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Committee & Speaker Biographies

Committee & Speaker Biographies

2019 PDA Data Integrity Workshop

September 18-19, 2019, Washington, DC

  • Jacqueline Veivia-Panter

    Jackie Veivia-Panter

    Legend Biotech

    Jackie has many years of experience within pharmaceutical quality across the product life cycle. Her experience includes site head quality, R&D quality lead and corporate/divisional quality roles within quality systems. She has worked at large and small pharmaceutical companies including Pfizer, Abbott/Abbvie and Celgene.  She led the global Data Integrity team at Celgene developing and implementing DI policies, procedures and training. Her current role is with Legend Biotech leading Global Quality Systems and Compliance.  In addition, Jackie is the Chair of the Regulatory Affairs and Quality Advisory Board (RAQAB) at PDA and leads the Data Integrity Interest Group. She was also involved in the Data Integrity Q&A document on inspections and is currently involved in the Technical Report for Data Integrity in Quality Management Systems.

  • Ronald Tetzlaff

    Ronald F. Tetzlaff, PhD

    PAREXEL International

    Dr. Tetzlaff is currently Corporate Vice President, PAREXEL International LLC. His 50+ years of experience includes 27 years as an Investigator with the FDA, and during the past 25 years with PAREXEL he has provided GMP compliance and quality system services to companies located throughout the world. He received B.A. in Zoology from the University of Washington, Seattle and M.S. and Doctor of Philosophy degrees in Pharmaceutics from the University of Georgia, Athens. Dr. Tetzlaff is a member of PDA and FDLI, and is active in industry programs on quality management, GMP compliance, and data integrity related issues, having made more than 300 presentations at various national/international industry symposia and FDA training programs, and he has published more than two dozen articles and several chapters in textbooks. He is currently a steering committee member of PDA Task Force on Data Integrity, and for past 20+ years has served a member of the Conference Advisory Committee for the UGA International GMP Conference.

  • Peter Baker

    Peter E. Baker, MS

    Green Mountain Quality Assurance and formerly with the FDA

    Peter E. Baker spent 11 years as an FDA Drug Investigator, with 7 of those years spent working in FDA’s overseas offices located in India, China and Chile.  Peter was named FDA Investigator of the Year in 2013 for his work uncovering serious breaches in data integrity, and has special interest in big data management and compliance with 21 CFR Part 11. He speaks Chinese (Mandarin) and Spanish, and has performed more than 100 foreign drug inspections around the world on behalf of the FDA. His inspection experience includes performing six systems manufacturing inspections of API’s, intermediates, and finished dosage, including complex small and large molecules.

    Peter holds a Bachelor of Science (B.S) degree in Biology-Chemistry from Point Loma Nazarene University, a Masters of Science (M.S.) in Chemistry from San Francisco State University, and is an active member of PDA, DIA, and ISPE.

  • 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.

  • 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.

  • Thomas Friedli

    Prof. Dr. Thomas Friedli

    University of St. Gallen

    Professor Dr. Thomas Friedli is director of the Institute of Technology Management at the University of St.Gallen, Switzerland, and head of the Chair of Production Management. After graduating in Business Administration from the University of St.Gallen and obtaining his doctorate, Thomas was appointed as a professor for production management in 2004.

    His main research focus lies in the realm of Operational Excellence in the pharmaceutical industry. Throughout the years, Thomas and his research team have been holding close ties with industry partners for various research projects. Besides, Thomas authored several books about Operational Excellence in the pharmaceutical industry and the FDA Quality Metrics Research reports, comprising results from the research project on quality metrics funded by the FDA.

    He is teaching in several executive programmes in St.Gallen, Salzburg, and Fribourg. Furthermore, he was a battalion commander in the Swiss Armed Forces and is still an active colonel in the staff of the chief of the army.

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    Ronald D. Gunn, MS, MBA

    Kaleo, Inc.

    Ron is kaléo‘s Chief Operating Officer. He is responsible for overseeing the manufacturing and supply chain, quality assurance, medical affairs, pharmacovigilance, development and regulatory affairs aspects of kaleo's business. Ron has more than 30 years of pharmaceutical/biotechnology development and operations experience. Prior to joining kaléo in 2008, Ron served as Executive Vice President and Chief Operating Officer for Insmed Incorporated where his responsibilities included R&D, regulatory affairs, finance, manufacturing and quality assurance. Prior to joining Insmed, he held several development and operations positions with domestic and foreign companies within the pharmaceutical industry. Ron received a BS from Radford University and earned an MS in Statistics and an MBA from Virginia Commonwealth University.

  • Julian Macuvele

    Julian Macuvele, MSc

    University of St. Gallen

    Julian Macuvele is a Research Associate at the Institute of Technology Management at the University of St.Gallen, Switzerland. In his research, Julian focuses on Production Management and on driving Operational Excellence and Lean Production with cutting-edge technologies and innovative management approaches. Before starting the phd program at the University of St.Gallen, Julian earned his Master's degree in mechanical engineering at RWTH Aachen University, Germany with a focus on design and development.

  • Julie Maurhoff

    Julie C. Maurhoff, CQA

    Ultragenyx Pharmaceutical

    Julie Maurhoff is a Senior Director of GxP Compliance and Inspection Readiness at Ultragenyx Pharmaceutical.  She is an ASQ Certified Quality Auditor and Quality professional with over 25 years of industry experience spanning Quality Operations in BioPharma, Medical Device, Food and GLP industries, including Technical Recruiting and Talent Placement.  She has spent the past 15 years focused on pharmaceutical GMP Auditing and Regulatory Inspection preparation and execution.  Julie is a mindful meditation practitioner.

  • Amy McLaren

    Amy L. McLaren

    Ultragenyx Pharmaceutical

    Amy McLaren is a Senior Director of Quality and Compliance at Ultragenyx Pharmaceuticals and heads Global Health Authority Inspection Management and Risk Management.  Amy is a seasoned Clinical Research and Quality professional with 23 years of experience in a variety of indications including Neurology, Oncology and Rare Disease.  Throughout her career, she has managed Phase II and pivotal Phase III Clinical Programs and led cross-funtional teams and sites across the globe through the process of Regulatory Agency Inspection.

    Amy’s experience has taught her the importance of both technical expertise and emotional intelligence as it relates to individual and team performance. Being an effective leader in today’s world is complex. Over the course of her career, she has experienced the evolution of the workforce. Today’s talented professionals demand leaders to be engaging and inspiring – while cultivating teams where diverse skill-sets and perspectives are not only welcomed, but leveraged.  Amy brings to her organization an eye for continuous improvement and believes that a balance between structured framework and creativity is necessary for people to do their best work.

    Amy is a 300-Hour Certified Mindfulness Meditation Teacher, holds her Yellow Belt in Kaizen and received her BS from Temple University in Kinesiology. 

  • Ervin Rodriguez

    Ervin Rodriguez

    GlaxoSmithKline

    Ervin Rodriguez is currently Vice President, Quality Systems for Pharmaceutical Supply Chain at GSK. Ervin has a Bachelors degree in Psychology from the University of Puerto Rico and a Masters degree in Industrial/Organizational Psychology from the Puerto Rico Institute of Psychology.

    In his current role, he is responsible for Data Integrity, the Quality Digital Solutions team, Computer Validation teams, Manufacturing ERP Quality Programme, Quality Data Analytics, Quality Risk Model, Quality Workflow and Quality Dashboard. He is also responsible for Global Human Performance & Compliance Training.

    Ervin's team is the link between manufacturing Quality and Tech/IT innovation, leading implementations for automated lab systems, documentation systems, predictive risk analytics and electronic batch record systems.

    Ervin has been with GSK for 15 years and has had roles as VP of Human Resources and Site Director of the Cidra plant in Puerto Rico. Before joining GSK, Ervin had leadership roles in a number of fields including Training, Organizational Development, HR, Communications, Public Affairs and Logistics Capability for companies like Intel, Schering Plough and Eli Lilly.

  • Gregory Tewalt

    Gregory L. Tewalt, PhD

    Kaleo, Inc.

    Gregory Tewalt has over 30 years of experience within pharmaceutical, biopharmaceutical, and drug/device combination product organizations worldwide.  He led company and divisional technical and quality strategy to include: developing laboratory and manufacturing system commissioning, qualification and validation practices for clinical and commercial small and large molecules aligned with industry standards and regulations; actualizing initiatives for a new CMO to establish the Quality Management System (QMS), integrating risk management principles to streamline facility and equipment qualification practices; and successfully executing 2011 USFDA Process Validation practices.

    Gregory is the Director of Quality Systems and Compliance at Kaleo, Inc. in Richmond, Virginia, where he manages, implements, and maintains kaléo’s QMS for all GxP operations aligned with applicable regulatory, ICH and ISO guidelines and standards. He develops and implements continuous quality system improvements, has redesigned and implemented a robust risk-based supplier qualification program, manages and conducts internal and supplier audits, and ensures inspection readiness at kaléo and all suppliers.

    Gregory champions data integrity and quality culture programs within the Development and Operations organization at kaléo; hosting the annual kaléo Quality Summit, which fosters transparent and collaborative partnerships with kaléo suppliers utilizing discussion of current regulatory trends and topics, invited speakers, and group participation exercises.

  • 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.