Knut Zellerhoff, Ph.D

Michael Trautmann, MD

Michael Trautmann has over 25 years of biopharmaceutical industry experience and has been a consultant since 2012. He studied medicine at the Universities of Goettingen and Marburg, Germany and Geneva, Switzerland. His PostDoc at the Institute of Clinical Biochemistry and Experimental Diabetology at the University of Geneva (under Claes Wollheim and Albert Renold) was supported by the German National Research Fund (DFG). His clinical training in Internal Medicine and Gastroenterology in the Department of Internal Medicine, University Hospital Marburg, Germany (Head: Rudolph Arnold) focused on Diabetes and the Endocrine Gut. 1993-2012 he worked at Eli Lilly in Germany and mostly in global functions in Indianapolis, IN, USA. He was involved in clinical development programs in all stages from preclinical to Phase IV. His involvement included insulin developments (including Lispro insulin), obesity drugs (including leptin), and GLP-1 receptor agonists (including exenatide in the Lilly-Amylin alliance) resulting in 4 global drug approvals and numerous publications. Proven strengths include IND/NDA compilation and management (including EU submissions and Japan), protocol design and development, study report generation. Excellent interpersonal and communication skills with the ability to lead teams to achieve objectives successfully.

 

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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

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

Frances Mielach, Ph.D, RP.h

Gabrielle Wiederkehr, MSc

Grant Williams, MD

Susan Manley, MS

Biostatistics

Alan Fisher, DrPH

Regulatory Science & Innovation; Biomedical Advanced R&D

Carol Linden, PhD

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

Health Policy Development

Steven Grossman, JD

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.

CMC, Formulation/Process Development & Sourcing

David Bergstrom, Ph.D

Jo Van Betsbrugge, PhD

Knut Zellerhoff, Ph.D

Medical Device

Eric Kolb

Melissa Thompson

Paul Goode, 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

Steven Grossman, JD

Defense & National Security Practice

Dean E.Calcagni, MD

Steven Grossman, JD

Commercialization and Business & Corporate Strategy

Brian Oscherwitz, MBA, PMP

Lisa Jansa, MBA

Martin Lafontaine

Thomas Seoh, J.D.

Kinexum Associates

Elijah Abass

Brontë Jenkins