Join us at our Garnet Valley, PA facility for our complimentary lunch seminar on May 2nd entitled: "Accelerating Development Through Integrated Drug Substance & Drug Product Strategies: Fully integrated programs to shorten the clinical pathway"
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Tuesday, May 2, 2023
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Quotient Sciences - Garnet Valley
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Register for our seminar here
Seminar Summary
Over the past two decades the contract development and manufacturing organization (CDMO) sector has become more sophisticated and is now considered an integral part of almost every drug development program. Big pharma companies embrace outsourcing as a strategic way of accelerating development timelines and gaining additional R&D capacity. For biotechnology companies, CDMOs are increasingly seen as extensions of their R&D teams, providing expertise, consultancy and capabilities that are fully integrated with their own pre-existing activities.
The service sector, which has grown and scaled to accommodate the industry’s needs, has however become siloed, with separate vendors each handling different activities – from medicinal chemistry, to preclinical studies, to clinical research, to product development and manufacturing. Yet we know that drug development is a multi-disciplinary effort that requires collaboration between several groups to efficiently advance a molecule to proof of concept.
The interplay between drug substance and drug product development is of particular importance, but the activities relating to each are the responsibility of a different company, or deeply siloed parts of the same company. There are huge downsides and inefficiencies with this siloed and functional outsourcing. The challenges are exacerbated when we consider the complexity of today’s molecules and target product profiles, with timeline pressures ever present.
The seamless coordination between drug substance and drug product manufacturing results in a more efficient and accelerated development plan. Integrating all activities under a single organisation in an entirely non-siloed way encourages close relationships between multidisciplinary experts, creating a more agile approach to pharmaceutical development. Process chemists can work alongside analytical and solid-state chemists to ensure rapid development and optimization of drug substance. Formulation scientists and solid-state teams can together provide clear and unambiguous data for optimizing drug substance form, leading to rapid drug substance, dosage form design and drug product manufacturing.
The ultimate benefit is a significant shortening of the timeline from candidate selection to clinical development. On average drug development timelines will be reduced by 2-4 months, translating into significant R&D cost savings and ensuring the faster provision of new medicines to patients.
Join Dr. Paul Quigley, Quotient Sciences' Principal Research Fellow for Drug Substance, and Brad Rowe, Sr. Director of Integrated Development, as they shares how a fully integrated program can speed up transition from candidate selection to proof of concept and shorten the pathway to clinical development.
Key learning objectives:
- How holistic scientific oversight can improve the overall drug development program
- How drug substance attributes can affect downstream drug product and clinical outcomes
- How risks and critical path activities can be managed with greater flexibility and scheduling
- How to manage consumption of drug substance with more efficient manufacturing processes
- How to speed up the transition from candidate selection to clinical development
- How to improve knowledge and methods transfer between drug substance and drug product activities
- How outsourcing can be simplified – improved project management, contracting and communication
About our speakers
Dr. Paul Quigley, Principal Research Fellow, Drug Substance
Dr. Paul Quigley was head of Technology Transfer for Johnson Matthey Ltd. and previously head of New Product Introduction and Head of Technical Services for Shasun. 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 received his Ph.D. in Natural Product Chemistry from University College Dublin and MBA from Warwick Business School. 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.
Brad Rowe, Senior Director of Integrated Development
Brad Rowe has over 18 years of pharmaceutical product laboratory and testing support experience, as well as project management and general program guidance responsibilities. He has a background in analytical chemistry and has overseen teams in a variety of testing support including analytical method development and validation, product testing and QC ranging from pre-clinical through commercial marketed products.