Leadership

Michael Sharp, Ph.D

Dr. S. Michael Sharp has over four decades of experience as a Regulatory Affairs and Clinical Research Executive.  He began his career in clinical research at Sandoz (now Novartis) in oncology and endocrine clinical development.  Upon FDA’s implementation of the Medical Device Amendment to the FDC Act in 1976, he moved to the medical device arena, and has held senior management positions with a number of device companies, including Vision Laboratories, VISX, Intelligent Surgical Lasers, AAI Phama, Conformis, and Angiodynamics.  He began his consulting practice in 2012 advising medical device companies on regulatory strategy and assisting in the entire regulatory approval process. He also provides advice and assistance to companies with regulatory compliance issues, such as Form 483 and Warning Letter responses.

Michael holds a Ph.D. in Management and is a diplomat of the “Advanced Program for Pharmaceutical Executives” from Dartmouth College’s Tuck School of Business. In supporting early and development stage companies, his approach is to be both a consultant on regulatory and clinical development and an adviser to management team on corporate strategy as whole, not just the functional silo of regulatory matters. Over the span of his career, Michael has successfully managed the regulatory and clinical development of a number of unique medical devices, including the first fully-automated microscopic system for FISH, first patient-unique knee replacement system, and the first excimer laser for corneal ablation refractive surgery.

Michael has also worked in academic medicine, including as Assistant Professor of Oncology, Director of Clinical Research and Chief Regulatory Officer for the Winship Cancer Center at Emory University.  His expertise has been recognized with his election as a Fellow of the Regulatory Professionals Society in the first class of Fellows and election a Fellow of the American Society for Laser Medicine and Surgery.  He has been the Editor-In-Chief of Clinical and Medical Case Reports.

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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.