Tatyana Chorny answered a series of questions written by marcus evans before the forthcoming Medical Device Safety Monitoring and Reporting Conference, January 17-18, 2013 in Las Vegas, NV. Tatyana shares her thoughts on timely reporting and regulatory compliance.
September is Sickle Cell Awareness Month, a time when the medical community will gather with the patient population in the hopes of advancing research in this significant unmet medical need. One company, ADVENTRX Pharmaceuticals [NYSE: ANX], is attempting to engage the investor community and the sector’s most promising drug developers through the First Annual Sickle Cell Disease Therapeutics Conference, taking place September 19th, 2012 in New York City.
Arena and Vivus’ approval of their obesity drugs — the first such approved in 13 years — have sent shockwaves throughout the industry. With Orexigen’s drug on the way, these have the potential to dramatically alter an entire sub-sector once left for dead. Still, despite positive data and FDA support, these drugs did not reach approval phase without several speed bumps along the way. And more questions are yet to come.
With the 2012 Presidential election upon us, healthcare – both as a social service and essential sector of our economy – is once again a main pillar in the heated political debate. Ann Romney and Michelle Obama, both with a direct connection to Multiple Sclerosis, have opened up to campaign supporters in recent months about the effects of this debilitating disease.
In Part II of our special report on the state of companies operating in central nervous system disease in the public markets, we look at one of the most promising nanocap companies we believe is ready to skyrocket.
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.
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.
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.
In Part III of our interview with Dr. Qin Shi of Edgetech Law we visit the concept of human genome sequencing as a mainstream commodity.
In Part II of our special interview series, Dr. Qin Shi of Edgetech Law discusses the emerging areas of significant unmet need in life science, and what investment opportunities may arise.
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