Top 10 Innovations for 2007
#1
Cancer Vaccines
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These targeted therapies are being used to prevent cancer and treat patients more specifically according to the type of cancer they have. One example of a cancer vaccine is the HPV vaccine developed to prevent cervical cancer caused by human papillomaviruses.
This has been a clinical and commercial success, with sales over $1 billion for 2007-2008. This cervical cancer vaccine is now widely used, with 25% of American teenage girls vaccinated in 2007. - These targeted therapies are being used to prevent cancer and treat patients more specifically according to the type of cancer they have. One example of a cancer vaccine is the HPV vaccine developed to prevent cervical cancer caused by human papilloma viruses. Approximately 25% of American teenage girls were vaccinated with the HPV vaccine in 2007. Currently, researchers are working on developing therapeutic vaccines for a variety of cancers including breast, lung, colon, skin, kidney, and prostate.
There are more than 270 therapeutic vaccine candidates currently in the pipeline. The FDA approved the first therapeutic vaccine for advanced prostate cancer in 2010.
#2
Designer Therapeutics Using Selective Receptor Antagonists
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Novel therapeutics have been created to block receptor activation that leads to improved patients' outcomes. Examples include therapeutics that: block the peripheral side effects-such as constipation and nausea-of opioid medications for pain which can adversely affect patients and lengthen hospitalizations; and control the body's stress response to mediate eating and smoking.
There have been some setbacks in this field, with the recent withdrawal of an SRA-obesity drug from U.S. market trials, and the suspension of the drug in the EU because of a poor risk/benefit ratio in clinical practice. - Novel therapeutics have been created to block receptor activation that leads to improved patient outcomes. Examples include therapeutics that block the peripheral side effects-such as constipation and nausea-of opioid medications for pain, which can adversely affect patients and lengthen hospitalizations; and control of the body's stress response to mediate eating and smoking. Research in this area continues with new trials being conducted in multiple areas, such as treatment of muscle and bone disorders.
#3
Neurostimulation for Psychiatric Disorders
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Neurostimulation, such as deep brain stimulation (DBS), is emerging as a significant treatment option for millions of Americans who are suffering from treatment-resistant depression and treatment-resistant obsessive-compulsive disorder.
Investigational results continue to show effectiveness of neurostimulation in the treatment of resistant forms of depression and OCD. There is also a growing acceptance of DBS for treatment of Parkinson's, essential tremor, and dystonia. - Neurostimulation, such as deep brain stimulation (DBS), is emerging as a significant treatment option for millions of Americans who are suffering from treatment-resistant depression and treatment-resistant obsessive-compulsive disorder. Studies of DBS in the treatment of resistant forms of depression continue to show promise.
DBS has been approved by the FDA for the treatment of dystonia, essential tremors, and drug-resistant obsessive-compulsive disorder. Current research is focusing on the use of DBS for multiple clinical applications, such as the treatment of Tourette syndrome, drug-resistant epilepsy, and obesity.
#4
Optical Coherence Tomography (OCT)
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This noninvasive imaging technology is used in the treatment and diagnosis of eye diseases, such as diabetic retinopathy and macular holes.
This technology has become ubiquitous in the identification and treatment of eye disease. In addition, OCT is being developed for intravascular imaging to assess unstable plaque in coronary arteries. - This noninvasive imaging technology is used in the treatment and diagnosis of eye diseases, such as diabetic retinopathy and macular holes.
OCT has been approved by the FDA and has since become a highly useful medical imaging technique with a market that may top $800 million by 2012. Ophthalmology is predicted to remain the dominant application, but experts envision OCT applications and products expanding to include cancer detection, glucose monitoring, dermatology, and dentistry. In addition, one OCT is being developed for intravascular imaging to assess unstable plaque in coronary arteries. Regulatory approvals in the U.S. and Europe are expected in 2011.
#5
Bronchial Thermoplasty (BT)
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BT involves the controlled application of heat in the lungs to improve pulmonary function and reduce asthma symptoms. This therapy is used to ward off asthma attacks.
In a recent international study with patients with severe asthma, 50% of the study subjects were able to completely stop taking their inhaled steroids after undergoing BT. One year later, they were still having positive asthma control. Commercial acceptance, however, is still a few years away. - BT involves the controlled application of heat in the lungs to improve pulmonary function and reduce asthma symptoms. This therapy is used to ward off asthma attacks.
The FDA approved the very first BT device for treatment of severe persistent asthma in early 2010.
#6
Ranibizumab
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This drug therapy inhibits uncontrolled blood vessel formation in the eye, which is the primary cause of age-related macular degeneration, and the leading cause of new blindness in older Americans.
The drug has since become a clinical and commercial success ($700 million in sales since introduction) and remains the standard of care for age-related macular degeneration; new trials are testing combination therapies, which may allow similar or improved outcomes with fewer treatments. - This drug therapy inhibits uncontrolled blood vessel formation in the eye, which is the primary cause of age-related macular degeneration, and the leading cause of new blindness in older Americans.
The drug has since become a clinical and commercial success (more than $2 billion in sales since introduction) and remains the standard of care for age-related macular degeneration. Intravitreal injection of the drug has been approved recently by the FDA for the treatment of macular edema after retinal vein occlusion. Several new trials are currently ongoing to test combination therapies with drugs such as volociximab and dexamethasone, which may allow similar or improved outcomes with fewer treatments.
#7
Endografting
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This is a minimally invasive repair technique traditionally used in cardiology and now being used to treat vascular disease, including thoracic abdominal aneurysms.
This technique has since gained worldwide acceptance, with high success rates reported in trials in Asia. In the U.S., one device is approved by the FDA and competing devices are undergoing clinical trials. - This minimally invasive repair technique traditionally used in cardiology is now being used to treat vascular disease, including thoracic abdominal aneurysms. Multiple studies have demonstrated the satisfactory performance of endografting for treatment of atherosclerotic vascular disease in a variety of clinical settings.
Endografting has become an accepted and important therapy for the emergency and elective treatment of diseases of the aorta and peripheral vasculature.
#8
Targeted cancer therapies
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This involves using second generation, small molecule tyrosine kinase inhibitors to block or modulate disease and provide treatments for advanced cancers, such as renal cell carcinoma.
An evolving success, with significant advances already reported. Lapatnib gained FDA approval in 2007 for patients with advanced, metastatic breast cancer that is HER2 positive. - This involves using second generation, small molecule tyrosine kinase inhibitors to block or modulate disease and provide treatments for advanced cancers, such as renal cell carcinoma. This technology has been an important advance with several agents in this genre that are either in clinical trials or that have been approved for a variety of cancers including leukemia, pancreatic, breast, lung, and renal. Research is currently being conducted on new drug compounds as well as ways to improve existing drugs through combination therapies and new ways to administer them.
The FDA has granted priority review to a new compound for the treatment of adults with newly diagnosed chronic myeloid leukemia.
#9
Left Ventricular Assist System (LVAS)
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This is the first implanted ventricular assist device that senses when to increase or decrease the rate of blood flow. The device takes over most of the function of the left ventricle, and helps generate the force necessary to propel oxygen-rich blood throughout the body.
This has been a commercial success and continues to give new hope for patients awaiting heart transplants. There have been several successful clinical trials and subsequent FDA approval for devices used as bridge-to-transplant. Several commercial models are now available from different manufacturers. New generation devices that minimize the biologic impact of support and that incorporate increasingly sophisticated responsiveness to the body's variable circulatory demands will continue to expand the utility of this revolutionary approach to end-stage heart failure. - This is the fi rst implanted ventricular assist device that senses when to increase or decrease the rate of blood fl ow. The device takes over most of the function of the left ventricle, and helps generate the force necessary to propel oxygen rich blood throughout the body. This concept has become a commercial success with many trial successes. The role of LVAS as a bridge to transplantation for endstage, medically refractory heart failure has been well established.
As a potential extension of this therapy, the NIH has recently established funding for clinical investigation into the use of these devices as an alternative to medical management in less advanced cases of heart failure. These newer pumps are smaller and potentially more durable and longer lasting than the current generation of pumps. Currently, these devices can be used in the U.S. in FDAapproved clinical investigations.
#10
Convection-enhanced delivery of drugs
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This emerging drug delivery method is being used to administer medication directly to the site where it is needed, without exposing the rest of the body to a drug's effects.
At this time, it's still too early to judge the technology's overall success. While the initial phase III trials failed to show benefit of the experimental drugs delivered via CED, other studies have shown that it is an effective drug delivery technique. Advancements in CED catheter technology and real-time imaging of drug distribution made over the past year are leading to the development of a new series of clinical trials for both brain tumors and movement disorders. - This emerging drug delivery method is being used to administer medication directly to the site where it is needed, without exposing the rest of the body to a drug's effects.
The current success of this concept is diffi cult to gauge as a large number of studies have been conducted with confl icting reports of effi cacy. However, development is continuing with the aim of improving the overall drug delivery process as well as the catheters needed to implement it. Additional clinical trials can be expected in the future while the medical industry tries to advance this concept.
