Janmeet Anant, PhD
Janmeet Anant, Ph.D., PMP, RAC serves as a Senior Regulatory Consultant at MilliporeSigma, focused on pharmaceutical manufacturing, specifically working on sterile injectables. Janmeet has been a key member of the Paradigm Change in Manufacturing Operations (PCMO), which is a Quality Risk Management (QRM) team of the Parenteral Drug Association (PDA). In addition, Janmeet serves as an Executive Board Member for the Bioprocess Systems Alliance (BPSA), Vice-Chair of a subcommittee of the American Society of Mechanical Engineers - Bioprocessing Equipment (ASME-BPE) standard setting organization, and a member of the Regulatory Governance Team at BioPhorum. With over 20 years of experience in the pharmaceutical industry, Janmeet has been consulting on complex regulatory strategy projects with pharmaceutical drug manufacturers, leveraging skills from his Project Management Professional (PMP) and Regulatory Affairs Certification (RAC). Janmeet has a Bachelor of Science degree in Chemistry and a Ph.D. in Pharmacology.
Jeffrey C. Baker, PhD
National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL)
Dr. Jeffrey Baker is a cell physiologist and biochemist by training. He spent over 20 years in the pharmaceutical industry leading process development and manufacturing of both legacy and first in class biological products and then 10 years at the United States FDA as Deputy Director, Office of Biotechnology Products, CDER. In the latter role he received several CDER awards for renewing and rebalancing OBP review, inspection, and research practices and in 2018 received an FDA Honors Award for contributions to “modernizing the U.S. regulatory system for biotechnology. products through sustained creative leadership and collaboration.” He was CDER liaison to Manufacturing USA and the Advanced Manufacturing National Program Office and worked on interagency advanced manufacturing program development during the COVID pandemic. He retired from the FDA in 2021 but remains active in the biotech community as a Senior Fellow in the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL), Senior Strategic Advisor for the Center for Biotech Innovation at MIT, and as adjunct faculty/guest lecturer at several universities .
George Bernstein, PhD, ChE
Double Dragon Consulting
George Bernstein, Ph.D., is Managing Principal of Double Dragon Consulting, Inc., a consulting firm with a network of Subject Matter Experts (SMEs) located in the US, Europe, and Asia Pacific (China, India). Dr. Bernstein has a Ph.D. in Chemical Engineering and over 30 years of experience in pharmaceutical manufacturing, laboratory operations, data integrity, training effectiveness assessments, and quality risk management. Since 1988, Dr. Bernstein has consulted internationally with major pharmaceutical companies and has lectured Internationally on quality systems and root cause analysis to industry trade groups, quality organizations, and at Interphex.
Dr. Bernstein’s experience, insights, and innovative problem solving have been integral to his work which ranges from training effectivenss, GMP compliance, facility design, construction, and commissioning to business process re-engineering and process optimization. He has developed global quality standards (GLP, GCP, GPP) for a major international pharmaceutical company, and has assisted many clients with audit preparation, remediation activities, and communications with the US FDA.
Anthony C. Bevilacqua, PhD
Dr. Anthony Bevilacqua is a Principal Scientist at Mettler-Toledo Thornton. He earned a doctorate in Analytical/Physical Chemistry from Tufts University. Since 1994, he has led several areas of Research and Product Development that include: impact of CO2 on pure water, ultrapure water as a conductivity solution standard, development of digital sensors, and expansion of real-time analytical parameters (conductivity, TOC, microbial detection, ozone, sodium, and silica) for measurement/control of high purity water systems, including pharmaceutical water systems.
Anthony was the conductivity consultant to USP during the implementation period for <645> Water Conductivity and <643> Total Organic Carbon USP chapters in the mid-1990’s, and he developed the theory, methods, and practicesfor conductivity testing for Purified Water and WFI. Anthony was Chair of the USP Pharmaceutical Water Expert Committee from 2000-2010. Anthony’s role continued in the 2010-2020 USP Chemical Analysis Expert Committee, and he is currently serving on the current committee for 2020-2025. For the last 25+ years, he has been working with EP, JP and other Pharmacopeias for international harmonization of pharmaceutical water quality standards and analytical test methods. He has multiple patents and delivered hundreds of presentations and numerous papers in pharmaceutical, microelectronics and water purification forums.
Benjamin Borgo, MS, PhD, MBA
Benjamin currently leads a team of forward-thinking product and service managers within MilliporeSigma's Genome Engineering and Modulation franchise. His first exposure to CRISPR-based genome editing was as a graduate student where he attempted to engineer novel protein variants using computational protein design in the Rosetta software suite. This work inspired a passion for CRISPR technology which he has brought with him to his current role within a company that is laser-focused on developing and utilizing revolutionary genome editing technologies for therapeutic applications. Prior to joining Merck KGaA, he has worked in various commercial and technical leadership roles at Berkeley Light Inc., Agilent Technologies, Nanopore Diagnostics, and several small start-up companies focused on software applications. Ben has a PhD in computational biology from Washington University in St. Louis, and an MBA from Wash U's Olin School of Business.
Donna Boyce is Senior Vice President of Global Regulatory Affairs. In this role, Donna is responsible for the global regulatory strategy, regulatory operations, global clinical pharmacology (GCP) quality, and global regulatory policy for Pfizer’s Drug and Vaccines Portfolio.
Donna joined Pfizer in May 2013 as the Vice President, Global Regulatory Affairs, Vaccines.
Donna has 25+ years of experience in Regulatory Affairs in the pharmaceutical industry, with over 20 years of vaccine global regulatory expertise, including CMC, clinical development, labeling, and promotion. She is an accomplished and energetic leader with a strong management background able to develop organizations and motivate staff. Donna is passionate about regulatory science and its strategic role within the pharmaceutical industry.
Before joining Pfizer, Donna spent 13 years at GSK, where she held several roles, including the Head of Vaccines Regulatory Affairs for North America. Donna also spent seven years in Regulatory Affairs at Merck & Co. Inc., serving as the Global CMC Regulatory Franchise Leader for Pneumococcal Vaccines.
Michael Brothers, PhD
Dr. Michael Brothers is currently a Principal Scientist and Techncial Program Manager at UES Inc. In this role, Dr. Brothers executes and supports a portofolio of research programs. Dr. Brothers supports and manages teams (~25 scientists) that specialize in sensors and device development, sensors testing, and field research, supporting research programs and aims within the 711th Human Performance Wing (711th HPW) at the Air Force Research Laboratory. Dr. Brothers personal research focuses on biosurveillence and chemical surveillence, including both developing novel devices and identifying, acquiring, and testing emerging technologies. Through this experience, Dr. Brothers has performed work on devices and methods for bioaerosols, chemical vapors, and wastewater sampling. Prior to UES Inc., Dr. Brothers graduated from the University of Cincinnati with a B.S. in Chemistry and Biology before obtaining his Ph.D. from the University of Illinois Urbana-Champaign in Chemical Biology, studying bacterial toxin structure and function, including for zoonotic toxins. During his graduate education, Dr. Brothers received both a Department of Homeland Security Research Fellowship as well as a Chemical Biology Interface Traineeship, providing additional insights into challenges in pathogen detection, emergence, and surveillance.
Paul Cashen, MSc
Paul Cashen is the Senior Bioprocess Specialist for the United Kingdom & Ireland, specialising in small-scale development and optimisation of Downstream Processing (DSP) technologies and applications. He has over 10 years of experience in development, optimisation and scale-up of biologics, with a primary focus on Gene Therapy applications.
He joined Pall in 2016 as a Bioprocess Specialist, focusing on early development in downstream processing, providing technical support and innovation for internal and external projects. His responsibilities include process development, troubleshooting, customer training and consultancy for all DSP applications from initial harvest to final filtration.
Paul’s academic background includes a BSc in Biomedical Sciences and an MSc in Industrial Biotechnology, both from Liverpool John Moores University.
UCB Pharma SA
Bob Chaplinsky is the Head of Quality Management Systems at UCB. A seasoned quality professional, Bob has shaped and guided quality teams at international biotechnology companies. Prior to joining UCB, Bob was the Director, Quality Intelligence at GlaxoSmithKline Biologicals where he worked with cross-functional teams spanning numerous global manufacturing sites. He began his career at Biogen Idec where he rose to Associate Director, Quality Assurance International, before joining Amgen. Bob received his Bachelor of Science in Biology and Biochemistry from Clarkson University.
Jerry L. Chapman, BS, MBA
Jerry Chapman is Senior GMP Quality Expert at Redica Systems. He brings over 40 years’ experience in the pharma industry, including 31 years at Eli Lilly, where he worked in product development, biosynthetic human insulin manufacturing, and site and corporate quality. He designed and implemented a comprehensive GMP Intelligence process to identify, analyze, and archive pertinent drug GMP regulations, inspection findings, trends, and best practices in the U.S. and internationally. Chapman was founder and chairman of the GMP Intelligence subgroup of the Midwest Discussion Group from 2005 to 2010. He was Senior Editor at International Pharmaceutical Quality for six years; Editor-in-Chief for Xavier Health; has been an invited speaker at PDA, AAPS, ISPE, and RAPS events; and has served as a consultant to the animal health and compounding pharmacy industries. At Redica Systems, Chapman works with the machine learning and data science teams building computer models that examine enforcement actions and other data and produce analyses the way an expert would in the past using hard copy documents and a highlighter. His articles detailing and analyzing current hot topics among the pharma industry and international regulators appear on the Redica Systems Conference Spotlight page.
Michael de la Torre
Michael de la Torre is the CEO at Redica Systems, formerly known as Govzilla. Redica Systems is a technology company using data, analytics, and expertise to deliver meaningful insights to quality and safety professionals around the world. By applying artificial intelligence to large and disparate government data sets, Redica Systems empowers its customers to improve compliance, increase product quality, and build a more efficient organization. Redica Systems serves over 200 customers in the pharma, medical devices and food industries. Its headquarters are in Pleasanton, CA.
Prior to joining Redica Systems, Michael held executive roles in Product Management, Sales and Marketing, and Business Development. He began his career at McKinsey & Company. Michael received his Bachelors in International Finance from Texas A&M University where he was also scholarship football player.
He received his MBA from University of Chicago Booth School of Business where he was valedectorian of his graduating class.
Robert Dean, MBA
Merck & Co., Inc.
Bob is currently a Director/Team Leader in Merck's Office of Advertising and Promotion Review. Bob started his career as an in-process QC Chemist with Abbott Laboratories. He performed similar duties for Alpharma before transitioning to field sales with UCB Pharma, Alza, and eventually J&J. Bob left industry for public service at FDA where began his role in DDMAC as a Regulatory Review Officer. As DDMAC grew and transitioned to OPDP, Bob's responsibilities increased as he assumed the role of Division Director, Division of Direct to Consumer Promotion (now the Division of Advertising and Promotion Review 2). During his time at FDA, Bob was instrumental in leading several high profile efforts for OPDP, including; Issuing 5 enforcement actions on the same day to manufacturers of ADHD medications, issuance of 14 Google Sponsored Link letters, and co-developer of FDA's Bad Ad Program.
Anne Marie Dixon-Heathman, MBA
Cleanroom Management Associates, Inc.
Owner and President of Cleanroom Management Associates, Inc., a consulting firm based in The Villages, FL, that specializes in competitive benchmarking, training, and auditing of clean and aseptic operations and management.
Actively engaged in the field of contamination control for over 40 years with extensive experience in the areas of cleanroom operations, training, technical writing, strategic consulting, facility start-up, construction protocols, and process optimization. Has trained over 1,000,000 cleanroom technicians and managers.
Past President of IEST and Current Head of US Delegation to ISO TC 209 - Cleanrooms and Associated Controlled Environments.
Derek I. Duncan, PhD
Dr. Duncan began his career at the Dutch Institute for Atomic & Molecular Physics. He then moved into industry and has been based at the LIGHTHOUSE office in Amsterdam since 2003, responsible for developing applications for pharmaceutical process monitoring and finished product inspection. A member of PDA since 2004, Dr. Duncan has been a regular contributor to PDA conferences and Interest Groups and was the recipient of the 2015 PDA Europe Service Appreciation Award and the 2020 PDA Edward Smith Packaging Science Award. He holds a degree in Physics and Mathematics from Louisiana State University and a Ph.D. in Atomic & Molecular Physics from the University of Virginia.
Michael T. Edey
Michael Edey is a Senior Principal Engineer, Global Technology & Engineering at Pfizer Inc. The role is undertaken as a member of a corporate team with responsibilities for Primary Packaging for the Pfizer Sterile Injectables Network. Michael has a diverse background in Pharmaceuticals with over 25 years of experience in Production Management, Quality Assurance, and Technical Leadership. More recently with a global technical role leading CCIT initiatives with an emphasis on quality risk management as part of the application of a holistic science-based approach.
Mary E. Farbman, PhD
Merck & Co., Inc.
Mary Farbman leads a team of GMP experts responsible for compliance support at Merck’s manufacturing facilities across the globe. She previously worked at FDA/CDER’s Office of Compliance, where she was responsible for authoring and reviewing warning letters and other compliance documents, conducting microbiological reviews of therapeutic protein manufacturing processes, and performing pre-license inspections of BLA products. In industry, she has worked at both the site and global levels in various compliance and auditing roles as well as in the R&D arena. Her areas of expertise and interest include biotechnology, sterile products, and analytical techniques. She holds a doctorate degree in biological chemistry from MIT, where she studied the enzymatic mechanisms of bacterial unfoldases and proteases.
Jim (James) M. Fries
Jim Fries is a success-based executive with more than 25 years of experience building medical device and diagnostic companies across all pathways, including growth-oriented commercial initiatives, regulatory, and market access. Jim has been involved in driving thought-leader panels and committees within the areas of vascular intervention, cardiometabolics, diabetes, orthopedics, and pharmaceutical quality, which has resulted in numerous guidelines and consensus papers. Jim became CEO of Rx-360 in February of 2018, as a way of fulfilling his personal lifelong commitment to patient safety.
Karen Ginsbury, MSc
PCI Pharmaceutical Consulting Israel
Karen Ginsbury is a pharmaceutical consultant with a passion for quality: defining and meeting all the requirements all the time. A member of PDA for over 30 years, former RAQAB member, PDA letter editorial team and interest group leader, founder and former president of the Israel Chapter of PDA. Karen works with companies to set up, maintain and improve their Quality Management Systems.
Donna Gulbinski’s expertise spans worldwide operations, quality, and regulatory experience across vaccine, biological, pharmaceutical and device technologies where she was an operational leader with a history of delivering exceptional quality, compliance and business performance.
Donna has a 30-year plus career where she held positions of significant responsibility for Quality and GxP Compliance, including various roles in drug discovery, operations, quality and regulatory affairs at Merck & Co., Bristol Myers Squibb and Lachman Consultants. Donna is currently the Chief Quality & Regulatory Affairs Officer at Civica, Inc., a new independent not-for-profit company founded by health systems and philanthropies to address critical generic drug shortages caused by market failures.
Aidan J. Harrington, PhD
Aidan Harrington is a Principal Consultant with DPS Group based in Cork, Ireland who has worked in the Biopharmaceutical Industry since 1992. He is a graduate of University College Cork with a BSc in Microbiology, a PhD in Molecular Biology and is a Qualified Lead Auditor. He worked in QA, Validation and Engineering roles at Schering-Plough, now MSD, a biological API and fill finish facility for 7 years prior to joining DPS Group, a global consulting, engineering and construction company in 1999. He has been a Project Manager and Consultant on multiple pharmaceutical manufacturing facility designs, C&Q programs and start-ups, in addition to auditing of facilities as part of pre-inspection readiness programs. He is the principle regulatory / cGMP design consultant for the DPS group supporting new pharmaceutical manufacturing facility designs from concept studies to start-ups and operational readiness. Since Nov 2019, Aidan has worked as Program Manger with responsibility for operational readiness for a start up Cell Therapy facility.
Aidan is President of the PDA Ireland Chapter