Directed a team of consultants to manage the CMC function for a fixed-dose combination product with multiple strengths, including: product development; analytical development and validation; process scale-up, validation, and continuing process verification (CPV); and commercial launch supplies. Provided direction for Intellectual Property (IP) development, CMC regulatory filing and defense for US FDA and EMA, and site compliance for FDA inspection. European manufacturing site identification and selection.
Assembled team of three consultants for preformulation, formulation and analytical activities for 'drug-product' IND enablment of a new chemical entity. Transitioned activities to partner company after acquisition.
Supported cross-functional CMC activities in new startup from inception to engage a 10 person consultant team across multiple NCE clinical product candidates (including DPI, oral tablet, lyo). Supported CMC diligence on multiple product acquisitions. Covered drug substance, drug product, analytical, device, and manufacturing site selection activities. Created and hired CMC organization to transition to employee driven teams that will be complemented by the consultant group.
7 year relationship on high level CMC submission planning and strategic advisor on analytical and biopharm issues to support 2 product approvals. Authored specific NDA/MAA sections and regulatory defense responses. Maintained relationship for 4 years after company acquisition to support regulatory filings and approvals.
Supported API sourcing, HPLC, dissolution, & particle size method development across multiple projects. Conducted supportive stability studies. Retained as strategic advisors on new product concepts and formulation IP.
Designed media studies and fast tracked numerous dissolution studies (~20) in a month to complement a dissolution method development program.