The Life Cycle Management (LCM) Community represents a diverse group of scientists from pharmaceutical industry, government, and academia who are interested in the science of clinical pharmacology as a discipline to address the drug development challenges during post approval changes and life cycle management (e.g., dosing regimen and/or route of administration changes, combination drug development, improved formulations and/or devices, 505(b)(2) applications).
The mission of the LCM Community is to promote interaction and knowledge sharing of novel application of clinical pharmacology, PK/PD and pharmacometrics or other modeling approaches that can be utilized in life cycle management and post approval activities. We accomplish our mission by:
- Highlighting the role of clinical pharmacology and model-informed drug development (MIDD) tools in the approval of new dosing regimens and dosage forms.
- Highlighting the application of clinical pharmacology in the development of combination products.
- Stimulating collaboration between LCM Community and other ASCPT Communities to highlight the role of clinical pharmacology in expanding indications to pediatric populations and repurposing the approved drug products to new indications.
- Highlighting the regulatory and clinical pharmacology challenges associated with generic and biosimilar drug development.