A conference for those looking to engage in paradigm-shifting dialogue that leads to solutions for staying ahead.
PharmaLink Strategic 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.
Consultant, MGB Solutions
Grace Breen is a consultant with over 30 years of experience in the pharmaceutical industry. She is the former Head of Quality for SCA Pharma and had held global leadership roles at Impax, Hospira, and Catalent. Grace has Quality and Compliance expertise spanning API’s, solid oral and parenteral dosage forms, and infusion devices. At SCA Pharma, a 503B outsourcing company, Grace led a cGMP cultural transformation; at Impax, she implemented a contemporary and integrated Quality and Compliance strategy; and at Hospira, she led a global Commercial Quality team that focused on the needs and satisfaction of the customer.
Grace earned a post-graduate diploma in Pharmaceutical Manufacturing Technology from Trinity College Dublin, Ireland; an M.S in Chemistry from Dublin City University, Ireland; and a B.S. in Chemistry from University College Cork, Ireland. She is eligible to act as Qualified Person (QP) under EU law.
Jennifer L. Brown
Senior Director, Global Regulatory Affairs Chemistry, Manufacturing and Controls, Pfizer Inc
Jennifer L. Brown is currently a Director in the Global Chemistry, Manufacturing & Controls group within Global Regulatory Affairs at Pfizer Inc in Groton, Connecticut. Brown and her team are responsible for CMC strategy for a global portfolio of investigational and commercial products. Brown has a bachelor’s degree in chemistry from Muhlenberg College in Allentown, Pennsylvania, and a master’s degree in regulatory affairs from Temple University. She has been at Pfizer for over 20 years, in Analytical R&D and then GCMC. Prior to joining Pfizer, Brown was a Peace Corps volunteer in Gabon, Central Africa, teaching middle school science, and she also served as a Pfizer Global Health Fellow, working at the Kakuma Refugee Camp in northern Kenya for several months in 2005.
Lead Quality Advisor, Regulatory Surveillance and External Engagement, Elanco Animal Health
Brent Conatser has more than 30 years of global experience in the pharmaceutical industry. In his current role at Elanco, Conatser is responsible for development, implementation, and management of a comprehensive, proactive, surveillance program for the global external regulatory environments relative to GxP requirements for the animal health industry, which includes communication and collaboration with subject matter experts and global Quality and Regulatory Leaders regarding the impact of new proposed laws, regulations, and guidelines for veterinary products. Previous experience includes leadership positions in Regulatory GMP Compliance and Worldwide Clinical Compliance with Pfizer, and in Regulatory Affairs with Janssen Pharmaceutica. Prior to his industry experience, Conatser was employed by the U.S. Food and Drug Administration as an Investigator in the Detroit, Chicago, and Baltimore Districts and a Compliance Officer in the Cincinnati District Office. Conatser holds a bachelor’s degree in biology from the University of Tennessee.
Vice President Quality and Regulatory, Drug Product Europe and North America, Thermo Fisher Scientific
Consumer Safety Officer, FDA
Senior Director, Quality Operations, Merz North America, Inc.
Ashley Goldberg joined Merz North America in 2011 and is currently Head of Quality for Merz North America. Responsibility includes a broad range of Medical Products for Medical Dermatology, Neurology and Aesthetic use. She has held previous roles in sterile large- and small-volume parenteral manufacturing quality and in product development specializing in advanced aseptic processes in Blow Fill Seal Technology. Goldberg led the creation and maintenance of Baxter’s Global Supplier Audit and Re-Evaluation Schedule and oversaw the implementation of an electronic Supplier Audit and Re-Evaluation Module. Before moving to Merz, she was responsible for Global Supply Chain quality strategy and compliance at Baxter Healthcare. Goldberg has been certified as a Six Sigma Green Belt, is a Certified Manager of Quality/Organizational Excellence, and a Certified Quality Auditor. She received her bachelor’s degree in biology and management from Hope College and her MBA from Marquette University.
Regulatory Manager, Oral Care, Procter & Gamble
Director, Global Chemistry, Manufacturing & Controls, Pfizer
Connie Langer is a Director at Pfizer Global Product Development in Groton, Connecticut. She joined Pfizer in 1998 as a scientist in the Pharmacokinetics, Dynamics, and Metabolism Department, where she employed quantitative and qualitative mass spectrometry techniques to study drug metabolism, biopharmaceutics, and the environmental fate and effects of pharmaceuticals.
Langer is currently a regulatory strategist in the Global CMC department, managing and executing life-cycle CMC regulatory activities, providing global strategy and regulatory submissions for investigational studies, and she’s responsible for new commercial registrations and post-approval maintenance for licenses of pharmaceutical products. Langer co-chairs the International Consortium for Innovation and Quality in Pharmaceutical Development ICH Q12 working group and is a member of the ISPE PQLI® ICH Q12 Working Team.
She has a bachelor’s degree in chemical engineering and a master’s degree in oceanography from the University of Connecticut and a drug development certificate from the School of Pharmacy, Quality Assurance and Regulatory Affairs at Temple University.
President of DL Advisors LLC
David is the President of DL Advisors LLC where he advises on strategy, acquisitions and provides target assessments and due diligence support. He is an Independent Director on the Boards of SK Pharmteco, a global CDMO operating predominantly in the Pharmaceutical API space, and Yposkesi, a Cell and Gene Therapy CDMO.
David has over 37 years of global experience in the Pharmaceutical and Biotechnology Industry, most recently holding Senior Vice President roles at Shire Pharmaceuticals with Global responsibility for Supply Chain and for Manufacturing.
David has a degree in Pharmacy from the Welsh School of Pharmacy, University of Wales Institute of Science and Technology (now Cardiff University).
Partner and Deputy Chair for FDA & Life Sciences, King & Spalding
Chris Markus focuses on federal and state regulation of drugs, biologics, biotechnology, and related products. As a partner in the FDA and Life Sciences practice and Deputy Practice Group Leader, Markus represents clients in a range of regulatory strategy and compliance evaluations, enforcement matters, and business transactions.
She represents drug, biologic, and other healthcare products companies and investors with compliance and enforcement under the Food and Drug Administration, the Drug Enforcement Administration (DEA), and related state agencies such as boards of pharmacy. Markus also represents clients in business transactions, including strategic planning, due diligence, and assessment, that involve product development and approval, safety, labeling, marketing and advertising, manufacturing, and supply chain.
CDR Jeffrey Meng
Program Division Director, Office of Pharmaceutical Quality Operations, ORA, FDA
CDR Jeffrey Meng is an engineer officer in the U.S. Public Health Service and currently serves as the Program Division Director for the Division of Pharmaceutical Quality Operations III within the ORA Office of Pharmaceutical Quality Operations. CDR Meng leads over 70 FDA pharmaceutical investigators, compliance officers, management, and support staff responsible for facility inspections, investigations, and compliance throughout the Midwest and internationally in support of FDA’s mission to provide safe and effective pharmaceuticals for consumers. CDR Meng began his FDA career in 2009 as an Investigator, with advancing roles as a Drug Specialist, Supervisory Investigator, and Director of Investigations Branch prior to his current position as the Program Division Director. He leveraged broad experiences throughout his FDA career, including rotations to the FDA Office of International Programs (OIP) China Office in Shanghai, China and to the FDA Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality (OPQ), Office of Quality Surveillance (OQS).
Lead Quality System & Compliance Consultant, King & Spalding
Steve Niedelman retired from the Food and Drug Administration in 2006 after a 34-year distinguished career, where he served as the Deputy Associate Commissioner for Regulatory Affairs and as Chief Operating Officer of the Office of Regulatory Affairs. He ensured consistent interpretation of FDA’s regulatory policies by directly overseeing offices at the headquarters of the Office of Regulatory Affairs (ORA), including the Office of Regional Operations, Office of Enforcement, and the Office of Criminal Investigations. While at ORA, Niedelman served as the principle liaison to the Center for Devices and Radiological Health, and was a member of the Global Harmonization Task Force (GHTF) Steering Committee, FDA/Medical Device Industry Grassroots Initiative Steering Committee, and the CDRH Post-Market Initiative Steering Committee.
He joins King & Spalding from Crowell & Moring LLP, where he was a senior consultant in its healthcare group. Previously, Niedelman was executive vice-president of Quintiles Consulting. He specializes in regulatory, enforcement, and policy matters involving industries regulated by the U.S. Food and Drug Administration. He provides strategic advice, insight, and guidance to the medical device, pharmaceutical, biologics, and food industries to ensure compliance with the requirements of the federal Food, Drug and Cosmetic Act.
Head of Corporate Quality Compliance, Perrigo Company
Brandon Persinger has more than 20 years of experience in the pharmaceutical and biopharmaceutical manufacturing industry having held roles in operations, quality and compliance. He is currently head of Corporate Quality Compliance for Perrigo Company, with responsibility for internal audit, regulatory enforcement monitoring and compliance risk management, and oversight for Consumer Affairs including consumer call center. Persinger has held prior roles at Pfizer and Amgen. He holds a bachelor’s degree in chemical engineering from the University of Michigan, and resides with his wife and daughter in Saugatuck, Michigan.
Global Director of Quality Systems, Compliance & Governance, Procter & Gamble
Regina Shipman is the Global Director of Quality Systems, Compliance & Governance at Procter & Gamble. Prior to joining P&G, she held leadership positions with Johnson & Johnson, Novartis, and Greer Laboratories, and has amassed more than 20 years of diverse experience working in GxP (includes support to businesses under Consent Decree).
Shipman’s global expertise in Pharma, Device, Biological, Consumer/Nutritional, and Animal Health businesses is reflected by numerous awards and industry recognitions. Her vast experience and knowledge in the areas of Global Project Management, Gap Analysis, Auditing, Risk Management, Six Sigma project(s), Investigation & CAPA Writing, and Complaint Processing is lauded and solidly positions her as a go-to person whose passion for advancing Quality is boundless. A South Carolina native, Shipman holds a master’s degree in Quality Assurance and Regulatory Affairs and now serves the Greater Cincinnati community in various board member roles and activities.
President and Principal, Compliance and Regulatory Affairs, Greenleaf Health
John Taylor is the President and Principal of Compliance and Regulatory Affairs for Greenleaf Health, following a distinguished career of more than 20 years at the U.S. Food and Drug Administration. He held three high-profile positions at FDA: Counselor to the Commissioner; Acting Deputy Principal Commissioner; and Acting Deputy Commissioner for Global Regulatory Operations and Policy. As Counselor to the Commissioner, Taylor served as the principal advisor to Commissioner Margaret Hamburg on issues that impacted the agency’s programs, policy making, management, budget, and administration. In his role as Acting Deputy Commissioner for Global Regulatory Operations and Policy, Taylor provided leadership and direction to more than 4,000 employees in FDA’s Office of Regulatory Affairs (ORA) and Office of International Programs (OIP).
He began as an attorney within FDA’s Office of the Chief Counsel (OCC) in 1991. In 2005, he left FDA to spend four years working in industry, first as Divisional Vice President for Federal Government Affairs at Abbott, then, in 2007, as Executive Vice President for Health at the Biotechnology Industry Organization (BIO).