Gary Musso, PhD

President at Musso and Associates LLC

Speaker

Dr. Musso is President of Musso and Associates LLC, a consulting company providing CMC regulatory, technical and compliance services. Dr. Musso received his Ph.D. in 1984 from the University of Chicago. He has worked for 40+ years in the biotech industry with major leadership roles in two approved oncology drugs; VP Operation at Proteolix/Onyx (Kyprolis®- multiple myeloma) and VP Development at Praecis (Plenaxis®- prostate cancer). He has also had significant contributions to the following approved products: Vyleesi®, Angiomax®, Tymlos®, and Trulance®. In 2005, Dr. Musso started Musso and Associates LLC and has worked with over 80 companies to support CMC regulatory and technical development programs and M&A activities. His scientific interests are in peptides, small molecule drugs, and sophisticated drug delivery systems. Assisting smaller organizations and research institutes with effective strategies and efficient drug development processes are the focus of his company's efforts. With respect to CMC regulatory, I have contributed major NDA CMC authorship to Vylessi®, Kyprolis® and Plenaxis®. Have assisted clients in strategy and authorship of over 100 global regulatory submissions including US IND, IND CMC amendments, Canadian CTAs and European and Asian IMPDs for small molecules, peptides and oligonucleotides. In addition, I have led CMC regulatory strategy and authorship for dozens of CMC End of Phase 2 FDA interactions and EU scientific advice meetings.