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Anthony Bevilacqua is director of R&D at Mettler-Toledo Thornton where he leads several areas of research and product development including high temperature conductivity measurements, impact of CO2 on pure water, and ultrapure water as a conductivity solution standard. Based on this work and Thornton’s leadership in accurate conductivity measurements, Bevilacqua was the conductivity consultant to the USP and PhRMA throughout the generation and implementation period for the (645) and (643) general chapters in the mid 1990s. Bevilacqua worked with these groups to establish the theory, methods, and practices used for conductivity testing of purified water and WFI. He has led national and international conferences regarding the impact of USP requirements for purified water and WFI systems, as well as the effect of on-line real time measurements for in-process control (PAT) of water systems. Bevilacqua was elected by the USP to serve a chair of the Pharmaceutical Water Expert Committee from 2000-2005. This effort continues as he was re-elected as chair for the 2005-2010 cycle, and he serves on USP’s Executive Committee also.

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Peter Bigelow is senior vice president of the Wyeth Consumer Healthcare Operating Unit, Technical Operations and Product Supply (TO&PS). He is responsible for supply of Wyeth’s Consumer Healthcare products globally. The consumer supply network includes six manufacturing sites, external suppliers, technical support functions and supply chain. Wyeth Consumer Healthcare includes such well known brands as Advil, Centrum Vitamins, Chapstick and Robitussin. Bigelow also oversees capital engineering and packaging service functions for Wyeth. Bigelow joined Wyeth in 1995 as vice president of global engineering services. Prior to joining Wyeth, he spent 13 years with Smithkline Beecham (now GlaxoSmithkline) in a variety of engineering and operations roles. Bigelow received a BS in mechanical engineering from Villanova University and an MBA from Philadelphia University.

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Scott Boisvert joined Merck in 2000 as a project engineer. His projects at Merck include a 15,000 ft² large-scale bulk fermentation facility in Elkton, Virginia, USA, and two bulk cell culture facilities in West Point, Pennsylvania, USA, totaling 310,000 ft², which include aseptic robotic roller bottle processing. He spent 11 years at A/E firms (Kvaerner John Brown and Fleur Daniel) in process and project engineering roles working on various bulk API and biotech projects. Boisvert graduated from Rensselaer Polytechnic Institute with a BS in chemical engineering.

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Tom Brennan is co-founder and technical director of EirGen Pharma, Ltd., located in Waterford, Ireland. He has more than 20 years experience in the pharmaceutical industry in a number of technical roles. From 1996 to 2005, he was responsible for pharmaceutical development at IVAX Pharmaceuticals Ireland (now Teva). He holds a number of pharmaceutical formulation patents and was involved in the development and commercialization of approximately 15 new products within this role. EirGen Pharma supports companies in the development and commercial clinical trials supplies of their highly-potent pharmaceutical products. The company has the capabilities to safely handle steroidal, hormonal, oncology and cytotoxic molecules in a purposely built, high-containment facility utilizing innovative isolation technology. Their facilities can also facilitate the development of moisture sensitive molecules in an environment below 30%RH. EirGen Pharma has considerable experience in successfully developing and supplying high-potency pharmaceutical products. Brennan received a M.Sc. from University of Manchester UK and an MBA from University of Limerick, Ireland. He is also an ASQ trained Six Sigma Black Belt.

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Steve Brooks is the vice president of Pfizer Global Operations Risk Management Services (RMS). In this capacity, he is responsible for providing EHS, security and business continuity planning services to several Pfizer divisions, including global research & development, animal health and worldwide pharmaceutical operations. Brooks is a member of Pfizer’s EHS leadership team and the global operations executive leadership team. Brooks and his leadership team are responsible for developing strategy, policies, and standards for driving continuous improvement in the management of risk across all supported divisions and locations. Brooks has more than 24 years experience within Pfizer, including work as a discovery scientist, an EHS professional and as a leader of operational risk functions. He has established an EHS network supporting R&D, a global business protection function, comprising business continuity planning and information protection programs serving R&D; and assumed responsibility for a security network which primarily supports R&D sites. Brooks is a leading player in the development and growth of business savvy “green” programs within Pfizer, including Pfizer’s recognized Green Chemistry program and developing Green Buildings program. Brooks holds a first class honors degree in chemistry. He is a Chartered Safety Practitioner (UK) and a Member of the American Society of Safety Engineers.

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Roger Brunkow joined Cook Pharmica in April, 2005, and is currently serving as the director of technology and strategic planning. He has been involved in the design, construction, startup and operation of biopharmaceutical manufacturing facilities for 22 years beginning with Eli Lilly and Company in 1980. Brunkow was a part of the team that brought Human Insulin to the market in 1983 through genetically engineering E Coli. He was part of the management/senior engineering team involved in the conceptual design, construction, startup, and validation of facilities for Human Growth Hormone; a new Human Insulin process that increased capacity; a larger third generation Human Insulin bulk manufacturing facility; and a facility for the manufacturing of enzymes from genetically engineered E Coli and Picia Yeast hosts, Glucagon from recombinant organisms, and Activated Protein C from a genetically engineered human mammalian cell line. Following retirement after 27 years with Eli Lilly in 2000, Brunkow was vice president of manufacturing for Integrated Biosystems for 9 months, and then started a consulting business. He provided his expertise in biopharmaceutical manufacturing and bioprocess technician training, including the design of facilities that would provide an environment for bioprocess technician training, and technology transfer for bioprocessing and technology application for equipment vendors. Brunkow was a founding member and is president of the Society of Bioprocessing Professionals (SBP), dedicated to educational networking for people involved in biotechnology manufacturing. He was an instructor and seminar director for ASME Bioprocess Technology Seminars for 13 years. He has lectured at several other conferences, been a coauthor of an early book on Bioprocessing Cleaning Validation, and authored several published articles. Brunkow graduated from the University of Wisconsin in 1963 with a BS in chemical engineering.

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Rory Budihandojo is the computer validation manager at Boehringer-Ingelheim Chemicals in Petersburg, Virginia, USA, responsible for computer validation programs and Part 11 compliance of laboratory, manufacturing, and IT systems. He has more than 20 years of worldwide pharmaceutical experience with responsibilities in R&D, manufacturing (API and finished dosage), quality assurance, IT, pharm tech, and quality audit. He has performed method, process, facility, utility, equipment, and computer validation, as well as GMP auditing of contract manufacturers, suppliers, and internal audit. He has validated chromatography, LIMS, PLC, SCADA, DCS, DMS, BAS, ERP, SAP, and change control systems. He was a member of the PhRMA and PDA CSV Committee, and a founding member of GAMP® Americas, where he now serves as the vice chairman and as a global GAMP Council member. Budihandojo has published several articles in computer validation and was the lead author of PDA Technical Report No.31. He serves on the editorial board of Pharmaceutical Technology, BioPharm International, Pharma Magazine, Pharm Tech Europe, and Pharmaceutical Engineering. He has a diploma in electronics, and degrees in chemistry and mathematics

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Jeff Campie currently maintains the position of senior director of commercial quality assurance for Gilead Sciences located in Foster City, California, USA. In addition to heading the commercial quality assurance organization, Campie is responsible for the quality systems and corporate audit function within the company. Prior to joining Gilead Sciences, he was director of quality systems at Serono/Merck in Geneva, Switzerland. He has held positions of increasing responsibility within the R&D and commercial sectors of Smith Kline Beecham, Rorer, Janssen Pharmaceutica (Johnson & Johnson), Rhone-Poulenc Rorer, Élan, and Eli Lilly & Company. For the past 13 years, Campie has focused in the areas of GxP compliance auditing, quality system development and enterprise risk management initiatives. He is a chemist by education having attended Philadelphia College of Pharmacy & Science (PCPS) located in Philadelphia, Pennsylvania, USA.

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Art Caruso joined Merck & Co., Inc., in May 2002. His tenure at Merck has included four years of technical support for vaccine formulation and filling as part of the sterile process technology and engineering (SPT&E) department within the Merck Manufacturing Division (MMD) located at West Point, Pennsylvania, US. Caruso has provided support for the commissioning and qualification of aseptic filling and LYO process equipment, and the technology transfer and launch of new vaccine products within conventional aseptic and barrier isolation facilities. Prior to joining Merck, he had approximately four years of experience working as a validation specialist for ValSource and Integrated Project Services (IPS). Caruso holds a bachelors of science degree in genetics and developmental biology and a masters in manufacturing management from Pennsylvania State University.

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Alberto Cavallero leads KlingStubbins’ architectural design studio in Washington, DC, and establishes the design direction for all architectural, master planning and sustainable design projects. In his 10 years with KlingStubbins, he has been instrumental in the success of national and international commissions, earning numerous awards for design excellence from the American Institute of Architects. His experience includes headquarters complexes, mixed-use developments, specialized research facilities, secure government facilities and international commissions. Cavallero’s work has been nationally published, and he is a frequent lecturer and guest critic.

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Kris Chatrathi has more than 20 years of experience in the fields of engineering and research and development. Since joining CRB as a senior process engineer he has been utilizing process simulation tools on conceptual and detailed design of small and large scale multi-product biopharmaceutical facilities. He has also been a process lead for various facilities producing biologics including vaccines, protein complexes and proteins from transgenic plants. Chatrathi has been involved in the design of all areas of a bio-pharmaceutical facility including upstream, downstream, media and buffer preparation, process utilities, and filling operations. During his career, he has worked as technology director, application research manager and product development manager. He has served as the chairman of the Safety and Health Division of the American Institute of Chemical Engineers, and has assisted ASTM and NFPA technical committees in the development of standards and guidelines. Chatrathi holds two patents and has published many articles on the topics of flammability and explosibility. He earned his doctorate in chemical engineering from the University of Arkansas.

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Ann Christensen is a project director for CE&IC with 20 years experience in process design, process development, and project management for the pharmaceutical and biopharmaceutical industries. Christensen began her career with SmithKline as a process development engineer and spent the past 15 years as a member of CE&IC's process engineering team. Over the past 8 years, she has been focused on potent compound related projects for active pharmaceutical chemicals, final dosage forms, and biologic facilities. Christensen has designed containment systems to meet exposure limits as low as 0.1 μg/m³, along with many projects in the 0.1 to 50 μg/m³ range. She holds a BS Ch.E and an MS Ch.E., both from the University of Delaware.

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Patrice Cloué has 20 years experience in containment systems for nuclear and pharmaceutical industries. His career started by designing manipulation and transfer systems for nuclear hot cells. He participated to the first application of these techniques to the pharmaceutical processes. He joined the La Calhène US operation in 1992, as an application and project engineer. He has since participated to the design of over 250 isolator systems for sterile and toxic processes. Patrice Cloué is presently Director, Corporate Technology at Getinge-la Calhène, in Rush City Minnesota.

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Steve Coates is the director of IS global computer system compliance in Wyeth, Frazer, Pennsylvania, US. He has 30 years experience in the pharmaceutical industry quality assurance and information services, including 13 years of Q.A. laboratory management. He has managed a computer-related audit function and has been responsible for the compliance of GMP-impacted computer systems for the past 17 years. He is regarded as having expertise in software quality engineering as well as computer systems validation, electronic records management, risk management, and auditing. He has presented numerous seminars and workshops on computer systems quality engineering, regulatory compliance, and more recently, risk management. Coates is the current chair for the GAMP® special interest group on risk management (ISPE).

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Andrew Collentro is technical director for Water Consulting Specialists, an engineering and consulting firm serving the pharmaceutical and biotechnology industries. He has more than 12 years of experience in the design, commissioning, and qualification of pharmaceutical water purification systems; specializing in process design and regulatory compliance of USP Purified Water and WFI Systems. Collentro is a member of the ISPE training faculty, and has taught courses for PDA and other industry organizations. He is also a developer of the ISPE courses on pharmaceutical waters, and a steering committee member for the ISPE Critical Utilities Community of Practice.

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Brian Cox joined Eli Lilly and Co. in 1998 and has worked in a variety of roles focused on hygienic utility systems in multiple manufacturing and development sites. His current assignment is as quality assurance engineer supporting hygienic utility systems for several manufacturing areas. Cox has a B.S. in chemical engineering from Purdue University.

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Bruce Davis works for AstraZeneca in the United Kingdom. His current responsibilities are for the company capital program, covering all global 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 in the continents of America , Europe, Asia, and Australasia . He has chaired the ISPE Technical Documents Committee and is now a member of the Technical Documents Executive Committee. He chaired the Task Team that wrote the ISPE Baseline® Guide on Sterile Manufacturing Facilities, and also is chairing the team that is currently updating this Guide. He has given many presentations and organized educational events for ISPE in the US, Europe, and Australia. Regarding other organizations, he also is secretary to the ASTM E55.03 Committee.

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Connie P. Degen received her bachelor’s of science degree in food biochemistry from the University of California at Davis, California, USA. Since that time she has held several positions in quality and manufacturing operations in both the food and pharmaceutical industries. Some of these positions include microbiologist, project manager, laboratory manager, and quality director for a sterile parenteral contract manufacturer, Baxter Pharmaceutical Solutions. As quality director, Degen was responsible for all aspects of GMP manufacturing and laboratory activities, as well as all quality-client interface and audits. She joined Cook Pharmica in 2004. In 2005, she received a Graduate Certificate in regulatory and quality compliance from Purdue University, and is currently working toward her master’s degree in the same area of study. Degen is a Member of the Parenteral Drug Association (PDA), Society for Bioprocessing Professionals (SBP), Regulatory Affairs Professional Society (RAPS), and International Society for Pharmaceutical Engineers (ISPE).

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Paul N. D'Eramo is executive director, quality and compliance worldwide for Johnson & Johnson. In that position, he is responsible for regulatory outreach and compliance oversight for the Johnson & Johnson family of companies. His compliance role involves partnering with J&J operating companies to resolve quality and regulatory compliance issues, and supporting initiatives involving new facilities, new products, and regulatory inspections. As part of his outreach duties, D'Eramo works with industry trade associations and regulatory agencies to develop new guidelines and regulations. He is a past chairman of the ISPE Board of Directors and is currently the chair of the regulatory affairs committee. D'Eramo has been a speaker at numerous industry symposia in the US, Europe, and Asia, and has organized several joint industry/FDA training initiatives. Before joining J&J in 1997, D'Eramo worked for the FDA for 20 years as an investigator, compliance officer, regional drug specialist and manager of the Regional Pre-Approval Inspection Program. While at FDA, he was instrumental in forming the partnership between ISPE and the FDA which lead to the creation of the Baseline® Pharmaceutical Engineering Guides and the SUPAC "Similar Equipment" Addendum. For these efforts, he was awarded the ISPE Professional Achievement Award and Vice President Al Gore's "Hammer Award" in 1997. D'Eramo received his BS in pharmacy from Rutgers College of Pharmacy and is a registered pharmacist in New Jersey.

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Maria Diaz has 14 years of experience in the pharmaceutical industry. Before joining Pfizer, she held positions of increasing responsibility in the areas of manufacturing, technical services, technology transfer, cleaning, and process validation. As a technology transfer/technical services manager, she was responsible for the validation program (process and cleaning validation) of two drug product pharmaceutical plants in Puerto Rico. She is familiar with immediate, rapid, and extended release solid dosage forms. Diaz joined Pfizer in 2004 as a quality system and technical services validation manager with responsibility for global training on process and cleaning validation, supporting the development of quality standards and good practices. She has presented the subject of cleaning validation at Pfizer sites, the Pharmaceutical Industry Association in Puerto Rico, and the Venezuela Ministry of Health. She holds a BS degree in pharmaceutical sciences from the College of Pharmacy, University of Puerto Rico.

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Raymond Doyle, PE, provides primary engineering leadership and design direction for all projects in his Washington, DC, office. He plays a pivotal role in advancing innovative, energy-sensitive engineering solutions for projects under his direction. He is highly regarded within the professional community for his experience in the development of system concepts, collection of detailed engineering data, and analysis of energy consumption. Doyle is a leader on collaborative projects that require detailed engineering integration, and received an ASHRAE technology award for an innovative, energy-recovery design project.

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Walker Lee Evey is the president and CEO of the Design-Build Institute of America. In this position he brings personal commitment to design-build project delivery coupled with a varied background in both the public and private sectors. He is an outspoken advocate of integrated project delivery, demonstrating the effectiveness of innovative partnering and teaming approaches combined with cutting edge acquisition techniques. Evey was most recently senior vice president of 3D/International, Inc., a design, management and construction company that employs 600 professionals in 18 offices nationwide. While at 3D/International, he took a leave of absence to serve as senior advisor to the Iraqi Ministry of Housing and Construction headquartered in Baghdad, Iraq. In that position he was responsible nationwide for repair and construction of all roads and bridges, housing and public buildings. Before coming to 3D/International, Evey was the program manager for the 10-year, $4 billion Pentagon Renovation Program. He was responsible for all aspects of the program including budgeting, requirements determination, planning, design and construction and acquisition strategy. During this time he served as source selection authority for all of the Renovation's acquisition activities and developed a series of cutting-edge acquisition techniques which have had significant impact on design and construction acquisition across the Federal Government. Evey championed the use of design-build delivery, achieving significant cost savings and rapid project completion. Evey also led the "Phoenix Project" which successfully rebuilt the damaged Pentagon in only one year after the terrorist attack of 11 September 2001.

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Joseph Famulare is the deputy director, Office of Compliance in the Center for Drug Evaluation and Research. Office of Compliance is composed of the Immediate Office of the director and four divisions which cover new drugs and labeling compliance, manufacturing and product quality and compliance, risk management and surveillance, and the Division of Scientific Investigations. The Office is responsible for a number of drug quality program areas including: addressing public health risks associated with legal violations; developing and overseeing drug compliance programs designed to reduce consumer exposure to risks of unsafe and ineffective drugs; monitoring the quality of human drugs through inspectional coverage, product testing, and other pre- and post-market surveillance activities; developing policies and compliance strategies to ensure that over-the-counter and prescription drugs are of high-quality, properly labeled, safe, pure, and meet applicable drug approval requirements; and developing policy and standards to achieve high product quality through application of current good manufacturing practice requirements. Famulare began his career as an investigator in Newark District in 1977. He subsequently worked as a resident in charge investigator in the Buffalo District and a supervisory investigator in the New York District. Much of his fieldwork has been in the drug cGMP area.

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Jochen Feichtinger, PhD, is currently a project manager in the surface engineering division within corporate research at Robert Bosch GmbH. He joined Robert Bosch GmbH in 2003 as a project manager in corporate research and development. He has been involved in vacuum technology for coatings and surface treatment and has performed extensive studies on surface sterilization. He has several scientific publications and presentations and holds patents. Feichtinger is a physicist by profession and holds a PhD in electrical engineering from Stuttgart University.

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Richard Forsyth is an associate director with GMP quality at Merck & Co., Inc. He is responsible for internal and external facility audits as well as document audits for regulatory submissions. He has worked in quality for two years; in cleaning validation for more than 14 years; and previously, served for 23 years as an analytical chemist in pharmaceutical R&D. Forsyth has a broad range of GMP/GLP analytical experience including methods development and validation, as well as formulation development and project management. His academic training includes an MS in chemistry and an MBA in management from St. Joseph’s University in Philadelphia, Pennsylvania, US.

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Mark Foss has been head of engineering for Boehringer Ingelheim in the UK for the last eight years. He has worked since 1977 in both the nuclear and pharmaceutical industries for BNFL, SmithKline Beecham, Roche Products and Glaxo. He is a member of the industry board and European Steering Committee of the GAMP® Forum (Good Automated Manufacturing Practice) where he chairs the Process Control and Calibration Special Interest Groups, which have produced ISPE good practice guides. He is co-chair of the Good Engineering Practice Special Interest Group. These groups have developed the industry good practice guides for the management of calibration and good engineering practice due to be released by ISPE in 2007. He has had articles on maintenance management, lean manufacturing, calibration and process control published by ISPE and the Institute of Measurement and Control. He has also been a speaker on the above and other topics at many ISPE and other industry conferences, seminars, and symposia.

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Stephen Franey is a senior project architect specializing in biopharmaceutical design and master planning. He has more than 10 years experience in GMP process facility design. Franey has been an instructor and committee member at the Art Institute of Philadelphia, computer animation department, and is an expert in building information modeling design philosophies.

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Richard L. Friedman is the Director of the Division of Manufacturing & Product Quality in the Center for Drug Evaluation and Research (CDER). In this position, he directs the evaluation of drug inspection regulatory recommendations as well as interpretation and development of CGMP policy. He has been employed by FDA since 1990, including prior positions as New Jersey District Drug Specialist, CDER Senior Compliance Officer, and Team Leader of Guidance and Policy. Friedman is an adjunct faculty member of Temple University School of Pharmacy in their QA/RA graduate program. He has authored several publications on topics including sterile drugs and quality management systems, and was awarded The George M. Sykes Award by the Parenteral Society for outstanding journal paper for the year 2005. Prior to joining FDA, Friedman worked in the toxicology research division of an innovator pharmaceutical company. 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.

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Mike Gadway has more than 28 years of experience in general manufacturing and six years of experience in the pharmaceutical industry. During his 28 years, he has worked with the book binding industry in the areas of supply chain management and warehouse, and had various manufacturing and management roles, including production and maintenance. Gadway is a director at Shire pharmaceutical and responsible for dispensing, packaging, manufacturing investigations, and operation excellence. He has overseen the overall lean and efficiency improvement initiatives at Shire and for the past year, with his leadership, Shire has seen major yield, cost, and capacity improvements that resulted in significant bottom line improvements. Prior to joining Shire, Gadway worked at Wyeth and assumed the responsibilities of its quality operation that included the business operations in the laboratory environment and operational improvements. He is a member of American Society for Quality and American Production Inventory Control Society and has earned APICS certifications in MRP, capacity planning, shop floor control, and basics of supply chain management. Gadway earned his BS degree in industrial management.

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Damian Greene works for Pfizer Global Manufacturing (PGM) in New York, and leads the PGM API Operations Team. He began his career with Pfizer in 1983 as a production supervisor at the Terre Haute Indiana site. He moved to the Ringaskiddy, Ireland site in 1985 and worked in process engineering and citric recovery. In 1988, Greene moved to the New York Headquarters as a production service manager. In 1992 he moved to the Groton Connecticut site and held a number of roles including advanced technology development manager, and team manager for a number of manufacturing departments. In 2003, Damian was appointed director/team leader of the API Operations Team. He has a BE in chemical engineering from University College Dublin, and an MSc in chemical engineering from the University of Missouri at Rolla.

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Charles P. Hoiberg is the Executive Director for Global Regulatory Portfolio and Projects in Pfizer's Global Regulatory CMC and QA Group. He received a BS in chemistry from the College of William and Mary and a PhD in biochemistry (chemistry minor) from the 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 Secretary for the ISPE International Board of Directors. 

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Jessica Hunt is currently a principal validation engineer with Schering-Plough in the clinical supplies area with a focus on the cleaning verification/validation program. She has worked in the pharmaceutical industry for 11 years, with nine years of experience in validation. Her experience in validation includes method, equipment, packaging, cleaning, and computer validation and facilities qualification. Hunt has Bachelor of Science degrees in both chemistry and biology.

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Yoshimitsu Ishihara began research at the Chemo-sero Therapeutic Research Institute in 1977. From then until 1985, Ishihara was engaged in research for the Hepatitis B Virus and acquired new drug approval of plasma derived from the Hepatitis B Vaccine in 1985. From 1985 to 1988, he was in charge of clinical study for the recombinant Hepatitis B Vaccine “BIMMUGEN” and got approval of the new drug in 1988. From 1988 to 1990, he was in charge of development of fibrin glue used in a surgical operation, and got approval of the new drug “BOLHEAL” in 1991. From 1990 to 1996, he was in charge of quality control for plasma products as a manager. In this period, he acquired a patent (Japan; 2555549, USA; 5582596 and EU; 634140) for fibrin glue. From 1996 to 1999, he was in charge of production control for plasma products, human vaccines and vaccines for animals as manager. Since then he has been in charge of the filling and packaging department for all products, and completed the new pre-filled syringe plant for preservative-free vaccines as deputy general manager and then general manager. Ishihara completed a master’s course at Shimane University, where he majored in biological science.

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Masanobu Iwasa is currently deputy general manager of the medical promotion department at Nipro, where he is responsible for the development, production and sales of medical product containers and infusion systems. He joined Nipro after graduating from Momoyama Gakuinn University (St. Andrews University) in 1982 with a degree in economics.

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Terry Jacobs, AIA, is a principal with Jacobs/Wyper Architects, LLP, an architectural, planning and interior design firm founded in 1981 in Philadelphia, PA. The firm’s practice focuses in part on large and complex projects for corporate and educational clients including research laboratories, manufacturing facilities, and data centers for the biotechnology, pharmaceutical and electronic industries and research universities, many delivered using design-build. Jacobs has substantial experience managing the design aspects of complex design-build projects. He was an adjunct professor at both Temple University and Drexel University and a visiting critic at the University of Pennsylvania. He has won design awards from the American Institute of Architects and the Pennsylvania Society of Architects. Jacobs earned his BA from Dartmouth College and his Masters in architecture from the University of Pennsylvania. He co-edited a new book entitled, “Good Design Practices for GMP Pharmaceutical Facilities,” the book is a single source reference for professionals involved in the planning, construction, validation, and maintenance of modern pharmaceutical facilities. He is chairman of ISPE’s North American Education Committee and was president of the Delaware Valley Chapter of ISPE. He has been a course leader and speaker at numerous ISPE events, and a member of ISPE since 1981.

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James (Jim) W. John is a project leader with ProPharma Group, working with healthcare companies in the areas of computer and automated systems validation and 21CFR Part 11 evaluation and remediation. For the past 15 years, he has worked in business development and consulting as a resource for Brock Solutions and CimQuest. He has also served as a manufacturing consultant for the FDA regulated industries with Rockwell Automation. The foundation for the past 15 years was initially laid with BASF where he spent ten years working in plant operations and chemical engineering. He also spent four years working in the manufacturing IT group at Nabisco. John has been involved in guideline in ISA, ISPE, Pharmaceutical-Online, and ISPE’s Pharmaceutical Engineering magazine. He has been a featured speaker on validation issues at conferences in the U.S., Canada, Mexico, Japan and several countries in Europe. His professional affiliations include chairman of the JETT Consortium SIG of GAMP® Americas, member of the GAMP® Americas steering committee, steering committee member for PDA Computer Validation Group, industry and advisory board member for PDA’s audit repository and ISPE Instructor for computer System Validation and Part 11.

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Yatindra M. Joshi, PhD, is vice president of pharmaceutical and analytical development at Novartis Institute for Biomedical Research, East Hanover, New Jersey, USA. His responsibilities include chemical and pharmaceutical profiling, pharmaceutical development, life cycle management, process development/scale-up and validation, analytical development, clinical manufacturing, and project management functions. His interests and expertise include dosage form design, application of statistical models for formulation and process optimization, scale-up and validation, drug delivery research, streamlining and accelerating drug development process, improving efficiency through robotics and automation, achieving organizational excellence, and building high performance organization. Joshi received his BS and MS in chemistry from Delhi University, Delhi, India, PhD in chemistry from Dalhousie University, Halifax, NS, Canada, and MBA from the Wharton School of Business, University of Pennsylvania.

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Satoshi Kawamura joined Nipro Corporation in 1990 and has held numerous positions with the company over the last 17 years. From 1990-1993 he was engaged in parenteral production operations, then in 1993 he was assigned to the NIS1-KA project, an isolator based, highly-automated aseptic production system for a combination “half-kit” product that was at that time the largest isolator installation in Japan. In 1994, Kawamura became general manager of “half-kit” production and was assigned to the development of double-bag kit products (PLW) and the development of production facilities for those products. Then in 2001 he was assigned to construction of the Odate Factory for the PLW products and became factory manager in 2002. In 2003 he was also assigned responsibility for the construction of a new building for double-bag kit production (G-building) and in 2004 he was assigned to manage a project for the construction of another new building for these products (H-building).

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Koji Kawasaki began his business career at Kyocera Corp., and later transferred to Luwa, Japan, Ltd., before founding Airex Co., Ltd. in 1997. He has handled various engineering projects associated with air conditioning and airflow control for the sterile areas in many pharmaceutical plants in Japan. Specifically, he has wide-ranging practical expertise regarding unidirectional flow units, and is noted as one of the leading figures in this field. Airex Co., Ltd., now enjoys a unique position as a Japanese firm that manufactures isolator units in its own right to advance its isolator technology even further. In this way, Kawasaki and the other members of Airex are making an active contribution to the industry as the pioneers of isolator technology in Japan. Kawasaki is a graduate of Shinshu University, where he majored in chemical engineering.

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Greg Killian is a pharmaceutical program manager within Siemens Global Center of Competence that supports Siemens product, service, and solution offerings for the pharmaceutical and biotechnology industries. As part of the organization, Killian manages programs that ensure industry needs are met from a regulatory, financial, quality, and business process standpoint. He is actively involved in Siemens strategic planning and execution in the FDA regulated industries focused in several areas including: real-time quality, manufacturing excellence, drug authentication/anti-counterfeit, and regulatory compliance. Killian received his B.S. in mechanical engineering from Villanova University, and his MBA from the University of Massachusetts.

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Alex Konopka is currently an engineering consultant in the Engineering Technical Center at Eli Lilly and Company. He has spent the last nine years concentrating on global regulatory issues, projects, GMP qualifications, and other activities related to clean waters and other critical utilities at Lilly. Besides involvement with ISPE on critical utilities, he has been a main committee member of ASME-BPE and participates with AICHE on these subjects. Over the last 29 years, Konopka has been involved with many engineering activities at Lilly. Engineering areas he has worked in include chemical manufacturing, pharmaceutical production plant facilities design/startup, environmental controls engineering including fume and liquid/solid wastes incineration and utility/power systems design and operation. He has a BS and MS in chemical engineering from the Illinois Institute of Technology. He is a registered Professional Engineer in the State of Indiana.

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Carole Kuzian is a senior building design principal for CE&IC, with 19 years of experience. She has been employed at CE&IC for 14 years, during which time she has been focused almost exclusively on the building design aspects of pharmaceutical projects. She has successfully completed the design of several new API and OSD facilities, as well as many renovations to existing API and OSD facilities. Kuzian has been actively involved in ISPE, serving as an author for the architectural chapters of both the API and OSD Guide revisions.

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Brian H. Lange, PE, is director of engineering in sterile and packaging operations for Merck & Co., Inc., in West Point, Pennsylvania, US. His responsibilities include capital management, maintenance and operations for facilities and utilities supporting barrier, liquid and lyo manufacturing along with packaging operations. Previous to his current position, Lange was associate director of lyo operations where he was responsible for lyo filling and packaging of biological and pharmaceutical products. Lange was also manager of sterile filling and responsible for liquid filling of sterile biologicals and pharmaceuticals. Before moving into vaccine manufacturing, he spent a great deal of his 18 year career with Merck providing engineering support to all facets of research including facilities, solid and sterile clinical manufacturing, and utility generation and distribution. Lange is highly-active within ISPE as a past chairman of the International Board of Directors, a past president of the Delaware Valley Chapter and a member of the Society's Facility of the Year judging committee. He served ISPE as a course leader and speaker on many occasions and has been published in Pharmaceutical Engineering. Lange is a graduate of Villanova University with a Bachelors in mechanical engineering and is a registered Professional Engineer in the state of Pennsylvania.

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Thomas Larkin is currently director of engineering for Shire Pharmaceuticals Human Genetic Therapies (HGT) Division in Cambridge, Massachusetts, USA. He has more than 17 years of experience, mainly on the parental side of the biotechnology industry, but also with some solid oral dosage work. Project work includes the engineering side as well as project management in several countries in Europe as well as the United States. Larkin holds a BS in economics and biomedical engineering from Rensselaer Polytechnic Institute and an ME in chemical/biochemical engineering from Tufts University.

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Jack Lysfjord is vice president of consulting for Valicare, a division of Bosch Packaging Technology. Since 1981, he has held a variety of management positions with Bosch Packaging Technology (formerly TL Systems Corporation). Prior experience was with Dahlberg, Litton, Medtronic and Onan. He is a member of the International Society for Pharmaceutical Engineering (ISPE), past member of its board of directors, recipient of the 2001 Richard Purdy Distinguished Achievement Award, Member of the Year 1994, Chairman of the ISPE Asia Task Team, past chairman of the Marketing Advisory Council, and past chairman of the Vendor Committee. He holds other memberships in the Parenteral Drug Association (PDA), the American Glove Box Society (AGS), The Parenteral Society (UK), The Isolator Users Group (UK), R3 Nordic (Nordic Clean Room Processing Society), and Barrier Users Group Symposium (BUGS) of which he is Chairman. He is a frequent speaker and course leader on the topics of aseptic processing, RABS (Restricted Access Barrier Systems) and barrier/isolator systems in the U.S., Europe and Asia and has been the author and co-author for numerous technical papers and articles. He holds a B.S. in mechanical/industrial engineering from the University of Minnesota, and an MBA from the University of St. Thomas.

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Rafi Maslaton is currently president of cResults. He has more than 15 years of diversified experience in operations, manufacturing engineering, information systems, and business management issues for Fortune 500 firms. Prior to joining cResults, he served as COO of Sparta Systems, the maker of TrackWise, overseeing the complete project life cycle for clients. During his time at Sparta, Maslaton assisted in business development as well as client support for over 110 FDA-regulated organizations, 19 of which are top 20 life science companies. Prior to working at Sparta, he was a senior partner at an operation consulting firm, responsible for the pharmaceutical and biotech sectors. Over the last 15 years, Maslaton has managed projects for Fortune 500 clients such as Abbott, Amgen, Baxter, Bausch and Lomb, Bayer, Centocor/OBI, C.R. Bard, Eli Lilly, Fort Dodge, Genentech, J&J, Novartis, Par, Pfizer, Pharmacia, Roche, Shire, Schering-Plough, Teva and Wyeth, Agere Systems, Alpha Industry, Anadigics, HADCO, IBM, Intel, Lucent, Motorola, Nortel Network, Philips, Raytheon, and Siemens. As a highly-respected operations management expert, he has been a featured speaker at several conferences, including those for ISPE, CBI, ASQ, SWE, and INTERPHEX.

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Edwin Melendez has been with the FDA for the past 23 years. He began his career with the FDA in 1983 at the San Juan District Office, experiencing a wide-variety of field work, including inspections of manufacturers in foods, drugs, devices, and biologics. In 1988, he was appointed to the drug pre-approval cadre. Later he became a member of the foreign inspection cadre and regularly conducted inspections of pharmaceutical firms worldwide. In 1993, he was promoted to Resident-In-Charge of the Mayaguez Resident Post, and in 1996, he was promoted to compliance officer of CDER’s Office of Compliance, Division of Manufacturing and Product Quality, Foreign Inspection Team, at Rockville, Maryland. He served as an advisor to the Pan American Health Organization on drug cGMP training and inspection programs. In 2006, he was certified as a Level III Drug Investigator forming part of the Pharmaceutical Inspectorate cadre. Currently Melendez serves as a contact person for cross-contamination issues related to Beta-Lactams and Potent Compounds. He continues to conduct inspections of international and domestic pharmaceutical manufacturers for compliance with Drug cGMP regulations and policies. He also assists compliance officers and investigators evaluate foreign and domestic inspection activities in drug manufacturing operations for compliance with cGMP regulations and policies. Melendez worked as a QC/QA technician for a Johnson & Johnson drug/device manufacturer prior to his FDA career and has a Bachelor’s degree in chemistry from the Inter-American University of Puerto Rico.

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Michael J. Miller, PhD, is a senior research fellow in the manufacturing science and technology function of Eli Lilly and Company. In this role, he is responsible for providing technical leadership in microbiology and sterility assurance within manufacturing, quality, engineering, and product development. He is also accountable for leading Lilly’s corporate initiatives for process analytical technology (PAT), microbiological validation of barrier isolation technology and rapid microbiological methods. Prior to joining Eli Lilly, Miller held numerous business development, quality and R&D leadership roles at Bausch & Lomb and Johnson & Johnson. He has authored more than 60 technical publications and presentations in the areas of rapid microbiological methods, PAT, ophthalmics, disinfection and sterilization, and has served as chairperson for numerous rapid microbiological methods technical conferences in the United States and Europe. Most recently, he was editor of the Encyclopedia of Rapid Microbiological Methods, a three-volume reference co-published by the PDA and Davis Healthcare International Publishing. Miller holds a PhD in microbiology and biochemistry from Georgia State University (GSU), a BA in anthropology and sociology from Hobart College, and has served as an adjunct professor at GSU and the University of Waterloo, School of Optometry.

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George P. Millili, PhD, is senior director of pharmaceutical technology services for GPSG, a division of Johnson & Johnson. His current responsibilities include leading global new product introductions, packaging development, marketed product support, and validation of new and existing process technologies. Prior to Johnson & Johnson, he worked for Merck and Co. as senior director regional technical operations. Millili received a bachelor’s of pharmacy degree from Temple University School of Pharmacy in 1977. Upon graduation, he worked for McNeil Pharmaceutical in pharmacy R&D in the formulation/process development and clinical supply groups. Following his tenure with McNeil, he entered graduate school at the Philadelphia College of Pharmacy and Sciences and earned a PhD in pharmaceutics in 1990. He then was employed by Schering Plough Pharmaceuticals in Kenilworth, New Jersey in the process development/process improvement groups. Following his tenure at Schering Plough, he was employed by DuPont Pharmaceutical as executive director, worldwide manufacturing technology.

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Hiroaki Mizuno is associate department manager of the production technology department at Taiyo Pharmaceutical Industry Co, Ltd., and has been with the company since 2002. He is currently involved in engineering a new solid formulation integrated building and various injection product projects, and previously managed pre-filled syringe projects. Taiyo Pharmaceutical Industry Co, Ltd., is a 2007 Facility of the Year Awards category winner in Equipment Innovation. From 1995 to 2002, Mizuno managed new plant construction projects for Ikeda Mohando, Ltd., and engineered the external preparation line of ointment and liquid formulation for preparation, filling, and packaging. From 1987 to 1995, he worked for Kitano Seisakusho Co., Ltd., in the manufacturing technology department and was involved with design and development of various automations and work saving systems as well as engineering works for the plant. Mizuno holds a BA in engineering from Toyama University.

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Pankaj Mohan, PhD, is currently Director in Genentech, Inc. in South San Francisco, California. He is responsible for the design and execution of a state of the art world class Fill Finish Manufacturing Facility. Mohan has over 18 years of Bio/Pharmaceutical experience which includes 12 years with Eli Lilly and Company in various leadership and technical assignments in UK and USA-leading commercialization and manufacturing 3 years in academia with a center of excellence in Biochemical Engineering at University College London, UK, and about 2.5 years of experience in India . Mohan has an undergraduate degree in Chemical Engineering from the Indian Institute of Technology (India), a PhD in Bio/Chemical Engineering from University of Birmingham (UK), a Masters in Financial Management from London (UK) and an Advanced Management Program (executive education) from Duke, NC (USA). He is a corporate member (CEng) and Fellow of the Institution of Chemical Engineers (FIChemE), UK. He has recently compiled his experience in a book called “Pharmaceutical Operations Management” published by McGraw-Hill. He has over 30 external publications and has been key note speaker in various global conferences.

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Moheb Nasr, PhD, is the director of the Office of New Drug Quality Assessment (ONDQA), Office of Pharmaceutical Science (OPS), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA). ONDQA is responsible of all aspects of quality assessments (pre and post marketing) of new drugs regulated by CDER. Nasr is a member of FDA's council on pharmaceutical quality. Nasr obtained his PhD degree in chemistry at the University of Minnesota in Minneapolis. Nasr holds a B.S. degree in pharmacy and a Master's degree in pharmaceutical analysis, both from Cairo University, Egypt.

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Bruce Naumann, PhD, DABT, is a senior principal scientist and director of occupational and environmental toxicology at Merck & Co, Inc. In this role he provides leadership and technical guidance to the company on a broad range of occupational and environmental toxicology issues. He also serves as secretary of Merck’s Industrial Toxicology Advisory Committee and directs a research program focused on improving the use of science in risk assessment. Naumann received his PhD from New York University and is certified by the American Board of Toxicology. He has more than 20 years of experience as an occupational toxicologist within the pharmaceutical industry. In addition to his responsibilities at Merck, Naumann is a member of the ACGIH Chemical Substances TLV Committee and the AIHA WEEL Committee.

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Thomas Otto assumed the position of managing director technical operations at Vetter Pharma-Fertigung GmbH & Co. KG in December 2002. He began employment with Vetter Pharma-Fertigung GmbH & Co. KG as a project engineer. From 1995 to 1999, he was manager of the department of packaging materials development. From 2000 to 2002, he headed the department of research and development at Vetter. Otto graduated from the Vocational School in Stuttgart with an engineering degree in packaging technology and print processing in 1990.

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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. His responsibilities have included projects in South America, Puerto Rico, and Europe. Currently, he is assigned to the construction of Johnson & Johnson’s bulk bioprocess plants for its Centocor affiliate in Europe. Petko is chair of the ISPE committee for risk-based qualification and global strategic initiative for the development and implementation of Johnson & Johnson’s commissioning and qualification guidelines. In conjunction with Paul N. D’Eramo, Executive Director, Worldwide Policy and Compliance Management, Johnson & Johnson, Petko is responsible for the implementation of training for Johnson & Johnson’s global affiliate of companies in the area of equipment qualification. He has incorporated the required commissioning and qualification activities into Johnson & Johnson’s web-based project delivery process and is 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, and is a graduate of the engineering management program at California State University in Los Angeles, California, US.

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Michael Porter is a director in the sterile process technology and engineering group of Merck & Co., Inc. Since 1987 he has held a variety of divisional engineering and supervisory positions within Merck’s Manufacturing Division, focusing on manufacturing, lyophilization, and barrier isolator technology filling of vaccines and sterile pharmaceuticals. Porter is currently responsible for start-up of a new vaccine manufacturing facility in Durham, NC, US. He has prior experience in plant and process design in the petrochemical industry, and holds a BS in chemical engineering from Villanova University. Porter has been co-chair of the ISPE Barrier Isolation Conference for over a decade. He is a Member of the ISPE, and has presented on the subjects of barrier isolation and clean room automation technologies dozens of times to the pharmaceutical community.

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Johannes Rauschnabel is currently director of process engineering at Bosch Packaging in Crailsheim. He joined Robert Bosch GmbH in 1995 as a project manager in corporate research and development center. He was involved in vacuum technology for coatings and surface treatment and performed extended studies on surface sterilization. Rauschnabel has several scientific publications and presentations and holds patents. He is now responsible for process engineering and coordinates barrier systems activities at Robert Bosch GmbH Packaging Technology – Pharma. Rauschnabel is a chemist by profession with a PhD from Tübingen University. He has been an ISPE Member since 2003 (Chapter Germany/Switzerland), a frequent speaker at ISPE events, and chairs the European ISPE Containment Forum.

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Ewart Richardson works in the pharmaceutical industry and has held responsibilities for the introduction of isolation technology. He has worked in the field of isolation and pharmaceutical processing developing processes for major blue chip companies including GlaxoSmithKline, AstraZeneca, and Pfizer.

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Carl Roe is the high purity water technical leader for Abbott's Global Engineering Services group and is the current chairman of Abbott's Process Engineering and Pharmaceutical Water Engineering Standards Committees. He is a member of the USP Pharmaceutical Waters Expert Committee. He is also a Member of ISPE, and serves on the steering committee for the ISPE Critical Utilities Community of Practice. Roe earned his BS in chemical engineering from the University of Cincinnati in 1979, and his PE registration in Texas in 1983. Prior to joining Abbot in 1983, he worked in process design and project engineering for Union Carbide and Bechtel, Inc.

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Paul Rosselli was educated in London, England, as an architect at Tottenham Technical College and the North East London Polytechnic. He commenced work with a small company of architects in the City of London, and then joined the chief architects department of a large telecommunications company in London working on projects and traveling worldwide. He joined Swiss Company Interplan 4 and worked in the Middle East and on Middle East projects for a number of years. He was a project architect in a small practice in Basel, Switzerland and performed town planning and hotel work in the Sultanate of Oman. He worked for F. Hoffman–La Roche Limited’s building department on projects in Switzerland and then internationally. This included site master planning, office buildings, packaging plants, warehousing, production facilities, residential and commercial. Since 2004, Rosselli has been based in Shanghai as a project manager, completing the SHiP project and presently working on the new Roche Shanghai Expansion Project (RoSE).

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Greg Ruklic has more than 23 years of experience in the biopharmaceuticals industry, primarily with automation and integrated MES-related systems design, validation and quality/compliance oversight. Working for PDM, Genetics Institute and Wyeth, Ruklic has successfully implemented validated manufacturing systems internationally, and has held leadership positions in the development of corporate level systems compliance standards. Currently, he is involved with Wyeth Biotech operating unit program leadership and oversight of guidelines and standards for computer system life cycle activities. He is a GAMP® MES SIG co-leader and core team author for Good Practice Guide documentation.

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Sally Rush is vice president of Seiberling Associates, Inc. (SAI). She is on the board of directors and has been with the company since 1984. Rush’s primary focus is clean and sterile process design in the pharmaceutical and biotech industry. She has more than 20 years involvement in pharm/bio industries ranging from fermentation/MCC, bulk, API, and sterile fill-finish facilities. This work involves directing all project activities from concept through design, installation, commissioning and validation of facilities that require process integrity, reliability, and flexibility. She is often requested to lecture on her area of expertise, process/CIP/SIP integration, for our clients and professional association educational seminars. Rush graduated from Ohio State University in Columbus, Ohio with a BSc in food science and a MsC in food engineering science. She is a Member of ISPE and PDA.

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Richard Saunders, PhD, is currently vice president of pharmaceutical development at Wyeth and is based in Pearl River, New York, US. He is responsible for all small molecule dosage form development activities including preformulation, formulation for all phases of clinical development, and technology development and transfer of to-be-marketed formulations on a global basis. His responsibilities also include clinical trial material manufacture and supply. Saunders has been in the pharmaceutical industry for 30 years, approximately half that time in Europe before moving to Wyeth in Pearl River in 1993. He is also a member of the PhRMA Drug Product Technical Group.

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Robert Sausville is director, division of case management (DCM), office of compliance and biologics quality, at FDA’s Center for Biologics Evaluation and Research (CBER). DCM is responsible for enforcement actions for biologics, review of advertising and promotional labeling and all CBER recalls. His previous position at CBER was as a branch chief in DCM from 2001-2005. Prior to joining DCM, Sausville spent eight years in CBER’s division of manufacturing and product quality where his responsibilities included review of establishment and biologics license applications and supplements related to viral vaccines, monoclonal antibodies, in-vitro diagnostic kits and plasma fractionation products, as well as inspection of manufacturing facilities.

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Thomas Schultz, PhD, has held positions of increasing and diverse responsibilities since joining Johnson & Johnson in 1984. He established the regulatory sciences function within the Global Regulatory Affairs, Chem-Pharm organization of the Johnson & Johnson Pharmaceutical Research & Development, L.L.C., in January 2002. Prior to joining Regulatory Affairs, he directed the activities of the US-based pharmaceutical sciences group for 15 years. He served on the Product Quality Research Institute (PQRI) Process Robustness and BACPAC II Working Groups. Schultz is a member of the ISPE Regulatory Affairs Committee, and a member of both the PhRMA Asia Pacific and Latin American Technical Committees, and currently serves as international CM&C regulatory liaison to the PhRMA Technical Leadership Committee. Schultz has been as an invited lecturer to the Chinese State Food and Drug Administration (SFDA), Center for Drug Evaluation since 2004. He received a BS in pharmacy and a PhD in pharmaceutics from the Philadelphia College of Pharmacy and Science. Currently an adjunct professor at Temple University, School of Pharmacy, he maintains teaching responsibilities in both the graduate departments of pharmaceutics and regulatory affairs/quality assurance.

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Andrew A. Signore, PE, PMP, DBIA, is co-founder and CEO of Integrated Project Services (IPS). Founded in 1989, this engineering and project delivery firm focuses on healthcare/pharma facilities. He held senior engineering positions at SmithKline, Pfizer, and Merck. He earned his BSChE from Manhattan College and a MBA from Pace University. He is a registered professional engineer in Pennsylvania, New York, Ohio, New Jersey, Delaware and North Carolina. Signore was inaugural president of Design Build Institute of America’s Delaware Valley Chapter and is a charter holder of a DBIA designation, and is past president of the New Jersey Chapter of Project Management Institute (PMI). In addition, he is past chairman of the International Society for Pharmaceutical Engineering (ISPE) National, past president of the ISPE Delaware Valley Chapter, and a frequent ISPE course leader. Signore received ISPE’s Distinguished Achievement Award for his many professional contributions to the Society.

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George Smith joined the division of manufacturing and product quality (DMPQ) in CDER’s Office of Compliance in July of 2002. He has a Masters degree in computer science and more than 20 years experience in computer system development and validation. He has managed and directed numerous IS/IT departments within regulated environments including those requiring compliance to GXPs. Smith was responsible for implementing all of the IS/IT procedures needed to meet GLP requirements related to Computer System Validation (CSV) and Part 11 at a new laboratory facility in North Carolina. Currently he is a member of the guidance and policy team within the DMPQ. As a member of the Part 11 Working Group he was involved with the development and issuance of the Part 11 scope and application guidance and is currently working with the group on the proposed amended Part 11 regulation and companion guidance.

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Russ Somma has been involved in production support, scale-up, pilot plants, as well as early and full development activities of pharmaceutical products, which include novel as well as traditional dosage forms, during his 29 year tenure with Novartis. He has provided support for 21 NDAs in the chemistry, manufacturing and control area, from submission through the pre-approval inspection phase. As president of SommaTech, an affiliate company of IPS, his focus was on pharmaceutical technology and helping clients achieve their FDA regulated product goals for fast submission, seamless approval, cost effective product, and a secure supply chain. He is the past chairman of ISPE’s SUPAC Equipment Guidance Steering Committee, and currently chairs the ISPE-PCC. Russ earned his Ph.D. in pharmaceutical technology under N.G. Lordi at Rutgers University College of Pharmacy in 1987. Prior to this he earned his BS degree in pharmacy in 1974 and a Masters degree in 1980 from Rutgers University.

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Jim Spavins is currently vice president of Pfizer's Pharmaceutical Sciences Global Reg. CMC organization, and is based in Groton, Connecticut, US. During his 27-year career at Pfizer, Spavins held numerous positions, starting as a process and fermentation engineer in manufacturing, then moving to chemical process development and head of the analytical research and development department. He has been the pharmaceutical sciences team leader of several late stage development candidates during his career. He is currently a member of ISPE's RAC committee and has presented at numerous forums on Quality by Design, including application to early and late stage candidate development and use of PAT. His wide interest in effective product development includes being a recipient of a Presidential Citation for Green Chemistry in 2002. Spavins did his undergraduate work in chemistry at Queens College City University of New York and has Masters degrees in chemical engineering and analytical chemistry, both from State University of New York at Buffalo.

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Govi Sridharan is a senior automation engineer working for Corporate Automation Engineering at Genentech, Inc., South San Francisco, California, USA. He started his career as a management consultant at Ernst and Young for the life sciences practice. His primary focus has been implementing MES solutions at biopharmaceutical manufacturing facilities for Genentech and Wyeth Biopharma. His current role is systems architect for the next generation MES implementation and functional lead for enterprise application integration using S95 standards at Genentech, Inc. He has a Masters degree in mechanical engineering and more than seven years of MES implementation experience.

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Philip Sumner, MS PE, has 20 years experience in the design, construction and operation of pharmaceutical utility systems and construction projects. In his position with Pfizer Global Engineering as technology manager of GMP utility systems including water and steam, he is responsible for GMP utility systems project design, reviews, and system operational support on a global basis. Sumner has a BS and MS in civil environmental engineering from Tufts University and is a registered professional engineer.

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Edward J. Tannebaum, AIA, is a senior principal at integrated project services (IPS). A registered architect in 18 states, he oversees project delivery efforts at IPS, including strategic and conceptual planning and design and build facilitation of pharmaceutical manufacturing facilities. Tannebaum’s experience includes three years in a small Philadelphia-based commercial architectural firm where he worked on industrial projects including pharmaceutical manufacturing facilities. He has six years experience as a facility manager for a Johnson & Johnson Company where he managed facility design and construction for the McNeil Healthcare Division of Johnson & Johnson, manufacturers of the Tylenol Brands. For 12 years, Tannebaum was with an ENR Top 200 Construction Manager where he served as senior project manager to the director of project management for the vice president of business development. This firm specialized in high-end corporate, private collegiate and healthcare facilities. He worked 12 years as a senior partner in an ENR TOP 100 Design/ Build Firm which leads design/build operations, and specializes in the management of project execution of pharmaceutical facilities throughout the United States. Tannebaum holds a bachelors degree in architecture and was a charter member of the Design Build Institute of America (DBIA). He was an officer and board member of the Delaware Valley Chapter of ISPE and is a frequent presenter at the ISPE Annual Meeting workshops and seminars, as well as regional educational events. His recent collateral activities include membership in the Carpenters Company of Philadelphia and PA, the oldest trade organization in the U.S. that dates back to 1732. He also is a member of the Dean’s Advisory Council for the College of Architecture at Kansas State University, where he has also been a guest lecturer.

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Cecilia Taylor has more than 10 years of experience in pharmaceutical process engineering and process safety projects in API manufacturing at Merck sites worldwide. She continued her tenure at Merck for three years in West Point, Pennsylvania, US, in the engineering organization responsible for process/capacity improvements, filling line startups and tech transfers for aseptic filling using barrier isolator technology for vials and syringes. She has been at Genentech since 2004, starting in a similar role for the filling business unit and currently is in corporate engineering as the lead engineer for the new filling isolator lines on the Hillsboro, OR project. Taylor has a BS from MIT and MS from UCLA in chemical engineering.

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Peter Vishton, PE, is a technology engineer for pharma water systems at Wyeth Pharmaceuticals in Collegeville, Pennsylvania, USA. He has more than 20 years experience in pharma engineering. For almost 10 years he has focused on pharma water and steam systems. Vishton has B.S. and M.S. degrees in engineering from Drexel University and a Professional Engineer’s License. He has been a Member of ISPE for 15 years and has presented at several conferences about pharma water systems. He was a member of the core team that drafted the ISPE Good Practice Guide for Commissioning and Qualification of Pharma Water and Steam Systems.

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Andy Walsh is a well known speaker on cleaning validation and has given numerous presentations over the past ten years with IIR, Barnett, WorldPharm, IVT and ISPE. He has hands-on experience in cleaning validation, which includes writing policies and master plans and developing swab methods for both HPLC and TOC. Walsh frequently speaks on using TOC for cleaning validation, developing master plans and setting acceptance limits. He is currently chairing a committee to write a cleaning guideline for ISPE and is a team member of ISPE's Risk-MAPP (Risk-Based Manufacture of Pharmaceutical Products) team. Walsh has more than 17 years of validation experience in pharmaceutical and biotech companies including Johnson & Johnson, Schering-Plough, and Hoffmann-La Roche. His validation experience includes equipment qualification, process validation, computer systems validation and cleaning validation. Walsh has a Master's degree in microbiology and is currently working on a degree in computer programming.

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Patricia Weideman, PhD, is currently the director of global occupational and environmental toxicology at Schering-Plough Corporation. As part of Schering-Plough Global Safety and Environmental Affairs, she oversees Schering-Plough’s global programs for science-based chemical hazard and risk assessments and communications, including the global Material Safety Data Sheet program, and the occupational toxicology-testing programs for active ingredients and process intermediates used in the company’s research and manufacture of human pharmaceuticals, consumer health care products, and animal health products. These efforts support, among other things, the development of internal occupational exposure limits for active pharmaceutical ingredients and the corporate safety and industrial hygiene programs. In addition, she and her team have responsibility for the environmental toxicology-testing program that supports the company’s drug registration efforts in the US, Europe, and Canada, as well as providing toxicological expertise for pharmaceutical in the environment issues. Weideman is also responsible for the corporate program for the notification of chemicals in all global jurisdictions in which Schering-Plough or its representatives conduct research and manufacturing. She received her PhD in environmental health sciences from New York University and her BS in environmental toxicology and industrial hygiene from Clarkson University, Potsdam, New York, USA. She has held positions in occupational toxicology at Merck & Co., Inc., and DuPont Pharmaceuticals prior to joining Schering-Plough; she has been a registered professional nurse for more than 25 years. Weideman is an active member of the Society of Toxicology, the Mid-Atlantic Chapter Society of Toxicology, and the ad hoc Occupational Toxicology Roundtable. She is currently the president of the Occupational and Public Health Specialty Section of the Society of Toxicology.

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Julian Wilkins is founder and vice president with PharmaConsult US, Inc. An architect by training, Wilkins commenced his career designing pharmaceutical facilities in Europe. In 1991 he founded a UK based isolator company for the emerging need for pharmaceutical containment. The company carried out many projects worldwide for aseptic and potent containment at all scales of pharmaceutical operation. He moved to the US in 1997 and set up PharmaConsult US in 1999. Since its formation, the company has provided independent advice, design and support for containment projects including Bristol-Myers Squibb, Mallinckrodt, Merck & Co., Pfizer, Sanofi Sythelabo, Seattle Genetics, Schering Plough, Wyeth as well as Apotex, Novex, and Organichem. Wilkin has spoken at many seminars worldwide on the subject of containment and has contributed articles and chapters to periodicals and books on containment. Wilkins is currently co-chair of the ISPE API Community of Practice.

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Stephanie Wilkins, PE, is President of PharmaConsult US, Inc., which provides potent compounds containment consulting to the pharmaceutical industry. Wilkins has more than 22 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, 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 is past Chair of the Webinar Subcommittee. 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.

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Steven J. Wisniewski is senior associate and director of compliance for integrated project services (IPS), a full-service engineering firm specializing in the delivery of technical complex projects, and that offers complete design/build, commissioning, validation and FDA compliance services for the pharmaceutical, biotech, health care, and specialty manufacturing industries. Wisniewski has more then 30 years experience in the pharmaceutical, biotech, and device industries. Prior to joining IPS, he was senior consultant for drug and device associates and has served in senior management roles at Sterling Winthrop and Bausch & Lomb. He has completed a wide variety of pharmaceutical manufacturing, filling and critical support operations to major R&D laboratories, facilities and upgrades. He holds a BSME from Rensselaer Polytechnic Institute, is a Member of PDA, and an active Member of ISPE. He has served the ISPE board of directors since 1982, and was chairman of the board in 1991. Currently, Wisniewski is chairman of the ISPE Community of Practice for Commissioning and Qualification, and is on the ISPE task teams developing the revised ASTM Verification Standard and the revised C&Q Baseline® Guide.

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Patrick Wong is director of global engineering, Bristol-Myers Squibb (BMS) Company with office located in New Brunswick, NJ. He holds a BSChE from Tri-State University and an MSChE from Columbia University. Since joining Bristol-Myers Squibb 19 years ago, Patrick has worked extensively in both design engineering and project management completing various project assignments in Europe, Asia, North Americas and Puerto Rico in bulk biologics, bulk pharmaceutical chemicals and pharmaceutical finishing areas. Prior to joining BMS Wong was previously with Hoffman LaRoche and Revlon. He is a member of the ISPE Technical Document Committee, Co-Chairman for the revision of the ISPE Bulk Pharmaceutical Chemicals Baseline Guide (to be published in 2006), and a Steering Committee Member of the ISPE Community of Practices for both API (Active Pharmaceutical Ingredient) & C&Q (commissioning & qualifications). Wong is a registered professional engineer in New Jersey and a member of the National Engineering Society Tau Beta Pi.

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Paul Wreglesworth is currently global technology director within the supply & capability group of operations at AstraZeneca. Until recently he was director of new product management with responsibility for the manufacturing strategy for the company's anti-cancer products in which role he developed a particular interest in the handling of hazardous compounds. Wreglesworth has a BSc (Hons) in pharmacy. His considerable experience of the development, manufacture and sourcing of pharmaceuticals were gained at both local site and corporate level.

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Sokhorn Yim has been at Genentech for more than four years and is currently working in process development engineering. Her role in PDE is to serve as PDE lead for an isolator vaporized hydrogen peroxide (VHP) residual study and to provide support for a time pressure filling system project related to the hillsboro fill finish (HFF). Her other projects are supporting commissioning cell culture pilot plant (CCP2), centrifuge, and chromatography skid for pilot plant purification. During her years at Genentech, she worked as an engineer that oversaw the entire freeze/thaw tank project. Prior to joining Genentech, Yim worked at Advent Engineering as a validation engineer for about a year. She worked at Chiron as a process development engineer for about 4 years, where she led tech transfer, and developed purification processes at small scale to manufacturing scale. Yim received both her BS degrees in chemical engineering from Oregon State University (OSU) and chemistry from Pacific Lutheran University (PLU) in 1998.

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Fangdong Yin has worked in the pharmaceutical industry for 17 years at major pharmaceutical companies including Merck and Eli Lilly and Co. He has worked in areas including process development/optimization, scale-up and transfer, process modeling, API and parenteral manufacturing (solution filling and freeze-drying). He has also worked in vaccine manufacturing, vial, syringe and cartridge manufacturing, tech transfer, process validations and third-party manufacturing and operations. Yin has a BS in chemistry from Peking University, China, and a PhD in chemical engineering from California Institute of Technology.

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Tim Ziemann is a senior technical manager for Genentech’s Corporate IT department in South San Francisco California. He has 10 years of industry experience which includes assignments in process development, automation engineering, manufacturing, quality assurance and now information technology. In his current role, he is responsible for leading the computer validation program associated with a corporate wide operational excellence initiative, which is a part of a next generation MES implementation. Prior to working at Genentech, Ziemann held positions at Aventis, Novartis, Steifel Laboratories, and Parexel Consulting. He has a BS in chemical engineering from the University of Colorado at Boulder. Ziemann is currently enrolled in the University of California’s Haas School of Business where he is pursuing an MBA.

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Gary V. Zoccolante is the pharmaceutical technical director for US Filter, a Siemens business. Zoccolante has more than 30 years of experience in the development and operation of high-purity water systems for the pharmaceutical, biotechnology, cosmetics, and semiconductor industries. He has been involved in the development and application of filtration, deionization, reverse osmosis, and ultra filtration equipment for pharmaceutical applications, and holds patents in water purification processes. Zoccolante was a member of the ISPE Water and Steam Systems Baseline® Guide task team and is a frequent ISPE course leader. He has written several articles regarding pharmaceutical water system design, regulatory compliance, and operation. Zoccolante earned his BS in mechanical engineering from Northeastern University.

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More bios to come...