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.
Deputy Commissioner for Policy, Planning, Legislation and Analysis
As Deputy Commissioner for Policy, Planning, Legislation and Analysis, Anna Abram plays a critical role in overseeing the development and implementation of key policy initiatives and provides strategic policy direction to advance FDA’s mission and vision of protecting and promoting public health.
Prior to being appointed to this senior leadership position at the FDA, Ms. Abram served in the Office of the Secretary at the Department of Health and Human Services (HHS).
Ms. Abram is a respected FDA policy thought leader with more than thirteen years of health care policy experience, including more than a decade of working on health care policy in the United States Senate. She served as the long-time Health Policy Director and Senior Advisor to Senator Richard Burr at the Senate Health, Education, Labor and Pensions (HELP) Committee. In this role, she was actively involved in a range of health care issues under both the Senate HELP and Finance Committees. Her tenure at the Senate HELP Committee was particularly distinguished by her contributions to advancing bipartisan FDA and medical and public health preparedness and response legislation, including securing multiple patient-centered drug and device provisions in the Food and Drug Administration Safety and Innovation Act and 21st Century Cures laws.
Over the years, Ms. Abram has played key roles in advancing legislation to support innovation on behalf of patients and strengthen our nation’s public health. She spearheaded the bipartisan negotiation and enactment of the most significant security enhancements to our nation’s pharmaceutical supply chain in the past 25 years through the Drug Quality and Security Act. She also was instrumental in strengthening our nation’s medical countermeasure work and medical and public health preparedness and response programs through the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013.
Ms. Abram was previously appointed by President George W. Bush to serve as an Associate Director at the Domestic Policy Council at The White House. In this role, Ms. Abram coordinated the development and implementation of a range of health care policy issues, including food, drug and public health policy. She coordinated the White House-led, interagency policy process to reauthorize the President’s Emergency Plan for AIDS Relief (PEPFAR) in 2008.
Ms. Abram graduated magna cum laude from the University of Pennsylvania.
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.
VP & GM Cincinnati Regional Operations, Pharma Services Group
Thermo Fisher Scientific
Mandy Bosse has more than 19 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.
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.
Senior Vice President
Grace has over 25 years of global experience in the Pharmaceutical and Medical Device industry and has held global leadership positions at Hospira, Catalent Pharma Solutions, Pliva Inc., Janssen Pharmaceutica and Elan Pharmaceuticals. Her Quality and Compliance expertise spans API’s, solid dosage forms, parenterals, and infusion devices. Most recently with Impax (formerly CorePharma), Grace was responsible for the development and execution of a contemporary Corporate Quality and Compliance strategy. Grace holds a post graduate diploma in pharmaceutical manufacturing technology from Trinity College Dublin, Ireland, an M.S. in chemistry from Dublin City University, Ireland and a B.S. in chemistry from University College Cork, Ireland.
Vice President, Quality Systems & Post Market Quality, Global Surgery, Ethicon & Cardiovascular & Specialty Solutions
Johnson & Johnson
Adrienne is Vice President of Quality Systems and Post Market Quality, Ethicon & Cardiovascular & Specialty Solutions at Johnson & Johnson. She is responsible for the successful implementation of policies and strategies for quality systems and post market quality to assure compliance with regulations and industry standards, and implementing a globally integrated quality management system approach balancing customer satisfaction and regulatory compliance with business objectives. Adrienne has over 22 years of experience within the medical device & diagnostic, nutrition, consumer, and pharmaceutical industries. Prior to joining Johnson & Johnson in 2011, she held positions of increasing responsibility in quality systems, regulatory compliance, quality operations, and supply chain at Abbott.
Director, Global Chemistry, Manufacturing & Controls
Jennifer L. Brown is currently a Director in the Global Chemistry, Manufacturing & Controls group within Worldwide Regulatory & Safety at Pfizer Inc in Groton, CT. With a small team, she is responsible for CMC strategy for a global portfolio of investigational and commercial products. Jen has a bachelor’s degree in chemistry from Muhlenberg College in Allentown, Pennsylvania, and a master’s degree in regulatory affairs from Temple University. Jen has been at Pfizer for 20 years, in Analytical R&D and then GCMC. Prior to joining Pfizer, Jen was a Peace Corps volunteer in Gabon, Central Africa, teaching middle school science, and Jen also served as a Pfizer Global Health Fellow, working at the Kakuma Refugee Camp in northern Kenya for several months in 2005.
Associate Director, Treyburn & Supplier Quality Assurance
Cathleen has over 25 years of experience in the Pharmaceutical and Medical Device industry and has held quality leadership positions at Digene Diagnostics, DentSply International, Dornier Medical Systems, Solvay (Abbott) Pharmaceuticals, Dendreon Corp, Aaron Industries, and Purdue Pharma L.P. Cathleen’s expertise includes third party manufacturing, product complaint monitoring, and implementation of various quality systems. She has extensive quality and compliance knowledge of medical device, biologic, solid, liquid oral dose, and transdermal manufacturing.
In her current role Cathleen leads the external supplier quality assurance group, and heads the quality function for Purdue’s Durham, North Carolina, manufacturing facility. She is currently working on a M.S. in regulatory affairs from Johns University. Cathleen holds an M.B.A. from the University of Phoenix and a B.S. in microbiology from the University of Georgia.
Head of Quality, Business Line Silica, Region North America
Dale Carter is the Head of Quality for the Business Line Silica in the Region North America. He is responsible for product quality and compliance with IPEC/PQG GMPs for the manufacturing of Silica products at facilities in Tennessee, Maryland, Pennsylvania, Alabama, and New York. Dale is a Board member of EXCiPACT and a member of the NSF Joint Committee for Pharmaceutical Excipients that wrote the ANSI/NSF/IPEC/363 Good Manufacturing Practices for Pharmaceutical Excipients. He is a Past Chair of International Pharmaceutical Excipient Council of the Americas and currently serves as Vice Chair Membership. Dale received an M.S. in chemistry from North Carolina State University and a B.S. in chemistry from Davidson College. He is an ASQ Certified Quality Auditor. Prior to joining Evonik/JM Huber Dale worked for Pfizer, The Coca-Cola Company, and Archer Daniels Midland Company.
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.
Vice President, Operations
Troy Fugate utilizes 30 years of hands-on insight into Quality Assurance, Validation, Workforce Development and Training skills to evolve GMPs from a regulation to a value-added habit. Mr. Fugate has been a partner in Compliance Insight since 2001, helping companies around the world, and serves in a variety of roles including: Workforce Development, Strategic Compliance Initiatives, and FDA Mitigation.
Compliance Insight serves as a workforce mobilizer to facilitate performance excellence. Their uniqueness stems from a blend of three elements – Insight – Infusion - Integration. Their goal has been, and will always be, to provide value to any firm by offering simple, practical solutions in the areas of Quality, Regulatory and Clinical compliance.
Mr. Fugate has been a proponent of proactive, sustainable compliance solutions and is an enthusiastic supporter (not to mention co-leader) of Good Supply Practices initiated by Xavier Health.
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.
Team Lead, Pharmaceutical Sciences Quality Assurance, Global Supply
Diana Grohs is currently a Senior Manager in the Pharmaceutical Sciences Quality Assurance Group within Global Supply at Pfizer, Inc in St. Louis, MO. She and her team are responsible for the quality related on-boarding and oversight of external contracted parties providing GMP services to support clinical trials. This includes manufacturing, testing, and other specialized contracted services for biologics, small molecules, gene therapy products, and medical devices.
Diana has a bachelor’s degree in animal science from the University of Missouri-Columbia and a master’s degree in biotechnology from Washington University in St. Louis. Diana has been at Pfizer for 13 years in various Quality roles. Prior to joining Pfizer, Diana worked for Monsanto Co. for 22 years in various R&D roles including Analytical, Quality Control, and Quality Assurance.