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Committee & Speaker Biographies

Committee & Presenter Biographies

2022 PDA/FDA Joint Regulatory Conference

12-14 September 2022

  • Kurt Davies

    Kurt Davies

    AstraZeneca

    Kurt Davies serves as the Quality Site Lead for AstraZeneca in Mt. Vernon Indiana.  The Mt. Vernon site is AstraZeneca’s largest manufacturing and packing facility in the Americas region.  Kurt is a graduate of Purdue University, USA where he received a B.S. degree in Mechanical Engineering Technology.

    Kurt started his pharmaceutical career as a Maintenance Team Leader in 2003 with Bristol Myers Squibb within their Evansville and Mt. Vernon Indiana facilities.  While with Bristol Myers Squibb, Kurt served in leadership roles in Maintenance, Formulation, Packing, and Supply Chain.  In 2010, Kurt transitioned to Quality where he served in leadership roles within Quality Product Release, and Compliance.  In 2015 Kurt transitioned to AstraZeneca where he has served in Quality leadership roles including Head of Compliance, Director of Quality Assurance, Director of Quality Control and Microbiology, and most recently (2022) was appointed to Quality Site Lead.  Kurt also serves on multiple not for profit, community-based organizations.

  • Lance DeSouza

    Lance De Souza, MBA

    U.S. FDA

    Lance De Souza, MBA, Director, Compliance Branch, Office of Pharmaceutical Quality Operations, Division IV spent several years in the pharmaceutical industry before beginning his FDA career in the San Francisco District Office as a drug investigator in 2002. He independently led domestic and foreign regulatory inspections and performed in-depth investigations of drug and compounding pharmacy facilities. He earned his Level III Drug Investigator Certification in 2010 and served as the SAN-DO Drug Specialist until he was selected to become a SAN-DO Compliance Officer in 2015. In December 2020, he assumed the DCB role for ORA's OPQO-IV and currently leads a team consisting of seven Compliance Officers, one Recall Coordinator, and one Program Support Specialist. Lance holds a BA in Integrative Biology from the University of California at Berkeley and MBA from the University of Phoenix. He and his wife have a teenage son and young daughter. Together, they enjoy travelling and the outdoors.

  • Daniel DeCiero

    Daniel DeCiero

    U.S. FDA

    Daniel DeCiero is a Consumer Safety Officer in CBER’s Office of Compliance Biologics Quality (OCBQ), where he performs reviews and evaluations of compliance and enforcement actions for biological products, drugs and devices regulated by CBER. He has been at the Agency since 2015 and was previously a Process and Facilities reviewer in CDER's Office of Process and Facilities. In this role, he assessed proposed manufacturing and testing processes for filed drug applications (ANDA/NDA), including performing and assessing pre-approval inspections for related manufacturing facilities. Prior to joining FDA, he worked in systems engineering at General Dynamics and at Merck performing laboratory and pilot-plant scale development of APIs. He has a M.S. degree in Regulatory Science from the University of Maryland Baltimore and a B.S. degree in Chemical Engineering from Worcester Polytechnic Institute.

  • Nicole Deschamps

    Nicole Deschamps

    GSK
    Nicole Deschamps, PhD is a Director of Product Quality at GSK where she provides end-to-end product quality leadership and oversight for small molecule and biopharm programs throughout product and process development, technology transfer, commercialization, and major lifecycle changes.  Nicole has a PhD in Chemistry and started her career at GSK in 2007 in process development where she specialized in the application of laboratory automation tools, advanced manufacturing technologies, Quality by Design, and continuous improvement.  In her current role, Nicole has the privilege of collaborating within dynamic cross-functional teams to deliver new life-saving medicines to patients, often via accelerated regulatory approval pathways, new manufacturing technologies such as continuous manufacturing, and lifecycle changes for critical products to continuously improve and ensure compliant and robust supplies of product to our patients.  Nicole lives in North Carolina with her husband, two teenaged children and pet dog.  She can often be spotted cheering on her kids at the soccer fields, hiking, and walking the dog.  She now considers her kitchen to be her lab and loves to cook and garden. 
     
  • Madushini Dharmasena

    Madushini Dharmasena

    U.S. FDA

    Madushini Dharmasena, Ph.D. is currently working as a Senior Pharmaceutical Quality Assessor in FDA/CDER/ Office of Pharmaceutical Manufacturing Assessment (OPMA) Office of Pharmaceutical Quality (OPQ). Dr. Dharmasena joined the Division of Bacterial, Parasitic and Allergenic Products in CBER in 2010 following a postdoctoral fellowship at National Cancer Institute. At CBER she reviewed INDs and BLA supplements with a focus on product quality and manufacturing for biological products including live attenuated bacterial vaccine candidates, recombinant protein vaccine candidates and live biotherapeutic products. In addition to review, she maintained an active research program and developed bifunctional oral vaccine candidates for the prevention of shigellosis and typhoid (FDA patent E-2012-016). In 2018 she joined OPMA, DMA Branch IV as a primary reviewer and has led numerous pre-license inspections of biologics manufacturing facilities. Dr. Dharmasena holds a Ph.D. degree in Microbiology and Immunology from Dartmouth Medical School, New Hampshire.

  • John Diehl

    CDR John W. Diehl, MS

    FDA

    CDR John W. Diehl, M.S., is the Chief, Medical Products and Tobacco Policy Branch, in the FDA/Office of Regulatory Affairs/Office of Strategic Planning and Operational Policy, Division of Policy.  He is responsible for overseeing  the development of new or modified FDA regulation, guidance, and compliance policies for medical products regulated by FDA and working on cross programmatic policy issues impacting ORA .

    CDR Diehl also served as the Director, Compliance Branch, in FDA/ORA/Office of Pharmaceutical Quality Operations, Division II, where he oversaw compliance and recall matters for FDA regulated pharmaceutical firms. And, he served as Acting Director, Compliance Branch and the Special Assistant in FDA’s Dallas District, and as Compliance Officer in the Center for Devices and Radiological Health’s, Office of Compliance.  Prior to working at FDA, he served as a Regulatory Specialist for the Biomedical Advanced Research Development Authority.

    CDR Diehl was commissioned as an Officer in the Commissioned Corps of the United States Public Health Service in September, 2008. He received his Bachelor of Science degree in Biology from the Catholic University of America, Washington, D.C., and a Masters of Science degree in Biotechnology with a Concentration in Regulatory Affairs from The Johns Hopkins University, Baltimore, MD.

  • Arwa ElHagrasy

    Arwa El Hagrasy, PhD

    Alnylam Pharmaceuticals

    Arwa El Hagrasy is Associate Director, Regulatory Affairs (CMC) at Alnylam Pharmaceuticals since 2021. She is currently regulatory CMC strategy lead for lifecycle management of Alnylam’s first oligonucleotide lipid nanoparticle product, Onpattro®. Prior to Alnylam, Arwa worked at FDA as quality assessment lead for ~7.5 years and has reviewed a wide variety of drug product applications submitted to the Agency, including those implementing emerging technologies and advanced pharmaceutical manufacturing. Arwa has over 8 years of prior experience in industry and academia, with focus on the implementation of process analytical technology tools and continuous manufacturing in the pharmaceutical industry. Arwa received her B.S in Pharmacy, Cairo University, Egypt, Ph.D. in Pharmaceutical Sciences from Duquesne University in Pittsburgh, and did a post-doctoral fellowship in the Chemical Engineering Department at Purdue University, IN.

  • 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.

  • Richard Friedman

    Rick L. Friedman, MS

    U.S. FDA
    Richard L. Friedman is Deputy Director, Office of Manufacturing Quality, which is part of the compliance office in FDA's Center for Drug Evaluation and Research (CDER). This position includes oversight of regulatory action decisions relating to manufacturing site acceptability, and promoting sound regulatory policy development. Mr. Friedman has authored several publications on topics including sterile drugs and quality systems. Mr. Friedman has been a faculty member in Temple University School of Pharmacy’s QA/RA graduate program since 2003. Prior to joining FDA in 1990, Mr. Friedman worked in the toxicology research division of Parke-Davis. Mr. Friedman received his B.S. in Biology with honors from Montclair State University in 1989, and his M.S. in Microbiology from Georgetown University School of Medicine in May, 2001.
  • Lisa Gibson

    Lisa Gibson

    Thermo Fisher Scientific

    Lisa Gibson is the Director of QA for Acquisitions and New Site Integration for ThermoFisher Scientific Pharma Services Group (PSG).  Prior to this role, Lisa served as the Site Quality Head for PSG’s Oral Solid Dose development and manufacturing facility in Cincinnati, Ohio for 5 years.

    Lisa spent the first 23 years of her career working for Procter & Gamble, across their many consumer goods divisions.  She held roles throughout her career in manufacturing, supply chain, corporate functions and quality assurance.  In her most recent role at P&G, she was the Global QA Head for their ingestible drugs division.  Lisa graduated from the University of Missouri – Rolla with a BS degree in Chemical Engineering.

  • Francis Godwin

    Francis RW Godwin, MBA

    U.S. FDA
    Francis Godwin received his undergraduate degree from MIT in Chemical Engineering in 2001. After graduation he worked as a process engineer designing, building, and optimizing chemical plants. He was certified as a Black Belt in Six Sigma performing quality improvement projects and teaching Six Sigma principals. He then worked in pharmaceutical process validation for both batch and continuous processes for APIs and finished dosage manufacturing operations. Later, he managed an analytical chemistry laboratory conducting analyses for production, QA, and research testing. In 2009 he received an MBA from Georgetown University and since then, has been working at FDA in CDER's Office of Compliance. He has served in various functions within compliance, and is currently the Director of the Office of Manufacturing Quality, overseeing regulatory and enforcement actions for both foreign and domestic drug CGMP cases.
  • Marea Harmon

    Marea K. Harmon

    U.S. FDA

    Marea Harmon began her FDA career with the Philadelphia District Laboratory as a cooperative education student and later became an FDA Chemist.  Her work included analyzing pharmaceutical dosage forms, training other analysts, and conducting inspections.  In 2000, Marea became a New Jersey District Investigator at the Voorhees Resident Post.  There, she conducted pharmaceutical establishment and laboratory inspections.  Marea relocated in 2007 to work in Rockville, MD as the Drug Training Officer at what was then the Division of Human Resource Development.  In 2008, Marea joined the Center for Veterinary Medicine (CVM), where she continues to work as a Compliance Officer within the Division of Drug Compliance. 

  • Matt Harrison

    Matt Harrison, BSc Hons

    GSK

    Matt Harrison leads Digital and Data Sciences across CMC at GSK alongside heading CMC Project Delivery in the Vaccines organisation.

    This role presents a unique opportunity to lead how data and digital technologies impact at scale R&D and New Product Introduction strategy of Vaccines and medicines.

    Matt has a Chemistry Degree from Liverpool University and has spent more than 23 years in the Pharmaceutical industry. He has a deep understanding of the laboratory and manufacturing domains gained from a variety of technical and digital leadership roles in both the core business and IT functions.

    Matt is passionate about how digital and data can make a difference to how medicines and vaccines and are developed and launched for the benefit of patients, our planet and our experiences in the workplace.

  • Sharyl Hartsock

    Sharyl D. Hartsock

    Eli Lilly and Company
    Sharyl Hartsock began her 30+ year pharmaceutical career with Eli Lilly and Company, where she held various quality leadership roles supporting both parenteral and medical device manufacturing. Through the years, she developed a deep operational understanding of quality systems and aseptic processing needed to ensure sustained regulatory compliance and patient safety. This foundation enabled transition into an enterprise role as the Senior Director of Global Quality Systems. In this role, Sharyl has primary responsibility for establishment and maintenance of the enterprise Quality Management Systems, oversight of global manufacturing and quality data management, and administration of Information Systems Quality. Prior to that, she was the Senior Director of Quality supporting Indianapolis parenteral manufacturing and new product commercialization. Ms. Hartsock received her BS degree in Pharmacy from Butler University in 1989.
  • Brooke K. Higgins, MS

    U.S. FDA

    Brooke K. Higgins is a Senior Policy Advisor for the Global Compliance Branch 3 within the Division of Drug Quality I, Office of Manufacturing Quality, Office of Compliance at FDA's Center for Drug Evaluation and Research. Ms. Higgins is responsible for evaluating domestic and international pharmaceutical inspection reports, reviewing responses from industry, preparing associated regulatory actions, and providing training to ORA and CDER personnel. 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 domestic and international drug manufacturing inspections, 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.

     

  • Lori Hirsch

    Lori F. Hirsch, JD

    Bristol-Myers Squibb

    Lori Hirsch, Vice President, Regulatory Compliance and External Engagement Quality.  Lori leads the Regulatory Compliance and External Engagement Quality group which is responsible for developing and implementing a closed loop quality system for external regulatory engagement and internal regulatory compliance assessment and monitoring to ensure that the BMS company-wide integrated quality GxP management system is operating effectively and in compliance with current regulations and expectations; thereby ensuring proactive quality and compliance, risk identification, mitigation and communication.  This group supports the end to end GxP continuum and includes such areas as  our GMP/GDP auditing group, IT Quality Assurance, External Engagement , Data Integrity Center of Excellence and our enterprise-wide Compliance and Monitoring Group.  Lori joined BMS in January 2018 and prior to this, she served as Managing Counsel, Merck Manufacturing Division, and was a member of the Global Quality leadership team. Lori is an active participant in industry organizations and well-known to many regulators.  Lori received a Bachelor of Arts degree from Tufts University and a Juris Doctor degree from The University of Michigan Law School.

  • Mai X. Huynh, MS

    U.S. FDA

    Mai Huynh is the Team Leader of the Sterile Drugs Team in the Division of Manufacturing Technologies/FDA/ Center for Veterinary Medicine. The Sterile Drugs Team is responsible for the review of pre and post-approval pioneer applications for veterinary injectable drug products.

    Mai joined CVM in 1989 as a manufacturing reviewer, became a team leader and also a master reviewer for her expertise in sterility assurance validation and modified release injectables. Mai is an active member of the Parenteral Drug Association and serve as government liaisons for several USP Expert Committees.  Mai is CVM’s VICH Quality Lead, as well as a member of several FDA's inter-center manufacturing working groups.

  • Susan Hynes

    Susan Hynes, MA

    GSK

    With 26 years in the pharmaceutical industry, Susan joined GSK in November 2020 to lead the Pharma Quality Organization, which includes over 4000 employees across all sites in the global network, Product Quality R&D, suppliers, and local operating companies (country quality teams).

    Susan is currently responsible for setting strategy and providing leadership, direction and focus for Quality in the Pharma Supply Chain and Pharmaceutical Product Development.

    Prior to GSK Susan worked for Takeda, where she was Vice President and Site Lead for their Biologics Operations and completed the divestment of the facility to MSD. She held several roles of increasing responsibility throughout her 18 years with Bristol-Myers Squibb including Site Quality Director, Head of Global Quality Pharmaceutical Manufacturing Global BU and General Manager, Biologics Operations. Susan holds a B.Sc. degree in Analytical Science from Dublin City University, Post Graduate Diploma in Business Management from Irish Management Institute, and a Master’s degree in Project Management from the University of Limerick all located in Dublin.

  • Jay Jariwala

    Jay Jariwala

    U.S. FDA

    Jay Jariwala is a Team Leader with the Office of Manufacturing Quality, Office of Compliance, CDER, where he provides leadership and operational oversight of compliance officers assessing violative establishment inspections and resulting regulatory actions. During his tenure he spearheaded numerous regulatory actions such as injunctions, warning letters, regulatory meetings, and import alerts.  He also participates in inspections as a Subject Matter Expert. He was instrumental in developing various risk-based assessment processes including Warning Letter review procedure. He also represented CDER in Mutual Reliance Agreement Initiative in assessing various EU drug inspectorates’ capabilities. Due to his multi-center background, he was a member of the group instrumental in developing CGMPs for Combination Products, resulting FDA guidance, and investigator training.

    Previously, he served as an Assistant Country Director with FDA’s India Office from 2017 to 2019.where he managed establishment inspections, advised FDA leadership on drug policy issues, and collaborated with various governmental, internal, and industry stakeholders.

    He began his FDA career in 2008 in CDRH, where he spent 7 years in Office of Compliance and held positions of increasing responsibilities starting as a compliance officer to a quality system specialist, and was part of Medical Device Single Audit Program (MDSAP) team.

  • Maik Jornitz

    Maik W. Jornitz, MSEng

    G-CON Manufacturing, Inc.
    Maik W. Jornitz, President and CEO of G-CON Manufacturing Inc., is a technical expert with 35 years of experience in bioprocesses, especially sterilizing grade filtration and single-use technologies, including regulatory requirements, integrity testing, systems design, and optimization. Jornitz has published a multitude of books, book chapters and scientific papers. He is the former Chair of the PDA Board of Directors and Science Advisory Board, and member of multiple PDA Task Forces. He is working member of ASTM E55, an advisory board member of the Biotechnology Industry Council, ICAV and multiple science journals. As a faculty member of various training activities, including PDA TRI, he trains members of the industry and regulatory authorities on a frequent basis. He received his M.Eng. in Bioengineering at the University of Applied Sciences in Hamburg, Germany and accomplished the PED program at IMD Business School in Lausanne, Switzerland