Leadership

Richard Paul, MD

Dr. Richard Paul is an actively licensed Internal Medicine M.D. with more than two decades of experience in drug development, regulatory affairs and clinical research. He has worked as a practicing physician, a pharmaceutical company development executive and CRO executive.  Rich’s experience spans medical safety, clinical research, and regulatory strategy. In addition to his generalized drug development knowledge, Dr. Paul has experience in metabolic, hematology, oncology, CNS disease including Pain, Parkinson’s Disease and Alzheimer’s dementia, respectively.

 

Dr. Paul started his career after securing his Medical Degree with post graduate work at Albert Einstein College of Medicine, NY, Rutgers University’s Internal Medicine Residency program and a Fellowship tenure at Harvard Medical School/Joslin Diabetes Center.  Following the postgraduate work, Rich enjoyed private clinical practice treating adults and juveniles with diabetes and metabolic diseases for over 9 years before transitioning into pharmaceutical research with Pfizer.  He has also held executive leadership positions in clinical research, regulatory and medical safety departments with Ergo Science, Grünenthal USA, Shionogi USA and Schering Plough Corporation.   Notably, Dr. Paul was the founding Managing Director of Grünenthal USA, establishing the subsidiary for Grunenthal GmbH of Germany.

 

 

Through the course of his accomplished career, Rich has served many clients and employers in the areas of scientific and regulatory consultation.  Dr. Paul has multi-divisional FDA experience having represented and participated with a number of Biotech and Pharmaceutical sponsors supporting Investigational and New Drug Applications with the US FDA and other international regulatory agencies.  Further, Dr. Paul has led global regulatory groups for two CROs and one biotech organization.

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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