New England PharmAssociates

Excellence in life sciences asset development

Case Studies

Pre-clinical drug development leadership

Engagement:
Early stage biopharmaceutical company had selected a development candidate following a successful small molecule lead optimization effort. The client needed a Director of Pre-Clinical Development to make the transition to clinical trials.

Solution:

  • Held meetings with executive team to map out client objectives and to delineate timeline and cost constraints.
  • Identified and interviewed candidate contract research vendors to carry out scale-up/API manufacturing, GLP toxicology, formulations development/APS manufacturing and stability monitoring to produce a short list for selection.
  • Collaborated with regulatory expert to audit selected vendor facilities
  • Led the pre-clinical development program – coordinated activities of contract vendors working with subject matter experts in regulatory, pharmacology, toxicology and process chemistry.
  • Conclusions:
    The team met the client’s objective of concluding pre-clinical work within 1 year of candidate selection. The data produced formed the basis for a strategic partnership to fund clinical development. This promising drug candidate is in Phase III clinical trials.