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Committee & Speaker Biographies

Committee & Presenter Biographies

2022 PDA Annual Meeting

04-06 April 2022

  • Jason Kerr

    Jason Kerr, MBS, MBA

    Redica Systems

    Jason Kerr is an experienced quality and regulatory professional and has been a champion in engaging, connecting, and promoting regulatory compliance in the dynamic biopharmaceutical landscape. Driven by data, he takes pride in providing the best possible outcome while remaining compliant and efficient. As a GXP Senior Specialist at Redica Systems, Jason's goals include enhancing the quality and regulatory knowledge and advancing key topics, such as data integrity, throughout the industry. He previously worked at Amgen where he monitored global regulatory intelligence and identified quality requirements to be triaged, assessed, and implemented to ensure compliance. This included designing and implementing a system to track changes being implemented and provide regular updates to key stakeholders.

  • Shelley Preslar

    Shelley M. Preslar, MBA

    Azzur Training Center Raleigh LLC

    Shelley Preslar is the Founder and President of Azzur Training Center and has more than 27 years of FDA-regulated industry experience that includes time spent in both operating and consulting companies. Her technical experience spans Quality Systems, Compliance, Validation, Metrology, Maintenance, Manufacturing Operations and Training. Throughout her career she has served the industry by participating in both PDA and ISPE as a speaker, volunteer, board member, technical group leader and co-chair on teams that have produced industry technical guidance documents, and industry leading conference events.

    Shelley holds a Bachelor of Science in Marine Biology from the University of North Carolina at Wilmington and a Masters of Business Administration in Global Management from the University of Phoenix. She is also a proud veteran of the U.S. Army and the U.S. Marine Corps.

  • Kakolie Banerjee

    Kakolie G. Banerjee, PhD

    MilliporeSigma
    Kakolie Banerjee is a Senior Scientist in the Virology and Microbiological Sciences department at Millipore Sigma. She has been part of the company for over three years as a Virologist in Process Solutions business, supporting BioProcessing efforts. Her work includes viral inactivation and clearance studies using model mammalian viruses and bacteriophage. Prior to that, she worked as a Staff Scientist at Sample6 (now known as Corvium Inc.), and helped developed an AOAC-Certified phage-based method to detect foodborne pathogens. Kakolie did her Ph.D. in Food Science from Pennsylvania State University, studying mechanisms of Shiga-toxin expression in E. coli O157:H7. Prior to that she got her bachelor’s degree in Life Sciences from the University of Delhi, and an M.S. in Food Safety from North Dakota State University investigating the molecular based detection of Fusarium spp.
  • Lori Dingledine

    Lori Dingledine

    Spark Therapeutics, Inc.
    Lori Dingledine is currently working in Quality Control at Spark Therapeutics, responsible for Microbial Control and Compendial Testing.  Lori has over 20 years of experience in the gene therapy, biopharmaceutical, and medical device industries in management roles in Quality Control laboratories responsible for analytical, bioanalytical, microbiology, physical testing, and QC inspection.
     
  • Kristen Dowling

    Kristen Dowling

    Amgen Inc.
    Kristen Dowling has over twenty years of experience in the pharmaceutical industry. She is currently a Senior Manager in Quality Assurance for Amgen in West Greenwich, Rhode Island. She oversees a multi-layered team responsible for QC Equipment Management, QC Investigations, Supplier Quality Management, and Analytical Quality Systems. Previous to this role, Kristen worked in Corporate Quality Control where she supported global Quality Control strategic objectives to ensure alignment with regulatory compliance expectations and business requirements. She continues to support the network as the global process owner for both the Analytical Investigations and Method Invalid Tracking/Trending processes. Kristen holds a Bachelor of Science degree in Microbiology from the University of Rhode Island.
  • Mirko Gabriele

    Mirko Gabriele, PhD

    ThermoFisher Scientific
    Mirko Gabriele is currently the Sr Director, Global Sterile Strategy Technology And Innovation of the ThermoFisher Scientific. Mirko started his career in Quality Control as team leader and supervisor, he held then, the position of R&D Chemist working on new entities synthesis and analytical development. In 2008 he joined Patheon, Ferentino site as Technology Transfer Project Manager. In 2010 he joined the Business team as Business Manager, dealing with contract negotiation, budget and Client relationship. In 2012 he was Technology Transfer Manager controlling manufacturig site porfolio, then Global Technology Transfer covering TTs on the 11 NA and EU sites. Latest role in operations as Technical Operations Director. He has 17+ year of experience in pharma, with experiences in API and Finished Product. Mirko has a degree in Pharmaceutical Chemistry, an executive MBA and a PhD. He is QP as well. He collaborates with PDA since 2010. In 2014 he led the PMCO task force issuing the TR 65 on ; since September 2012 he is member of the PDA RAQAB and reviewer for PDA Letter Committee. Funder and Co-leader of the Interest Group on TT since August 2015 and PDA European Trainer in TT.
  • Guido Kremer-van der Kamp

    Guido Kremer-van der Kamp

    Merck Chemicals GmbH

    Guido Kremer-van der Kamp has more than 25 years of experience in the BioPharmaceutical industry with single-use, multi-use, facility, and process design. He has held various positions with global responsibilities in process development, operations, consulting and technology management. He is currently Senior Consultant in the Global BioPharmaceutical Center of Excellence at Merck. Guido graduated in Biotechnology at the University of Applied Science in Mannheim with tenures at the National University of Singapore and a student fellowship at the Institute of Molecular and Cell Biology (IMCB) in Singapore.

  • Amanda Bishop McFarland

    Amanda McFarland, MS

    ValSource, Inc.

    Amanda McFarland is a Senior Consultant for ValSource and in this role assists companies with the design and implementation of CGMPs, Microbiology, and Quality Risk Management programs. She specializes in the creation and implementation of risk management programs, developing risk-based strategies and risk facilitation. Prior to joining ValSource, Amanda worked to integrate a global risk management program by developing the procedures required and training the organization in the execution of consistent risk management tools.

    Ms. McFarland currently serves as the PDA QRM interest group co-lead, the co-chair of the PDA Membership Advisory Committee (MAC) and co-chair of the PDA /ANSI standard on QRM in aseptic processing.

  • Mary Oates

    Mary Oates, PhD

    Sanofi

    Dr. Mary Oates has 30 years of biopharmaceutical experience in Quality, Manufacturing Operations and Regulatory Affairs. She is currently SVP and Head, Vaccines Industrial Affairs at Sanofi. Prior to this, she spent 25 years at Pfizer, holding multiple senior leadership roles. In Operations, she was responsible for the Biotechnology and Consumer manufacturing plants and operational excellence for the entire manufacturing division. Dr. Oates was also the Global Quality Operations leader at Pfizer for 8 years, with responsibility for quality oversight of all GMP activities. She has also held positions at Glaxo and Lachman Consultant Services.

    Dr. Oates currently serves on the Board of Directors of the Parenteral Drug Association and was a member of the ICH Expert Working Group for Q12, a Quality Guideline on Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management. She also led or contributed to numerous Pharmaceutical Research and Manufacturers of America working groups through her career.

    Dr. Oates holds an undergraduate degree in Biochemistry from Queens College and a Ph.D. in Analytical Chemistry from the University of North Carolina in Chapel Hill.

  • Ken Paddock

    Kenneth Paddock

    Baxter Healthcare

    Ken Paddock is a Quality Sterility Assurance Director at Baxter Healthcare. As the Global Sterility Assurance (SA) Lead within the quality group, Ken is accountable for directing a global team of Regional Sterility Assurance Representatives to develop and implement a harmonized SA strategy plan across Baxter. In addition, his team provides quality oversight for microbial control and cleanroom behaviors at the facility level and is accountable for regional sterility assurance compliance. Ken has over 25 years of experience in the pharmaceutical industry including terminal sterilization (moist heat, radiation and ethylene oxide), product/process development and environmental monitoring programs.

    Currently, Ken is a PDA Chapter Board Member and has been elected to multiple positions within the chapter since 2010. In addition, he is a member of PDA’s Science Advisory Board.

  • Diane M. Paskiet, MS

    West Pharmaceutical Services, Inc.
    Diane Paskiet has over thirty years of experience in the pharmaceutical industry. She is currently the Director of Scientific Affairs at West Pharmaceutical Services where she is involved in science and regulatory programs associated with safety and compatibility of pharmaceutical packaging and combination products. She previously oversaw site operations for West-Monarch Analytical Laboratories. Diane serves on the Product Quality Research Institute (PQRI) Steering Committee and has been an active member of PDA for over twenty years. She is part of the faculty of the Parenteral Drug Association Training Institute. Lastly, she is author, co-author and speaker of several papers and books related to pharmaceutical packaging systems, delivery systems and combination products.
  • Susan Schniepp

    Susan J. Schniepp

    Regulatory Compliance Associates Inc.

    Susan Schniepp has over 40 years of quality assurance experience in the pharmaceutical industry. She has earned several awards from the PDA, including Distinguished Author Award, Distinguished Service Award, and Gordon Personeus Award.

    Sue’s publications include the book, Understanding the United States Pharmacopeia and the National Formulary: Demystifying the Standards-Setting Process, for which she was awarded the 2007 PDA’s Distinguished Author Award. She co-edited and contributed to the books Pharmaceutical Outsourcing: Quality Management and Project Delivery and SOPs Clear and Simple for Healthcare Manufacturers.

    Serving as a volunteer in a number of capacities, she has served on the PDA Board of Directors from 2011- 2013 and from 2016- 2019 and is currently the Chair of the BoD (2022 - 2024). Sue has served on numerous planning committees, including the PDA/FDA Joint Regulatory Conference Planning Committee since 2002. She is currently working part of the working group writing a technical report relating to manufacturing data integrity issues and participating in PDA’s standard setting activity regarding purchasing controls.

    Sue is also an editorial advisory board member and columnist for Pharmaceutical Technology (since 2007) and BioPharm International Magazines. She holds a bachelor of science degree in Microbiology from Northern Illinois University.

  • Kristin Valente

    Kristin N. Valente, PhD

    Merck & Co., Inc.
    Kristin Valente is a Director of Technical Operations for several of the vaccines manufactured at Merck's West Point, Pennsylvania site.  She has over 12 years of technical experience in vaccines and biologics, encompassing process development, commercialization, and commercial manufacturing support.  In her current role, she leads a team of scientists and engineers providing technical support for drug substance, drug product, and packaging operations.  In her prior roles, she has advanced the field of host cell protein impurities, developed vaccine drug substance manufacturing processes, and launched multiple vaccine products.  Kristin holds a bachelor's degree (Massachusetts Institute of Technology) and a doctorate degree (University of Delaware), both in Chemical Engineering, has published several impactful peer-reviewed manuscripts, and currently holds an Adjucnt Faculty Position at the University of Delaware.  She has been active in the PDA since 2018 and has recently joined the PDA science advisory board.
     
  • Arne Zilian

    Arne Zilian, PhD

    Novartis

    Arne has 25 years of experience in the Pharmaceutical Industry. He has worked in Analytical Development, Chemical Development, Pharmaceutical Development, Manufacturing Operational Excellence and Manufacturing Science and Technology.

    In Novartis, he was the global program lead for ‘Predictive Processing’ and for Continued Process Verification. He served as the lead author for the cross-divisional quality standards for process validation and for CPV. Over the last years, he was instrumental in building the Manufacturing Science and Technology organization. Until recently he lead the program for manufacturing data science in the Cell & Gene Therapy area.

    Currently he leads the ERP transformation program for manufacturing systems.

    In PDA, he has been engaged in the interest groups for CPV and for Manufacturing Intelligence.

    Arne holds a Ph.D. in Analytical Chemistry and a Master in Chemistry.

    He is also a certified Kepner Tregoe trainer for situation, decision and problem analysis.

  • Janmeet Anant

    Janmeet Anant, PhD

    MilliporeSigma

    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

    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 Bevilacqua

    Anthony C. Bevilacqua, PhD

    Mettler-Toledo Thornton

    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

    Benjamin Borgo, MS, PhD, MBA

    MilliporeSigma
    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

    Donna Boyce

    Pfizer Inc.

    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

    Michael Brothers, PhD

    UES, Inc.
    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.
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    Paul Cashen, MSc

    Pall Corporation

    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.

  • Bob Chaplinsky

    Bob Chaplinsky

    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 Chapman

    Jerry L. Chapman, BS, MBA

    Redica Systems
    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

    Redica Systems

    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

    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.
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    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 Duncan

    Derek I. Duncan, PhD

    Lighthouse Instruments

    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 Edey

    Michael T. Edey

    Pfizer Inc.

    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 Farbman

    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.

  • James Fries

    Jim (James) M. Fries

    Rx-360

    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

    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

    Donna Gulbinksi

    Civica Inc.

    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 Harrington

    Aidan J. Harrington, PhD

    DPS Group

    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

  • Susan Dounce

    Susan M. Dounce, PhD

    West Pharmaceutical Services, Inc.

    Susan is currently Director of Commercial Technology Development at West Pharmaceutical. Prior to joining West, Susan has held various technical, commercial and academic roles in the Healthcare industry with Datwyler, W.L. Gore and as an Adjunct Professor at Temple University.  She also serves as Vice Chair for the PDA Packaging Science Interest Group.  She holds a B.S. in Chemistry from the University of Rochester and a Ph.D. in Physical Chemistry from the University of Pennsylvania.

  • Mauro Giusti

    Mauro Giusti, Dr

    Eli Lilly Italia

    Dr. Mauro Giusti holds a Master Degree in Chemistry at University of Florence and he is Board Certified as Chemist and as Technical Director (QP) . During the 32 years with Eli Lilly, he has covered several positions within the Lilly Manufacturing organization dealing both with Lilly plants and with CMOs in the Europe/Africa/Asia. He spent working 5 years outside of Italy, both in USA and in UK.

    From 2003 to 2019 he led Technical Svcs/Mfg Science Department, with responsibility for Metrology, C&Q, Sterility Assurance, Process Validation, new processes/technology for Biotech products, including combi products. In 2009 he added the responsibility for Manufacturing Procurement.

    In September 2019 he has taken a new role, as Advisor, Site External Network, dealing with external entities and leading a Lilly Global project for improvement of technical capabilities in Parenteral Manufacturing.

    He has served as member of the Italy Chapter of PDA, with several participations to forums both as speaker and as chairman. In November 2019 he became Co- Chair for he Process Validation Interest Group. In August 2020 he was named to the PDA Science Advisory Board (SAB). In December 2021 he has been elected as President, PDA Italy Chapter.

  • Marc Glogovsky

    Marc Glogovsky, MS, SM (NRCM)

    Valsource, Inc.

    Marc Glogovsky is the Microbiology Business Unit Manager and Senior Microbiology Consultant with ValSource, Inc., focusing on development and improvement of contamination control strategies, validation of rapid microbiological methods (RMMs), and establishing risk-based environmental monitoring programs.

    Marc has more than 20 years of microbiology experience in the pharmaceutical industry. He has been an active PDA member since 2000, is currently serving on PDA’s Science Advisory Board, where he is also the Interest Group Liaison, and is a member of both the ATMP Advisory and Education Advisory Boards. He is the North American chair of the Microbiology/EM Interest Group, has served on numerous Technical Report committees, and has co-chaired the Microbial Data Deviation Investigations and Environmental Monitoring Technical Reports and the ATMP Microbiology Points to Consider report.

    Marc was a founding member of the PDA Mycoplasma task force and is an active advisor to the PDA Environmental Monitoring Task Force. In 2020, Marc received the James P. Agalloco award for his efforts at PDA’s Training and Research Institute (TRI), where he has been a faculty member teaching EM courses, for more than 10 years.

    Marc earned his B.S. in Biology from Monmouth University and his M.S. in Microbiology from Rutgers University.

  • Gabriele Gori

    ThermoFisher Scientific

    Gabriele Gori has been in the sterile Pharmaceutical/Vaccine/Medical Device business since 1994 – in different local and global roles in multinational companies, including, but not limited to, Bausch & Lomb, Novartis, GlaxoSmithKline and Thermo Fisher. Since Dec 2021 he is the Quality Site Head of the Thermo Fisher site in Monza (Italy) leading a team of 450+ Quality associates. Prior to that, from 2010 to 2015, he had been in role as Global Head, GMP Compliance and Auditing at Novartis Vaccines in Basel (Switzerland) and later on from Sept 2015 to Nov 2021 he had been in role as Vice President, Global Head of Audit and Risk Management at GlaxoSmithKline Vaccines in Wavre (Belgium).

    Within PDA, he is the co-chair of the task force in charge of developing “Points to Consider“ documents for aseptic manufacturing and of the task force in charge to comment to the revised draft of the EU GMP – Annex 1. Member elected of the PDA Board of Directors from 2010 through 2015, he is part of the Science Advisory Board of the association since 2015 and acting as SAB vice-chair since June 2021.

    Gabriele holds a bachelor in Chemistry and a master in Quality Management.

  • GhadaHaddad

    Ghada N. Haddad, PhD

    Merck & Co., Inc.

    Ghada Haddad is currently an Executive Director, leading the Global cGMP and Compliance Auditing Organization at Merck & Company. Prior to that she was the Head of the Global Quality Risk Management Center of Excellence, building a team of experts to develop and implement a robust and sustainable QRM program. She holds a chemistry degree, an MBA and a PhD and has over 22 years of experience, working in the Biotech and Pharmaceutical industries in the areas of Quality Risk Management (QRM), Validation, Quality Systems and Regulatory, including research, management (people and projects), process development, auditing, regulatory agency inspection, change control and validation. Haddad was the chair of the Paradigm Change in Manufacturing (PCMO) initiative: QRM in Packaging and Labeling, QRM for the Design, Qualification, and Operation of Manufacturing Systems task forces, co-chaired the Aging Facilities Points to Consider and co-chaired the 2018 and 2019 Annual PDA Conferences and the 2019 PDA Quality Week. She is also a faculty member for PDA’s Training and Research Institute and a Science Advisory Board member and a member of the PDA Board of Directors.

  • Jane Halpern

    Jane L. Halpern, PhD

    IAVI

    Jane Halpern, Ph.D. is Executive Director of Regulatory Affairs at IAVI. Dr. Halpern has over 25 years of experience in biologics development and has held positions in government as well as both small and large biotech companies. She worked at the FDA, Center for Biologics Evaluation and Research (CBER) as a researcher/reviewer for 10 years where she reviewed applications for both investigational and commercial products. Dr. Halpern has held senior management positions at ID Biomedical Corporation, GSK Biologics, and Novavax Inc. At ID Biomedical Corporation, she led the global regulatory team that was responsible for obtaining FDA accelerated approval of a seasonal influenza vaccine and that supported the acquisition of ID Biomedical by GSK. She has experience with all stages of product development from newly discovered entities to lifecycle management of licensed products. Dr. Halpern currently serves as a co-chair of the PDA Vaccine Interest Group and is a member of the Regulatory Affairs/Quality Assurance Advisory Board for PDA. She received her B.S. in Physiology from the University of California, Davis and her Ph.D. in Pharmacology from the University of Rochester.

  • Peter Makowenskyj

    Peter J. Makowenskyj, MEng

    G-CON Manufacturing, Inc.

    Peter has over 17 years of experience in pharmaceutical and biopharmaceutical industries. Peter held various roles within industry, primarily around process solutions and engineering for drug substance facilities. He has extensive knowledge of bioprocess manufacturing and helped design new facilities and retrofit existing facilities. Peter joined G-CON Manufacturing in 2016 where he now consults with clients in the design of their cGMP facilities utilizing G-CON’s pre-fabricated autonomous clean rooms by capitalizing on his process and regulatory know how.

    Peter received his Bachelor of Science in Chemical Engineering and a Minor in Biomedical Engineering from Cornell University. He received is M. Eng in Chemical Engineering from Cornell University. He is also very active within the PDA where he currently sits on the PDA BioAB, co-Leads the Biopharmaceutical Manufacturing IG, and Mobile Manufacturing Task Force.

  • Toni Manzano

    Toni Manzano

    Aizon
    Toni is the co-founder and CSO of Aizon, a cloud company that provides big data and AI SaaS platform for the Biotech and Pharma industry. He is also co-chair of the Biomanufacturing IG and co-chair of the CPV of the Future initiative at the PDA, active collaborator in the AI initiative for AFDO and he teaches AI subjects at the Universities (UAB and OBS), member of the Science Experts in the Spanish Parliament on big data and artificial intelligence topic and collaborator with the UN in AI subjects. He has written numerous articles in the Pharma field and holds a dozen international patents related to the encryption, transmission, storage and processing of large volumes of data for regulated environments in the cloud. Toni is Physicist, Master in Information and Knowledge Society and post graduated in quality systems for manufacturing and research pharmaceutical processes.
  • Amanda Bishop McFarland

    Amanda McFarland, MS

    ValSource, Inc.

    Amanda McFarland is a Senior Consultant for ValSource and in this role assists companies with the design and implementation of CGMPs, Microbiology, and Quality Risk Management programs. She specializes in the creation and implementation of risk management programs, developing risk-based strategies and risk facilitation. Prior to joining ValSource, Amanda worked to integrate a global risk management program by developing the procedures required and training the organization in the execution of consistent risk management tools.

    Ms. McFarland currently serves as the PDA QRM interest group co-lead, the co-chair of the PDA Membership Advisory Committee (MAC) and co-chair of the PDA /ANSI standard on QRM in aseptic processing.

  • Joachim Regel

    Joachim W. Regel

    Merck Chemicals GmbH
    Joachim Regel has more than 25 years of experience in the BioPharmaceutical industry with focus on single-use, multi-use systems, facility and process design activities. He has held various positions at Millipore, Rommelag, LEWA Process Technologies and Merck Group including Global Key account responsibilities in Sales and European Technology management. His recent activities where mainly implementation of innovative continuous DSP Systems design, project development and consulting for SU units. He is currently active in a Sales Development function in LIP´s in EMEA. He is part of a multidisciplinary team at Merck Germany, developing and supporting local Process implementations and BDS/F+F plant projects. Joachim graduated in Biotechnology at the University of applied Science in Gießen, Germany.
  • Sabrina Restrepo

    Sabrina Restrepo, PhD

    Merck & Co., Inc.

    Sabrina's responsibilities at Merck have included technical operations support in several areas such as deployment of single-use systems in vaccine manufacturing, process improvements, technical collaborations with single-use systems’ suppliers, regulatory remediation plans, vaccines localization technology transfers, cell culture media and drug substance manufacturing. She is the recipient of the 2018 Frost & Sullivan Manufacturing Leadership Award in the Engineering and Production Technology Leadership category for the Design, Evaluation and Implementation of Single-Use Components for Ebola Zaire Vaccines Drug Substance Manufacturing, 2020 PDA Distinguished Service Award and 2020 Merck Manufacturing Science & Technology Big Innovation Award. Currently, she is the co-lead of the PDA Vaccines Interest Group and member of the PDA Biopharmaceutical Advisory Board.

    Prior to joining Merck, she worked at Irvine Scientific, Allergan and the Instituto Colombiano del Petróleo where she contributed to the development and manufacturing of cell culture media products, process characterization and improvement of Botox® and development of biological wastewater technologies, respectively.

    Sabrina has published four technical publications, co-authored three BioPhorum Industry documents, and presented at numerous conferences.

    She holds a BS and MSc degrees in Chemical Engineering from Universidad Nacional de Colombia and PhD degree in Engineering from the University of Akron, Ohio.

  • John Shabushnig

    John G. Shabushnig, PhD

    Insight Pharma Consulting, LLC

    John is the founder of Insight Pharma Consulting and is an expert in visual inspection.  He has extensive industry experience including Sr. Manager/Team Leader for microbiology and aseptic support in Pfizer’s Global Quality Operations.  He began his career as a Research Scientist with The Upjohn Company responsible for Process Analytical Technology and visual inspection.  He served as the Director of Technical Support and Engineering for Pharmacia and later served as the Business Unit Director of the Center for Advanced Sterile Technology.

    John holds a B.S. in Chemistry from Carroll College and a Ph.D. in Analytical Chemistry from Indiana University.  He is an active member of the PDA, having served as the Chair of the Board of Directors and as the Chair of the Science Advisory Board.  He organized and leads the Visual Inspection Interest Group.  He is also an instructor at PDA's Training and Research Institute.  John serves on the USP Dosage Forms Expert Committee and chairs the Visual Inspection of Parenterals Expert Panel.  He presents and publishes frequently in the fields of spectroscopic analysis, process analytical technology, rapid microbiological test methods and visual inspection.  He is a co-author of the recently published book Visual Inspection and Particulate Control.

  • Edward Trappler

    Edward H. Trappler

    Lyophilization Technology, Inc.

    Edward Trappler has over 40 years of industry experience that includes product development, toxicology and clinical supply manufacturing, and parenteral production. In 1992 he founded Lyophilization Technology, Inc. as a source of scientific and technical services coupled with research and education for expanding the knowledge and understanding of lyophilization throughout the healthcare product industry.

    Ed has contributed to six books, authored and presented numerous papers and courses internationally. He is an active member of the Parenteral Drug Association, serving as chairperson of the Lyophilization Interest Group, Validation Task Force, and Education Advisory Board. He has lectured for the AAPS, ISPE and PDA. He has received numerous recognitions and the PDA awarded him the Gordon Personeous Award for his contribution to the PDA, the James Agalloco Award for Education, and the Martin VanTrieste Award for Outstanding Contributions to the Advancement of Pharmaceutical Science.

  • Eva Urban

    Eva M. Urban, MSc

    CSL Behring

    Eva M. Urban is the Director at CSL Behring leading the Global Internal Audits & Compliance team. She has 30 years of experience in various roles – quality and operations and R&D - in Biopharma (Lonza, Celgene, CSL). Areas of expertise are Risk Management and Quality Systems, including design and implementation locally and globally, leading Internal Auditing and Hosting Regulatory Inspections, Quality Operations, Biotech R&D, Biopharmaceutical API (DS) Manufacturing, Aseptic Processing, External Vendor Quality Oversight. Eva holds a MSc in Biology from University of Kaiserslautern, Germany. Eva is a volunteer at PDA: member of the RAQAB (Regulatory and Advisory Board), Chair of the working group for the IPEC/PDA Technical Report “QRM for Excipients”, Co-Lead of the Quality Risk Management Interest Group, Co-Lead of the Quality Systems Interest Group, Planning Committee Member for PDA Conferences, Co-Chair of the Remote Audits and Inspections Task Force. Eva received the PDA Distinguished Service Award in 2021.

  • Rick Watson

    Rick J. Watson

    Merck & Co., Inc.

    Rick Watson graduated from Rutgers University with a Bachelor's degree in Chemical Engineering. He has 27 years of experience in the field of process design and process modeling and is a certified Black Belt in Lean Six Sigma. Rick has spent the past twenty years at Merck focusing on the visual inspection processes for parenteral products. During this period he led a team of engineers responsible for optimizing existing automated and manual inspection processes and developing new inspection systems. Rick's current role includes providing a global strategy and process support for visual inspection and primary packaging components for Merck manufacturing sites around the world.