Joy Cavagnaro, PhD

Robert Kaster

 

Robert Kaster brings more than 30 years of pharmaceutical/biopharma experience from both small and large organizations (including Wyeth and DuPont Pharma) and has been consulting since 2007.  He holds a B.S. in Pharmacy from the Philadelphia College of Pharmacy and Science (University of the Sciences in Philadelphia) and is a registered pharmacist.  Rob is also an American Society for Quality (ASQ) Certified Quality Auditor (CQA).   His background includes CMC Regulatory Affairs, CMC drug product formulation development/manufacturing and GXP Quality Assurance.  Strengths include CMC regulatory submission compilation (US/ex-US) and CMC FDA strategy/meetings as well as CMC product/process development/validation clinical through commercial manufacturing.  His Quality experience includes QA/Compliance program development/oversight, extensive auditing (facility-Pharma and CMO/CRO, documents, regulatory submissions, PAI-readiness), generation of SOPs, protocols, validations, CAPA assessment and quality agreements.  Rob has successfully worked with numerous multi-disciplinary teams, project lead on many occasions with a focus on client’s needs and deliverables.

 

 

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.