Regulatory Professional-Rare disease
Novo Nordisk
Sunny Kamlesh Dave, MPharm, is a global regulatory affairs professional, rare disease at Novo Nordisk. He has expertise in novel (NCEs/NBEs) and biosimilar drug development. He was previously an assistant manager with Biocon Biologics, where he gained expertise in regulatory strategies from
early drug development through approval and lifecycle management for monoclonal antibodies, fusion mAbs, and oral insulin in targeted therapeutic areas including rare and life-threatening diseases. He was also responsible for evaluating expedited pathways, such as priority medicines and orphan drug, breakthrough, and fast track designations. Dave also led the regulatory intelligence and policy function, engaging with internal and external
stakeholders for policy evaluation, including a successful effort to waive a pivotal clinical trial requirement for insulin biosimilar products. He has been an invited speaker at the National Institute of Pharmaceutical Education and Research, India, and is an accomplished author for internationally recognized publications. Dave has a master of pharmacy degree in pharmacology from Manipal University, India.
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Sunday, September 11, 2022
8:30 AM – 4:00 PM MST