Dave Edwards, PhD

TODD J. LORENZ, MD


Dr. Lorenz is a board certified endocrinologist who comes to Kinexum from Portola Pharmaceuticals where he was Senior Vice President, Clinical Development and Scientific Licensing.  At Portola, he developed the Phase 3 clinical program for betrixaban and initiated the international APEX clinical trial as well as consulting on the in-house programs for the andexanet alfa (a Factor Xa inhibitor antidote) and the proprietary Syk-JAK inhibitor. Prior to that, he served as Chief Medical Officer at Catalyst Biosciences, where he led strategic development plans in the areas of coagulation and transplant immunology. He has also served as Vice President at Johnson & Johnson Pharmaceutical Research Division where he led the Natrecor program and pursued in-licensing efforts with the cardiovascular business development group. He has held other senior positions in the biotechnology industry, including Chief Medical Officer at both Orexigen Therapeutics and at Corgentech, and Vice President of Medical Affairs at COR Therapeutics, where he was responsible for the clinical program for Integrilin. Dr. Lorenz has co-authored numerous scientific publications in peer-reviewed journals including JAMA, The Lancet, the New England Journal of Medicine, Circulation, Arthritis and Rheumatism, the Journal of the American College of Cardiology the Journal of Vascular Surgery and the American Heart Journal. He holds a B.A. in chemistry from Case Western Reserve University and an M.D. from Case Western Reserve University, School of Medicine. In addition to his services to Kinexum, Dr. Lorenz is a clinical development consultant to the SPARK program at Stanford University that provides interim funding for faculty projects that are candidates for out-licensing.

Services provided by Dr. Lorenz include:

  • Development plans for all phases of clinical investigation from translational research through clinical phases 1-3 and post-marketing studies
  • Authorship and/or editorial review of all regulatory documents (e.g., IND, clinical protocols, New Drug Applications)
  • Strategy and preparation for communications and meetings with regulatory authorities (pre-IND, Types A-C and Advisory Panels)
  • Evaluation/preparation for in- and out-licensing activities including due diligence and communication with potential investors
  • Development of clinical trial materials (e.g., statistical analysis plans, case report forms)

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Leadership List

Officers

G. Alexander Fleming, MD
Founder and Executive Chairman

Thomas Seoh, J.D.
President and Chief Executive Officer

Brian Oscherwitz, MBA, PMP
Chief Operating Officer

 

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

John K. Whisnant, Jr, MD

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

Dia Hill

Frances Mielach, Ph.D, RP.h

Gabrielle Wiederkehr, MSc

Grant Williams, MD

Joshua Sharlin, Ph.D

Michael Sharp, Ph.D

Susan Manley, MS

 

Biostatistics

Alan Fisher, DrPH

 

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

 

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.

Virgil Whitehurst, Ph.D

 

CMC, Formulation/Process Development & Sourcing

Anand Khedkar, Ph.D

David Bergstrom, Ph.D

Jo Van Betsbrugge, PhD

Knut Zellerhoff, Ph.D

Robert Kaster, RPh., ASQ-CQA

 

Medical Device

Michael Sharp, 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

 

Defense & National Security Practice

Dean E.Calcagni, MD

 

Commercialization and Business & Corporate Strategy

Brian Oscherwitz, MBA, PMP

Lisa Jansa, MBA

Martin Lafontaine

Thomas Seoh, J.D.