Case Studies

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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.

Designed and implemented processes and procedures for startup, development and manufacture of medicinal cannabis for a startup company, including equipment assessment and purchase and personnel identification and hiring.  Participate in Science Advisory Board meetings and implement formulation strategies to quickly introduce new products to market.  Collaborate with regulators on industry guidelines and best practices.

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.

Established CMC presence with a team to direct activities at Phase 1 for Phase 3 clinical trial readiness and drug product registration strategy.  Identification of new CDMO partners and management of technical transfer activities for multiple drug substance, drug product and packaging partners.  Develop and author briefing books for interaction with regulatory agencies and IND/IMPD/CTA for clinical trials.