ThermoFisher Aims to Get FDA OK for its Ion Torrent PGM

By Paula Myers

At this year’s CHI Molecular Medicine Tri-Conference at the Moscone Convention Center, San Francisco, February 11th, there were over 3000 attendees and more than 200 exhibitors. I visited some of the many booths on the exhibit floor. One of those was the ThermoFisher booth. I spoke with Zhen Mahoney,Sr. Clinical Sales Specialist/Pharma Business. Mahoney talked about the acquisition of Life Technology and how it affects ThermoFisher.  Thermo will have to absorb Life’s 9,000 employees. Thermo currently has 40,000 employees. Mahoney pointed out that Life has a broad product portfolio. Ion Torrent, which Life acquired in 2010, is located at Oyster Point near South San Francisco. The rest of company is located at Carlsbad, California, near San Diego, including the Invitrogen and Gibco brands. These groups are staying intact, according to Mahoney.

She also pointed out that the company submitted an application for 510K marketing clearance to the FDA for its Ion PGM system for use as a diagnostics medical device. They are hoping for a 3 to 4 month approval timeframe. By comparison, the Illumina MiSeq took about 9 months to get FDA 510K approval because it was the first of its kind. The Illumina MiSeq received a relatively fast approval because the company worked closely with FDA reviewers so that they can understand its technology. The MiSeq platform serves as a template to the FDA for follow-on platforms from Illumina and other desktop sequencer vendors. Mahoney said that the next revision for their Ion Torrent electronic P-2 Chip is coming later in 2014. It will have 660 million wells.

Some of the other firms that I visited included: Guardant Health, Diagenode, and Epitomics. I focused on companies involved in epigenetics. Guardant Health is a two-year-old service company for individuals. In February, they released GUARDANT360, the first pan-cancer blood test that provides doctors with real-time genetic information to help them prescribe the right treatments for their cancer patients.

  Diagenode is a company originally from Belgium and sells Japanese made disruptor shearing machines such as the Bioruptor Pico for DNA, chromatin, and RNA shearing. Epitomics, located in Burlingame, California, offers custom antibody services for use in epigenetics research. Li Fang, Project Manager of Custom Antibody Services at Epitomics, said that Abcam is buying the company. Abcam is a supplier of antibodies,proteins, kits and reagents.

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Translating Medicine from Civilian Life to the War Zone and Back Again.

I recently viewed a PBS documentary tv show called ‘Battlefield Medicine’ from the BBC hosted by a UK doctor from the UK’s NHS to see what is going on in wartime medicine that might be helpful back home in the UK.  He travelled all thje way to a medical base in Afganistan to see first hand of how doctors there save the lives of wounded soldiers.  I noticed that there are some new methods and technologies being used to help reduce the death rate of soldiers suffering from some horrific trauma injuries from gunshot, shrapnel and IED explosions.

Injured soldiers can bleed out 5 litres of blood in 5 minutes.

Solution: comrades in the field are trained to use nylon tourniquets that they all carry to stop bleed outs from arm and leg wounds. The do so in the 1st 10
mins. after a soldier is wounded.

Solution: airlift helicopter now comes with a Dr and nurse on board are prepared for incoming injured soldiers, they can do  in-air surgury, transfusions, etc. Special blood infusion technology devices was created to infuse blood into shoulder bone and or sternum in chest.

Solution: At trauma hospital ER, bleeding patients are given a 50-50 mix of whole blood and plasma rather than just whole blood because more plasma is needed to make clots faster to stop bleeding. Localized pain drip meds target nerve via catheter that connect to injured area rather than treat whole body with morphine.

The Dr traveled to the USA to an Atlanta hospital ER to learn about a clinical trial that uses progesterone to increase blood flow in patient brains that suffered from traumatic brain injury (TBI).  Rat studies showed that brain damaged rats given progesterone had less dead tissue areas than brains of untreated rats (controls).

The Dr traveled to a Pittsburg med. center and learned that ER is using extreme cold water (saline) infusion (10 deg C) to put patient in coma-like condition for nearly 1 hr (rather than 5 mins.). This procedure suspends activity in brain and heart while surgeons work in patients trauma issues. When stabilized, patients blood is re-infused to bring back body temp to normal range.
The UK Dr. concluded that advances in civilian trauma medicine often is used in military medicine but is modified to fit the field hospital situation.
Knowledge gained from the military applications can often be used in civilian trauma medical applications.  The UK Dr working with the UK NHS hopes to see
some of the military trauma procedures and technologies that he has seen would someday help save more lives in the civilian trauma ER situations such as car crash victims.

Smart Pill Helps Patients With Drug Compliance

San Jose Convention Center, December 6, 2011. During the luncheon at the conference part of the BIOMEDevice Expo and Conference, I met Patricia Johnson, Director for Pharma Integration, at Proteus Biomedical, Inc. , a medical device maker.  She explained to me about one of the company’s products.  She said that they have developed ingestible event markers (IEMs) that use the body to power the device.

IEM’s are tiny (the size of a grain of sand), digestible sensors made from food ingredients.  The IEM can be integrated into any drug tablet or capsule without changing its properties or performance.  After the pill is swallowed, the stomach fluids activate the pill.  The IEM creates a digital signal that is then detected by a microelectronic recorder, which can be configured as either a skin patch or a tiny device implanted under the skin.  The detector records the information that includes the type of drug, dose, and place of manufacture, etc.  It also measures and reports vitals such as heart rate, activity, and respiratory rate.  The information is sent up to the cloud where it can be retrieved and reviewed by the doctor.  Two of its partners include Novartis and Medtronic.

Drug non-compliance as well as making sure a drug regimen is working is a big problem with older or chronically ill patients.   This can reduce the number of doctor visits and relieve some of the stress felt by family caregivers.   It is especially helpful for patients that live alone and in remote areas.  Being a caregiver myself, I am excited about the potential of this product.

Healthcare Reform and Its Impact on the Medical Device Firms

I recently attended the The BIOMEDevice Exhibition and Forum held at the San Jose McEnery Convention Center so that I might learn more about the medical device industry.  During the opening luncheon I listened to an interesting keynote talk given by Robert Grant.  Mr. Grant is a the President of Bausch and Lomb’s Surgical Division. He previously worked at Allergan, the company known for Botox and various eye care products.  Robert gave out some interesting information about national healthcare spending, a key regulatory and legal case involving a medical device and his comments about the impact of the recent ‘Healthcare Reform’ law on the medical device industry.

Robert said that the annual US healthcare spend has reached about $2.5 trillion. That figure works out to about $8,000/year,  for each person living in the US.  The US spending figure exceeds healthcare spending in other industrialized nations. Compared to the US, the country with the next biggest healthcare spend is Sweden, with $5,000/yr per person.   Australia and the UK are about the same, at $3,400/yr. per person

According to Robert, the high costs in HC are driven mainly by aging and obesity (diabetes). He also asserted that another spending driver is by how we educate doctors in this country.  It takes 4 to 6 years longer in the US to train doctors than it does in other countries.  For example, in other countries, students go from high school straight into medical school. In contrast, the costs of malpractice in the US is going up every year. Other countries have limits on malpractice claims against doctors.  Furthermore, all payors, device manufacturers, and so on, are profit-centric organizations that are looking to get higher earnings per share.  None of tese economic drivers have been addressed in the recent healthcare reform law.

The FDA is the safety watch-dog and is really tightening down now on device manufacturers.  This situation is especially likely following  the outcome of the Riegal vs. Medtronic case. Charles Riegel and his wife, petitioner Donna Riegel, brought suit against respondent Medtronic after a Medtronic catheter ruptured in Charles Riegel’s coronary artery during heart surgery. The catheter is a Class III device that received FDA premarket approval. The Riegels alleged that the device was designed, labeled, and manufactured in a manner that violated New York common law. The District Court held that the MDA pre-empted the Riegels’ claims of strict liability; breach of implied warranty; and negligence in the design, testing, inspection, distribution, labeling, marketing, and sale of the catheter, and their claim of negligent manufacturing insofar as the claim was not premised on the theory that Medtronic had violated federal law. The Second Circuit Court affirmed this case.

Medical device manufacturers go through the FDA, therefore the FDA is on the hook for the safety of medical devices.  The FDA is not motivated to get products to market.  As a result, they are not in a hurry to approve devices because of risk of products.

Robert summarized his observations and concerns with the following points:

  • Companies are having trouble raising money so they are leaving the country.
  • Aging and diabetes will break our healthcare system.
  • The High Cost of Malpractice Cases
  • The Doctors’ Education System Needs to Change
  • The FDA is not willing to take needed risk to get products on market sooner. Top people left the FDA since the Obama election.  Dan Schultz left FDA.  All that has led FDA to become more risk adverse.

He said that smart companies understand that the best opportunities often arise during the more difficult situations such as recessions or economic downturns. We’re going down such a time right now.  Republicans say ‘No’ to everything, but that’s not a good idea.

Robert said that its OK for companies to take reasonable business risks and make mistakes. People learn from mistakes, innovate, and improve their companies.  His company’s product is Crystalens, an intraocular lens.  Actress Florence Henderson is their spokesperson.  Their product is for cataract surgery. Cataract surgery patients can only get 20/40 vision from the procedure.   He said that their product is better than Lasik.  CMS has agreed to reimburse for their product.

For example, Robert said that when he was at Allergan, Cindy Crawford went up to him while he was attending an industry event and asked to be a spokesperson for their product Latesse, an eyelash grower. Robert was surprised that she knew about him and was very flattered.  He discovered that Baby Boomers want premium outcomes. Robert believes there’s a great opportunity in bad times.  Healthcare is at a precipice at this time.  It is unfortunate that medical device companies have to pay a new tax now under the new ‘Healthcare Reform’ law.

In closing his talk, Robert recited from memory the opening sentence from US Constitution, which listed several visionary points.  He talked about these points and also talked about President John Adams, one of the writers of the constitution.  He said that he viewed a TV show about him on HBO.  In 1776 John Adams described what should happen every July 2, but it actually turned out to be July 4th.  July 3rd he predicted future celebrations which continue to do every year.

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