Knut Zellerhoff, Ph.D

Russ Neubauer Ph.D

Dr. Neubauer has over 35 years of experience in the areas of oncology, infectious diseases, women’s health, hematology, immunology, vaccines, virology, and toxicology. He has over 25 years’ experience in the pharmaceutical industry and has led productive teams of as many as 20 individuals. Dr. Neubauer has participated in the creation and implementation of product development strategies and had responsibility for the preparation and approval of documents and reports intended for submission to US and foreign regulatory agencies. These documents include product labels; NDA, BLA, and European dossier submissions; responses to questions from regulatory agencies; Corporate Direction Circulars; IND submissions; IND annual reports; clinical study reports; Investigator’s Brochures; preclinical research reports; and toxicology study reports. He has served on committees for national and regional scientific associations, authored 74 publications, 89 presentations, and 5 patents.

By effectively combining leadership, expertise, and knowledge of corporate and regulatory requirements Dr. Neubauer is able to achieve project goals. Communication and interpersonal skills, demonstrating initiative, flexibility, and innovation help him to effectively manage resources, programs, and projects for clients. He believes the best project results derive from the efforts of an interactive team and a desire for continuous improvement.

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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

Arthur Santora, MD, PhD

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

Arthur Santora, MD, PhD

Asoke Mukherjee, Ph.D

Brian E. Harvey, MD, Ph.D

Catherine Bernard, Ph.D

Christopher Kotsopulos, MS

Doug Muchmore, MD

Frances Mielach, Ph.D, RP.h

Gabrielle Wiederkehr, MSc

Joshua Sharlin, Ph.D

Scot Faulkner, MPA

 

EU Regulatory

Catherine Bernard, Ph.D

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, RP.h

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

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

Dahlia Sperling

Russ Neubauer, Ph.D

Sandor Bernath, PhD, MBA

 

Process & Innovation management

Elizabeth Whalley Buono, BSN, RN, MBA, JD

Scot Faulkner, MPA

 

Business Strategy & Management Support

Stephen Casey, MBA

Lisa Jansa, MBA

Martin Lafontaine

 

Founders

G. Alexander Fleming, MD

Lisa Jansa, MBA