The role of biopharmaceutics in early drug development
Sponsored by: Quotient Sciences
- Drug Development
- Clinical Trial Manufacturing
Date: 6 October
Time: 10AM London/11AM Brussels
Nominated candidates entering clinical development often have sub-optimal physicochemical, biopharmaceutic or DMPK properties for oral delivery. Development teams are challenged with how to understand the properties of new drug candidates, how to design the appropriate formulation strategy and how to move quickly and successfully into early phase clinical trials. Along the way, it is important to identify developability risks and take steps to mitigate these factors, balanced carefully against time and cost investments.
This webinar discusses effective strategies being used by biotech and pharmaceutical companies to overcome biopharmaceutic challenges for small molecules in today’s drug development pipeline; and explores alternative approaches for accelerating your early development plan.
Learn about case studies relating to:
• Poor solubility molecules
• Drugs with short half-lives
• Preclinical to clinical translation.
Senior Drug Development Consultant, Quotient Sciences
Vanessa has over 20 years industry experience providing biopharmaceutics support to discovery, development and clinical programs. Vanessa has previous experience at AstraZeneca as a permeability expert working in the Pharmaceutical Development dept. where she lead the global Caco-2 facility for development, liaising with discovery scientists to ensure selection of NCE with appropriate biopharmaceutical properties, introduced the IV microtracer technique and also provided biopharmaceutical support to both Discovery and Development programs. Vanessa joined Quotient Sciences in 2012 and has led the implementation of Modelling and Simulation and been heavily involved in the Pharmaceutical Sciences in vitro characterisation strategy, as well as designing clinical studies and providing scientific support through clinical study delivery.
Dr. Shriram Pathak,
Shriram is a member of the scientific consulting group at Quotient and has a comprehensive experience in the biopharmaceutical aspects of formulation design and development. He has a thorough understanding of the new technologies in the field of drug absorption modelling and has been involved in the development and optimization of biorelevant tests (dissolution, precipitation, absorption tests) to provide in vitro, in silico and in vivo correlations. Prior to joining Quotient in 2019, Shriram was a member of the modelling and simulations group at Certara, UK, where he was involved in the development of mechanistic modelling tools to inform a rational formulation design. Shriram has previously worked at Dr. Reddy’s Laboratories where his role involved the development of bioequivalent drug products.
Key Learning Objectives
- The importance of salt and polymorph screening and prototype selection for pre-clinical assessment
- BCS or DCS assignment and developing a formulation strategy for poorly soluble molecules
- The role of physiologically based pharmacokinetic (PBPK) modelling and simulation (M&S) for rational formulation design
- Teasing apart the drivers of poor bioavailability - In-vitro testing / in-silico techniques / in-vivo preclinical studies / clinical assessments
- Choosing the appropriate dosage form for first-in-human trials
- Formulation optimization using adaptive clinical programs
- Director/Manager of Pharmaceutical Development
- Director/Manager of Formulation Development
- Formulation Scientist
- Manufacturing Scientist
- Director/Manager of Clinical Manufacturing
- Director/Manager of R&D
- Heads of Outsourcing