Yesterday, our friends at BIOtechNOW posted the following information about participating in a survey about the FDA. We encourage you to check it out:
Posted by georgeatbio on February 1st, 2010
In an ideal world, everyone would have a strong and positive relationship with the FDA. With that as a goal, PricewaterhouseCoopers has launched its fifth survey –Improving America’s Health V Survey – to gauge the working relationship between the life sciences industry and the FDA. Your feedback is important to make this survey a success.
To participate, please send an email to PricewaterhouseCoopers.and.BIOCOM@us.pwc.com with “Life Sciences FDA Survey” in the subject line. A survey will then be forwarded to you. The survey should take only 15 to 20 minutes to complete. All responses to the survey will be kept confidential and private.
Those who participate in the survey will receive a preview copy of the results prior to their public release. The survey will close on Feb. 26. Please help foster improved relations between our industry and the FDA.
I don’t know about you, but we’re pretty excited about the event on February 12th –
Now Serving: 9 Billion: Global Dialogue on Meeting Food Needs for the Next Generation.
If you’re as excited as we are to get answers to some of the most critical questions we face in meeting a growing global population’s food and water needs, here’s a site badge you can place on your blog, website, facebook page… just about anywhere. Click the “Get Widget” button to get started.
As we recover from Super Bowl Sunday and several feet of snow, we give you our weekly round up of new things video and biotechnology. This week we’ve got a couple of biotech CEO’s and a company whose goal is to solve world hunger. And we learn that biotech tastes like chicken. Go figure.
Meet Matt Caspari – I always enjoy meeting founders of biotechnology companies. They never cease to impress me. I’m not just blowing smoke. Sure they can be a bit cocky (understatement). But you can’t beat them when it comes to intelligence, willingness to take risks, and thinking big. This video features Matt Caspari. Watch (and listen) as Matt walks through his approach and vision for Aurora Biofuels. See how biotech is made.
Syngenta Takes Stock – And is doing that very well. Here’s a report by Bloomberg featuring Michael Mack, chief executive officer of Syngenta AG. The world’s biggest maker of agricultural chemicals today reported better-than expected profit last year, buoyed by demand for genetically modified seeds.
Funny Name, Cool Stuff – The name is it4ip s.a. It is a Belgian start-up. Here’s the cool stuff. It develops, manufactures and commercializes precision membranes based on track etching technology. This is an old video but it was new to us. Check them out here.
The Truth About Monsanto – Here’s the latest from Monsanto. If you’ve been trolling around the blogosphere on GMOs lately you may have come across all sorts of scary stories and crazy accusations about Monsanto suing farmers. Well, here’s the ‘real’ story. Garrett Kasper cuts through the misinformation and explains what the fuss is all about.
Biotech … Tastes Like Chicken – At least after Fu-Hung Hsieh, a Missouri University professor of biological engineering and food science gets through with it. His soy substitute for chicken is much like the real thing, including having health benefits like lowering cholesterol and maintaining healthy bones.
Here’s the Plan – That is the strategic plan for BBSRC, the British-based bioscience company. This is a company that doesn’t set the bar low. Their goal: feeding 9 billion people sustainably by 2050. Remember we said we liked biotech companies because of their willingness to think big?
Davos, Sustainability, and Biotechnology – A note that this is a long video and it talks about a lot more than biotechnology. But an interesting dialogue of CEOs on sustainability, job growth and … occasionally … biotechnology.
Transgenic seed technology began to transform India’s cotton industry in 2002. Genetically modified cotton acreage has increased three-fold since that year, and the lives of millions of Indian families have been improved as cotton farmers income has increased by $124 million (USD). Indian farmers today represent some of the world’s most rapid adopters of biotech crops.
Happy Friday morning everyone! Let’s jump right into today’s biotech news.
DRUG CEOS UNDER PRESSURE–Newspapers across the country have featured stories of biotech and pharma CEOs who explain the difficulties that today’s economy and the issue of health care reform are posing.
In a separate article, Dow Jones Newswires/The Wall Street Journal reports on a high and “generational” turnover among pharmaceutical CEOs. “The new leaders are taking over an industry under pressure. The past decade has brought heightened scrutiny of drug safety, government probes of sales and marketing practices, and greater pricing pressure from drug-benefit plans and generic competitors. Drug makers feel compelled to control costs and do more to get results from the billions of dollars they pour into their research labs” (Loftus, 2/2).
BIOTECHNOLOGY GROUP OBJECTS TO U.S. STANCE ON GENE PATENTS–The Biotechnology Industry Organization recently issued a letter to the U.S. Department of Health and Human Services opposing certain provisions within a policy that would make it more difficult for scientists and companies to uphold gene patents.
“It is not the time to undertake or recommend policy changes that would undermine the foundations of American life science innovation,” said the letter signed by the chief executive officers of the biotechnology group and companies including Genzyme Corp. of Cambridge, Massachusetts, Monsanto Co. of St. Louis, Bayer AG of Germany and Human Genome Sciences Inc. of Rockville, Maryland.
A companion letter from the presidents of the Council on Governmental Relations, an association of research universities, and the Association of American Universities also objected to the proposals, saying they “will harm rather than advance the interests of patients and the public by impeding the development of effective genetic tests and patient access to them.”
THE ECONOMICS OF BIOLOGICS–Today, Portfolio.com reports on the issues involved in data exclusivity, the development of generic biologics and the recent developments in health care reform.
The threat: the White House’s move to reduce the amount of protection brand-name drug companies would have for groundbreaking biologic drugs before their generic competitors can use their data to produce cheaper, similar versions. Considering that the average single biologic takes 10 to 15 years and $1.2 billion to research and develop (and that’s not including any new special facility costs or other capital costs that a firm may incur), big money is clearly at stake for the industry.
Compared to traditional, small-molecule chemical drugs, biologics—drugs that offer the best hope for finding new cures and treatments to debilitating diseases such as cancer, AIDS, Alzheimer’s, and rheumatoid arthritis—are highly complex and made of larger living molecules. Their composition makes them virtually impossible to replicate. Attempts to produce generic, yet not-quite-the-same, versions are referred to as “follow-on biologics,” or “biosimilars.”
GLAXO TO SHUTTER NEUROLOGICAL PROGRAMS, CREATE RARE DISEASES UNIT–GlaxoSmithKline yesterday announced yet another cut to R&D, this time at the cost of almost $800 million.
Specifically, Glaxo says it will stop R&D efforts in certain neurological areas, with work grinding to a halt in depression and pain, according to Bloomberg. The company will focus on Alzheimer’s, Parkinson’s and multiple sclerosis and create an R&D unit that will concentrate on new therapies for rare diseases. Glaxo makes it quite clear that this new unit would be an active collaborator.
“We are allocating capital to areas where we can get the best return on investment,” the company says in the statement. CEO Andrew Witty told reporters that the budget cuts included a further reduction in the company’s workforce that would amount to the “hundreds rather than thousands” in the U.K.
OFFICIALS MOVE TO BOOST PRODUCTION OF BIOFUELS — The Obama administration hopes to create green jobs and cut US reliance on foreign oil. On Wednesday they announced a push to boost the production of biofuels, which could increase annual farm income by $13 billion and reduce greenhouse gas emissions.
U.S. Agriculture Secretary Tom Vilsack told reporters Wednesday that biofuels production could create “thousands of green jobs in all regions of the country.”
Meeting with members of his cabinet and governors from across the country, President Barack Obama said reaching the goal of 36 billion gallons of biofuels a year “will decrease our dependence on foreign oil by hundreds of millions of barrels per year.”
COMPARATIVE EFFECTIVENESS AND HEALTH CARE SPENDING IMPLICATIONS FOR REFORM — An article in The New England Journal of Medicine discusses whether comparative effectiveness analysis, or the assessment of the added improvement in health outcomes relative to cost, should be used to examine the US health care policy.
Title VIII of the American Recovery and Reinvestment Act of 2009 authorizes the expenditure of $1.1 billion to conduct research comparing “clinical outcomes, effectiveness, and appropriateness of items, services, and procedures that are used to prevent, diagnose, or treat diseases, disorders, and other health conditions.” Federal support of “comparative effectiveness” research has been viewed as a cornerstone in controlling runaway health care costs.
US EPA SLASHES CELLULOSIC ETHANOL TARGET FOR 2010 – The Obama administration cut the 2010 US cellulosic ethanol mandate by 94 percent, according to Bloomberg.com.
The U.S. Environmental Protection Agency reduced the nation’s cellulosic goal to 6.5 million gallons from the 100 million required under a 2007 energy law. The rule issued today found that corn-based ethanol produces lower greenhouse gases emissions than were anticipated in a May proposal, clearing the way for more use of the fuel.
“This is at its root an effort to reduce greenhouse gas emissions,” EPA Administrator Lisa P. Jackson said in a White House conference call. “The numbers we used in the proposal were not right.”
A GENETICALLY MODIFIED FUTURE — In the past 13 years genetically modified seeds have shifted to become the norm in the US, and that is not expected to change.
The number and variety of genetically modified seeds are expected to quadruple in five years.
“There are currently about 30 seeds available, manufactured by corporations,” said Pamela Ronald, professor of plant pathology at the University of California at Davis. “In five years, there will be approximately 120 seeds, half of which will come from Asia and Latin America.”
BIOMEDICAL JOBS APPEAR TO BE ‘RECESSION RESILIENT’ – California’s biomedical community has weathered the rough economic waters and held onto their jobs, according to a recent report.
The report yesterday from the La Jolla-based California Healthcare Institute says the biomedical work force shrank slightly in the 12 months through March 2009 but was still up by more than 1,000 jobs from 2007.
Altogether there were 272,181 jobs in areas that ranged from biopharmaceuticals and medical devices to academic research and laboratory services, according to the report. The industry employed 24,123 people in San Diego County.
GENE PATENT TRIAL BEGINS: BIOTECH RESEARCHERS SUED OVER OWNERSHIP OF GENE DISCOVERIES — The Huffington Post reports a judge on Tuesday weighed whether a lawsuit should proceed that seeks to invalidate a company’s patents on two genes linked to an increased risk of breast and ovarian cancer.
The case challenging whether anyone can hold patents on human genes has broad implications for the biotechnology industry and genetics-based medical research.
Last March, the American Civil Liberties Union and the Public Patent Foundation sued Myriad Genetics Inc., the University of Utah Research Foundation and the U.S. Patent and Trademark Office in U.S. District Court in Manhattan.
9 OUT OF 10 CONSUMERS ‘CONFUSED BY GM’ — According to a recent consumer survey, only 7 percent of consumers can demonstrate an understanding of GM technology.
Speaking at a high-level Westminster debate on the future of food on Tuesday (2 February) Joanne Denney-Finch, chief executive of IGD, the food and grocery experts, said consumers trusted the FSA more than anybody else.
“Consumers don’t have enough information to make an informed choice on GM.
“Shoppers are very clear that the FSA, who they believe has a lot of integrity, should give them that information,” she said, adding consumer knowledge on GM had remained stationary for more than a decade.
TOP TEN AGRICULTURAL LAW DEVELOPMENTS IN 2009 — Read AgriMarketing’s choices for the “Top Ten” agricultural legal and tax developments that impacted the agricultural sector in 2009.
1. One-Year Lapse of the Federal Estate Tax.
2. IRS Position A Loser in Insurance Company Demutualization Case.
3. IRS Loses Major Chapter 12 Bankruptcy Case.
SHELL PLANS $1.63 BILLION INVESTMENT IN BRAZILIAN ETHANOL — Royal Dutch Shell PLC plans to create a mulitbillion dollar joint venture with Brazilian company Cosan SA to produce and sell ethanol made from sugar cane.
The joint venture “helps to consolidate ethanol as a global commodity,” said Cosan Chairman Rubens O. Silveira Mello.
A partnership with Cosan would give Shell access to one of the world’s biggest biofuel markets: All new cars sold in Brazil are equipped with “flexfuel” engines, which run on any mix of ethanol and gasoline. The joint venture would be one of Brazil’s largest fuel distributors, with 4,500 filling stations around the country.
OBAMA 2011 BUDGET REQUEST: FOOD AND DRUG ADMINISTRATION — The Food and Drug Administration is seeking a 6 percent budget increase, which would give them about $4 billion for 2011. For the full budget, click here.
“No one knowledgeable about the FDA thinks it can do a credible job improving food safety in the U.S. without a far larger increase in funding than Obama has managed to eke out of his frozen budget and without dramatically strengthened legal authority,” said Rena Steinzor, who teaches at the University of Maryland Law School and is president of the Center for Progressive Reform.
The agency also says it will use the additional funds to approve more generic drugs and generic biologics, improve the safety surveillance of medical devices and make that data more widely available to physicians, the public and researchers.
OBAMA BUDGET PLAN CALLS FOR GENERIC DRUGMAKER FEES – Reuters reports that yesterday President Barack Obama proposed fees on generic drugmakers to help reduce review times for the cheaper copycat medicines and clear a backlog of applications.
Documents outlining Obama’s fiscal 2011 budget plan also proposed funding increases at the Food and Drug Administration “to bring more safe, effective and lower cost generic drugs and generic biologics to market” and to “expand postmarket safety surveillance of medical products.”
TRANSGENIC TOMATOES LAST LONGER – Suppressing enzymes that promote ripening extends the shelf life of tomatoes by 30 days, scientists from the National Institute of Plant Genome Research in India found.
The scientists identified two enzymes that accumulate in tomatoes at critical stages during the fruit’s ripening and which promote excessive softening that accounts for as much as 40 percent of post-harvest fruit loss. They used genetic engineering to “silence” the enzymes, making tomatoes twice as firm.
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