Edwards was employed for 42 years in the pharmaceutical and life sciences arenas.
From 1990 to 2010, he held Regulatory Affairs positions of increasing responsibility at TAP/Takeda Global Research & Development Center, Lake Forest, Illinois. Between 1996 and 2010, he led the implementation and oversight of the esubmission paradigm. This resulted in TAP’s dominance in eCTDs during 2006-08, with TAP submitting more than half of all eCTDs sent to FDA.
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Antoinette Azevedo founded e-SubmissionsSolutions.com (a California corporation) in 2000 to advise all sizes of biotechnology and pharmaceutical companies on the use of technology to manage regulatory documents and publish electronic submissions. She has a fully-validated hosted system for producing eCTD and Non-eCTD electronic submissions, including validation software and FDA Electronic Submission Gateway production account.
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Through his company R&D Advisors, Dr. Mitchell Seymour provides regulatory affairs outsourcing services for industry and academia. Regulatory experience includes regulatory writing and regulatory submissions, FDA meeting preparation and engagement, regulatory strategy, regulatory intelligence, and regulatory due diligence.
As a life scientist, Dr. Seymour has over 25 years experience in basic science and clinical research in industrial and academic settings.
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Katherine Ulman retired from Dow Corning Corporation, now a wholly owned subsidiary of The Dow Chemical Company, after more than 40 years of employment. While at Dow Corning, she held positions as a global regulatory compliance manager for their Healthcare Business as well as regulatory manager of the Dow Corning Healthcare Industries Materials Site.
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