Oncology drug development is a demanding, complicated and highly competitive area. While there has never been as much opportunity and promise for patients, the challenges to achieve market success are ever increasing. At tranScrip we bring many years of high-end experience in designing and delivering oncology programmes, including targeted treatments, immunotherapies, vaccines, cell-based products and novel cytotoxics. We are able to help our clients seize opportunities, address challenges and succeed in their drug development or lifecycle management goals by adapting and adopting novel approaches and regulatory pathways.
What we do
When there is a problem or gap, we can become your long-term partner and create a way to resolve the issue together.
Why we are different
Our oncology teams are renowned for integrating seamlessly with our clients to design product strategies and plans from translational science through to registration and medical affairs. Whether your products target solid tumours or haematological malignancies, we will be able to help.
tranScrip has a track record of achievements that include
Designing and delivering large, complex, cross-functional oncology programmes.
Preparation of development strategy, design of Phase II/III studies and regulatory interactions for an immunotherapeutic.
Serving as the “one-stop shop” drug development organisation for small biotech companies.
Providing clinical development and regulatory affairs team to support a HDAC inhibitor programme in prostate cancer.
Interpreting ‘diﬃcult’ outcomes in clinical trials and steering discussions with the regulatory authorities.
Data interpretation and regulatory interactions to support MAA and NDA for a modified cytotoxic which failed primary endpoint in Phase III.
Fielding multi-functional submission teams to author and deliver MAAs and NDAs.
Pivotal trial reporting and full dossier preparation for targeted therapy in solid tumours.
Providing management and oversight for all drug safety needs.
Assessment of drug-drug interactions and risk profile for potential toxicity for combinations of PI3K inhibitors.
Support to product launch and lifecycle management.
Providing medical affairs support for VEGF TKI in renal cell cancer.