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.
President, Drug Product Division North America Pharma Services
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.
Director, CMC Regulatory Affairs
(Acting) Quality Assessment Lead
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.
Director, Office of Pharmaceutical Quality Operations, Office of Regulatory Affairs
Alonza Cruse is Director, Office of Pharmaceutical Quality Operations (OPQO) within the FDA Office of Regulatory Affairs (ORA). His office is responsible for all pharmaceutical quality inspections and investigations, working in conjunction with FDA’s Center for Drug Evaluation & Research (CDER) and Center for Veterinary Medicine (CVM). Additionally, Mr. Cruse continues to lead ORA’s pharmaceutical collaboration efforts under the program alignment initiative.
From 2013-2015 Mr. Cruse served as the Director (Acting) of the Office of Medical Products & Tobacco Operations (OMPTO) within ORA, overseeing activities such as Generic Drug User Fee Amendments (GDUFA) implementation, pharmacy compounding, and the development of a New Inspection Protocols Program (NIPP). From 2000-2015, Mr. Cruse was the Director, FDA’s Los Angeles District Office, where his responsibilities included providing executive leadership to implementing, managing and evaluating FDA's regulatory operations. Mr. Cruse first joined ORA in 1983 as a microbiologist. He received his bachelor of science degree in medical technology from York College (City University of New York).
Program Division Director, Division of Pharmaceutical Quality Operations III, ORA
Mr. Czabaniuk holds a B.S. degree 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.
Director of Regulatory Affairs
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.
Professor, Production Management
St. Gallen University
Thomas Friedli is a Professor for Production Management at St. Gallen University in Switzerland.
His main research interests are in the fields of managing operational excellence, global production management and management of industrial services. He is a lecturer in the (E)MBA programs in St. Gallen, Fribourg and Salzburg. He spent several weeks as Adjunct Associate Professor at the Purdue University in West Lafayette, USA. Prof. Friedli leads a team of 15 researchers who develop new management solutions for manufacturing companies in today’s business landscape. He also is the editor, author or co-author of 14 books and various articles.
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
Connie Langer is an Associate Director at Pfizer in Groton, Connecticut, where she is accountable to manage and provide global strategy and submissions for investigational studies, new commercial registrations and maintenance of product licenses. She had the unique opportunity to work closely with the FDA on Pfizer’s first comprehensive QOS. Connie holds an MS from the UConn and has been actively volunteering at local elementary schools for the past 25 years to promote careers in STEM fields.
Director of Investigations Branch, Division of Pharmaceutical Quality Operations III, ORA
Lieutenant Commander Jeffrey Meng is an engineer officer in the U.S. Public Health Service and currently serves as the Director of Investigations Branch for the Division of Pharmaceutical Quality Operations III within the ORA Office of Pharmaceutical Quality Operations. LCDR Meng leads a team of approximately 40 FDA pharmaceutical investigators, supervisors, and support staff conducting facility inspections and investigations throughout the US Midwest and internationally in support of FDA’s mission to provide safe and effective pharmaceuticals for the American public.
LCDR Meng began his FDA career in 2009 as an Investigator with advancing roles as a Drug Specialist and Supervisory Investigator prior to his current position as the Director of Investigations Branch while leveraging broad experiences 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 Surveillance (OS). LCDR Meng obtained his B.S.E. and M.S.E. in Biomedical Engineering from the University of Michigan and is an ASQ (American Society for Quality) CPGP (Certified Pharmaceutical GMP Professional).
Head of Global Quality
Dr. Mire-Sluis is currently Head of Global Quality for AstraZeneca. He was Vice President, North America, Singapore, Contract and Product Quality at Amgen Inc. He was previously Principal Advisor, Regulatory Science and Review, Office of Biotechnology Products, CDER and Head of Analytical Sciences and Standards, Office of the Director, CBER, FDA, in Bethesda, Maryland. He trained in Genetics and Biometry and has a PhD in Cell biology and Biochemistry.
Dr. Mire-Sluis was the Head of the Cytokine Group in the Division of Immunobiology at the National Institute for Biological Standards and Control, Potters Bar, UK. Dr Mire-Sluis specialized in the development of assays for the characterization and quantitation of biological products. He then became Director of BioAnalytical Sciences at Genentech and prior to joining FDA, was Executive Director of Analytical Sciences at CancerVax Corporation, San Diego. He is the Chairman of the IABS Biotherapeutics Committee, Vice Chairman of the USP Biologicals Characterization Expert Committee, an expert for the International Committee for Harmonization and on the board of the Journal of Immunological Methods.
Dell is a Supervisory Investigator in the Office of Regulatory Affairs, Office of Pharmaceutical Quality Operations, Division 3 at the Food and Drug Administration where he supervises a group of Drug Investigators including GDUFA Drug Investigators. Dell has been with the Agency over 17 years with more than 4 of them as a supervisor. He remains stationed in the Columbus Ohio Resident Post where he started. He believes strongly in his public health mission and embraces his role as a supervisor believing that one of the most important roles a supervisor can have is to mentor the team he leads and is a part of.
As an Investigator, Dell has conducted numerous inspections primarily in the Drug program area as well as in the Veterinary Medicine, Food, and Nonclinical program areas. He carries this inspectional experience into his role as a supervisor. 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 bachelor’s degree in biology and completed graduate classes in microbiology and biochemistry at Ohio University.
Assistant Commissioner for for Medical Products and Tobacco Operations
Ms. Morrison is the Assistant Commissioner for Medical Products and Tobacco Operations in the Office of Regulatory Affairs at the Food and Drug Administration (FDA) where she leads the four program directors in the coordination and management of ORA’s field and headquarters in the areas of medical products and tobacco. Ellen is the inaugural leader for the Program Executives leading the field Biologics Program, Pharmaceutical Quality, Medical Device and Radiological Health and our Bioresearch Monitoring Program. This includes inspections and emergency preparedness and response activities relative to medical products.
Ellen has completed programs in Crisis Management Leadership and National Preparedness Leadership from the John F. Kennedy School of Government at Harvard University and attained a graduate certificate in Terrorism Studies from the University of St. Andrews in 2013.
Ms. Morrison started her FDA career as an Investigator eventually specializing in Biologics in several Districts prior to joining ORA headquarters. 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.
Sarah Nielsen is a Principal Scientist within Janssen Supply Chain leading Real Time Release Testing. Sarah and her team/colleagues are responsible for the development of in-line process analytical technology (PAT) methods and real-time release test methods for both Batch and Continuous Manufacturing. Sarah started her career with J&J 10 years ago as a post-doctoral fellow working on cardiovascular stent research, and about 5 years ago moved to her current role which focuses on PAT and development of surrogate QC release test methods.
SVP Global Quality
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.
Sr. Director Regulatory CMC Team Leader
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.
Vice President, Global Quality Assurance and Regulatory Affairs
Thermo Fisher Scientific
Peter Shearstone joined Thermo Fisher Scientific in 2018 as Vice President, Global Quality Assurance and Regulatory Affairs (QARA), and is responsible for leading the company’s global, corporate QARA team to ensure our products are safe and comply with their intended use. Headquartered in Waltham, Massachusetts, Thermo Fisher is the world leader in serving science; our mission is to enable our customers to make the world healthier, cleaner and safer.
Prior to joining Thermo Fisher, Peter worked in executive-level quality and regulatory roles for 30 years, most recently at Sysmex America, where he served as Vice President, RA/QA/Clinical and Medical Affairs. Prior to that, he held QA leadership roles at Abbott Diagnostics and Siemens Healthcare.
Peter holds a bachelor's degree in biology from Salem State University in Salem, Massachusetts.
Global Section Head, Health Care Quality Systems & Capabilities for Cosmetics, Devices, Drugs & Food
Procter & Gamble
Nancy Singer founded Compliance-Alliance LLC in 2004 to specialize in the professional development for government, association and business professionals. She has taught over 1700 people how to improve their communication practices. She is on the faculty of George Washington University Medical School and Health Science Program, and she has taught classes at Johns Hopkins University, University of Southern California, and Harvard Symposia. Previously she served as Special Counsel for the Advanced Medical Technology Association. For her efforts to improve communication between the government and the regulated industry, Nancy received Vice President Gore’s Reinventing Government Hammer Award and the FDA Commissioner’s Special Citation. She began her career as an attorney with the United States Department of Justice doing litigation for FDA enforcement cases. Subsequently she was a partner at the law firm of Kleinfeld Kaplan and Becker. Nancy is a retired commander in the Naval Reserve.
Master Biopharaceutics Reviewer/Biopharmaceutics Lead
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).
Senior Director, External Affairs, Quality Intelligence and Inspection
Novo Nordisk A/S
Assistant Commissioner for International Programs (Acting)
Operations Research Analyst
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.