• What we are expected to support changes rapidly – therapeutic modalities continue to expand.
• Success to our patients depends on us integrating formulation, clinical, container closures and delivery systems.
• Integrating medtech and pharmaceutical/biologics development therefore becomes even more important than ever
• Developing breakthrough therapies requires us to look WAY ahead to assets even earlier.

In the keynote for this conference, Dr Sinclair will reflect on how significantly the challenge of delivering breakthrough therapeutics has become – from the range of therapeutics modalities (from traditional small molecules to targeted gene therapies) – and as timeline pressures impact traditional processes for development. Where historically, therapies could be approved and launch in less “patient-friendly” presentations and then migrate to easier-to-use formats, competitive pressures and patient expectations now demand that the commercial presentation be included earlier in clinical development. These pressures mean that the “serial” development we used to be able to implement will no longer meet the need: as an industry, we need to implement “concurrent engineering” of the therapy – integrating formulation, filling, clinical work, assessment of container closure systems, and design and development of a patient-friendly delivery system

Brent Sinclair

Vice President, Combination Product Development and Drug Delivery

AbbVie, Inc