International Board of Directors, 2008-09

 Charles P. Hoiberg, PhD is an Executive Director in Pfizer's Global Regulatory CMC group. He received a BS in chemistry from the College of William and Mary and a PhD in biochemistry (chemistry minor) from Pennsylvania State University. He worked for more than eight years at Sterling Drug Inc. in R&D before joining the US FDA. Dr. Hoiberg had a leadership role and held numerous positions in the Agency and was involved in many global initiatives. When he retired from the Agency, he was the Deputy Director of the Office of New Drug Chemistry and the Associate Director for International Activities. He was the CDER ICH Quality Coordinator and represented the Agency in negotiations of many ICH guidelines. He has maintained close contacts with many worldwide regulators and industry leaders. While at the Agency, he was very involved in working with ISPE on developing the SUPAC Equipment Addendum. Dr. Hoiberg has been a frequent lecturer for ISPE at its domestic and international programs in Europe and Asia. He is currently the Chair of the ISPE International Board of Directors and a member of various ISPE Committees, including the Regulatory Affairs Committee, PQLI Steering Committee, President's Advisory Council, and the Science and Technology Task Team.

Vice Chair: Alan Mac Neice, Elan

 Alan Mac Neice is Senior Director for Projects for Elan's Biologics division in Ireland. During his career, Mac Neice has had responsibility for both capital projects and operations, including maintenance, facilities, safety and environment responsibilities. Mac Neice holds a degree in chemical engineering and a number of business qualifications including an MBA. His 24-year career has been entirely within the manufacturing sector of the pharmaceutical industry. He has worked with five different US and European multinationals in a diverse range of manufacturing operations, including chemical APIs, biotech APIs, aseptic dose forms, oral solid dose forms, and the extraction of natural medicine. A member of the Ireland Affiliate since 1992, Mac Neice has been a committed ISPE volunteer as an organizer, speaker, and advisor. From 1998 to 2004, Mac Neice served on the Irish Affiliate Management Committee, including a two-year term as Chairman. Under his stewardship, the Affiliate membership grew by 60% and the first Student Chapter outside of North America was established. Mac Neice is currently Vice Chair of the ISPE International Board of Directors and has been a member of the Board since 2005.

Treasurer: Andre Walker, CPIP, BiogenIdec Manufacturing ApS

  Andre Walker is Director of Manufacturing Engineering and Facilities for Biogen Idec's Large Scale Commercial Manufacturing Operation in Hillerod, Denmark, were he is responsible for the maintenance and engineering support of all equipment and utilities, including the metrology and validation functions. He and his family recently relocated to Denmark from the USA, where he held a similar role at Biogen Idec's Manufacturing Operations in Cambridge, MA. He has more than 27 years of experience in the areas of process development, scale-up, implementation, validation, and manufacturing support. A chemical engineer by training, his efforts as principal process development engineer won a Corporate award from Duracell, International. At Bayer Diagnostics, Walker formed and staffed a new engineering department, oversaw IVD diagnostics manufacturing, and was heavily involved in designing their validation and compliance systems. A member of the ISPE International Board of Directors since 2003, he is currently serving as Treasurer. He also serves on the Resource Analysis Task Team, and the steering committees of the Packaging COP and the Biotech COP. His past contributions to the Society include four years on the North American Affiliate Council, two of which he served as chair, and several years on the Boston Area Chapter Board, including terms as vice president, program chair, and president.

Secretary: Arthur Perez, PhD, Novartis Pharmaceuticals Corporation

 Arthur (Randy) Perez, PhD currently holds the position of Executive Expert, IT Quality Assurance for Novartis Pharmaceuticals. His responsibilities at Novartis include a wide range of IT Compliance issues, such as GxP, Sarbanes-Oxley, and data privacy. He serves on several global Novartis teams dealing with computer systems compliance issues, and has authored many of the firm's global GxP compliance policies. During his 25-year tenure at Novartis, he has developed a broad range of experience, working as a chemistry group leader in process research, managing a chemical manufacturing process validation program, and running a QA validation group for pharmaceutical operations. Dr. Perez was a member of the PhRMA Computer Systems Validation Committee from 1995-1999, and was instrumental in the formation of GAMP Americas when that group started in 2000. In 2002, he was elected Chairman of GAMP Americas and became a member of the global GAMP Council. 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. Dr. Perez has been a speaker and a course leader at numerous conferences in the US and Europe, and has been published in industry journals and textbooks. In 2005, he was elected to the ISPE International Board of Directors and is currently serving as Secretary.

Director: Nuala Calnan, PM Group

 Nuala Calnan is a Principal Consultant with Project Management Group, Ireland and has over 17 years experience in the pharmaceutical industry, with experience across the secondary pharmaceutical sector and more recently in the biopharmaceutical sector. She has a strong technical background in new facility design. Her previous roles have ranged from engineering operations to global engineering capital projects management and in that time she has demonstrated an aptitude for complex, large scale facility start up projects. Through these roles, Calnan has developed a detailed operational working knowledge of the pharmaceutical regulatory cGMP environment, both FDA and EMEA and she has been involved in preparing several facilities for FDA and IMB inspections. In addition to her career experience, Calnan has been involved with ISPE since 1996 and has held committee positions at both Irish affiliate and at European level. She is currently a member of the ISPE International Board of Directors, Chair of the International Executive Education Committee, Board Liaison to the European Education Committee, a member of the Steering Committee for the Commissioning and Qualification Community of Practice (C&Q COP) and the UK and Ireland Process Analytical Technology (PAT) COP. She is actively involved in responding to the recent initiatives within the regulatory environment and is a member of the Author Task Team which produced the recent ASTM International Standard on Commissioning and Qualification. Calnan is also a member of the team currently updating the ISPE Baseline Guide for C&Q. She graduated in 1991 with a Bachelor of Science in Engineering (BSc Eng) degree and achieved her MBA in 2002.

Director: Charlotte Enghave, PhD, NNE Pharmaplan

 Charlotte Enghave, PhD is employed as Senior Consultant in the Finished Product Department at NNE Pharmaplan in Denmark. Previously she was manager of sales and marketing and before that responsible for conceptual designs of new pharmaceutical facilities. Enghave has 14 years of experience with pharmaceutical projects. She has a broad experience within pharmaceutical manufacturing of sterile bulk and is a leading expert within isolator and barrier technology and associated sterilisation techniques. Enghave holds an MSc in mechanical engineering and a PhD in measuring technique. She has international experience from an EU founded project where she was stationed at Physicalische Technische Bundesanstalt in Germany. During this project, she also gained the PhD degree within metrology. Enghave has been a Member of ISPE for 14 years, and is a Director on the International Board of Directors. She is co-founder of ISPE Nordic Affiliate in 2000, and the immediate past Chairman. She is a member of ISPE Sterile Products Processing Community of Practice steering committee. Furthermore she has been the co-chairman of the yearly reoccurring ISPE "Barrier Isolation Technology Conference" in Europe since 1999.

Director: Nigel Frost, Thermal Transfer Ltd

 Nigel Frost is Managing Director of Thermal Transfer Ltd., a UK based pharmaceutical contracting company, specializing in the design and construction of turnkey pharmaceutical facilities. Frost is also a member of the ETDE UK Board of Directors, a wholly owned subsidiary of Bouygues construction, which is one of the world's largest construction companies. Qualified in Building Services Engineering at Salford University near Manchester, England, Frost is the outgoing Chairman of the ISPE UK Affiliate, which has more than 1,300 ISPE members. He received their Member of the Year Award in 2000. His most recent engagement is as Vice Chairman of the ISPE European Affiliate Council and is also a member of the International Membership Services Committee, regularly attending ISPE meetings in both Europe and the US. Frost currently serves on the ISPE International Board of Directors.

Director: Joan Gore, RPh, Eli Lilly & Co

 Joan Gore is the Manager of the Clinical Trial Packaging and Support Services organization at Eli Lilly and Co. Gore, a registered pharmacist, has expertise in both oral and parenteral manufacturing, packaging, parenteral formulation development, CT material supply, GMPs, import/export regulations, supply chain management, global business process improvement, and third party management. The majority of her nearly 25-year career at Eli Lilly has been spent in the Clinical Trial Materials area. During that time, she also led strategy development for CTM and the broader product development division. Gore has been on the ISPE Clinical Materials Committee (North American Regional Steering Committee) since 2002 and has served as the Chair of the committee. During her time on the steering committee, she helped revise the Introductory US Clinical Trial Materials Training Guide, was an author of the Comprehensive Guide to Clinical Materials and has served as a speaker on related topics. As part of her role as Chair, she was involved with the consolidation/globalization of the North American (CMC) and European (IMPG) COPs into the Investigational Products COP. She has served on the ISPE Community of Practice Council and currently serves on the International Education Executive Committee and the Training Advisory Committee. A member of the ISPE International Board of Directors since 2006, Gore is affiliated with the Great Lakes Chapter.

Director: Damian Greene, Pfizer Inc

 Damian Greene works for Pfizer Global Manufacturing (PGM) in New York. He has a BE in chemical engineering from the University College Dublin, and an MSc in chemical engineering from the University of Missouri at Rolla. Greene began his career with Pfizer as a Production Supervisor at the Terre Haute Indiana site. He has worked in a number of manufacturing roles, including at the Ringaskiddy Ireland site, at the Groton Connecticut site, and at Pfizer New York Headquarters. In 2008, Greene was appointed to his current role of Senior Director Plant Network Strategy, API. He is Co-Chair of the ISPE Community of Practice Council. Greene currently serves on the ISPE International Board of Directors.

Director: Tomiyasu Hirachi, EEM Japan CO., Ltd.

 Tomiyasu Hirachi is Representative Director and President of EEM Japan Co., Ltd. For more than 35 years, he has been involved in engineering, production, project management, and factory operation. Hirachi joined Sandoz Japan in 1989 and successfully completed the solid dosage form factory expansion as well as grassroots construction of the research center project as a local project manager. He was then responsible for Engineering, Production, and Head of Technical Operation Division, successively. In 1998, after the merger of Sandoz and Ciba-Geigy, Hirachi joined Shionogi & Co., Ltd. as president of Bushu Pharmaceuticals Co., Ltd., pharmaceutical third-party manufacturing company newly created by Shionogi. He played a leading role in establishing the company. In 2002, he was assigned as director and Settsu factory manager of Shionogi & Co., Ltd. In 2004, he moved to Shionogi Qualicaps Co., Ltd. (now Qualicaps Co., Ltd.) as president. Hirachi established an engineering and factory operation consulting company in 2007. He is one of the founders and the first Chairman of ISPE Japan Affiliate, and remains as a Director and as Chairman of the Program Committee of the Affiliate. Hirachi is a former member of the ISPE Professional Certification Commission and the International Leadership Forum. Hirachi has served on the ISPE International Board of Directors since 2006.

Director: David Petko, PE, Auxilium Pharmaceuticals, Inc.

 David E. Petko, PE, is currently Senior Director, Auxilium Pharmaceuticals, Inc.. He has more than 20 years of pharmaceutical manufacturing experience in the areas of solid dosage, sterile, and bioprocess engineering. Recently, he has been assigned to the construction of Johnson & Johnson's drug combination facilities and bulk bioprocess plants for its affiliates in Europe. Petko was the co-chair of the ISPE committee which developed the ASTM Standard for "risk-based commissioning and qualification," and is Co-Chairing the revision to the ISPE Commissioning and Qualification Baseline® Guide. He is responsible for the strategic initiatives for the development and implementation of Johnson & Johnson's qualification guidelines and has been responsible for design and construction administration of Johnson & Johnson's worldwide regulated manufacturing facilities. Petko is a licensed professional engineer and holds a BS in engineering from Drexel University in Philadelphia, Pennsylvania, US. Petko currently serves on the International Board of Directors.

Director: Stephen Tyler, Abbott Laboratories

 Stephen Tyler is a Director of Strategic Quality and Technical Operations in Global Pharmaceutical Operations at Abbott Laboratories, a worldwide-diversified health care company, in Abbott Park, Illinois, USA. He is an international board member for ISPE. He received B.S.degrees in Applied Biology and chemical engineering from the Georgia Institute of Technology, and a M.S. in microbiology from the University of Georgia. Tyler joined the Strategic Quality and Technical Operations organization in 2008. The Strategic Quality and Technical Operations group provides strategic centralized technical support for data analysis, quality technology transfer, risk assessment and management and development of enhanced quality systems. Previously he was Director of Process Sciences and Engineering, an organization that provided technical support to Abbott?Ts drug product and substance manufacturing organization.

Director: Stephanie Wilkins, PE, PharmaConsult US Inc

 Stephanie Wilkins, PE, Lean Six Sigma Green Belt, is the co-Chair of the ISPE Risk-MaPP Baseline Guide Task Team and is a member of the ISPE International Board of Directors. She is president of PharmaConsult US, Inc, which provides potent compounds containment consulting to the pharmaceutical industry. Wilkins has over 25 years of professional experience in project management, engineering and validation solutions for the pharmaceutical/biotech industry including research, development, pilot plant and manufacturing facilities. Wilkins joined ISPE in 1993 and served on the inaugural Article of the Year subcommittee, the Publications Committee, Co-chair of the Membership Services Committee, Chapter Council and Chair of the North American Education Committee for 3 years where she accepted the Committee of the Year award in 2001. Wilkins has also served as a reviewer for articles to be placed in the Pharmaceutical Engineering Journal as well as contributed articles, given lectures and organized courses for ISPE. Wilkins graduated from the Pennsylvania State University with a Bachelor of Architectural Engineering.

Director: Guy Wingate, BSc, MSc, PhD, GlaxoSmithKline

 Guy Wingate, PhD is currently Quality Director at GlaxoSmithKline and has 17 years of experience working in the pharmaceutical industry. At GSK, he has had overall responsibility for quality for one of GSK's largest manufacturing sites, responsibility for QA Technology Strategy, leading a major revision to the GSK corporate Quality Management System, and overall responsibility for Computer Compliance standards and implementation. Wingate has been involved with the GAMP COP for 15 years in various capacities; most recently he has chaired its governing body GAMP Council since 2000 and led the Task Teams producing GAMP®4, GAMP®5 and the GAMP® Good Practice Guide on Compliant Electronic Records and Signatures. Wingate also currently co-chairs ISPE?Ts Task Team writing a new Baseline® Guide for the Science and Risk-Based Approach for the Specification, Design, and Verification of Facilities, Utilities, and Equipment Systems which is based on ASTM E55 principles. Wingate is a Chartered Engineer and holds a BSc, MSc, and PhD from University of Durham in computing, advanced electronics, and engineering science respectively. He is widely published in journals and books, and regularly chairs and speaks at conferences in the US and Europe. He is also Visiting Lecturer for the University of Manchester's M.Sc. course on Pharmaceutical Engineering Advanced Technology (PEAT) and Dublin Institute of Technology's accredited MSc course on Validation Sciences. Wingate currently serves on the ISPE International Board of Directors.

Past Chair: Bruce Davis, Global Consulting

 Bruce Davis is Director of Global Consulting in the United Kingdom. He has an external role including his commitment to ISPE. Davis is a professional engineer, and prior to the above responsibilities, he worked in a range of other businesses, mainly in the engineering field, where he was responsible for new formulation assets internationally. He has wide international knowledge and has been involved in sterile, oral solid dosage, packaging, and bulk plants and laboratories in many countries. He chaired the Task Team that wrote the ISPE Baseline® Guide on Sterile Manufacturing Facilities. He is one of the leaders of ISPE's Product Quality Lifecycle Implementation (PQLI) initiative. He has given many presentations and been involved in educational events for ISPE in America, Europe and Asia-Pacific. He has completed seven years as a member of the ISPE International Board of Directors. Regarding other organizations, he also is secretary to ASTM E55.03 on Pharmaceutical Standards.