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

Life Sciences, Clinical Trials, Pharma Manufacturing & Supply Chain, Drug Discovery & Development, Preclinical,
  • Wednesday, June 15, 2022 | 11:30am EDT / 8:30am PDT / 4:30pm BST
  • 60 min

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 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. Understanding what strategy to move forward with, what processes and technologies are available and who to partner with, is key.

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Utilizing characterization and screening technologies early on can help to overcome the most challenging of syntheses and 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. In addition, leveraging a partner with in-house drug substance, drug product and clinical testing capabilities can greatly improve efficiencies, reduce overall development timelines and increase 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 webinar, the featured speaker 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.

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Join this webinar as the speaker explores case studies to demonstrate how drug substance and drug product development plans can be accelerated through innovative science and expertise to get drug substance off the critical path.

Speaker

http://Stephen%20McQuaker,%20Quotient%20Sciences

Stephen McQuaker, Director, Drug Development Consulting, Quotient Sciences

Dr. Stephen McQuaker has over ten 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).

Message Presenter

Who Should Attend?

  • Chief Scientific Officers
  • Medicinal Chemists
  • Process R&D Chemists
  • Preclinical Formulations Scientists
  • Research Fellows/ R&D Scientists
  • CMC Management
  • Technical Operations
  • Outsourcing Managers
  • Drug Substance Process Development Engineers
  • Project Managers
  • Manufacturing Director
  • CMC Consultants

What You Will Learn

Attendees will:

  • Gain a better understanding of the different routes that drug developers can take to synthesize and manufacture drug substance
  • Learn about key technologies that can be employed to establish a robust, and commercially scalable synthetic process
  • See how drug substance and drug product development plans can be accelerated through innovative science and expertise
  • Hear how integrated drug substance and drug product capabilities can aid in selecting the best molecules to move forward to the clinic

Xtalks Partner

Quotient Sciences

Quotient Sciences is a drug development and manufacturing accelerator providing integrated services across the entire development pathway for small molecules & peptide drug programs. We cut through silos across a range of drug development capabilities, saving precious time and money in getting drugs to patients.

We work with customers in a flexible way by either designing and delivering fully integrated programs at each stage of the development lifecycle, or by providing them support through tailored individual services in Drug Substance Synthesis & Manufacturing, Formulation Development, Clinical Trial Manufacturing, Commercial Manufacturing, Clinical Pharmacology, Data Sciences, Bioanalysis and Drug Development Consulting.

Quotient Sciences has over 30 years of experience developing a breadth of formulations across a range of indications and across an array of drug product formats including oral, inhaled, parenteral & topical. We also have a depth of expertise in modified release, oral peptides, ADME studies, Radiolabelling, Scintigraphy, Pediatrics, and we have the ability to handle highly potent compounds. Our innovative approach to formulation development is based on our proven track record in early clinical evaluation delivering phase-appropriate formulations across the product development pathway from candidate selection thru commercial product launch.

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