Archive for February, 2011



Staying Productive ­– Virtually

February 28th, 2011
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If you’ve ever missed a connection because of a delayed flight, or been stuck in traffic for hours, you understand one of my biggest pet peeves: inefficient use of time.
 
Because we – and our clients – are spread around the world, we use a variety of tools to keep us productive and efficient from virtually any location. These tools allow us to work remotely and sometimes they even eliminate the need for commuting or travel.
 
Some tools that we use include:

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TRI-CON – Diagnostics, Drug Discovery & Biologics: Oh My!

February 21st, 2011
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Sometimes, between the hotel room, the lectures, the networking, the power lunches and the data consumption at a conference, you’re on the plane home before you have time to reflect upon why you attended in the first place. I’m excited to be heading to the 18th International Molecular Medicine Tri-Conference in San Francisco this week—and I’m setting out my reasons for going this year beforehand.
 
I always look forward to this conference because of its balanced range of life science topics, including those with technical, scientific, business, strategy, regulatory and reimbursement slants. Within this balanced range of topics, the Tri-Con uses a channel structure to help attendees “tune in” where they can get the biggest bang for their buck. I’m excited to learn more about the following specifics within each channel: Read the rest of this entry »

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The Phenomena Otherwise Known as DTC Genetic Tests

February 14th, 2011
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“I looked in the Yellow Pages. ‘Furniture Movers’ we’ve got; ‘Strange Phenomenon’, there’s no listing.” – Diane in Poltergeist
 
I had to laugh at one of last week’s headlines on the Daily Scan from Genome Web. It was titled, “They’re Baaaaaack!” Before reading the article, I imagined it had something to do with the Poltergeist series of movies where chaos and unexplained phenomena occur – objects careening through the air along with visitations from old and terrifying ghosts.   But when I read the article, it had to do with the revisiting of the direct-to-consumer genetic (DTC) tests rather than some type of paranormal activity.  Not exactly a poltergeist but nevertheless a phenomenom that 1) won’t go away, 2) is somewhat chaotic, and 3) is worth following.
 
From March 8-9, 2011, the Molecular and Clinical Genetics Panel of the FDA’s Medical Devices Advisory Committee will host a public meeting.  The group will take comments and make recommendations on DTC tests.  Several issues are on the agenda with the focus on the risk and benefits of such tests and the potential availability to consumers without a physician’s prescription.
  Read the rest of this entry »

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Upcoming 510(k) Improvements: FDA’s Tall Order

February 9th, 2011
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On January 19, the FDA’s Center for Devices and Radiological Health (CDRH) announced its action plan to address deficiencies of the 510(k) program. As the program exists today, some have argued that there’s a lack of clarity, efficiency and speed in the process. With that in mind, there’s been a push by industry, patient advocates and other critical stakeholders for significant change. Needless to say, the FDA has a tough balancing act to perform in this space.
 
For context, here’s a current definition of the 510(k) program from the FDA website:
 
“Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance. This is known as Premarket Notification – also called PMN or 510(k). This allows FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories.” Read the rest of this entry »

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This Is Not Your Grandfather’s Big Diagnostics

February 7th, 2011
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Danaher Corporation (NYSE:DHR) announced today (see San Francisco Chronicle story here) that it has entered into an agreement with Beckman Coulter, Inc. (NYSE: BEC) to acquire Beckman for approximately $6.8 billion. When the acquisition is complete, Beckman will become part of Danaher’s Life Sciences and Diagnostics business segment.
 
This is yet another example of the diagnostics landscape’s rapid upheaval in which different players will clearly be dominating and leading the industry.
 
The diagnostics industry shake up is in full swing: As we wrote recently, sequencing technology (one critical part of the Dx space) is changing at an earth-shattering speed and today’s announcement is evidence of what is happening on the market level. Need more evidence? Check out this post by Xconomy’s Luke Timmerman on “diagnostics warming up.”
  Read the rest of this entry »

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Adding DNA to the ABCs of Med School

February 3rd, 2011
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Last week, GenomeWeb News reported (free subscription required for full access) that a multi-disciplinary team from Tufts University had “urged gradual and calculated incorporation of genomic material into medical school training programs” after the team had looked at potential consequences of introducing genomics-related training into the curriculum at Tufts University School of Medicine.
 
According to the GenomeWeb article, several medical school faculty members were voluntarily genotyped using 23andMe tests. Medical students then analyzed the collected information. Based on a year’s plus analysis and implementation of the program, the researchers called for inclusion of personal genomics-related training and information within medical schools.
 
The lead study author wrote, “We strongly advocate that genomic analysis and personalized medicine is a necessity for modern medical school education… Our experiences illustrate that adding this material to a medical school curriculum is a complex process that deserves careful thought and broad discussion within the academic community.”
  Read the rest of this entry »

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