Madhav Kamat
Senior Advisor: CMC & Sterile Product Development
Worldwide Consulting Associates
Dr Madhav Kamat is a seasoned pharmaceutical development executive with over 40 years of experience advancing complex sterile and biologic drug products from early development through global regulatory approval and commercialization.
Dr Kamat is a recognized expert in CMC strategy, lyophilization, aseptic processing, and complex injectables, with a strong track record supporting IND, NDA, BLA, and 505(b)(2) programs across global markets.
Dr Kamat's former roles include senior technical leader at Bristol-Myers Squibb and Johnson & Johnson, and a trusted advisor to pharmaceutical companies on development, scale-up, and regulatory execution.
Dr Kamat frequently engages as an expert witness in high-profile biologics and oncology patent litigation, bringing deep technical insight to investment and legal decision-making.