FDA/Xavier PharmaLink speakers are hand-selected by the PharmaLink Strategic Committee to deliver purpose-driven content that dives below the surface, challenge status quo, engage attendees in collaborative dialog, and provide practical information that can be implemented. Our speakers are thought leaders who are sure to facilitate insightful discussion.
District Director & Program Division Director, Office of Human & Animal Food, East 5
Steven Barber is the District Director of the Cincinnati District office and Program Division Director for the Office of Human & Animal Food, East 5. During his 25-year career with FDA, Steve has worked in six different field offices (Chicago, Kansas City, Florida, San Juan, Baltimore, and Detroit). Within these districts, Steve served in the laboratory as an analyst conducting food and drug analyses, as an investigator conducting medical device and drug inspections, both domestically and internationally, and as a compliance officer. Steven has served as the Director of the Compliance Branch in FDA’s Detroit District Office since 2008.
Senior Vice President
Grace has over 25 years of global experience in the Pharmaceutical and Medical Device industry and has held global leadership positions at Hospira, Catalent Pharma Solutions, Pliva Inc., Janssen Pharmaceutica and Elan Pharmaceuticals. Her Quality and Compliance expertise spans API’s, solid dosage forms, parenterals, and infusion devices. Most recently with Impax (formerly CorePharma), Grace was responsible for the development and execution of a contemporary Corporate Quality and Compliance strategy. Grace holds 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.
Director, Global Chemistry, Manufacturing & Controls
Jennifer L. Brown is currently a Director in the Global Chemistry, Manufacturing & Controls group within Worldwide Regulatory & Safety at Pfizer Inc in Groton, CT. With a small team, she is responsible for CMC strategy for a global portfolio of investigational and commercial products. Jen has a bachelor’s degree in chemistry from Muhlenberg College in Allentown, Pennsylvania, and a master’s degree in regulatory affairs from Temple University. Jen has been at Pfizer for 20 years, in Analytical R&D and then GCMC. Prior to joining Pfizer, Jen was a Peace Corps volunteer in Gabon, Central Africa, teaching middle school science, and Jen also served as a Pfizer Global Health Fellow, working at the Kakuma Refugee Camp in northern Kenya for several months in 2005.
Associate Director, Treyburn & Supplier Quality Assurance
Cathleen has over 25 years of experience in the Pharmaceutical and Medical Device industry and has held quality leadership positions at Digene Diagnostics, DentSply International, Dornier Medical Systems, Solvay (Abbott) Pharmaceuticals, Dendreon Corp, Aaron Industries, and Purdue Pharma L.P. Cathleen’s expertise includes third party manufacturing, product complaint monitoring, and implementation of various quality systems. She has extensive quality and compliance knowledge of medical device, biologic, solid, liquid oral dose, and transdermal manufacturing.
In her current role Cathleen leads the external supplier quality assurance group, and heads the quality function for Purdue’s Durham, North Carolina, manufacturing facility. She is currently working on a M.S. in regulatory affairs from Johns University. Cathleen holds an M.B.A. from the University of Phoenix and a B.S. in microbiology from the University of Georgia.
Vice President Regulatory Science, Quality Assurance, and Compliance
Elanco Animal Health
Brent has more than 25 years of global experience in the pharmaceutical industry. In his current role at Elanco, Brent 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 that 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, Brent was employed by the U.S Food and Drug Administration as an Investigator in Detroit, Chicago and Baltimore Districts and a Compliance Officer in the Cincinnati District Office. Brent holds a bachelor’s degree in biology from the University of Tennessee.
Associate Director, R&D Quality
Lauryn has over 18 years of multidisciplinary experience in the pharmaceutical industry with roles in Quality Control, Pharmaceutical Technology, Project Management, and Quality Assurance. Lauryn is experienced in analytical methodologies, product and method transfer, scale-up and launch, CMO oversight, process improvement, global system implementation, and global project management.
In her current role, she has a variety of R&D quality responsibilities including quality CMC leader for pharmaceutical development projects, providing quality oversight for complex development supply chains for clinical supplies and establishing phase appropriate quality systems and procedures to support the R&D development pipeline.
Lauryn has a bachelor’s degree in chemistry from York College of Pennsylvania and a master’s degree in biotechnology from Johns Hopkins University.
Program Division Director, Division of Pharmaceutical Quality Operations III, ORA
Mr. Czabaniuk holds a B.S. degree in in environmental health and has 40 years of experience in public and private scientific organizations. Mr. Czabaniuk is currently serving as the FDA/ORA Program Division Director (PDD) for the Division of Pharmaceutical Quality Operations III. He is one of four national PDD’s responsible for pharmaceutical regulatory oversight in 13 Midwest states including, MI, IN, OH, KY, IL, MO, KS, NE, IA, MN, WI, SD, and ND.
Prior to joining the FDA in 2002, Mr. Czabaniuk was an independent consultant in the contract pharmaceutical testing industry. His primary responsibilities were laboratory management and the review of Pharmaceutical analytical data including finished product release and validations related to NDA/ANDA applications. Mr. Czabaniuk began his career in the environmental testing industry (18 years) where he held numerous scientific and managerial positions. Management positions included: Branch Manager, Laboratory Director, VP General Manager for a Division of three multi state environmental testing laboratories, and corporate QA Director for national network of 8 environmental/radiochemical laboratories. He also served as a Project Manager for: nuclear/chemical hazardous waste clean-up investigations; industrial wastewater/groundwater/surface water contamination studies; and source and ambient air pollution studies.
Associate Professor and Director, Regulatory Affairs
George Washington University
Dr. Daniela Drago is an Associate Professor and the Director of Regulatory Affairs Programs at The George Washington University’s School of Medicine and Health Sciences. Before joining academia, she held senior positions in the pharmaceutical and medical device industry. She worked in global regulatory and medical affairs roles at F. Hoffman-La Roche/Genentech, Vifor Pharma, Reckitt Benckiser, and Bausch & Lomb. Daniela currently serves on the board of directors of the Association of Graduate Regulatory Educators (AGRE) and on the Regulatory Affairs Certification Board (RACB). She received her Ph.D. in chemistry from the Swiss Federal Institute of Technology (ETH Zurich).
Supervisor, Consumer Safety Officer
Steve Eastham has been with FDA for 25 years. He has a degree in Biology from Northern Kentucky University. In his career with FDA he was an investigator for 12 years, specializing in drugs before becoming a Supervisor. Steve currently oversees the Cincinnati District’s human drug program and supervises approximately 10 investigators. He manages some of the district’s most complex drug work.
Supervisory Chemist, FDA Forensic Chemistry Center
Global Director, Corporate Quality Systems and Programs
Tami is Global Quality Leader with 23 years of experience in the Pharmaceutical Industry. She is a chemical engineer by education, joining Perrigo in 2000. Tami has held positions in Quality Assurance and Control, Research and Development, and Technical Engineering. She is a certified Lean Six-Sigma Blackbelt and a Certified Quality Engineer. She is also HACCP certified and a Safe Quality Food Practitioner. Her experience spans solid, semi-solid, and liquid drug dosage forms, API’s, and Infant Formula/Foods. Tami has led multicultural Quality teams in the implementation of global quality systems such as global change control, EDMS, SQM, quality investigation and CAPA, global quality programs, global technology council, and auditing to support compliance. She is a strategic, global continuous improvement leader and change agent advancing the culture of sustainable quality throughout all levels in the organization.
Pharma Solutions Executive
Senior Vice President, Technical Operations
Sr. 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. She 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. Ms. Goldberg has been certified as a Six Sigma Green Belt, is a Certified Manager of Quality/Organizational Excellence, a Certified Quality Auditor, received her Bachelor’s degree in Biology and Management from Hope College and her MBA from Marquette University.
Director of Operations
Director of Technical Operations and CMC Supply Chain
Senior Vice President, Head of Small Molecule Operating Unit, Technical Operations
David joined Shire in February 2011 as Vice President for Supply Chain Strategy and Product Commercialization in the Specialty Pharmaceuticals Division and was promoted to Senior Vice President Global Supply Chain and Quality in June of the same year. Since then he has headed up the Supply Chain organization for the consolidated Shire and since April 2016 has been Head of the Small Molecules Operating Unit.
Previously David has worked for Ciba-Geigy, SPIMACO, Rhone Poulenc Rorer, Eli Lilly and Genzyme and has over 33 years of experience covering both Pharmaceutical and Biotech Manufacturing and Supply gained in Europe, Middle East, Japan and the USA.
David has a degree in pharmacy from the University of Wales Institute of Science and Technology. He is on the Strategic Committee of the FDA/Xavier Pharmalink Conference, is a member of the faculty of Supply Chain Management World and their Future of Health Care Board.
Associate Director, Global Patient Safety
Lead Quality System & Compliance Consultant
King & Spalding
Mr. 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 Office of Criminal Investigations. While at ORA, Mr. 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 health care group. Previously, he was executive vice-president of Quintiles Consulting. Mr. Niedelman 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.
University of Cincinnati, College of Law
Professor O’Reilly has been involved with FDA issues since 1974. He authored the standard reference encyclopedia on FDA for westgroup.com, which the U.S. Supreme Court quoted with the words, “The experts have written…”. He chairs the FDA committee of the American Bar Assn., is on the editorial board of the Food & Drug Law Journal, formerly chaired the programs committee of the Food & Drug Law Institute, and was keynote speaker at the FDA’s midwest celebration of its 100th anniversary in 2006. Before his academic career, he was principal FDA legal adviser for Procter & Gamble, and is the last active member of the team that negotiated the terms of the 1976 medical device amendments. He has published 51 texts and 215 articles since 1977.
Drug Specialist and Pre-Approval Manager
FDA, Cincinnati District Office
Nick Paulin began his career with FDA in 2007 in Cincinnati District of the FDA. Nick is a Drug Specialist, and conducts pharmaceutical inspections domestically and internationally. He serves as a Pre-Approval Manager, FARS/MSB Monitor, and is a mentor to New Hires. Prior to starting his career at FDA, Nick was a math/science teacher, and has a biology degree from Purdue University. Nick enjoys running and spending time with his wife and three-year-old daughter.
Director, Xavier Health
Dr. Marla A. Phillips joined Xavier University in 2008 as the Director of Xavier Health, where she leads initiatives with FDA officials and Pharmaceutical and Medical Device professionals. Marla began working in the pharmaceutical industry for Merck in 1996 where she took on roles of increasing responsibility, culminating in position of Head of Quality Operations at the Merck North Carolina facility. She holds a B.S. in chemistry from Xavier University, and a Ph.D. in organic chemistry from the University of North Carolina – Chapel Hill.
Senior Director, Secure Supply Chain
Matt has over 13 years of experience in the medical device, pharmaceutical and life sciences industry; working both for manufacturers, wholesalers and for a large consulting firm. He has held various roles in the areas of product development, lean six sigma, business system implementation, and operational leadership. His most recent responsibilities have included leading a global medical device serialization effort, device UDI implementation and, until joining AmerisourceBergen, he was the serialization program lead at a mid-size pharmaceutical company.
He is currently the business lead for the serialization efforts at AmerisourceBergen and also manages the team responsible for supporting existing and future DSCSA business tasks.
President and Principal, Compliance and Regulatory Affairs
John Taylor joins Greenleaf following a distinguished career of more than 20 years at the U.S. Food and Drug Administration. During John’s time at the agency, he led several of its priority initiatives.
At Greenleaf, John continues his commitment to healthcare innovation as the firm’s President and Principal of Compliance & Regulatory Affairs, providing strategic consultation to FDA-regulated clients on enforcement and compliance matters.
From 2009 – 2014, John 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, John served as the principal advisor to Commissioner Margaret Hamburg on issues that impacted the agency’s programs, policymaking, management, budget and administration. In his role as Acting Deputy Commissioner for Global Regulatory Operations and Policy, John provided leadership and direction to more than 4,000 employees in FDA’s Office of Regulatory Affairs (ORA) and Office of International Programs (OIP).
John began as an attorney within FDA’s Office of the Chief Counsel (OCC) in 1991. During this time, John was responsible for all phases of criminal and civil litigation related to violations of the Federal Food, Drug, and Cosmetic Act, and other federal laws. In 1997, John was promoted to Senior Advisor for Regulatory Operations and Policy within FDA’s Office of the Commissioner; he was later named Director of the Center for Drug Evaluation and Research’s (CDER) Office of Compliance. In 2000, John accepted his position as Director of ORA’s Office of Enforcement. Two years later, John was promoted to Associate Commissioner for Regulatory Affairs (ACRA).
In 2005, John left FDA to spend four years working in industry, first as Divisional Vice President for Federal Government Affairs at Abbot, then, in 2007, as Executive Vice President for Health at the Biotechnology Industry Organization (BIO).
John has received multiple honors, including the Health and Human Services Secretary’s Award for Distinguished Service (1997, 2000, 2003, 2004, 2005 and 2011) and the FDA Award of Merit (2000, 2003 and 2005). John received his J.D. from the College of William and Mary and is a graduate of Pennsylvania State University with a B.A. in History.
Pharmaceutical and Compliance Consultant
Bill Webb has over 30 years of experience in Pharmaceutical Quality Operations, and in his most recent role, was responsible for internal US WorldMeds Quality Assurance and Quality Control, and international Quality oversight of CMOs and CLOs. Other previous experience includes Director Quality Assurance and Quality Control North America for Aptalis Pharmatech. In that role he was responsible for multi-site Quality Systems compliance, international supplier audits and qualifications. Additionally, while at the Forest Pharmaceutical facility in Ohio, Mr. Webb was responsible for Quality at various levels. Mr. Webb is currently engaged in pharmaceutical and compliance consulting.