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.

Dr. Hira Ahluwalia, President, Material Selection Resources Inc.
Dr. Hira Ahluwalia is President of Material Selection Resources Inc. Material Selection Resources (MSR) is a materials engineering and corrosion consulting organization based in New Jersey, USA serving the chemical, pharmaceutical, fabrication and metal industries.

Dr. Ahluwalia has extensive experience in the field of corrosion and material science and has published numerous technical papers. His areas of expertise include material selection, corrosion testing, metallurgy, alloy development, and failure analysis. He has a Ph.D. in materials and corrosion engineering from Newcastle University, United Kingdom. A 20-year ASM and NACE member, Ahluwalia is Chairman of the NACE Annual Conference Program Committee and was section chair of the new ASM Corrosion Handbook. He is also a Nickel Institute consultant and Materials Technology Institute (MTI) consultant.

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.

Narlin B. Beaty, Ph.D., Principal, Qualification Process Solutions, LLC
Narlin Beaty, Ph.D. is a Principal in Qualification Process Solutions (QPS), an engineering firm that specializes in pharmaceutical process design and implementation. He is also a founder of Sublimation Science, a wholly owned subsidiary of QPS, and a service organization to the parenteral pharmaceutical industry specializing in lyophilization commissioning, cycle development and both machine and product cycle validation. Previously he served as the Chief Science Officer at Chesapeake Biological Laboratories, Inc. in Baltimore Maryland. Dr. Beaty has 25 years of experience in diverse areas of sterile manufacturing, engineering related to fill and finish of pharmaceuticals, sales, and contracts. Over the past two decades he has been closely involved in the transfer of scores of processes from the development lab to commercialization. In addition to lyophilization projects, Dr. Beaty is knowledgeable in test method development and testing validation; sterile process design and manufacturing validations; preparation of clinical trial materials; container-closure system design; and accelerated and ongoing stability studies. He holds BS and MS degrees from the Univ. of Texas at Austin, and a Ph.D. in Biological Chemistry from the Univ. of Michigan at Ann Arbor. His current professional associations include the American Association for the Advancement of Science, the American Chemical Society.

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.

Ernie Benway, Senior Training Specialist, Swagelok
Ernie Benway is currently the Senior Training Specialist for Orbital Welding for the Swagelok Company. He has worked for the Swagelok Company since 1969 in a variety of capacities, ranging from Engineering, Research & Development, Operations, and Sales & Marketing. He is a Certified Welding Inspector (CWI), Certified Welding Instructor (CWE) and ASNT NDT Level III (VT).

He holds more than twelve United States and foreign patents for fluid system components and orbital arc welding equipment.

He has published a number of articles on orbital welding in the pharmaceutical industry.

Ernie has been an active member of technical committees for the past 17 years. He is currently the Chairman of the General Requirements Subcommittee, and a member of the Material Joining Subcommittee and a member of the Main Committee for the ASME BPE Standard.

Tamas Blandl, Ph.D., Scientist, AMGEN Process Development, Amgen Fremont
Tamas received his Ph.D. in Biochemistry at the University of Notre Dame. Following that, he was a Postdoctoral Fellow in the Department of Protein Engineering at Genentech, working on structural biology projects using NMR. He then joined Gryphon Therapeutics and worked on a drug discovery project using protein synthesis technology and phage display. He moved to the Process Sciences department at Abgenix in early 2004, where he has been a scientist in Purification Development. Tamas transferred to Amgen with the acquisition of Abgenix by Amgen earlier this year. His primary focus is on purification development for human antibodies. Currently he is involved in the commercialization of panitumumab, a human therapeutic antibody directed against the EGF receptor with multiple potential oncology indications.

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.

Daniel Caparoni , Process Engineer, Merck & Company, Inc.
Dan Caparoni is a Process Engineer specializing in biologics/vaccine facility and equipment design, fabrication, installation, start-up and qualification. Since joining Merck & Co., Inc.'s Process Engineering group in 1998, he has acquired extensive experience supporting existing facility operations with process upgrades including capital improvements and maintenance initiatives. Recently, Dan led key aspects of a new $100M USD recombinant vaccine purification facility from design through OQ. Prior to that, Dan spent over 6 years as a project engineer involved with the design, construction and start-up of industrial facilities. Dan is currently involved with the design and start-up of a 100 million dose Fermentation and 45 million dose Purification facility, providing design, fabrication, installation, automation, start-up and qualification support.

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.

Sunniva R. Collins, Ph.D., Technology Director, Swagelok Technology Services Company
Sunniva R. Collins, Ph.D. is Technology Director of Swagelok Technology Services Company, a new business unit formed in 2007 to market and commercialize SAT12, Swagelok’s patented Low-Temperature Colossal Supersaturation (LTCSS) process. She joined Swagelok in 1995 as a research metallurgist and has served in engineering management positions, most recently as Manager, Standards and Product Regulatory Compliance. She received her doctorate and master of science in engineering degree in materials science and engineering from Case Western Reserve University. She was Swagelok’s Principal Investigator on a three-year DoE-funded project to evaluate LTCSS, which completed at the end of 2006. The results of this research have been outstanding, and contributed significantly to Swagelok’s recognition by ASM with the 2006 ASM Engineered Materials Achievement Award for LTCSS.

Dr. Collins has worked to develop key standards on welding, surface finish requirements, and corrosion test methods for the semiconductor equipment industry. She has also instructed courses for ASME on Bioprocessing Equipment (BPE) and for the International Society of Pharmaceutical Engineers (ISPE). Collins is active in ASM International and was the Cleveland Chapter Chair from 2000 to 2001. She is listed in Who’s Who in America, Who’s Who in Science and Engineering, and Who’s Who in American Women.

Dr. Robert Conway, Worldwide Director of Marketing, Cuno's Healthcare Group
Dr. Conway has been involved in filtration for pharmaceutical applications for 25 years with experience in both microfiltration and ultrafiltration systems. He is a member of the International Society of Pharmaceutical Engineers (ISPE) and the Parenteral Drug Association (PDA) and serves on the Filtration Committee. Dr. Conway received his Ph.D. degree in Microbiology and Biochemistry from Emory University School of Medicine in Atlanta, Georgia. He has numerous publications in the area of filtration and has been an instructor at the Center for Professional Advancement.

Charles Crosier, Project Engineer, Diosynth Biotechnology
Charles is currently a Staff Engineer within the Project Engineering Department at Diosynth Biotechnology Services, Inc. in RTP, North Carolina. He has 15 years of experience related to process and project engineering as well as commissioning and validation activities within the biotechnology and pharmaceutical industries. His project 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 (formerly Trenton State College) and a Masters of Business Administration from North Carolina State University.

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.

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.

Alex Fotopoulos, Director of Engineering Technology, Biogen Idec - Global Engineering & Facilities Group
With Biogen Idec for 13 years, Alex has held various positions in Process and and Product Devemopment and Engineering. Some of Alex's current responsibilities include the management of conceptual and engineering feasibility studies to support capital projects and process engineering as well as the evaluation and implementation of new process technologies and process modeling to support continuous improvements efforts in clinical and commercial manufacturing of biopharmaceuticals. Alex holds a Diploma and an MS in Chemical Engineering and an MBA.

James D. Fritz, Senior Development Manager for TMR Stainless
Dr. Fritz received his Ph.D. in Metallurgical Engineering from The Pennsylvania State University in 1987 after which he worked for 6 years as the as a Research Engineer for DuPont. He joined Allegheny Ludlum in 1993 as a Research Associate where he supervised Allegheny Ludlum’s Corrosion Laboratory and assisted customers with corrosion problems. He currently serves as a Senior Development Manager for TMR Stainless responsible for various projects related to the pharmaceutical, chemical processing, and power industries. He is a NACE International certified Material Selection Design Specialist and a member of the Metallic Materials of Construction Subcommittee of the ASME BPE Standard. He has over twenty-five years experience with corrosion resistant alloys and has published over 30 technical articles on corrosion and corrosion resistant alloys.

Lisa A. Gonzales, Sr. Regulatory Specialist-Validation Support, GE Healthcare
Ms. Gonzales is a Sr. Regulatory Compliance Specialist- Validation Support with GE Healthcare. In her current position she is responsible for providing education / support on validation (regarding chromatography issues & the execution of IQ/OQ protocols for GE Healthcare equipment) and other GXP issues to customers and internally to the company Service, Marketing, and Sales groups.

Prior to joining GE Healthcare in February 1999, she has over 20 years of experience in the Medical Device (in Vitro Diagnostics) and Biopharmaceutical Industries (Gene Therapy). Her previous positions include Quality Assurance where she performed quality audits for Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and Good Laboratory Practices (GLP); managed the Material Review Board and Complaint Review Board; coordinated the Batch Record Review of all manufacturing and quality control records and product release. Previous positions include Manufacturing Supervisor of Conjugation Chemistry; R & D Research Associate and Quality Control Chemist.

Ms. Gonzales is a Certified Quality Auditor (CQA) from the American Society of Quality since 1997. She has been a licensed Clinical Laboratory Scientist with the state of California since 1983.

Ms. Gonzales received her B.S. degree in Medical Microbiology and Technology from Colorado State University.

Leon Gordon, Consultant, DME Alliance
Leon has served the biopharmaceutical industry as a consultant since 1991 and has been employed in the pharmaceutical industry for close to 30 years. As a consultant to the industry, Leon has often been involved with defining the needs of the client and identifying the resources required to implement a project. This front end thinking marries his process engineering background with his project management skills, filtered through his years of experience, to achieve an acceptable solution in the most efficient fashion. As an employee of the biopharmaceutical / pharmaceutical industry he has implemented major engineering and construction projects as project director/ manager / and engineer and process expert.
Leon graduated from Rutgers University as a Chemical Engineer, and has been trained at MIT and the University of Wisconsin in fermentation and downstream processing and pharmaceutical secondary manufacturing.

Guerry Grune, Ph.D., P.A., Principal, ePatentManager.com
Guerry Grune, Ph.D., P.A. is a Principal at ePatentManager.com. He brings with him over 20 years of accomplishments and experience with IBM and ABB Corporation, where some of the winning proposals submitted were; a corroded underground oil-filled high voltage power line; and the first U.S. Life Cycle Assessment (LCA) study of power and distribution transfomrers. It was the LCA work that led to development with his wife and ePatentmanager colleague, Carla O. Grune, of the LCAPIX software module (patent pending) combining, for the first time, Life Cycle Assessment with Activity Based Costing. This activity led to becoming the Principal Consultant for KM Limited, an environmental consulting company specializing in LCA and software development. In November 1995, Guerry joined Mitsubishi Chemical America's Virginia Operations as Manager of Optical Photoreceptor Development (for electrophotography) and in January 1997 he accepted the position as Manager of Intellectual Property. Guerry has authored over 30 publications and technical disclosures, has 5 U.S. patents either pending or granted and 3 International (PCT) filings listing him as the inventor.

Ken Hamilton, Director of Process Engineering, Genentech
Ken Hamilton has over twenty years experience in the biopharmaceutical industry. Currently, he is the Director of Process Engineering 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 responsibility for the process engineering conceptual thru 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 at a director engineering at Biogenidec. There has 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 an assignment to assume the role for manufacturing technology for a new manufacturing facility for Biogenidec to be constructed in Denmark.

Prior to Biogenidec, Ken Hamilton was at Matrix Pharmaceutical for five years. There he led a team to design and build, then ran the engineering got a formulation, fill and finish facility. Before this, he was at Mallinckrodt for five years; there he developed several processes, being awarded a process patent. He also led a process transfer to a partner company in Norway. Before this, Ken Hamilton was at Flour Daniel and started at the Biosciences laboratory at Unilever in the UK.

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.

Roger G. Harrison, Professor, School of Chemical, Biological and Materials Engineering, University of Oklahoma
Roger G. Harrison received his B.S. degree in chemical engineering from the University of Oklahoma and his M.S. and Ph.D. degrees in chemical engineering from the University of Wisconsin-Madison. Before joining the School of Chemical, Biological and Materials Engineering at the University of Oklahoma in 1988, he worked for six years in the Fermentation Research and Development Department at the Upjohn Company in Kalamazoo, Michigan, and for seven years in the Biotechnology Division at the Research Center of Phillips Petroleum Company in Bartlesville, Oklahoma. His work at Upjohn and Phillips focused on bioseparations. His research at the University of Oklahoma has focused on the engineering, expression, and purification of recombinant proteins produced in Escherichia coli bacteria.

He is first author with three coauthors (Paul Todd, Scott Rudge, and Demetri Petrides) of the textbook Bioseparations Science and Engineering, published by Oxford University Press in 2003. This text is designed for juniors, seniors, and graduate students and to date has been adopted for courses at 52 universities. In 2006 he and his coauthors received the Meriam\Wiley Distinguished Author Award for this book from the American Society for Engineering Education, which is given every two years for an outstanding new engineering textbook.

Dennis Healey, P.E., 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 recently completed a Master of Science in Computer Information Systems. For the past twelve years Dennis has been teaching college level courses involving PLC configuration and programming. 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.

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.

Eric Isberg, Product Manager, Liquid Pharmaceuticals, Bosch Packaging Technology, Inc.
Eric Isberg is Product Manager in liquid pharmaceuticals for Bosch Packaging Technology, specializing in advanced aseptic processing for product filling operations and in filled product inspection equipment. He has 15 years of experience working in the areas of biopharmaceutical and pharmaceutical processing. Previously, he worked in the biopharmaceutical industry at PDL Biopharma and Biogen Idec in the areas of equipment and process validation, manufacturing, process development, and technical services. He holds a BA degree in Biology from Gustavus Adolphus College. He is a member of the International Society for Pharmaceutical Engineering (ISPE), the Parenteral Drug Association (PDA) and the American Glovebox Society.

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.

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.

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.

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, Principal Engineer, Process Engineering, Merck & Company, Inc.
Alan has worked for Merck &Co., Inc. for over 20 years in process development, technical support, and, since 1996, in process engineering for sterile and biological products. He determines facility requirements for products, leads design development for process equipment, and carries the process engineering effort from design through licensure. Alan serves as an engineering expert for sanitary and sterile design, bioreactor equipment, and CIP. He assists other engineers in the development of designs that integrate good sanitary design principles and reliable operation across a variety of biological production and sterile filling projects. He also serves as an expert adviser to technical and operating groups in troubleshooting cleaning, sterilization and processing. He is responsible for development of sanitary design training for Merck engineering. He holds a B. S. in biochemistry and an M. S. in chemical engineering from Michigan State University.

Dr. Ash Ramzan, Principal Consultant, Woodley Bioreg Ltd.
Dr. Ramzan utilises over 14 years of biopharmaceutical and pharmaceutical industrial experience ranging from analytical methods development, optimisation and validation through to process development and validation to provide consulting services to client companies in Europe, USA, Indian Subcontinent, and Australia. He has prepared a number of Regulatory dossiers both for the EU and the USA. Dr. Ramzan provides subject matter expertise including project and programme management for pharmaceutical and biotech development and regulatory programmes. Prior to joining Woodley BioReg Ltd, Dr. Ramzan worked for Ipsen Ltd (the UK division of the French Beaufour-Ipsen Group) as a Technical Affairs Manager. His role at Ipsen encompassed a diverse range of cross-functional responsibilities with effective operation at the crossroads between "Science", "Manufacturing", "Quality" and "Regulatory Affairs". He was the Responsible Person for the validation activities of a contract manufacturer and the delivery of a cGMP compliant biopharmaceutical to over 40 World territories. Dr. Ramzan is a CMC expert whose experience includes but is not limited to: Programme and Project Management; Development and Process Validation (Analytical, Equipment, Cleaning, Facilities and Utilities, Training); Regulatory Compliance and Support (preparation and submission of IND, MAA, BLA including eBLA and CTD including eCTD, Comparability Protocols, preparation of answers to regulatory questions, Regulatory Agency meetings); Quality (cGMP audits, Critical Process Audits, Validation Audits, Due Diligence, and GAP analysis audits) and Technical support (pipeline product development, in vitro assay development, scientific programme and project management). Furthermore, Dr. Ramzan has experience in the successful Technology Transfer of the manufacture of a complex biologic including analytical methods. Dr. Ramzan's expertise also includes the management and implementation of Regulatory Compliance programmes for both Pharmaceuticals (small molecules) and Biopharmaceutical (biologics and vaccines). Previously, Dr. Ramzan held a number of positions in Medeva Pharma, Liverpool, U.K. during the scale-up, manufacture and EU licensure of Hepagene™ (a third generation vaccine for Hepatitis B which is currently approved in Europe). He has extensive expertise in the technical and analytical development of biochemical and biophysical methods and their validation for biological products in particular with vaccines using conventional and state-of-the-art techniques. Dr. Ramzan received his Ph.D in Protein Biochemistry and BSc. (Honours) in Biochemistry from the University of Liverpool, UK.

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.

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.

Paul L. Sturgill, Owner/Operator, Sturgill Welding & Code Consulting
Paul L. Sturgill (Lynn) is Owner/Operator of Sturgill Welding & Code Consulting, an independent consulting firm. He was previously Director of Engineering, Safety, Training & Quality for Purity Systems, Inc. He has 25 years of experience in welding and metallurgical engineering with Rockwell International, EG&G, Lockheed Martin Astronautics, and Dynamic Materials Corporation. His welding experience includes the GTAW, RW, and EBW processes and familiarity with many materials, including 304L and 21-6-9 stainless steels, OFHC copper, aluminum alloys, Inconel, pure titanium, pure zirconium, and pure nickel.

Lynn has been a member of the ASME Bioprocessing Equipment (BPE) Standard subcommittee on Material Joining since 2003. He was named Vice-Chairman of the subcommittee on Metallic Materials of Construction in 2005. Lynn is also a member of the Subgroup General Requirements of Section IX of the ASME Boiler and Pressure Vessel Code.

Lynn has a B.S. degree in Metallurgical Engineering from the University of Tennessee, Knoxville, and has finished the M.S. course work in the Welding Engineering program at the Colorado School of Mines in Golden. He is an AWS Certified Welding Inspector (CWI), an ASNT Level III Visual Testing (VT) Inspector, and an ASQ Certified Quality Auditor (CQA).

He has published a number of articles in the open literature, on topics such as the effect of embedded oxygen on the penetration characteristics of austenitic stainless steels and the development of a power output measuring standard for electron beam welders, in addition to the Purity Systems, Inc. Technical Highlights series.  

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.

John Vitti, National Sales Manager, Sanitary Diaphragm Valves Division, Crane Saunders
John has held his position at Crane Saunders since March 2001 when Crane purchased Saunders from Alfa Laval. He is responsible for the Northeast territory and assist the NE distributor channels by making joint or direct calls on end users, OEMs and Engineering firms for valve product approvals and specifications.Prior to 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. John's main focus, however, was geared toward the pharmaceutical industry since the location of many end users and engineering firms are within a radius of 100 miles or so to Philadelphia. He also held positions as the Northeast Regional Manager and as a Sales Representative for Keystone Valve - Philadelphia area. Prior to Keystone, he held various positions with ITT Engineered Valves for 12 years.

James Vogel, President, Process Facilities Services Incorporated
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.

Jim Whitman, Director - Project Controls Group, Global Engineering Services, Wyeth Pharmaceuticals
Jim has over 25 years of Project Execution / Control experience mostly with respect to the Defense and Pharmaceutical industries. He has worked for RCA, Bendix Aerospace, Smith Industries, Fluor and Wyeth. Jim has been with his current employer, Wyeth, for better than 6 years. At Wyeth, he is currently the Director of Capital Project Controls. His major focus has been with regard to infusing standardization & effective project execution techniques from contract development through project completion. Jim has a BS degree in Business Administration from Rowan University and an MBA from St. Joseph's University. Jim is married with two high school aged boys.

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.