Posts Tagged ‘biotechnology’



Three Steps Toward Actualizing the White House’s Bioeconomy

May 7th, 2012
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The White House Office of Science and Technology Policy (OSTP) recently released its “National Bioeconomy Blueprint”—a detailed proposal on how advances in our knowledge of biology and biotechnology have spurred significant enough economic activity (e.g., labor, capital and resources) to create a new type of economy for the United States.
 
While the report focused on many areas outside of healthcare, the following three points struck me as significant for those of us who spend our time thinking about life sciences:

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Can We Take the Excitement out of the FDA? Agency Could be Turning a Corner

October 10th, 2011
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The U.S. Food & Drug Administration (FDA) likes to trot out the statistic that claims it regulates about $100 billion in biomedical R&D each year: investments made by industry (and government) to create new innovations to treat today’s health challenges. But the agency has been hesitant to address another facet of investments: that they should be predictable. As the late, great economist Paul Samuelson said, “Investments should be like watching paint dry. If you want excitement, take $800 and go to Las Vegas.”
 
Anybody who’s watched the stock market the last few years knows we would rather live without this kind of excitement. However, the latest documents issued by the FDA – from Research Use Only/Investigational Use Only (RUO/IUO) guidance to LDT to the latest strategy document on boosting innovation (read coverage from Xconomy) – are inconsistent enough to make drug development resemble a Roulette wheel, rather than a science-based, multi-year, multibillion-dollar strategy to develop therapeutics and diagnostics. Even venture capitalists, not known for their risk-averseness, have gone to Congress to demand more predictable responses from the FDA.
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Investors May Back a Revolution, but It Takes the People to Start One

May 19th, 2011
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A recent article posted by Luke Timmerman of Xconomy.com paints a bleak picture for the state of biotech investment. He explains that the general public no longer views biotech as worthy of the almighty buzz factor, i.e., the magazine cover stories and TV morning shows so important to the elusive independent investor. He suggests that the biotechnology industry may never capture the public’s imagination again, a strong assertion considering the amazing things happening in genomic research, companion diagnostics, medical technology, telemedicine and other parts of the sector. But is the buzz factor the only thing that matters in an age of consumer empowerment? What about the equally powerful phenomenon of simply going viral?
 
In some ways Mr. Timmerman’s article, in which he speaks of investor excitement for TECHnology versus BIOTECHnology, may not present a fair comparison. Facebook and LinkedIn do not have an entity like the Food & Drug Administration (FDA) that sends years of data to the trashcan more frequently than it approves a product for use. Nor do many technologies reckon with the complex reimbursement issues faced by products utilized within the healthcare system.
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