Integrated programs to bridge molecules from discovery into clinical development
There are many challenges that drug developers face when bridging from drug discovery into pre-clinical and clinical development. To address them, Charles River and Quotient Sciences have formed a collaboration that leverages the expertise of both companies to create a world-leading capability that supports customers from discovery through to clinical development. Learn more about how the companies are working together.
Why have Charles River and Quotient Sciences decided to collaborate?
Charles River provides medicinal chemistry, in-vitro and in-vivo biology, drug metabolism and pharmacokinetics (DMPK), early pharmaceutics, and non-clinical safety services to support customers from early discovery, through to Investigational New Drug (IND)/Clinical Trial Authorization (CTA) submission, and on to delivery of a new medicine.
Quotient Sciences provides drug substance synthesis and manufacturing, drug product design and development, clinical trial manufacturing, and clinical testing services, supporting customers from lead candidate selection all the way through to commercialization.
Through our collaboration, customers can access unique integrated programs that bridge molecules from early discovery to proof of concept (POC) and beyond. This removes obstacles from the critical path, reduces development risks, and shortens the clinical development pathway. Charles River and Quotient Sciences’ capabilities provide deep scientific expertise, flexibility for customers, dedicated project teams, and a bespoke service that is tailored to each development program.
What expertise and experience does each company bring to the collaboration?
Together, we have over 100 collective years of company experience, supporting hundreds of biotechs and all top 20 multi-national pharmaceutical companies. We've worked on thousands of molecules across all stages of development.
Additionally, each company brings unique experience:
- Charles River has worked on over 80% of the drugs that have been approved by the US Food and Drug Administration (FDA) over the last 3 years. They have discovered 92 pre-clinical candidates, with scientists named as co-inventors on over 420 patents.
- Quotient Sciences has been conducting first-in-human (FIH) trials in the US and UK for over 30 years. When it comes to integrated program delivery, Quotient Sciences has completed 500+ integrated programs using Translational Pharmaceutics®, a novel platform to accelerate drug development and reduce costs.
What services and solutions are available through the collaboration?
Scientific solutions and key development goals are at the heart of every program, and our agile and adaptive approach ensures that we meet project needs. Each integrated program has a dedicated project governance team that spans the entirety of the project to ensure on-time delivery.
We offer integrated programs that span our two organizations to shorten development timelines, including:
- Discovery – lead optimization and early pharmaceutics, translational biology, gap analysis
- Candidate development – selecting the right molecules to move into development
- Safety assessment – late lead optimization to IND-enabling studies and beyond
- Early development – accelerating molecules through FIH to POC
- Late development – accelerating products through to market authorization
- Project management – planning and integration of critical path activities, risk management
Our customers benefit from a culture of quality science, technical excellence, and direct peer-to-peer communication with subject matter experts to drive strong collaboration. We work in multi-disciplinary project teams, offering discovery, CMC (chemistry, manufacturing, and controls), clinical, and biopharmaceutics knowledge all within one team. Projects are data-driven and led by the science. The collaboration also reduces supply chain challenges and simplifies the outsourcing process.
Can you give an example of how the collaboration made a difference to a customer’s program?
For a US biotech client focused in the oncology space, Charles River rapidly identified an alternative candidate molecule based on efficacy data to progress into late lead optimization. Quotient Sciences provided GMP manufacturing of the drug substance and associated analytical and ICH stability studies to support the clinical studies. Early engagement with Quotient Sciences led to rapid supply of increasing quantities of drug substance with parallel safety assessment and clinical formulation design.
Key project benefits included:
- efficient technical transfer within established project teams
- minimal transition time between discovery and development
- rapid process development of the chemistry, improving the overall yield from approximately 40% to 70%
- removing chromatography steps by selecting an appropriate salt form that was advantageous.
The outcome was that over 100 g of GMP drug substance was delivered to scheduled timelines and specifications, achieving significant savings for the client.
Contact us to learn more.