Resources

The Integration of Drug Substance and Drug Product

14 July 2021

Upcoming Live Webinar

July 14, 2021.

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.

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
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