Orphan Drug Development for Rare Diseases
v
About the Authors
Sundar Ramanan, PhD, MBA, is senior vice president of biotherapeutic strategic operations at Just-
Evotec 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 biopharmaceu-
tical 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, MPharm, 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 thera-
peutic 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.
Acknowledgments
RAPS and the authors thank Linda McBride, RPh, RAC, who volunteered her time to review and
provide valuable feedback on this first edition of this book. RAPS also thanks Eva A. Temkin, JD, for
crafting the Foreword.
v
About the Authors
Sundar Ramanan, PhD, MBA, is senior vice president of biotherapeutic strategic operations at Just-
Evotec 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 biopharmaceu-
tical 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, MPharm, 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 thera-
peutic 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.
Acknowledgments
RAPS and the authors thank Linda McBride, RPh, RAC, who volunteered her time to review and
provide valuable feedback on this first edition of this book. RAPS also thanks Eva A. Temkin, JD, for
crafting the Foreword.