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
Founder and Executive Chairman

Thomas Seoh, J.D.
President and Chief Executive Officer

Brian Oscherwitz, MBA, PMP
Chief Operating Officer

 

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, B.S.

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.