International Board of Directors, 2007-08

Chair: Bruce Davis, AstraZeneca

Bruce Davis works for AstraZeneca in the United Kingdom. His current responsibilities are for the company global capital program, covering all business areas including operations, R&D, and commercial. He also manages various internal business projects and 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 six 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.

Chair: Charles Hoiberg, PhD, Pfizer

Charles P. Hoiberg is an Executive Director in Pfizer's Reg CMC - Policy and Regulatory Environment 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 FDA. Dr. Hoiberg had a leadership role and held numerous positions in the Agency and was involved in numerous 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. He represented the Agency in negotiations of many ICH topics and has had 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 Vice Chair for the ISPE International Board of Directors and a member of various ISPE Committees, such as RAC, PQLI, and the Science and Technology Task Team.

Vice Chair: Charles Hoiberg, PhD, Pfizer

Charles P. Hoiberg is an Executive Director in Pfizer's Reg CMC - Policy and Regulatory Environment 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 FDA. Dr. Hoiberg had a leadership role and held numerous positions in the Agency and was involved in numerous 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. He represented the Agency in negotiations of many ICH topics and has had 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 Vice Chair for the ISPE International Board of Directors and a member of various ISPE Committees, such as RAC, PQLI, and the Science and Technology Task Team.

Treasurer: Alan Mac Neice, Elan

Alan Mac Neice is Project Director for Biologics at Elan's Biopharmaceutical Science's campus in Ireland. Over his career, Mac Neice has held responsibilities 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 23-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 medicines. 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 the Treasurer for the ISPE International Board of Directors and a member of the Board since 2005.

Secretary: Andre Walker, CPIP, BiogenIdec Manufacturing ApS

Andre Walker is Director of Manufacturing Engineering for Biogen Idec's Commercial and Clinical Operations in Cambridge, Massachusetts with responsibility for all GMP equipment, utilities, metrology, and validation. He has more than 25 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 also serves on the Resource Analysis Task Team, the Membership Services Committee, and the Biotech Community of Practice Steering Committee. 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.

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 the ISPE since 1996 and has held committee positions at both Irish affiliate and at European level. She is the current 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.

Director: Joan Gore, RPh, Eli Lilly & Co

Joan Gore is the Manager of the US Clinical Trial Planning and Packaging 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 vast majority of her nearly 23-year career at Eli Lilly has been spent in the Clinical Trial Materials area where she has held a variety of jobs of increasing responsibility. Gore has been a manager in the area for eight years where she has been responsible for all aspects of the CT Material organization. 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 is currently serving as the Chair of the committee. During her time on the steering committee she helped revise the Introductory US Clinical Trial Materials Training Guide and was an author of the recently published Comprehensive Guide to Clinical Materials. As part of her role as Chair, she has been actively working on the consolidation/globalization of the North American (CMC) and European (IMPG) COPs. She serves on the ISPE Community of Practice Council. Gore also has participated in the Investigational Materials Discussion Group and the Midwest Clinical Supply Group.

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 in 1983 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 Pfizer New York headquarters, and at the Groton Connecticut site. In 2003, Greene was appointed to his current role of Director/Team Leader of the PGM API Operations Team. He is Founder and Co-Chair of the ISPE API Community of Practice and Co-Chair of the ISPE Community of Practice Council.

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

Tomiyasu Hirachi is Representative Director and President of Qualicaps Co., Ltd. He is one of the founders and the first Chairman of ISPE Japan Affiliate. He is contributing to ISPE Japan Affiliate as a Former Chairman. Hirachi is a member of ISPE Professional Certificate Commission and International Leadership Forum. For more than 35 years, he has been involved in engineering and the pharmaceutical industries. He has vast experience in project management, and has served in pharmaceutical companies as plant manager and a senior manager. He joined Sandoz Japan in 1989 and successfully completed the solid dosage form factory expansion, and grass root construction of the research center project. He then attained the positions of Engineering Manager, Production Manager, and Head of Technical Operation Division. In 1998, after the merger of Sandoz and Ciba-Geigy, Hirachi joined Shionogi & Co., Ltd., and became the president of Bushu Pharmaceuticals Co., Ltd., which is a newly created third party manufacturing subsidiary company of Shionogi. In 2002, he became the director and Settsu factory manager of Shionogi & Co., Ltd. In 2004, he became the President of Shionogi Qualicaps Co., Ltd. (current company name is Qualicaps Co., Ltd.).

Director: John Nichols, Retired

John Nichols, an engineer with more than 30 years of experience in the Life Sciences industry, is currently Director of Pharmaceutical Technology at Foster Wheeler. In this role, he is responsible for global coordination of technology while providing consultancy for specific projects. Prior to this, Nichols was engineering director for extract technology Ltd., and manager of pharmaceutical engineering for Foster Wheeler Reading Office, where he was responsible for staff involved in the design of bulk pharmaceuticals, bio-chemicals, and secondary finishing facilities. Starting at the first ISPE UK meeting in Stratford, he has presented at numerous ISPE events on the subjects of containment, risk, and innovation and has organized a number of seminars. He is a Member of ISPE's International Board, member (past Chairman) of the ISPE European Education Committee, and International Education Committee, is a member of ISPE's Knowledge Management Task Team, and was part of the Steering Group (European Technical Advisor) on the recent BPC/API Baseline® Guide update. He was ISPE's Member of the Year in 2003. He is currently involved in ISPE's new Facility of the Year Award and the API Community of Practice initiatives. He obtained his BSc in chemical engineering from Imperial College, London, and a Diploma in management from Thames Polytechnic, London, and is a Fellow of the Institution of Chemical Engineers.

Director: Arthur Perez, PhD, Novartis Pharmaceuticals Corporation

Dr. Arthur (Randy) Perez, Executive Expert, IT Quality Assurance for Novartis Pharmaceuticals, has served on the ISPE International Board of Directors since 2005. 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 24-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. He was a member of the PhRMA Computer Systems Validation Committee and was instrumental in the formation of GAMP Americas when that group started in 2000. He initiated and led the Global Information Systems SIG, which wrote a GAMP® Good Practice Guide that was published in 2005. In 2002, he was elected Chairman of GAMP Americas and became a member of the global GAMP Council. Perez has been a speaker and a course leader at numerous ISPE Continuing Education seminars in the US and Europe, and has been published in industry journals and textbooks.

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

David E. Petko, PE, is currently Engineering Director, Worldwide Engineering and Real - Estate, Johnson & Johnson. 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.

Director: Stephanie Wilkins, PE, PharmaConsult US Inc

Stephanie Wilkins, PE, is President of PharmaConsult US, Inc., which provides containment consulting to the pharmaceutical industry. Wilkins has more than 24 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 when she served on the inaugural Article of the Year Subcommittee. Since 1993, Wilkins has remained active in ISPE by participating or chairing the following; the Publications Committee, chair of the Webinar Subcommittee, co-chair of the Membership Services Committee, Chapter Council, chair of the North American Education Committee for three years where she accepted the Committee of the Year Award in 2001, vice president and chair of the Program Committee for the ISPE New Jersey Chapter, and currently serves on the ISPE International Board of Directors, Containment COP Steering Committee and as Chair of the Risk-MaPP Baseline® Guide Task Team. Wilkins has also served as a reviewer for articles in Pharmaceutical Engineering as well as contributed articles, given lectures, and organized courses for ISPE. Wilkins graduated from Pennsylvania State University with a Bachelor of Architectural Engineering.

Past Chair: Jane Brown, GlaxoSmithKline

Jane R. Brown is Manager, GMP Compliance for GlaxoSmithKline in Research Triangle Park , North Carolina , USA . She has been involved in Quality Assurance/Regulatory Compliance in the pharmaceutical and medical device industries for more than 20 years. Brown has been a member of ISPE since 1993, and has served on the Board of Directors for the Carolina-South Atlantic Chapter and as President of that Chapter. She has served on the International Board of Directors since 2000. She founded Student Chapters at North Carolina State University, the University of North Carolina, Duke, and Campbell Universities , and assisted in the formation of Chapters at Clemson, James Madison, and NC A&T Universities. Brown was Co-Chair of the Student Affairs Task Team, and now is a member of the Student Development Committee and the University Relations Committee. She also is Board Liaison for the North American Affiliate Council. Brown is a member of the Industry Advisory Council for the Food Science Department at NC State University, where she earned a BS degree. She also is a member of the BioNetwork Industry Advisory Board for the North Carolina Community College System and a member of the Advisory Council for the Food Systems Leadership Institute.