John K. Whisnant, Jr, MD

Elizabeth Whalley Buono, BSN, RN, MBA, JD

Elizabeth Whalley Buono, BSN, RN, MBA, JD Liz brings over 25 years of life science experience in legal, regulatory, operational and executive roles in drug, device, clinical research and healthcare packaging companies. After successful careers in clinical nursing and big pharma, Liz obtained a JD in Health Law and Economics and practiced Food & Drug, Fraud & Abuse, Insurance and Privacy law at Wiley, Rein LLP in DC. Transitioning in-house to Altria Client Services, Liz managed the legal and health ethics considerations associated with tobacco harm reduction clinical research and new product development. As V.P., Global Quality, Regulatory and External Affairs at WestRock, Liz focused her business and legal acumen into a dual law and executive role with jurisdiction over global healthcare regulatory and legal support for the company’s healthcare innovation work. At Westrock, Liz was integral in creating an innovative manufacturer to retail supply chain model for Walmart, permitting introduction of the first US $5.00 generic drug program and the first retail-branded adherence program. Additionally, she worked with CVS to pilot hardware and software designed to dispense personalized co-mingled co-packaged daily medication. Liz’s consulting practice is focused on healthcare innovation and new product development where she can utilize her skills in Regulatory & Compliance Analysis, Novel Technology Navigation, and Differential Disease Management. Liz holds a JD in Health Law and Economics from the George Mason University as well as an MBA from St. John’s University and a BSN/RN from Boston College School of Nursing.

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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

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

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