CPhI NA Lunch Seminar: Moving Drug Substance Off the Critical Path

18 May 2022

"Moving Drug Substance Off the Critical Path- Streamlined Strategies to Accelerate to First-in-Human & Beyond"

Join us for a lunch seminar during CPhI North America in Philadelphia on Wednesday, May 18th from 12-1pm at the Loews Philadelphia Hotel.

Seminar Overview

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 Director of Drug Development Consulting, Dr Stephen McQuaker, 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.

Event Details:

Date: Wednesday, May 18th

Time: 12:00pm - 1:00pm EST (Registration/Check-in will open at 11:30am) 

Location:  Loews Philadelphis Hotel- Meeting Room Suite on the 33rd Floor  -  1200 Market St, Philadelphia, PA 19107

*Lunch will be provided from the delicious Bank & Bourbon restaurant during the seminar

Speaker's Information:

Dr Stephen McQuaker – Director, Drug Development Consulting

Dr Stephen McQuaker has over 10 years’ experience across a range of chemical industries including pharmaceuticals, flavour and fragrance and fast moving consumer goods. He is experienced in upstream and downstream focussed roles, including process research and development, new technology and formulation development, as well as in pilot plant and commercial scale manufacturing support functions. He has first-hand experience of drug candidate development programs through non-clinical and early clinical phases, including GMP drug substance manufacturing at multi-kilogram scale, using both batch processing and continuous flow technologies.

Stephen holds a PhD in organic chemistry from the University of Glasgow and has also conducted academic research in the areas of synthetic organic chemistry and chemical biology, at the State University of New York at Stony Brook (NY, USA) and at the Buck Institute for Research on Aging (CA, USA).