Due diligence and clinical development programs for several new Rx-to-OTC opportunities in the upper respiratory category, and women’s health
Due diligence reviews for medical devices, small molecules and biologics in both upper and lower respiratory categories
Development of clinical protocol in the Pediatric Cough/Cold Category, sought out appropriate CRO’s to conduct a complex study, and obtained bids for a potential Sponsor
Participated in advisory boards in the immunology and respiratory categories and mock FDA presentations
Advised several OTC manufacturers on FDA regulatory strategy issues, and clinical project design
Advised venture capital and other financial institutions on advisability of investment in early and late stage projects
Developed clinical programs for U.S regulatory approval as drugs and new claims for complementary medicines
Developed a novel KOL and advisory board program
Development of strategies for advertising review at NAD
Development plans for herbal actives to be approved as drugs in U.S.
Development of a new product for an oncology indication
A novel immunology product for Europe
Advertising and promotion review; development of challenges and responses
Sales force training
Medical monitoring of clinical protocols in multiple sclerosis and various malignancies
