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13 Minute Fitness Meal

Posted: August 18, 2011 at 11:13 am


http://www.scoobysworkshop.com In this video I'm going to show you a quick meal for muscle gain and fat loss. Five awesome things about this meal: 1 its so easy that even I can make it 2 it tastes great 3 its quick! takes less than 15 minutes 4 no shopping trip, its all in yoru freezer 5 no mess, cook it on your BBQ

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13 Minute Fitness Meal

Dr Moshe Dekel Holistic Medicine Introduction

Posted: at 11:13 am


http://www.DrDekel.com Dr. Moshe Dekel and Holistic Medicine.

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Dr Moshe Dekel Holistic Medicine Introduction

Rob Riches WBFF Fitness Model Contest Prep. 12 Weeks Out

Posted: August 17, 2011 at 10:35 pm


Follow Optimum Nutrition athlete, Rob Riches, as he documents his 12 weeks preparation through video and blogs, showing how he trains, the foods he eats, the supplements he takes, and his fitness workouts, to be ready for the WBFF World Fitness Model Championships in Toronto on August 27th 2011. You can follow rob and his daily posts on Facebook and Twitter below: twitter.com/RobRiches http://www.facebook.com/pages/?The-Official-Rob-Riches-Fitness-Group/?109378955772447 Daily blog: http://www.robrichesfitness.wordpress.com For more information on training, nutrition, modeling and competing, check out http://www.robriches.com and http://www.onacademy.co.uk

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Rob Riches WBFF Fitness Model Contest Prep. 12 Weeks Out

Petition Started To Stop Behavioral Health Facility

Posted: at 1:21 pm


An application filed with the city of Seneca to rezone a property between Townville and Fairplay Streets from residential to commercial has some neighbors upset.

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Petition Started To Stop Behavioral Health Facility

Is Fresh Food Always Better than Frozen? (Diet

Posted: August 16, 2011 at 3:51 pm


People often assume that food in its natural form is the healthiest option.

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Is Fresh Food Always Better than Frozen? (Diet

LifeVantage- Protandim anti-aging formula

Posted: August 15, 2011 at 6:22 am


http://www.vastabundance.com - The biochemical markers of your body aging to decrease after a few days on Protandim.The Anti-aging protection Protandim provides accumulates overtime. The longer you take Protandim, the more Anti-aging protection you sustain.Protandim kills one million free radicals persecond.

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LifeVantage- Protandim anti-aging formula

Nobody is Arguing that Radical Life Extension is Impossible

Posted: August 14, 2011 at 3:55 pm


A thought for the day: nobody out there is seriously arguing for the impossibility of radical life extension, and I don't think anyone has been for quite some time. It is a given in the present diffuse discussion on the future of medicine and human longevity that at some point advances in biotechnology and nanotechnology will lead to greatly extended lives: centuries and longer lived in good health and vigor. Aging will be brought under control by medicine, like any number of other once intractable medical conditions.

It wasn't always this way. People in past centuries might have hoped for the plausibility of radical life extension, but couldn't have said in certainty that it was possible. We, on the other hand, know far more about physics, chemistry, and biology: we know that there is no wall created by the way the universe works standing in our way. The only reason we presently age and suffer is because we haven't yet advanced far enough down the path of biotechnology that is clearly visible and well understood. Aging is, at root, a matter of atoms and molecules in the wrong place and the wrong configuration. Moving atoms and molecules around to order, en masse, and with precision, is a task that we know is possible. We do it all the time, and are learning ever greater finesse with each passing decade.

Yesterday the tools were found molecules that happened to do something useful with other molecules. Today we make use of designed molecules for particular operations, knowing much more about the molecular machinery of our cells. Tomorrow the biotechnologists will build and repair complex molecular machinery that performs far more effectively than our evolved biology.

Thus discussions on the engineering of human longevity focus on how, when, and (sadly) whether it should be done at all. I see great strategic importance in the right groups gaining ground in the "how" discussion - we're all going to age to death just like our ancestors if the scientific community remains focused on metabolic manipulation to slow damage accumulation rather than the repair of damage exemplified by SENS, for example. Similarly if there are not good inroads made in growing the community of researchers interested in SENS and related lines of research.

Discussions on "when" can probably be skipped as lacking rigor: no-one knows. All the meaningful timelines depend greatly on seeds sown now that will only bear fruit in the 2030s - the course of twenty years remains a matter of long term planning and great uncertainty in specific outcomes while we're stuck living lives that top out at a century (and that with great luck). The beginnings of a larger research community, the outcome of the debate over strategy in longevity research, and so forth. It is interesting to ponder and plot the windings of future events, but that time is probably better spent on influencing the "how" discussion or materially contributing to progress.

As to the discussion on whether engineering longevity is desirable, or should be blocked by people in power - I think it never hurts to take a little time to oppose such lines of thought. Unthought opposition to extending human life or even simply intervening in the disease of aging is widespread, and success in building the research communities and funding institutions of the next few decades depends on a certain degree of broad public support.

But all that said, no-one out there is seriously arguing that radical life extension is impossible.

The Correlation Between Species Lifespan and Mitochondrial Membrane Composition

Posted: at 3:55 pm


Damage to mitochondrial membranes is an important feature of the complex process by which mitochondrial DNA damage contributes to aging. It is known that differences in membrane composition may be an important factor in species of unusual longevity, such as naked mole rats. Here is another open access study on this topic: "The cellular energy produced by mitochondria is a fundamental currency of life. However, the extent to which mitochondrial (mt) performance (power and endurance) is adapted to habitats and life-strategies of vertebrates is not well-understood. A global analysis of mt genomes revealed that hydrophobicity (HYD) of mt membrane proteins (MMPs) is much lower in terrestrial vertebrates than in fishes and shows a strong negative correlation with serine/threonine composition (STC). Here, we present evidence that this systematic feature of MMPs was crucial for the evolution of large terrestrial vertebrates with high aerobic capacity. An Arrhenius-type equation gave positive correlations between STC and maximum lifespan (MLS) in terrestrial vertebrates ... In particular, marked STC-increases in primates (especially hominoids) among placentals were associated with very high MLS-values. We connected these STC-increases in MMPs with greater stability of respiratory complexes." This sort of study should be viewed as supporting evidence for the importance of work on repairing mitochondrial damage - confirmation of the importance of mitochondria to aging and longevity.

Link: http://gbe.oxfordjournals.org/content/early/2011/08/10/gbe.evr079.abstract

Human Uncoupling Proteins and Longevity

Posted: at 3:55 pm


Uncoupling proteins are involved in the processes by which metabolism determines natural longevity through their effects on mitochondrial activity, and are of interest to calorie restriction researchers: "The brown fat specific UnCoupling Protein 1 (UCP1) is involved in thermogenesis, a process by which energy is dissipated as heat in response to cold stress and excess of caloric intake. Thermogenesis has potential implications for body mass control and cellular fat metabolism. In fact, in humans, the variability of the UCP1 gene is associated with obesity, fat gain and metabolism. Since regulation of metabolism is one of the key-pathways in lifespan extension, we tested the possible effects of UCP1 variability on survival. Two polymorphisms (A-3826G and C-3740A), falling in the upstream promoter region of UCP1, were analyzed in a sample of 910 subjects from southern Italy (475 women and 435 men; age range 40-109). By analyzing haplotype specific survival functions we found that the A-C haplotype favors survival in the elderly. Consistently, transfection experiments showed that the luciferase activity of the construct containing the A-C haplotype was significantly higher than that containing the G-A haplotype. Interestingly, the different UCP1 haplotypes responded differently to hormonal stimuli. The results we present suggest a correlation between the activity of UCP1 and human survival, indicating once again the intricacy of mechanisms involved in energy production, storage and consumption as the key to understanding human aging and longevity."

Link: http://www.ncbi.nlm.nih.gov/pubmed/21827845

More Cautiously Evaluating the Consequences of Excess Fat Tissue

Posted: at 3:55 pm


Wealth, in the most general sense, is a blade of many edges. Let us consider food, for example, which has moved over the centuries of growing wealth from being expensive and unreliably supplied to its present state of being cheap and exceedingly reliable in supply in all the stable regions of the world. That has been a passage of stages: from the bootstrapping of early longevity gains and better land use in the 1700s, all the way through to the stunning advances in productivity that resulted from applications of the first wave of modern biotechnology in the 60s and 70s. Unfortunately we humans are not well adapted for an environment of abundant and cheap food: by following our instincts and ingrained preferences we wind up fat and sedentary, a state that causes significant harm to health and longevity.

This is one of those temporary issues, a matter of a handful of decades. Medical biotechnology will catch up to the new demands of the population, and at some point humans will learn to alter themselves such that there are no longer any detrimental consequences to overeating, or being fat, or being sedentary. That isn't so far away: perhaps fifty years at the outside. In the meanwhile there is willpower or there is a shorter, less healthy life. Your choice.

The data on what exactly excess body fat will do to you - on average, statistically speaking - has been growing over the past years. Fat is metabolically active, an eager and pushy partner in the feedback loops and controlling systems of your metabolism. A lot of what it does is bad in the long term: spurring chronic inflammation, for example. Even comparatively early in life, putting on the pounds and keeping them on for years at a time has a sizable impact on your risk of later suffering all of the most common age-related conditions. Failing to exercise appears to be just as bad in a whole different set of ways.

In any case, here is recently published research from a long-term study that adds yet more data on the costs of fat tissue - and thus the costs of the lifestyle choices needed to gain and maintain that fat tissue:

While some past studies have shown that persons carrying a few extra pounds in their 70s live longer than their thinner counterparts, a new study that measured subjects' weight at multiple points over a longer period of time reveals the opposite. Research from Adventist Health Studies recently published in the Journal of the American Geriatrics Society showed that men over 75 with a body mass index (BMI) greater than 22.3 had a 3.7-year shorter life expectancy, and women over 75 with a BMI greater than 27.4 had a 2.1-year shorter life expectancy. Generally, a BMI between 18.5 and 24.9 is considered normal weight, and a BMI of 25 to 29.9 is considered overweight. A BMI of 30 or more is considered obese.

Previous work in this area by others found a protective association for a high body weight among the elderly. Pramil N. Singh, DrPH, lead author of the paper and an associate professor in the School of Public Health at Loma Linda University, says the data from many past studies is problematic because only a single baseline measure of weight was taken, which does not account for weight changes or how weight changes affect life expectancy. Additionally, most past studies had mortality surveillance of fewer than 19 years, which analyses have shown to be an inadequate amount of time to study risks associated with weight.

"We had a unique opportunity to do 29 years of follow-up with a cohort that was also followed for mortality outcomes," Dr. Singh said. "Across this long period of time, we had multiple measures of body weight, which provided a more accurate assessment."

Using Lasers to Spur Stem Cells Into Action

Posted: at 3:55 pm


A novel way to manipulate stem cells: "Though the heart is known to contain some stem cells, they have a very limited ability to repair damage caused by a heart attack [and] researchers have had to look elsewhere. One of the first efforts to use stem cells to reduce heart scarring involved harvesting them from the bone marrow and inserting them back into the heart muscle, close to the heart's blood supply, but this had limited success. Prof. Oron, who has long used low level lasers to stimulate stem cells to encourage cell survival and the formation of blood vessels after a heart attack, was inspired to test how laser treatments could also work to heal the heart. He and his fellow researchers tried different methods, including treating the heart directly with low level lasers during surgery, and 'shining' harvested stem cells before injecting them back into the body. But he was determined to find a simpler method. After a low-level laser was 'shined' into a person's bone marrow - an area rich in stem cells - the stem cells took to the blood stream, moving through the body and responding to the heart's signals of distress and harm ... Once in the heart, the stem cells used their healing qualities to reduce scarring and stimulate the growth of new arteries, leading to a healthier blood flow. To determine the success of this method, Prof. Oron performed the therapy on an animal model. Following the flow of bone marrow stem cells through the use of a fluorescent marker, the researchers saw an increase in stem cell population within the heart, specifically in the injured regions of the heart. The test group that received the shining treatment showed a vastly higher concentration of cells in the injured organ than those who had not been treated with the lasers."

Link: http://www.eurekalert.org/pub_releases/2011-08/afot-ta081011.php

Investigating the INDY Gene

Posted: at 3:54 pm


The I'm Not Dead Yet (INDY) gene is one of the earlier longevity genes discovered by researchers in course of investigating the effects of calorie restriction. Here is a recent update: "It is known that excess calorie consumption leads to obesity, insulin resistance and increased mortality, whereas calorie restriction reduces accumulation of body fat and improves cellular energy balance and insulin action - reversing obesity and type 2 diabetes, delaying the aging process, and prolonging life in primates and many other species. It has also been shown in the past that reduced expression of the so-called 'INDY' gene in D. Melanogaster flies and C. elegans worms promotes longevity in a manner similar to calorie restriction. But until now, the cellular mechanism by which this happens was unknown. [Researchers] generated a mouse with the so-called 'INDY' gene deleted. Loss of the gene altered chemical levels in the cellular signaling network in a way that improved mitochondrial action in the liver, metabolism of fatty acids, and cellular energy transport. Overall, these traits protected the mice from diet-related accumulation of body fat and insulin resistance that evolve, as we age, into type 2 diabetes. Discovering how deletion of the INDY gene would impact mitochondrial metabolism in the liver was key, because that is the main organ where the INDY gene does its work."

Link: http://opac.yale.edu/news/article.aspx?id=8772

An Example of the Promise of Advanced Immune Therapies

Posted: at 3:54 pm


The immune system is a powerful tool for the selective destruction of unwanted cells, and researchers are a fair way down the road of engineering the activity of the immune system to form therapies. You might look at granulocyte transplant therapy as an example of the sort of tools that are under development. Here is an article on another line of research that has just reached the stage of early tests in humans:

In the research published Wednesday, doctors at the University of Pennsylvania say the treatment made the most common type of leukemia completely disappear in two of the patients and reduced it by 70 percent in the third. In each of the patients as much as five pounds of cancerous tissue completely melted away in a few weeks, and a year later it is still gone.

...

the researchers removed certain types of white blood cells that the body uses to fight disease from the patients. Using a modified, harmless version of HIV, the virus that causes AIDS, they inserted a series of genes into the white blood cells. These were designed to make to cells target and kill the cancer cells. After growing a large batch of the genetically engineered white blood cells, the doctors injected them back into the patients. In similar past experimental treatments for several types of cancer the re-injected white cells killed a few cancer cells and then died out. But the Penn researchers inserted a gene that made the white blood cells multiply by a thousand fold inside the body. The result, as researcher June put it, is that the white blood cells became "serial killers" relentlessly tracking down and killing the cancer cells in the blood, bone marrow and lymph tissue.

An editorial and research paper are available if you are interested in delving further into the details. Unfortunately this work suffers from much the same problem as efforts to develop granulocyte transplant therapies, which is that there are next to no sources of funding for research groups at the cutting edge of immunotherapy. The article relates what is a sadly common story in this part of the scientific community:

So why has this remarkable treatment been tried so far on only three patients? Both the National Cancer Institute and several pharmaceutical companies declined to pay for the research. Neither applicants nor funders discuss the reasons an application is turned down. But good guesses are the general shortage of funds and the concept tried in this experiment was too novel and, thus, too risky for consideration. The researchers did manage to get a grant from the Alliance for Cancer Gene Therapy, a charity founded by Barbara and Edward Netter after their daughter-in-law died of cancer. The money was enough to finance the trials on the first three patients.

This is a good example of how philanthropy modeled on venture investment - backing a range of early stage, high risk, high reward projects - can help break up the log-jams that result from institutional reluctance to fund the cutting edge in any field. The larger an institution, the more they will tend towards only backing the safe choices, but by doing that they ensure that the backing of their resources has little chance of producing radical change. Hopefully other projects, such as work on granulocyte based therapies, can find the connections needed to benefit from similar sources of funding and vision.

Understanding Our Non-Regenerative Hearts

Posted: at 3:54 pm


Why are hearts in humans and other higher animals not able to regenerate like salamander hearts? Answering that question would be a step on the road to recreating that ability when needed: "A new study has shed light on why adult human cardiac cells lose their ability to proliferate, perhaps explaining why our heart have little regenerative capacity. The study, done in cell lines and mice, may lead to methods of reprogramming a patient's own cardiac myocytes, or muscle cells, within the heart itself to create new muscle to repair damage ... Recent research suggests that mammals do have the ability to regenerate the heart for a very brief period, about the first week of life. ... During human development, cardiac myocytes are made by progenitor stem cells and proliferate to form the heart. Once the heart is formed, the myocytes transform from immature cells into mature cells that cannot proliferate. That's not so for newts and salamanders, whose cardiac myocytes can go back and forth between immature, or primitive, states to proliferate and repair damage and then revert back into mature cells once the damage is repaired. [Researchers believe] the reason adult human cardiac myocytes can't do this is quite simple - when the myocytes are in a more primitive state, they are not as good at contracting, which is vital for proper heart function. Because humans are much larger than newts and salamanders, we needed more heart contraction to maintain optimum blood pressure and circulation."

Link: http://timesofindia.indiatimes.com/life-style/health-fitness/health/articleshow/9553629.cms

Exercise Versus Memory Loss

Posted: at 3:54 pm


Another of the many benefits of exercise: a study "shows that a small amount of physical exercise could profoundly protect the elderly from long-term memory loss that can happen suddenly following infection, illnesses or injury in old age. ... aging rats that ran just over half a kilometer each week were protected against infection-induced memory loss. ... Our research shows that a small amount of physical exercise by late middle-aged rats profoundly protects against exaggerated inflammation in the brain and long-lasting memory impairments that follow a serious bacterial infection. Strikingly, this small amount of running was sufficient to confer robust benefits for those that ran over those that did not run. This is an important finding because those of advanced age are more vulnerable to memory impairments following immune challenges such as bacterial infections or surgery. With baby boomers currently at retirement age, the risk of diminished memory function in this population is of great concern. Thus, effective noninvasive therapies are of substantial clinical value. ... Past research has shown that exercise in humans protects against declines in cognitive function associated with aging and protects against dementia. Researchers also have shown that dementia is often preceded by bacterial infections, such as pneumonia, or other immune challenges. ... Previous research has shown that immune cells of the brain, called microglia, become more reactive with age. When the older rats in the study encountered a bacterial infection, these immune cells released inflammatory molecules called cytokines in an exaggerated and prolonged manner. ... In the current study we found that small amounts of voluntary exercise prevented the priming of microglia, the exaggerated inflammation in the brain, and the decrease of growth factors."

Link: http://www.eurekalert.org/pub_releases/2011-08/uoca-sao080911.php

Another Important Human Muscle Structure Built in the Lab

Posted: at 3:54 pm


Good news is now arriving frequently from the tissue engineering community, who really seem to be hitting their stride of late, especially when it comes to muscle. Recreating structured muscle is the simple stuff on a relative scale of difficulty - at least in comparison to lungs and other intricate organs - but this is still a very challenging task. Dumb muscle isn't just dumb muscle: it has to be the right shape, have the right nerve structures, the right distribution of tiny blood vessels, the right layering and fiber types, and so forth. Don't underestimate just how much work was involved in coming to the point at which researchers can announce this latest advance:

Researchers have built the first functional anal sphincters in the laboratory, suggesting a potential future treatment for both fecal and urinary incontinence. Made from muscle and nerve cells, the sphincters developed a blood supply and maintained function when implanted in mice.

...

Current options for repair of the internal anal sphincter include grafts of skeletal muscle, injectable silicone material or implantation of mechanical devices, all of which have high complication rates and limited success. To engineer an internal anal sphincter in the laboratory, the researchers used a small biopsy from a human sphincter and isolated smooth muscle cells that were then multiplied in the lab. In a ring-shaped mold, these cells were layered with nerve cells isolated from mice to build the sphincter. The mold was placed in an incubator for nine days, allowing for tissue formation. The entire process took about six weeks.

Numerous laboratory tests of the engineered sphincters, including stimulating the nerve cells, showed normal tissue function, such as the ability to relax and contract. The sphincters were then implanted just under the skin of mice to determine how they would respond in the body. Mice with suppressed immune systems were selected so that there would be no issues with rejection. ... After 25 days of implantation, each sphincter was re-tested and also compared with the animals' native sphincters. The engineered sphincters had developed a blood vessel supply and continued to function like native tissue.

As the news release points out, this is one of the areas where the available prosthetic alternatives are just not that great; engineering a replacement sphincter in machinery is a hard challenge at our present level of technological prowess. So that a research team has constructed a functional biological sphincter is very promising - and this is especially true given that there are dozens of sphincters scattered throughout the body. It is an oft-reused structure, and being able to build any one type of sphincter from a patient's own cells implies that building the others is also a very realistic goal. So all in all, this is an encouraging example of progress in the field.

Good Data? $100. Good Product Development? $100. Good Commercialization Strategy? Priceless.

Posted: at 3:54 pm


I'm not going to fool anyone into believing I'm a therapeutic product development expert but that's not going to stop me from making a few humble observations in light of the Dendreon "fiasco" of last week which I have no doubt will one day be considered an unfortunate pothole on their road to eventual success.

(though perhaps not before certain current management finds themselves polishing their CVs or retiring to spend their time alternating between their yachts and the courtroom defending their questionable stock trading antics)

I received the following message this morning by email. I don't include it here to promote or endorse or even comment on NWBT, DCVax, Linda Powers, or Toucan Capital in any way -- or in a way that is blind to all the things right or wrong about any of them -- but simply to illustrate the 3 points I want to make below the email.
NWBT HIGHLIGHTS COST EFFECTIVENESS OF DCVAX® IN VIEW OF RECENT IMMUNOTHERAPY PRICING CONCERNS

Northwest Biotherapeutics' (OTC.BB: NWBO)... DCVax® immune therapies for a broad range of cancers (including prostate, brain, ovarian and others) hold the promise, based on available data to date, of being cost effective and priced below other immune therapies while still providing substantial profit margins for the Company and longer survival for patients.

The investor concerns in the news relate to the pricing and reimbursement of Provenge for late stage, metastatic prostate cancer. Provenge is priced at $93,000 for one month of treatment and was approved by the FDA based upon having added 4.5 months of patient survival (to reach overall survival of 25.9 months).

NWBT’s DCVax® will be priced in the range of $37,000 per year for up to 3 years of treatments. In NWBT’s Phase I/II multi-center clinical trial in late stage, metastatic prostate cancer, DCVax® added 18 months of patient survival (to reach overall survival of 38.7 months). DCVax® has previously been cleared by the FDA for a 612-patient, randomized, controlled Phase III trial, although the trial has not yet begun. As is typical before a Phase III trial, the manufacturing processes and product costs have already been determined.
...
...

The key to the substantial pricing advantage of DCVax® is NWBT’s proprietary batch manufacturing process together with its cryopreservation technology for frozen storage of the finished vaccine. NWBT has spent a decade developing and improving its manufacturing and cryopreservation processes. The manufacturing of personalized, living cell products is expensive. But the frozen storage of living cells is quite low-cost – once the specialized freezing technology is worked out for a particular type of cells (the culture conditions, rate of freezing, density of cells and many other factors).

NWBT’s manufacturing methods produce – in a single manufacturing run – a large batch of personalized DCVax® product for 3 years of treatments are much less costly than separate manufacturing runs for each treatment. The technology for freezing the master immune cells (dendritic cells) which comprise DCVax® enables these
cells to remain frozen for years and, when needed, to be thawed and “come back to life” with full potency.

This approach makes DCVax® an "off the shelf” product [for that patient] for several years of treatments after just one manufacturing run. In contrast, Dendreon must do a separate manufacturing run for each one month of treatments. In addition, Dendreon's Provenge product is fresh and not cryopreserved, which limits its shelf life to at most a few weeks.

Another important factor in the cost effectiveness of DCVax® is its simplicity and ease of administration. DCVax® is delivered as a small intra-dermal injection under the skin, similar to a flu shot. As such, it can be administered in any physician’s office or clinic. There is no lengthy intravenous infusion, with the attendant patient discomfort, cost and need for a specialty infusion center. In contrast, Dendreon’s Provenge is delivered by intravenous infusion.

The cost effectiveness of NWBT’s DCVax® is enhanced by the fact that DCVax® is targeting a portion of the prostate cancer market that is 4 times the size of the market segment that Dendreon’s Provenge is currently targeting....

Now this is NWBT clearly blowing their horn - nothing wrong with that - in an attempt to woo back frightened investors. I'm agnostic as to whether any of it is true but it does serve to draw out several points of distinction between what some companies might do to optimize their products for commercial success versus what others might do in an overriding belief that clinical benefit is the only precursor to the happiness of investors, the physician community, patients, and partners.
What I say below is not a commentary, in criticism or praise, on any particular company including NWBT or Dendreon. Many others - Luke Timmerman among the best of them - have provided outstanding and in-depth analysis of the Dendreon story along the way.
I'm only interested in what we as an industry might learn from recent experiences or trends and to perhaps facilitate a useful discussion based on 3 simple observations from someone who has swum in this cell therapy pond for now just over a decade:
1. There is a tendency among some to believe that what we are making (cell-based therapies) are so revolutionary and compelling that the products should almost sell themselves - to investors, partners, regulators, insurers, physicians, and patients.
Of course we know it's not true but sometime we act like it is.
Appligraf and Dermagraft didn't sell themselves to physicians even after regulatory approval. Neither is Provenge apparently-- though they did a good job of selling it to very vocal patient groups. Organogenesis and Advanced Biohealing had to work very long and hard to get profitable reimbursement and market penetration. Dendreon will too.
Investing early in understanding potential clinical adoption hurdles, reimbursement issues, and how the product is and will be perceived not by its champions but by its critics and most importantly, the average agnostic practitioner, is not easy to do because it means spending precious resources long before there is a product to sell but it may mean the difference between a product which eventually sells and one which doesn't.
2. There is a tendency to de-emphasize what I call the "ancillary sciences" around a product -- like lowering the cost of goods, optimizing fresh or frozen storage, cell delivery (e.g., injection/application science) mechanisms, in vivo cell tracking, onsite clinical handling, etc.
Product development science is a science. The science that turns good data into something commercially viable. Not everyone is good at it and certainly this is where a lot of companies fail. PD is not the 'second cousin' in the room of esteemed basic and clinical science.
Take these examples when considering the cellular immunotherapy sector:
Several prominent immunotherapy investigators I have spoken with strongly believe cell-based immunotherapies will require long-term administration to be meaningfully effective -- certainly longer than 3 doses in 3 months. Did Dendreon lock into their clinical protocol too early?
Other immunotherapy companies - like Opexa Therapeutics for instance - create multiple doses for a patient from a single patient collection thus saving considerable expense and creating a better patient experience. Did Dendreon lock into their manufacturing protocol too early?
Other companies are investing heavily in finding ways to extend viable shelf-life of their fresh products or to create cryopreserved versions of their product to optimize its commercial viability.
Imagine a Dendreon that only had to build one manufacturing facility (with a backup CMO) to serve the US market rather than 3 facilities. With a cryopreserved version of the product or a version that had longer than its current limited shelf-life (~72 hours I believe?) that might have been possible.
At every point in clinical development there must be concurrent R&D towards the product's:
  1. science (e.g., MOA, characterization, etc),
  2. clinical effect, and
  3. how to optimize its commercial viability - a big part of which is what we think of as 'product development'.
This is the 3-legged footstool of a commercialization strategy geared for success (credit to Bob Preti of Progenitor Cell Therapy for this analogy).
But 'product development' is also not always about the product strictly speaking and even an expansive definition of product development is only part of a good commercialization strategy.
There is significant component of it that is about studying ways to lower the cost of goods, improving manufacturability and scalability, how hard/easy it is to handle, the patient treatment experience, the physician experience, how it impacts patient's QOL (quality of life), not just what side effects it generates but what side effects it prevents (resulting from other treatments or no treatment) and the cost-savings that generates, etc.
Other cell therapy companies have been more proactive in terms of engaging not only KOLs but average practitioners in a meaningful way that might impact their product and clinical design as well as reimbursement and clinical delivery issues.
3. There is an understandable, largely VC-driven, desire to race forward to the next trial phase when a phase-repeat to optimize or better understand different aspects of the product might be the better way to go.

What's worse? Facing the prospect of not being able to get funding or a partner on the terms one wants for a 2nd phase II or burning through a bunch more money in phase III in an attempt to bring a product to market that isn't market ready? I understand its a tough choice -I'm not saying it's an easy one - but one is certainly more strategic and, as pharma says, is certainly a "de-risking" pathway.
Consider the ratio of products we've seen thus far in the cell therapy industry's short life-span that have been raced to phase III or (worse yet) market only to seriously stumble if not fail when they get there. I can think of 8-10 off the top of my head and there are less than 20 cell or tissue based therapies on the market in US/EU that have received any kind of formal regulatory approval.
Some would argue that this is a prime example of why spinning companies out of academia too early is not beneficial because companies want to minimize exploratory science and lock into a "product" too early. I would argue that this may be true if the problem is understanding the product characterization or mechanism of action but not if your problem is related to how best to develop/optimize the product for commercial viability. Few academics are geared to think this way.
Summary
I certainly don't believe Dendreon failed to identify or consider each and every one of the things they might have done better along the way. I'm sure they did and sure they made calculated judgement-calls about how to approach each one.
Since I'm not a shareholder I don't have to worry myself about being critical of their decisions but rather simply to do what I can to ensure that we as an industry do our best to learn from what - with the benefit of retrospect - may be apparent they did right and wrong.
What are your thoughts? To what extent are the problems that Dendreon has experienced along the way with PROVENGE a predicable result of it being a first-generation product or the result of insufficient focus on critical investigation into the less sexy "ancillary sciences" of product and commercial optimization?
(comment below and/or in the LinkedIn Cell Therapy Industry Group)



http://www.celltherapyblog.com hosted by http://www.celltherapygroup.com

International Stem Cell Corporation: A Company with Scores of Potential by Deborah Sterescu

Posted: at 3:54 pm


International Stem Cell Corp (OTCBB:ISCO) is a company to watch this year, with several promising developments in store, according to a conference call with investors this morning.


The company, whose parthenogenetic stem cell technology can be used to derive pluripotent stem cells, meaning they can be transformed into any cell type in the body, has many important advantages at its fingertips.


Regenerative medicine is a market that is set to boom in the coming years, as more and more companies are developing therapies based on stem cell use. International Stem Cell's long-term goal is to be a universal supplier of stem cells for not just one, but a host of therapies.


The company's parthenogenetic stem cells are derived from unfertilized eggs, avoiding the ethical issues behind the destruction of viable human embryos, and giving cell-therapy companies one big reason to chose International Stem Cell as their supplier of choice when the time is right.
These parthenogenetic cells, like embryonic cells, also have the capacity to become almost any cell type in the body, but have demonstrated they are better in terms of the immune system, as one single stem cell line can be genetically matched to millions of people, reducing the need for immunosuppressants.


The company holds the world's largest collection of research-grade human parthenogenetic stem cell (hpSC) lines, which it uses along with its partners to investigate cellular therapies for a number of incurable human diseases.


Its plan is to establish a US bank of its clinical-grade human parthenogenetic stem cells that will be capable of being immune-matched to millions of patients, so that a physician could call up and request a specific cell type for people. The company, which recently received approvals to enroll around 3 US donors for its bank, already has a collection of ten human parthenogenetic stem cell lines used for research purposes, which were derived outside the US.


These cell lines could potentially be used to cure a number of diseases, including cancer, heart disease, liver disease, among many others. Already, the company has several trials in the works, and has successfully demonstrated in pre-clinical animal studies that its stem cells can be used to create viable liver cells.


Currently, efficacy tests in rat models are in progress for the liver cells, with results anticipated soon. If successful, the company said it plans on aggressively initiating the FDA process, with the aim of beginning first stage clinical trials sometime in 2012. The hope is that International Stem Cell will attain Fast Track designation, as few alternative options are available to patients suffering from liver disease.


The company also has trials in the works for Parkinson's disease and diseases of the eye, and is actively looking for collaborative or joint venture opportunities, as well as in-licensing and out-licensing arrangements.


In addition to its hugely potentially valuable stem cell therapy business, the company also two other operations that are set to generate revenue in the meantime. Lifeline Cell Technology, which saw sales grow by 35% in the first quarter, develops manufactures and markets the Lifeline brand of cell-culture products, which are used by researchers to grow human cells for pre-clinical research.


The subsidiary's products are developed using parent International Stem Cell's technology, and the company expects that as trials for researchers progress into more advanced stages, its technology will be embedded in this progress, potentially generating hundreds of millions of revenue.


In the last quarter, Lifeline Cell gained over 200 new customers due to new product introductions and the development of distribution channels internationally, a strategy it plans to continue.


Lastly, International Stem Cell's Lifeline Skin Care business sells skin care products based on its stem cells, having a very successful launch at the end of last year. The company planned on selling 1,000 products, but sold 7,000 initially, and plans to aggressively kick start major marketing initiatives again in September.


International Stem Cell is a company with scores of upside potential, and though future capital raising has not been ruled out, it has a facility that allows it to draw equity as necessary.
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Part Two: The Ellis Martin Report – Interview with Ken Aldrich of International Stem Cell Corp.

Posted: at 3:54 pm


International Stem Cell Corporation trades under the symbol ISCO.OB on the Over the Counter Bulletin Board and is based in Carlsbad, California where Ellis Martin had the pleasure of interviewing Executive Chairman Kenneth Aldrich. 


International Stem Cell has developed a process to derive stem cells similar to Embryonic Stem Cells without the need for fertilized embryos and with minimal exposure to non-human cells. These factors provide ISCO a unique leadership role in the field of regenerative cell therapy. Additionally, Lifeline Cell Technology, (a wholly-owned subsidiary of International Stem Cell Corporation (ISCO) develops, manufactures and markets high-quality human primary cells, stem cells, media and reagents for sale to pharmaceutical, academic and government scientists. 

The company's management pioneered the development of the normal human cell culture market through the creation of Clonetics® Corporation in the 1980s and has over 20 years combined experience in research, development, manufacturing, quality control, marketing and sales of human cell culture products. Lifeline's products are distributed in the United States and Europe. http://www.ellismartinreport.comhttp://www.intlstemcell.com contact: martinreports@gmail.com 
International Stem Cell is a paid sponsor of The Ellis Martin Report

The Ellis Martin Report: Interview with Ken Aldrich of International Stem Cell Corp.

Posted: at 3:54 pm


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"Ken Aldrich of International Stem Cell Corp (ISCO.OB) on the Present and Future of Stem Cell Research and Applications"

The Ellis Martin Report: International Stem Cell Corporation trades under the symbol ISCO.OB on the Over the Counter Bulletin Board and is based in Carlsbad, California where I have the pleasure of interviewing Executive Chairman, Kenneth Aldrich. International Stem Cell has developed a process to derive stem cells similar to Embryonic Stem Cells without the need for fertilized embryos and with minimal exposure to non-human cells. These factors provide ISCO a unique leadership role in the field of regenerative cell therapy. Additionally, Lifeline Cell Technology, a wholly-owned subsidiary of International Stem Cell Corporation (ISCO), develops, manufactures and markets high-quality human primary cells, stem cells, media and reagents for sale to pharmaceutical, academic and government scientists. The company’s management pioneered the development of the normal human cell culture market through the creation of Clonetics® Corporation in the 1980s and has over 20 years combined experience in research, development, manufacturing, quality control, marketing and sales of human cell culture products. Lifeline’s products are distributed in the United States and Europe. Ken Aldrich, welcome to the program.
For the complete text version of this broadcast: http://www.ellismartinreport.com/node/148

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