Leadership

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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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