PharmaLink 2022 Committee
The PharmaLink Strategic Committee is made up of the following FDA officials and industry experts who provide strategic guidance and insight to topics and trends that inform the PharmaLink agenda each year.
Grace
Breen
Grace Breen brings 30+ years of pharmaceutical expertise, formerly serving as Head of Quality at SCA Pharma and holding global leadership roles at Impax, Hospira, and Catalent. She led quality transformations and compliance strategies across various pharmaceutical forms. She holds chemistry degrees from Irish universities and is qualified as an EU QP.
Jennifer
Brown
Jennifer L. Brown directs Global Chemistry, Manufacturing & Controls within Regulatory Affairs at Pfizer, managing CMC strategy for investigational and commercial products. Her 20+ year Pfizer career spans Analytical R&D and GCMC. She holds degrees from Muhlenberg College and Temple University, and served as Peace Corps volunteer in Gabon and Pfizer Global Health Fellow in Kenya.
Brent
Conatser
Brent Conatser oversees global regulatory surveillance at Elanco for animal health GxP requirements. His 30+ year career includes leadership roles in compliance at Pfizer and Janssen, and service as FDA Investigator and Compliance Officer. At Elanco, he manages regulatory impact analysis and collaboration with Quality and Regulatory Leaders. He holds a biology degree from University of Tennessee.
Machelle
Eppler
Lindsey
Fleischman
Ashley
Goldberg-Nee
Rachel
Jenkins
Connie
Langer
Connie Langer serves as Director at Pfizer Global Product Development, managing CMC regulatory strategies since joining in 1998. Initially a scientist studying drug metabolism, she now oversees regulatory submissions and product maintenance. She co-chairs ICH Q12 working group and holds degrees in chemical engineering and oceanography from UConn, plus a drug development certificate from Temple University.
David
Lowndes
David leads DL Advisors LLC, providing strategic and acquisition guidance while serving as Independent Director for SK Pharmteco and Yposkesi. With 37+ years in pharmaceuticals and biotech, he previously held SVP roles at Shire Pharmaceuticals managing global supply chain and manufacturing. He holds a Pharmacy degree from Welsh School of Pharmacy, Cardiff University.
Chris
Markus
Chris Markus serves as partner and Deputy Practice Group Leader in FDA and Life Sciences practice, specializing in drug and biotech regulation. She advises clients on regulatory strategy, compliance, and enforcement matters with FDA, DEA, and state agencies. Her expertise includes business transactions involving product development, safety, manufacturing, and supply chain management.
Jeffrey
Meng
CDR Jeffrey Meng directs FDA’s Division of Pharmaceutical Quality Operations III, leading 70+ staff in facility inspections and compliance across the Midwest and internationally. Since joining FDA in 2009, he’s served as Investigator, Drug Specialist, and Branch Director, with rotations in FDA’s China Office and Center for Drug Evaluation and Research.
Steve
Niedelman
Steve Niedelman advises on FDA regulatory and enforcement matters, following 34 years at FDA where he served as Deputy Associate Commissioner for Regulatory Affairs and COO of Office of Regulatory Affairs. He previously held positions as executive VP at Quintiles Consulting and senior consultant at Crowell & Moring LLP. At FDA, he oversaw regulatory operations and served on key industry committees.
Brandon
Persinger
Brandon Persinger serves as head of Corporate Quality Compliance at Perrigo Company, bringing 20+ years of pharmaceutical and biopharmaceutical experience. He oversees internal audit, regulatory enforcement, compliance risk management, and Consumer Affairs, following roles at Pfizer and Amgen. He holds a chemical engineering degree from the University of Michigan.
Regina
Shipman
Regina Shipman serves as Global Director of Quality Systems, Compliance & Governance at Procter & Gamble, bringing 20+ years of GxP experience from roles at Johnson & Johnson, Novartis, and Greer Laboratories. Her expertise spans pharmaceutical, device, biological, and consumer health sectors, specializing in quality management and compliance. She holds a master’s in Quality Assurance and Regulatory Affairs and actively serves on Cincinnati community boards.
John
Taylor
John Taylor serves as President and Principal of Compliance and Regulatory Affairs at Greenleaf Health, following 20+ years at FDA. He held senior FDA positions including Counselor to the Commissioner and Acting Deputy Commissioner for Global Regulatory Operations and Policy, overseeing 4,000+ employees. His experience includes roles as Divisional VP at Abbott and Executive VP at BIO.
