Lynn Schaich

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

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

Christopher Kotsopulos, MS

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

Marijke Adams PharmD, Ph.D

Peggy Hagerty

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