Recognized expertise in Vaccines, Biologics, Cell therapeutics Industry, CDMO governance and oversight, Contract Execution, Tech transfer, Quality Operations, Continuous Improvement, and Risk Mitigation.
Strategic advice and leadership to advance development of innovative drug products and ensure efficient progression of CDMO oversight from research to first-in-human, pivotal studies,
Due diligence activities or third-party reviews for partnering negotiations and joint development of drug candidates and technical submissions for regulatory authorities (USFDA, European Medicines Agency and Health Canada).
Experienced in a variety of therapeutic areas including anti-inflammatory, oncology, nosocomial, osteoporotic, gastrointestinal disorders and numerous biological products such as immune modulators, blood products, oncolytic and payload viruses, monoclonal antibodies and growth factors.
Partnering negotiations, Technical review / CMC submissions, M&A and joint development of Biologics and Biopharmaceutical candidates including nonclinical drug development strategies, gap analysis, and program planning.
Ability to build and sustain business relationships with the in-house personnel, key opinion leaders in all sectors including leading industry organizations, accelerating time-to-market, and controlling development costs.