Integrated Drug Product Development – Considerations from Pre-Clinical to Commercialization

Previously Aired on October 27, 2021

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Overview

Whilst supporting well-understood and established clinical and regulatory pathways, drug product development programmes do require tailored project-specific strategies. Phase-appropriate formulation approaches are balanced with a long-term plan anticipating clinical outcomes, formulation optimisation, formulation revision, programme acceleration, scale-up considerations and more.

A successful programme supported by an integrated team and flexible, proactive planning is key to ensuring a tactical or unexpected change in strategy can be managed without significant impact to timeline or cost. This webinar will present strategies utilized by Curia formulation development and manufacturing teams and will include case studies of developing an approach to lifecycle management from pre-clinical activities through commercialization.

In this webinar you’ll learn:

  • Capability & planning requirements for effective integrated drug product development
  • Phase- appropriate considerations for development programmes from simple to complex formulations
  • Techniques for adapting when challenges occur and ensuring continuous improvement plans are embedded through projects
Who should attend:
  • Directors
  • Senior Directors
  • VPs of Manufacturing
  • Sterile Drug Product Manufacturing
  • Development 

Presenters

Presenter
Iain MacGilp, Ph.D.
(Presenter)
Senior Director, Drug Product Development,
Curia
View Biography
Presenter
Anish Parikh
(Presenter)
VP, Drug Product Business Development
Curia
View Biography
Presenter
Michael Auerbach
(Moderator) Editor-in-Chief
Pharmaceutical Outsourcing