1. NIH: Action on Translation.
Last year on the FasterCures "Top 10" list, we highlighted NIH's new Therapeutics for Rare and Neglected Diseases (TRND) program as a potential model for the role NIH could play more broadly in helping promising basic discoveries bridge the "valley of death" between preclinical development and clinical research. In late 2010, the agency's Scientific Management and Review Board proposed the creation of a Center for Advancing Translational Sciences to do just that. The new Center, which NIH Director Francis Collins has committed to have up and running by the end of 2011, "would generate innovative tools, technologies, and ideas that would transform translational efforts throughout the scientific community." There's sure to be debate about what this new Center will and should do, and whether it will detract from NIH's basic research activities or deliver greater value to already important work.
2. Health IT: Will "meaningful use" be meaningful for research?
Since 2009, the federal government has put the pedal to the metal to accelerate widespread adoption of electronic health records by health providers and hospitals, and get them to "meaningfully use" these systems for data capture and sharing of the most elementary kind. What has not yet happened is a necessary focus on the secondary uses (an unfortunate term) of that data, including, very importantly, clinical research. 2011 will be the year to tell the feds what needs to happen to ensure that all that data being collected by docs is accessible to researchers trying to cure the diseases they're treating. Researchers and patients must drive that conversation. Have you asked your provider how their EHR system is faring? Stay tuned for FasterCures' paper on this topic in early 2011.
3. FDA: Stand and deliver.
2010 ended with industry commenting about the low number of products approved by FDA over the year, and FDA commenting about the low number of New Drug Applications submitted by industry. 2011 will almost certainly be consumed by the wrangling over PDUFA reauthorization. Getting more done with less will most certainly be a theme. We'll be focusing our attention on longer-term concerns, such as: Has the agency made progress on its regulatory science agenda (debuted last year)? What is the new Joint Leadership Council with NIH doing? Could this be the year the Reagan-Udall Foundation takes off? The heat is on.
4. Pharma: Can you learn something from the oil and gas industry?
Industries like microprocessors, film, and oil and gas have all faced market-driven inflection points and have reinvented themselves to respond. For example, the oil and gas industry has consortia that engage in pre-competitive research and exploration; companies take a more holistic view, and understand the need for sharing data to reduce risk and price volatility. Similarly, the pharmaceutical industry needs data-sharing and trusted third parties to help it tackle common challenges. What can be learned from these models, and who can create the framework for applying those lessons in this sphere?
5. Where is our GPS: Mapping the pre-competitive space.
Over the last year we've seen increasing interest within the biotech and pharmaceutical industries in collaborating more across companies and sectors on pre-competitive areas of research. But the concept remains ill-defined. Can you pre-compete and remain competitive? How should intellectual property be treated, and can it be handled in a standardized way? Will this be done in a one-off manner, or can it be managed/organized? Can we create a "marketplace" that will help facilitate the exchange of pre-competitive information? Keep an eye on new efforts like Sage Bionetworks' Archipelago initiative, which aims to create just such a marketplace.
6. Follow the leaders across the Valley of Death (but remember to pack some provisions).
We have been very interested to see over the last year a wide variety of new experiments aimed at addressing barriers to financing, skills, and incentives that will move promising ideas through the pipeline. At the end of 2010, we released a new white paper, Crossing Over the Valley of Death, which highlighted the importance of translational research and the challenges it presents. At Partnering for Cures 2010, we heard presentations from almost half a dozen different efforts with similar goals -- from various initiatives to develop university intellectual property further before licensing it, to creation of portfolios of projects rather than companies for investment, to "social business enterprises" to fund development of promising discoveries. We'll be interested to see which models rise to the top but more importantly, who can demonstrate tangible results, and then how do we grow them?
7. Grab your partner: Is venture philanthropy the new venture capital?
More and more biotech and pharma companies are forming alliances with nonprofit disease foundations -- not just as advocates for their products and sources of clinical trials participants, but, at a time of increasing costs and declining success rates for new therapies, as potential research funding partners. Is this a phenomenon of significant scale and impact? How do these deals work? What does each party bring to the table? What results have been achieved? On the subject of venture capital, we're watching folks like Third Rock Ventures who are still willing to invest in early-stage development, and Enlight Biosciences, which is investing pharma funds in enabling technologies.
8. Tear down this wall: The academia/industry business interface.
The business interface between universities and companies is an area in crying need of more standardization. One-off deals have high transactional costs, and yet the parties are reluctant to adopt the best practices of others. Successful models of university-industry collaboration in places like University of California San Francisco -- where the focus is on high-value research moving from universities into development at companies, rather than on royalty revenue for either party -- need to be spotlighted, studied and replicated. And universities need to significantly rethink their internal reward structures to value industry collaboration and patents, not just government grants and publications. Who best to lead the charge here?
9. The future of research: Don't trust anyone under 40?
By now the statistics are familiar: The average age of an investigator receiving his or her first NIH grant is 42-years-old. NIH is funding significantly more investigators over the age of 60 than under the age of 40. Plenty of people are worrying about how to attract and keep young people in the system as it currently exists. Not many are trying to see the world through their eyes and build a system that works for them. Technology, social networking, collaborative work, data sharing, crowd sourcing, interdisciplinary science, convergent disciplines are all increasingly second nature to the establishment of tomorrow. Maybe we need to learn a lesson from them today -- and get out of their way, or risk losing an entire generation, and more.
10. See the world: Disease and the search for cures know no borders.
To help think about what research and business models of the future can and should look like, see what's happening in places that don't operate within the system that has grown up over 50 years in the U.S. Not only is intellectual capital locating elsewhere, but places like India, China, Singapore, and Africa are innovating out of necessity and producing some remarkable results with great speed and in some cases, few resources. And what about countries with wealth like Norway and Qatar -- how can we engage them to invest significantly in medical research; can we initiate a Global Giving Pledge for sovereign wealth funds to dedicate resources to finding cures? The Rolling Stones told me that "Time waits for no one."
Follow Margaret Anderson on Twitter: www.twitter.com/fastercures
Noah Efron: The Meeting of Science and Religion in Real Life
Unfortunately, many/most people with PKD don't reveal they have it and it is not that well known, making it seriously underfunded by the NIH.
The good news with PKD is that both genes that cause the disease have been discovered.
It would be a WIN-WIN for the 600,000 Americans with PKD and a WIN-WIN for Medicare, that pays for dialysis and kidney transplants, if a little pill retarding cyst development can keep people's kidneys from failing! That drug-repurposing effort is the latest pursuit of the PKD Foundation (www.pkdcure.org) --a tiny foundation with only an $8 million operating budget fighting a Goliath-size disease.
If ever there was a disease that screamed for a cure, it's PKD. Maybe someone at the NIH will listen. And, perhaps, President Obama will act on his State of the Union promise to "look at other ideas" to reduce Medicare and Medicaid spending.
couldnt find a current blog really relevant to this from Common Ground magazine [ greater Vancouver regional district ] : " new promising news for parkinson's : a Saponin in Ginseng contains a stimulating factor for stem cell growth etc "
also Common ground says " a Euopean parlaiment law of 2004 will make many herbal and natural medicines including traditional chinese [[ of which ginseng is one]] and ayur vedic medicines illegal on april 1 2011
something for huffposters to do
Maharishi ayur veda etc all traditional medicine is way mor eimportant positive sustainable and neccessry than drugs
drug companies are trying to kill the competition
couldnt find a current blog really relevant to this from Common Ground magazine [ greater Vancouver regional district ] : " new promising news for parkinson's : a Saponin in Ginseng contains a stimulating factor for stem cell growth etc "
also Common ground says " a Euopean parlaiment law of 2004 will make many herbal and natural medicines including traditional chinese [[ of which ginseng is one]] and ayur vedic medicines illegal on april 1 2011
something for uffposters to do
maharishi ayurveda etc all traditional medicine is way mor eimportant positive sustainable and neccessry than drugs
drug companies are trying to kill the competition
couldnt find a current blog really relevant to this from Common Ground magazine [ greater Vancouver regional district ] : " new promising news for parkinson's : a Saponin in Ginseng contains a stimulating factor for stem cell growth etc "
also Common ground says " a Euopean parlaiment law of 2004 will make many herbal and natural medicines including traditional chinese [[ of which ginseng is one]] and ayur vedic medicines illegal on april 1 2011
something for uffposters to do
Maharishi ayur veda etc all traditional medicine is way mor eimportant positive sustainable and neccessry than drugs
drug companies are trying to kill the competition
Breast feeding may be the key to both overweight and underweight problems.
My idea is that the lack of at least one year of breast feeding for infants is causing both overweight and underweight problems across the world. And that's just one of many subconscious problems.
I suggest that weaning sets up a food in and waste out pattern - probably in the ENS, Enteric Nervous System, that subconsciously programs us for our lives. If there is not enough breast milk before that weaning period - the infant will be 'hungry'/angry from then on. He will move toward food and become overweight.
If the weaning is too soon such that the child's digestion system can't handle the new non-breast milk, solids, then the child will always be 'too full' (of food he can't yet digest) /fearful from then on. He will move away from food and become underweight.
Time to promote one year of breast feeding.
Those with weight problems - should be infants that were NOT breast fed for one year.
"Before 1900, most mothers breastfed their infants. Breastfeeding rates declined sharply worldwide after 1920, when evaporated cow's milk and infant formula became widely available. " - faqs.org
2. Health IT: Will "meaningful use" be meaningful for research? The UK cancelled its Health IT system - too fragmented, too costly. US has far more providers and there will be less integration.
3. 3. FDA: Stand and deliver. It is in the self-interests of regulators to prolong and procrastinate their decisions. There is only bureaucracy and delay in research here.
4. Pharma: Can you learn something from the oil and gas industry? BIG PHARMA learns from its bottom line. It is failing in its embrace of vaccines, etc. There is nothing coming from them until we understand the cause of chronic diseases.
5. Where is our GPS: Mapping the pre-competitive space. More regulation, disorganisation and delay - nothing useful here.
10. See the world: Disease and the search for cures know no borders. CORRECT - China and India will be doing the research work in low, cost, low regulation environments. EVery major US centre needs a base in a Chines/Indian institution.
The U.S. medical community itself is at least the third leading cause of death in this country. Depending on how you do the accounting, it actually may be the leading cause of death, ahead of heart disease and cancer.
http://www.jhsph.edu/bin/s/k/2000_JAMA_Starfield.pdf
So, one way to stay healthy is to avoid the medical community (except for accidents and injuries) by preventing illness in the first place. I believe it is a mistake to look to the medical community for primary illness prevention. After all, if primary prevention was successful, medical schools, doctor's offices, medical insurance companies, pharmaceutical companies, and hospitals would become ghost towns.
To increase the chances that a true illness prevention program will not become yet another pawn of BigPharma and BigAgri, I suggest the formation of an Office of Primary Illness Prevention (OPIP). It must be independent of: the food industry, the industry-controlled FDA/EPA/USDA triangle, Big Pharma, the medical community, the Surgeon General, and the NIH. It would conduct government funded university research into areas that have been completely ignored, such as using nature as a paradigm for health. I have personally funded such research with great results. A discussion and references can be found in "The Wellness Project" .
Roy Mankovitz, Director
http://www.MontecitoWellness.com
A research organization
But if you want to steer clear from doctors, hospitals and pharmaceuticals, that's your prerogative.
Merrck wasn't innocent in all this; I agree it was overprescribed and many patients weren't explained the risks involved in taking it (unless, of course, they read the accompanying literature that came with each filled prescription).
A more immediate way to distribute information would be wellness apps. personal medical records should be an mobile phone app. that information should be part of a barcode scanner or AR app - for making diet choices like "eat this not that." or time to take your pills (vitamins or whatever floats your boat).
AI medical apps would be extremely useful for mobile phone users around the world that do not have immediate access to medical care. they would also be useful for consumers in general.
eventually the lab on the chip should be innovated for more frequent blood tests - checking for protien markers for organ illness, stress and etc. and looking further forward, a nanofactory on a chip should also be innovated toward this goal.
personally, it sounds odd to me that you would advocate avoiding the medical care industry rather than improving upon it. the natural health industry should learn to play nice - negotiate terms for working symbiotically with traditional western medicine. it would be more useful to patients.
Let’s take the simple example of what to eat to stay healthy. Ask 10 MD’s/nutritionists and you’ll probably get 10 different/conflicting answers. We all "know" that a healthy diet is a low fat, high fat, low carb, high carb, vegan, vegetarian, Atkins, South Beach, Blood Type, metabolic type, blah blah diet. Right? We all “know” that one diet does not fit all humans, right? Put that in your app.
For virtually every other species, and certainly other mammals including primates, one size does indeed fit all when it comes to diet. The ideal diet for a cat anywhere in the world is a rat, and the ideal diet for a cow anywhere in the world is grass. Our omnivorous cousins (chimps and bonobos) eat fruit, leaves, and meat.
Could there be an ancient diet that nature evolved all humans to eat? My research uncovered The Original Diet that our ancestors followed for 100,000 generation¬s, that was abandoned about 10,000 years ago and has not appeared in print until recently. It took a study of paleoanthr-opology, botany, ethnobiolo¬gy, primatolog¬y, paleopatho¬logy, and zoopharmac¬ognosy to uncover it. It looks nothing like what you might expect, and experiment¬s are underway to evaluate it. No app needed.