Chair: Charlotte Enghave Fruergaard is Director of Technology 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. Charlotte Enghave Fruergaard has been an ISPE Member for 17 years; she 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. Charlotte Enghave Fruergaard holds an MSc 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.
Vice Chair: Damian Greene is Global Network Strategy Lead for 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 nearly 8 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.
Treasurer: Brian H. Lange PE is Executive Director - Global Supply Chain, Merck & Co, Inc. He has been with Merck for over 24 years and held leadership roles in Manufacturing, Engineering and Quality. Prior to his current role, he spent 12 years in various leadership roles within Vaccine and Sterile Operations, as well as Director of Quality Engineering supporting the Global Vaccine Operations network. Brian Lange has been a Member of ISPE for 21 years and is a past Chairman of the ISPE International Board of Directors. He served on numerous International Committees over the years, chairing the Education and Technical Documents Committees as well as the Chapter Council. He is currently a judge for the FOYA program. In 2012 he was the co-leader of the Future Visioning Team and he was also a conference leader for the cGMP Conference held in June. Brian Lange holds a BS in Mechanical Engineering from Villanova University and he is a registered Professional Engineer in the Commonwealth of Pennsylvania.
Secretary: Andrew D. 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 more than 23 years Andy Skibo has served on the judging panel for the FOYA program, 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.
Mike Arnold is Senior Director, Strategic Partnerships for Pfizer where he is the global leader for the Pharmaceutical Sciences Business Continuity program and the Pharmaceutical Sciences leader for transition teams managing transfer of development operations to Pfizer’s alliance partners. Previously he held the position of Global Process Head for Pfizer’s World Wide Pharmaceutical Science Supply Chain in addition to a number of progressive leadership roles during his 30 year career with the company. Mike Arnold is a member of the International Leadership Forum (ILF) and a core member of the IBM Cloud Coalition. He has been an ISPE Member for 14 years where he has served in numerous leadership roles including Chair of the Investigational Products Community of Practice and Chair of the Communities of Practice Council. 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 an active Connecticut Pharmacist.
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 12 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.
Joe Famulare is Vice President - Global Quality Compliance and External Collaboration at Genentech where he is integral 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 was elected to the ISPE International Board of Directors in 2010. Joe Famulare has a BS in Biology in Environmental Studies from St. John's University and extensive training in manufacturing, microbiological and chemistry, regulatory risk management and leadership.
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 a senior reactor operator at a commercial nuclear power plant. Tim Howard has been an ISPE Member for 19 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).
Doyle R. Johnson is the New England Operations Leader for Hargrove Life Sciences LLC. Previously he was the Senior Director of Facilities and Operations at Genzyme’s Biologics Division. He has more than 25 years of experience designing, building and operating BioPharma and Chemical Process Plants, and has worked in both US and European plants. Doyle Johnson has been an ISPE Member for 17 years. He currently serves on the Biotechnology and Critical Utilities Community of Practice Steering Committees. Previously he was President of the ISPE Boston Chapter and spent five years on the Chapter’s Board of Directors. Doyle Johnson holds a BS degree in Chemical Engineering from Cornell University, an MS in Organic Chemistry from Northeastern University and an MBA from Babson College.
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 14 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.
Morten Stenkilde is currently Director of QA for Novo Nordisk in Denmark. Previously he served as Quality Director at the Novo Nordisk A/S Insulin Filling plant in Tianjin, China. He has more than 15 years of pharmaceutical manufacturing experience in the areas of solid dosage, contract manufacturing, and sterile manufacturing. He has been the leader of construction projects for both solid dosage and sterile manufacturing. Morten Stenkilde has been an ISPE Member for 8 years. He served on the Steering Committee for ISPE Greater China Affiliate and worked to develop the Community of Practice for sterile manufacturing in China. He has also been a member of ISPE’s Website Strategy and Body of Knowledge committees. Morten Stenkilde holds a Master of Science in Pharmacy degree from Danmarks Farmaceutiske Universitet.
Udo J. Vetter is currently Chairman of the Control Board of the Vetter Group of companies, a specialty CDMO; a Director on the Board of Gerresheimer AG, a major glass supplier to the pharmaceutical industry; and a Director on the Board of Gland Pharma in India. He also manages UV-Cap GmbH & Co. KG, a privately held investment company and serves as chairman of the trustees of Sigmaringen-Albstadt, a German University. During his 39 years in the pharmaceutical industry he spent seven years with Schering-Plough in the United States and Puerto Rico. Udo J. Vetter has been a Member of ISPE for 22 years. He is a member of the International Leadership Forum (ILF), serves on the Finance and Audit Committee, the Aseptic Conference Committee, and the Facility of the Year Award Committee. He was co-founder of ISPE's German-Swiss-Austrian Affiliate in 1991 and served three years as the Affiliate Chair. Udo J. Vetter holds a Bachelor of Science in Pharmacy from the University Washington, Seattle, and he is a registered US pharmacist.
Past Chairman: Arthur "Randy" Perez currently holds the position of Director, IT Risk Management and Compliance for Novartis Pharmaceuticals. His responsibilities at Novartis include a wide range of IT Compliance issues, such as GxP, Sarbanes-Oxley, and data privacy. During his 29-year tenure at Novartis, he has worked as a chemistry group leader in process research, managed a chemical manufacturing process validation initiative, and ran both a GMP training program and a QA validation group for pharmaceutical operations. Randy Perez has been an ISPE Member for 10 years. He was instrumental in the formation of GAMP Americas and from 2002-2008 he was Chairman of that group. He has been a member of the global GAMP® Council since 2002. He initiated and led the Global Information Systems SIG, who wrote a GAMP® Good Practice Guide that was published in 2005, and was part of the core team that led the development of GAMP® 5, published in 2008. He was elected to the ISPE International Board of Directors in 2005, and he served as Chairman in 2012. Randy Perez earned a BS in Chemistry at MIT and a PhD in Organic Chemistry at University of Michigan.