Our FDA/Xavier PharmaLink Strategic Committee is made up of the following FDA officials and industry experts:
Vice President and General Manager
Thermo Fisher Scientific
Mandy Bosse has more than nineteen years of pharmaceutical industry experience with expertise in pharmaceutical operations, technology transfers, strategic client relationship management, talent development and building high performance teams.
Mandy is the VP & GM of Cincinnati Operations for the Pharma Services Group at Thermo Fisher Scientific since January 2017. Mandy has held 10 roles of increasing responsibility with Thermo Fisher Scientific and predecessor companies (Patheon, Aventis). Her prior responsibility included Global leadership for the Drug Product Services (DPS) Business Management (BM) covering client management and demand management across 11 DPS sites, design and implementation of global technology transfer function (TT) and design/harmonization of BM/TT client interface model.
Mandy completed a Bachelor of Science in Chemical Engineering from the University of Cincinnati and Advanced Management Program at Harvard Business School.
Senior Vice President
Grace has over 30 years of experience in the pharmaceutical industry and is currently SVP Quality at SCA Pharma. She previously held global leadership positions at Impax, Hospira and Catalent Pharma Solutions and has extensive Quality and Compliance expertise that spans API’s, solid oral and parenteral dosage forms, and infusion devices. At SCA Pharma, a 503B outsourcing company, Grace is leading a cGMP cultural transformation. At Impax, she implemented a contemporary and integrated Quality and Compliance strategy and while at Hospira, Grace led a global Commercial Quality group that focused on the needs and satisfaction of the customer.
Grace is eligible to act as a Qualified Person under EEC Directive 75/319 provisions, she 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.
Elanco Animal Health
Brent has more than 30 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 30 years. He has a degree in biology from Northern Kentucky University. In his career with FDA, he was an investigator for 12 years conducting inspections in various commodities before specializing in drugs and eventually becoming a Supervisor. Steve is one of five Supervisors in Pharma Division 3 which covers a north-central geographic section of the US. Steve supervises approximately 10 investigators that conduct both domestic and foreign drug inspections.
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.
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.
Global CMC, Environmental Sciences, and Pharmacokinetics, Dynamics, and Metabolism
Senior Vice President, Head of Small Molecule Operating Unit, Technical Operations
David joined Takeda 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 Takeda 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.
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 Medicine
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.
Vice President, Business Management
Thermo Fisher Scientific
Jill Otto, Vice President, Business Management for Thermo Fisher Scientific is responsible for North America Commercial Drug Product, Global Business Management, Integrated Offering and Global Technology Transfer Program Management. Jill has been with Thermo Fisher for 17 years and during her tenure she has worked in roles of increasing leadership responsibility in Business Management, Process and Project Engineering. Jill has a Bachelor’s of Science in Chemical Engineering from the University of Cincinnati and an MBA from Xavier University. Jill is based in Cincinnati, Ohio.
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.
Drug Specialist, Pharma Division III
Lindsey Schwierjohann began her career with FDA in 2010 and has been a Drug Specialist since 2015. She conducts pharmaceutical inspections both domestically and internationally. While with FDA Lindsey has completed multiple details in the Beijing, China office as a Drug Specialist conducting inspections throughout China. Lindsey serves as a mentor to new investigators. Prior to FDA, Lindsey earned a biology degree from the University of Kentucky.
Senior Director Global Quality Compliance and Systems – Knowledge Management
Takeda Pharmaceutical Company
Elaine joined Takeda Pharmaceuticals Global Quality Compliance and Systems group in June 2016 to develop the companies Knowledge Management processes. Prior to this, Elaine worked with Teva Pharmaceuticals, responsible for Quality Compliance with European and Israeli operations. In her current role is responsible for developing Takeda’s Supplier Quality Management program.
Elaine has 22 years of experience in the Pharmaceutical Industry. She holds an MSc in Pharmaceutical Manufacturing Technology. Elaine has held positions in Quality Assurance, Compliance, Quality Control and Research and Development.
Global Section Head, Health Care Quality Systems & Capabilities for Cosmetics, Devices, Drugs & Food
Procter & Gamble
President and Principal, Compliance and Regulatory Affairs
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. 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. In 2005, John 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).
Director, Global CMC Regulatory Affairs
Janssen Research & Development
Leslie Weiss, RPh, MBA, is a Director, Global CMC Regulatory Affairs at Janssen Research & Development, LLC, a division of Johnson and Johnson. She leads a team of CMC professionals who support the introduction of new registrations globally as well as navigate the challenging and exciting world of post approval changes, working closely with the supply chain. Leslie is part of the Continuous Manufacturing team responsible for developing and implementing the global regulatory strategy for CM. Leslie has a pharmacy degree from Rutgers University and a MBA in Health Administration from Widener University. She has spent the past 10 years within CMC Regulatory Affairs with more than 24 years of service at Johnson and Johnson.