san francisco chronicle

California grants ignite a boom of lab construction

Wed, 07 May 2008 06:59:56 -0400

After four years of litigation and detailed planning, the first $271 million in facilities grants is just about ready to be doled out by the California stem cell institute. And that in turn will trigger more than three-quarters of a billion dollars worth of new construction for the laboratories that are being designed to develop the stem cell therapies of the future.

In the Bay Area alone four projects are vying for funding. If all four win, builders will construct $443 million in new stem cell laboratories.

California's $3 billion stem cell initiative--which was bitterly opposed by conservative groups--has inspired universities in the state to come up with ambitious plans for new research centers, leveraging the bond money with hundreds of millions of dollars of their own money. The state's plans involve stepping in where the federal government has refused to tread for seven years, and they are well on their way to making the state a world leader in the field.

- read the report in the San Francisco Chronicle

FDA ready to start adding biomarker safety tests

Fri, 18 Apr 2008 06:59:56 -0400

The San Francisco Chronicle is reporting that the FDA is prepared to back a new safety standard on preclinical drugs that could--at some point--significantly reduce the time and expense of testing a new therapy. The new standard would rely on seven biomarkers that indicate kidney injury. And the FDA wants to adopt a series of such biomarker tests that could flag heart damage, liver damage and cancerous side effects.

"Today, the FDA gives approval for a new drug or device, but there has previously been no way to obtain approval for a new and better way to test a drug for its safety," Raymond Woosley, president and CEO of the nonprofit Critical Path Institute, tells the Chronicle. Woosley is working with the FDA to safely speed drug development.

For now, though, the FDA says it will only accept the new biomarker test in addition to the animal safety studies the researchers already rely on. So any savings that a developer can look forward to will have to follow a period of added costs.

- read the article in the San Francisco Chronicle

Stem cell institute in wrangle over office costs

Thu, 13 Mar 2008 07:59:55 -0400

California's stem cell institute says the property management company that promised to underwrite all their office operating costs in San Francisco appears to be reneging on the deal, and they're bringing out the legal guns to make them pony up as promised.

The dispute dates back to a deal negotiated by San Francisco's mayor to give the institute a 10-year, rent-free office in San Francisco as an incentive to lure them to the Bay area. As part of that deal, Stockbridge Capital Partners allegedly promised to cover almost half a million dollars in annual office overhead for utilities, parking and so on.

Stockbridge says that it's keeping its pledge to provide rent-free space and has been working with contributors to cover costs. The institute says it wants to make sure all i's are dotted and every t is crossed before operating costs stack up.

- read the article from the San Francisco Chronicle

Related Articles:
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California institute outlines stem-cell strategy. Report
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Wealthy supporters back California stem cell research. Report

A look inside Pfizer's biotech center

Maureen Martino — Fri, 09 Nov 2007 11:46:11 -0500

Look alive, small biotech. Pfizer is looking to the little guys to save its skin as it faces dwindling profits and competition from generics in the coming years. Recently, Pfizer announced that it was launching a biotherapeutics and bioinnovation center, to be based in South San Francisco. The company is aggressively pursuing partnerships with small developers while at the same time fostering internal development of its own biotech drug candidates. And Corey Goodman, co-founder of Exelixis and Renovis, is heading up the whole thing.

In an interview with the San Francisco Chronicle, Goodman shares some juicy tidbits about Pfizer’s biotech plans over the next few years. “Goodman will be seeking collaborations among the kind of struggling, venturesome and often cash-hungry biotech outfits he previously helped found. Along the way…[he] hopes to create an independent, entrepreneurial science outfit backed by the resources of a major corporation,” notes the Chronicle. The company is hoping to emulate the success of biotechs like Genentech and Amgen by developing a line of biologic drugs, including proteins and antibodies.

Goodman is scouting and financially supporting small drug developers with the hope that their innovative drugs may someday make it into Pfizer’s pipeline. He has also been put in charge of Rinat Neurosciences, a biotech Pfizer snapped up last year. The company gained Rinat’s experimental therapies for pain, Alzheimer's and other neurological diseases, but Rinat maintained its own name and core mission. Goodman says this hands-off approach is a model for future partnerships.

Another key area for Pfizer will be the hot field of RNAi technology, where Goodman vows the company will become a leader. Merck, Novartis and Roche have all inked RNAi tech deals in the last year. While it is still an unproven technology, it's a possibility Pfizer can't afford ignore.

Goodman has his work cut out for him, but he hopes that when he’s finished the world’s largest drug developer will be as innovative as a small drug developer but with the resources of the world's largest R&D budget. "I'm sure there are going to be critics or cynics who say you can't take a major pharmaceutical company and make it more entrepreneurial," he said. "I think we can unleash a lot of that entrepreneurial spirit within Pfizer. It's a question of the culture I build."

- read the San Francisco Chronicle article for more

Related Articles:
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Sources: Biogen gets bidders, with Pfizer in lead. Report
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Pfizer tops the charts in global R&D spending. Report
Pfizer hires new R&D chief, launches biotech center. Report
Pfizer's future rests with biotech. Report
Pfizer to invest $50M in biotech start-ups. Report
Pfizer goes public with R&D pipeline. Report

SPOTLIGHT: Does the patent cliff drive innovation?

Fri, 10 Aug 2007 06:59:53 -0400

Is generic competition good for the biotech and pharma industries? An article from The San Francisco Chronicle argues that as aging drugs go off patent, companies are forced to push innovation to new heights in an effort to render older drugs obsolete. Article

FDA endorses accuracy of microarray tech

Sun, 10 Sep 2006 20:01:35 -0400

The FDA's Microarray Quality Control project has delivered a badly needed endorsement of the microarray technologies out on the market. Spurred by studies that suggested varying results among the different microarrays on the market, the FDA set out to determine how accurate they were in delivering results. Microarrays have played an enormous role in identifying a new generation of drug leads, helping spur the development of the biotech industry. The agency found that the microarrays delivered consistent results, which should lift the suspicion that the data delivered could be fundamentally erroneous. But don't expect the FDA to release a ranking of devices by quality. Different devices work in different ways.

- read the report on microarrays from the San Francisco Chronicle

Sirna posts positive data on RNAi therapy

Thu, 10 Aug 2006 20:01:37 -0400

Sirna Therapeutics posted positive data from an early stage trial of its experimental therapy for macular degeneration. Sirna-027 demonstrated its ability to ward off loss of vision in 24 of 26 patients with wet, age-related macular degeneration. Sirna has been focused on developing a therapy using RNAi technology, which stops cells from making proteins that--in this case--damage the eye. In this case the therapy is intended to prevent the development of blood vessels in the retina. Sirna inked a $250 million licensing deal on its RNAi work with Allergan last year. "This is the first demonstration of biological activity of a chemically optimized siRNA in humans," said Sirna CMO Roberto Guerciolini.

- read the San Francisco Chronicle article on Sirna and RNAi

Calif. gives $150M to stem cell research

Thu, 20 Jul 2006 20:01:39 -0400

In the wake of President Bush's stem cell funding veto, Gov. Arnold Schwarzenegger (R) has authorized a $150 million loan to the California Institute for Regenerative Medicine, an agency that aims to spend $3 billion on stem cell development in the next decade. In 2004 Californians passed Proposition 71, a research funding bill that positioned the state to become a leader in the stem cell research. But despite popular support for the Institute, funding has yet to take off because of legal objections by those who oppose stem cell research and the $3 billion price tag it carries. In April a state judge handed the Institute its first legal victory, but more than a year of litigation is expected before the California Supreme Court delivers its final word.

"The governor felt that there was a risk that the industry and movement would be set back by the veto, and he wants California to be a leader in industry," Adam Mendelsohn, Schwarzenegger's communications director, told the San Francisco Chronicle. The loan, combined with another $50 million of funding from private foundations, will expand the Institute's budget to $200 million this year. The agency hopes to push its budget to $300 million in coming years.

- read this article from the San Francisco Chronicle
- see this FierceBiotech special report in which California ranked first in the top five regions targeting biotech business

Poll finds problems at the FDA

Thu, 20 Jul 2006 20:01:38 -0400

A study released by the Union of Concerned Scientists has found that about 15 percent of FDA staffers polled say they've been "asked to… inappropriately exclude or alter technical information or conclusions in an FDA scientific document." In addition, 39 percent of respondents stated that the FDA wasn't "acting effectively to protect public health." The questionnaire was sent to almost 6,000 FDA workers and 997 responded.

The survey underscores critics concerns that the science isn't the only factor that informs the FDA's decisions. The agency has taken heat for the Vioxx debacle, and a head women's health official resigned in protest to the way politics interfered with science in the FDA's handling of Plan B, a controversial morning-after contraceptive. A spokeswoman for the FDA dismissed the poll, saying it was unscientific and asked leading questions.

- check out this San Francisco Chronicle article

Novartis to build $600M flu plant in N.C.

Tue, 18 Jul 2006 20:01:39 -0400

With the help of a $220 million federal government grant, Novartis announced it will build a $600 million flu-vaccine manufacturing facility in North Carolina. Construction will begin in 2007 and the plant will be ready for vaccine production for the 2012 flu season. Novartis's decision to construct a new plant is an effort to update older manufacturing facilities that have had production problems in recent years. Rather than making the vaccine from chicken eggs, production at the new facility will obtain the vaccines using cell-culture technologies. It's a method that is quicker and more reliable to the traditional approach, though the FDA has yet to approved the method for flu vaccines. Novartis will pump out an estimated 50 million doses of the vaccine from the new plant.

The North Carolina facility will also be equipped to produce up to 150 million avian flu vaccines in the event of a pandemic. In early May, five pharmaceutical companies--MedImmune, DynPort Vaccine, GlaxoSmithKline, Novartis and Solvay Pharmaceuticals--won a combined $1 billion dollars worth of government contracts in the race to develop new technology to make flu vaccines needed to combat a human pandemic. Interestingly, the project's $600 million price tag is $200 million more than CEO Daniel Vasella had projected May.

- read this San Francisco Chronicle article
- check out this The Washington Post report for background on the government contract

U.S. scientists renew stem cell cloning efforts

Sun, 07 May 2006 20:01:37 -0400

With South Korean claims of a successful cloning program for embryonic stem cells in tatters, researchers in the U.S. are diving back into the field. UCSF scientists, for example, have relaunched an effort that had been halted five years ago. Therapeutic cloning is expressly permitted under California's Proposition 71, which was passed in 2004. And even though the state's $3 billion stem cell program is in limbo pending a final court decision, California researchers are expected to play a lead role in the field.

- read the report from the San Francisco Chronicle

3M puts drug arm on auction block

Mon, 03 Apr 2006 20:01:39 -0400

3M says it is considering selling its drug development and marketing operation. 3M has hired Goldman Sachs to advise it on various alternative strategies, which typically is code for putting a company up on the auction block. The group, which employs 1,500 people, develops and sells drugs in dermatology, women's health, cardiology and respiratory medicine.

"The best way for this business to grow is for it to be free to pursue separate strategies under the direction of a dedicated pharmaceutical industry company with a business model better suited to maximize its potential," said Brad Sauer, executive vice president of 3M Health Care.

- read the report from the San Francisco Chronicle

Biotech crowd descends on SF for annual deal-fest

Mon, 09 Jan 2006 19:01:38 -0500

A big biotech crowd has descended on San Francisco for the JP Morgan Healthcare Conference. The annual deal-fest aims at putting together entrepreneurs from 296 companies with investors at a time when licensing deals are hotter than ever. Burrill & Co. noted that the industry inked $17.1 billion in new licensing deals last year, up from $10.9 billion in 2004. With big pharma still struggling to reload its pipeline, 2006 is shaping up as another big year in biotechnology. About 7,000 attendees have turned out for the conference.

- read this article from the San Francisco Chronicle

Sen. demands probe of early access to trial data

Mon, 08 Aug 2005 20:01:38 -0400

A weekend report in the Seattle Times that medical researchers are accepting large fees to deliver early news on the outcomes of clinical research trials has touched off a furor in Washington, DC. Senator Charles Grassley (R-Iowa), who has headed Senate probes of the pharmaceutical industry, has called for a formal investigation of 26 reported cases where early data on research trials were delivered to Wall Street research firms.

According to the report, Gerson Lehrman Group has 60,000 doctors available to discuss research information with clients who pay as much as $1 million per year for the information. But the research group denies any wrongdoing, saying that doctors are paid upwards of $500 per hour even if they cut off discussions when it involves confidential information.

- read this story from the San Francisco Chronicle

Genentech stock surges as new drugs deliver big revenue

Mon, 11 Jul 2005 20:01:37 -0400

Wall Street was cheering Genentech's high-priced roster of biotech meds, bidding up the biotech giant's stock price after it announced a whopping 73 percent increase in quarterly profits. Operating revenue jumped 35 percent to $1.5 billion for the three months ended June 30. Genentech Chairman and CEO Arthur Levinson told analysts that the company is in an "exciting phase of transformation and growth," with a string of positive clinical trials behind it and a slate of nine FDA applications ahead.

- read this story from the San Francisco Chronicle for more

FDA panel splits on Pulminiq

Mon, 06 Jun 2005 20:01:38 -0400

Chiron's Pulminiq -- a treatment for preventing lung transplant rejection -- has received a split decision by an influential FDA advisory panel. The panel voted 8-8 on Pulminiq after staffers had questioned the accuracy of data drawn from a small clinical trial. The trial found a 79 percent reduction in the risk of death among the 26 patients using the drug. Some members of the panel wondered if other factors could have influenced the data. The drug is only a small one for Chiron, though, with an estimated market value of $40 million to $75 million. The FDA will now take up the issue and decide by July 14.

- read this article from the San Francisco Chronicle