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OneMedRadio: Aptiv Solutions and a Novel Approach to Trial Design

July 26, 2012 Herina Ayot 0

How can one optimally design a clinical trial program for a medical device for a FDA clearance/approval submission? OneMedRadio spoke with Dr. Vladimir Dragalin and Dr. Michael Feldstein of Aptiv Solutions to discuss the changing tides of medical device regulatory and the advantages of using an adaptive design trial.

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JOBS Act: If Two’s a Party, Then What is Crowdsourcing?

July 26, 2012 admin 0

OneMedForum NY 2012 was well received and the turnout met and exceeded expectations. Unlike the past several years, there is a higher level of optimism within the investment community, according to attendees. The crux of this optimism, of course, is the perceived greater flow of capital to microcap companies that the JOBS Act can provide.

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JOBS Act: The IPO Market, Before and After

July 24, 2012 Herina Ayot 0

Christine Jacobs, CEO of Theragenics, enlightened OneMedForum NY 2012 attendees on a categorical operational observation: while the number of employees represent a fair barometer of her company’s success, they also define her compliance costs. Jacobs and David Weild, former NASDAQ Vice Chair, discussed the evolving market landscape with the passing of the JOBS Act.