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.
District Director & Program Division Director, Office of Human & Animal Food, East 5
Steven Barber is the District Director of the Cincinnati District office and Program Division Director for the Office of Human & Animal Food, East 5. 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 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.
Director, Office of Policy for Pharmaceutical Quality
Ashley Boam currently serves as Director of the Office of Policy for Pharmaceutical Quality (OPPQ) in the Office of Pharmaceutical Quality (OPQ) in the Center for Drug Evaluation and Research (CDER). OPPQ is responsible for developing and clearly communicating science- and risk-based policies and standards related to drug product quality, including application review and inspection. This Office also coordinates OPQ’s work with international regulatory authorities on quality issues, leads CDER’s compendial operations, coordinates CDER’s involvement in quality standard-setting organizations, and addresses policy issues related to drug-device combination products.
Prior to joining CDER in 2013, Ashley spent nearly 20 years in the Office of Device Evaluation (ODE) in FDA’s Center for Devices and Radiological Health (CDRH), serving as a scientific reviewer, a Branch Chief in the Division of Cardiology Devices, and finally as Associate Director for Regulations and Guidance for ODE. Ashley received her MSBE from the University of Alabama at Birmingham and her B.S.E. from Tulane University, both in biomedical engineering.
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.
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.
Director, Regulatory Policy & Intelligence
Charles “Chris” Celeste joined LEO Pharma, Inc. in 2015 as Director of Regulatory Policy and Intelligence. Prior to joining LEO, he was the Director of Regulatory Information and Submissions for EAS Consulting Group, LLC. and Director of Regulatory Operations and Intelligence at Kendle International’s Regulatory Affairs (formerly AAC Consulting Group) with responsibilities for regulatory submissions (INDs/NDAs/ANDAs/DMFs), developing regulatory strategies, import issues and general regulatory questions. Primary responsibilities in his current role with in LEO’s Regulatory Policy and Intelligence group, include disseminating key U.S. regulatory information, and providing ad hoc regulatory intelligence and analyses. Chris has a Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals Society (RAPS).
Vice President Regulatory Science, Quality Assurance, and Compliance
Acerta Pharma (AstraZeneca group)
Fabric Home & Power Quality
Procter & Gamble
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.
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 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.
Organic Laboratory Branch Director, Forensic Chemistry Center
Cheryl L. Flurer, Ph.D., is the Organic Laboratory Branch Director of the Forensic Chemistry Center. She joined the FCC in 1992 as a Research Chemist, with expertise in the chromatographic separation of proteins. Later she served as a separations team leader and then as a supervisor, specializing in the analysis of suspect pharmaceuticals and dietary supplements, prior to becoming Branch Director in 2012.
Dr. Flurer is responsible for leading a staff of 30 and directing all activities of the branch which provides specialized analytical services in support of criminal and regulatory investigations involving consumer complaints, product tampering, microbiological contamination, counterfeit and unapproved pharmaceuticals and devices, and fraudulent/adulterated products. Dr. Flurer serves a member of the ORA/CDER/CVM Strategic and Scientific Compliance Steering Committee and the FBI’s CBRN (Chemical, Biological, Radiological and Nuclear) Sciences Unit Partner Laboratory workgroup. Dr. Flurer received her Ph.D. in analytical chemistry from Indiana University.
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.
Research Fellow in Global CMC
Tom Garcia is a Research Fellow in Global CMC, Pfizer Inc., Groton, Connecticut. He received a B.S. in Pharmacy from Albany College of Pharmacy in 1983, and a Ph.D. in Industrial and Physical Pharmacy from Purdue University in 1989.
Prior to joining Global CMC in 2003, Tom spent over 14 years in the pharmaceutical industry in the areas of process development and technology transfer, where his primary interests were powder mixing, blend and content uniformity, and the use of statistical techniques during process development, optimization, and in the assessment of process capability and robustness. He was active in defining regulatory strategies for Quality by Design (QbD) dossiers, and is currently involved with defining development and regulatory strategies for products being manufactured by continuous manufacturing. Tom is a member of the ICH Q 13 (Continuous Manufacturing) Expert Work Group. He is an Adjunct Associate Professor in the Department of Pharmaceutical Sciences at Albany College of Pharmacy and Health Sciences, and held a similar position at Campbell University (1996 – 2000).
Tom was a member of the SUPAC IR Industry Training Committee (1995-1996), served as Chair of the Product Quality Research Institute (PQRI) Blend Uniformity Working Group (2000-2004), was a member of the ISPE Product Quality Lifecycle Implementation Control Strategy Task Team (2007-2010), led the ISPE BUCU Group (2013-2016), and is a co-leader of the ISPE Continuous Manufacturing Group.
Pharma Solutions Executive
Ms. Stephanie Gaulding is a Principal Consultant in DPS’s Strategic Consulting Group. As a Quality Systems professional with over 20 years’ experience in Pharma, Biotech and Medical Device industries, she draws on her experience to develop, redesign and implement efficient and sustainable quality systems for her clients resulting in compliance with global regulatory requirements and industry best practices. Ms. Gaulding is an ASQ Certified Quality Auditor and ASQ Certified Pharmaceutical GMP Professional. She holds a M.Sc. in Biotechnology from Johns Hopkins and a B.Sc. in Biology from Virginia Tech.
Ms. Gaulding is an active member of PDA, ISPE, and ASQ including co-teaching the ISPE “Applying Quality Risk Management” course, serving as a member leader in ASQ Human Development and Leadership Division, and participating in the Certified Pharmaceutical GMP Professional Exam development process.
Senior Vice President, Technical Operations
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.
Director of Operations
Adam currently serves as Director of Operations for Cook MyoSite Incorporated, a Cook Group company. Cook MyoSite is currently conducting several clinical studies for their autologous cell-therapy treatment. Adam is responsible for providing strategic direction to the Manufacturing Operations, Technical Services, Customer Logistics and Finance units, as well as the Project Management and Operational Excellence Office. Adam has been with Cook MyoSite for over 11 years, where much of his focus has been directed toward establishing a scalable supply chain for commercialization of Cook MyoSite’s cell therapy treatments.
Prior to joining Cook MyoSite, Adam earned his B.A. in business management & economics and B.S. in biology from the University of Pittsburgh at Johnstown and his M.B.A. from the University of Pittsburgh.
Director of Technical Operations and CMC Supply Chain
Vice President, Regulatory Affairs
Christopher Jordan is the Vice President, Regulatory Affairs at Endocyte, Inc, a research phase pharmaceutical company developing targeted therapies for treatment of prostate cancer and other solid tumors.
Prior to joining Endocyte in 2013, Christopher spent >25 years at Eli Lilly in a variety of drug development roles covering pre-clinical to post approval settings. While at Lilly, he led global regulatory teams on multiple diabetes projects, including the pivotal clinical trials for insulin peglispro and approvals of drug/device combination products for Humalog U100 KwikPen and Humulin R U500 insulin syringe. He currently leads development and implementation of global regulatory strategy for Endocyte’s product portfolio across all indications. Christopher received a B.S. in chemistry from Purdue University and a MSHS in regulatory affairs from George Washington 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.
Senior Vice President, Head of Small Molecule Operating Unit, Technical Operations
David joined Shire 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 Shire 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.
Director of Pharmacy
Vice President of Digital Innovation
As Vice President of Digital Innovation at Sparta Systems, Steve is uniquely qualified to enhance Sparta's mission of advancing the value of Quality Management Systems for the life sciences industry. As domain expert and industry evangelist, Steve serves as a key resource across the company, sharing his leadership, and experience while contributing to customer interactions, thought leadership and product development. In this role Steve supports Sparta’s mission of helping the industries they serves create higher quality, safer products, streamline their operations, lower risk and assure compliance, using innovative cloud solutions that support their digital journey.
Steve has nearly three decades of experience within life sciences. Prior to joining Sparta, he held several high-profile positions within Johnson & Johnson, most recently as VP of Quality Systems Shared Services for all three segments of the company (Pharmaceuticals, Medical Devices and Consumer).
His earlier career was spent in virology research at the University Hospital St. Thomas’ in London.
Steve holds a BSc in Medical & Industrial Biology from Cardiff University in Wales, UK.
Associate Director, Global Patient Safety
Brian J. McCormick has been with Perrigo since 2006 and possess a degree in biology from Central Michigan University. Brian has held many positions in Continuous Improvement, Quality Assurance and Control, Pharmacovigilance, Product Quality Complaints and Technical Operations. He has Rx and OTC experience in solid, semi-solid and liquid dosage forms. Prior to joining Perrigo in 2006, Mr. McCormick worked in the automotive industry managing the design, research and development, engineering and manufacturing of a product from inception to launch.
Director in Global CMC
Megan McMahon is a Director in Global CMC at Pfizer in Connecticut. Megan received her B.S. in Chemistry from Purdue University and M.S. in Regulatory Affairs/Quality Assurance from Temple University. Megan started at Pfizer in Chemical R&D as an analytical chemist and has worked in Regulatory CMC for the past 11 years. She is a member of Pfizer’s Impurity Council and Stability Council. Megan was a founding member of the AAPS Chemical and Biological API Focus Group in 2009 and served as chair in 2012 and 2013.
Megan is currently an active member of the AAPS CMC Community steering committee and has taken a leading role on the AAPS Virtual Round Table series. In addition to her support of AAPS, Megan is an active member of the IQ Analytical Leadership Group, IQ Risk Based Predictive Stability Working Group, and leads the IQ Lean Stability Working Group.
Corporate QA, Audits & Assessments and Digitization Leader
Vice President of Quality
Pharmaceutical Technical Lead
BSI Group America
Ben Mills is the Pharmaceutical Technical Lead for BSI. At BSI he manages clients’ supplier audit programs and serves as a GMP consultant to the pharmaceutical industry. Ben has more than 23 years’ experience in the biopharmaceutical Quality arena. His experience includes Quality Systems, Supplier Management, Quality Process Improvement, GMP/GDP Auditing, Executive Facilitation/Training, and Contractor Management. Ben is the former co-chair of the Rx-360 Audits Operations Group.
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.
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.
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 five-year-old daughter.
Associate Director of Corporate Quality Compliance
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.
Director, Commercial Transformation and CRM Solutions
Manager, Quality Engineering
Mike Reske is presently the Quality Engineering Manager at Perrigo in Allegan, Michigan, where he has been employed for the last 22 years. In his current role, he is responsible for annual product reviews, deviation trending, internal limits, and other lifecycle process monitoring activities. He has held positions in technical support and R&D, and is also currently part of the leadership team overseeing the rollout of the Quality Metrics initiative. Mike is a trained statistician, with an M.S. degree in applied statistics from Western Michigan University.
Senior Director, Technical Steward
Eda Ross Montgomery, Ph. D. is currently Head of PRO.GO, Process Governance and Data Management, Technical Operations, at Shire, where she is responsible for process validation and continuous process verification for Shire’s Plasma and Biologics products. She is also responsible for providing visibility to product and project performance and for strategy and execution around support for major process investigations. She held previous leadership positions in both Technical (R&D and Commercial) and Quality at Shire, Vertex, Bristol-Myers Squibb, and DuPont Pharmaceuticals.
Eda has over 25 years of experience in the pharmaceutical industry and over 15 years experience implementing Quality by Design across all phases of the product lifecycle. She obtained her B.S. in chemistry from Rensselaer Polytechnic Institute and Ph.D. in analytical chemistry from U of North Carolina at Chapel Hill.
Sr. Supply Director
VP, Manufacturer Operations
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.
Vice President, Global Quality Assurance
Procter & Gamble
Consumer Safety Officer, Drug Specialist
Medical Officer, CDER/OND/DCRP
Vice President, Global Quality Assurance and Regulatory Affairs
Thermo Fisher Scientific
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).
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.
Pharmaceutical and Compliance Consultant
Bill Webb has over 30 years of experience in Pharmaceutical Quality Operations, and in his most recent role, was responsible for internal US WorldMeds Quality Assurance and Quality Control, and international Quality oversight of CMOs and CLOs. Other 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. Additionally, while at the Forest Pharmaceutical facility in Ohio, Mr. Webb was responsible for Quality at various levels. Mr. Webb is currently engaged in pharmaceutical and compliance consulting.
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.
Vice President of Global Quality
Jacques Zimmowitch is Vice President of Global Quality. Prior to this, Zimmowitch was Vice President of Global Quality for Drug Product Operations for Americas and Asia and Global Computer System Operations for Eli Lilly and Company. In this capacity, he provided strategic direction and was responsible for Good Manufacturing Practices (GMP) compliance at the company’s Drug Product, Device and Distribution Operations in the Americas and Asia and for overall quality of the Lilly US Sales and Marketing affiliates. He also provided ultimate quality oversight for Consumer Product Quality Assurance (Complaints) programs globally and led the Parenteral Network Quality Steering Team, setting technical direction for quality and sterility assurance activities at these manufacturing sites. Zimmowitch was a member of Eli Lilly’s Manufacturing Policy Committee which is the governing body for Manufacturing and Supply Chain for Eli Lilly’s global manufacturing operations.
Zimmowitch joined Lilly initially in 1991 and held multiple assignments in France and in the US through 2007 covering: Technical Services/Manufacturing Science, Quality Control Laboratory, Global Supply Chain, Operational Manufacturing and both Manufacturing Sites Quality Assurance and Global Quality Assurance. For two years, he led the Quality and Regulatory organization of Becton Dickinson, Pharmaceutical Systems business unit, before he rejoined Lilly in October 2009.
Zimmowitch was born and raised in France and holds a Master of Science (DEA Biology/Physiology) from France University of Paris and a Master of Business (Essec – France).
Jacques represented Eli Lilly and Company and the Pharmaceutical Industry as a member of the PhRMA GQMC (Global Quality and Manufacturing Committee).