinical operations

We’re focussed purely on cell and gene therapies in the UK and Europe. With our blend of scientific experience in clinical trial delivery, we can offer you support when you need it.

Our team is your team

We can help you get the right data to demonstrate efficacy and safety to UK and European regulators and payers.

We work with our network in the UK to help you match your clinical design with clinical units that are the best possible fit for your therapy.

We’ll help you find efficiencies in scale, cost and time by sharing our understanding of the challenges and requirements for cell and gene therapies to achieve market access.

We help you match your clinical design with clinical units that are the best possible fit.

In this video the Clinical Operations team at Cell and Gene Therapy Catapult and Anthony Ting, Vice President of Regenerative Medicine, Athersys inc. discuss the ongoing clinical study using Multistem to treat ARDS.

Our clinical team

Advice

Bespoke data

You never know when your project might need a little extra help. If you hit a stumbling block, we can work through it with you, and help optimise your development path.

Our feasibility, site identification and operational delivery could be highly relevant to your therapy. We advise with data that helps demonstrate relevance and predictive power in a young and still emerging market.

Predict

Partners

We make it our job to anticipate the challenges your therapies might come up against, and can work with you to solve your unique route to achieve market access.

We can help you to find the right partners: sites that we have a relationship with, collaborators to assist within a consortia and a network of specialist service providers.


Our flexible operating model:

Developing a close relationship

Our experience in clinical trials spans across the landscape of disease indications, with a range of clinical backgrounds.

This wide ranging experience means that we’ve been able to develop close relationships with key players in the UK clinical field.

We work 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.

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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