Advancing the CMC Development of Oncology Medicines

Register free: ​ https://www.pharmtech.com/pt_w/advancing​

Event Overview: Oncology drugs dominate today’s pharma industry pipeline with more than 5500 molecules in development in 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 associated with developing oncology drug products to accelerate to proof-of-concept and toward a successful commercial launch.

Key development considerations include the following:

• What dosage form is needed for proof-of-concept studies and what will the final commercial product look like?
• Does the molecule chemistry present additional challenges?
• Can the risk of a poor formulation delaying or terminating the program be reduced?
• 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 to overcome for oncology patient trials?
• How can manufacturing processes be optimized and scaled-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. This presentation, given by experts from a contract development and manufacturing organization and a biotechnology company, will outline development challenges and share case studies.

Key Learning Objectives:

• Review drug substance and biopharmaceutics considerations
• Understand the regulatory frameworks for NCEs and existing marketed drugs (e.g., 505b2)
• Develop the right dosage form for each stage of clinical development
• Review patient-centric and age-appropriate formulations
• Discuss flexible and adaptive manufacturing and supply chains for oncology trials
• Develop methods to scale up processes in readiness for commercial launch

Speakers: Dr. Asma Patel, Executive Director of Product Development, Pharmaceutical Sciences, Quotient Sciences Nottingham

John Zucaro, PE Senior Vice President, CMC

Time and Date: Tuesday, November 17, 2020 at 11am EDT| 8am PDT| 4pm GMT| 5pm CET

On demand available after final airing until Nov. 17, 2021

Sponsor: Quotient Sciences

Register free:​ ​ https://www.pharmtech.com/pt_w/advancing​