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Jim Agalloco
President, Agalloco & Associates
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| James Agalloco is President
of Agalloco & Associates, a technical service firm to the
pharmaceutical and biotechnology industry. He has 30 years
of management experience in pharmaceutical manufacturing, pharmaceutical
engineering, computer systems validation, technical services,
and research and development. Additionally, he is an internationally
recognized expert on process and systems validation. He has
extensive knowledge of pharmaceutical and BPC manufacturing
technology. He was previously Director, Worldwide Validation
and Automated Technology for Bristol-Myers Squibb. He received
his BS in Chemical Engineering from Pratt Institute in 1968
and his MS, also in Chemical Engineering from Polytechnic Institute
of New York in 1979. He received his MBA in Pharmaceutical Studies
from Fairleigh Dickinson University in 1983. He is a past President
of the Parenteral Drug Association and served as an Officer
or Director from 1982 to 1993. He has served as a chairman and
member of numerous PDA committees. He is a frequent author and
lecturer on the subject of process and computer systems validations. Jim can be reached at 908-874-7558 or via email at . |
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Howard L. Levine, Ph.D.
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| Howard L. Levine, Ph.D. is
an internationally recognized specialist in process development,
manufacturing, and engineering, with over 20 years of experience
in the biopharmaceutical industry. Before founding BioProcess
Technology Consultants, Dr. Levine was Vice President of Manufacturing
Operations at Repligen Corporation and has worked in process
development and manufacturing for Amgen, Genentech, and Xoma.
Dr. Levine is a member of the Editorial Advisory Boards of BioPharm
Magazine and Bio/Pharmaceutical Outsourcing Report. He is a
member of the Neose Technologies, Inc. GlycoAdvance Advisory
Board and also serves on the Scientific Advisory Boards of DSM
Biologics, ASEPCO, and the Boston Area Chapter of the International
Society of Pharmaceutical Engineering (ISPE). He was chairman
of the Parenteral Drug Association’s (PDA) Task Force on Chromatography
Validation, has lectured extensively on downstream processing
and manufacturing in biotechnology, and is coeditor of a directory
of biologics contract manufacturers. He holds a Ph.D.
in chemistry from the University of Chicago and completed a
postdoctoral fellowship at Harvard University. Howard can
be reached at 978-371-1733 or via email at . |
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David M. Marks, PE
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| David M. Marks PE is principle
consultant for DME Alliance Inc., providing engineered solutions
for GMP systems, including equipment design, automation, compliance,
and project management services exclusively to the biopharmaceutical
industry. He is a frequent speaker and consultant on GMP project
management, equipment design, and compliance topics. His professional
experience is concentrated in the application of large-scale
bioprocess equipment in FDA licensed facilities, having served
many of the leading international biotech and pharmaceutical
firms since 1989. Functioning in various engineering and management
capacities, he has represented owners, engineers, and manufacturers
of custom GMP biopharm equipment. Prior to founding DME in 1998,
he managed the engineering department for Associated BioEngineers
and Consultants (ABEC). A graduate of Lafayette College, he
holds a BS in Chemical Engineering and is a registered Professional
Engineer. David can be reached at 877-842-7123 or via email at . |
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