Chair: Damian Greene is Global Network Strategy Lead, Global Manufacturing & Supply for Zoetis (formerly Pfizer Animal Health) where he is responsible for the company's manufacturing and supply network strategy, product sourcing, and long-range capacity planning. Throughout his 29 year career at Pfizer he has held leadership roles in Pfizer's Global Supply, Manufacturing, Food Sciences and Chemical Divisions where he has been responsible for API operations, product launch, and network evaluation/restructuring. Damian Greene has been a Member of ISPE for 9 years where he has been involved in the API Community of Practice and has chaired the Community of Practice Council. He was elected to the ISPE International Board of Directors in 2007. Damian Greene holds a BE in Chemical Engineering from University College Dublin, an MSc in Chemical Engineering from the University of Missouri-Rolla, and a Certified Diploma in Accounting and Finance from the Chartered Association of Certified Accountants.
Vice Chair: Andy Skibo is Regional Vice President, Biologics-Supply, MedImmune/AstraZeneca where he affects changes in manufacturing operations, quality oversight, and cross-functional relations throughout the company. Previously he has worked in other senior leadership roles at Amgen, Genentech, and Foster Wheeler, among others. In these roles he has been responsible for significant aspects of the companies’ operations including engineering, construction, and validation for large-scale capital projects related to bio-pharmaceutical manufacturing. He is a member of the International Leadership Forum (ILF), and a member of the Materials Technical Advisory Committee of the US Department of Commerce, specializing in non-proliferation issues associated with biological and chemical weapons. As an ISPE Member for 24 years Andy Skibo has served on the judging panel for the Facility of the Year Award, he has been a conference leader, and he participates on several committees. He was elected to the ISPE International Board of Directors in 2011. Andy Skibo holds a BS in Organic Chemistry and an MS in Chemical Engineering, both from MIT.
Treasurer: Joe Famulare is Vice President - Global Quality Compliance and External Collaboration at Genentech/Roche, Pharma Technical Operations. He is active in aligning industry and international regulatory authorities around policy and harmonization, and also heads the company’s inspection readiness, GMP auditing and is integral to determining the company's compliance strategies, among other duties. Joe Famulare joined Genentech in 2009 as the Senior Director of Genentech's Quality and Compliance External Collaboration function after a 32 year career at FDA. He is the former Deputy Director, CDER Office of Compliance, FDA, where he led an extensive team heading GMP GCP, and GLP Compliance programs. He was a founding member and served on the Council of Pharmaceutical Quality. He also held a number of progressive roles at FDA throughout years of public service. As a Member of ISPE for more than 15 years, Joe Famulare presently serves as a member of the CGMP Executive Planning Committee; Chair of ISPE’s PQLI Initiative, serves on the ISPE Regulatory Compliance Committee and is active in ISPE global activities as a speaker and panelist, most recently in ISPE events in Japan and China. He is a member of the International Leadership Forum (ILF). He recently co led the publication of PQLI's Quality System Guideline on Process Performance and Product Quality Monitoring. He was elected to the ISPE International Board of Directors in 2010. Joe Famulare has a BS in Biology and Environmental Studies from St. John's University and extensive training in manufacturing, microbiological and chemistry, regulatory risk management and leadership.
Secretary: Mike Arnold is the Business Process Owner for Investigational Products and Senior Director of Strategic Partnerships for Pfizer's Global Clinical Supply Chain. He has worked in the Pharmaceutical Industry for the past 31 years. Mike Arnold is a member and Past-Chair of the ISPE Investigational Products Community of Practice, a member of the ISPE Regulatory Subcommittee, a member and Past-Chair of the ISPE Community of Practice Council, current Chair of the ISPE Strategic Forum, active member of the ISPE International Board of Directors and an active member of the International Leadership Forum (ILF). He is a contributing author to ISPE’s Good Practice Guide on Interactive Response Technology and has been a speaker at local and international educational events. In 2011 ISPE named him its Member of the Year. Mike Arnold holds a BS in Pharmacy from the University of Rhode Island College of Pharmacy and is a licensed, registered and active pharmacist in the state of Connecticut. In 2012 he was elected “Pharmacist of the Year” by the Connecticut Society of Health Systems Pharmacists.
James A. Breen Jr, PE, LEED AP is the Vice President, Worldwide Engineering and Technical Operations in Johnson & Johnson's Supply Chain group based in New Brunswick, New Jersey. He has been employed by Johnson & Johnson for 15 years. Prior to this he worked for the General Electric Company and for Hercules Incorporated in both domestic and international assignments. Jim Breen is Past President of the ISPE New Jersey Chapter, a member of the ISPE Facility of the Year Award judging team, and a member of the International Leadership Forum. Jim Breen holds a Bachelor of Engineering from Stevens Institute of Technology, an MBA from Drexel University, and a Masters of Engineering in Technology Management from the University of Pennsylvania Wharton School. He is a registered Professional Engineer and LEED AP.
Jennifer Lauria Clark, CPIP is a Technical Services Project Manager for Commissioning Agents; she is currently providing services to Novo Nordisk on the company’s behalf. At Commissioning Agents Jennifer is responsible for business development project engineering, commissioning and qualification planning, protocol development and execution, project startup and coordination, among other duties. Previously she held positions at Yonkers Industries where she provided services for Merck, BD, GSK and Biogen and others. Jennifer Lauria Clark has been a Member of ISPE for more than 9 years and actively involved in the Society's local and international activities. She presently serves as the President of the ISPE CASA Chapter, is a member and past chair of ISPE’s Young Professionals Committee, and a member of ISPE’s Pharmaceutical Engineering Committee and the Annual Meeting Planning Committee. Jennifer Lauria Clark was also an active student member of ISPE and held progressive roles in her student chapter’s board. She has a degree in Industrial Engineering from North Carolina State University. Jennifer Lauria Clark earned her CPIP designation in 2012.
Jim Durkin is currently a Project Manager with the National Health Service in the UK, where he is responsible for a new green-field, manufacturing facility for sterile products. His prior experience includes similar green-field, start-up projects with Advanced Medical Solutions, Fresenius-Kabi and Astra-Zeneca. Mr. Durkin was Managing Director for Pharmaplan Ltd and was responsible for establishing their UK offices. Jim Durkin has been a Member of ISPE for more than 21years, a Member of the ISPE UK Affiliate and has been active in many international organizations. He is a Chartered Engineer, Institution of Engineering & Technology and earned a BSc (Honors) in Manufacturing Engineering from University of Birmingham and Masters in Business Administration from London & Liverpool Business Schools.
Mark Fitch is currently Senior Vice President of Global Operations for Impax Laboratories, Inc., with responsibilities for manufacturing operations in California, Pennsylvania and Taiwan. He has held positions of increasing responsibility at The Upjohn Company, Schering-Plough, Knoll/BASF Pharmaceuticals, Mylan Pharmaceuticals and Nycomed US, Inc. Mark Fitch has been an ISPE Member for 16 years. He authored a Pharmaceutical Management Training Module for a CPIP course and is a former Member of the Editorial Board of the Journal of Pharmaceutical Innovation. Mark Fitch is a past Chairman of the PMA (PhRMA) Committee on cGMP and serves as a member of the Dean’s Advisory Council, University of Georgia, College of Pharmacy. Mark Fitch holds a BS in Pharmacy and Pharmaceutical Sciences from Purdue University, where he had been recognized as a Distinguished Alumnus. He also holds an Advanced Management Certificate from Northeastern University.
Thomas Hartman is Vice President of GMP Operations, Biopharm CMC, for GlaxoSmithKline, where he leads GMP manufacturing, testing and support operations, and engineering for Clinical Trial Material (CTM) production of biopharmaceutical assets within the CMC group of the Biopharm R&D division. Prior to his 12 year tenure with GSK, he worked for Lyondell Chemical Company (previously ARCO Chemical Company) for 22 years in various engineering and operational roles within the US and Europe. Thomas Hartman has been a Member of ISPE for 12 years. He serves as an industry advisor to the Delaware Valley Chapter, participates in the Chapter’s annual Owners Advisory Forum and hosts Chapter educational events on the GSK campus. Thomas Hartman is active in an industry liaison and mentor role for the Mechanical Engineering Department at Villanova University. Thomas Hartman earned a BME from Villanova University and an MBA from Eastern University.
Tim Howard, CPIP, PE is a Vice President of Global Operations and Company Officer at Commissioning Agents, Inc. In this role, he oversees human resources development, the company safety program and operations execution. He also provides consulting services for risk management, risk-based commissioning and qualification projects and quality systems implementation. Prior to his work with Commissioning Agents, Mr. Howard was a naval nuclear submarine officer, and later became a senior reactor operator at a commercial nuclear power plant. Tim Howard has been an ISPE Member for 20 years. He presently serves on the Annual Meeting Planning Committee and chairs the Award Committee for ISPE. In the past, he has served as Chair of the Carolina-South Atlantic Chapter (CaSA) membership committee and as a CaSA Chapter Board Member. He is a longtime member of ISPE’s North American Education Committee, having served as Chair and Co-Chair for three years and as a member of the committee since 2002. Mr. Howard earned a BS degree in Mechanical Engineering from North Carolina State University. He is a registered professional engineer and a Certified Pharmaceutical Industry Professional (CPIP).
Gordon Leichter is the Eastern Regional Sales Manager for Belimed where he is responsible for the positioning and marketing of custom engineered sterilization and washing equipment in the US market. Previously he held positions with Pharmadule, Getinge, and Steris among others where he has worked on the operational side of manufacturing pharmaceutical process equipment in addition to sales and marketing roles. Gordon Leichter has been a Member of ISPE for 15 years. He has served as Board member and President of the New Jersey Chapter, Chair of the Sterile Products Processing Community of Practice, Co-Chair of the Body of Knowledge Committee, as a member of the Supplier Advisory Council, and as a course leader at educational events. He was elected to the ISPE International Board of Directors in 2010. Gordon Leichter holds a BSBA in General Management and an MS in Management from Thomas Edison State College, and a PhD in Business Administration from Touro University.
Robert "Bob" Matje, PE, CPIP is the Senior Director of Engineering at Endo, a position which he has held since June 2012. At Endo, he runs engineering operations for Qualitest, Endo’s Generic Manufacturing division, including reliability and maintenance, environmental, health and safety, automation, capital and qualification. Robert Matje worked at Pfizer (then Wyeth) between 1999 and 2012. He held numerous positions, including Program Manager for Pfizer’s Global Serialization Project Management Office and Program Director for PNS Projects in Puerto Rico. Robert Matje has been a Member of ISPE for 12 years and is Past President of the Delaware Valley Chapter. He serves on the PCC Recertification and Credential Viability Committees, the Facility of the Year Committee, the Community of Practice Council and chairs the Oral Solid Dosage CoP Steering Committee. Robert Matje earned a BS in Engineering at Lafayette College and an MS in Engineering at Villanova University. He is a Registered Professional Engineer in Pennsylvania and was awarded his CPIP designation in 2012.
Christopher "Chris" Reid is the CEO and Principal Consultant and owner of Integrity Solutions Ltd., a firm that supplies IT project delivery and quality and compliance services in the pharmaceutical, medical device, biotech and healthcare related industries. Chris is responsible for global operations covering ISL’s offices in the UK, USA and Japan. Prior to this he worked for Eutech Limited and Imperial Chemicals Industries plc. Chris Reid has been a Member of ISPE for 13 years. He is the current Chair of GAMP Europe, the Co-Chair of the COP Council, a Member of the GAMP Council and a Corresponding Member of the Content Evaluation Team. He is also a Steering Committee Member of GAMP UK. Chris Reid holds a BSc (Hons) in Computing Science from Staffordshire University.
Fran Zipp (Sakers) is the Group Executive Vice President and Head of Quality Operations at Teva, where she reports directly to the CEO. She is responsible for quality and compliance GxP functions globally, as well as QA oversight of IT systems, Regulatory Affairs and third-party suppliers. Prior to her 5 years at Teva, Fran Zipp (Sakers) was employed by Wyeth Pharmaceuticals at the executive level. She also worked at Applied Analytical Industries, Inc. and Novartis. Fran Zipp (Sakers) serves on the ISPE Drug Shortage Working Group and the ISPE Quality Metrics Initiative Team. In addition, she is a member of the International Leadership Forum (ILF), currently serving on the Executive Committee. Fran Zipp (Sakers) holds a Bachelor of Science in Chemistry from Duke University. She has also done graduate work in Pharmacology at the State University of New York at Buffalo and in Management Science at Stevens Institute of Technology.
Past Chairman: Charlotte Enghave Fruergaard is Partner, Global Consulting for NNE Pharmaplan Denmark where she has 18 years of experience with projects focused on pharmaceutical production, isolator and barrier technology and sterilization techniques. She has led or participated in projects throughout the Nordic region, the European continent, in the US and in Brazil. A member of ISPE for 17 years, Charlotte Enghave Fruergaard is a founding member of the Nordic Affiliate and served on the Affiliate Board of Directors in a variety of roles including Chair. She has been an ISPE conference leader and has participated on the Sterile Products Processing Community of Practice Steering Committee. She was elected to the ISPE International Board of Directors in 2007 and is currently the Vice Chair. Charlotte Enghave Fruergaard holds an M.Sc. and a PhD in Mechanical Engineering from Danmarks Tekniske Universitet as well as an EBA in Engineering Business Administration from Copenhagen University College of Engineering.