Weekly Roundup 7.8.16

Perhaps it is a throwback to childhood, but summer always seems to go by faster than other seasons. And this summer is no exception. Sunflowers are blooming, daisies are beaming, lawn mowers are mowing. It seems everywhere you look, summer is well along when in my  mind, the buds have just pushed and daffodils were in bloom. July 4th came and went already when it seems like we just had Memorial Day. Before you know it, we will be back to school.

You may still be away from the long Fourth of July weekend or enjoying a shorter work week if you are back. Just prior, a lot happened last week and some this and since there was no Weekly Roundup last week, we are coving two weeks.  Here is some of what I found interesting:

  • FDA Launches Oncology Center of Excellence – Both public and private institutions are in the process of responding to President Obama’s “Cancer Moonshot” announced in this year’s State of the Union message and headed by Vice President Biden. The gist of the effort is to better coordinate resources focused on cancer treatment and research to effect outcomes more quickly by concentrating efforts across the board. As part of its response this week FDA named Dr. Richard Pazdur as the Acting Head of FDA’s Oncology Center of Excellence (OCE). According to the agency release, Dr. Pazdur will be working to bring closer collaboration across the FDA centers (devices, biologics, drugs) to develop greater coordination and review of new advances. In his blog posting on the topic, Dr. Pazdur also stressed that the effort will also engage outside FDA as well, ensuring that patients have a voice. Many aspects of Dr. Pazdur’s professional experience and personal life went into the choice. While often FDA communications are in FDA-speak, you can read a very nice 2016 New York Times article about him here.
  • FDA Chips in to Move the Needle in Precision Medicine – In his 2015 State of the Union message President Obama launched the Precision Medicine Initiative aimed at speeding up the process by which we would be able to deliver therapies for patients that are determined to be the right ones rather than treatment by trial and error. Fundamental to success in that goal is the development of genetic testing. There are many moving parts, but this week FDA added a contribution with the announcement that the agency was issuing two guidance documents to provide a “streamlined approach” for oversight of genetic testing. According to FDA’s release, new sequencing technologies will allow for the examination of millions of DNA variants at a time, rather than taking a more piecemeal approach.  NIH urged researchers to adopt the best practices outlined in the draft guidance documents which the release states were developed to enhance test development while maintaining safety. The two draft guidance documents can be found here and here.
  • Zika, NIH and the Olympics – A lot is being written, and a lot more is likely to be written, about Zika and the upcoming Olympics in Brazil. This week NIH announced that it was funding a Zika study of the U.S. Olympic team to monitor potential infections among them. The stated goal of the study is to better understand how the virus persists in the human body as well as to identify personal factors that may influence the course of the infection. In another Zika development, FDA announced an Emergency Use Authorization for an In Vitro diagnostic device for use in the detection of Zika virus.

There is more of interest, but that’s it for me this week folks. Next week I will provide you with an update on what FDA had to say during the first half of 2016 and how it compares to other years. Until then, have a good weekend!

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