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Original Business Thinking for the Life Sciences |
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Allan M. Green, MD, PhD, JD, LLC Attorney at Law |
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About US |
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The practice of Allan M. Green, MD, PhD, JD, LLC is focused on matters faced by FDA-regulated industry. We offer information as well as insights into current issues facing FDA-regulated industry and its investors..
We are committed to using our experience in law and business, as well as our backgrounds in clinical medicine and scientific research, to assist stakeholders in translational research—that is, moving new discoveries from the research bench into the clinic. With deep life science industry expertise, our goal is to help clients improve their performance. Our practice leaders are all experienced and successful in dealing with the problems of FDA-regulated industries. All have extensive operating experience as well as specific technical knowledge of this area.
Our Insights and Commentary on issues of importance to the life science sector are published on this site. Please use the buttons on the left to explore our current offerings.
For more information e-mail us at: info@fdaregs.com
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Allan M. Green, M.D., Ph.D., J.D.
Allan M. Green is a physician, lawyer, and research scientist with operating management experience.
Dr. Green was formerly medical director of New England Nuclear/Dupont Medical Products and was subsequently founding CEO of Theseus Medical Imaging Inc. He served as President of Neuroptix, Inc.. He has served on various government committees as a technical consultant and has held several medical school appointments and is the author of many scientific papers in biochemistry and drug development. He is well known for his Issues and Commentary series that analyzes competitive commercial aspects and potential markets for emerging pharmaceutical technologies. He has successfully represented many American and Canadian clients in their relationships with the FDA and has organized a number of multi-disciplinary conferences on healthcare, pharmaceutical and funding issues. In addition, he is an attorney and has been ‘of counsel’ to major law firms with established healthcare practices.
Dr. Green received his B.S. in economics in 1966 and his Ph.D. in biochemistry and metabolism in 1971, both from the Massachusetts Institute of Technology. He received his M.D. from Case Western Reserve University School of Medicine in 1972 and holds Board certification in both Internal Medicine and in Nuclear Medicine. He received his J.D. from Boston College Law School in 1991.
He has published over 30 articles in peer-reviewed Scientific Journals and holds several US Patents.
E-mail: amgreen@fdaregs.com
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Joseph D. Cascio
Joe Cascio is a highly experienced cGMP manufacturing operations and facilities construction management executive with a comprehensive and diverse background in establishing and directing the operations of biotechnology and biopharmaceutical companies and managing the technical and administrative activities of hospital laboratories and blood banks.
He has served in senior level management capacities and technical consulting roles during his career and has an extensive background in cGMP facility design, certification, validation, start-up and fill/finish operations. He directed the construction, opening and operations of 26 cGMP facilities, of which 20 were new and 6 were renovations.
He is adept at providing compliance support for cGMP, QA/QC, regulatory and accrediting agency requirements. He has provided assistance with cGMP compliance issues, FDA manufacturing issues, cGMP auditing, technology transfer, technical project management, SOP and protocol development, cGMP training program design and implementation, contract negotiation, lease and purchase of equipment, supplies procurement and materials management.
Joe is proficient at assessing organizational needs, setting priorities and developing overall business strategy in FDA regulated industry settings.
Prior to serving as a biopharmaceutical consultant, Joe held positions as Chief Operating Officer at a radiopharmaceutical imaging company, Vice President of Operations at several biotechnology and biopharmaceutical companies, Laboratory Manager and Blood Bank Manager positions at several medical institutions nationwide.
Joe holds a Masters in Immunohematology and a Bachelor of Science in Medical Technology in addition to certification and licensure as a Blood Bank Specialist and a Clinical Laboratory Scientist.
E-mail: info@fdaregs.com |