Joy Cavagnaro, 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
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

Brian Oscherwitz, MBA, PMP

Chris Yun

Gabrielle Wiederkehr, MSc

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

Lana Pauls, MPH

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

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