7.21.2007

Slashdot | Optimum Copyright Period Decided by Math

Slashdot | Optimum Copyright Period Decided by Math: "'So how long should a copyright be valid for? A Cambridge student has stepped into the discussion with a dispassionately calculated estimate of the optimal period a copyright should be granted. Ars' point of view: 'Neither the US nor the UK are in any danger of rethinking copyright law from scratch, but if they were looking for guidance in how to set up their systems, Pollock has it. He develops a set of equations focused specifically on the length of copyright and uses as much empirical data as possible to crunch the numbers. The result? An optimal copyright term of 14 years, which is designed to encourage the best balance of incentive to create new work and social welfare that comes from having work enter the public domain (where it often inspires new creative acts).' The original paper is available (pdf) online.'"

biotechtalk.net � Cell Genesys shares soar on positive GVAX prostate trial data (at MarketWatch)

biotechtalk.net � Cell Genesys shares soar on positive GVAX prostate trial data (at MarketWatch): "Biotech Press - Biotechnology News
Cell Genesys shares soar on positive GVAX prostate trial data (at MarketWatch)
Shares of Cell Genesys Inc. rallied Monday, a move higher precipitated by positive research data for GVAX, the biotechnology company's prostate-cancer drug therapy."

7.18.2007

Cleveland BioLabs Phase II Hormone-Refractory Prostate Cancer Trial Advances to Next Phase

Cleveland BioLabs Phase II Hormone-Refractory Prostate Cancer Trial Advances to Next Phase: "CLEVELAND, April 5 /PRNewswire-FirstCall/ -- Cleveland BioLabs, Inc. (Nasdaq: CBLI; BSE: CFB), announced today that its Phase II efficacy study for Curaxin CBLC102 in advanced, hormone-refractory (androgen independent) prostate cancer has progressed to the next phase."

Callisto Intends to Move Guanilib into Clinical Trials in Ulcerative Colitis

Callisto Intends to Move Guanilib into Clinical Trials in Ulcerative Colitis: "Callisto Pharmaceuticals, Inc. (Amex: KAL; FWB: CA4), a developer of new drug treatments in the fight against cancer and other major health threats, announced today additional data confirming efficacy of Guanilib, a first-in-class compound currently being developed for the treatment of inflammatory bowel disease (IBD), in two different standard animal models of experimental colitis. Guanilib is an orally deliverable compound designed to mimic a naturally-occurring hormone called uroguanylin. The drug is currently in preclinical development and Callisto intends to move the drug into clinical trials in ulcerative colitis. Guanilib is a proprietary program that was developed in-house by Callisto scientists and the company owns 100% of the worldwide manufacturing and marketing rights."

biotechtalk.net � Nasdaq Panel Grants Corcept Therapeutics’ Request for Listing on the Nasdaq Capital Market (Market Wire)

biotechtalk.net � Nasdaq Panel Grants Corcept Therapeutics’ Request for Listing on the Nasdaq Capital Market (Market Wire): "Biotech Press - Biotechnology News
Nasdaq Panel Grants Corcept Therapeutics’ Request for Listing on the Nasdaq Capital Market (Market Wire)
Corcept Therapeutics Incorporated announced today that a Nasdaq Listing Qualifications Panel has granted the company's request to be listed on the Nasdaq Capital Market, effective with the market opening on Monday, April 9, 2007"

SignOnSanDiego.com > News > Business > Biotechnology -- Sweeping stem cell patents rejected

SignOnSanDiego.com > News > Business > Biotechnology -- Sweeping stem cell patents rejected: "The patent office agreed with the challengers, stating the patents should not have been issued because the science they covered was not unique.

The patents were issued in 1998, 2001 and last year for work by University of Wisconsin scientist James Thomson. They cover the process used to pull stem cells out of fertilized embryos. They also cover the embryonic stem cells themselves, making it necessary for researchers to pay a licensing fee to use the cells no matter where the cells are obtained.

These patents, combined with federal funding restrictions on human embryonic stem cell research, have been cited as the two biggest obstacles to the growth of a field that scientists hope will lead to therapies for diseases such as diabetes, Parkinson's and cancer.

According to patent office reviewers, scientific articles published before the first Wisconsin patent was issued should have made it obvious to someone in the field how to pull stem cells out of a primate embryo and coax them to live for a year in a petri dish."

Armless Fianc�e Shows Off Engagement Hat | The Onion - America's Finest News Source

Armless Fianc�e Shows Off Engagement Hat | The Onion - America's Finest News Source: "Armless Fianc�e Shows Off Engagement Hat"

Hidden Valley Ranch Bombed By Balsamic Extremists | The Onion - America's Finest News Source

Hidden Valley Ranch Bombed By Balsamic Extremists | The Onion - America's Finest News Source: HIDDEN VALLEY, CA–A radical Balsamic fundamentalist group detonated an estimated 800 pounds of TNT at the Hidden Valley Ranch compound Monday, killing 11 and injuring dozens more. "Let no salad again be foully tainted by the corrupt regime of Hidden Valley," said Martin Pulaski, leader of the Nation Of Balsam, in a statement claiming responsibility for the deadly attack. "We shall not rest until every salad's flavor is enhanced by a light and tangy vinaigrette, not buried in a shameful avalanche of buttermilk."

radio/
http://origin.theonion.com/content/node/45147

BBC NEWS | Middle East | British blamed for Basra badgers

BBC NEWS | Middle East | British blamed for Basra badgers: "UK military spokesman Major Mike Shearer said: 'We can categorically state that we have not released man-eating badgers into the area."

Wired Science - Wired Blogs

Wired Science - Wired Blogs: "Futurist extraordinaire Freeman Dyson bets that within fifty years, biotechnology will suffuse everyday life just as computer technology does now.

It's not a new vision, but Dyson sketches it well, moving from the everyday (DIY genetic engineering for pigeon fanciers and schoolchildren) to green industrial:"

Green technology could replace most of our existing chemical industries and a large part of our mining and manufacturing industries. Genetically engineered earthworms could extract common metals such as aluminum and titanium from clay, and genetically engineered seaweed could extract magnesium or gold from seawater. Green technology could also achieve more extensive recycling of waste products and worn-out machines, with great benefit to the environment. An economic system based on green technology could come much closer to the goal of sustainability, using sunlight instead of fossil fuels as the primary source of energy. New species of termite could be engineered to chew up derelict automobiles instead of houses, and new species of tree could be engineered to convert carbon dioxide and sunlight into liquid fuels instead of cellulose.

How humanity gets to there from here -- where, outside of agriculture, a handful of medicines and a scattering of expensive reproductive technologies, biotechnology hasn't amounted to a whole lot -- is a tricky matter, though.

Dyson notes that "genetic engineering will remain unpopular and controversial so long as it remains a centralized activity in the hands of large corporations." Quite right. But there's other obstacles to biotech than popularity: there's also the matter of understanding living systems well enough for the kids to mess with them.

The reductionist physics and the reductionist molecular biology of the twentieth century will continue to be important in the twenty-first century, but they will not be dominant. [...] The reductionist physics and the reductionist molecular biology of the twentieth century will continue to be important in the twenty-first century, but they will not be dominant.

Dyson couches his vision in an irksome bit of biohistorical justification: until about three billion years ago, horizontal gene transfer was the rule rather than the exception; then Darwinian evolution took over, with its stark lines and brutal competition; and now, thanks to human-engineered gene swapping and the primacy of culture rather, that's coming to an end.

We are moving rapidly into the post-Darwinian era, when species other than our own will no longer exist, and the rules of Open Source sharing will be extended from the exchange of software to the exchange of genes. Then the evolution of life will once again be communal, as it was in the good old days before separate species and intellectual property were invented.

Um, sure. "As it was in the beginning...." But the rest of Dyson's dream is appealing and engaging enough to forgive him this bit of quasi-religious mysticism. After all, what good futurist isn't a mystic, too?

Related Wired coverage: fellow uber-futurist Stewart Brand interviews Freeman Dyson.

Herb Greenberg: Serious about Osiris?

Herb Greenberg: Serious about Osiris?: "Osiris' (osir) stock got a boost after stem cell biotech company presented positive data on a heart drug it's working on. Merely a Phase 1 trial? No worries; it's the story that counts. Stock opened up 20% until investors sobered; as I write this it's up about 9%. (Isn't this the same company whose stock got clobbered several weeks ago after Phase 1/2 trials for a knee repair drug didn't go so well? Indeed it is.) Former bull Eun Yang, of Jefferies, who downgraded the stock after the recent disappointment, didn't change his mind on the heels of the early heart drug results. He says he wants to see detailed data. The big hype and hope for this company will be the results of Phase 3 trials for its graft-vs.-host drug. According to Yang, however, that's already in the stock. (Not that positive results, in a story-driven market such as this, won't keep it from going higher at the time.)"

Predicting the outcome of phase III trials using p...[Basic Clin Pharmacol Toxicol. 2005] - PubMed Result

Predicting the outcome of phase III trials using p...[Basic Clin Pharmacol Toxicol. 2005] - PubMed Result: "Biometrics & Clinical Informatics, Johnson & Johnson Pharmaceutical Research and Development, Turnhoutseweg, B-2340 Beerse, Belgium. fdridder@prdbe.jnj.com

Maximizing the likelihood of success in Phase III is the ultimate goal of the use of modelling and simulation in the drug development process. The success in Phase III depends primarily on two questions: 1) Is the drug regimen actually efficacious and safe in the targeted patient population?, and 2) Will the planned Phase III clinical trial(s) be successful in demonstrating this? Traditionally, the first question is addressed in a qualitative, overall interpretation of available study results. Integrating this information into a formal statistical model of the action of the drug, allows running simulations to investigate the impact of uncertainties and imprecision in this knowledge. The second question is related to having an adequately designed clinical trial. Clinical trial simulation, using a drug action model, supplemented with appropriate models for disease progression and trial execution, allows assessing the impact of typical design features such as doses, sample size, in-/exclusion criteria, drop-out and trial duration on the trial outcome and thus optimising trial design. In this contribution, the use of modelling and simulation in the Phase II to Phase III transition is illustrated using real data of a drug for symptom relief in a chronic condition. A dose-response model of the clinical response was developed using data from Phase II. Simulations were performed to 1) generate the range of possible outcomes of ongoing Phase III trials and compare these to the blinded data being generated from these trials; 2) assess the robustness of the ongoing Phase III trials with respect to uncertainty of the true dose-response, patient variability in baseline severity and drug-response, and 3) assess the likelihood of achieving a clinically relevant response with a dose lower than those included in the trials.
"

Jobs, News and Views for All of Higher Education - Inside Higher Ed :: Easing Friction Over Tech Transfer

Jobs, News and Views for All of Higher Education - Inside Higher Ed :: Easing Friction Over Tech Transfer: "Susan B. Butts, the senior director of external science and technology programs at the Dow Chemical Co., said she also sees a potential for more collaboration between universities and industry, especially since private funding for research and development has increased over the years to about double the amount of federal funding today. But, she said, a primary obstacle to more partnerships is the potential for disputes over intellectual property."

ARE WE READY FOR GENERIC BIOTECH? / Safety concerns -- and enormous profits -- at issue as industry braces for copycat drugs

ARE WE READY FOR GENERIC BIOTECH? / Safety concerns -- and enormous profits -- at issue as industry braces for copycat drugs: "GENERIC BIOTECHNOLOGY DRUGS: A LOOK AT THE PROS AND CONS
Arguments for:

Billions of dollars in medical costs could be saved by using copycat versions of biotechnology drugs.

The potential savings are growing larger every year because biotech drugs are the fastest-growing segment of the national pharmaceutical bill.

Arguments against:

Generic drugmakers can't assure that copies of biotech drugs are exact because they can't duplicate proprietary manufacturing methods.

Biotech companies must be shielded from generic competition longer than conventional pharmaceutical companies because creating biotech drugs is costlier and riskier than traditional drug development."

ARE WE READY FOR GENERIC BIOTECH? / Safety concerns -- and enormous profits -- at issue as industry braces for copycat drugs

ARE WE READY FOR GENERIC BIOTECH? / Safety concerns -- and enormous profits -- at issue as industry braces for copycat drugs: "Biotech advocates maintain that copycat biological drugs can never really be identical to the brand-name drug. Biotech drugs are produced by bacterial or mammalian cells that have been genetically engineered to make the needed molecule. Manufacturers of generics don't have access to those proprietary cell lines or the recipes for the nutrient broths in which they grow, said Rob Garnick, a veteran Genentech executive who oversees manufacturing quality control."

Jobs, News and Views for All of Higher Education - Inside Higher Ed :: Easing Friction Over Tech Transfer

Jobs, News and Views for All of Higher Education - Inside Higher Ed :: Easing Friction Over Tech Transfer: "The Economist called it “possibly the most inspired piece of legislation to be enacted in America over the past half-century.” That was in 2002, referring to a law passed in 1980 that has been widely credited with boosting American competitiveness, stimulating the economy and bringing thousands of new technologies to the market."

7.17.2007

ScienceDaily: Study Urges Compensation-based Approach To Drug Patent Compulsory Licensing

ScienceDaily: Study Urges Compensation-based Approach To Drug Patent Compulsory Licensing: "Under complex World Trade Organization rules, governments are permitted to issue patent compulsory licenses, which allow countries to manufacture cheaper versions of patented pharmaceuticals for non-commercial use or in cases of health care emergencies. Just recently, Brazil and Thailand have invoked these rules simply to lower the cost of expensive AIDS and heart medications-a strategy that Cahoy argues should be more controlled. In his paper, Cahoy identifies three myths that have typically obscured workable remuneration rules:"

Myth No. 1:Equitable compulsory licenses must offer savings from the market. Cahoy argues that it is possible for patent holders to be compensated at market prices even when compulsory licenses are invoked. At the very least, he writes, market compensation should be integrated into the debate.

Myth No. 2:Pharmaceutical companies should be indifferent to compulsory licensing so long as "reasonable" remuneration is available. Compulsory licensing supporters say that pharmaceutical companies should be satisfied with payments that allow them to break even or turn a small profit, but Cahoy argues that the equity in such a payment scheme is far more elusive than many suggest.

Myth No. 3:Antitrust compulsory licenses provide a reliable royalty benchmark. Cahoy argues that the low royalties attached to remedial compulsory licenses for antitrust violations should not be used to set remuneration levels in non-punitive cases in which the patentee has done nothing wrong.

Taking these myths into account, Cahoy's proposed licensing regime keeps innovation incentives intact, but also ensures that developing countries have access to pharmaceuticals.

7.16.2007

biosink notebook

biosink notebook: "Pharma Marketing Blog: Why Grow Your Own Drugs When You Can Buy Them Off the Street?
pharmamkting.blogspot.com/2007/07/why-grow-your-ow...
I've argued that the $1 Billion number is based less on actual costs than on a Tufts' analysis, which includes about $400 million in 'lost opportunity' costs (see 'Tufts Hangs Tough on Opportunity Cost Analysis')."

7.15.2007

Report: Tech transfer must look for hits, not just home runs - Kansas City Business Journal:

Report: Tech transfer must look for hits, not just home runs - Kansas City Business Journal:: "A 'home run mentality' in university technology transfer offices may be keeping many valuable research projects from reaching first base in the commercialization process.

That is the contention of a report released by the Ewing Marion Kauffman Foundation Thursday at the national Innovation Policy and the Economy Summit in Washington, D.C.

According to the report, universities tend to focus their limited technology-transfer resources only on the patenting and licensing of technologies that promise big, fast paybacks.

The report -- written by Kauffman researchers Robert Litan, Lesa Mitchell and E.J. Reedy -- argues that universities should shift from a sole focus on that patent/licensing model, which seeks to maximize income, to a volume model. A volume model emphasizes the number of innovations that university research generates and the speed at which those innovations are commercialized."

Kudlow's Money Politic$: Four Dead Bodies

Kudlow's Money Politic$: Four Dead Bodies: "Just as you should strongly suspect murder if you discover four dead bodies in an alley, you should be very wary of future inflation if four key market-price indicators are acting in unison. These include rising gold, a soft dollar, expanding bond spreads, and strong commodities. "

Clinical trial 'hidden gems' luring big pharma

Clinical trial 'hidden gems' luring big pharma: "An increasing number of factors are luring sponsors to offshore clinical trials to 'hidden gems' across the globe, delegates heard at this week's Accelerating Patient Recruitment & Retention in Clinical Trials conference, run by SMi in London.

The US is still dominant in the clinical trials arena, carrying out 53 per cent of the world's 59,000 Phase I-III studies, however, US investigator groups are continuously underperforming with patient recruitment, with 50 per cent of sites recruiting less than 5 per cent of patients and 30 per cent recruiting 50 per cent of patients.

Despite notorious issues with recruitment, this is no longer the country's number one cause for trial delay either, with contract and budget delays taking over the number one spot of woe and 94 per cent of all US trials are now delayed over a month.

Meanwhile in Europe, ethics committee review and application; patient recruitment; legal review, contract and budget negotiations; and protocol amendment are the biggest trial headaches.

As a result, R&D spend by pharmaceutical companies is growing by 10 per cent a year in the US - with much of this being spent on Phase III studies - while their spend outside the US is growing 13 per cent."

Vonage is the Latest Victim of Patent Abuse — AMERICAN.COM: A Magazine of Ideas, Online

Vonage is the Latest Victim of Patent Abuse — AMERICAN.COM: A Magazine of Ideas, Online: "It's not clear how any of this promotes 'the progress of science' as required by the Constitution. Because of the high cost and uncertainty of the patent system, most software companies don't even try to find patents they might be infringing. Instead, they sign cross-licensing deals with as many companies as possible, and they pray that the remaining companies won't sue them before they've had time to develop a patent war-chest of their own. This is great for patent lawyers, but it's not clear how anyone else benefits."

Vonage is the Latest Victim of Patent Abuse — AMERICAN.COM: A Magazine of Ideas, Online

Vonage is the Latest Victim of Patent Abuse — AMERICAN.COM: A Magazine of Ideas, Online: "Luckily, the Supreme Court heard two cases this term that will give them the opportunity to rein in these abuses of the patent system. In the case of KSR v. Teleflex, it can put real teeth in the non-obviousness requirement, so that the patent office is more likely to reject bad patents.

The court should also take advantage of Microsoft v. AT&T to reinstate the principle that software is not eligible for patent protection. That was the rule that was applied until the 1980s, when a series of rulings by the newly created Court of Appeals for the Federal Circuit effectively legalized software patents. The Supreme Court has never ratified that judicial innovation, and Microsoft v. AT&T gives the courts an excellent opportunity to remedy the Federal Circuit's mistake."

The upstart revolution in biotech - FierceBiotech

The upstart revolution in biotech - FierceBiotech: "It struck me that this year there's a distinct abundance of promising companies being bankrolled by some very eager venture capital groups. It's a thoroughly non-scientific approach to trend-spotting, but for me it underscores just how strong the drug development field is right now. A good business plan, experienced management and a couple of intelligent licensing deals can propel a company into clinical development in relatively short order. "