Improving Solubility and Accelerating Drug Development through Integrated Programs

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

Event Overview:

Molecules with solubility challenges continue to dominate drug development pipelines, increasing the demand for formulation technologies that can solve these issues. Amorphous solid dispersions is one such technology that offers many benefits when addressing solubility challenges. Spray drying, in particular, allows for simple, scalable systems to be quickly developed, and ultimately provides drug products for clinical evaluation faster.

However, technologies such as spray drying cannot be successful in isolation. Development programs must be constructed in a way to advance these challenging molecules rapidly to the next milestone whilst keeping an eye on the downstream process development and commercialization. By leveraging an integrated approach, drug developers can rapidly screen formulation technologies and dosage forms in as early as the preclinical stage, using biorelevant in-vitro screening tools and physiologically based in-silico models to flag developability problems. This approach is essential before quickly transitioning drug candidates into clinical studies to understand a molecule’s full potential, with the ultimate goal of getting treatments to patients faster.

Join CMC Consultant, Peter Timmins, Lonza’s Sr. Research Fellow, David Lyon, and Quotient Sciences’ CSO, Peter Scholes, as they outline how a variety of data-driven strategies and integrated program designs can simplify development processes and reduce costs. Using expert insight and case studies they will showcase how spray drying can solve solubility challenges, and demonstrate how integrating GMP manufacturing and clinical testing can rapidly accelerate development timelines.

Key Learning Objectives:

• The drug delivery challenges presented by poor solubility
• A review of formulation and manufacturing technologies to improve solubilization
• How pharmaceutical spray drying can overcome poor drug solubility
• The benefits of integrating drug substance to drug product manufacturing
• In vitro tools and in silico methods to select SDD formulations
• Choosing the right formulation for preclinical studies and dosage forms for First-in-Human (FIH) studies
• The benefits of integrating GMP manufacturing and clinical testing to drive development efficiency
• Optimizing and validating SDD drug product performance based on clinical data
• How Quotient and Lonza can work together to deliver an integrated program

Speakers:

Peter Scholes, Ph.D.
Chief Scientific Officer
Quotient Sciences

Dr Peter Scholes is the Chief Scientific Officer at Quotient Sciences. Peter has over 25 years’ experience in the pharmaceutical industry. In his role at Quotient, he has been instrumental in identifying and implementing the innovative and flexible benefits of integrating pharmaceutical development and clinical testing in early research. He is responsible for Quotient’s scientific strategy, to identify new technologies, capabilities, and services to accelerate the development of medicines for patients. Peter has served as a committee member for the UK Controlled Release Society and APS Biopharmaceutics focus group and in 2013 set up a GastroPlus™ user group with industry colleagues as a discussion forum for PBPK modelling and simulation science. In 2010, Peter was named one of PharmaVOICE’s 100 most inspiring people in the life-sciences industry. He was appointed as an Honorary Professor in Pharmaceutical Sciences at Nottingham University in August 2015 and also serves as a trustee and board member for the Nottingham Festival of Science and Curiosity.

David Lyon, Ph.D.
Senior Fellow, Global R&D
Lonza, Small molecules

David Lyon serves as a Senior Fellow, Global R&D, at Lonza’s site in Bend, Oregon, USA, where he advises on internal and external collaborations for bioavailability enhancement technologies, modified release, and bioprocessing. David joined Bend Research as a Research Chemist in 1991. During his tenure at Bend Research, he held positions of increasing responsibility, leading numerous large-scale research programs and ultimately being named Senior Vice President, Research prior to the company’s acquisition by Capsugel and, subsequently, Lonza. His areas of expertise include extensive work with amorphous solid dispersions for bioavailability enhancement of active compounds with low aqueous solubility, as well as the development of modified release formulations and bioprocesses. David received his Bachelor of Science degree in Chemistry from Western Washington University and his Ph.D. in Inorganic Chemistry from the University of Oregon. Subsequently, he completed postdoctoral work at the California Institute of Technology.

Peter Timmins, Ph.D.
Drug Development Consultant

Peter Timmins is a drug product design and development consultant based in the North West of England with several decades of experience in the research-based pharmaceutical industry, where his most recent role was Executive Director, Drug Product Science and Technology with Bristol Myers Squibb. Additional to his current consulting activities, where he is supporting clients with compounds at all stages of development, he is also a Visiting Professor in the Department of Pharmacy at the University of Huddersfield, contributing to teaching and research, as well as an Honorary Professor in the School of Pharmacy at the University of Nottingham. Although experienced and knowledgeable in small molecule formulation across all dosage form types, Peter’s particular areas of expertise include the formulation of amorphous dispersion intended to provide bioavailability enhancement, and the design, characterization, and development of modified-release products. Peter has a Batchelor of Pharmacy degree and a PhD in natural products chemistry, both from the University of Bradford.

Time and Date:

Wednesday, February 23rd 2022 at 11am EST | 5pm CET

On demand available after final airing until February 23, 2023.

Sponsor: Lonza

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