The integration of Drug Substance and Drug Product
Sponsored by: Quotient Sciences
- Drug Substance
Date: 14 July
Days to go: 31
Time: 10AM US West Coast/ 1PM US East Coast
Fully integrated programs to shorten the pathway to clinical development
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.
This webinar will highlight how a fully integrated program can speed up transition from candidate selection to proof of concept and shorten the pathway to clinical development.
VP, Drug Development Sciences
Sarah Stevens, Ph.D. is the Vice President, Drug Development Sciences at Quotient Sciences. Sarah is responsible for global leadership of the Drug Development Consulting team, and the design of differentiated, integrated programs of work for pharma and biotech clients.
Sarah qualified as a PhD Pharmacist and then completed post-doctoral research at the University of Strathclyde in Glasgow prior to starting her career in industry. Over the last 15 years, Sarah has held a range of scientific and leadership roles within CDMO organizations, most recently at AMRI where Sarah led development and commercial sites both in the UK and US and was responsible for Drug Product Development.
Head of Drug Substance and Isotope Labelling
Dr Paul Quigley was head of Technology Transfer for Johnson Matthey Ltd. and was 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 graduated with a PhD in Natural Product Chemistry from University College Dublin in 1988 and with an MBA from Warwick Business School in 2000. 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.
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
- Heads of Pharmaceutical Development
- Heads of Formulation Development
- Formulation Scientist
- Manufacturing Scientist
- CMC Scientist
- Heads of Clinical Manufacturing
- Heads of R&D
- Heads of Outsourcing
- Chief Scientific Officer