Partha Roy, Vice President, Technical, PAREXEL Consulting
Partha draws on over 17 years of drug development experience including 5+ years of review experience at FDA with proven expertise in Clinical Pharmacology and Regulatory Sciences across multiple therapeutic areas encompassing both small molecules and biologics. Besides new drugs and novel biologics, Partha has specific review and development expertise in Inhalation and Nasal Products, Biosimilars, Complex Generics and OTC drug products. Over the last 5 years at PAREXEL, Partha has been providing strategic guidance on various clinical and regulatory aspects around Biosimilar Development, 505(b)(2) and 505(j) pathways, dose selection, PK and PK/PD, biomarkers, clinical trial design, and pediatric plan. Partha led the Regulatory team that is instrumental in securing FDA approval for Inflectra, the first monoclonal biosimilar approved in the US.
At PAREXEL, Partha line manages US Principal Consultants with responsibility for leading thought leadership based activities that highlight PAREXEL Consulting to industry decision makers and align with PAREXEL Consulting business and strategic objectives and marketing priorities. At FDA, Partha supported the Division of Pulmonary, Allergy and Rheumatology Products and the Offi ce of Non-Prescription Products as Clinical Pharmacology Senior Reviewer and Team Leader. Prior to joining FDA, Partha worked in the pharma industry (CRO, brand and generic manufacturer) for 7 years and supported early clinical development as a PK/PD expert.