Join our complimentary lunch seminar in Oxford, UK at Milton Park Innovation Centre
Seminar Title: 'Accelerating Development Through Integrated Drug Substance & Drug Product Strategies: Fully integrated programs to shorten the clinical pathway'
|Date & Time||Location|
Wednesday, 28th September, 2022
|Milton Park Innovation Centre
10:30am - 1:00pm - Registration and Seminar Presentation
|99 Park Drive
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 Vice President of Integrated Development Services, Early Development Asma Patel and Eleanor Row, Executive Director of Commercial, 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. Charlotte Hannigan, Associate 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
Asma Patel, Vice President, Integrated Development Services, Early Development
About: Asma is the Vice President of Integrated Development Services at Quotient Sciences Nottingham, with responsibility for overall management of product development for studies including operational delivery of formulation development and technical project management groups. She has over 19 years’ experience in preformulation and formulation in academia, industry and contract manufacturing organisations. Her expertise covers a wide range of dosage forms, including oral modified release delivery and formulation strategies to improve oral delivery of poorly soluble compounds, which are particular fields of experience and interest. Asma received her PhD in formulation of novel anticancer prodrugs from De Montfort University.
- 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.