Advancing Pharmaceutical Development, Manufacturing, QbD, Regulatory CMC
After completing 20 years in Pharmaceutical Industry in USA, in 2009, Ram Nyshadham founded Advanceutics, Inc., a consulting company to advance CMC and Pharmaceutical Development needs for small molecule drug development programs. He is actively consulting with numerous publicly traded and privately held Biotech, Pharmaceutical, and CDMO companies based in San Francisco bay area and Europe in the broad area of Pharmaceutical Product Development and Manufacturing.
Prior to consulting, Ram was an Executive Director of Pharmaceutical Development at CV Therapeutics where he was an architect for building integrated CMC development (API, Analytical, Drug Product, and Packaging) and provided CMC leadership for approval of 2 NCE products and numerous programs from late stage discovery to phase I. He managed an annual budget of $3-4M, 3-4 directors, and 12-16 staff members. Prior to CVT, Ram worked at Forest labs and Yamanouchi.
He has an overall track record of more than 10 products to market from different stages of development. He represented his companies at meetings with FDA in Rockville, MD, served as SME for successful PAIs by US FDA and EMEA. He has extensive experience in managing CMOs, successfully negotiated more than 15 R&D agreements, commercial supply, and co led quality agreements. He has written a book chapter on "Process Development and Scale-Up of Oral Fast-Dissolving Tablets" in a book titled "Drug Delivery to the Oral Cavity" (Publishers: CRC Press), review articles in drug delivery, 5 issued patents and few patent applications in review. He has led and moderated numerous round table and panel discussions at AAPS (national and local bay area chapter) and presented more than 25 presentations in various forums. He also serves as adjunct faculty at Dept of Pharmaceutics and Medicinal Chemistry at University of Pacific, Stockton, CA.
Professional Carrer History