Meet the Authors: Orphan Drug Development for Rare Diseases

Sundar Ramanan, PhD, MBA  is senior vice president of biotherapeutic strategic operations at JustEvotec Biologics. With more than 20 years of experience in the biotechnology industry, he is a seasoned executive with broad expertise across biopharmaceutical drug development, operations, clinical and commercial strategy, policy, and regulatory affairs. Before joining Just-Evotec, he was the vice president
and head of global regulatory affairs at Biocon Biologics, where he engaged with key stakeholders to advance industry-shaping policy, resulting in the Phase 3 waiver for insulin biosimilars. He also led teams in obtaining the first US FDA approval for an interchangeable biosimilar. Before Biocon, Ramanan worked at Amgen, where he was responsible for international regulatory strategy and policy for biologics and biosimilars. He has led teams in the successful development and approvals of several biopharmaceutical drug candidates, from the early stages through commercialization and lifecycle management across multiple therapeutic areas, including oncology, hematology, inflammation, metabolic disorders, general medicine, and rare diseases. Ramanan received a PhD in bioengineering from Oregon State University and an MBA from the University of Michigan.

Sunny Kamlesh Dave is a global regulatory affairs professional at Novo Nordisk. He has expertise in novel 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.