A Perspective from JP Morgan Healthcare Conference 2012
Posted by: Patrick Terry on January 17, 2012 | 1 Comment »
Related to: Healthcare Trends, Uncategorized
The more things change, the more they seem the same.
Back in 2002 I can recall interesting development. Among the industry standard bearers who presented to the packed audience of bankers, investors and executives, a strange new group of presenter emerged: Hospitals, both large and small attempted to “sell” their wares to the highest bidders.
Posted by: Patrick Terry on October 18, 2011 | 1 Comment »
Related to: Healthcare Trends, In Vitro Diagnostics
The Tale of Two Tests
“It was the best of times, it was the worst of times, it was the age of wisdom, it was the age of foolishness, it was the epoch of belief, it was the epoch of incredulity, it was the season of Light, it was the season of Darkness, it was the spring of hope, it was the winter of despair, we had everything before us, we had nothing before us, we were all going direct to heaven, we were all going direct the other way – in short, the period was so far like the present period, that some of its noisiest authorities insisted on its being received, for good or for evil, in the superlative degree of comparison only.” —Opening paragraph of A Tale of Two Cities by Charles Dickens
During a presentation last week at Scientia by Dr. Maureen Cronin, Sr. VP of Product Development at Foundation Medicine, I was awakened again to what wonderful people I have worked with in my career in the age of the genome.
When I step back and ponder what makes me passionate about the technological innovation that permits us to quantitate biology using advanced measurement science to optimize the practice of medicine and improve patient outcomes, I get fired up and energized to be an agent of change. I am compelled to be purposely disruptive; I get impatient and want to force the legacy systems of evidence review, pricing and reimbursement, regulatory policy, and established health care practice into obsolescence. I want to make the situation clear, stark in contrast – so we can all easily recognize, in the age of wisdom, what foolishness we have allowed to continue to operate to our own detriment. When medical need and the suffering of patients demand a new level of urgency and responsiveness from us all, how is it that we allow an ever increasingly refractory system of health care delivery to exist? How is it that, while truly compelling scientific advancements are taking place, we continue to construct more and more obstacles in their path to helping patients. We need to recognize that the revolution is upon us!
Evidence Generation and Health Economics: Emerging Challenges Facing Innovators in Healthcare
Posted by: Patrick Terry on September 1, 2011 | No Comments »
Related to: Healthcare Trends
Due to the dilemma of healthcare cost sustainability, policy makers and federal agencies are expected to increase thresholds of evidence and levels of bureaucracy for coverage and payment of healthcare products. This trend will present serious challenges to product developers in healthcare, including demonstrating utility evidence, patient outcome evidence, clinical and comparative effectiveness, and so on. Understanding how to navigate these issues will become increasingly important for any innovators in healthcare.
View the video blog from Patrick Terry, Principal at Scientia Advisors
Posted by: Patrick Terry on June 27, 2011 | No Comments »
Related to: Healthcare Trends
Can an FDA Frequently Asked Questions (FAQ) document be a game changer for industry? The recently introduced “Draft Guidance for Industry and FDA Staff – Commercially Distributed In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only: Frequently Asked Questions” may be a case in point. It is the latest in a line of documents that could profoundly affect a number of industry stakeholders, but were introduced without the formal and more thoughtful regulatory development process.
In recent years, the FDA has increasingly attempted to use sub-regulatory level 1 guidance documents as functionally binding regulations in lieu of formal rule-making procedures. The FDA and, especially, the Office of In vitro Diagnostics Office (OIVD) routinely have attempted to promulgate new regulatory-like requirements through guidance documentsii iii iv v. That route is faster than the often years-long formal notice-and-comment rulemaking process, but it significantly lacks the transparency and accountability that defines the formal policy making approach.
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