Frances Mielach, Ph.D, RP.h

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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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