Catherine Bernard, Ph.D

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

Julie has over 30 years of experience in basic sciences and clinical research with both academic and the pharmaceutical industry.  She has an extensive background in Institutional Review Board activities with both the University of Cincinnati IRB as the IRB Director and Chair for the Social and Behavioral IRB.  She has worked with Schulman IRB.  She has worked with both industry, academics and government agencies to train and guide research investigators on Good Clinical Practice in pharmaceuticals, medical devices and human participant protections.

 

Julie received both her undergraduate degrees in microbiology and nursing from the University of Florida.  She received her Master’s degree in Public Health from the University of South Florida in epidemiology and biostatistics.   Her epidemiology coursework continued at the Johns Hopkins School of Public Health.  She received her Regulatory Affairs Certification (RAC) in 2015.  Julie is a member of Regulatory Affairs Professional Society (RAPS), Drug Information Association (DIA), Public Responsibility in Medical Research (PRIM&R), Association for Clinical Research Professionals (ACRP) and has remained a member of the Greater Cincinnati Health Council Consortium of Institutional Review Boards since 2009.  

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, Ph.D

Brian E. Harvey, MD, Ph.D

Charles Alexander, 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

Peter Damsbo, MD

Richard Paul, MD

Rob Walsh, MD

Simon Bruce, MD

Theo Gana, MD, Ph.D

Todd J. Lorenz, MD

 

Regulatory Affairs

G. Alexander Fleming, MD

Arthur Santora, MD, Ph.D

Asoke Mukherjee, Ph.D

Brian E. Harvey, MD, Ph.D

Catherine Bernard, Ph.D

Christopher Kotsopulos, MS

Dia Hill

Doug Muchmore, MD

Frances Mielach, Ph.D, RP.h

Gabrielle Wiederkehr, MSc

Grant Williams, MD

Joshua Sharlin, Ph.D

Michael Sharp, 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

David Bergstrom, Ph.D

Knut Zellerhoff, Ph.D

Robert Kaster, RPh., ASQ-CQA

 

Medical Device

Michael Sharp, Ph.D

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, Ph.D, MBA

 

Process & Innovation management

Elizabeth Whalley Buono, BSN, RN, MBA, JD

Scot Faulkner, MPA

 

Formulation Development

David Bergstrom, Ph.D

 

Business Strategy & Management Support

Stephen Casey, MBA

Lisa Jansa, MBA

Martin Lafontaine

 

Founders

G. Alexander Fleming, MD

Lisa Jansa, MBA