Knut Zellerhoff, Ph.D

Knut Zellerhoff, Ph.D

Knut Zellerhoff, Ph.D., is a professional with 35 years of experience in the Pharmaceutical Industry. Following scientific training in chemistry(Goettingen Univ.) initial tasks in the industry were devoted to synthesis and discovery of small molecules as potential candidates for drug development. He was promoted to the emerging area of project management in drug development and soon took over the combined responsibility for Project Management and Regulatory Affairs at Bayer AG, involving numerous newmolecular entities for the treatment of cardiovascular, infective,inflammatory and metabolic diseases in all stages of development. He led numerous project teams in transitioning projects from local to global development or co-development with partner companies. Beyond the territories of particular interest like Europe, Japan and North America he helped all countries involved in the global development process according to their specific needs in achieving clinical trial permissions and marketing approvals. He made significant contributions to the development of tools and global organization of Project Management and Regulatory Affairs, both within the company and in international organizations. In recent years areas of particular interest included small synthetic molecules, biotechnology and botanical products with focus on CMC strategies/plans, documentation and regulatory processes.  Dr. Zellerfhoff's last positions at Bayer AG were Head of Pharma Project Controlling and Bench marking and VP, Regulatory Affairs International/Global Regulatory.

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Leadership List

Officers

G. Alexander Fleming, MD
Executive Chairman

Thomas Seoh
President and Chief Executive Officer

Stephen Casey, MBA
Chief Operating Officer

 

Clinical Development

G. Alexander Fleming, MD

Brian E. Harvey, MD, Ph.D

Charles Alexander, MD

Giora Davidai, MD

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

Guenther Karmann, Ph.D

John K. Whisnant, Jr, MD

Michael Trautmann, MD

Peter Damsbo, MD

Richard Paul, MD

Rob Walsh, MD

Simon Bruce, MD

Theo Gana, MD, PhD

Todd J. Lorenz, MD

 

Regulatory Affairs

G. Alexander Fleming, MD

Asoke Mukherjee, Ph.D

Brian E. Harvey, MD, Ph.D

Christopher Kotsopulos, MS

Doug Muchmore, MD

Frances Mielach, Ph.D, RPh.

Gabrielle Wiederkehr, MSc

Joshua Sharlin, Ph.D

 

EU Regulatory

Michael Trautmann, MD

 

Clinical Operations/Project Management

Chris Yun

Diane Paul, MS, RN

Gabrielle Wiederkehr, MSc

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

Lynn Schaich

Susan Manley

 

Pre-Clinical

Asoke Mukherjee, Ph.D

Dave Edwards, Ph.D

Frances Mielach, Ph.D, RPh.

Joy Cavagnaro, Ph.D

Marijke Adams PharmD, Ph.D

Monalisa Chatterji,Ph.D

Virgil Whitehurst, Ph.D

 

CMC and Clinical Supplies Management

Knut Zellerhoff, Ph.D

Robert Kaster, Rph., ASQ-CQA

 

Medical Device

Christopher Kotsopulos, MS

Rob Walsh, MD

 

QA/QC

Christopher Kotsopulos, MS

Joshua Sharlin, Ph.D

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

Lynn Schaich

Robert Kaster, Rph., ASQ-CQA

 

Medical Writing/Regulatory Submissions

Marijke Adams PharmD, Ph.D

Peggy Hagerty

Russ Neubauer, Ph.D

Sandor Bernath, PhD, MBA

 

Process & Innovation management

Elizabeth Whalley Buono, BSN, RN, MBA, JD

 

Business Strategy & Management Support

Lisa Jansa, MBA

Stephen Casey, MBA

 

Founders

G. Alexander Fleming, MD

Lisa Jansa, MBA