Helping Physicians See Beyond The Human Eye

For the medicine of decades ago, a simple X-ray was enough for diagnosis.  For an increasing amount of known biomarkers, the human eye even when aided by an x-ray is not enough. Advances in molecular biology improved the understanding of many diseases and natural processes and helped fuel the development of imaging techniques that diagnose disease on the molecular, or biological, level -- based on the interaction of proteins and other cellular-level compounds. These imaging modalities assess the molecular basis of cell function and dysfunction.      Molecular imaging techniques include nuclear medicine imaging -- positron emission tomography (PET) and single photon emission computed tomography (SPECT) and combination PET/CT and SPECT/CT techniques – as well as ultrasound, magnetic resonance imaging (MRI) and computed tomography (CT) imaging that are used with molecular imaging agents.  Molecular imaging makes it possible to take a personalized approach to detecting and managing an illness. In this manner, patients benefit from earlier, more accurate diagnoses and safer, more effective treatments. 

       Molecular imaging techniques are based on technologies that have an intrinsically high resolution, which makes it possible to detect low concentrations of target biomolecules found in tissue.  The key to growth and finding more clinical applications for molecular imaging is the development of new and more specific biomarkers. Specific molecular biomarkers will allow physicians to transition from treating the illness to treating the illness in the individual, opening up a new paradigm in health care. 

     It is possible to predict the best treatment options by characterizing, through molecular imaging techniques, the disease in an individual. Individualized treatment plans will optimize patient outcomes because those patients who are not predicted, or expected, to respond to a specific therapy will not receive that treatment. Researchers can predict whether a medicine might be effective, ineffective, or toxic in certain individuals. Moreover, health care costs will decrease as a result of properly utilizing resources.Tests and examinations that can help doctors diagnose disease earlier and the most appropriate treatment are in order. Such tests, including imaging diagnostics, can lessen health care expenses and improve patient prognosis. Annual growth for molecular imaging modalities through 2015 will be good as the knowledge which molecular modalities have to offer will spur use of these imaging systems, and research will lead to greater Diagnostic use in the clinic. 

      Molecular imaging has evolved into a pillar of molecular medicine. It combines functional imaging with structural imaging so that specific in-vivo molecular processes can be identified and spatially pinpointed, often with the use of imaging contrast agents that bind to specific biological proteins. Molecular imaging is undertaking diagnostic and treatment roles as it enables physicians to pinpoint the locations of disease and track the progress of therapies. The same contrast agents used to highlight disease sites may even be able to carry drugs that can be selectively unleashed precisely where they are needed.

Kalorama Information's report on molecular imaging breaks down developments in molecular imaging and provides company profiles and trends in the market

  

          

So Called "Junk DNA" May Be Useful After All

Since the sequencing of the human and other genomes in the 1990s, it has been recognized that large sections of the genome did not appear to be coding for genes that produced protein products. This observation earned these regions the unfortunate title of “junk DNA”. Recent studies, however have put to rest the notion that organisms cart around a load of useless DNA sequences. It is now evident that these megabases of DNA are essential for controlling the flow of genetic information, and that these regions carry networks of epigenetic and genetic regulatory genes coordinating this activity.

A slew of papers published simultaneously in Nature and Science have revealed the complexity of the genome’s regulatory networks.  Starting in 2003, the ENCODE project revealed  that 76% of the genome is transcribed into RNA molecules that do not translate into proteins. These RNAs are involved gene regulation by combining with and blocked specific messenger RNA molecules. These regulatory RNA molecules travel to different sites within the cell where they exert their controlling influences.

In addition, the researchers identified genes that code for regulatory proteins that influence gene activity by binding to specific sites within the DNA. These proteins frequently exert their regulatory power by binding to the histones, a class of DNA-associated proteins that form part of the epigenome.

While these studies are building an understanding genetic regulation and its complexities in humans, they are also aiding in our analysis of disease processes. The investigators identified many genetic regulatory variants related to diseases such as diabetes, bipolar disorder, Parkinson’s disease and lupus. The researchers further state that they have uncovered regulatory DNA variation in a variety of pathological states, revealing important insights into the origins of these conditions.

The understanding genomic and epigenomic regulatory networks in human disease represents a new paradigm and a basis for the development of radical new drug therapies.

A more detailed look at the role of epigenetics in clinical medicine and epigenetics in drug discovery is the subject of a recent Kalorama report, Epigenetics, a complete market research survey of the nascent epigenetic industry authored by K. John Morrow, Jr. PhD.

Pagano Story Demonstrates That EMR is not the Only Privacy Concern

EMR gets slammed quite often as a potential privacy pitfall, but patient privacy-protected information is often unfortunately leaked whether the information is in an electronic record or not.  The story behind a major news story involving an NFL coach, broken today, demonstrates how, despite all the talk about electronic medical records as a privacy concern, there is just as much privacy danger from those old fashioned sources as well.

Word of mouth of healthcare providers can be just as effective in leaking details of a patient's conditions, despite privacy concerns.   Celebrities are often the victim of an anonymous nurse or lab technician handling HIPPA-protected information in an unprofessional manner.

Chuck Pagano, coach of the Indianapolis Colts was diagnosed with a treatable form of leukemia that will keep him off the sideline of his NFL team for a few months, according to media reports.    He is a popular coach and there are hopes for a fast recovery.

What we find interesting about the story, coming from a healthcare IT viewpoint, is that the reporter Bob Kravitz, the reporter at the Indianapolis Star  who broke the story, obtained the information through a privacy violation that had nothing to do with computers.  He told ESPN radio that he obtained the story when he went to buy a new car.  The salesman told him about it, saying he heard it from a friend who knew someone who treated him at the hospital.

Privacy is one of the concerns for EMR systems, but it is a broader issue that has many aspects to address.  Reports of violations, such as lost laptops or inappropriate access of records are commonly reported. Most hospitals, likely aware of extant potential for privacy violations with or without EMR, have not allowed concerns to reduce their enthusiasm for paperless medicine.   EMR systems continue to be expanded at major US healthcare systems.  .  EMR 2012 details the market for these systems and the reasons behind this growth.  

Vaccine Sales Drop For First Time in Over a Decade

At Kalorama we've sometimes been seen as promoters of the vaccine business, because we do yearly reports, and we have identified vaccines as the future growth area of pharmaceuticals in a time where 'blockbuster' single-molecule drugs are not plentiful.  We insist we call it like it is, and over the past decade it's simply the case that vaccines have been growing.  In 2011 however, given the over stockpiling of influenza vaccine in 2010, the market dropped about 30% according to our latest report.  So I suppose, we have a good objectivity test here.  When the market is down, as it now appears it was in 2011, we report that as well.   However, the interest, buzz and comparative growth prospects of vaccines have not declined.  R&D interest from top pharma presages a good future for these products.

In our report, Vaccines 2012, we demonstrate how the decline should be short lived, and what products are immune to the decline in the overall market.  

Good Viruses? Yes, Thanks to DNA Sequencing

Genetic Engineering News, one of Kalorama's favorite sources of information in the biopharma world, (and an avid user of Kalorama's Market Estimates) carries a story on the discovery of viruses that have a positive function.  In this case, they are referring to 'viruses that can zap zits.'  Which in practice means, isolated phages of virus have been found using heavy sequencers which can kill  P. acnes --  that elusive bacteria responsible for acne.

According to the article: 

After isolating, then sequencing the genomes of 11 Propionibacterium acnes phages, a team of researchers from the University of California (UCLA). and the University of Pittsburgh says it found similarities between the phages that may make them suitable against P. acnes, the bacterium believed responsible for the zits so many have long tried to zap.

What's significant about this article is that discovery of these type of treatments is only possible through DNA Sequencing.  The more research 'hits' that we see in the coming years, the more funding agencies will take an interest in sequencing research labs.  We needn't add that this is especially true where the target is one of heavy consumer interest.  These type of discoveries will increase the relevance of systems and drive the market for innovative, faster systems with more read length.  Kalorama's new report
http://www.kaloramainformation.com/DNA-Sequencing-Equipment-7118427/  details the current state of DNA Sequencing Equipment Markets.

Some Parts of Healthcare Reform Not Dependent on Election

Romney or Obama?   Well for a good deal of healthcare and the way it operates it may not matter.  Yes this runs against a lot of the conventional wisdom and certainly cable news talk.  As our Kalorama KeyPoint LinkedIn site article details, there are a number of provisions of healthcare reform that are already underway or will be underway shortly, and the take within the hospital community is that even a repeal would not 'change the changes' that hospitals are expected to face very much.   Besides since so many hospitals are making changes in the direction of the policies in healthcare reform such as population-based care and increased technology, repeal may not broadly change what some entities are doing.

The following parts of President Obama's healthcare reform legislation are likely to still be a component of Federal healthcare policy even if the act is repealed by a future Congress and President, though their presence may not be as obvious:

• Decreasing reimbursements for primary care 
• Transition to ICD 10
• IT incentives for EMR purchasing and requirements / penalties for non-compliance
• ACOs already likely underway are unlikely to be terminated.  While new ACOs may not form in a repeal, there is a likelhood of  move a pay-for-value system as opposed to strictly a pay-for-volume system
  

These are changes that while they are in the law and may be technically removed in a repeal, are likely to be parts of any President's healthcare policy anyway, unless an unexpectedly large amount of funding for healthcare is appropriated.  

Dartmouth Hitchock's Director of Clinical Services sums it up pretty well.   "Organizational priorities will not be affected if health reform is repealed, which I do not believe will happen."

Beyond Nicoderm: Transdermal Patches See Growth

It is anticipated that the transdermal/transmucosal drug delivery market will  continue to grow beyond the smoking cessation technology that first brought them to the marketplace, according to Kalorama Information's just-published report on this topic.   The market for drugs that use technologies to deliver therapeutics through the skin is expected to be driven by various factors including the loss of patent protection for blockbuster drugs and the need to avoid the first pass effects  of oral drug delivery. 

Additionally, with an added focus on active transdermal technologies, new applications will likely cause a resurgence of interest in transdermal delivery of products. Recent advances in biotechnology and molecular biology have resulted in a large number of novel molecules with the potential to revolutionize the treatment and prevention of disease. However, such potential is severely compromised by significant obstacles to delivery these drugs into the body. These obstacles mean that drug delivery and targeting is now recognized as the key to effective development of many therapeutics. Transdermal and transmucosal drug delivery systems continue to gain market acceptance as a preferred method of administration.

 Interest in transdermal/transmucosal drug delivery dropped until the early 1970s. In 1981 the first dermal patches, Transderm-Scop for scopolamine (ALZA) and the Transderm-Nitro (ALZA), were launched on the market. Nitro-Dur (Key) and Nitro-Disc (Searle) followed in 1982, and in 1985, Boehringer Ingelheim released Catapress-TTS for clonidine, using ALZA’s drug delivery technology. This spurred a number of transdermal product offerings including::   Estraderm (CIBA) for estradiol, Duragesic (Janssen) for fentanyl, Testoderm (ALZA) for testosterone, Minitran (3M) for nitroglycerin.

These products and more are covered in The World Market for Transdermal Drugs, from Kalorama Information.