Join our complimentary lunch seminar in Basel Switzerland at Radisson Blu Hotel
Seminar Title: 'Accelerating Development Through Integrated Drug Substance & Drug Product Strategies: Fully integrated programs to shorten the clinical pathway'
|Date & Time||Location|
|Tuesday, 20th September, 2022||Radisson Blu Hotel|
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 Quotient's Director, Drug Development Consulting, Client Services, Dr. Stephen McQuaker, Eleanor Row, Executive Director of Commercial & John McDermott, Vice President of Scientific Consulting as they share how a fully integrated program can speed up transition from candidate selection to proof of concept and shorten the pathway to clinical development. David Ross, Senior Director of Business Development will also be there to field any questions you may have about the presentation.
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
- Dr. Stephen McQuaker, Director, Drug Development Consulting
About: Dr. Stephen McQuaker has over 10 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).
- Eleanor Row, Executive Director, Commercial
About: Eleanor Row has over 15 years’ experience in the pharmaceutical and contract research environment working with multinational companies such as Sanofi-Aventis and Covance. She holds a PhD in Chemistry/Pharmacology from The University of Sheffield. Her subsequent postdoctoral studies were carried out at the University of Liverpool under the supervision of Dr A. Stachulski and Professor P. M. O'Neill developing anti-parasitic and anti-malarial compounds.
In 2006, Eleanor moved to Sanofi–Aventis focusing on the synthesis of radio/stable labelled compounds and has a proven track record for delivering high quality materials to sponsors. She has held a variety of Senior Leadership roles and as an APM accredited Project Manager has first-hand experience of leading early candidate development programs.
- John McDermott, Vice President, Scientific Consulting
About: John has over 20 years industry experience in roles in pharmaceutical sciences with Rhone Poulenc Rorer, Covance and Quotient Sciences, which he joined in 2001. He has been central to the development of Quotient's Translational Pharmaceutics approach, which integrates formulation development with clinical manufacturing, regulatory support and clinical testing, to help achieve flexible and efficient First-in-Human studies and fast development. In addition, John has a significant body of experience in scintigraphy imaging studies for oral and inhaled dosage forms, including the development and validation of radiolabeling methods.