Researchers at Brigham and Women’s Hospital (BWH) have found that two common over-the-counter allergy medications may reduce both obesity and type 2 diabetes in mice. The medications, called Zaditor and cromolyn, stabilize a population of inflammatory immune cells called mast cells. This research appears in the July issue of Nature.

 

Boston, MA, August 06, 2009 –(PR.com)– Guo-Ping Shi, a biochemist from the Department of Medicine at BWH, began to suspect such a connection when, in a previous study, he found mast cells present in a variety of inflammatory vascular diseases.

Mast cells are immune cells that facilitate healing in wounded tissue, primarily by increasing blood flow to the site. However, in certain conditions mast cells build up to levels far beyond what the body needs. As a result these cells become unstable and eventually, like punctured trash bags, leak molecular “garbage” into the tissue. This can result in chronic inflammation that causes asthma and certain allergies.

As Shi and colleagues discovered, mast cells were far more abundant in fat tissue from obese and diabetic humans and mice than they were in normal weight fat tissue. This led to an obvious question: by regulating mast cells, could we then control the symptoms?

To find out, Shi and colleagues took a group of obese and diabetic mice and, for a period of two months, treated them with either ketotifen fumarate (also called Zaditor) or cromolyn, both over-the-counter allergy drugs.

“We knew from published research that both cromolyn and Zaditor help stabilize mast cells in people suffering from allergy or asthma,” said Shi. “It’s almost as if the drugs place an extra layer of plastic on the ripped trash bag. So it seemed like a logical place to begin.”

The mice were divided into four groups. The first was the control group; the second group was simply switched to a healthy diet; the third was given cromolyn or ketotifen fumarate; and the fourth was both given the drug and switched to a healthy diet.

While symptoms of the second group improved moderately, the third group demonstrated dramatic improvements in both body weight and diabetes. The fourth group exhibited nearly 100 percent recovery in all areas.

To bolster these findings, Shi and colleagues then took a group of mice whose ability to produce mast cells was genetically impaired. Despite three months of a diet rich in sugar and fat, these mice neither became obese nor developed diabetes.

“The best thing about these drugs is that we know it’s safe for people,” says Shi. “The remaining question now is: Will this also work for people?”

Shi now intends to test cromolyn and ketotifen fumarate on obese and diabetic non-human primates.

The research was funded by grants from the National Institutes of Health.

About Brigham and Women’s Hospital:-
Brigham and Women’s Hospital (BWH) is a 777-bed nonprofit teaching affiliate of Harvard Medical School and a founding member of Partners HealthCare, an integrated health care delivery system. BWH is committed to excellence in patient care with expertise in virtually every specialty of medicine and surgery. The BWH medical preeminence dates back to 1832, and today that rich history in clinical care is coupled with its national leadership in quality improvement and patient safety initiatives and its dedication to educating and training the next generation of health care professionals. In July 2008, the hospital opened the Carl J. and Ruth Shapiro Cardiovascular Center, the most advanced center of its kind. Through investigation and discovery conducted at its Biomedical Research Institute (BRI), BWH is an international leader in basic, clinical and translational research on a diversity of human diseases and is at the forefront of personalized medicine. BWH has approximately 900 scientific investigators and more than $450 million in research support, more than 50 percent of which comes from the NIH. BWH is also home to major landmark population studies, including the Nurses’ and Physicians’ Health Studies and the Women’s Health Initiative, which have provided important information on diet and lifestyle risk factors for common chronic diseases. For more information about BWH, please visit http://www.brighamandwomens.org/

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Electron Microscope – Nanodiamond Crystals

 

GoogleNews.com, AssociatedContent.com, Spring/Summer 2009, by Vonda Sines  –Nanodiamonds have a carbon structure a lot like that of a piece of jewelry. However, they have many more practical uses.

According to the Nanoscale Science & Nanotechnology Group at Newcastle University in the United Kingdom, a nanodiamond is one member of the carbon nanomaterial family. Along with fullerenes and nanotubes, it’s been in the news in the last few years because of its unique physical and chemical attributes. Early studies of nanodiamonds focused on defense and weapons research. Current projects include explorations in fields such as astrochemistry and medicine.

A nanodiamond is created by detonating powerful solid explosives such as TNT and RDX, then gathering the soot that remains from the explosion, according to the Abazias diamond blog. The soot left behind contains tiny diamonds. To make these leftovers sparkle enough to look like diamonds, technicians must expose them to a high-energy electron beam, then heat them to 800 degrees Celsius.

Although the resulting product has many unique characteristics, in some ways, it closely resembles its cousin, the retail diamond. Nanodiamonds have a rounded shape. They also possess an active surface and a diamond-like hardness useful in a variety of technical applications. The strength of a nanodiamond can be compared to that of Teflon.

These materials are unusually hard and resistant to steel corrosion. They have angstrom finishes of polished surfaces and in some ways physically resemble rubber. These versatile byproducts of an explosion also have the same lubricating ability as oils.

Nanodiamonds have a role as light beacons for chemotherapy. They are used as light when attached to cancer cells. Current technology permits them to reach exactly the right zone of the patient’s body with greater and greater accuracy. They’re so small, they can attach to microscopic cells.

Researchers have also found that nanodiamonds are soluble in water. As a result, when used as a treatment for illness, they cause little or no inflammation in the patient’s body.

What still puzzles researchers is how long a life a nanodiamond can be expected to have. Its lifespan doesn’t extend to “forever” like that sparkler in the jewelry store. As a result, some scientists are attempting to discover how long nanodiamonds can remain in a patient’s body before becoming toxic or disappearing entirely. Other researchers are concentrating on how to test the level of toxicity of these tiny diamonds. While the jury’s still out, the use of nanodiamonds in medicine is still considered experimental.

Like black diamonds, nanodiamonds are used in a variety of industrial processes. They make great polishing material, engine oil additives, metal lubricants and fillers for rubber and plastics.

The Spring 2009 issue of Northwestern magazine reported that a Northwestern University research team led by engineering professor Dean Ho has developed a promising nanodiamond patch that can deliver chemotherapy drugs to sites from which malignant tumors have been surgically removed. The flexible microfilm device looks like a piece of plastic wrap. It can be customized into various shapes. Using it can reduce patients’ exposure to many toxic drugs.

The Northwestern researchers have proven that the nanodiamond device released the chemical doxorubicin in a sustained and satisfactory manner. Implanting the device during the surgery to remove a tumor would be a novel way to deliver the drug as a chemotherapy agent.

In order to make the patch, Ho and his team embedded millions of drug-carrying nanodiamonds in the FDA-approved polymer parylene. The researchers discovered that the chemotherapy drug was released slowly and consistently. This contrasts with the normal initial drug “burst” considered a negative factor in traditional chemotherapy.

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Dean Ho PhD (photo by Andrew Campbell)

 

Northwestern University, EVANSTON, Ill. — Bacterial infection is a major health threat to patients with severe burns and other kinds of serious wounds such as traumatic bone fractures. Recent studies have identified an important new weapon for fighting infection and healing wounds: insulin.

Now, using tiny nanodiamonds, researchers at Northwestern University have demonstrated an innovative method for delivering and releasing the curative hormone at a specific location over a period of time. The nanodiamond-insulin clusters hold promise for wound-healing applications and could be integrated into gels, ointments, bandages or suture materials.

Localized release of a therapeutic is a major challenge in biomedicine. The Northwestern method takes advantage of a condition typically found at a wound site — skin pH levels can reach very basic levels during the repair and healing process. The researchers found that the insulin, bound firmly to the tiny carbon-based nanodiamonds, is released when it encounters basic pH levels, similar to those commonly observed in bacterially infected wounds. These basic pH levels are significantly greater than the physiological pH level of 7.4.

The results of the study were published online July 26 by the journal Biomaterials.

“This study introduces the concept of nanodiamond-mediated release of therapeutic proteins,” said Dean Ho, assistant professor of biomedical engineering and mechanical engineering at the McCormick School of Engineering and Applied Science. Ho led the research. “It’s a tricky problem because proteins, even small ones like insulin, bind so well to the nanodiamonds. But, in this case, the right pH level effectively triggers the release of the insulin.”

A substantial amount of insulin can be loaded onto the nanodiamonds, which have a high surface area. The nanodiamond-insulin clusters, by releasing insulin in alkaline wound areas, could accelerate the healing process and decrease the incidence of infection. Ho says this ability to release therapeutics from the nanodiamonds on demand represents an exciting strategy towards enhancing the specificity of wound treatment.

In their studies, Ho and his colleagues showed that the insulin was very tightly bound to the nanodiamonds when in an aqueous solution near the normal physiological pH level. Measurements of insulin function revealed that the protein was virtually inactive when bound to the nanodiamonds — a beneficial property for preventing excess or unnecessary drug release.

Upon increasing the pH to the basic levels commonly observed in the skin during severe burns, the researchers confirmed the insulin was released from the nanodiamond clusters and retained its function. Exploiting this pH-mediated release mechanism may provide unique advantages for enhanced drug delivery methods.

The researchers also found the insulin slowly and consistently released from the nanodiamond clusters over a period of several days.

Insulin accelerates wound healing by acting as a growth hormone. It encourages skin cells to proliferate and divide, restores blood flow to the wound, suppresses inflammation and fights infection. Earlier investigations have confirmed an increase in alkalinity of wound tissue, due to bacterial colonization, to levels as high as pH 10.5, the pH level that promoted insulin release from the nanodiamonds in the Northwestern study.

Ho’s group next will work on integrating the nanodiamond-insulin complexes into a gel and conducting preclinical studies. The researchers also will investigate different areas of medicine in which the nanodiamond-insulin clusters could be used.
 
Nanodiamonds have many advantages for biomedical applications. The large surface area allows a large amount of therapeutic to be loaded onto the particles. They can be functionalized with nearly any type of therapeutic, including small molecules, proteins and antibodies. They can be suspended easily in water, an important property in biomedicine. The nanodiamonds, each being four to six nanometers in diameter, are minimally invasive to cells, biocompatible and do not cause inflammation, a serious complication. And they are very scalable and can be produced in large quantities in uniform sizes.

By harnessing the unique surface properties of the nanodiamonds, Ho and his colleagues have demonstrated that the nanodiamonds serve as platforms that can successfully bind, deliver and release several classes of therapeutics, which could impact a broad range of medical needs.

Ho’s research group also has studied nanodiamonds for applications in cancer therapy. They demonstrated that nanodiamonds are capable of releasing the chemotherapy agent Doxorubicin in a sustained and consistent manner. (Ho is a member of the Robert H. Lurie Comprehensive Cancer Center of Northwestern University.)

In addition to using the nanodiamonds in their particle form, Ho’s group has developed devices that harness the slow drug-release capabilities of the nanodiamonds. More recently, his team has shown that nanodiamonds are effective in dispersing insoluble drugs in water, boosting their potential for broader applications in medicine.

The National Science Foundation, the National Institutes of Health, the Wallace H. Coulter Foundation and the V Foundation for Cancer Research supported the research.

The title of the Biomaterials paper is “Nanodiamond-Insulin Complexes as pH-Dependent Protein Delivery Vehicles.” In addition to Ho, other authors of the paper are Rafael Shimkunas (first author), Erik Robinson, Robert Lam, Steven Lu, Xiaoyang Xu, Xueqing Zhang and Houjin Huang, all from Northwestern, and Eiji Osawa, from the NanoCarbon Research Institute at Shinshu University, Nagano, Japan.

You may have noticed that many products now are labeled with “nano”. These products include “nano” cosmetic products, “nano” clothes and “nano” water, etc. Although nanoscience has advanced our technology by making better products, it also impacts our world by raising social and environmental concerns.

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Nanodiamond crystals with average size of 4nm.
Image Courtesy: PlasmaChem GmbH, Berlin, Germany.

Examples on the bright and dark sides of nanoparticles

First of all, we shall take a look of some good and bad examples on using nanoparticles. Nanoparticles are very small particles with all three dimensions less than 100 nm and one dimension between 1 – 10 nm (Fig. 2). Nanoparticles are sometimes called nanopowders or nanocrystals. However, some nanoparticles are not new to us. Carbon nanoparticles are usually produced in burning charcoals and vehicle exhaust. Currently, many materials ranging from metal to insulator can be made in the form of nanoparticles. Some of these materials have even been used commercially. For example, some new cosmetic products contain aluminum oxide nanoparticles which help to clean up dirt on our skin. Here are some potential applications of nanoparticles.

Nanomedicine

Although it sounds like science fiction, nanomedicine is expected to eliminate common diseases and virtually all medical pain and suffering by implementing nanotechnology to improve our current medical practices. It is expected that nanotechnology can make better drugs by improving our methods of chemical synthesis. Future drugs will contain nanoparticles that can be delivered into the human body faster, easier, and to the precise locations in the body. In addition, the nanoparticles can carry out different functions and kill different diseases at the same time. Finally, these particles can stay in our body for a long time so that we are no longer vulnerable to the same infection.

Nano paint

This is a rather mature technology that we have been seeing and using almost daily. A thin layer of nano paint containing nanoparticles can possess anti-bacterial and detoxicating abilities for killing microorganisms almost instantly. In addition, it also carries de-odorizing effect that can keep the nearby environment fresh. The nano paint has already demonstrated its usefulness during the SARS period where the public areas were kept clean. 

Nano weapon

Almost any technology can be used to develop weapons. Since nanoparticles are very small and can carry different chemical functions, they can be used for making bio-weapons. With their small size, they can easily penetrate into our body, release toxic substances and kill us almost instantly. In addition, because of their lightweight and small size, they can be spread in public area at exceedingly fast speed without being detected. Even worse, lethal diseases can also be attached on nanoparticles to increase their destructiveness. As a result, nanoparticles can be used as biological or chemical weapons to kill or seriously impede on an individual as well as the entire city.

Therefore, as is the case of many new technologies, nanoparticles can be angelic or evil depending on how we use the technology. It can have potential threats to our society. In addition, the long-term effects of exposing us to these nanoparticles are not really known and cautions should be taken when working with them. The following example is extracted from The Economist.

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The term ‘nanodiamond’ is broadly used for a variety of diamond-based materials at the nanoscale (the length scale of approximately 1 – 100 nanometer) including pure-phase diamond films, diamond particles and their structural assemblies. Methods of nanodiamond synthesis are diverse involving methods such as a gas phase nucleation at ambient pressure to high pressure high temperature graphite transformation within a shock wave.

There is a special class of nanodiamond material called ‘ultra-nanocrystalline’ diamond (or ‘ultra-dispersed’ diamond) with the characteristic size of the basic diamond constituents encompassing the range of just a few nanometers to distinguish it from other diamond-based nanostructures with characteristic sizes above ~10nm. Within this class of the materials, very attractive for the nearest future nanotechnological applications are ultrananocrystalline particles produced by detonation of carbon explosive materials (characteristic size of primary particles ~ 3-6 nm) developed in the former USSR in the 60-s. The nanodiamond synthesized from carbon contained in the molecules of explosives by the detonation of the explosive is often called nanodiamond of detonation origin or detonation nanodiamond. This class of nanodiamond material is technologically important since detonation nanodiamond can be produced in bulk quantities.

Detonation nanodiamond (DND) materials posses different degrees of diamond purity and a wide variety of functional groups/elements at the surface of diamond particles (Fig.1) depending on the method of purification of detonation soot obtained after the explosion. Detonation diamond purity and surface chemistry significantly vary from vendor to vendor.

Traditional detonation nanodiamond applications include metal-diamond galvanic coatings, polishing pastes and suspensions, polymer composities, lubricating oils, greases and lubricant-coolants. Novel detonation nanodiamond niche applications developed recently include DND for systems of magnetic recording, adsorbent of a new type, as a component in the production of diamond ceramics and moulds made of diamond-containing materials, as coatings in field emission devices, catalyzes of heterogeneous and electrochemical catalysis, in proton-conducting nanocomposite membranes in fuel cells applications. DND had also been employed for seeding substrates used in the CVD growth of diamond films. Preliminary investigation demonstrated that DND is non-toxic and biocompatible, that make it attractive for bio-applications taking into account its rich surface chemistry that can be modified in a controllable way.

In our research we pursue applications based on nanodiamond of detonation origin, including field emission devices, nanocomposites for microelectronics as well as bioapplications.

GoogleNews.com, OncologyNursingNews.com, August 2009, by Delicia Yard  —  Fast-breaking developments in the field of “personalized medicine,” also referred to as precision medicine, molecular therapy, or pharmacogenomics, are set to alter the kind of cancer treatment information oncology nurses will need to know.  

Lawrence Lesko, PhD, director of clinical pharmacology and biotherapeutics at the Food and Drug Administration (FDA), described the changing landscape in April during a lecture he delivered at the University of Maryland School of Pharmacy in Baltimore: “We have a public health crisis in this country. Drugs are intended to treat symptoms, not diseases,” he pointed out. “New [personalized] drugs will now be developed by pathways, by going after the biochemical actions set off by genes. Cancer gets it.”

In other words, new drugs and development trends in cancer research are focused on genetic keys for fighting different forms of the disease. Technology is allowing scientists to tailor drug delivery to an individual’s genetic code and a particular cancer’s molecular profile.  

“What we’re finding out about cancer is that when choosing a therapy, one size doesn’t fit all,” said Michael C. Heinrich, MD, professor of medicine (hematology and medical oncology) at Oregon Health and Science University (OHSU) School of Medicine and the Portland (Oregon) VA Medical Center, and a member of the OHSU Cancer Institute.  

Dr Heinrich made this statement when announcing the results of a study he led, which revealed that the targeted therapy sunitinib (Sutent) had varying effects on gastrointestinal stomach tumor (GIST), depending on the type of genetic abnormality in a patient’s particular form of cancer. All 97 of the study participants experienced clinical benefit from sunitinib, but the benefit was significantly influenced by the nature of the genetic abnormality.

“As we learn what’s broken, we are learning new treatments to go after what’s broken-what’s driving the growth of the tumor,” noted Dr Heinrich. “With certain genetic mutations, some drugs work better than others.”

Simply 1 More Tool for Decision-Making
Typically, the genetic testing for cancer patients is done at the time of diagnosis. Results are usually returned within a day or two, and the therapeutic regimen is determined based on that information.

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“It’s very interesting, but it’s just another tool used as far as patient selection is concerned,” explained Jodi L. Grabinski, PharmD, MSc, in an interview with Oncology Nursing News. Dr Grabinski, an assistant professor at the University of Texas College of Pharmacy in Austin, has published research on sunitinib (J Oncol Pharm Pract. 2007;13[1]:5-15) as well as the pharmacogenomics of other anticancer agents (J Pharm Pract. 2007;20[3]:246- 251). “You’re still going to use your normal labs, and clinical parameters, and everything else to make those decisions. Primarily, because most oncology patients are getting blood drawn anyway, you [just] draw another tube for genotyping.”

Having taught a genomics class for advanced-practice nurses who help make therapeutic decisions, Dr Grabinski finds that “A lot of it is just learning and understanding the terminology, because of all the numbers and letters that have been put together for each of the genes. That’s probably the toughest part.”

Is It Really Happening?
While the nurses in Dr Grabinski’s class often found the concept of personalized medicine to be fascinating, they would frequently ask if it were really being put into practice. In fact, Dr Grabinski said, this form of therapy has been applied in the pediatric leukemia population for “a number of years,” but has only begun to emerge in the adult cancer population, unevenly, in the last few years.

“I think for some places it’s a struggle, but I think there are certain institutions that are certainly adopting it and putting it into practice,” she commented. “It varies between clinicians: For example, some routinely [do genetic testing for administering] tamoxifen and have really been implementing pharmacogenomics in their practices, whereas others aren’t quite convinced it’s really worth it.”

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“There’s a lot of physicians who are very speculative as to the efficacy of it,” concurred oncology nurse Joyce Ingold, RN, MSN, OCN, patient care coordinator at Translational Genomics (TGen) Clinical Research Services at Scottsdale (Ariz) Healthcare. Moreover, she added, “I think there are a lot of physicians that aren’t even aware of this, because it’s still all experimental.”

That is not the case at TGen, the oncology clinical trials (Phase I and Phase II) arm of Scottsdale Healthcare’s 3-hospital system. In April, at the 100th annual meeting of the American Association for Cancer Research held in Denver, Daniel Von Hoff, MD, physician-in-chief of the TGen Research Institute, relayed the results of a TGen study that demonstrated the success of molecular profiling.

The 66 study subjects had breast, ovarian, colorectal, or another “miscellaneous” cancer. They were treated at Scottsdale Healthcare or one of several other facilities around the country. Tumors had grown previously in all patients during 2 to 6 prior treatments, including conventional chemotherapy. But after molecular profiling identified precise targets, new treatments were administered and for many patients the cancer did not progress for significant periods of time; some tumors were even reduced.

Nurses and Patients Need Education
“Since the mapping of the genes in the past 10 years, we’ve been able to look at the specific makeup of your specific tissue that is cancerous,” recounted Ms Ingold in an interview with Oncology Nursing News. “So with that we can look at the pathways that make you different than your next-door neighbor who also has breast cancer and [understand] why you would respond to a treatment and she wouldn’t. As oncology nurses get certified I think we need to have more education as to what all these different pathways are, and what drugs on the market target these specific pathways.”

Nurses in some practices potentially could be tasked with recommending molecular profiling and/or writing the molecular-based treatment regimens, but the data driving this form of therapy is vast and ever-changing. “I think for a nurse to come into oncology and to be given some of this information might be too much as they’re first learning oncology,” agreed Ms Ingold. “But perhaps during their rotations they can be introduced into it and have a research practicum or spend some time in the different areas where they work in clinical trials at their specific site of practice, or we could develop an online program for oncology nurses who work at sites that don’t do Phase I trials.”

The structure of the training component notwithstanding, “I just think nurses need to be introduced and at least have a taste of [molecular profiling],” Ms Ingold affirmed. “And if they’re not going to work in clinical trials, at least they know key phrases and know what to educate their patients about. I don’t see a lot of doctors spending a lot of time explaining all this to their patients, so who other than the nurse is going to be doing all that?”

Two subpopulations of oncology patients will be most interested in personalized medicine, according to Ms Ingold: those who have cancers for which there is no standard-of-care therapy, “the orphan cancers, where we don’t know how to treat the-thymic cancers, certain sarcomas.” The other group includes patients who have undergone standard therapy for their cancer, but with unsuccessful outcomes.

“I get a lot of calls from patients, and they’re on their sixth line of chemotherapy from their oncologist, and I just cringe, because if their oncologist is throwing at them a sixth type of chemotherapy, you and I both know he’s just grabbing out of a hat,” Ms Ingold said.

Although she acknowledged that it’s far too early to declare molecular profiling a standard intervention for all cancer patients, Ms Ingold estimates that personalized medicine will become much more widespread in the next 2 to 5 years. “This is a whole new way of looking at treating cancer, but we need to remember that this is not for those individuals who are responding to a standard-ofcare therapy or for those cancers for which there is already an evidence-based, standard-of-care therapy. People who have cancer are going to [look for] anything out there, so we need to make sure we educate them appropriately.”

One good source of information on personalizing cancer care is the National Comprehensive Cancer Network (www.nccn.org), says Ms Ingold. “I point a lot of patients there; the website has good algorithms: You have breast cancer, you have 3 positive nodes, it’s bilateral… It has a really nice evidence-based direction of what you should be treated with.”

GoogleNews.com, PharmTech.FindPharma.com, August 6, 2009, by Stephanie Sutton  -The number of alliances between diagnostics companies and pharmaceutical companies is set to rise because of the growth of personalized medicine, according to a report from PricewaterhouseCoopers (PwC).

“We expect alliances with the pharmaceutical industry to increase in the next 2-5 years, but this will be driven by factors including the pricing of diagnostics, the extent of reimbursement coverage and the burden of any clinical validation work required for market access,” said PwC Director Loïc Kubitza in a statement about the report.

The report, Diagnostics 2009: Moving Towards Personalized Medicine, claims that the drive toward personalized medicine influenced three of the 10 largest merger and acquisition deals in 2008. In addition, four of the licensing deals by the 10 largest in vitro diagnostics companies were motivated by personalized medicine. The PwC statement also highlighted the recent deal between GlaxoSmithKline (London) and Enigma (Salisbury, UK), a UK-based diagnostics group, to develop a test that quickly diagnoses specific strains of influenza as evidence of the trend for personalized medicine.

According to PwC, the drive toward personalized medicine is caused by several factors, including regulatory agencies that are introducing requirements to test for certain biomarkers before prescribing certain drugs. More people may also now undergo genetic testing because of legislation introduced in the US and Europe last year that protects individuals from genetic discrimination.

“Pharmaceutical companies understand the contribution of biomarkers and diagnostics in improving the design and probability of success of clinical trials,” said Simon Friend, global pharmaceuticals and life sciences industry leader at PwC, also explaining that greater emphasis is now being placed on a companion biomarker test when deciding on a drug’s reimbursement. He added: “These factors will combine to accelerate the development of new diagnostics for personalized medicine. Together we anticipate that alliances and collaboration will be inevitable as the market need expands.”

Stephanie Sutton is an assistant editor at Pharmaceutical Technology Europe.

GoogleNews.com, iStockAnalyst.com, August 6, 2009, by Jim Nelson  —  Many of the big transformational technologies set to change the science of medicine are based on single simple concepts. These include stem cells and RNA interference. There is another transformational change coming, however, that involves a huge array of technologies. I’m talking about “personalized medicine.”

Currently, medicine is, to a large degree, a “one size fits all” proposition. Doctors watch for adverse effects and check personal and family histories. Medical technologies, however, are designed for the general population, not individuals.

That’s going to change…

The Problem With the “Normal Curve”

We know that many current treatments work on some people, yet not others. Some drugs are safe for many people, but have dangerous side effects for others. This is because all of us have individual differences in our genetic code based on heredity and environment. Even slight differences can lead to very different reactions to medications.

This has created serious regulatory problems. Drugs are denied regulatory approval not because they do not work, but because some fraction of the population suffers adverse effects. As a result, we are often denied incredibly effective therapies simply because they are not universally effective.

This shockingly primitive state of affairs exists because, until very lately, we simply have not had the tools to get to the genetic roots of disease. Scientists and pharmaceutical companies haven’t precisely known how a particular drug’s chemical profile interacts with a genetic one. Medical science, in turn, has been unable to tailor drugs to work with a specific genetic makeup.

The Impact of the Genome

This is rapidly changing. Just a few short years ago, the human genome was first mapped. The genome, as you know, is the entire collection of genetic code that defines us at a biological level. Now scientists are studying single genes and their individual expressions.

It is meaningful, from the investor’s perspective, that Dr. Francis Collins, the head of the Human Genome Project, has just been selected by the Obama administration to head up the National Institutes of Health. Collins has long been a prominent champion for using the knowledge gained from human genome to accelerate personalized medicine. 

This is important because institutional forces, with lobbying clout, always resist change. Much of Big Pharm, and its regulators, are vested in the “one size fits all” model. Many of the old players fear personalized medicine because it threatens the existing hierarchy. Collins’ presence at the top of the NIH will help counter this institutional resistance.

Incidentally, Collins has stated that genomics is currently where the computer industry was back in the 1970s – at the beginning of a technological revolution. While he was speaking in scientific terms, we should remember that the ’70s was also the right time to begin investing in a diversified portfolio of breakthrough computer technologies. Those who did so, despite claims that it was too risky or early, were made rich.

Dr. Collins is not alone in his views about personalized medicine. Former FDA director under G.W. Bush Dr. Andrew Von Eschenbach urges that the FDA approval process be overhauled and streamlined to help accelerate the adoption of personalized medicine. He is on record predicting that the medical industry will, in fact, undergo this profound metamorphosis.