Leadership

THEO GANA, MD, PhD

Dr. Gana has over 19 years of management and hands-on operational experience in clinical research and development in the biopharmaceutical industry layered on a firm regulatory background.  Prior to his industry experience, Theo conducted clinical and laboratory research in academia for over 12 years.  His unique biopharma background/experience spans the entire new drug development process including the clinical trial process (Phases I – IV; clinical operations; and medical monitoring), animal toxicology and pharmacology testing.  He has successfully taken several drug products through development to approval for marketing in the USA (INDs & NDAs)

 

Theo has been a consultant to companies in the biopharmaceutical industry in the USA and Canada since 2004.  Prior to this, he was at Biovail Corporation (now Valeant Pharmaceutical International) where he set up and directed the Clinical Development Department as Director and Senior Director.  Prior to that, he was Clinical Study Director at Isoclinika, Inc., a subsidiary of Isotechnika, Edmonton, AB, Canada. In academia, Theo was Research Associate & Data Coordinator at the Department of Surgery, University of Toronto & Division of General Surgery, St. Michael’s Hospital, Toronto.  Theo was also an International Research Fellow at the Department of Surgery, SMRI, University of Alberta, where he concurrently received his PhD in Experimental Surgery.  He received his MD (MBBS) degree from Ahmadu Bello University, Zaria, Nigeria. 

 

 

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Leadership List

Officers

G. Alexander Fleming, MD
Executive Chairman

Thomas Seoh
President and Chief Executive 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

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

David Reinhold Brill, Ph.D

Dia Hill

Doug Muchmore, MD

Frances Mielach, Ph.D, RP.h

Gabrielle Wiederkehr, MSc

Grant Williams, MD

Joshua Sharlin, Ph.D

Joyce Reyes

Lana Pauls, MPH

Michael Sharp, Ph.D

Scot Faulkner, MPA

 

EU Regulatory

Catherine Bernard, Ph.D

Michael Trautmann, MD

 

Clinical Operations/Project Management

Chris Yun

Gabrielle Wiederkehr, MSc

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

Lana Pauls, MPH

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, Formulation/Process Development & Sourcing

Anand Khedkar, Ph.D

David Bergstrom, Ph.D

Joyce Reyes

Knut Zellerhoff, Ph.D

Robert Kaster, RPh., ASQ-CQA

 

Medical Device

Michael Sharp, Ph.D

Rob Walsh, MD

 

 QA/QC

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/Electronic Submissions

Brandon Jones

Dahlia Sperling

Russ Neubauer, Ph.D

Sandor Bernath, Ph.D, MBA

 

Process & Innovation Management

Elizabeth Whalley Buono, BSN, RN, MBA, JD

Scot Faulkner, MPA

 

Defense & National Security Practice

Dean E.Calcagni, MD

 

Commercializing and Business & Corporate Strategy

Lisa Jansa, MBA

Martin Lafontaine

Stephen Casey, MBA

Thomas Seoh

 

Kinexum Associate

Jennifer Zhao

 

Founders

G. Alexander Fleming, MD

Lisa Jansa, MBA