How we develop new treatments
Academics and pharmaceutical companies trust us as their first choice partner for early phase experimental oncology drug development. Find out why.
We have more than 3 decades’ experience developing new cancer treatments. Partnering with us means shared risk and reward. We offer:
- decades of experience in bringing novel anti-cancer treatments to patients
- funding and management from preclinical development through to completed trial
- access to a UK-wide early phase clinical network of leading scientific investigators
- a complete regulatory package – we sponsor the trial and manage all your MHRA regulatory documents
- confidential peer review by international experts in the field
- safety toxicology, drug manufacture, formulation, assays and biomarkers, including novel biomarker and assay development
- stringent protocols to maintain the highest quality trials and clinical data
The benefits of developing your drug with us
We specialise in:
- Phase 1
- Combinations of registered and unregistered agents
- Early phase 2 proof of principle
- Non-critical-path trials with agents in active commercial development
Our trials focus on:
- Safety data
- Biological endpoints
- Modulation of target biomarkers
We have a world-class portfolio covering a wide spectrum of cancers and therapy types. Since 1980, we’ve taken over 140 novel anti-cancer agents through preclinical development and early -phase first-in-man trials, partnering with companies like AstraZeneca, GSK, Lilly, Pfizer, Schering-Plough and Johnson & Johnson.
Seven drugs developed by us have been approved and marketed for treating cancer:
- Zytiga (abiraterone acetate) for prostate cancer
- Temodar (temozolomide) for brain cancer
- Etopophos (etoposide phosphate) for lymphoma, sarcoma, leukaemia, lung, brain and testicular cancers
- Alimta (pemetrexed) for lung cancer
- Lentaron (formestane) for breast cancer
- Zinecard or Savene (dexrazoxane) for reducing chemotherapy side effects
- Lozoxantrone (biantrazole) for leukaemia
We’ll act as trial sponsor and main point of contact with the MHRA. We’ll also develop, manage and maintain all regulatory documents for the MHRA and Ethics submission throughout the trial, including:
- Clinical Trial Authorisation (CTA) application
- Investigational Medicinal Product Dossier (IMPD)
- Investigator Brochure
- Clinical Trial Protocol
- Informed Consent Documents
- Protocol amendments
Safety on all our clinical trials is overseen by our in-house medics and an external panel of experts on the Protocol Safety and Review Board (PSRB).
Manufacture of your agent is supported by our Biotherapeutics Development Unit (BDU) and Formulation Unit, who will:
- develop clinical formulations to EU Good Manufacturing Practice (GMP),
- manufacture reliable, high quality supplies of new therapies at all stages from laboratory to clinic.
We offer unique access to world-leading research laboratories and scientific investigators. We have a close relationship with a network of Clinical Trials Units and the Experimental Cancer Medicine Centres.
Our trials comply with Good Clinical Practice (GCP), Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP). We also carry out annual audits on selected laboratories, systems and clinical trials.
We use Electronic Data Capture (EDC) to collect, manage, clean and review clinical trial data. Data are checked for completeness and consistency.
Interested in working with us?
Learn more about partnerships and joint funding opportunities, email us at email@example.com.
Speak to our Clinical Partnerships Team for more information and advice on project applications.