Subject: Compliance

Stephen R. Schwartz

Stephen R. Schwartz, is a consultant on claims support for Stephen Schwartz and Associates as well as the founder and former President and CEO of IRSI with over 50 years of experience in conducting claim support clinical trials. Mr. Schwartz has worked on some of the industry’s largest and most influential cosmetic launches over the… Continue reading Stephen R. Schwartz

Barry Friedman Ph.D

Barry A. Friedman, Ph.D., is a Senior Consultant in the Biotechnology, Regulatory Compliance, Microbiology and Aseptic Processing arena. From 2000 to 2007, Dr. Friedman was associated with Cambrex Bio Science Baltimore, a contract manufacturer of GMP bulk biopharmaceuticals located in Baltimore, MD. In that capacity as the Director, Quality Control, he managed a multi-shift Department… Continue reading Barry Friedman Ph.D

David Long

David Long worked for Rhône Poulenc Health Division (now Sanofi-Aventis) in Quality Assurance (QA) for over twenty years where he gained considerable experience in all three Good Practice disciplines, GLP, GCP and GMP. When he left Rhône-Poulenc he was Senior Director R&D worldwide for Quality and for Process Improvement. Mr. Long has since worked for… Continue reading David Long

Jennifer R. Martin

Jennifer R. Martin is Director of Regulatory Affairs  North America and Global Skin Health for the Colgate-Palmolive Company and a longtime regulatory affairs and product safety professional. She has more than 30 years of experience in analyzing legislation and regulation and applying it to assure product safety and compliance for cosmetics, drugs, medical devices, foods,… Continue reading Jennifer R. Martin

Lucia Mokres

Dr. Lucia Mokres is a Biotechnology Entrepreneurial Consultant based in the Bay Area, specializing in helping early stage companies with novel technology gain traction and develop an investable technology and business model, and helping later stage companies work through regulatory and clinical challenges. Prior to establishing her consultancy, she was the Chief Medical Officer of… Continue reading Lucia Mokres

Joseph A. Albanese, Ph.D.

Joe Albanese, Owner and Managing Director of Albanese Consulting LLC, which he formed after more than 29 years experience in the pharmaceutical industry. He recently retired from Janssen Pharmaceuticals (part of Johnson and Johnson) where he held positions in R&D, Supply Chain, and Quality in both Small Molecule and Biotherapeutics development and manufacturing. As part… Continue reading Joseph A. Albanese, Ph.D.

Burton A. Amernick

Burton A. Amernick is a Senior Partner in the law firm of Polsinelli LLC, a General Practice National AM LAW 100 law firm, where he specializes in patent and trademark causes. In 2020, US News and World Report in their Best Law Firm Listing ranked Polsinelli LLC in Tier One for Patent Law. He was… Continue reading Burton A. Amernick

Michael Barile

Mr. Barile has over thirty-five years of experience in the medical device, pharmaceutical, human tissue and biotechnology industries. He has held the executive quality assurance position in both start-up and large multi-national corporations, specializing in difficult turnaround situations. His depth of experience in both line and corporate management has given Mr. Barile a unique and… Continue reading Michael Barile

Frank Carroll

Frank Carroll is Director of Supply Chain and Facilities for Zosano Pharma/ZP Group LLC in Fremont CA. He has over 25 years of experience in the Pharmaceutical, Device, Biologics and Biotech industries in many aspects of operations including manufacturing, purchasing, materials management, strategic alliance management, implementation of advanced project management and MRP/ERP systems and senior… Continue reading Frank Carroll

David L. Chesney

David L. Chesney is the Principal and General Manager of DL Chesney Consulting, LLC, Cumberland Foreside, Maine. He founded the company in 2016 following 23 years with the FDA and 21 years as Vice President of Strategic Compliance Consulting Services for a major US-based CRO. He began performing GCP inspections for the FDA as early… Continue reading David L. Chesney