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. Additional PharmaLink 2018 speakers and moderators are being added often.
Cincinnati District Director
Steven Barber has been selected to the position of District Director for the Cincinnati District. 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 has 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.
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, Supplier QA
Cathleen Carson is the Associate Director of Supplier QA at Purdue Pharmaceuticals, previously at Sequoia Consulting Group as their Principal Consultant.
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.
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.
Global Director, Corporate Quality Systems and Programs
Tami is Global Quality Leader with 21 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.
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.
Principal Scientist, Oral Care Regulatory Affairs
Procter & Gamble
Michael has over 10 years of hands-on regulatory experience in both the Over-the-Counter drug and medical device fields. Michael started his tenure at Procter & Gamble in the upstream drug development division and then found his way to Regulatory Affairs. He has successfully managed and executed regulatory strategies for both drug and medical device projects to ensure regulatory compliance and successful FDA interactions. In addition to his numerous responsibilities with Procter & Gamble Michael serves as one of the Industry Co-Chairs for Xavier Health’s Cincinnati Chapter. Michael holds a Ph.D. in Reproductive Physiology from North Dakota State University.
VP Global Quality Compliance and Systems
Takeda Pharmaceutical Company
William A. (Al) Kentrup joined Procter and Gamble in December 2012 as Director of Corporate Quality. Prior to his work with Procter and Gamble, he was Vice-President of Quality for Sandoz (Novartis), North America where he provided Quality leadership in remediation of the North America manufacturing sites. Additionally, while in this role, Al was actively involved with the Rx360 industry consortium and completed a two year term as Vice-Chair.
Al has an extensive 31-year career in Quality leadership positions having also worked at Pfizer (formerly Wyeth) and Aventis and predecessor companies. At Pfizer, he provided leadership in designing and implementing the Manufacturing and Supplier Quality Assessment organization. He began his career 1982 at Merrell-Dow Pharmaceuticals as a Quality Control Chemist. Al holds a bachelor of science degree in chemistry from Northern Kentucky University.
Head of Small Molecule Operations
David has over 28 years of experience in the Pharmaceutical and Biotech Industries and has experience living and supplying medicines in Europe, the Middle East, Japan and the US. His experiences include roles working for Ciba Geigy, SPIMACO, Rhone Poulenc Rorer, Eli Lilly, and Genzyme in a variety of functions. He currently leads the supply chain organization for the Specialty Pharmaceuticals Division for Shire, based in Wayne, Pennsylvania and operates a fully outsourced supply model.
Dell has been an Investigator with the FDA for over 13 years. He recently accepted a promotion to Supervisory Investigator under the Agency’s GDUFA program. He is supervising Field Drug Investigators conducting inspections and investigations at generic drug manufactures. He remains stationed in the Columbus Ohio Resident Post of the Cincinnati District where he started.
Dell is a member of the FDA’s Pharmaceutical Inspectorate. Prior to this new position, as an Investigator, he conducted inspections primarily in the Drug program area as well as in the Veterinary Medicine, Food, and Nonclinical program areas. Prior to joining the Agency, his private sector work included approximately 10 years in the quality assurance and laboratory settings for the pharmaceutical and food industries. He held responsibilities ranging from running bench microbiology testing and analytical testing in the chemistry lab to being the Director of QA for a multiplant food company.
Dell has designed and implemented the startup of a pharmaceutical microbiology laboratory and a food microbiology/proximate chemistry laboratory. He graduated from Capital University in 1989 with a bachelors degree in biology and completed graduate classes in microbiology and biochemistry at Ohio University.
Assistant Commissioner for Operations, Office of Regulatory Affairs
Ms. Morrison is the Assistant Commissioner for Operations in the Office of Regulatory Affairs at the Food and Drug Administration (FDA) where she leads a team serving as the focal point for coordination and management of ORA’s field activities, including the approval and issuance of assignments from headquarters and centers. In addition, Office of Operations provides direction to field scientific resources, field import operations, and serves as the contact point to the U.S. Customs Service and other federal agencies involved in import activities.
Ms. Morrison received her B.A. in Biology from Regis College, and completed graduate work in Environmental Health at New York University; she has completed courses in Crisis Management Leadership and National Preparedness Leadership from the John F. Kennedy School of Government at Harvard University and also attained a graduate certificate in Terrorism Studies from the University of St. Andrews in 2013.
Ms. Morrison was instrumental in monitoring the blood safety program in coordination with the American Red Cross. In 2002, FDA named Ms. Morrison the Director of Emergency Operations, Office of Crisis Management, where she directed and coordinated FDA’s emergency preparedness and response activities with other federal, state, local, and international agencies. In 2003 she became the first Director of the newly established Office of Crisis Management, where she advanced the priorities of the Commissioner through development and management emergencies, crisis management, and security policies and programs for FDA. Ms. Morrison returned to the Office of Regulatory Affairs in 2012 as the Acting Assistant Commissioner for Operations, and a year later was officially named Assistant Commissioner. She has received numerous FDA awards and special citations for her public service. She embraces her role as a public servant and mentor to the next generation of those seeking to protect the public health.
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.
Divisional Vice President Compliance and Operations Services
Agnes Ortega is Divisional Vice President, Compliance and Operations Services AQR/EHS. She assumed her role in June 2014.
Agnes has responsibility for establishing, implementing and maintaining strategies related to Global EHS, Quality Intelligence and Applications, Quality Operations and Global Compliance. This includes conducting evaluation of internal and external trends to assess risk to Quality and EHS Compliance for Abbott’s established and emerging markets; establishment and maintenance and development of corresponding IT solutions; execution ofGlobal Compliance Audits; and maintenance of AQR/GES Training and Documentation.
Agnes possesses 31 years of robust Quality Management experience in the Pharmaceutical and Medical Devices industry working for major firms such as Warner Lambert, Schering-Plough, AstraZeneca, which includes the successful implementation of remediation actions associated with Consent Decrees.
She earned a bachelor’s degree in biology from University of Puerto Rico, Rio Piedras.
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.
Associate Director of Program Development
Michelle Rich joined Xavier University as the Associate Director of Program Development in January of 2017. Michelle spent nearly nine years as a National Account Manager at American Thermal Instruments, providing temperature monitoring solutions to pharmaceutical and medical device manufacturers to support supply chain compliance. Michelle also has a background in pharmaceutical sales. Michelle holds a B.S. in organizational communication from Ohio University.
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.
Technical Staff Technologist, Support & Deployment Services
Michael is a Technical Evangelist providing vision and leadership through transformational business intelligence and data science initiatives. His insights into supply chain, manufacturing and software services is foundational to his message that a proper perspective should be at the core of all data science and product performance analytics.
Michael enjoys taking the confusion out of Big Data and distilling complex concepts down to tangible examples. His passion for demonstrating real world scenarios of Dells SupportAssist Intelligence Engine, helps people understand that predictive and proactive Business Analytics running at the “Speed of Thought” are feasible platforms for all companies across multiple industry. Michael is an innovator with multiple patents spanning hardware and software methods such as Dell’s Reliable Memory Technology.
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.
National Expert Investigator
Robert Tollefsen is the National Expert Investigator for Drugs and Computer Systems in the Division of Field Investigations within the Office of Regulatory Affairs in FDA.
He began his career in FDA in 1991 as a chemist in the drug section of what is now FDA’s Pacific Regional Laboratory Northwest. Tollefsen is called upon to participate in FDA’s more complex inspections of primarily drug and biotech companies across the US and throughout the world. He is an instructor at numerous national training courses for FDA investigators and FDA analysts to include; pre-approval investigations (advanced drug school), basic drug school, orientation to international inspections, computer system validation, introduction to inspections of pharmaceutical laboratories and computer aided inspections.
He has given presentations at numerous academic and industry seminars across the US and internationally and has participated as an instructor at the University of Washington’s course on biomedical regulatory affairs. Tollefsen received his BS with double majors in chemistry and biology and minor in mathematics from Eastern Washington University with honors.
Senior Director, Quality
Bill Webb has over 30 years of experience in Pharmaceutical Quality Operations, and in his current role is responsible for internal US WorldMeds Quality Assurance and Quality Control, and international Quality oversight of CMO’s and CLO’s. His 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. Previous experience also includes varying levels of responsibility in Quality at Forest Pharmaceutical’s Ohio facility.
CEO and President
Jim Wulfeck is the founder and President of the The Mastery Institute and the creator of GMP Mastery™, a 21st century strategy for making GMP a value-adding business strategy.
Jim created the GMP Institute in 1977, and grew it to be the world leader in helping food, drug, medical device and cosmetic manufacturers embrace the challenge of complying with the Food and Drug Administration’s Good Manufacturing Practice (GMP) Regulation.
Since 1977, Jim has traveled the world consulting, developing and conducting GMP training workshops, and performing GMP audits that positively influence the business performance and results of manufacturing organizations in the United States, Puerto Rico and over 70 countries. Examples of his published training programs include: “GMP Makes Good Business Sense”; “GMP – Why Do We Need It?”; “The Ten Principles of Good Manufacturing Practice”; “GMP – The Best Way To Comply”; “Written Procedures – Our Roadmap To Quality”; “Write It Down – Keep Good Records”; “Doing The Job Right The First Time”; “Check And Double Check”; “Keep It Clean” and “Auditing For Compliance and Improvement”.
Ombudsman, Office of Regulatory Affairs
Jessica L. Zeller is the Office of Regulatory Affairs (ORA) Ombudsman at the U.S. Food and Drug Administration and has held this position since its inception in 2015. She is responsible for informally addressing concerns, complaints, and disputes arising between ORA and external parties, including industry, government entities (federal, state, territory, and tribal), and other members of the public. Ms. Zeller began her career at FDA in 2004 as a litigation attorney in the Office of Chief Counsel and subsequently was the deputy director of the Office of Compliance and Enforcement at FDA’s Center for Tobacco Products. Before returning to FDA as ORA ombudsman, Ms. Zeller spent two years as lead FDA attorney for Procter and Gamble. She holds a Bachelor of Science University Scholar degree (biology) from Xavier University and J.D. and M.A. (bioethics) degrees from the University of Virginia.
Vice President for Commercial Technology North America
Bob Zinser is the North American Vice President for Commercial Technology at Patheon. Patheon is a provider of pharmaceutical development and commercial manufacturing services. In his current role, Bob is responsible for commercial technologies used at the Toronto, U.S. and Puerto Rico sites of Patheon. He has spent more than 40 years in the pharmaceutical industry, with extensive experience in Quality Control, Manufacturing, Packaging, Supply Chain, Contract Management, Business Management and five years as Cincinnati Site Director. Bob holds bachelor of science and master of science degrees in chemistry, and an M.B.A. in management, all from Xavier University.