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Committee & Speaker Biographies

Committee & Speaker Biographies

2020 PDA Data Integrity Workshop

Sept. 2 | Sept. 3 | Sept. 9 | Sept, 10

  • Monica Cahilly

    Monica J. Cahilly, MS

    Green Mountain Quality Assurance

    Monica Cahilly, President, Green Mountain Quality Assurance LLC has been consulting nationally and internationally for 28 years, with specialized interest in Data Governance / Data Integrity Assurance. Monica’s work includes investigations and assessments, application integrity policy, preparing responses to FDA observations, developing global compliance programs, and training.  Monica was invited in February 2009 by U.S. FDA to present to CDER Offices of Compliance the topic of ‘Detecting Aberrant GxP Data and Handling Practices’ and has subsequently provided on-going training in Data Integrity Investigations to U.S. FDA as well as World Health Organization (WHO), Medicines and Healthcare Products Regulatory Agency (MHRA), Health Products Regulatory Agency (HPRA), Health Canada (HC), European Medicines Agency (EMA), Italian Medicines Agency (AIFA), China NMPA, Swissmedic, Pharmaceutical Inspection Co-operation Scheme (PIC/S), Japanese Pharmaceuticals and Medical Devices Agency (PMDA), Therapeutic Goods Administration (TGA), and others. Monica’s most recent interests include working in healthcare policy to prevent and detect data integrity issues as these relate to safe, effective, and cost-effective medicines. Monica has a bachelor’s degree in Biochemistry from Dartmouth College, a master’s degree in Genetic Toxicology from M.I.T., is a member of PDA, DIA, ISPE, and SQA, and is RQAP-GLP.

  • Els Poff

    Els Poff

    Merck & Co., Inc.

    Els Poff is Executive Director, Data Integrity Center of Excellence.  She is responsible for overseeing the execution of all quality and GMP compliance remediation activities related to data integrity for all Merck manufacturing sites and external partners network.

    Els graduated from the Industrial College of Brussels, Brussels, Belgium where she earned a BS in Industrial Engineering and a Masters of Engineering degree in Mechanical & Industrial Engineering.

    Els is an active member of the PDA Data Integrity Task Force and is currently leading the development of a PDA Technical Report around Data Integrity in Manufacturing.

  • Mark DiMartino

    Mark A. DiMartino, MS

    Amgen Inc.

    Mark DiMartino is currently the Director of Quality Data Sciences at Amgen, Inc. In this role Mark is responsible for the application of Artificial Intelligence (AI) 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 to all Operations’ sites outside of Puerto Rico. 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 has a BS in Cellular Biology from the University of Illinois Urbana-Champaign and an MS in Applied Statistics from DePaul University.

  • Kir Henrici

    Kir Henrici

    The Henrici Group

    Kir Henrici is the CEO of the Henrici group; a boutique consultancy providing strategic quality and compliance solutions to FDA regulated drug, biotech, and medical device innovators around the world.  She has a special interest in data integrity and the science of data analytics in the emerging next generation of big data, IoT, smart manufacturing and Artificial Intelligence.

    Kir Henrici has extensive industry experience serving in executive and consulting roles for Nutraceutical, Pharmaceutical, Biotech and Medical Device industries, to include managing and supporting FDA inspections, communications and remediation for companies in receipt of 483’s, Warning Letters, Untitled Letters, and Import Alerts.  She has gained global and diverse exposure, perspective and working knowledge of quality, compliance and technical projects and solutions impacting companies around the world; supporting a range of initiatives including Pre-Approval readiness, organizational/functional area/quality system audits and assessments, complex risk management and remediation, technical reviews of GMP electronic/manual data related to manufacturing and laboratories, and enterprise harmonization of policies and procedures.

    Ms. Henrici has a special focus on Data Integrity, leading global and site level data governance programs to include designing and executing protocol driven DI assessments, risk analysis, remediation plans and process improvements throughout the organization to ensure a holistic integration of DI principles and controls.  She has developed and delivered training modules for Data Integrity to meet basic and advanced training requirements that include level one, annual refreshers, and advanced DI training for auditors.  Additional core expertise includes Deviation/Investigation Management and Root Cause Analysis, CAPA, Change Control, Risk Management and Validation.

    Ms. Henrici has a strong knowledge base of sterile processing/aseptic practices, oral solid manufacturing, continuous manufacturing/Process Analytical Technology (PAT), Quality by Design (QBD), IT and computerized systems and integrations.

    Ms. Henrici is also a author/co-author and contributor for presentation(s) and training modules for key industry forums to include PDA/FDA Joint Regulatory Conference, PCCIG, IQPC and PICs.  She serves as a Co-Lead for the PDA Task Force team responsible for the Data Integrity in the Quality Management System technical report, and a team member for the DI in Manufacturing technical report.  She also serves on the Steering Committee for the PDA Data Integrity Workshop scheduled for fall 2019, and was a contributor to the PDA/DHI Book: Assuring Data Integrity for Life Sciences.

  • Aditi Thakur

    Aditi S. Thakur, MS

    U.S. FDA

    Aditi S. Thakur, M.S.  joined the FDA, Office of Process and Facilities in 2015 as a chemist, where she performs pre-approval assessment of submissions and participated on Preapproval Inspections (PAIs).  Prior to the FDA, she worked in two separate cGMP complaint specialty pharmaceuticals companies involving complex soft gelatin and inhalation dosage forms. Aditi earned a M.S. in Industrial Pharmacy from Long Island University. Aditi is currently working as a acting quality assessment lead, and is responsible for primary and secondary review of Process/Facility reviews. Aditi has been involved in various data integrity cases in Agency.  Aditi’s interests include data Integrity evaluation of the submissions, regulatory manufacturing risk assessment, and complex manufacturing processes and dosage forms.

  • Patrick Blacha

    Patrick D. Blacha

    Eli Lilly and Company
    Patrick Blacha is currently Senior Advisor, Technical Service/Manufacturing Sciences (TS/MS) for Eli Lilly and Company. In addition to his current role, Patrick held senior leadership positions for Eli Lilly and Company in Parenteral Network TS/MS and site Quality. Prior to Lilly, Patrick held various leadership positions in Quality and TS/MS at Pharmacia, G.D. Searle Monsanto and Abbott Laboratories. Patrick has over 30+ years of quality assurance/quality control and technical services experience in API/Drug Product manufacturing and medical device assembly. He has extensive experience in guiding project teams in all aspects of product and process control strategies, integrating knowledge management and quality risk management throughout the product lifecycle. Patrick received his B.A. in chemistry from Catawba College and his M.C. in chemistry from North Carolina State University.
  • Tom Cosgrove

    Tom Cosgrove, JD

    Covington & Burling LLP and formerly with the FDA

    Tom Cosgrove is a partner in Covington’s Food, Drug and Device Practice Group. He joined Covington in 2017 from the Food and Drug Administration (FDA), where he was a senior official charged with ensuring the quality of drugs and therapeutic biologics marketed to U.S. patients. Mr. Cosgrove brings a wealth of experience to bear in helping clients navigate the complex world of pharmaceutical compliance and enforcement in the United States and around the globe.

    At FDA, Mr. Cosgrove held senior leadership positions within the Office of Compliance in the Center for Drug Evaluation and Research (CDER), including leading the organization as Acting Director in 2016. Beginning in 2014, he led the Office of Manufacturing Quality (OMQ), where he was responsible for CDER’s enforcement activities covering current good manufacturing practice (CGMP) and drug quality. As Acting Director of CDER Compliance in 2016, Mr. Cosgrove oversaw OMQ as well as the offices responsible for enforcing FDA’s requirements for drug approval and labeling, human drug compounding, drug supply chain security and integrity, and clinical trials and bioequivalence studies.

  • Travis Frick

    Travis A. Frick, MSc

    GlaxoSmithKline
    Mr. Frick is a technical operations and quality executive with extensive experience managing transformational change in business-critical settings. Hands on leader who enjoys working in a fast pace environment. His experience includes execution and delivery of strategic priorities across a global network and developing talent within the organization. Innovative change manager who drives metric-driven quality enhancements, process improvements and operational efficiencies. Travis exudes a passion for personnel and business development, data integrity, and manufacturing process execution (and continuous improvement).
  • Sebastian Hanet

    Sebastian R. Hanet

    Amgen Inc.
    Sebastian Hanet is currently a Sr. Associate Data Scientist at Amgen within the Quality Data Sciences (QDS) group. In his position, Sebastian specializes in using natural language processing and machine learning to build end-to-end artificial intelligence applications to support manufacturing and quality related goals. Prior to QDS, Sebastian worked in the Operations Information Systems department where he helped support data science platforms and built visualization tools for scientists in Process Development.

    Sebastian holds a B.S. in Computational and Systems Biology from the University of California, Los Angeles.
  • Brooke K. Higgins, MS

    U.S. FDA

    Brooke K. Higgins is a Senior Policy Advisor for the Global Compliance Branch 1 within the Division of Drug Quality I, Office of Manufacturing Quality, Office of Compliance at FDA Center for Drug Safety and Evaluation.  Ms. Higgins is responsible for evaluating domestic and international pharmaceutical inspection reports, reviewing responses from industry, and preparing associated regulatory actions. She has also served as an expert witness on CGMP violations in federal court. Prior to joining CDER in 2014, Ms. Higgins spent 12 years with the Office of Regulatory Affairs, first as an Investigator and later as a Pre-Approval Manager, both for the Baltimore District.  While working as the Pre-Approval Manager, she continued performing drug manufacturing inspections, both domestically and internationally, became a member of the Pharmaceutical Inspectorate, and was a Level II drug certification auditor. Ms. Higgins received a M.S. in Food Science, focusing on food microbiology, and a B.S. in Biology from Virginia Tech.

  • Michael Maltman

    Michael Maltman

    Merck & Co., Inc.
    Michael is a member of the Date Integrity Center of Excellence at Merck & Co. Inc, manufacturing division, which defines the compliance expectation for Data Integrity as part of the Quality management system and provide s guidance for implementation.  He has 22 years of experience with software development and  GXP system validation, he has worked on the manufacturing, vendor and consulting sides of the business.  He has managed IT testing departments and Quality Validation departments supporting over 100 site based and enterprise systems.   He holds a Bachelor of Science, Computer and Information Sciences from Temple University.
  • Toni Manzano

    Toni Manzano, PhD

    Bigfinite

    Toni Manzano is Cofounder and CSO of Bigfinite, a SaaS company that is transforming manufacturing operations with the use of AI and IIoT technologies for pharmaceutical and biotech companies. For over two decades, he has led software projects for international pharmaceutical companies covering the entire production process and supply chain. Today, Toni is a part of the scientific committee with PDA Europe and with the AI Xavier Manufacturing team. He worked as a researcher at the University of Barcelona as a physicist and teaches big data and artificial intelligence in postgraduate courses at the UAB. He is also a member of the Science Experts in the Spanish Parliament on big data and artificial intelligence. He has written numerous articles 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.

  • Brian McBreen

    Brian T. McBreen, Jr.

    Amgen Inc.
    As Director, Knowledge Analytics at Amgen, Brian leads Agile Product Development for the Quality Data Sciences organization, which is focused on applying machine learning and natural language processing to unlock insights in manufacturing and quality data. Brian also leads the advancement of Knowledge Management across the Operations business function, which includes process development, global manufacturing operations, quality, supply chain and engineering.

    Brian joined Amgen in 2003 and has held roles of increasing responsibility focused on web, portal, collaboration and knowledge management. Prior to Amgen, he spent 5 years in the defense industry developing web applications and IT solutions for US Navy customers. Brian has a BS in Business Administration, Information Systems from California State University, Northridge. He is a Certified Scrum Product Owner (CSPO), Certified ScrumMaster (CSM) and serves on the executive committees of the Knowledge Leaders Council and The Conference Board Knowledge & Collaboration Council.
  • Tracy Moore

    Tracy Moore

    MHRA

    Tracy has been a GMP Inspector since 2011 and prior to joining the MHRA worked in the pharmaceutical industry for 22 years working across most dosage forms within Quality and technical roles. Her experience ranges from starting as a QC analyst to holding senior managerial and technical positions and she is an eligible Qualified Person in the UK. Tracy is currently lead of the MHRA Inspectorate Technology team responsible for providing guidance and strategy for new and emerging technologies and data integrity. To assist in MHRA pandemic efforts, Tracy is currently also participating in the MHRA Task Force for supply chain aspects.  Tracy is the deputy of the PIC/S Strategy and Development Sub Committee and leads specific PIC/S working groups.

  • Amy Muhlberg

    Amy B. Muhlberg, PhD

    U.S. FDA
    Amy Muhlberg is a Staff Fellow at FDA in CDER’s Office of Pharmaceutical Quality in the Office of Policy for Pharmaceutical Quality, where she leads the development of guidance documents and responses to citizen petitions regarding drug product quality and manufacturing across the product lifecycle. She has two decades of FDA policy experience in trade associations, regulated industry, and on Capitol Hill. Amy earned her Ph.D. in Biochemistry from The Scripps Research Institute in La Jolla, California, and received her undergraduate degree in Biology from McGill University in Montréal, Canada.
  • Mark Newton

    Mark E. Newton

    Heartland QA

    Mark Newton is a Pharmaceutical Quality professional with 37 years of experience in data integrity, LIMS, validation of computer systems, analytical systems, risk management, and quality systems, especially in the regulated laboratory space. He held roles in QC Labs, Computer Systems QA, Laboratory Informatics and QA during his 34-year tenure at Eli Lilly and Company. As an independent consultant since retiring from Lilly in 2018, He has helped firms with forensic data reviews, good documentation practices, risk evaluation, flowcharting processes to identify data integrity gaps and improving quality systems.

    Mark been actively involved in ISPE/GAMP publications for a decade, having contributed to the GAMP Good Practice Guide for Computerized Laboratory Systems (2012), Records and Data Integrity Guide (2017) and Data Integrity-Key Concepts Good Practice Guide (2018). He has also co-written articles with Robert McDowall on data integrity topics that have appeared in LC/GC Magazine.

  • Anne Renton

    Anne V. Renton, MBA

    Eli Lilly and Company

    Anne V. Renton is a Research Scientist in the Technical Service Manufacturing Science Organization at Eli Lilly and Company.  She previously worked in Quality Assurance and has been at Eli Lilly since 2002. She had over fifteen years’ experience in quality and manufacturing prior to joining Lilly. Her experience includes; quality risk management, six sigma initiatives, implementing lean manufacturing, optimizing manufacturing processes and quality system implementation.  Anne holds a Bachelor of Science degree from Indiana University and an M.B.A. from Indiana Wesleyan University.

  • Carmelo Rosa, BS, MS, PsyD

    U.S. FDA

    Carmelo Rosa has a B.S., M.S., Psy.D. He started with the FDA in May 1990 as an Investigator for the Los Angeles District. Dr. Rosa later transferred to the San Juan District, where for 13 years he served as a pharmaceutical drug Investigator and 6 years as a Compliance Officer. He is member of the foreign drug inspection cadre. He has conducted many inspections of complex pharmaceutical inspections and other commodities regulated by the FDA that have resulted in significant regulatory actions initiated by the FDA. In August 2008 relocated to Maryland to work for CDER as Compliance Officer. In 2009 he was promoted to Team Leader at CDER/DMPQ/OC/ICB, and then to Branch Chief for the International Compliance Branch. He currently serves as the Director for the Division of International Drug Quality I. Dr. Rosa is one of the FDA officials responsible for the review of non-compliant inspections (domestic and foreign), and is involved in FDA’s decision to initiate an enforcement action against pharmaceutical manufacturing and testing facilities that fail to comply with CGMPs. Dr. Rosa has served as an invited Professor at the University of Puerto Rico, School of Law, where he teaches a course on Federal Regulations Enforced by FDA and a General Overview to the FD&C Act. He works very closely with International Regulatory Authorities in different collaboration initiatives. Dr. Rosa is the former Chair for the PIC/S API Expert Circle.

  • Karen Takahashi

    Karen K. Takahashi, MA

    U.S. FDA

    Karen Takahashi is a Senior Policy Advisor at FDA in CDER’s Office of Pharmaceutical Quality in the Office of Policy for Pharmaceutical Quality.  Karen is a co-author of the guidance for industry "Data Integrity and Compliance With Drug CGMP."  Prior to 2015, she spent fifteen years as a Senior Policy Advisor and Compliance Officer in CDER’s Office of Manufacturing and Product Quality.  At the beginning of her career, Karen was an Investigator with FDA’s New England District Office.  She holds a Master of Science degree from Boston University and a Bachelor of Science degree from the University of Wisconsin-Madison.