CPHI Webinar Series
Leveraging Real-Time Clinical Data to Deliver Certainty in Solubility Enhancement and Modified Release Development
What will this webinar address?
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 how the application of Quotient Sciences’ Translational Pharmaceutics® to re-engineer this process has created a Rapid Formulation Development and Clinical Testing approach, using clinical data to improve decision-making and halve development timelines using case studies from over 300 delivered programs. Key learning objectives:
John McDermott is 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.
Andrew has two decades of experience in the pharmaceutical industry, spanning from preclinical development, through early clinical formulation development into late stage development, scale up and commercialisation. Andrew has a particular interest in enabling technologies for bioavailability enhancement, characterisation of all delivery formats, innovate technologies and understanding drug product structure – drug product function relationships. Andrew’s focus at Quotient Sciences is in Translation Pharmaceutics and the acceleration in candidate progression and associated benefits provided by tighter integration of formulation development, clinical drug product manufacture and clinical dosing. Prior to Quotient Sciences, Andrew worked at Cooper Surgical and Healthcare as a Program Director and at Catalent as an Open Innovation Director covering two business units. Prior to this, Andrew spent 15 years at Juniper Pharma Services and Molecular Profiles CDMO’s in a variety roles combining technical and commercial knowledge, sitting at the operational and business interfaces with external clients. Andrew holds a BSc, MSc and PhD in physical chemistry from the University of Bristol.
James is an experienced events producer, who has developed and led multiple events across the life science industry for leading events organisations, while keeping the highest standards in terms of quality and delivery. Now at Informa Markets as Senior Content Producer, James oversees the content for CPHI North America and CPHI webinar series, helping in creating cutting edge sessions and providing guidance in creating interactive and educational talks.
This webinar is brought to you by
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Thursday 12th December, 2024
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3pm BST/ 4pm CET
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60 minutes
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Free
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