Ramachandra (Ram) G. Naik, MD

Ramachandra (Ram) G. Naik, M.D.

 

Ramachandra G. Naik, MD

 

Ramachandra (Ram) G. Naik, MD, brings three decades of global institutional experience in patient care and clinical research, in both academic- and private-practice settings, and in drug and device development and medical affairs in the biopharmaceutical industry, with demonstrated clinical, strategic business, and executive leadership skills. He is currently a Professor of Medicine in the Division of Endocrinology, Diabetes, and Metabolism and an Assistant Dean at SUNY Upstate Medical University, Syracuse, NY, and is actively engaged in patient care, clinical research, and administrative activities.

 

Dr. Naik spent more than a decade of his professional career in private practice in Mumbai, India, as a Senior Consultant Endocrinologist at Bombay Hospital. He relocated to the United States in 2007 to join as an Assistant Professor of Medicine and Pediatrics at Barbara Davis Center for Childhood Diabetes at the University of Colorado Denver, where he was involved in patient care and clinical research activities in T1D; he was an investigator in several phase 2/3 clinical trials in the areas of immune interventions in T1D, insulin pumps, continuous glucose monitoring, and newer devices of insulin administration.

 

Dr. Naik transitioned into biopharmaceutical industry in 2009, and since then, has handled roles of progressively increasing responsibilities spanning all phases of clinical development and device development. Initially, as a Director in Global Cardiovascular Metabolism Franchise at Novartis Pharmaceuticals Corporation, he provided clinical leadership to late-stage development programs in diabetes and lipid disorders, was involved in business development and licensing activities, and worked closely with the translational medicine team on early development projects. He drove the initiative of establishing the Novartis “Metabolism Center of Excellence” in Hyderabad, India. Later, as a Therapeutic Area Clinical Director at Merck Research Laboratories, Dr. Naik provided strategic clinical leadership to multiple, global development programs from proof-of-concept through phase 3 registrational studies in diabetes and reproductive endocrinology. He was a core member of the Joint Development Committees of the co-development programs involving external partners (Pfizer and Samsung Bioepis). Subsequently, Dr. Naik worked at Johnson & Johnson Diabetes Care Companiesas the Senior Medical Director of Worldwide Clinical Affairs,with a focus on businesses across three distinct J&J companies providing direct leadership to insulin delivery platform (hybrid closed-loop insulin delivery program and patch insulin delivery system). In addition to providing strategic leadership to regulatory clinical studies for class II and class III devices, he designed and executed real world evidence generation studies, and provided clinical leadership for payer interactions, including value-based contracting, clinical support to digital platform, and franchise medical affairs leadership in the Asia-Pacific region. While pursuing his industry career, Dr. Naik held an academic appointment as an Adjunct Associate Professor at the University of Pennsylvania, and continued to maintain limited patient care activites.

 

Dr. Naik has been an active member of several professional societies, including the ADA and the Endocrine Society. He has served on the Research Grant Review Committee of the ADA. He was a recipient of 2014 Global Corporate Award in “Healthcare and Global Impact.” Dr. Naik has published in the area of autoimmune diabetes, has authored chapters in international textbooks on diabetes (including “Ellenberg & Rifkin's Diabetes Mellitus,” 6th ed., and “Therapy for Diabetes Mellitus and Related Disorders,” 5th ed., American Diabetes Association), and has given invited talks at national and international meetings. He was on the Advisory Boards of several pharmaceutical companies in India and the US prior to joining the biopharmaceutical industry.

 

Dr. Naik completed his post-doctoral training in endocrinology, initially, at All India Institute of Medical Sciences, New Delhi, India, and later, at the University of Washington, Seattle, WA. He was a receipient of the Juvenile Diabetes Research Foundation Postdoctoral Fellowship Award at the University of Washington. Later, Dr. Naik also pursued an executive business education from Kellogg School of Management, Northwestern University, Evanston, IL.

Experts

Clinical Development

G. Alexander Fleming, MD

Arthur Santora, MD, Ph.D

Brian E. Harvey, MD, Ph.D

Charles Alexander, MD

Doug Muchmore, MD

Giora Davidai, MD

Gordon B. Cutler, Jr., M.D.

Grant Williams, MD

Guenther Karmann, Ph.D

John K. Whisnant, Jr, MD

Michael Trautmann, MD

Mustafa A. Noor, MD, FACP

Peter Damsbo, MD

Ramachandra (Ram) G. Naik, M.D.

Simon Bruce, MD

Theo Gana, MD, Ph.D

Todd J. Lorenz, MD

Regulatory Strategy and Operations

G. Alexander Fleming, MD

Arthur Santora, MD, Ph.D

Asoke Mukherjee, Ph.D

Brian E. Harvey, MD, Ph.D

Catherine Bernard, Ph.D

David Reinhold Brill, Ph.D

Dia Hill

Frances Mielach, Ph.D, RP.h

Gabrielle Wiederkehr, MSc

Grant Williams, MD

Joshua Sharlin, Ph.D

Michael Sharp, Ph.D

Susan Manley, MS

 Biostatistics

Alan Fisher, DrPH

EU Regulatory

Catherine Bernard, Ph.D

Gabrielle Wiederkehr, MSc

Michael Trautmann, MD

Clinical Operations/Project Management

Brian Oscherwitz, MBA, PMP

Chris Yun, B.S.

Gabrielle Wiederkehr, MSc

Julie Waltz Gerlach, B.S.N., M.P.H., R.A.C.

Susan Manley, MS

Pre-Clinical

Asoke Mukherjee, Ph.D

Dave Edwards, Ph.D

Frances Mielach, Ph.D, RP.h

Joy Cavagnaro, Ph.D

Michael B. Zemel, Ph.D.

Virgil Whitehurst, Ph.D

CMC, Formulation/Process Development & Sourcing

Anand Khedkar, Ph.D

David Bergstrom, Ph.D

Jo Van Betsbrugge, PhD

Knut Zellerhoff, Ph.D

Robert Kaster, RPh., ASQ-CQA

Medical Device

Michael Sharp, Ph.D 

QA/QC

Brian Oscherwitz, MBA, PMP

Jennifer Zhao, B.S.

 Medical Writing/Electronic Submissions

Jennifer Zhao, B.S.

Kristi Hultberg, B.S.

Sandor Bernath, Ph.D, MBA

Botanicals

Jinhui Dou, Ph.D.

Government Relations and Public Affairs

Scot Faulkner, MPA

Defense & National Security Practice

Dean E.Calcagni, MD

Commercialization and Business & Corporate Strategy

Brian Oscherwitz, MBA, PMP

Lisa Jansa, MBA

Martin Lafontaine

Thomas Seoh, J.D.