"Moving Drug Substance Off the Critical Path: Streamlined Strategies to Accelerate to First-in-Human & Beyond"
Join us for a happy hour seminar & networking reception during BIO in San Diego on Wednesday, June 15th from 4:00-6:30pm at Roy's at the San Diego Waterfront.
Wednesday, June 15th, 2022
Roy's at the San Diego Waterfront
3:30pm - 4:00pm
4:00pm - 5:00pm
Wine Bar Area
The need for accelerated drug development has become even greater, with added pressure on CDMOs to deliver customer’s programs in a timely, efficient, and agile manner. In this industry, time is not just money, it can impact the entire program. A program which has been through years of careful consideration, strategic discussions, and planning in order to get medicines to patients in need. Drug substance plays a major part in ensuring a drug program achieves its major milestones, keeps to budget, and delivers on its corporate goals. As every molecule and development program is different, there is no single manufacturing solution, so understanding what strategy to move forward with, what processes & technologies are available and who to partner with is key.
Utilizing characterization & screening technologies early on can help to overcome the most challenging of syntheses and help to avoid future changes that would create downstream drug product difficulties. Determining the best manufacturing process for your molecule, whether it’s traditional batch style or continuous flow can also aid in getting therapies to the clinic faster. Plus, leveraging a partner with in-house drug substance, drug product and clinical testing capabilities can greatly improve efficiencies, reduce overall development timelines & increases the potential for both clinical and commercial success. But how do drug developers know which strategy and approach is right for their molecule?
In this presentation, Quotient's Principal Research Fellow for Drug Consultant, Dr Paul Quigley, will discuss the different routes that drug developers can take to synthesize and manufacture their drug substance and evaluate their pros and cons. He will share how integrated drug substance and drug product capabilities in the candidate selection stage can aid in selecting the best molecules to move forward with into drug substance and beyond. He will also touch on the key technologies that can be employed to establish a robust, and commercially scalable synthetic process. Using case studies, he will demonstrate how drug substance and drug product development plans can be accelerated through innovative science and expertise in order to help you get your program’s drug substance off the critical path.
About our speaker
Dr. Paul Quigley, Principal Research Fellow of Drug Substance
Dr. Paul Quigley is Principal Research Fellow of Drug Substance at Quotient Sciences. Paul has over 20 years experience in the Fine Chemical and Pharmaceutical industries in a variety of senior management roles, covering Technical Management of UK Sites, and Senior Project and Operational roles within a number of international organizations including ICI, Schering Plough, Clariant, Johnson Matthey and Rhodia.
Paul graduated with a PhD in Natural Product Chemistry from University College Dublin in 1988 and with an MBA from Warwick Business School in 2000. He has co-authored a number of papers in the areas of Biocatalysis, Organic Synthesis, Polymer Chemistry and Natural Product Chemistry, and has generated several Patents in this area.
Paul is a Member of the Royal Society of Chemistry and the Association of MBAs.