Who We Are
Vikas Moolchandani, PhD
Vice President of CMC and Product Development
Dr. Moolchandani serves as Executive Vice President for CMC & Product
Development at Oncovir, Inc since May 2022. He is a highly motivated biotech
leader with over 15 years of industry and FDA experience in large and small
molecule research and development. As an ex-FDA regulator, he has unique
experience and understanding of global regulatory CMC requirements from clinical
development to commercialization of biologics and small molecules. Prior to
joining Oncovir Inc. Dr Moolchandani worked at US FDA in the capacity of Sr.
CMC Reviewer for seven years where he performed CMC reviews of regulatory
submissions, including 505 (b) (1) (2) NDAs, 505(j) ANDAs, BLAs, INDs,
pre-INDs, pre-ANDAs, supplements and amendments of variety of dosage forms. In
that role, he collaborated with the Office of regulatory affairs (ORA) to
conduct onsite and virtual Pre-Approval Inspections of drug manufacturing and
release testing facilities.
Prior to FDA, he worked at Nutrilite Health Institute as a Principal Scientist in the areas
of product and process development for variety of solid oral dosage forms. His
previous responsibilities and experience include formulation and process
engineering at Ostuka Pharmaceuticals health products, at Genzyme (Sanofi) for
next generation advanced phosphate binder Renvela® and at Enanta
Pharmaceuticals for preclinical evaluation of next generation macrolides for
respiratory infections.
Dr. Moolchandani received his Ph.D. in Pharmaceutical Science from University of
Maryland, Baltimore, M.S. in Clinical Sciences from University of
Massachusetts, and B.S. degree in Pharmacy from the state university of Bhopal,
India. He has collectively published more than 30 research
papers and presentations and has co‐authored three book
chapters.