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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.

  • 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.

  • 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.