Drug Product Strategies to Accelerate from Candidate Selection to Proof-of-Concept
Sponsored by: Quotient Sciences
- GMP Drug Product Manufacturing
- Formulation Development
- Clinical Trial Manufacturing
- Drug Product Development
- First-in-Human Trial
- Proof of Concept Trials
Date: 17 June
Time: 10AM London/11AM Brussels
Integration of Pharmacy Compounding and GMP Drug Product Manufacturing for Seamless Product Supply
Proof-Of-Concept (POC) is a pivotal milestone in the drug development process and yet around 80% of drug candidates continue to fail by the end of Phase II. As a result, biotech and pharma companies are continuously seeking creative ways of re-engineering the early development process to shorten project timelines, reduce costs and improve overall R&D productivity.
Companies are intensely focused on hitting key clinical milestones to gain a competitive edge and timelines for starting clinical development are becoming shorter. Since the team working on the clinical plan is seldom involved in the overall CMC strategy, the clinical formulation, or drug product, is not always given the same level of attention and investment. As such, companies may abbreviate the CMC package and develop exploratory formulations to begin clinical trials sooner, presenting major downstream risks. Firstly given today’s challenging drug substance chemistry, a fit-for-purpose first-in-human (FIH) formulation may not provide adequate systemic exposure to allow study endpoints to be met, and secondly, such simple drug products are likely to be unsuitable for next stage patient studies if positive clinical results are obtained.
This raises some key questions for drug development teams:
• How can we therefore build in more flexibility within the FIH studies to respond to human clinical data?
• How can we exit FIH with a “patient ready” dosage form to avoid a huge time and cost penalty whilst clinical development is effectively paused whilst formulation and CMC activities are “caught up”?
• How can we achieve these important goals whilst still managing CMC investments?
This webinar will summarise how a fully integrated development plan can bring together the needs of the drug product team and the clinical development team.
Dr Nutan Gangrade,
Global VP, Pharmaceutical Sciences
Nutan has over 25 years' experience within the pharmaceutical industry. Prior to his current role, Nutan served as Senior Director of Formulation Development at QS Pharma and is a founding team member. He has previously held positions at Bristol-Myers Squibb (DuPont Pharmaceuticals Company) and Wyeth-Ayerst Research (American Cyanamid Company). In these positions, he was the CMC lead for several products in various phases of development. Nutan graduated with a Ph.D. in Pharmaceutics from the University of Georgia.
Dr Andrew Lewis,
VP, Pharmaceutical Sciences
Andy has over 15 years’ experience in the pharmaceutical and drug delivery industry. He currently leads a team of 120 scientists working on formulation development, clinical manufacturing and pharmaceutical analysis projects. Dr Lewis is dedicated to overcoming drug delivery challenges, including solubility enhancement, controlled release and transmucosal delivery of proteins and peptides. He is a member of the Academy of Pharmaceutical Scientists of Great Britain and is currently Secretary of the Controlled Release Society.
Key Learning Objectives
- Hear how proof-of-concept can be accelerated with integrated product development, manufacturing and clinical testing programs
- Understand how flexibility in dosage form design can be achieved to maximize speed, managing costs and decrease risks, particularly for challenging compounds
- See how adaptive clinical protocols empower real-time dose and formulation changes within the first-in-human program
- Learn how pharmacy compounding and GMP manufacturing integration can help bridge from first-in-human formulations to patient friendly dosage forms
- Recognise how to maintain seamless and uninterrupted drug product supply for clinical trials in healthy volunteers and patients to accelerate POC milestones
- Learn how drug product manufacturing and supply can be tailored to patient recruitment to maximize program efficiency
- See how supply chains can be simplified and streamlined
- Director/Manager of Pharmaceutical Development
- Director/Manager of Formulation Development
- Formulation Scientist
- Manufacturing Scientist
- Director/Manager of Manufacturing
- Director/Manager of Clinical Manufacturing
- Director/Manager of R&D
- Heads of Outsourcing
- Chief Scientific Officer