Join Quotient's Executive Director of Product Development, Dr Asma Patel and TYME's Sr. Director of CMC, John Zucaro on November 17th for an oncology focused 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 drug products in order to accelerate to proof-of-concept and onwards towards a successful commercial launch.
Key Development Considerations:
· What dosage form do we need for proof-of-concept studies and what will the final commercial product look like?
· Does the molecule chemistry present additional challenges?
· Can we reduce the risk of a poor formulation delaying or terminating the program?
· Will the molecule begin clinical evaluation in patients or healthy subjects?
· What is the target patient population, and will a pediatric formulation also be required?
· Are there clinical supply chain challenges we need to overcome for oncology patient trials?
· How can we optimize manufacturing processes and scale-up for commercial launch?
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, Quotient Sciences and Tyme will outline some of the development challenges and share case studies. Quotient is an innovative development and manufacturing organization with more than 30 years’ experience in developing oncology drugs. Tyme is a biotechnology company developing a range of treatments for advanced cancers.
Topics Covered in this Webinar include:
· Drug substance and biopharmaceutics considerations
· Regulatory frameworks for NCE’s and existing marketed drugs (e.g. 505b2)
· Developing the right dosage form for each stage of clinical development
· Patient-centric & age-appropriate formulations
· Flexible and adaptive manufacturing and supply chains for oncology trials
· Scaling up processes in readiness for commercial launch
Who Should Attend:
· VP/Director/Manager of Pharmaceutical Development
· VP/Director/Manager of Formulation Development
· VP/Director/Manager of Chemistry/CMC
· Formulation Scientist
· Manufacturing Scientist
· Director/Manager of Clinical Manufacturing
· Director/Manager of Supply Chain
· Director/Manager of R&D
· Heads of Outsourcing