StuartLeeMarcusMDPh.D.

Summary

• As only the second DUSA senior staff member hired in 1993, reporting to CEO, was responsible for all R&D processes, including clinical and preclinical development, regulatory affairs and CMC oversight. Assembled a team of in-house clinical research staff, and maintained preclinical, device development, and regulatory affairs using outside consultants. The team initiated a series of Phase I/II clinical trials testing the safety and efficacy of Levulan® (aminolevulinic acid HCl) topical photodynamic therapy (PDT) for the treatment of different dermatologic indications including psoriasis, actinic keratosis (AK), and superficial basal cell carcinoma. In early 1994 we chose the AK indication as the most direct means to marketing approval. Drug development (a proprietary Kerastick® applicator) and device development (a U-shaped blue light illuminator to treat lesions of the whole face or scalp at once, the BLU-U®) proceeded in parallel. After drug- and light-dose ranging Phase II trials, were completed, my team and I prepared the package for the end-of-Phase II meeting and presented it to the Dermatology Division, which included members of CDRH and CDER. Phase III trials began in 1997, and my team and I prepared the NDA/PMA combination package which was filed in 1998. NDA approval was awarded in 1999. The PMA for the commercial light source was approved in 2000. There were no clinical, preclinical, or device issues which were raised by the FDA during the approval process. Was responsible for and participated in presentations at DODAC Advisory Committee meeting held despite DUSA’s having received an “approvable” letter, presumably since it was the first time PDT was to be approved in Dermatology. Brought Regulatory Affairs in-house. In 2003 created office of Medical Affairs and became Chief Medical Officer while continuing other duties. In 2012 DUSA was purchased by Sun Pharmaceuticals and in 2016 I dropped the CMO function.