Formulation and Drug Delivery

The home for communication and discussions about innovative formulation and drug delivery ideas, their applications and challenges that face successful biopharmaceutical use of those novel concepts.

Leadership

CHAIR
Michiel Lodder, OctoPlus, Inc.

Mission

MISSION STATEMENT
The mission of the Formulation and Drug Delivery Committee is to serve as the home for communication and discussions that are fluid, relevant and timely amongst the formulation and drug delivery professionals of the MBC member companies about innovative formulation and drug delivery ideas, their applications and challenges that face successful biopharmaceutical end use of those novel concepts.

TARGET AUDIENCE
  • Formulation and Drug Delivery professionals, scientists and engineers of the MBC member companies
  • Members of the other MBC committees where there are significant scope of interactive and cross-functional communication (e.g., Process Development, Project Management, Clinical, Business Development, Marketing, etc.)
  • Representatives of Regulatory and Quality organization of the MBC member companies

Action Plan

The committee will provide speakers and topics that are of significant interest to the member companies based on open discussions. It is envisioned that the committee will be the forum to foster and facilitate communication and open discussions on formulations and drug delivery concepts and approaches for successful implementation, Chemistry Manufacturing and Control (CMC) and stability issues. The committee hopes to act as the window to the biopharmaceutical formulation and delivery innovations.

Topics

  • Novel formulation and drug delivery concepts
  • Novel approaches for macromolecule stabilization
  • Chemistry, Manufacturing and Control (CMC) issues in biopharmaceutical product development
  • Successful biopharmaceutical formulation and delivery decision tree
  • Infrastructure for formulation and drug delivery research
  • Phase appropriate development and characterization of formulation and delivery
  • Interactive forum for learning from other committees to become an integrated member of the biopharmaceutical product development team
  • Drug substance's PK, PD, stability and other requirements to successfully implement new formulation as a part of product life cycle management.

Meetings

Date Event
5/29/08 Topics in Transdermal Drug Delivery
4/23/08 Customizable Sustained Release from Oral Delivery Systems

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