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.
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.
Jennifer L. Brown
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.
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.
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
Art O. Czabaniuk (invited)
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.
Vice President, Quality and Regulatory Affairs
IBM Watson Health
John joined IBM in May of 2016 and is responsible for ensuring Watson Health’s portfolio complies with all relevant lifescience related regulations. Prior to joining Watson Health, John was with Boston Scientific for nine years and had a number of positions there including the head of International Quality, Distribution and Supply Chain and management board level positions for their Endoscopy and Urology and Women’s Health. Prior to Boston Scientific, John worked for Johnson & Johnson and held quality related positions in their device, diagnostic, and pharmaceutical sectors. John has over 20 years of experience with FDA regulated industries and has special expertise in Design Control, Software Quality, and Quality Systems.
Mark A. DiMartino
Director, Quality Data Sciences
Mark is the Director of Quality Data Science in the Quality Data Science group at Amgen, Inc. In this role Mark is responsible for the application of cognitive computing techniques such as natural language processing and machine learning on manufacturing and quality related data with the goal of unlocking insights and improving operations. Prior to this role, Mark was the Director of Quality Engineering (QE) responsible for statistical support for all areas within operations, including: delivery devices; commercial, clinical and contract manufacturing; analytical method; development, transfer, and validation; product stability; product commercialization; and product characterization
In addition to his QE role, Mark also served as the global network lead for the Product and Process Performance Network (PPP) which is charged with developing and improving the Continued Process Verification (CPV) procedures at Amgen and representing Amgen’s position on CPV externally.
Mark holds a M.S. in applied statistics from DePaul University and a B.S. in cellular biology from the University of Illinois. He is an American Society for Quality Certified Quality Engineer (CQE).
Senior Director of Product
Patrick Hall is a senior director of data science products at H2O.ai, a leading AI company. Patrick works with H2O.ai customers to derive substantive business value from machine learning technologies and his internal product work at H2O.ai focuses on explaining complex automated decisions generated by AI and machine learning systems to business decision-makers.
Patrick is also currently an adjunct professor in the Department of Decision Sciences at George Washington University, where he teaches graduate classes in data mining and machine learning. Prior to joining H2O.ai, Patrick held global customer facing roles and R&D research roles at SAS Institute. He studied computational chemistry at the University of Illinois before graduating from the Institute for Advanced Analytics at North Carolina State University.
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 25 years. He has a degree in Biology from Northern Kentucky University. In his career with FDA he was an investigator for 12 years, specializing in drugs before becoming a Supervisor. Steve currently oversees the Cincinnati District’s human drug program and supervises approximately 10 investigators. He manages some of the district’s most complex drug work.
Cloud Solution Architect, Advanced Analytics & AI
Orrin has almost two decades of experience with analyzing, wrangling and curating data. Utilizing everything from embedded devices to clusters of servers to meet the needs of healthcare, financial services and retail organizations, Orrin built financial data solutions for the US Army as a civilian and then spent seven years with a global analytics company serving healthcare & retail customers. There he helped transform the data services organization from an IT cost center to the epicenter of value creation for the company utilizing automated processing, a global workforce, Hadoop, NoSQL and distributed computing platforms. After that, he spent a year with a large consulting firm helping healthcare, financial services, and manufacturing organizations with Hadoop, cloud, predictive analytics and other complex enterprise data solutions.
Since 2016, Orrin has been dedicated to helping healthcare organizations be successful with cloud solution deployments as an architect focusing on data warehousing, machine learning, advanced analytics and AI with Microsoft. With a distinct healthcare focus, he helps organizations extract more value from data while spending less by utilizing the cloud. Orrin has created and lead global technical teams across the US, Canada, UK, and India.
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.