Ken Morrison, PhD
Vice President, Oncology, Covance
How the end-to-end services only available from a contract research organisation can be key to speeding up the development of immuno-oncology drugs.
When it comes to access to immuno-oncology therapies, cancer patients cannot wait. However, the journey from lead asset identification to registered clinical treatment typically takes 5-10 years depending upon the therapeutic.
There are ways to make this journey faster and efficient says Ken Morrison, Vice-President of Oncology, at Covance Clinical. As a global Contract Research Organisation (CRO) supporting preclinical and clinical development across all therapeutic modalities in oncology, plus diagnostic services and expertise, Covance and parent company LabCorp support cancer drug developers.
As a global Contract Research Organisation (CRO) offering oncology discovery services in clinical trial drug development, plus diagnostic services and expertise, Covance and parent company LabCorp support both infectious disease and cancer drug developers.
“Clients can leverage the value of integrating diagnostics with drug development services,” says Morrison.
This is the only CRO in the world that can diagnose and genetically profile a cancer patient, and then support their enrolment in a suitable clinical trial to help identify a new vaccine or therapy while monitoring safety throughout treatment. “The expertise between Covance and LabCorp allows for accelerated decision making in drug development ,” says Morrison.
“Companies that are developing their oncology assets need a partner with the capability and understanding to support all the elements of the asset journey, ensuring optimal service delivery aligned with client and patient needs,” says Morrison. “This dictates the overall success of the program.”
What’s needed now
Cancer Vaccine Development: Triggered by the accelerated development strategies for coronavirus vaccines, companies are inspired to accelerate development of cancer vaccines.
Swift development of therapeutics for cancers where timelines are compressed, in both solid and haematological malignancies, where increasingly assets are tumour-agnostic and genetic mutation and / or Biomarker specific.
Cell or gene therapy in haematological and solid tumour disease: Unique non-clinical humanised mouse models, use of Organoids with specialist analysis are being adopted to assess the target activity of lead assets. There is also an exponential use for biomarker assays in cancer patient selection, unique characterisation of the chemistry, manufacturing and controls (CMC) required to support batch release. Plus identifying the right patients based on biomarker targets, then measuring response and long-term follow-up requirements.
From multivalent biologics, to other targeted biologic therapies including biosimilars engineered to influence the immune system, the linking of scientific targets throughout the development continuum can create a time-efficient approach to lead generation. Streamlined regulatory engagement from this point focused on CMC, non-clinical and clinical plan perspectives is critical to enter into the clinic expeditiously.
Identifying practical solutions
“We are seeing more efficient target identification, validation, and testing in non-clinical environments coupled with early regulatory consultation to ensure efficient access to the clinic. We also need a continued focus on driving faster, data-driven decision making throughout the development process especially in clinical,” says Morrison.
That means connecting data and cross functional development teams to make decisions, with a defined governance structure to make decisions faster.
Meanwhile, blended services and data integration will avoid sponsors shopping around for, and outsourcing to, multiple partners, saving time to market.
Clinical feasibility studies that incorporate all knowledge of the program enable faster start up to first-in-human trials.
What should clients look for?
Morrison recommends seeking:
- A preclinical oncology service offering unique models fostering efficient data-driven lead generation. Services spanning all aspects of entry into the clinic, including all facets of investigational new drug (IND) and clinical trial application (CTA) enablement, are also must-haves.
- The ability to select the patients most likely to benefit from therapeutics under development, by the use of biomarker detection assays and diagnostic services, plus specialty clinical pharmacology testing & analysis capabilities.
- Finally, global trial capabilities intertwined with central labs support to ensure flawless execution of trials and manage complex logistics associated with the movement of patient samples.
“Working with a CRO partner with expertise in the continuum of drug development, coupled with diagnostic capabilities ensures the efficient application of precision medicine strategies in cancer drug development, supporting faster data-driven decision making,” says Morrison.