The FDA's role has always been to balance safety and efficacy when it comes to approving drugs, medical devices and biological products. And yet the numbers are staggering, to bring a drug to market costs on average $2.7B and takes close to a decade. So how did we get here and what does the future hold? For this blog we take a look back at how the FDA came to be, how Dr. Scott Gottlieb's tenure as FDA Commissioners modernized the FDA, and some speculations for what the future holds.
Chances are, you know of someone who suffers from multiple myeloma, non-Hodgins lymphoma or multiple-sclerosis. Despite the familiarity of those conditions, all three are considered rare-diseases by the U.S. Food and Drug Administration (FDA) because they affect less than 200,000 people in the U.S.
According to estimates by the National Institute of Health, there may be as many as 7,000 rare diseases affecting approximately 25-35 million Americans. So what do rare diseases have to do with AI?
Albert Einstein is quoted as saying, "in the middle of difficulty lies opportunity." With the surge of healthcare data we have a great opportunity healthcare in a way not seen before. But, it is well known that using flawed data produces unreliable outputs. Given the breadth and depth of data that grows daily and the power of artificial intelligence (AI) – how do we leverage both to impact how drugs are discovered and developed?
Spring is the season of renewal, growth and new beginnings. It is also the time when the healthcare community gets together at key conferences to exchange ideas, findings and results. This year is no different with three major gatherings scheduled for May and June. Discussion of oncology and artificial intelligence are high on the agendas of all three events. Here's a rundown of what to look out for.
Memorial Day, the day that honors the men and women who died while serving in the military, traces its roots to the Civil War. The Civil War claimed more American lives than any other war, prompting the creation of the first national cemeteries. Shortly after, cities and towns across America began honoring the fallen by laying flowers and holding ceremonies at these cemeteries during the spring. As we honor those who gave their lives, we thought we would take a look back at the past 150 years to see how healthcare has evolved to better care for the military and those they protect.
Last summer, GNS Chief Commercial Officer and Co-Founder Iya Khalil wrote about the difficulty of watching her sister suffer through the devastating impact of migraine headaches. Researchers continue to seek therapies and treatments to help mitigate this widespread condition and recent discoveries hold out hope that progress is being made.
More than 39 million people in the U.S. and nearly a billion people worldwide suffer from migraines with about two percent of those being chronic cases. Even more impactful is that migraines are the third most prevalent and the sixth most debilitating...
National Chocolate Day: Ten Convincing Reasons You Should Eat More of the Stuff, The Telegraph, October 2016
No, Dark Chocolate Is Not a Health Food, Healthline, December 2018New Harvard study finds a glass of wine every day can have huge health benefits, Fox6 Milwaukee, December 2018No Amount of Alcohol Is Good for Your Health, Global Study Says, NPR, August 2018
Why do contradictory headlines like these continually pop up, highlighting the uncertain nature of scientific studies and raising confusion as to what is or isn’t good for us? Blame it on the relative ease and dependence on the...
The oft-told story is that it took Thomas Edison’s 10,000 attempts to perfect the invention of the light bulb. He is famously quoted as saying of his many prior unsuccessful efforts, “I have not failed. I’ve just found 10,000 ways that won’t work.”
There is an ongoing discussion as to whether the biopharma industry should adopt a similar attitude when it comes clinical trials. A recent article in BioCentury outlined the clinical trial tug-of-war between traditional frequentists and Bayesians who have been making their way into the arena, starting first in the medical devices field....
There's been a lot of conversation around value-based care (VBC) models, and payers, providers and biopharma – each have their own take on what VBC means to them. But lately there has been more conversation around patient-centered care and what that looks like through the lens of a value-based approach.
Value-based care – paying for outcomes as opposed to a fee for service or procedure – has been growing in recent years. A recent report found that the percentage of healthcare payments tied to value-based care reached 34 percent in 2017, up 23 percent from 2015, and affecting approximately...
In 1896, the marathon returned to popularity as a competition in the Summer Olympic Games in Athens. The Olympic Games turned out to be inspiring to visiting Boston officials who returned home ready to challenge the locals and establish what would become one of the world’s top marathons. Next Monday, April 15th, 30,000 runners will hit the road in what will be the 123rd Boston Marathon.
Across the Charles River and throughout the U.S. another race is being run, the race to bring artificial intelligence (AI) to the world of healthcare. So what does a long running (pun intended) marathon...