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Danone seeks to double nutrition business in 3-4 years

Posted: September 30, 2012 at 5:13 pm

Mumbai, Sept 30:

The French dairy giant Danone, which had earlier this year acquired the nutrition business of the city-based drug firm Wockhardt, plans to double the business in three to four years, a top company official has said.

The French firm had acquired the nutrition business of Wockhardt for a consideration of Rs 1,280 crore, paving the way for its entry into the domestic baby and medical nutrition market and the new entity was named Nutricia International.

The domestic baby nutrition and medical nutrition is a Rs 300-crore business and is growing at 15-20 per cent. We should grow faster than the market rate. We should be able to double our business in three to four years, Danone Group firm Nutricia International managing director Laurent Marcel told PTI on the sidelines of an industry event here.

Danone acquired Wockhardts various brands under its nutrition business, including Farex, Protinex, Dexolac and Nusobee, apart from related industrial operations from Carol Info Services based in Punjab.

Asked if the company would launch its global brands in the baby nutrition business here, Marcel said, We will leverage on the existing brands in the first phase, as we want to leverage the strengths of Wockhardts brands and understand the market better.

We will see when it is a good time to bring in new brands. This is a strategic roadmap that takes some time for implementation. Danone sells its baby nutrition products in 137 countries with a strong presence in the Asia-Pacific region, which accounts for around 40 per cent of its volumes.

Its baby nutrition brands include Milupa, Bledina, Gallia, Aptamil, SGM and Dumex among others.

Keywords: French dairy company Danone,acquired,nutrition business,Wockhardt,double business,French firm,entry,domestic baby,medical nutrition,market,new entity,Nutricia International,Danone Group firm Nutricia International managing director Laurent Marcel,

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Danone seeks to double nutrition business in 3-4 years

Danone plans to double domestic nutrition biz in 4 yrs

Posted: at 5:13 pm

Danone plans to double domestic nutrition biz in 4 yrs The French firm had acquired the nutrition business of Wockhardt for a consideration of Rs 1,280 crore Press Trust of India / Mumbai Sep 30, 2012, 13:09 IST

French dairy giant Danone, which had acquired the nutrition business of Wockhardt, plans to double the domestic baby and medical nutrition business in three to four years, a top company official has said.

The French firm had acquired the nutrition business of Wockhardt for a consideration of Rs 1,280 crore, paving the way for its entry into the domestic baby and medical nutrition market and the new entity was named Nutricia International.

Danone had earlier this year acquired drug firm Wockhardt's various brands under its nutrition business, including Farex, Protinex, Dexolac and Nusobee, apart from related industrial operations from Carol Info Services based in Punjab.

When asked if the company would launch its global brands in the baby nutrition business here, Marcel said, "We will leverage on the existing brands in the first phase, as we want to leverage the strengths of Wockhardt's brands and understand the market better.

"We will see when it is a good time to bring in new brands. This is a strategic roadmap that takes some time for implementation".

Danone sells its baby nutrition products in 137 countries with a strong presence in the Asia-Pacific region, which accounts for around 40% of its volumes.

Its baby nutrition brands include Milupa, Bledina, Gallia, Aptamil, SGM and Dumex among others.

On the investment side, Marcel remained tight-lipped on the amount, but said the company would be pumping in money to enhance capacity.

"We know factories will be reaching full capacity soon. So we will have to plan the next step of investment. We will invest for sure, but I cannot share the numbers. Our plan is to keep manufacturing here, so we will have to invest in production facilities in the coming years," he said.

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Danone plans to double domestic nutrition biz in 4 yrs

Everyday Health's New TV Series, "Recipe Rehab," Is First Show From A YouTube Original Channel To Air On Network TV

Posted: at 5:13 pm

NEW YORK, Sept. 28, 2012 /PRNewswire/ -- Everyday Health, Inc., the digital leader in health and wellness, announced the launch of "Recipe Rehab," the first program from a YouTube original channel to broadcast as a network television series. "Recipe Rehab,"produced by Everyday Health and Trium, will debut October 6th as an original, half-hour, weekly television series as part of Litton's Weekend Adventure, a block of educational and informational programming, which airs Saturday on ABC stations following "Good Morning America" in 95 percent of the country. In conjunction with the series debut, Everyday Health is also launching the show's website October 1st at BetterEats.com/RecipeRehab, where healthy meets delicious. Everyday Health's original YouTube channel (YouTube.com/EverydayHealth) will continue to have fresh "Recipe Rehab" content.

(Photo: http://photos.prnewswire.com/prnh/20120928/NY83097) (Logo: http://photos.prnewswire.com/prnh/20101112/NY00568LOGO )

The "Recipe Rehab" TV show is hosted by Danny Boome and features a rotating cast of acclaimed chefs - Spike Mendelsohn,Candice Kumai,Laura Vitale,Tana Amen, Govind Armstrong, Calvin Harris, and Mareya Ibrahim - competing to help rehabilitate America's favorite recipes and inspire children and their families to make healthy lifestyle choices. Each episode will take a real family's favorite decadent dish, such as fried chicken, macaroni and cheese or nachos, and challenge two renowned chefs to create a lower-calorie, healthier version of the dish, to be analyzed by Everyday Health nutritionists. Once the burners have been turned off and the dishes plated, the family becomes the judge as they cast their votes based on how the new, healthier recipes taste and how easy they are to make, declaring which rehabbed dish and chef will win each week. In the process, host Danny Boome and chefs from the elite "Recipe Rehab" kitchen share their healthy eating tips while inspiring and educating children ages 13-16 and their families to live healthier lives.

Together,"Recipe Rehab" andBetter Eats anchorEveryday Health's new healthy eating initiative, whichextends the Company's overall mission to help consumers make better health and lifestyle decisions every day. Better Eats, which will be cross promoted through the TV show and across the entire Everyday Health portfolio, will become a premier destination for consumers looking to make smart food choices for themselves and their families, and the marketers who want to reach them.

"Everyday Health is excited to offer a dedicated platform for healthy food programming that entertains and educates viewers, and is an integrated solution for advertisers," explained Mike Keriakos, Everyday Health President & Co-Founder. "This move furthers Everyday Health's position as a leading force in lifestyle content for the health and wellness category."

"Recipe Rehab" is the second broadcast TV show from Everyday Health, following "Everyday Health" which aired during the 2011-2012 broadcast season on ABC stations and garnered a prestigious Emmy nomination, the first for a show produced by a digital content company.

"We're excited to have produced an entertaining program that not only fares well across platforms, but also inspires real change and healthier lifestyles," stated Mark Koops, Executive Producer, "Recipe Rehab," Trium, and the co-creator of The Biggest Loser.

"Litton's Weekend Adventure enters its second season recognized as a leader in educational and informational programming. We welcome 'Recipe Rehab' and salute its mission to lead children, teens and their families to make healthier lifestyle choices," commented Dave Morgan, President and CEO of Litton Entertainment.

About Recipe Rehab "Recipe Rehab," produced by Everyday Health and Trium, the first program from a YouTube original channel to premiere on broadcast television. The popular program has expanded its format and it will debut on ABC stations as an original half-hour, weekly educational and informational series beginning October 6, 2012. Each episode, the show's host Danny Boome plays referee between two competing chefs on a recipe recreation, with a healthy twist. The recipe comes from a real family who submitted their favorite, decadent dish. The "Recipe Rehab" chefs compete to take it from unhealthy to healthy. Once the chefs' burners have been turned off and the meals have been plated, that featured family casts their vote on which dish is the 'better eats' based on ease-to-make, taste, and closeness to the original recipe. Each week, Danny also advises the audience on his recipe for a happy, healthy and stress-free kitchen.

Meet the cast of chefs from the elite kitchen of "Recipe Rehab" Tana Amen, Govind Armstrong, Calvin Harris, Mareya Ibrahim, Candice Kumai, Spike Mendelsohn and Laura Vitale and find their favorite rehabbed recipes at the TV show's website, BetterEats.com/RecipeRehab. Fans can continue to view the YouTube original program at YouTube.com/EverydayHealth.

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Everyday Health's New TV Series, "Recipe Rehab," Is First Show From A YouTube Original Channel To Air On Network TV

Health care experts see more choice, competition for Sonoma County patients

Posted: at 5:12 pm

Published: Saturday, September 29, 2012 at 2:45 p.m. Last Modified: Saturday, September 29, 2012 at 2:45 p.m.

In the aftermath of the 2001 collapse of Health Plan of the Redwoods, the countys largest HMO, many local hospitals and doctors battled each other for insured patients who had not yet been swallowed by fast-growing Kaiser Permanente.

Shrinking government reimbursements were forcing doctors to abandon their private practices and sign up for an employees paycheck from Kaiser or Sutter Health. District hospitals searched for a lifeline that could help them stay afloat.

To be sure, many of these problems still exist, but health care experts say a new era is about to begin one of greater competition among the local health care giants and more choices for individuals.

Two weeks ago, a Sacramento-based HMO known as Western Health Advantage announced that was entering the North Bay market by partnering with a regional network of hospitals and physicians in Sonoma, Napa and Marin counties. The insurance plan is expected to compete head-to-head with Kaiser on cost and quality when it begins selling coverage plans in the North Bay next year.

At the same time, Sutter Health, which runs Sutter Medical Center of Santa Rosa, announced that it had filed for a state license that would allow it to sell its own health plan.

These moves most immediately the arrival of Western Health Advantage take place on the eve of full implementation of President Barack Obamas health care overhaul.

While the verdict is still out on whether Obamas Patient Protection and Affordable Care Act will solve the countrys health care crisis, the medical industry is nevertheless gearing up for major changes in 2014. These include launching health insurance exchanges, the expansion of Medicaid, individual and employer mandates and the prohibition of insurance discrimination based on pre-existing conditions.

Dr. Walt Mills, a Kaiser family practice doctor and the new president of the Sonoma County Medical Association, said the presidents health care overhaul and health care economics are combining to drive the system toward a more vertically integrated and patient-centered model. That means both medical providers and health plans are increasingly expected to produce results: healthier patients.

If somebody ends up in the emergency room because they didnt have access to high-quality primary care in a medical home, thats of no value to the local community, Mills said.

Original post:
Health care experts see more choice, competition for Sonoma County patients

UCLA Longevity Center’s Healthy Aging Conference Set For Oct. 27

Posted: at 5:12 pm

Courtesy Image

The UCLA Longevity Center will host a Healthy Aging Conference, which will take place Saturday, Oct. 27 at the Olympic Collection Conference Center in West Los Angeles.

The conference theme is Healthy Aging Taking Control of Your Life and features a diverse group of speakers that represent the UCLA community and beyond.

Speakers announced include Dr. Gary Small, author and Director of the UCLA Longevity Center; UCLA geriatric physician and researcher Dr. David Merrill; motivational speaker and author Joan Moran; Tim Carpenter, Founder and Executive Director of EngAGE; UCLAs noted couples/sex therapy expert Dr. Walter E. Brackelmanns; Dr. L. Stephen Coles, Director of the LA Gerontology Research Group and the Supercentenarian Research Foundation; and many others.

Panels include:

Nutritious Eating for Healthy Aging

The Centenarians: Life Past the Century Mark

Train Your Brain: Boot Camp For Your Mind

Alzheimers Research Update

Sex After 70

See the article here:
UCLA Longevity Center’s Healthy Aging Conference Set For Oct. 27

Commentary on Progeria Therapy Trials at the SENS Foundation

Posted: at 3:48 pm

Over at the SENS Foundation, you'll find fairly detailed commentary from Michael Rae on the recent news of progress towards a viable therapy for the rare accelerated aging condition progeria. As I've noted in recent years, one of the things learned about the mechanisms of progeria is that they seem to be a greatly exaggerated version of processes that happen in all of us - in the same sense that the runaway mechanisms of Alzheimer's or Parkinson's disease (and many other age-related conditions) take place at low levels in all of us.

So should we do more than keep a weather eye on progeria research? Probably not:

All of us at SENS Research Foundation are inspired by the rapid progress that was made against this tragic disease ... However, it is also important not to read too much into this apparent advance in regards to its implications for the development of new medicines against the diseases and disabilities of aging. In particular, the common characterization of HGPS "progeria" as a disease of "premature aging" leads some to expect that this research has direct implications for the development of rejuvenation biotechnologies, targeting the damage and disabilities of aging.

It is true that the splicing defect responsible for formation of progerin is sporadically active in wild-type cells, and that number of cells in which progerin is present and the level at which it appears do appear to rise with aging. However, such cells are rare enough, and their progerin levels low enough, as to seem highly unlikely to meaningfully contribute to tissue dysfunction with aging, at least within the bounds of a currently-normal lifespan. Additionally, there is evidence that progerin can be turned over in the nuclear lamina, and the causal relationship between the higher prevalence of progerin in aging cells and cellular senescence or disease are not clear, leaving open the possiblity that repair of well-established forms of aging damage may in turn lead to the reversal or obviation of this phenomenon.

Notably, the need to remove "senescent" cells as part of a comprehensive panel of rejuvenation biotechnologies is already clear from first principles, and its potential to ameliorate aspects the frailty and disability of aging has been demonstrated in proof-of-concept rejuvenation research, rendering the specific role of progerin in the process moot. That is, removing "senescent" cells is essential whether progerin accumulation is a cause or a consequence of cellular senescence, and will be equally effective as a regenerative medical therapy against age-related disability in either case.

It is absolutely the case that we'd expect new and interesting challenges to show up once people are living well past the normal human life span. We'd expect to see forms of biological damage that are generally irrelevant over the course of a century turn out to be lethal at two centuries, for example - perhaps nuclear DNA damage, perhaps progerin accumulation, perhaps the fact that some important macromolecules are never normally replaced, perhaps more obscure aggregated metabolic waste products. So largely things we presently know about, can presently ignore, and will have a great deal of time to work on should it turn out to be problem down the line.


Shorter People Tend to Live Longer

Posted: at 3:47 pm

It is thought that size in humans relates to life expectancy via aspects of metabolism such as growth hormone - less growth hormone means a smaller size but longer life in mammal species. Ames dwarf mice are an example of this taken to an extreme through genetic engineering, lacking growth hormone but living more than 60% longer than their peers.

From an evolutionary perspective, an abundance of food and good health in early life or gestation is thought to trigger a more aggressive front-loading of growth and fertility - which comes at the cost of faster decline once an individual is beyond their reproductive lifespan:

Sardinians have been studied extensively looking for clue to long lifespan. In the current study researchers analyzed the role of a person's height in their eventual lifespan. The researchers analyzed the height of men when they entered the military at age 20 between the years of 1866 and 1915. A total of 685 subjects were analysed. These heights were then related to the persons eventual age at death. It was found that shorter people (shorter than 161.1 cm) lived significantly longer on average than taller people (taller 161.1cm). Furthermore at age 70, taller people lived on average 2 years less than shorter people. At age 70 each quarter inch of height reduced lifespan by one year.

The authors write: In conclusion, shorter people and taller people exhibit differences in longevity. Although a tall body generally reflects abundant nutrition and good living conditions during the growth period, this height has negative ramifications as well. Biological mechanisms indicate that a larger body places greater stress on cells, tissues, and organs, which can reduce longevity.

Link: http://extremelongevity.net/2012/09/26/shorter-people-live-longer/


Rate of Increase of Short Telomeres Predicts Longevity in Mammals

Posted: at 3:47 pm

Telomeres are the protective caps at the end of chromosomes. They shorten with cell division, and so are part of the clock which decides when a cell reaches the Hayflick limit and ceases dividing. There is much more to it than this, however: telomere length across all the cells in a piece of living tissue is dynamic, as there are processes that lengthen telomeres as well - such as the activity of telomerase.

In general average telomere length erodes with age, reflecting the progressive breakdown of the body's ability to maintain itself - but this proceeds quite differently in different tissues and different species. It can even be reversed in the short term if the health of an individual improves, though in the long term the overall progression is still downhill.

Shorter average telomere length has been correlated with measures of health in statistical studies, but data allowing prediction of longevity for an individual has proven elusive to date. Here, however, a more sophisticated measure of telomere dynamics is show to be predictive of life span in individual mice:

Aberrantly short telomeres result in decreased longevity in both humans and mice with defective telomere maintenance. Normal populations of humans and mice present high interindividual variation in telomere length, but it is unknown whether this is associated with their lifespan potential. To address this issue, we performed a longitudinal telomere length study along the lifespan of wild-type and transgenic telomerase reverse transcriptase mice.

We found that mouse telomeres shorten ?100 times faster than human telomeres. Importantly, the rate of increase in the percentage of short telomeres, rather than the rate of telomere shortening per month, was a significant predictor of lifespan in both mouse cohorts, and those individuals who showed a higher rate of increase in the percentage of short telomeres were also the ones with a shorter lifespan. These findings demonstrate that short telomeres have a direct impact on longevity in mammals, and they highlight the importance of performing longitudinal telomere studies to predict longevity.

Link: http://dx.doi.org/10.1016/j.celrep.2012.08.023


An Update on Myostatin Research

Posted: at 3:47 pm

Based on what we know today, inhibition of myostatin in muscle tissue looks like one of the few win-win, all-round beneficial alterations that could be made to human metabolism. Lacking myostatin, a mutation that occurs naturally in very rare cases, an individual has much more muscle, less fat, and resistance to some of the common issues that occur with aging - though it is unclear as to how much of that latter benefit stems from an extended ability to exercise and the comparative lack of visceral fat. A sedentary lifestyle and excess visceral fat are both very bad for you over the long term, causing a shorter life expectancy and greater risk of many forms of age-related disease and disability.

Myostatin inhibitors are under investigation as the potential basis for therapies to slow or reverse the progressive loss of muscle mass and strength that occurs with age, a condition known as sarcopenia. The physical frailty of aging is something of a self-reinforcing downward spiral, and addressing even just the muscle strength component of this decline could bring noteworthy benefits.

Research into myostatin dovetails with research into the decline of stem cells with aging, such as the satellite cells in muscle. The fading activity of the satellite stem cell populations that support muscle tissue is thought to be one contributing cause of sarcopenia. Others range from chronic inflammation through to a progressive inability to make proper use of leucine in the diet.

There is no claim that inhibition of myostatin will address the root causes of sarcopenia: it is more a matter of dialing up the "build muscle" switch to levels that do not normally occur as a way of compensation. As a method of doing so it seems to cause no undue complications - which is a good thing and sadly very rare due to the overwhelming complexity of our biology - but it is nonethless far from ideal. In that ideal world, we'd want all therapies (for aging or otherwise) to tackle root causes rather that patch over symptoms, but sometimes you take what you can get.

In any case, here is an update from the world of myostatin research with some additional information on how things tie together under the hood:

Blocking myostatin function in normal mice causes them to bulk up by 25 to 50 percent. What is not known is which cells receive and react to the myostatin signal. Current suspects include satellite cells and muscle cells themselves. In this latest study, researchers used three approaches to figure out whether satellite cells are required for myostatin activity. They first looked at specially bred mice with severe defects in either satellite cell function or number. When they used drugs or genetic engineering to block myostatin function in both types of mice, muscle mass still increased significantly compared to that seen in mice with normal satellite cell function, suggesting that myostatin is able to act, at least partially, without full satellite cell function.


to further confirm their theory that myostatin acts primarily through muscle cells and not satellite cells, the team engineered mice with muscle cells lacking a protein receptor that binds to myostatin. If satellite cells harbor most of the myostatin receptors, removal of receptors in muscle cells should not alter myostatin activity, and should result in muscles of normal girth. Instead, what the researchers saw was a moderate, but statistically significant, increase in muscle mass. The evidence once again, they said, suggested that muscle cells are themselves important receivers of myostatin signals. ... since the results give no evidence that satellite cells are of primary importance to the myostatin pathway, even patients with low muscle mass due to compromised satellite cell function may be able to rebuild some of their muscle tone through drug therapy that blocks myostatin activity.

"Everybody loses muscle mass as they age, and the most popular explanation is that this occurs as a result of satellite cell loss. If you block the myostatin pathway, can you increase muscle mass, mobility and independence for our aging population? [Our] results in mice suggest that, indeed, this strategy may be a way to get around the satellite cell problem."

So myostatin inhibition continues to look like a promising form of patch, in that it fails to address root causes but nonetheless produces meaningful benefits with few if any unwanted side-effects - which is more than can be said for many other forms of patch either in operation or under development in the world of medicine.


Overexpressing Fatty-Acid-?-Oxidation-Related Genes Extends Fly Lifespan

Posted: at 3:47 pm

Researchers here investigate another portion of the mechanisms of metabolism that are influenced by calorie restriction and many of the known longevity genes. This sort of discovery helps to fill in a very complicated landscape of intertwining effects and controllers of effects - at some point in the not too distant future the research community will be able to set out a complete map of how all of the longevity genes and known ways to extend life in laboratory animals relate to one another and work through an overlapping set of mechanisms:

In this study, we demonstrated that the overexpression of fatty-acid-?-oxidation-related genes extended median and maximum lifespan [in flies] and increased stress resistance, suggesting that the level of fatty-acid ?-oxidation regulates lifespan.

Consistent with our results, many investigations have suggested fatty-acid ?-oxidation as a lifespan determinant. One of the well-known longevity-candidate genes, AMPK reportedly regulates fatty-acid synthesis and oxidation. Moreover, calorie restriction and [insulin/insulin-like growth factor (IGF) signaling (IIS)] have been reported to promote fatty-acid ?-oxidation. In addition, enigma mutant, which exhibits oxidative stress resistance and a longevity phenotype, was found to encode a fatty-acid-?-oxidation related enzyme. ... However, the present study is the first to provide direct evidence that the modulation of fatty-acid-?-oxidation components extends lifespan.

Our data showed that lifespan extension by dietary restriction decreased with the overexpression of fatty-acid ?-oxidation-related genes, indicating that lifespan extension by fatty-acid-?-oxidation components is associated with dietary restriction. It was previously reported that calorie restriction increased whole-body-fat oxidation. Energy deprivation subsequent to calorie restriction activates AMPK, which subsequently enables the increase of fatty-acid oxidation necessary to utilize the energy resource. These findings suggested that fatty acid oxidation and dietary restriction are related by same underlying mechanisms.

Link: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3446750/


Anticipated short-term cell therapy industry clinical milestones

Posted: at 3:46 pm


What follows is an interesting but not exhaustive list of cell therapy industry clinical milestones we anticipate in the next 3-9 months as selected from the list of cell therapy products we are tracking in late-stage or post-commercial development.  

There are other commercial milestones we are monitoring as well as other clinical milestones we expect to see related to cell therapy products in earlier stages of the development pipeline that are not included below.

CellCoTec (http://www.cellcotec.com)
  • Having completed a trial in Europe of their device to enable POC production of an autologous chondrocyte cellular product in/with a biodegradable, load-bearing scaffold for the treatment of articular cartilage defects, they have now submitted their CE market application.  The CE mark application is under review and they anticipate a response in October.  
  • This device and the potential emergence of Sanofi's MACI in the European market next year may have an impact on Tigenix (EBR:TIG) most directly.

ERYtech Parma (http://www.erytech.com)

  • Their 'pivotal' phase 2/3 trial in Europe of lead product, GRASPA, for the treatment of Acute Lymphoblastic Leukemia (ALL) is scheduled for completion 2H 2012. 

GamidaCell (http://www.gamidacell.com)

  • Their 'pivotal' phase 2/3 trial in the US, Israel, and Europe of lead product, StemEx, for the treatment of leukemia and lymphoma, in joint development with Teva, completed enrollment in February and is scheduled for completion 2H 2012.  They have not been shy about the fact they expect to be in the market in 2013.

Innovacell (http://www.innovacell.com)

  • They raised over 8m Euro in April for a phase 3 trial in Europe for their lead product, ICES13, for the treatment of stress-urinary incontinence which was scheduled for a preliminary clinical data readout in Q4 2012 and be ready for market authorization in 2013. Since announcing the capital raise the company has been stone silent and no clinical trial registry has been filed.  Status unknown.

Miltenyi Biotec (www.miltenyibiotec.com)

  • Their phase 3 trial in Germany of CD133+ cells as an adjunct to CABG surgery for myocardial ischemia or coronary artery disease is scheduled for completion in January.

NovaRx (http://www.novarx.com)

  • Their phase 3 trial in US, Europe, and India of their lead product, Lucanix, for the treatment of advanced Non-small Cell Lung Cancer (NSCLC) following front-line chemotherapy is scheduled in clnicaltrials.gov for completion in October but we have learned they expect their next 'interim analysis' in February.

NuVasive (http://www.nuvasive.com)

  • They have a series of trials scheduled to complete 2H 2012 intended to provide additional clinical data to support its marketing of Osteocel Plus for the treatment of a growing number of orthopedic applications.

Sanofi's Genzyme (http://www.genzyme.com)

  • Having completed their phase 3 trial in Europe of MACI for knee repair (symptomatic articular cartilage defects of the femoral condyle including the trochlea), they expect to file their market authorization application (MAA) in 1H 2013.

Hope that's helpful and gives you a sense some of the late-stage things to watch for in the coming weeks and months.  


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


The cost of clinical trial data bias/loss, FDA’s new job and the need for bold leadership.

Posted: at 3:46 pm


The scandal of clinical trial data loss is eroding the fundamentals of evidence-based research and clinical medicine.

Before you right this post off as the stuff of conspiracy theories, fear-mongering, and 'alternative world views' consider that this view is shared by the likes of the FDA, the International Committee of Medical Journal Editors, the Cochrane Collaboration, and researchers at institutions like Johns Hopkins School of Medicine.

Here's the underlying premise as succinctly described by author Ben Goldacre:

"Drugs are tested by the people who manufacture them, in poorly designed trials, on hopelessly small numbers of weird, unrepresentative patients, and analysed using techniques that are flawed by design, in such a way that they exaggerate the benefits of treatments. Unsurprisingly, these trials tend to produce results that favour the manufacturer.

When trials throw up results that companies don't like, they are perfectly entitled to hide them from doctors and patients, so we only ever see a distorted picture of any drug's true effects. Regulators see most of the trial data, but only from early on in a drug's life, and even then they don't give this data to doctors or patients, or even to other parts of government. This distorted evidence is then communicated and applied in a distorted fashion."

Authors M. Todwin and J. Abramson summarize it thusly:

"Trials with positive results generally are published more frequently than studies that conclude that a new drug poses greater risks or is no more effective than standard therapy or a placebo. Furthermore, some articles may distort trial findings by omitting important data or by modifying prespecified outcome measures. Lack of access to detailed information about clinical trials can undermine the integrity of medical knowledge."

Here is a great list of very recent resources that may convince you of the merits of this concern:

Yesterday, the US Secretary of Health and Human Services announced (in an FR notice) that the FDA was now charged with ensuring all organizations comply with the heretofore enacted but relatively unenforced  requirement to submit all relevant clinical trial data to http://www.clinicaltrials.gov

For further commentary on this move see the following reports from:
What is abundantly clear to me is that the FDA is left almost powerless - and if not powerless than certainly without sufficient resources - to successfully enforce its new power.  This requires collective industry leadership.  Bold, industry-initiated standards, infrastructure and old-fashioned peer pressure.

Here's what I wish.  

I wish that as a cell therapy industry we - through organizations like ISSCR, ARM, ISCT, etc and leading publishers of some of our leading journals like Regenerative Medicine, Cytotherapy, Cell Stem Cell, Stem Cells, etc - would take a leadership position on an issue like this.

I believe that as a relatively small and nascent sector of the biopharma industry we are more likely capable of collaborating on something important like this than larger, more established [entrenched] and diverse sectors.  Of course it requires the political will and cajones.

The payoff from our sector in taking a leadership role on this issue could potentially be enormous in terms of providing our sector with truly transparent and useful data.  Perhaps even more important would be the public profile such leadership would provide the sector.  Such a move requires bold leadership, pain, and cost but this is the kind of stuff that moves the needle and goes down as critical pivot points in history. 

Just my thought for the day...


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


Fortune Magazine on California Stem Cell Agency: Warm, Personal and Favorable

Posted: at 3:46 pm

California's $3 billion stem cell
research effort today garnered a handsome dollop of favorable
national news coverage– a lengthy piece in Fortune magazine that
spoke of looming stem cell cures and the leading role of the state
stem cell agency.

The article led the Fortune web page online at one point this morning and
likely will be read by tens of thousands of persons, although it was not the cover story on the print product. 
Written by a former senior editor of
the magazine, Jeffrey O'Brien of Mill Valley, Ca., the piece was warm
and personal. He began with the story of his 95-year-old
grandmother and her health issues, ranging from arthritis to macular
degeneration. And he wrote,

“The citizens of California have
spoken. If my grandmother and I had the power to get the rest of the
country to follow, we would.”

O'Brien also discussed the science and
finances of the stem cell business. He said,

“To be clear, the earliest stem cell
therapies are almost certainly years from distribution. But so much
progress has been made at venerable research institutions that it now
seems possible to honestly discuss the possibility of a new medical
paradigm emerging within a generation. Working primarily with rodents
in preclinical trials, MDs and Ph.D.s are making the paralyzed walk
and the impotent virile. A stem cell therapy for two types of macular
degeneration recently restored the vision of two women. Once they
were blind. Now they see!

“Some experts assert that AMD could
be eradicated within a decade. Other scientists are heralding a
drug-free fix for HIV/AIDS. Various forms of cancer, Parkinson's,
diabetes, heart disease, stroke, and ALS have already been eradicated
in mice. If such work translates to humans, it will represent the
type of platform advancement that comes along in medicine only once
in a lifetime or two. The effect on the economy would be substantial.
Champions of stem cell research say it would be on the order of the
Internet or even the transistor.”

O'Brien continued,

“The obstacles along the road from
lab rat to human patients are many, of course, but the biggest by far
is money. With the dramatic events in the lab, you might think that a
gold rush would be under way. That's far from true. Long time
horizons, regulatory hurdles, huge R&D costs, public sentiment,
and political headwinds have all scared financiers. Wall Street isn't
interested in financing this particular dream. Most stem cell
companies that have dared go public are trading down 90% or more from
their IPOs. Sand Hill Road is AWOL. The National Venture Capital
Association doesn't even have a category to track stem cell

As for the California stem cell agency
itself, the article contained remarks from its Chairman J.T.Thomas,
President Alan Trounson and former chairman Robert Klein about the origins and progress of the California Institute for Regenerative Medicine (CIRM).
O'Brien wrote, 

“The $1.7 billion awarded so far has made one obvious mark on the state: a dozen gleaming research institutions. CIRM has proved adept at getting billionaires to donate funds to the cause.”

O'Brien interviewed a several
prominent businessmen who have contributed tens of millions of
dollars to stem cell research “about the prospects of a legitimate industry emerging.” One was “bond genius” Bill Gross, who has
contributed to UC Irvine. Gross replied.

“Goodness, you're talking to the
wrong guy. Our donation had nothing to do with business.”

Eli Broad, another big stem cell donor,
said pretty much the same thing. And Andy Grove, the former chairman
of Intel, was “surprisingly full of doom and gloom.” O'Brien

“For close to two hours, Grove argues
passionately about how the FDA is enabling predatory offshore
industries by impeding progress and the many reasons financiers want
no part of stem cells. "VCs aren't interested because it's a
shitty business," he says. Big Pharma? Forget it. CIRM? "There
are gleaming fucking buildings everywhere. That wasn't necessary."
When I press him to be constructive, he wearily offers one possible
solution. Rather than courting billionaires to put their names on
buildings, we need a system of targeted philanthropy in which the 99%
can sponsor the individual stem cell lines that matter to them.”

O'Brien said, however,

“It was clear during our talk that
Grove wants an economic model for stem cell research and development
to emerge, even if he's not willing to bet money on its happening.
And that puts him in good company.”

While the Fortune article has its
negative points about stem cell research, it is about as laudatory as
it is going to get at this point for the California stem cell agency.
The piece recognizes and even celebrates much of the work of the
agency. The article clearly details the void in financing
for commercialization of stem cell research, bolstering support for
efforts like those in California. Importantly, it also helps to push
the activities of the stem cell agency more fully into the national
discussion of stem cell research and its future. That should pay off
again and again in future news coverage and also benefit the stem
cell agency as it explores the possibility of additional funding –
either private or public – after the cash for new awards runs out
in 2017.

(The story is in the Oct. 8, 2012, edition of Fortune.)


$700,000 Blue-ribbon Study of CIRM All But Finished

Posted: at 3:46 pm

The $700,000 study of the $3 billion
California stem cell agency is nearly concluded and is expected to be
released sometime in November.

A draft of the report has been sent out
for “peer review” and no additional public meetings are
scheduled, according to a spokeswoman for the Institute of
, which is conducting the study. The IOM did not respond
to questions from the California Stem Cell Report about the number of peer reviewers or how they were selected.
The study began last year under a contract with the stem cell agency, which commissioned the effort, in
part, because agency directors hoped the findings by the blue-ribbon
panel would bolster efforts to win voter approval of another multi-billion dollar state bond issue. More recently the agency has
explored the possibility of private financing to continue operations.
The agency is expected to run out of
funds for new awards in 2017. It currently has something in the
neighborhood of $700 million for awards that is not already committed
in one fashion or another.
Christine Stencel, senior media
relations officer for the IOM, said in an email,

There will be no
further information-gathering meetings. The committee members have
finished drafting their report and it is now undergoing peer review.
Reviewers are anonymous to study staff and committee members; they
will be listed in the front matter of the report when it’s finished
and released.”

She said the stem
cell agency will not be given an opportunity to comment further.
Stencel said,

Sponsors are not
treated as peer reviewers; that is, they’re not afforded an
opportunity to comment on IOM draft reports prior to public release.
IOM is aiming for a public release in November (the exact time frame
will hinge on the duration of the peer review, which is influenced by
people’s schedules and adherence to deadlines). IOM is looking at
options for how best to hold this release, whether there will be an
event of some sort. Once plans are set, they’ll be noted on the
project web pages and IOM will alert the various stakeholders and
interested parties of the plans. The study is moving along and we’re
looking forward to the report’s debut in the not too distant


October CIRM Board Meeting Moved to Burlingame

Posted: at 3:46 pm

The location of the October meeting of
the governing board of the California stem cell agency has been
changed from Irvine to Burlingame, near San Francisco International
Airport, in an effort to save travel costs.  

CIRM Chairman J.T. Thomas said the
one-day meeting is being moved because the session will require the
attendance of a large number of CIRM staffers who are based in the
agency's San Francisco headquarters. They will be involved in
presentations involving the agency's new strategic partnership fund and other matters.
The date of the meeting remains
unchanged – Oct. 25. Look for posting of the agenda on the CIRM web
site on Oct. 15. The site of the meeting is the Hilton Bayfront
, 600 Airport Blvd.


CIRM Sponsoring Online Session with FDA on Thursday

Posted: at 3:46 pm

One of the lesser known activities of
the California stem cell agency is webinars that put researchers
together with the folks who make the federal decisions about whether
stem cell research will be turned into therapies.

One of those sessions is coming up on Thursday, and it is not too late for scientists and other interested
parties to get on board.
Writing on the stem cell agency's blog,
Cynthia Schaffer, CIRM's contract administrator and compliance officer
had this to say today about the webinars.

“The FDA very graciously donates
their time to speak on these webinars because they too have pledged
to maintain an active dialogue with the industry and provide
education on their regulatory expectations for product development in
the regenerative medicine field. CIRM science officer Kevin
wrote a paper
with Celia Witten of the FDA about the role of the
FDA in reaching out to regenerative medicine community, including
webinars such as these. 

“In that paper they point out that
the communication goes both ways:

“'Appropriate regulation requires a
strong understanding of the latest scientific developments to meet
current and future regulatory needs and challenges.'

“So the FDA benefits by learning from
the other speakers in the webinar – what is the current state of
the technology, what are investigator’s current thoughts on best
practices and the latest research findings, etc. They also learn what
the industry is facing by listening to the questions asked and the
discussion of the challenges during the Q&A sessions. A group of
FDA employees attend each of these CIRM sponsored webinars, and the
wide variety of other workshops and meetings that CIRM hosts
throughout the year.”  

(Editor's note: An earlier version of this item incorrectly identified Cynthia Schaffer as Cynthia Adams.)


$1.5 Billion in Stem Cell Awards Goes to Directors’ Institutions

Posted: at 3:46 pm

The Sacramento Bee today published an article that reported that $1.5 billion, more than 90 percent of the amount dispensed by the California stem cell agency, has gone to institutions linked to past and present directors of the agency.

The piece was carried on the front page of the newspaper's Sunday Forum section and was written by David Jensen, publisher-editor of the California Stem Cell Report.

The text of the Forum article is below. The Bee also carried a chart listing the top 10 recipient institution. The full text of the comments from Alan Trounson, president of the California stem cell agency,  and two other persons quoted in the article can be found here.

Stem cell cash mostly aids directors' interests

Special to The Bee

By David Jensen

With its latest round of awards earlier this month, California's stem cell agency has now handed out $1.5 billion to enterprises linked to its directors.

The figure amounts to 92 percent of the $1.7 billion awarded by the agency. The grants and loans range from $261 million to Stanford University, whose medical school dean, Philip Pizzo, sits on the agency's governing board, to $170,500 to Children's Hospital in Oakland, whose president, Bert Lubin, also is a member of the board.

The University of California, Davis, has received $128 million. Claire Pomeroy, chief executive officer of UC Davis Health System, is another one of the 29 board members. In all, 27 institutions with past or present representatives on the agency board have received funding.

None of this is illegal. And none of it is likely to change. The situation was created by Proposition 71, the 2004 ballot measure that established the state's $3 billion stem cell agency, formally known as the California Institute for Regenerative Medicine, or CIRM. The initiative was crafted so that virtually all of the institutions that stood to benefit from the state's largesse had seats at the table where the money is handed out.

The built-in conflicts of interest at CIRM have perturbed some experts in California government, but concerns have also reached into the scientific community. The prestigious journal Nature, in 2008, editorialized against what it called cronyism at CIRM. It said the agency "must fight the tendency of the academic institutions on the board to hoard dollars."

Some California scientists, wary of offending those who control the lifeblood of their research, privately grumble about an "old boys network."

Joe Mathews, co-author of "California Crackup," a study of major issues in state government, said last week: "California ballot initiatives are a terrible way to make public policy. And they are even worse as a method for making scientific policy."

The stem cell agency has a different view. Alan Trounson, president of the San Francisco-based enterprise, said: "There is no evidence that any of CIRM's funding decisions have been driven by conflicts of interest. Indeed, CIRM rigorously enforces its conflict of interest rules at each stage of the funding process to ensure that all decisions are made on the merits of the proposal for funding and not as a result of any conflicts of interest."

Mathews, California editor of Zocalo Public Square, and others point to the creation of the California stem cell agency as an example of abuse of the initiative process by special interests. The 10,000 words in Proposition 71 were written in private by Bay Area real estate investment banker Robert Klein and a handful of associates, who quietly determined the composition of the board. Klein later served six years as the first chairman of the stem cell agency, leaving in June 2011.

Klein later argued publicly that placing medical school deans and university and research institution executives on the board provided the expertise needed to make the decisions about how to spend the research money. However, the makeup of the board also served to win the support of institutions that envisioned the prospect of fresh cash – in this case money that the state borrows via bonds.

Mathews described the state's initiative process this way: "Essentially, to win the support of various groups whose money and backing is important to passage of a bond, a sponsor of an initiative bond will set up rules and include money specifically intended for each group. This is a form of pay-to-play. Agree to back the initiative, and you're in."

Bob Stern, who co-wrote the California Political Reform Act, said, "It would have been better had institutions receiving grants not to have had their representatives on the board awarding grants."

Trounson said the board follows "best practices" when it comes to grants and legal conflicts of interest. The agency has worked out an unusual procedure to prevent its directors from violating conflict of interest laws as they vote on applications that seek as much as $20 million each. Before each public session, agency attorneys determine which board members cannot vote on a proposal because of legal conflicts of interest. Applications to be approved are considered as a group. Each board member then votes on the entire group by saying, "Yes, on all those except with which I have a conflict."

No final tally is announced. The public can ferret out the overall vote a month or two later in the minutes of the meeting on the CIRM website (http://www.cirm.ca.gov). But the minutes do not list individual votes or conflicts of interest.

Domination of the board by academics and nonprofit institutions has led to bitter complaints from business. Less than 7 percent of all awards have gone to for-profit enterprises. Currently, however, the agency is embracing industry more warmly in an effort to commercialize stem cell research, which raises another set of coziness problems. They surfaced in July and again this month.

Klein, who led the stem cell ballot campaign before becoming chairman of the agency, appeared before his old board to lobby on behalf of a $20 million request from StemCells Inc. of Newark. The California firm was founded by the eminent Stanford stem cell scientist Irv Weissman. He sits on StemCells Inc.'s board, and he and his wife hold 273,821 shares of stock in the firm. Weissman was also an important backer of Proposition 71, working the "billionaire circuit" and raising more than $1 million for the campaign, according to an article in San Francisco magazine.

CIRM's reviewers had rejected StemCells Inc.'s application. After Klein made his pitch in July, the board sent the application back for re-review, an unusual procedure.

When the application returned to the board early this month, reviewers again rejected it. Klein again importuned his former colleagues, and – following a closed door session – the board approved the award, 7-5.

Eleven members were disqualified from voting because of legal conflicts of interest. It was the first time in the board's eight-year history that it approved an application twice rejected by reviewers.

Mathews said no likelihood exists of changing the board structure at CIRM. He said it is "baked in" by Proposition 71. That's because Klein and company wrote into the initiative a requirement for a super, super-majority vote – 70 percent – of each house of the Legislature to make any modifications.

Another initiative could be mounted, but that possibility is also exceedingly remote. 


Text of Comments on Awards to Stem Cell Directors’ Institutions

Posted: at 3:46 pm

Here is the full text of comments made
by the California stem cell agency, Joe Mathews, co-author of
California Crack-Up” and Bob Stern, former president of the
Center for Governmental Studies and co-author of the California
Political Reform Act
, in connection with the Sept. 23, 2012, article
in The Sacramento Bee headlined “Stem Cell Cash Mostly Aids Directors' Interests.” The comments were abbreviated for
publication in The Bee because of newspaper space constraints.

Comments by Alan Trounson, president of

“To make sure we do the best job of
managing taxpayer's money it's natural that we turn to people who
know most about stem cells and stem cell research. In fact, as the
state's own Little Hoover Commission reported in its analysis of
CIRM: “The fact that CIRM funding has gone largely to prestigious
California universities and research institutes is hardly surprising
and should be expected, given the goals of Proposition 71 and the
considerable expertise resident in these research centers.” But in
recruiting the best minds, we also adopt best practices to ensure
that there is no conflict of interest. Every board member has to
recuse themselves from voting on, or even being part of a discussion
on anything to do with their own institution, or to an institution or
company that they have any connections to. All this is done in
meetings that are open to the public. CIRM’s conflict of interest
rules have been subject to multiple reviews – by the Bureau of
State Audits, the Little Hoover Commission and the Controller – and
there is no evidence that any of CIRM’s funding decisions have been
driven by conflicts of interest. Indeed, CIRM rigorously enforces its
conflict of interest rules at each stage of the funding process to
ensure that all decisions are made on the merits of the proposal for
funding and not as a result of any conflicts of interest. 

“In addition all funding applications
are reviewed by an independent panel of scientists on our Grants
Working Groups, all of whom are out-of-state and meet strict conflict
of interest requirements, and it is their recommendations that help
guide the ICOC (CIRM governing board) on what to fund.”

Joe Mathews' comments:

“California ballot initiatives are a
terrible way to make public policy. And they are even worse as a
method for making scientific policy. 

“It's not merely that
this initiative was drafted in such a way as to benefit the
enterprises of its directors. It's that, under this initiative's own
provisions and the California constitution, it's so hard to change
Proposition 71 and fix what ails CIRM. Effectively, these provisions are
baked in, and nothing short of another vote of people can really make
the change. (Yes, there are provisions, as you know, that permit the
legislature by super-majority to do things, but supermajorities are
effectively out of reach in California). 

“Sadly, initiatives
like Proposition 71 are not uncommon. Many measures are drafted to benefit
the people who would support the measure, or oversee the program
established. This has been very common with bonds. Essentially, to
win the support of various groups whose money and backing is
important to passage of a bond, a sponsor of an initiative bond will
set up rules and include money specifically intended for each group.
This is a form of pay-to-play. Agree to back the initiative and
you're in. And it happens because there's no rule against it and
because passing initiatives in California require difficult,
expensive campaigns. 

“And this sort of thing will continue
to happen. There is no serious push to do anything about this.
Indeed, good government groups and reformers in California have
opposed changes to the initiative process -- because they want to use
the process for their own schemes.”

Bob Stern's comments:

“It would have been better had
institutions receiving grants not to have had their representatives
on the board awarding grants. On the other hand, we want to have the
most knowledgeable people on the board overseeing this very important
program. The question: Were these people the only qualified ones to
sit on the board?”


Bohol nutrition scholars go for zero malnutrition

Posted: September 29, 2012 at 8:11 pm

Cebu Daily News

BOHOL Gov. Edgar Chatto led the launching of the 10th Barangay Nutrition Scholars Congress at the Bohol Cultural Center on Thursday.

This is to jumpstart its program on zero malnutrition for Bohol in 2015.

Bohol Association of Barangay Nutrition Scholars president and national Outstanding Barangay Nutrition Scholar awardee Irenea Ordinario cited the strong leadership of Chatto as the organization continues its advocacy for nutrition improvement.

Nutrition programs in the province are implemented by the Provincial Health Office led by Dr. Reymoses Cabagnot and the Office of the Provincial Agriculturist headed by Nutrition Action officer Larry Pamugas.

Chatto recognized the efforts of barangay nutrition scholars and urged them to lead the implementation of various programs, such as Bahay Kubo Food always in the home or Faith, Herbal Organic Plants Enhancement (Hope) and Chicken always raised/ready in the yard (Charity).

The governor said sufficient food leads to proper nutrition, which in turn leads to healthy well-being.

This years regional outstanding barangay nutrition scholar awardee Christie Renoblas of Buenos Aires, Tubigon was recognized during the congress.

A barangay nutrition scholar for three years, Renoblas initiated several income generating projects (IGPs) to sustain their regular feeding program in the community. One of the IGPs is the swine raffle, where two male and female swine would be given to the residents for reproduction. A few months after birth when the piglets are not anymore put under milk, the residents will give back at least four piglets, of which three would be raffled off and one sold for nutrition fund.

Other IGPs are tilapia fishpond, a BNC garden where they grow vegetables used as ingredients for their feeding and the Palayan sa Nutrition, where one-fourth of the harvested rice is also used for the feeding.

Read more:
Bohol nutrition scholars go for zero malnutrition

Optimum Nutrition- Platinum Hydrowhey – First Nutrition.flv – Video

Posted: September 28, 2012 at 8:13 pm

28-09-2012 04:48 Platinum Hydro Whey from Optimum Nutrition

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Optimum Nutrition- Platinum Hydrowhey - First Nutrition.flv - Video

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