Join Quotient's Executive Drug Development Consultant, John McDermott, on Wednesday, September 2nd at 10:00am (London) for a live webinar entitled: Advancing the CMC Development of Oncology Medicines
Oncology drugs dominate today’s industry pipeline with over >5500 molecules in development for 2019 alone. With this number of molecules, the stakes are high, increasing the pressure on pharmaceutical scientists to get medications to patients as quickly as possible. But does the focus on speed mean sacrifices are made elsewhere in the development plan? Drug developers need to be mindful of the challenges that come with oncology molecules in order to accelerate from candidate selection to a successful outcome in the clinic.
Key Development Considerations:
· Will the molecule begin clinical evaluation in patients or healthy subjects?
· What dosage form do we need for initial clinical studies and what do we want as the final commercial product?
· Can we achieve the key early clinical milestones with a simple fit-for-purpose formulation?
· How can we reduce the risk of an under-performing formulation delaying or terminating the program?
· Does the molecule chemistry present additional challenges; is it highly-potent or cytotoxic? Is it poorly soluble?
· How can we avoid additional critical path bridging studies?
· What is the target patient population and will a pediatric formulation also be required?
In a market segment where concerns over development time and cost are even more accentuated, the need to manage R&D budgets while not compromising speed to market is crucial. In this presentation, we will outline some of the development challenges for oncology drugs and share some case studies on how Quotient has supported customers in advancing their molecules from the preclinical stage through to commercial launch.
Topics Covered in this Webinar include:
· Biopharmaceutics considerations for oncology drugs
· Bridging from Candidate Selection to Proof-of-Concept (POC)- How can we accelerate to patient data?
· Pediatric Medicines - Developing age-appropriate formulations
· Proof-of-Concept to Commercial Launch- How can we rapidly scale-up manufacturing and shorten the time to market?
As a fully integrated drug development, clinical testing and manufacturing organization, Quotient Sciences is well positioned to address the challenges associated with developing small molecule oncology therapeutics. We are dedicated to accelerating the development of new drugs for patients around the world providing individual services or fully integrated programs through our unique Translational Pharmaceutics platform. We have supported over 50 oncology programs during the last 5 years and our extensive formulation know-how, coupled with our agile and flexible approach to clinical and commercial manufacturing, makes us a valued end-to-end solution provider for the development, testing and manufacture of oncology drug products.