Atul is a physician with over 18 years’ experience in Clinical Research, Drug Development, and clinical practice, after getting education from top medical schools of India. Atul joined Navitas in February 2021, and prior to that he has worked with leading organizations like Ranbaxy, Panacea Biotec, Max Neeman International and Apcer Life Sciences. Atul has rich leadership experience in providing end to end scientific guidance in drug development (Phase 1-IV) across multiple therapeutic area portfolios, in diverse regulatory environments including FDA, EMA, MHRA, ANVISA and DCGI. Atul has been extensively involved in defending clinical strategy proposals with respect to scientific rationale, timelines and budget with senior executives. He has worked as Global Medical Lead (USA, Europe and Asia Pacific) in more than 50 studies across the continents for both drugs and devices. Atul has been involved extensively in developing complex innovative trial designs for complex protocols reducing the huge costs and time associated with standard clinical randomized controlled trials.
Apart from being a medical lead, atul has multifaceted experience in diverse clinical research domains including medical writing (Protocol, IB, CSR, eCTD etc), medico-regulatory (IND, NDA, BLA), drug safety and operations. Atul has been actively involved in multiple DSMBs and SRCs. He has been involved in negotiating clinical plans with FDA during pre-IND and type C meetings. He has been the part of successful marketing authorization approval of breakthrough therapies including PD-1 inhibitors, V2 antagonist, multiple biosimilars, vaccines and several repurposed therapies (for MDD, narcolepsy, psoriasis)