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CommentsA Bottle-Nosed Approach to Personalized Medicine
Six years ago I attended a biotech conference in San Francisco. One of the panels that intrigued me most was entitled, "Personalized Medicine: to Market in Five Years." Certainly, everyone was talking about the New Era of Personalized Medicine and I attended to listen to as many different perspectives on emerging industry trends as possible. The panel was exciting, the potential for individualized medicine was here today and all we needed to do was interpret the genetic data we were generating by the bucket load and bring new products to market!Let's do it!
So how many clinical development people were there? None. How many commercial development or marketing people were there? One, just me. So how on earth were all these R&D and genomics folks going to get to market? I asked - there was a pregnant pause...
Okay, so now it's 2006. Last week I attended the Second Annual Burrill & Co., Personalized Medicine Conference at Mission Bay in San Francisco. Six years ago the Mission Bay conference center had not yet broken ground. Today it stands as a tribute to a new era of biotechnology in San Francisco. But our new era of personalized medicine is still very much under construction. At the start of the year Steve Burrill predicted that, "The trend towards personalized medicine will accelerate. The pressure from payers will result in more product bundling, more personalized medicine, less "blockbusterology" (fewer "one size fits all" drugs). The FDA's Critical Path Initiative will drive progress in personalized medicine/theranostics. In 2006, the big stories at FDA will continue to center on the need to make reforms that strengthen drug safety while goosing innovation-goals agency officials insist are complementary."
In 2006 the big story at the FDA, leaving aside the Crawford departure or the elevation of politics over good science, was funding. In 1988, the FDA's budget was 97% of the Centers for Disease Control and Prevention (CDC) and 8% of the National Institutes of Health (NIH). In 2006, while the FDA's budget grew, it was only 28% of the CDC's budget and 5% of the NIH's. Going backwards is a strange way to accelerate!
So how can we accelerate genetically informed approaches to promote the faster development of safer and more effective drugs, to implement new genetic tests to determine which drugs work best for people, and to provide better information on the relative risks and benefits of medicines?
Make like dolphins!
Let's go back into the conference room. Who was there this week? There was very little representation from payers, even though everyone agreed they are a critical player in new medicine. There were very few technologists - even though everyone agrees that mass information sharing and communication is critical to better decision-making. How do we get everyone involved?
The problem is that few companies or government agencies are integrating web technologies effectively. Those who are - Revolution Health, Patients Like Me, are learning from the social networking leaders - Myspace, Second Life, YouTube, Google. Like dolphins they are using the web to gather, share and act on a constant flow of complex information to improve outcomes and further progress.
The decisions we make today about the future of medicine affect our fitness as a species. We have the technology, the innovation, and the money - we just have to make the right choices. It is only advantageous to follow the choice of a few individuals if they have more information regarding the entire situation and can communicate it effectively. Like dolphins, we need to use social networking technologies to accelerate the healthcare decision-making process. We are all in one big room on the Internet - patients, payers, regulators, scientists, leaders, followers, connectors, thinkers... Let's broaden the discussion, drive a consensus, and truly accelerate the new era of personalized medicine.
Through our Personalized Medicine news channel we will continue to comment on and distribute information for fellow dolphins out there - here's this weeks PM Alert:
Personalized Medicine Roadblock Alert! The federally sponsored Healthcare Information Technology Standards Panel delivered its first set of harmonized health IT standards last month. The panel was asked to select standards for automating three common health-related activities:
- Patient registration and medication history - the kind of information patients typically provide by filling out a paper form.
- Rapid transmission of data from doctors and emergency rooms to support biosurveillance and help alert officials to disease outbreaks.
- Electronic delivery of lab test results to doctors. But given changes in the house and senate and the Bush administrations ongoing unwillingness to support major federal funding for health IT federal agencies said they weren't ready to put the standards into practice.
Bring in the dolphins!
| September 16, 2007 at 9:09 pm
Personalized Cancer Treatment With Molecular And Cellular Diagnostics
As we enter the era of \"personalized\" medicine, it is time to take a fresh look at how we evaluate new medicines and treatments for cancer. More emphasis should be put on matching treatment to the patient, through the use of individualized pre-testing, having more respect for minimal partial response or stable disease, when it can be achieved through use of the least toxic and mutagenic drug regimens, and reserve the use of higher dose therapy or aggressive combination chemotherapy to those patients with tumor biologies most amenable to attack and destroy by these aggressive treatments.
Patients would certainly have a better chance of success had their cancer been chemo-sensitive rather than chemo-resistant, where it is more apparent that chemotherapy improves the survival of patients, and where identifying the most effective chemotherapy would be more likely to improve survival above that achieved with \"best guess\" empiric chemotherapy.
Gene expression means whether or not a gene (part of the patient\'s tumor cells DNA) is expressed, meaning is RNA being made from the gene (RNA is the intermediary which codes for protein synthesis and it is the activity of proteins - many of which are enzymes - which determine the behavior of the tumor cell). So gene expression assays can be either probing for the specific RNA messengers (messenger RNA) or it can mean looking for the proteins themselves.
Many have hoped that molecular tests would hold the key to success, particularly as more specific drugs are designed to hit the molecular changes that are responsible for the uncontrolled growth of cancer cells. Like testing breast cancer for the presence of hormone receptors and over-expression of growth factor receptors. However, most drugs cannot be looked at in this way and test that are now in use have limited predictive accuracy.
To overcome the problems of heterogeneity in cancer and prevent rapid cellular adaptation, oncologists are able to tailor chemotherapy in individual patients. This can be done by testing \"live\" tumor cells to see if they are susceptible to particular drugs, before giving them to the patient. DNA microarray work will prove to be highly complementary to the parellel breakthrough efforts in targeted therapy through cell function analysis.
It may be very important to zero in on different genes and proteins. However, when actually taking the \"targeted\" drugs that come from this research, do the drugs even enter the cancer cell? Once entered, does it immediately get metabolized or pumped out, or does it accumulate? In other words, will it work for every patient?
What would be more advantageous is to sort out what\'s the best \"profile\" in terms of which patients benefit from this drug or that drug. Can they be combined? What\'s the proper way to work with all the new drugs? If a drug works extremely well for a certain percentage of cancer patients, identify which ones. If one drug or another is working for some patients then obviously there are others who would also benefit. What\'s good for the group (population) may not be good for the individual.
So, all the validation of this gene or that protein providing us with a variety of sophisticated techniques to provide new insights into the tumorigenic process, if the \"targeted\" drug either won\'t \"get in\" in the first place or if it gets pumped out/extruded or if it gets immediately metabolized inside the cell, it just isn\'t going to work.
Dr. Len Lichtenfeld, deputy chief medical officer for the American Cancer Society, in a response about the Cancer Genome Project, said \"We\'re going to be able to take a cancer specimen, analyze it, and follow those genetic changes that influence particular pathways, then we\'ll use one, two, three of more \"targeted\" therapies, perhaps simultaneously, and be able to completely interrupt the flow of the cancer process.\"
I agree! Upgrading clinical therapy by using drug sensitivity assays measuring \"cell death\" of three dimensional microclusters of \"live\" fresh tumor cell, can improve the situation by allowing more drugs to be considered. The more drug types there are in the selective arsenal, the more likely the system is to prove beneficial.