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.
Senior Vice President, Global Quality, Technical Operations
Charlene is accountable for the global Quality function at Shire, a global biotechnology company focused on meeting unmet medical needs of patients with rare diseases and specialty conditions. In partnership with her colleagues at Shire, Charlene and her team provide a safe and ready supply of quality products and services to our patients and healthcare providers.
Charlene has more than 25 years in the biopharmaceutical industry bringing new products and technologies to fruition through robust team partnerships. Prior to joining Shire, she held leadership positions at Gilead Sciences, Cell Genesys and Chiron Corporation. She holds a Bachelor of Science degree in biochemistry from the University of California, Davis and a Masters in international business from Saint Mary’s College in Moraga, California.
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.
Senior Science Policy Advisor, Office of Policy for Pharmaceutical Quality
Commander Tara Gooen Bizjak is an engineering officer in the United States Public Health Service. She currently works as a Senior Science Policy Advisor in the Office of Policy for Pharmaceutical Quality, external policy. CDR Bizjak has been with the FDA for almost 14 years in the area of drug manufacturing, current good manufacturing practice (CGMP) inspections, and related policy. She started as a field investigator in the New Jersey District and transferred to CDER in 2007.
She is a subject matter contact for several CGMP topics, including pre-approval inspections, continuous manufacturing, pharmaceutical quality systems, water quality, and scale-up issues. Prior to her current role, she was a branch chief in the area of drug manufacturing pre-approval inspections and a senior advisor in the Office of Regulatory Affair’s Office of Policy and Risk Management. CDR Bizjak is an ASQ (American Society for Quality) Certified Quality Engineer and received a B.S. in chemical engineering from Cornell University and a Masters in biomedical sciences from Rutgers University.
Head of Procurement Risk, Sustainability, Performance & Innovation
Julie is responsible for defining the company’s supplier risk strategy, incorporating strategic, operational, financial and sustainability risks into the company’s global procurement activities and ensuring alignment with the company’s commitment to the Global Compact with respect to its supplier activities. Julie directs the company’s new Sustainable Procurement function, is a stakeholder member of Takeda’s Global Inclusion Council and participates in the Women’s Inclusion Network at Takeda.
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.
Vice President, Quality Systems & Post Market Quality, Global Surgery
Johnson & Johnson
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, NC 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.
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.
Senior Manager, Development Services
Pfizer CentreOne Contract Manufacturing
Andrea has more than 30 years of experience in the pharmaceutical industry working with both drugs and devices. She is currently a senior manager of development services for Pfizer CentreOne’s sterile injectables fill-finish operations. In this role, Andrea leads project teams through the development and scale-up of injectable drugs for the CDMO’s biopharmaceutical partners. Andrea started her career as an associate chemist with Abbott Laboratories, Hospital Products Division in 1986. She then moved into a technical operations role as a development engineer for sets and devices and eventually went on to become manager of the Flexible Container (I.V. bags) Product Support group. From there, Andrea moved into project management and has never looked back. Andrea has managed complex projects for Abbott, Hospira and Pfizer, in R&D, operations and contract manufacturing. Andrea holds a BS in chemical engineering from the University of Iowa and an M.S. in materials science & engineering from Northwestern University. She is also a certified Project Management Professional (PMP).
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.
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.
Global Trade Compliance
Andrea created the global trade compliance infrastructures at Hospira and Shire. She has global experience in policy and procedures, duty reduction, trade sanctions, controlled substances, and supply chain security. Andrea believes that trade compliance is a hidden strategic advantage for companies that can deliver significant cost savings, even in a duty-free environment.
Andrea started her career in corporate finance at Ford Motor Company and Abbott Laboratories. She has a B.S. in Finance and Business Economics & Public Policy from Indiana University, Bloomington and holds a Customs House Broker license from U.S. Customs & Border Protection.
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 33 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 Small Molecule Operating Unit for Shire, based in Exton, Pennsylvania and operates a fully outsourced supply model.
Kumar Madurai has 35 years of IT experience in Life Sciences, Healthcare, and Manufacturing environments. He currently works for CTG as a Principal Consultant and a Solutions Delivery Manager, responsible for advising clients on strategic planning and selection of technology and infrastructure and for developing and implementing custom solutions to solve today’s complex business problems.
He has experience designing, developing, and implementing ontology-based solutions using advanced semantic technologies for predictive quality assurance and knowledge engineering by linking enterprise data from multiple structured and unstructured data sources. As Data Scientist for the Medical Informatics Products team, he has used exploratory data analysis and applied machine learning algorithms for population health predictive analytics.
Prior to joining CTG in 2009, he spent 25 years at Fisher-Price/Mattel, serving as Director of Technology group leading applications, infrastructure and technical teams. He is currently working on his Ph.D. in the healthcare area at University at Buffalo.
Head of NPI Centre of Excellence and Operations Business Development
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.
Director, International Regulatory Affairs and Programs
United States Pharmacopeia (USP)
Dr. Nguyen is a physician and global health specialist in regulatory affairs focused on interventions to improve access to quality-assured medicines and regulatory capacity building. At USP, he directs the USP-APEC Center of Excellence on Securing Quality Through the Supply Chain, and USP’s Visiting Scientists Program, an exchange platform between USP, regulatory authorities, and related institutions around the world. Dr. Nguyen’s career has spanned government, clinical medicine, health policy, academia, and field work in public health. He is a former ORISE Fellow at the US FDA Office of the Commissioner, Office of International Programs, where he worked on international issues related to China and India, and on mapping international clinical trials activity for the agency.
Dr. Nguyen completed his clinical residency in Family Medicine at Georgetown as a Global Health Scholar, with training in Emergency Medicine from George-Washington University. He is currently on faculty at Georgetown University School of Medicine teaching population health, health policy, and evidence-based medicine. Dr. Nguyen received his M.D. from Tufts University and graduated cum laude from Harvard University with an A.B. in Biology.
Quality Assurance Supplier Manager
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.
Electrical Engineer, CDRH