Frank Abbato, Senior Process Engineer, DME Alliance
Frank Abbato has over a decade of experience with the biopharmaceutical industry, covering the varied fields of process engineering, process development, technology transfer, manufacturing, and equipment design. He has held lead roles in the design and delivery of custom process systems and facility designs for pilot through 20,000L scale (including bioreactors, MF/UF, depth filtration, centrifugation, pasteurization, CIP and SIP). His process development experience includes work with microbial fermentation, yeast fermentation, and mammalian cell culture for pre-clinical through GMP licensed processes. He is currently a Lead Engineer for DME Alliance and head of their Maryland office. Previous employment includes Human Genome Sciences, Entremed, and North American Vaccine. A graduate of Penn State University, Mr. Abbato holds a bachelor’s degree in chemical engineering.

Robert Barloga, Senior Application Engineer, Alfa Laval, Inc.
Robert Barloga is a Product Support Manager for disc stack centrifuges at Alfa Laval, Inc., a worldwide leader in centrifugal separation. Robert is recognized as a leader in the field of centrifugal separation, especially in the application of disc stack centrifuges within the Life Science industry with 19 years of centrifugal separation experience, including centrifuge sizing, selection, and configuration, field testing and start-up of centrifuges within the Bio-pharm industry, centrifuge module design, and supporting the R&D of new centrifugal designs. Robert holds a BS in Aviation Management, and an Airframe and Powerplant license from Lewis University.

Daniel Bauer, Partner, JW Rew Co.
Dan Bauer is a Partner with JW Rew Co., focusing on optimizing filtration process ROI through lean integration, technology selection, value analysis and test methodologies. Prior to recently joining JW Rew Co., Dan was Business Development Manager with GE Healthcare for 3 years, where he led product development teams, was a key member of an integration team for a major acquisition, and key member of the GEHC/Novavax Vaccine Collaboration. Dan’s experience also includes 12 years as a field specialist in bioprocessing with Pall Life Sciences following and prior to its acquisition of Gelman Sciences. During his career, Mr. Bauer has developed several disposable focused filtration product lines, led cross function teams on development of membrane strategies, has been an instructor on numerous filtration seminars, has helped clients optimize hundreds of filtration process streams and has served as an officer with the Capital Area Chapter of PDA. He holds a BS in Marine Sciences from the University of South Carolina and an MBA from Mount St. Mary’s University.

Benjamin Beneski, Senior Manager, Amgen
Benjamin Beneski is a Senior Manager with Amgen’s Manufacturing organization in Juncos, Puerto Rico, where his group provides technical support for drug substance manufacturing, including support of new product introduction. Previously, he was part of Amgen’s Process Development organization in Thousand Oaks, where he provided support and leadership for process transfer of cell culture products. Prior to joining Amgen, he worked as an engineer at Abbott Bioreasearch Center where he supported GMP manufacturing and process transfer and managed the construction and startup of new and remodeled cell culture facilities. He received an MBA from Northeastern University and holds BE in Chemical Engineering from Stevens Institute of Technology.

Tim Breece, Development Engineer, Genentech
Tim Breece received his BS in Chemical engineering from the University of California at Berkeley. He has worked for Genentech since 1984. Tim started in manufacturing and in 1988 he transferred to Recovery Process Development, then in 2005 transferred to technology assessment within Process Development. He has specialized in chromatography development from both mammalian and bacterial cell feedstocks. In addition to laboratory development, he has scaled up and transferred several processes to manufacturing sites in the United States and Europe.

Duane F. Bruley, Ph.D., P.E., Emeritus Professor (UMBC) and President, Synthesizer, Inc.
Dr. Duane Bruley received his BS ChE from the University of Wisconsin and is a graduate of the Oak Ridge School of Reactor Technology. He received his MS from Stanford University, and his a Ph.D. ChE from the University of Tennessee. From 1962 through 1973, Dr. Bruley was a Professor of Chemical Engineering at Clemson University. After that he was Head of Chemical Engineering at Tulane University and then Vice President of Academic Affairs and Dean of the Faculty at the Rose Hulman Institute of Technology. Dr. Bruley served as Head of Bioengineering and Director of the Rehabilitation Engineering Center at Louisiana Tech University from 1981 through 1985 and then as Dean of Engineering and Professor at Cal Poly San Luis Obispo from 1986 through 1991. Dr. Bruley was Dean of Engineering and a Professor at the University of Maryland Baltimore County from 1991 through 2005. He is a founding member of the ASME Bioprocess Engineering Sub Division and served as chairmen of the Sub Division for two terms. He has been a distinguished lecturer on Bioengineering for ASME for 4 years, and for AIChE for 1 year, and is responsible for founding a group with Dr. Robert Dean to establish the ASME Annual Bioprocess Engineering Seminar Series. Dr. Bruley has over 250 publications related to Bioengineering and has given over 400 presentations on the subject both nationally and internationally-a large number have been invited as Keynote Lectures.

Isaiah Cedillo, Senior Research Associate, Isis Pharmaceuticals, Inc.
Isaiah Cedillo is a Senior Research Associate in the Manufacturing group at Isis Pharmaceuticals, Inc. Mr. Cedillo earned his BS and MS degrees in Chemical Engineering from Stanford University in Palo Alto, CA. His research focuses on process optimization and scale up operations surrounding solid-phase chemical synthesis. He has 4 years of experience manufacturing therapeutic oligonucleotides. He recently attended FlexSim software training with the goal of in-house modification of the model created by CRB Consulting Engineers.

Kris Chatrathi, Senior Process Engineer, CRB Consulting Engineers
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, Kris 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.

Kris 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. He earned his Doctorate in Chemical Engineering from the University of Arkansas. 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. He has assisted ASTM and NFPA technical committees in the development of standards and guidelines. Kris holds two patents and has published many articles on the topics of flammability and explosibility.

Stephen Chew, Director of Quality Control LIMS, Baxter Healthcare
With over 30 years of experience in Microbiology in a variety of clinical and manufacturing settings, Stephen is currently responsible for all aspects of quality control testing (environmental monitoring, microbiology, chemistry and immunology) and the operation of the laboratory information system. He was responsible for the development and implementation of environmental monitoring systems as an integral part of an isolator based fill line SCADA system. He received his BS in Zoology from California State Polytechnic University, Pomona and completed graduate studies in Public Health at UCLA.

Charles Crosier, Senior Project Manager – Capital Projects, Diosynth Biotechnology Services, Inc., a part of Schering Plough Corporation
Charles is currently a Senior Project Manager within the Project Engineering Department at Diosynth Biotechnology Services, Inc. (a part of Schering Plough Corporation) in Research Triangle Park, North Carolina. He has 16 years of experience related to process and project engineering as well as procurement, commissioning and validation activities within the biotechnology and pharmaceutical industries. His project management experience includes simple equipment purchases to multi-million dollar facility upgrades and utility modifications. He has a Bachelors of Science Degree in Mechanical Engineering from The College of New Jersey, a Masters of Business Administration (MBA) from North Carolina State University and the Project Management Professional (PMP) Certification from the Project Management Institute (PMI).

John Cyganowski, Consulting Engineer, Millipore Corporation
With Millipore for 14 years, John leads an engineering group that provides hands-on, manufacturing scale support, to Millipore's Biopharmaceutical customers, across all Millipore technology platforms. Prior to this assignment, John was Technology Manager for Virus & Biomolecular Clearance helping customers develop, validate, and implement Viresolve viral clearance technology. Previously John served for 8 years as an Applications Engineer, specializing first, in Tangential Flow Filtration and later Aseptic Technology. Prior to joining Millipore, John worked for 5 years as a Plant Process Engineer with the Organic Chemicals Division of WR Grace.

Manuel A. del Valle, PE, Principal, Manuel A. del Valle Consulting, LLC
Manuel A. del Valle is the former Director, HVAC Design at the Greenville, South Carolina, USA office of Fluor, a worldwide Design, Build, Construct and Maintenance Company. Recently he has begun his own consulting firm. The bulk of his work has been in HVAC design for Pharmaceutical and Biopharmaceutical Facilities. In 1965 Manuel obtained his BSME degree from the University of Puerto Rico. He is a registered professional engineer in Puerto Rico and six states in the USA. In 1971 he began designing HVAC systems for Pharmaceutical facilities while managing the HVAC design department of Daniel Construction Co. Int'l. in Puerto Rico. In 1987 he began designing HVAC systems for Biopharmaceutical facilities while working for Fluor Daniel in their Greenville, South Carolina office. His design experience includes preparation of conceptual, preliminary, and construction documents of HVAC systems, as well as field supervision and troubleshooting. He has published a number of articles and lectured at various universities and seminars of national and international associations on HVAC design for Pharm/Bio facilities.

Alison Demarest, Principal, Meridian Group LLC
Alison Demarest has more than 20 years of experience in biotechnology and FDA-regulated industries under GMP and GLP, in both consulting and operating companies. She has conducted more than 50 audits domestically and overseas. She teaches at Johns Hopkins in the MS/Regulatory Affairs program and is a frequent lecturer on compliance topics at ASME and ISPE conferences, Hood College, UMBC, and Montgomery College.

Carlos Escobar, Senior Manager/Principal Engineer, Process Development, Amgen
Carlos Escobar is currently a Senior Manager/Principal Engineer with Amgen and has over 12 years of experience in the process engineering field within Research and Development for small and large molecules. He is currently responsible for managing the process engineering group for one of the peptibodies facility, with the responsibility to facilitate technology transfer, process development and scale up of peptibodies. Before joining Amgen, Carlos worked at Bristol-Myers Squibb (R&D) in 1998 to perform process development, scale up and technology transfer of small and large molecules. Prior to that, Carlos held manufacturing process engineering positions within Bristol. Carlos graduated from the University of Puerto Rico in 1996 with a BS in Chemical Engineering.

Sam Gabrielli, Senior Strategic Planner – Process R&D, Genentech
Sam Gabrielli is Senior Strategic Planner, Portfolio Planning & Economic Analysis in Process Research & Development at Genentech, Inc. and has 10 years experience in economic analysis and modeling of large scale cell culture processes. Mr. Gabrielli uses computer modeling to understand the economic impact of new technology implementation in new and existing bioprocess plants. Before joining Genentech, Inc., Mr. Gabrielli started a Winery and Vineyard company. He is a member of AICHE and ACS and has a BS from the University of California and an MBA from the University of Colorado.

Ken Hamilton, Director of Process Engineering, Genentech, Oceanside, CA
Ken Hamilton has over twenty years experience in the biopharmaceutical industry. Currently, he is the Director of Process Engineering and Automation at the Oceanside manufacturing site for Genentech. His responsibilities include process design, optimization and improvements to manufacturing process equipment at the site. In addition, he is responsible for the process engineering and automation from design conceptual through designed design, installation and start up for new processes that are transferred to the site. Prior to this, he was responsible for engineering technology, which involved development of models to assess manufacturing capacity and risk analysis applied to process equipment.

Prior to joining Genentech, he was a Director of Engineering at Biogenidec. There he led a team to design, construct and qualify a clinical and product launch mammalian cell bulk manufacturing facility. On completion of this project, he took a manufacturing technology assignment for a new manufacturing facility for Biogenidec to be constructed in Denmark.

Ken Hamilton has a Ph.D. in Chemical Engineering and has made fifteen papers / presentations to ASME, ISPE and AIChE. He has chaired several technical sessions for ISPE and ASME in the past.

Jeffrey Hamilton, Automation Manager, ABEC
Jeff graduated from Lafayette College in 1986 with a BSME, and performed mechanical design and application work in various machine control industries. After earning a BSEE degree in 1995, Jeff began to focus on electronics in various areas of machine control. He designed electronic systems for hydraulic machine control applications including layout of power distribution and instrumentation, configuration of analog and digital axis controllers, design of PLC and HMI software, testing and start-up of various equipment ranging from aluminum extrusion presses to bridge control. For the last eight years, he has developed control systems for biotech equipment builders, and for the last three years, as an automation manager with responsibility for electrical design, software design, documentation, FAT and equipment start-up. Jeff has worked primarily with Allen-Bradley PLC/HMI and with DeltaV DCS systems.

Mark Hannon, Senior Manager, Corporate Process Engineer, Genentech
In Mark Hannon's twelve years at Genentech he has been intimately involved in cGMP facility design, construction and qualification for bulk and aseptic fill facility as a Senior Facilities Engineer, Senior Group Leader and Senior Manager in Genentech Corporate Engineering. Mark was the HVAC Design Lead for Genentech's Vacaville Project, a green field 120,000L CHO biotech facility as well as the Mechanical Lead for Genentech's Parenteral Manufacturing Expansion, an aseptic fill line South San Francisco. He was also a process lead for B51-A3, a modular aseptic fill facility. Mark served as the design lead of numerous bulk, fill, lab, pilot plant, expansions and upgrades to Genentech's South San Francisco facilities. He led the SSF Plant Engineering function from 1999 through 2004 and was responsible for planning and executing upgrades to manufacturing facility HVAC, primary and critical utility systems. As a manager, he participated in HVAC conceptual design for the Clinical Parenteral Manufacturing Facility in South San Francisco and Genentech’s recent 200,000L CCP2 (Cell Culture Plant 2) in Vacaville, California. During his twelve years at Genentech he has provided support for FDA and other regulatory inspections support at the South San Francisco campus for HVAC and critical utility systems. Mark is working as the engineering liaison to Genentech’s corporate validation group in developing approaches to risk based commissioning and qualification in conformance with ICH Q8 and 9. He is the immediate past president of the award winning ISPE Bay Area Chapter. Prior to joining Genentech Mark spent sixteen years as a project manager for two large mechanical contractors completing industrial and commercial projects through California, including Genentech's Process Science Center.

Dennis Healey, P.E., Electrical/Automation Engineer, ABEC
Dennis graduated from Old Dominion University in 1986 with a BSET and worked as an Automation Engineer in the Pulp and Paper, Material Handling and Pharmaceutical industries. Dennis earned his license as a Professional Engineer in the Commonwealth of Pennsylvania in 1995 and has completed a Master of Science in Computer Information Systems. For the past thirteen years Dennis has been teaching college level courses involving PLC configuration and programming and robotics. Dennis has worked primarily with Allen-Bradley PLC/HMI and with DeltaV DCS systems.

Barbara K. Henon, Ph.D., Manager, Technical Publications, ARC Machines
Barbara K. Henon, Ph.D. is a Manager of Technical Publications at Arc Machines, Inc., a manufacturer of orbital GTA tube and pipe welding equipment. Barbara specializes in orbital welding of thin-wall tubing and components for biopharmaceutical process piping applications. She has over 15 years experience training orbital welding operators and engineers in the field for pharmaceutical and semiconductor high purity applications. Barbara is a seasoned technical writer on applications of orbital welding. Her honors include Pharmaceutical Engineering’s "Article of the Year" in 1999 and the American Welding Society’s (AWS) "Silver Quill" award in 1997. Barbara holds an AB in Zoology, from Mt. Holyoke College, an MA in Zoology from Columbia University, and a Ph.D. in Biological Sciences from the University of Southern California. Her postdoctoral research was in the Division of Neurosciences, City of Hope Research Institute. She is the former Vice Chair of the ASME Bioprocessing Equipment (BPE) Main Committee and is a current member of the BPE Materials Joining and Surface Finishes Subcommittees. She is also active on the AWS D18 and D10 Standards writing committees.

Sibylle Herzer, Ph.D., Fast Trak Staff Scientist, GE Healthcare Biosciences
After obtaining a diploma in Genetics and a Ph.D. in Cell Biology from the University of Basle, Switzerland, Billie joined Amersham Pharmacia Biotech as an expert in the Molecular and Cell Biology area in 1998. She transferred to Fast Trak Education Process Development in 1999. Since then, she had developed expertise in gene therapy and vaccine areas, as her primary focus in 2000. Billie has worked with customers on several virus projects such as: polio; adeno; adeno-associated; herpes; reo; and measles viruses. She is actively involved with developing purification processes for plasmid DNA, and other DNA therapeutics, as well as working on process development and optimization projects on recombinant proteins, native proteins, and polysaccharides from cell culture stages to final formulated product.

Most recently, Billie has established credibility demonstrating technical excellence in the Regulatory and Validation sector of drug and biologics life cycle studies. This has been achieved through enrollment with RAPS, supporting collaborations on new approaches to viral clearance strategies, implementing effective column life time studies emphasizing validation methods and a strong focus on Regulatory guidance and Validation requirements.

Mark Herr, Sales/Product Manager at Stainless Technology
BSCE from University of Missouri - Rolla in 1979. 28 years of ASME vessel design, Project Management, Sales Management experience in all industries with specific emphasis on BioPharm applications over the past 23 years. Currently Sales / Product Manager at Stainless Technology which is an ASME Vessel manufacturing company dedicated to the supply of vessels to only the BioPharm Industry.

John Higgins, Associate Scientist II, Process Biochemistry, MedImmune
John Higgins, leads the Clinical Manufacturing Tech Transfer and Support function within the Process Biochemistry department at MedImmune. John has 8 years of experience in downstream biopharmaceutical manufacturing, scale up and purification development. Before joining MedImmune, John worked at Centocor R&D performing purification development and scale-up/scale-down work for monoclonal antibodies. Prior to that, he held positions with Wyeth Vaccines Development and Diosynth, RTP. He is an active member of ACS and has earned his bachelor’s degree in Biological Sciences from the State University of New York at Buffalo.

Matt Hofacre, Director Customer Applications Management, STERIS Corporation
Matt has 10 years experience in pharmaceutical production equipment industries. He is currently the Director of Customer Applications Management at STERIS Life Sciences. Matt is responsible for design applications, project maintenance, and technical guidance for STERIS Finn-Aqua GMP Steam Sterilizers, Multiple-Effect Water Stills, Pure Steam, Generators, and, Reliance and HAMO Pharmaceutical Grade Washers, and AMSCO Sterilizers. Matt was previously an Application Engineer at Osmonics, Inc., Minnetonka,MN (Now GE Water Technologies) where his primary responsibilities included specification and application of high purity water systems including Reverse Osmosis, Deionization, Ozone Treatment, and Distillation for high purity water applications.Matt holds a B.S. in Chemical Engineering from the University of Cincinnati, an MBA from Cleveland State University and is a professional member of PDA, LAMA, and ISPE.

Arnold H. Horwitz, Ph.D., Senior Director, Cell Biology, XOMA LLC
Arnie Horwitz is Senior Director of Cell Biology at XOMA. His group is responsible for gene cloning, expression vector development and mammalian and microbial expression of recombinant proteins. During his time at XOMA, he has been involved in a variety of projects including implementation of XOMA's Human-EngineeredTM antibody technology, development of mammalian cell lines expressing various proteins including antibodies, soluble and cell surface receptors and bactericidal permeability-increasing protein (BPI) and related products as well as bacterial secretion of antibody fragments and fusions and yeast secretion of whole antibodies and antibody fragments. He also has led project teams for both internal and collaboration projects. Dr. Horwitz received his Ph.D. in microbiology from Pennsylvania State University and completed postdoctoral studies in molecular genetics at UCLA where he characterized regulatory elements of the L-Arabinose systems in E. coli and Salmonella typhimurium.

Wei Huang, Director of Process Engineering, Fluor Enterprises, Inc.
Wei Huang is a director of process engineering at Fluor Enterprises, Inc. She brings more than sixteen years of experience in the biopharmaceutical facility/equipment design, process development, operation support and biochemical research. During her career, she has led multiple major projects with biopharmaceutical clients such as, Amgen, Genentech, IDEC, Novartis, Baxter, Novo Nordisk, Elan, etc. Ms. Huang has extensive experience in areas of fermentation, cell culture, cell harvest, downstream purification technologies, aseptic fill and finish operation, clean and plant utilities. She holds an MS degree in Chemical and Biochemical Engineering from University of Maryland. Ms. Huang is a frequent speaker at various biopharmaceutical conferences and technical events. She is an award winner at ISPE publication and a member of ASME BPE subcommittee on design relating to sterility and cleanability of equipment.

Sean Illig, Deputy Director, Process Engineering, Sanofi Pasteur
Sean Illig has over eleven years of experience in the vaccines, biotechnology and pharmaceutical industry in the fields of process engineering, commissioning and qualification. Mr. Illig is currently the Process Engineering Manager with sanofi pasteur where responsibilities include oversight of design and improvements to existing process equipment as well as responsibility for process engineering for all phases of design, installation, commissioning and qualification for new processes / projects at the Swiftwater, PA facility. Previous employment includes CRB Consulting Engineers and Jacobs Engineering. Mr. Illig is an active member of ISPE and AIChE and holds a Bachelor of Science in Chemical Engineering from the University of Maryland.

Cliff B. King, Vice President, Technical Services, Flexsim Software Products Inc.
For the past 15 years, Mr. King has been Vice President of Technical Services for Flexsim Software Products, Inc. where he is a principal owner. Mr. King manages product development, software training, and consulting services for the company. Prior to Flexsim, Mr. King held positions with Hughes Aircraft, Thiokol Corporation, and Morton International, as Project Manager. Cliff King graduated Magna Cum Laude from Brigham Young University in 1984 with a degree in Mechanical Engineering.

Dan Klees, Sr. Industries Manager, Life Sciences, Endress+Hauser. Inc.
Dan Klees is the Sr. Industries Manager for Life Sciences at Endress+Hauser. Inc. located in Greenwood, Indiana. He received his Bachelor of Science and Master of Science Degrees in Physics from Miami University. Dan Klees has over 30 years of experience in this industry, having held management positions in sales and marketing with major instrumentation and automation companies as well as engineering management and executive management positions with integration and engineering firms. He is a member of ISPE and is a member of the ASME-BPE Standards Committee where he Chairs the ASME-BPE Measurement Instrumentation Standards Task Group. Dan has published several automation and advanced control algorithm articles in leading technical journals and has presented papers at International Symposiums. Dan Klees has been a graduate school guest lecturer on process automation at several Universities. Dan holds six (6) patents/patents pending related to hygienic process measurement instrumentation innovations and calibration methods. He is a Certified cGMP Instructor.

Paul Kubera, Vice President, Engineering, ABEC, Inc.
ABEC, Inc. is a designer and manufacturer of bioreactor, fermenter and associated systems for the biotech and pharmaceutical industries. Paul brings over 25 years of experience in process and product development, project management and technology transfer to leadership of ABEC's engineering team. Before joining ABEC in 2003 he led Lightnin's application technology and mixing research groups. With a background and on-going involvement in biological processes, he has been instrumental in providing clients with improved knowledge, understanding and performance of the mixing-related operations that lie at the heart of microbial reactor systems. Paul is an active member of ASME BPE sub-committees, task groups and technology transfer course offerings on bioprocess equipment design, working to translate industry needs into relevant standards and delivering this information to a global audience. He is a member of the North American Mixing Forum and has been a presenter and session co-chair at AIChE technical meetings. Paul is a graduate of Cornell University with a Bachelor of Science and Master of Engineering in Chemical Engineering.

Dr. Brian Lee, President and Co-founder, PBS Biotech, Inc.
Dr. Brian Lee is the president and co-founder of PBS Biotech, Inc of which business is to develop and commercialize innovative equipment and technology for disposable bioprocesses. He has 18 years industrial R&D experience with the Bioprocess R&D group at Merck & Co. Inc. and the Manufacturing Science and Technology group at Amgen Inc. Brian has been involved in commercial bioprocess development, characterization, scale-up, and technology transfer of various cell culture and microbial processes including DNA vaccine, antibodies, recombinant proteins, and natural products. He holds M.S. degree in Bacteriology from University of Wisconsin and Ph.D. degree in Biochemistry from Michigan State University. Brian also completed his postdoctoral training in Biopharmaceutical Chemistry and Biochemistry at University of California, San Francisco.

Philip R. Lyman, PhD, Director, Process Simulation, CRB Consulting Engineers
Philip R. Lyman, PhD, is Director of Process Simulation at CRB Consulting Engineers and has 16 years of experience in process modeling. Dr. Lyman uses computer modeling technologies to improve plant designs, de-bottleneck existing facilities and optimize operations for pharmaceutical and biotech companies. Before joining CRB, Dr. Lyman started a specialized engineering firm focusing on process simulation for the pharmaceutical and biotech industries. Prior to that, he held positions with Dow Corning Corp. and Air Products and Chemicals. He is an active member of ISPE and AICHE and has earned several degrees in Chemical Engineering: BS from University of Wisconsin-Madison, MS and PhD from Lehigh University in Bethlehem, PA.

Jeffrey Mahar, Director of Sales, CUNO Healthcare Group/a 3M company
Prior to joining CUNO, Mr. Mahar served as Product and Marketing/Sales Manager involving chromatography and centrifugation separations for the Healthcare Industries for nine years at Dorr-Oliver and Biotage. Prior to this, Mr. Mahar was a Process Development for 5 years at Genencor in Rochster, NY. Mr. Mahar serves as a main committee member for the ASME Bioprocess Standards. Jeff has both B. S. and M. S. degrees in Chemical Engineering from Rensselaer Polytechnic Institute and an MBA in International Business and Marketing from the University of Connecticut.

David M. Marks, President and Founder, DME Alliance Incorporated
David M. Marks is president and founder of DME Alliance Incorporated. He has 25+ years of experience in the specification, design and implementation of process systems. He is a frequent author, speaker and consultant on bioprocess technology, facility/equipment design & compliance topics. His professional experience is concentrated in the design and implementation of bioprocess systems for FDA-licensed facilities, having served many of the leading international biotech and pharmaceutical firms since 1989.

Prior to founding DME Alliance in 1998, David managed the engineering department for Associated BioEngineers and Consultants. He is active on the ASME Bioprocess Equipment (BPE) standard main committee, serves on the polymers subcommittee and is currently vice-chair of the design subcommittee. A graduate of Lafayette College, David holds a BS in Chemical Engineering and is a registered Professional Engineer.

Jerold Martin, Sr. Vice President, Global Scientific Affairs, Pall Life Sciences
Jerold Martin is Sr. Vice President of Global Scientific Affairs at Pall Life Sciences, responsible for technical and regulatory communications. He has over 30 years experience in Validation, Technical Services, R & D, Marketing and Business Development.

Mr. Martin has lectured extensively at biopharmaceutical companies and industry groups such as PDA, ISPE and ASME, as well as at regulatory agencies, throughout the world. He is the author of numerous publications on biopharmaceutical manufacturing and aseptic processing, including co-authorship of the PDA Technical Reports on Sterilizing Filtration of Liquids, Sterilizing Filtration of Gases, and Virus Filtration, the ASTM F838 Standard on Sterilizing Filtration and the ISO Standard on Aseptic Processing, Part II, Filtration. Mr. Martin is also Director and Technology Committee Chair with the BioProcess Systems Alliance (BPSA), where he co-authored the BPSA Recommendations for Component Quality Tests, Irradiation and Sterilization, and Extractables and Leachables from Single-use Systems for biomanufacturing. He is on Advisory Boards for IBC and PDA, where he received the 2007 PDA Distinguished Service Award, as well as on the Editorial Review Boards of American Pharmaceutical Review, Genetic Engineering News, Pharmaceutical Technology Europe and Contamination Control magazines. Mr. Martin holds an M. Sc. in Microbiology from the University of Toronto.

Steven Meier, Senior Engineer, Genentech, Inc.
Stephen has over 14 years of experience in cell culture process development and scale-up. He has a BS in chemical engineering from the University of Minnesota and a Ph.D. from the Massachusetts Institute of Technology. Recent experience includes process development, scale-up, validation, and process transfer for post-approval process changes; bioreactor design, facility design, and start-up for a pilot plant; and bioreactor and automation design for a major manufacturing facility.

Shaun J. McWeeney, Process Engineer, Centocor R&D, Inc.
Shaun J. McWeeney is a Process Engineer in PD Engineering at Centocor R&D, Inc. Shaun has over 10 years experience in automation and process engineering in several industries including specialty chemical, air separation, and bio-pharmaceutical. His experiences have led him to work with a wide array of automation systems. Currently, Shaun is a responsible for design, fabrication, installation, commissioning and qualification of new and existing equipment in the Phase 1 and Phase 2 clinical manufacturing pilot plant at Centocor R&D. Some examples of his work at Centocor include a small building expansion for a Post Viral area, capacity expansion with portable stainless steel tanks, and a production train of single use bioreactors. In his previous experience, Shaun worked at Siemens Energy & Automation, Inc. (formerly Moore Products, Co.) as an automation engineer. He received his Masters in Chemical Engineering from Villanova University, and BS in Chemical Engineering from Lehigh University.

Dr. Antonio R. Moreira, Executive Vice President, SPI USA, Inc. and Vice Provost for Academic Affairs and Professor of Chemical and Biochemical Engineering, UMBC (University of Maryland, Baltimore County)
Dr. Moreira was Chairman of the Chemical and Biochemical Engineering Department at UMBC from 1990 - 1995 and Associate Provost for Academic Affairs from 1995-1997. Prior to 1990, Dr. Moreira spent nearly ten years in the private sector, with management positions both in the food industry with International Flavors and Fragrances, Inc. and in the pharmaceutical/biotechnology area with Schering-Plough Corporation. He has significant experience with R&D, scaleup and introduction to commercialization of biotechnology products, such as alpha interferon. He has extensive experience in regulatory affairs, GMP compliance, and design and validation of biopharma facilities and processes. Dr. Moreira holds a B.S. degree in Chemical Engineering from the University of Porto, Portugal, and M.S. and Ph.D. degree in Chemical and Biochemical Engineering from the University of Pennsylvania. He has an active research program in bioprocess engineering and is a consultant to various biotechnology and pharmaceutical companies. He has received various awards including a NATO Senior Fellowship and the Halliburton Outstanding Young Faculty Award. He served as the President for the Chesapeake Bay Area Chapter of the International Society for Pharmaceutical Engineering; he is immediate past-chair of the Council for Biotechnology Centers for the BIO Industry Organization, and serves on scientific advisory boards for various organizations. He is a graduate of Leadership Maryland, class of 1998.

Marta Murray, Director of QA Engineering, Abbott Inc.
Ms. Murray recently joined Abbott, with over fifteen years of diverse process and product experience in the pharmaceutical and medical device industry including validation, optimization, analysis and troubleshooting of chemical synthesis and biotechnology processes for the production of bulk pharmaceuticals, biopharmaceuticals and finished products. Ms. Murray began her validation career with Boehringer Ingelheim developing and executing protocols to validate analytical and cleaning processes. Other validation experience includes process and equipment validation at Barre-National, management and coordination of validation activities at Oncor and director of validation activities for Cambrex Bio Science Baltimore. Before joining Abbott, Ms. Murray was with Kos Pharmaceuticals, responsible for the direction and coordination of all phases and activities related to equipment, utilities, processes, computer and cleaning validation for the manufacture of solid dose and aerosol products. Ms. Murray holds a B.S. degree in Chemical Engineering from the University of Puerto Rico.

Philip Nelson, Scientist, Amgen
Philip Nelson has spent the last 21 years working on the production and process development of large scale, recombinant pharmaceuticals. In that time Mr. Nelson has worked at Genentech, Connetics, Millipore, Abgenix and Amgen. He is currently responsible for a Process Engineering group performing facility and equipment design, process improvements and manufacturing non-conformance investigations for Amgen’s monoclonal antibody production in Fremont California. Mr. Nelson received his B.S degree in Genetics from U.C. Berkeley.

Marc Pelletier, Director, Strategic Biopharm Solutions Group (SBSG), CRB Consulting Engineers
Marc is Director of the Strategic Biopharm Solutions Group at CRB Consulting Engineers. The Group specializes in strategic planning, conceptual design, process engineering, risk assessment, compliance and validation for the Life Technologies. Before joining CRB, Marc was President of MPP BioDesigns, a consulting group also specializing in Bioprocessing. Although Marc is formerly trained in biochemistry, he has worked as a process engineer for most of his 25+ year career, all in the food and pharmaceutical and biotechnology sectors. Prior to consulting, Marc spent the majority of his career as an end user developing bioprocesses. His role on various projects include that of project manger, fermentation and downstream process design lead, equipment designer, facility designer, risk assessment moderator and validation manager. He is currently the vice-chair of the Seals Committee for the ASME BPE and is a member of the ASME BPE Main and Design Committees. He has served as adjunct professor at the University of Manitoba, Canada and Bemidji State University, MN. He is a frequent lecturer for the SBP, ASME CEI and ISPE.

Dr. Demetri Petrides, President, Intelligen, Inc.
Intelligen, Inc. is a software company that develops and markets simulation, design, and scheduling tools for a wide variety of industries. Dr. Petrides has extensive experience in modeling and optimizing biochemical, pharmaceutical, specialty chemical, and related processes. He holds a B.S. from National Technical Univ. of Athens (Greece) and a PhD from MIT, both in chemical engineering.

Dr. Michael J. Pikal, Professor and Pfizer Distinguished Chair in Pharmaceutical Technology, University of Connecticut
Dr. Pikal received his Ph.D. in physical chemistry (1966) from Iowa State University and was a Postdoctoral Research Fellow with the Lawrence Livermore Laboratory (1966-1967). Prior to joining Lilly Research Laboratories in 1972, he was assistant professor of chemistry at the University of Tennessee (1967-1972). His current research activities include the solid state chemistry of pharmaceuticals, particularly the stability of amorphous materials, characterization of solids by calorimetry, and the science and technology of freeze drying with a focus on optimization of formulation and process for labile proteins. Dr. Pikal is a member of the ACS and AAPS. He was the recipient of the Ebert Prize (1977) and the PDA's "best paper of the year" award (1989). He received the Eli Lilly & Co. "Presidents Award" in 1996. Dr. Pikal was the Busse Lecturer (University of Wisconsin, 1983) and the Enz Lecturer (University of Kansas, 1998). Dr. Pikal is a Fellow of the AAPS, and received the AAPS Research Achievement Award in Pharmaceutical Technologies in 2001, and the Criofarma award in Freeze Drying in 2006.

Alan Powell, Associate Director for Engineering, Process Engineering, Merck & Company, Inc.
Alan has worked for Merck &Co., Inc. for over 20 years in process development, technical support, and process engineering for sterile and biological products. He has developed sanitary and sterile design guidelines for Merck. He is responsible to mentor other engineers and review designs to ensure adherence to good design practice in new installations for bulk biological products and sterile filling areas. Over the past two years, he has been involved in bulk vaccine facility projects at Merck's plants in Pennsylvania and Virginia and in India; and sterile filling projects at Merck's plants in Ireland, the Netherlands, North Carolina, and Pennsylvania. Alan is also the technical lead for Merck's bioreactor equipment and CIP designs. He also serves as an expert adviser to technical and operating groups in troubleshooting cleaning, sterilization and processing. He holds a B. S. in biochemistry and an M. S. in chemical engineering from Michigan State University.

Scott Richmond, Senior Scientist, Human Genome Sciences, Inc.
Scott Richmond is a Senior Scientist at Human Genome Sciences, Inc. He holds a M.S. in Biotechnology and B.S. in Chemical Engineering from the University of Pennsylvania. At Human Genome Sciences, Scott has worked on the development, scale-up, and validation of microbial and mammalian processes at all stages of clinical development. He just completed the technical transfer of a late stage mammalian cell culture and recovery process to Human Genome Science's new commercial manufacturing facility containing two 20,000-L bioreactors. Validation of this process is scheduled to take places in the second half of this year. Current and past projects include, pasteurizer purchase and process development; development of post-commercial cell culture process; cell culture assay qualification; evaluation of secondary media vendors; in-process hold characterization experiments; media stability characterization studies; determination of cell culture process variability; and computational fluid dynamics modeling of cell culture bioreactors.

Rudy Smallwood, Associate Scientist II, MedImmune
Rudy Smallwood is manager of the Cell Culture pilot lab clinical production facility at MedImmune. Rudy has over 17 years of cell culture and fermentation experience in the biopharmaceutical industry. His experience includes process development and optimization, equipment commissioning, validation and facility start up. Rudy has held clinical development and manufacturing positions at companies such as Regeneron, Genzyme and SmithKline Beecham (now GSK). Mr. Smallwood earned a bachelor’s degree in Biology from the University of Charleston.

Mike Stella, Sales Development Manager, BOC Edwards Pharmaceutical Systems, Inc.
Mike Stella began his career with BOC Edwards Pharmaceutical Systems as Field Service Engineer in 1991. In the following years he has filled a number of roles including, Controls Systems Engineer, Test Supervisor, Customer Service Manager, Training Manager and Quality Manager. His current position is as Sales Development Manager with primary responsibility for the western United States.

Douglas Stockdale, President, Stockdale Associates, Inc.
Douglas Stockdale is the President of Stockdale Associates, Inc., which provides broad Aseptic Fill/Finish and Sterile Barrier Systems consulting services for the Life Sciences Industry. He had twenty years of aseptic operational experience with Baxter Healthcare prior to founding Stockdale Associates. He is an internationally known consultant, speaker, and writer about the issues of Aseptic Fill/Finish and Sterile Barrier Systems. His company provides innovative strategic and implementation solutions for product development, manufacturing, compliance/auditing and validation.

He is a member of PDA & ISPE and was recently a member of the Board of Directors for the Greater Los Angles chapter of ISPE. Mr. Stockdale has a MBA from University of La Verne and BS in Engineering from Michigan State University.

Jason Tansky, Staff Engineer, Centocor
Jason P Tansky has over ten years of experience in the vaccines and biotechnology industry covering varied the fields of process engineering, commissioning and qualification. He has lead teams responsible for the commissioning and qualification of vaccine and biotech projects. These C&Q activities included delivery of final formulation and fill, preculture, cell culture and down stream processing facilities and equipment. In addition, Mr. Tansky is a member of the Johnson and Johnson Core Commissioning and Qualification team. Mr. Tansky is currently a Staff Engineer with Centocor Research and Development. Previous employment includes Wyeth Research and Development Vaccines, Wyeth Vaccines and Ganes. Mr. Tansky holds a Bachelor of Science in Chemical Engineering and a Masters of Science in Engineering Management from the New Jersey Institute of Technology.

Dr. Paul Todd, Chief Scientist, Techshot, Inc.
Dr. Paul Todd is the Chief Scientist at techshot, Inc. Prior to joining techshot, Dr. Todd was, in chronological order, Lecturer in the Department of Physics, University of California, Professor of Biophysics at Penn State University (20 years) where he also served as chairman of the graduate program in genetics, founding director of Philadelphia's Bioprocessing and Pharmaceutical Research Center (a NASA Center of Excellence in Microgravity Research), Physicist, National Institute of Standards and Technology, and Research Professor of Chemical Engineering at the University of Colorado (10 years) where he also served as Associate Director of BioServe Space Technologies (a NASA Center for Space Commercialization). He received his education at Bowdoin College, Harvard University, MIT, University of Rochester and University of California. He co-edited eight books or proceedings in the fields of bioprocessing and of space research and co-authored (with R. G. Harrison, S. R. Rudge and D. Petrides) a textbook in bioprocess engineering, Bioseparations Science and Engineering (Oxford University Press, 2003). He served on DOE's Health and Environmental Research Advisory Committee and on the former NAS/NRC Space Applications Board and is past president of the American Society for Gravitational and Space Biology and on the editorial board of Journal of Biochemical and Biophysical Methods. He is co-author of 290 scientific papers and co-inventor on 7 issued patents.

Kent VanSooy, Assistant Director, Drug Substance Manufacturing, Isis Pharmaceuticals
Kent VanSooy is Assistant Director of Manufacturing at Isis Pharmaceuticals, and has 10 years of experience manufacturing therapeutic oligonucleotides. He recently managed a modeling project using FlexSim software to evaluate the capacity and determine the bottlenecks in a proposed manufacturing suite renovation and expansion.

John Vitti, National Sales Manager, Sanitary Diaphragm Valves Division, Crane Saunders
John Vitti is the National Sales Manager - Americas for Crane Saunders sanitary diaphragm valves and Crane ResistoPure sanitary hoses. He has held this position since March 2001 when Crane acquired Saunders from Alfa Laval. He is also responsible for the Northeast territory in supporting the New England distributor channels at end users, OEMs and Engineering firms for valve and hose product approvals and specifications. Prior to his joining Crane he worked for a ball valve company called SVF Flow Controls as the Northeast Regional Manager for 5 years. This position entailed selling both industrial and high purity ball valves – manual and automated. His main focus was primarily geared towards the pharmaceutical industry since the location of many of the end users and engineering firms are within a radius of 100 miles of the Philadelphia area. He also held the position of Northeast Regional Manager for Keystone Valves for 6 years selling industrial butterfly valves. And prior to Keystone, he was employed by ITT Engineered Valves (diaphragm valves) in various positions for 12 years.

James Dean Vogel, PE, President, Process Facilities Services Inc.
James Vogel is the President of Process Facilities Services Incorporated, a consulting firm focused on all areas of biopharmaceutical and utility engineering and how they best support the manufacture of a product. He has more than 25 years experience in the biopharmaceutical, food and cosmetic industries. He has worked as a Director, Project Manager, and Engineer (Plant Support, Process Development, Project and Automation), with Amgen, GlaxoSmithKline, ImClone, Sanofi-Pasteur, Lipton and Avon. Mr. Vogel is a member of the ASME BioProcess Equipment Standard Committee, leads the Rouge and Seal Performance Task Groups, and is a member of the ISPE North American Education Committee. He is a licensed professional engineer in NJ, and he has a ME in chemical engineering and a BS in biochemical engineering.

Dr. Sy-Dar Wang, Chief Technical Officer, Adimmune Corporation
Dr. Sy-Dar Wang received his MS and Ph.D. in biochemical engineering from MIT in 1979 and 1988, respectively. He has over 20 years of working experience in the biotechnology/biopharmaceutical industry and is now the Chief Technical Officer and Acting CEO of a human use vaccine development and manufacturer, Adimmune Corporation located in Taiwan, ROC. Before he joined Adimmune Corporation in 2003, he worked for several biotech companies in the U.S., including working for Tanox, Inc. as the Director of Manufacturing, working for SAIC Frederick as the Production Manager, as well as working for AMVAX, Inc., Chemgen Corporation, etc. His expertise is in the fermentation and cell culture process development, scale-up and pilot plant operation, GMP facility design, validation, and manufacturing management.

Jeffrey P. Welch, Sr. Project Manager, Human Genome Sciences, Inc.
Jeffrey P. Welch is a Sr. Project Manager in the Technical Services group at Human Genome Sciences. He has nearly 17 years experience in bioprocess including process development, equipment and plant design and manufacturing. Mr. Welch has led an effort to use process modeling software to simulate new processes, and evaluate the capabilities of HGS’s manufacturing facilities. Mr. Welch’s previous position was with BASF Bioresearch, now Abbott. Mr. Welch holds a BChE degree from M.I.T.

Rich Yeaton, President, East Coast Validation Services, LLC
East Coast Validation Services provides Validation and Commissioning services to GMP companies operating in both the Device and Parenteral worlds. Rich has over nineteen years experience executing and managing technical projects for GMP operations. His initial experience with GMPs and validation came on the Device side, as a Development Engineer for DuPont Diagnostics. Validating equipment that he designed gave him an appreciation for the difference between success in the lab and success in real world production. On the biotech and pharma side, Rich has extensive experience with validating GMP production equipment and critical utilities. He is familiar with various types of Process Validation, including API Process, Sterilization and Cleaning validation. He also has a great deal of experience managing system startups and facility shutdowns, which means that he has a really good stockpile of "War Stories" to trade with colleagues.