Leveraging Real-Time Clinical Data to Deliver Certainty in Formulation Development: Case Studies from Across 300 Delivered Programs

Medicon Valley Alliance and Quotient Science would like to welcome you to a Good Morning Meeting 24th of October 2024.

Drug product optimization is a critical development step that is common for most drugs that are progressing through today’s development pipelines to respond to suboptimal exposure profiles, to transition from an early development formulation to one suitable for chronic administration in patients, or as part of a life-cycle management strategy.

Traditional drug product optimization processes take 12-18 months to complete and place significant emphasis on the predictive power of laboratory and preclinical assessments. This approach is a non-optimal working model necessitated by the multiple disciplines required to develop, make and test new formulations in humans.

In this presentation, John McDermott will describe the application of Quotient Sciences’ Translational Pharmaceutics to re-engineer and streamline the drug product optimization process, using clinical data to improve decision-making and halve development timelines.

Learning Objectives:

• Develop an understanding of Translational Pharmaceutics when applied to drug product optimization
• Hear case studies on reformulation programs

Date: Thursday, 24th of October, 2024
Time: 8:30 – 11:00
Venue: Medicon Valley Alliance, Arne Jacobsens Allé 15, 2300 Copenhagen S, Denmark – Hub 2

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Program

Speakers​

John McDermott, Vice President of Scientific Consulting at Quotient Sciences John leads Quotient Sciences’ global drug development consulting, research fellows, modeling & simulation, and client services teams. He provides scientific expertise that helps Quotient Sciences’ commercial and operational teams maximize growth and ensure client programs’ success. John has over 25 years of experience in pharmaceutical sciences with prior roles at companies including Rhone Poulenc Rorer and Covance (later acquired by LabCorp). He joined Pharmaceutical Profiles in 2001, which, following a series of M&A and organic growth, was rebranded as Quotient Sciences in 2017. John has been central to the development of Quotient Sciences Translational Pharmaceutics®, the Company’s flagship drug development platform. This platform integrates formulation development, on-demand GMP drug product manufacturing, and healthy volunteer clinical testing to deliver time and cost efficiencies in small molecule and oral peptide drug programs and applications. John has significant experience in scintigraphy imaging studies for oral and inhaled dosage forms, including the development and validation of radiolabeling methods. He holds a Bachelor of Science degree in Chemistry, with a focus on Analytical Chemistry, from the University of Hull.

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