VITAL EVIDENCE

In U.S. Cancer Deaths, A Minus May Be a Plus

No one is declaring victory, but the number of Americans dying from cancer has dropped for the first time, according to a report being released today.

The most recent federal data show that deaths from cancer fell from 557,271 in 2002 to 556,902 in 2003. While it was a decline of only 369, it marked the first documented drop since the government started collecting statistics in 1930.

"This represents a real milestone," said Michael Thun of the American Cancer Society, which analyzed the data.

The death rate from cancer has been dropping since the early 1990s, but the total number of Americans dying continued to increase because the population is growing and getting older.

Link to full artcile from the Washington Post

Apocalypse now: fears of gene doping are realised

Unleashing the power of the human genome...will make unleashing the unleashing of the power of the atom look like child's play...

who said that?

A new substance has emerged that suggests the next stage in the drugs battle has started

THE grim new world of gene doping, for so long viewed as the apocalyptic future of illegal performance-enhancement in sport, has dawned in Germany. Experts had been concerned that advances in gene therapy would start to impact on sport by the time of the Beijing Olympics in 2008. However, evidence from a court case in Magdeburg, Germany, suggests that a new brand of cheats could be injecting in time for the Turin Winter Games, which start next week.

Gene doping is the big fear among those fighting for clean sport. It involves manipulation of the human genetic code and thus evades standard detection methods. And a German court has identified the distribution among coaches of a substance called Repoxygen, which works in this way to produce erythropoietin (EPO) indigenously.

“You would have to be blind not to see that the next generation of doping will be genetic,” Dick Pound, the chairman of the World Anti-Doping Agency, told scientists only two months ago. It seems that this next generation has arrived.


link to full article

The ISPE Survey

I got the ISPE survey regarding the professional certification program...

here's the link to the main page...

hard to figure if they're getting the right emphasis...

very little if anything on public safety...heavy on validation, commissioning , and development activities...

Pataki announces biotechnology grant program

The job creration machine keeps on rolling...

ALBANY, N.Y. -- Gov. George Pataki and the Republican-led state Senate are backing a program that aims to generate $800 million in new investment in biotechnology and medical research at institutions across the state.

The program, announced by Pataki and Senate Majority Leader Joseph Bruno, would create a $200 million grant initiative they hope will generate another $600 million in federal, not-for-profit and private sector matching funds.

The initiative, first announced earlier this month in the governor's State of the State address, will fund research at universities and hospitals around New York.

The plan would establish a two-part $200 million program including $40 million in capital funding, already authorized, and $160 million financed by the state Charitable Asset Foundation, a charitable trust formed with the proceeds of the Empire Blue Cross Blue Shield conversion to a for-profit company. The money would be used to recruit researchers and scientists and to buy new technology and equipment.

link to full article from newsday.com

Gates Pledges $900 Million for TB Research

DAVOS, Switzerland (AP) -- Bill Gates said Friday his charitable foundation will boost its funding for tuberculosis eradication from its current level of $300 million to $900 million during the next decade.

The effort is part of a larger campaign against tuberculosis announced at the World Economic Forum. The disease killed 1.6 million people last year.

The announcement came as Nigerian President Olusegun Obasanjo, British treasury chief Gordon Brown and Gates called for help to treat 50 million people and prevent 14 million tuberculosis deaths worldwide over the next decade.

"This is a very tough disease," the Microsoft Corp. chairman and co-founder said. "It is going to take all of us - private sector, the pharmaceutical companies, philanthropy and governments in countries that have the disease - to participate as well."

link to full AP article

FDA Panel Recommends OTC Weight-Loss Pill

and I've been trying to lose weight by eating less...How old-fashioned...


WASHINGTON - Federal health advisers voted Monday to recommend over-the-counter sales of a weight-loss pill now sold only with a prescription.

GlaxoSmithKline Consumer Healthcare still needs final Food and Drug Administration approval before it can sell a nonprescription version of orlistat, a diet pill already marketed in prescription form as Xenical. The FDA approved the prescription version of the fat-blocking pill made by Roche in 1999.

A joint FDA advisory committee voted 11-3 to recommend approval late Monday following a daylong hearing. The agency usually follows the recommendations of its outside panels of experts, but its final decision could take months. If approved, orlistat would be the first weight-loss drug sanctioned for over-the-counter sales. Roche will continue selling Xenical regardless.

"We are excited about the potential opportunity to provide consumers with an FDA-approved over-the-counter option that promotes gradual yet meaningful weight loss," said George Quesnelle, president of GlaxoSmithKline Consumer Healthcare North America.

link to full AP article

Biotech Center To Match VC Funding With Loans

Great idea, except the money can't be used for physical facilities...

Bootstrap biotechnology companies will have an easier time gaining traction thanks to a program launched by the North Carolina Biotechnology Center that will match venture capital investments with loans of up to $250,000. The Strategic Growth Award is designed to offer startup companies an additional avenue to help alleviate funding shortfalls that often occur between seed-funding stages and later venture capital investments, according to a written statement from the biotechnology center. SGA loans won't be restricted solely to research funding, say biotech center officials. The new loans can also be used for hiring employees, securing patent rights and pursuing business development and licensing opportunities. The loans, however, must be matched with an equal investment from a venture capital firm. While SGA loans cannot be used for physical facilities or to compensate corporate executives, these restrictions will not apply to the matching venture funds, officials say. The loan program is open only to North Carolina biotech companies involved in life sciences, natural products, agriculture, veterinary medicine or environmental endeavors. Triangle Business Journal reported in its Oct. 14, 2005 print edition that the Biotech Center was considering the loan program. The North Carolina Biotechnology Center is a private, nonprofit corporation headquartered near Research Triangle Park and supported by the North Carolina General Assembly. The organization operates four additional offices in Greenville, Wilmington, Winston-Salem and Asheville, with plans for a fifth office in Charlotte.

link to story on biospace.com

The FDA celebrates 100 Years!!!

link to site

This week in FDA history- January 10, 1961:

External D&C No. 15, a red color additive widely used in cosmetics before it was taken off the FDA's list of approved colors in 1960 because of safety concerns, is cleared for uses outside of the body. But this leaves fans of rosy lips little to smile about, since this "external use" doesn't include lipsticks.

MedImmune inflates flu vaccine production capacity to boost market presence

11/01/2006 - MedImmune will soon ramp up production of its intranasal flu vaccine after the US Food and Drug Administration (FDA) approved its new and larger flu vaccine manufacturing facility in Speke, England.

The new facility is 10 times larger than MedImmune's existing manufacturing facility in Speke, and will allow the company to produce up to 15 million doses per month, or about 90 million doses per influenza manufacturing season, of its trivalent, intranasal flu vaccine, FluMist.
This is a mammoth increase in vaccine production considering the company only produced 3 million doses of FluMist this year and the decision to ramp up production may seem somewhat ambitious.

link to full article

Penicillin and Amoxicillin's days are numbered

03/01/2006 - The threat of antibiotic resistance reared its ugly head again after US researchers found that the most common antibiotic treatments do not work in a significant number of cases, leading for calls to find viable alternatives to ageing, established, antibiotics.

Antibiotic resistance has become a problem in the pharmaceutical industry that no one wants to or knows how to deal with. This could be because the acceptance of a need for alternatives would essentially mean pharma has lost confidence of antibiotics such as penicillin and amoxicillin.
Researchers from the University of Rochester started with the analysis of data from 11,426 children who has suffered a common throat infection.

They found that 25 per cent of children given penicillin, along with 18 per cent given amoxicillin treatment needed further treatment within weeks.

link to full article

Coffee may lower breast cancer risk for some women

NEW YORK (Reuters Health) - Women with BRCA1 gene mutations, which confer a high risk of developing breast cancer, might decrease their risk by drinking a lot of coffee, according to a multicenter team of investigators.

Dr. Steven A. Narod, of the University of Toronto, Ontario, and colleagues examined the association between coffee consumption and the risk of breast cancer among 1690 high-risk women with BRCA1 or BRCA2 mutations.

The study included women from 40 clinical centers in four countries. A self-administered questionnaire was used to assess the average lifetime coffee consumption.

The likelihood of developing breast cancer among BRCA mutation carriers who drank 1 to 3 cups of coffee daily, 4 to 5 cups, or 6 or more cups was reduced by 10 percent, 25 percent and 69 percent, respectively, compared to those who drank no coffee, according to the report in the International Journal of Cancer.

When the investigators classified the women by mutation status, they found significant protection from coffee

link to reuters.com for full article

New blow to S Korea clone work

South Korea's disgraced human cloning scientist did not produce any stem cells tailored to individual patients as claimed, a panel has concluded.
A Seoul National University panel said it believed that Hwang Woo-suk never had the data he said he had.

Dr Hwang quit last week after the panel said some research was fabricated.

Correspondents say the finding is important as individually tailored stem cells were seen as a key to treating diseases like diabetes and Alzheimers.

The scientist maintains he has developed technology to produce such stem cells.

The panel said it would continue its investigation into other research by Dr Hwang, including the authenticity of a cloned Afghan hound which was claimed to be the world's first cloned dog.

link to full article by BBC

Experts make predictions for advances in health care in 2006

In case you're not too interested in the psychic predictions for the New Year...

From the first-ever cancer vaccine to a new drug set to take on "diabesity," 2006 promises to be chock full of health advances.

That's why WebMD asked thoughtful leaders in many fields to get out their crystal balls and tell us what's in store for 2006.

link to full article from WebMD

Researchers find 'no evidence' that hangover cures work

'Tis that season too...

LONDON (AFP) - Just in case there were any doubts, new research has concluded that the best way to beat a hangover -- at Christmas time or any other time -- is to steer clear of alcohol in the first place.

In a timely paper in the British Medical Journal, published Friday, three specialists in complementary medicine found "no compelling evidence" that conventional or alternative treatments can stave off the dreaded morning-after.

"Until the pathology of alcohol hangover is understood in more detail," wrote Max Pittler, Joris Verster and Edzard Ernst, "an effective intervention is likely to remain elusive."

"The most effective way to avoid the symptoms of alcohol-induced hangover is thus to practise abstinence or moderation."

Hangovers can be a real headache, and not just for revellers who have had a few too many.

link to full article

South Korean Stem-Cell Researcher Resigns

Oops!!!...

SEOUL, South Korea - South Korean researcher Hwang Woo-suk resigned from his university on Friday after the school said he fabricated stem-cell research that had raised hopes of new cures for hard-to-treat diseases.

A university panel, releasing initial findings of a probe, accused Hwang of damaging the scientific community with his deception, while South Korea's government rued the scandal surrounding the country's star scientist and said it may pull its funding for his research.

"I sincerely apologize to the people for creating a shock and disappointment," Hwang told reporters as he was leaving his office at Seoul National University, considered the country's top institution of higher learning.

"With an apologetic heart ... I step down as professor," he said.

However, Hwang still maintained that he had produced the technology to create patient-matched stem cells as he claimed in a May article in the journal Science.

"I emphasize that patient-specific stem cells belong to South Korea and you are going to see this," said Hwang, a veterinarian.

Earlier Friday, a panel of Seoul National University experts said Hwang had faked results of at least nine of 11 stem cell lines he claimed to have created in the May paper — the first confirmation of allegations that have cast a shadow over all his purported breakthroughs in cloning and stem-cell technology.

"This kind of error is a grave act that damages the foundation of science," the panel said.

link to full article

Reindeer shed light on sleep disorders

Tis the season...

Fatigue and health problems suffered by astronauts and shift workers could be better understood with the help of reindeer that live near the North Pole, scientists report today.

A Norwegian team has found that, unlike people, these reindeer have a weak body clock that is almost insensitive to the 24-hour cycle of darkness and light.

Living in the far north, the animals must cope with continuous daylight in the summer and darkness in the winter, so they must resort to other cues if they are to rely on their body clocks.

Prof Karl-Arne Stokkan, of the University of Tromso, and colleagues found by studying two sub-species of reindeer for a year that animals that undergo extremes of darkness and light "clock off".

link to full article...

Cancer's road map to metastasis revealed

sounds like good progress...

LONDON (Reuters) - Scientists have discovered how cancer spreads from a primary site to other places in the body in a finding that could open doors for new ways of treating and preventing advanced disease.

Instead of a cell just breaking off from a tumor and traveling through the bloodstream to another organ where it forms a secondary tumor, or metastasis, researchers in the United States have shown that the cancer sends out envoys to prepare the new site.

Intercepting those envoys, or blocking their action with drugs, might help to prevent the spread of cancer or to treat it in patients in which it has already occurred.

"We are basically looking at all the earlier steps that are involved in metastasis that we weren't previously aware of. It is complex but we are opening the door to all these things that occur before the tumor cell implants itself," said Professor David Lyden, of Cornell University in New York.

"It is a map to where the metastasis will occur," he added in an interview.

LANDING SITE FOR CANCER CELLS

Cancer's ability to colonize other organs is what makes the disease so deadly. Once the cancer has spread beyond its original site it is much more difficult to treat.

link to full article

Pennsylvania Lawmakers Talk About Biotech Measure

Biotechnology Future Investment Expansion Act of 2005, also known as BIOFIX...

Two Pennsylvania lawmakers who wrote legislation that they say can help spur research and development in biotechnology met with industry leaders Monday. Sen. Rick Santorum, a Penn Hills Republican, and Rep. Melissa Hart, a Bradford Woods Republican, earlier this year introduced the Biotechnology Future Investment Expansion Act of 2005, also known as BIOFIX, the federal legislation modifying Section 382 of the tax code to allow biotech firms to utilize tax breaks on their net operating losses. Currently, to help pay for the process of getting drugs and treatments approved, companies often have to undertake equity financing that triggers ownership changes, preventing the companies from claiming net operating losses. It takes about 10 years to develop a new drug or treatment and the cost is between $500 million and $800 million. "Currently, limitations imposed in the tax code prevent many biotech startups from taking advantage of tax incentives," Santorum said in a statement. "By updating this provision in the tax code to meet the needs of the biotechnology sector, companies are encouraged to expand their research," he said. Steve Zylstra of the Pittsburgh Technology Council was among the attendees for the roundtable discussion at the Pittsburgh Life Sciences Greenhouse in Hazelwood. He said the measure could "encourage new investment." "The BIOFIX Act of 2005 attempts to foster innovation, spur research and development and create cutting-edge high technology jobs by removing an unnecessary barrier in our federal tax code currently hampering the development of emerging biotechnology companies," he said in a statement.

link to article from biospace.com

Blogging the Annual Meeting- Day 4

Wednesday…last day here…can’t afford any more time away from the office…

Up…pack up, check out, etc, etc, etc… back to the resort for a last look around and some souvenir shopping…have to bring some good ones back since I’ve been gone for 4 days…

not very many people around… still lot’s of people coming out of the sessions at break time, but it seems that if you’re not there for a specific session, you went home…

Lunch in the resort, last stroll around, and off to the airport…

USAir and America west are merging and I’m stuck flying the day the computers won’t decide which airline is running the flight!!!

Whatever…back to Philly late, I had to be the last person out of the parking garage that night…have to be up early for work the next day, time zone change, traveling, now I know why they’re called “red-eyes”…

Blogging the Annual Meeting- Day 3

Tuesday…seminar day!!!

Bought the one day “a la carte” session pass…picked Tuesday for the Biotechnology session in the morning and the C and Q session in the afternoon…it would have been nice to be able to attend the full day in each, but that was the luck of the draw based on the schedule.

The Biotech session started the day off with a schedule adjustment to accommodate some of the speakers’ requirements…Tony Lubineicki gave a nice presentation on the progress made in the previous 25 years in the biotech industry…good background for some of us who weren’t there in the glory days of the industry. Another presentation was made to review possibilities for the next 25 years…maybe we will begin to realize the true power of the human genome…missed part of this for phone calls from the office…oh yeah, people back at the office are still working on the project!!!, should turned my phone off, not just on silent… the first part of the morning session finished up with a case study for a flash-track project presented jointly by a client and the consulting engineer...the remainder of the day seemed to be given over to discussion regarding development and production of generic biotech products, so I decided to give the rest of the session a miss.

So…over to the C and Q session which was continuing a good presentation of the new guideline document…some of the authors were available to present the overall intent and scheme…

Lunch was the ISPE working business meeting, but enjoyable nonetheless, given the number of speeches and sundry discussions regarding budget approvals, etc, etc, etc…out of that giant sea of people wandering in to the lunch hall, I still managed to run into someone I knew…

Spent the rest of the afternoon in the C and Q session…

Dinner that night was the big gala celebration…had to wear a jacket to dinner…lot’s of speechifying, good dinner, good entertainer…back to the hotel…

The presentations, or some of them anyway are available on the ISPE website…I’ll be reviewing the sessions in more detail as I get the time…look for more to come!!!

Live From The Lab, A Culture Worth A Thousand Words

They can do what???!!!...

Scientists have created living photographs made of bacteria, genetically engineering the microbes so that a thin sheet of them growing in a dish can capture and display an image. Bacteria are not about to replace conventional photography because it takes at least two hours to produce a single image. But the feat shows the potential of an emerging field called synthetic biology, which involves designing living cellular machines much as electrical engineers might design a circuit. "We're actually applying principles from engineering into designing cells," said Christopher A. Voigt, assistant professor of pharmaceutical chemistry at the University of California, San Francisco, and a leader of the photography project, which is described in a paper being published today in the journal Nature.

Blogging the Annual Meeting- Day 2

Monday!!!

up early, my body clock is still set on east coast time, breakfast at my dinky hotel...missed the delegates breakfast at the resort, oh well, my loss...

At the booth early, with a long day of "meet and greet" ahead...at least they serve coffee first thing...

nice to see people, surprising how many faces you know, walked around, looking at all the tabletop exhibits, good turnout...

lunch on the outside patio, delicious southwest style, good salsa, more spicy than I normally find...

back to the booth, waves of people hit the floor when the sessions come out, while the sessions are in sessions you get the impression that there aren't very many people in attendance...then suddenly it's packed...

Anyway, it seems about the same people mix, like there's 17 consultants circling the one client rep like sharks in bloody water...great fun!!!

At one point, about group of about seven of us found ourselves standing around a table chatting...not one of us was working where we used too last time we all saw each other, and not just on the consulting side either, client side too...so it was good to catch up with people...where are you now?

dinner on the back patio/ lawn...shook hands with the new ISPE director, seems like a nice guy...had to wear a jacket, but lots of entertaining southwest-type things to do, eat, band, rope a cow, etc, etc...some safety concerns were evident...like people doing the hatchet throw event after some number of drinks...but hey, nobody bounced anything off my head...

cut out after a while, though, another long day...

Merck Announces Initial Steps In Global Restructuring Program

Merck digs in...

WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Nov. 28, 2005--Merck & Co., Inc. (NYSE:MRK)

-- Initial Phase of Cost Reduction Program Expected to Yield Cumulative Pretax Savings of $3.5 Billion to $4.0 Billion in 2006-2010

-- Costs Associated with Restructuring Program Expected to be Substantially Complete by 2008

-- Elimination of 7,000 Positions Expected by End of 2008

-- Five of 31 Manufacturing Facilities Expected to be Closed or Sold

-- Full-Year 2005 EPS Expected to be $2.47 to $2.51 Excluding Charges, with Reported 2005 EPS of $2.04 to $2.10

-- Full-Year 2006 EPS Expected to be $2.28 to $2.36 Including Approximately $0.07 Impact from Stock Option Expensing but Excluding Restructuring Charges, with Reported 2006 EPS of $1.98 to $2.12


Merck & Co., Inc. (NYSE:MRK) today announced the first phase of a global restructuring program designed to reduce the Company's cost structure, increase efficiency, and enhance competitiveness. The initial steps will include the implementation of a new supply strategy by the Merck Manufacturing Division (MMD), which is intended to create a leaner, more cost-effective and customer-focused manufacturing model over the next three years.

"The actions we are announcing today are an important first step in positioning Merck to meet the challenges the Company faces now and in the future," said Richard T. Clark, chief executive officer and president of Merck & Co., Inc. "We are engaged in an ongoing effort to enhance efficiencies throughout the Company and improve the way we discover, develop, manufacture and market our medicines and vaccines and ensure that we get them to patients who need them as quickly, safely and efficiently as possible. Going forward, we also plan to pursue improved approaches to R&D, and marketing and sales. We look forward to discussing our initial plans at our Annual Business Briefing on December 15."

link to full article

Thanksgiving tips: Hold the bacteria

Enjoy your holiday!!!

WASHINGTON (AP) -- When Thanksgiving arrives next week, people should be groaning from full stomachs, not food poisoning.

More than 200,000 Americans get sick each day from what they eat, and turkey dinner with all the trimmings complicates it all. The government is offering some tips to keep holiday cooking from becoming an intestinal curse.

At the top of the list is washing your hands often, followed by keeping raw food separate from cooked food, using a food thermometer and storing leftovers in small portions in the fridge.

"It's a little bit more dangerous, obviously, when you have large gatherings and food laid out like this," said Richard Raymond, the nation's top food safety official. "We tend to feast and nibble and snack all afternoon."

During a food-safety demonstration at a food bank, the Agriculture Department's undersecretary for food safety walked along a table laden with raw and cooked turkey, stuffing, green bean casserole and pumpkin pie.

link to cnn.com for full article

Blogging the Annual Meeting- Day 1

Sunday- travel day!!! up at dawn, off to the airport...

crowded for a Sunday morning, where are all these people going? apparently, Phoenix...

typical travel hassles, long flight, driving in a strange city, getting lost...which way is east anyway?...found my hotel...eventually...some dinky little efficiency...everybody else got rooms at the main resort...oh well, off to find that...

arriving at the resort, it's so big I can't find the front door, oops, I mean main entrance, lobby, fountain/ reception area, etc, etc, etc...beautiful...

wander around a bit, check in with ISPE, no big lines...no problem...

off to the exhibit hall...it's booth central...trying to find my colleagues...

here we are, all set up and ready to go...It's "meet and greet" time... standing up for the rest of the afternoon, introducing myself to people I don't know...seems obvious, but it's a bit of a stretch for me, and others, I suspect...

dinner was out on the pool patio, hosted by DPR...very nice...

walked around the grounds, beautifully lit at night...fountains, pools, palm court...really very nice...

back to my dinky hotel room for some sleep, the time difference and the day's travels were catching up with me...

Life Sciences Short Of Workers, Threatened By Rivals

and I thought this was just on the engineering side of things

The life sciences industry in Northern California has grown from a collection of fledgling firms with potential into one that has commercialized hundreds of drugs and medical devices, but the region's regard as a world leader in the field is under threat, industry advocates warned Nov. 14. The warning came as BayBio, the region's life sciences trade and advocacy group, released a lengthy report that largely painted a positive picture of the state of the industry in Northern California. Life sciences firms in Northern California now have 240 products on the market to treat diseases such as cancer, and about 200 product candidates are in later stages of clinical trials. At least a third of all publicly traded domestic biotechnology firms are in Northern California, representing more than $150 billion in market value, and they are plowing nearly $4 billion annually into research, according to the report. The industry in Northern California employs some 85,000 workers. Hiring is proceeding at a rapid clip to fill nearly 8,000 more jobs that the sector is expected to generate by the end of 2006. Employment growth is expected to grow by 10 percent to 20 percent annually over the next several years, according to the report. But industry experts and advocates at the same time cautioned that the cost of living here, government bureaucracy, tax codes and an inability to supply enough trained workers to meet demand could hamper the region's ability to deliver new treatments and could cause some firms to leave the area. BayBio is taking the report on the road to Sacramento and Washington, D.C., and it hopes its message will resonate with lawmakers.

link from biospace.com

Continuous Education

Great idea, this continuous education thing...

I see that ISPE is now pushing for an industry certification for "pharmaceutical Professional"...we certainly are an industry driven by "expertise"...

now all we have to do is make the time for it...on the consulting side, a week out of the office for the annual meeting means a week trying to get back in the loop and playing catch-up...the rest of the world kept going while I was out trying to continue my education

no one is sitting around waiting for you to become an expert...and I doubt anyone is scheduleling your training sessions...

that's up to us...

Glaxo targets India for cancer drug research

I guess you can outsource anything...

LONDON (Reuters) - GlaxoSmithKline Plc plans to make India a major center for testing experimental cancer drugs, in a move highlighting the appeal of the country as a low-cost base for research.

Europe's biggest drug maker said on Thursday it had signed a collaboration with the University of Oxford's clinical pharmacology department to establish the first Indian cancer-trials network.

Glaxo, which has big ambitions in cancer, will outline its goals for tackling the disease at a research seminar for investors on November 30.

Its most important experimental cancer drug is lapatinib, a dual-action treatment which is being developed initially for breast cancer. It also has a promising vaccine to prevent cervical cancer, called Cervarix.

Glaxo said the new collaboration would enable the evaluation of new treatments in a range of cancer types, including gall bladder, liver and cervical cancers, which are more prevalent in India than in Europe or North America.

link to full articles from Reuters.com

Blogging the ISPE Annual Meeting...

Well, I had grand plans of blogging about the ISPE Annual Meeting and reviewing each day's activities...I had done a series of blogs for last year's Interphex meeting in NY...and had the same sort of thing in mind.

It turns out that the days have been so busy, along with extending into the nights, that this is the first time I have had a couple of minutes to sit down and gather my thoughts...

First things first, work is still going on in the office on East coast time...even if you get up early, they still have a 2 hour head start!!! like it's not hard enough to keep up when you're out of the office for three days...

I'll get back to it, maybe on the flight back...look for more to come...

Day 1

Day 2

Day 3

Day 4

Demand growing for pre-fillable syringes

technology marches forward...

02/11/2005 - The Parenteral Drug Association (PDA) recently held a conference in Munich to fuel the further development of the growing pre-fillable syringe market.

The conference, spearheaded by Gerresheimer's PharmaSystems subsidiary, Blunder Glas, was designed to update pharmacists on the latest technology and development priorities for pre-fillable syringes, including the highly topical aspect of drug delivery.

The injectable drug market is growing strongly at present, driven by the rising number of biologic drugs coming though the biopharma industry's pipelines.

As patients live longer and are diagnosed with chronic and often debilitating ailments, the result will be a dramatic increase in self-administration of injectable drug therapies.

This trend is creating an increased interest in routes of administration that are user-friendly and cost-effective.

The availability of an increasing number of drugs in pre-filled disposable cartridges and syringes are fueling the growth of these administrative new devices, at the expense of traditional injectable drug delivery devices.

link to full article from in-pharma tech

Scientists offer new hope for rapid production of bird flu vaccine

More new technology progress...we'll wait and see if it is viable...
maybe the emerging crisis will really push new manufacturing techniques forward.

WASHINGTON (AFP) - A new genetic technique developed by US and Japanese scientists could help drugs firms produce a vaccine for the deadly strain of bird flu more quickly, researchers said in a specialized magazine.

The improved "reverse genetics" technique makes the disarmed viruses that are the seed stock for producing large quantities of flu vaccine, said the study's co-author, Yoshihiro Kawaoka of the University of Wisconsin.

It could assist in the rapid manufacture of a vaccine for the virulent H5N1 strain of avian flu, which has killed more than 60 people in Asia since late 2003.

link to full article

Bush Outlines $7.1B Flu-Fighting Strategy

lots of political statements, etc, etc, etc...

look at the last 2 paragraphs regarding domestic production and new cell culture production technology...

WASHINGTON - President Bush outlined a $7.1 billion strategy Tuesday to prepare for the danger of a pandemic influenza outbreak, saying he wanted to stockpile enough vaccine to protect 20 million Americans against the current strain of bird flu as a first wave of protection.

The president also said the United States must approve liability protection for the makers of lifesaving vaccines. He said the number of American vaccine manufacturers has plummeted because the industry has been hit with a flood of lawsuits.

Bush said no one knows when or where a deadly strain of flu will strike but "at some point we are likely to face another pandemic."

...portion deleted...

The government already has ordered $162.5 million worth of vaccine to be made and stockpiled against the Asian bird flu, more than half to be made in a U.S. factory.

But the administration plan, to be released in more detail on Wednesday, calls for more than stockpiling shots. It will stress a new method of manufacturing flu vaccines — growing the virus to make them in easy-to-handle cell cultures instead of today's cumbersome process that uses millions of chicken eggs — as well as incentives for new U.S.-based vaccine factories to open.

link to full article

Roche seeking partners to increase Tamiflu production

Update from previous story regarding tamiflu

SHANGHAI (AFX) - Swiss drug maker Roche is in talks with companies to set up a global manufacturing network to increase capacity to produce the anti-bird-flu drug Tamiflu as soon as possible, the Shanghai Daily reported, citing a company executive.

Roche, which owns the manufacturing rights for Tamiflu, has received more than 100 requests from companies seeking licenses to make the drug, Jan Van Koeveringe, head of Roche global technical operations told the paper.

'The next thing we will do is send out inquiries to get the details of what capacity is available so we then have as soon as possible a global manufacturing network for the supply of Tamiflu,' the paper cited him as saying.

He said that an applicant company has to be able to 'add substantial capacity' to Roche's global supply chain before collaboration can occur. He did not give figures.

Roche has been under pressure to increase output of Tamiflu, as thousands of migratory birds moving across international borders carry with them the risk of spreading avian flu, the paper said. Growing fears of a bird-flu pandemic have caused global demand for the drug to soar.

Global health experts fear the virus could mutate and spread among humans, causing a worldwide epidemic. The H5N1 strain of bird flu has killed at least 63 people in Southeast Asia since 2003, the majority of them in Vietnam, the paper noted.

from Forbes.com

'Start of life' gene discovered

"Harnessing the Human Genome will make harnessing the atom look like childs play..."

I don't know who said that, or made a vaguely similar statement, but I believe it to be true.

I am continually amazed at what is being discovered in this area. I guess we are all waiting for more real-world results instead of pure research...


Scientists have found the gene responsible for controlling a first key step in the creation of new life.
The HIRA gene is involved in the events necessary for the fertilisation that take place once a sperm enters an egg.

Faults in this gene might explain why some couples struggle to get pregnant despite having healthy sperm, say the researchers from the UK and France.

link to full article on BBC.com

Flipped Genetic Sequences Illuminate Human Evolution And Disease

Maybe we should tech this in religion class...

y comparing the human genome with that of the chimpanzee, man's closest living relative, researchers have discovered that chunks of similar DNA that have been flipped in orientation and reinserted into chromosomes are hundreds of times more common in primates than previously thought. These large structural changes in the genome, called inversions, may account for much of the evolutionary difference between the two species. They may also shed light on genetic changes that lead to human diseases. Although humans and chimpanzees diverged from one another genetically about six million years ago, the DNA sequences of the two species are approximately 98 percent identical. Given the 2005 publication of the draft chimpanzee genome sequence, researchers can now readily identify the differences between the human and chimp genomes. These differences lend insight into how primates evolved, including traits specific to humans. The researchers published their findings in the October 28, 2005, issue of the journal Public Library of Science Genetics (PLoS Genetics). The paper was published early online. Senior author Stephen W. Scherer is a HHMI international research scholar, a senior scientist in the Genetics and Genomic Biology Program at the Hospital for Sick Children in Toronto, Canada, and an associate professor of molecular and medical genetics at the University of Toronto.

Stanford University Sees Biotech Campus

Everybody's doing it!!!

Stanford University has bought 29 acres and nearly 550,000 square feet of older office/R&D property in Redwood City with the hope that the site will become a new biotech hub with links to Stanford faculty, researchers and students. Stanford did not release details of the purchase of the site, once part of the Excite @ Home campus, from a partnership that includes San Francisco's TMG Partners. The sale price was also omitted from documents on file with the San Mateo County recorder's office. It is the largest off-site acquisition of real estate by the university, perhaps ever, according to the school's vice provost, and follows Stanford Hospital and Clinics' decision earlier this year to buy four neighboring buildings for outpatient medical care. That project, now awaiting Redwood City review, greatly colored the university's decision to buy the second tract, school executives say, because it opened possibilities for life-science-related commerce that would not otherwise have materialized.

link

Chiron misses flu vaccine production target again

18/10/2005 - Chiron has warned it will yet again fall short of targets for its US flu vaccine deliveries this year due to continuing production problems with its British manufacturing plant.

Speaking on a conference call on Monday, Chiron's chief executive Howard Pien said the plant would produce fewer than 18 million doses of flu vaccine for the 2005–06 flu season, down from a previous estimate of between 18 and 26 million doses.
In an average year in the US, influenza causes more than 200,000 hospitalisations and kills approximately 36,000 people, primarily in the over-65 population.

Influenza vaccination is the most effective way to prevent influenza.

link to full article from in-pharmatech

S.Korea launches ambitious global stem-cell project

SEOUL (Reuters) - South Korea launched on Wednesday a an ambitious project to make the country a global hub for stem-cell storage and research, hoping to further cement its status at the forefront of cloning research.

Helped by generous government support and an absence of some of the red-tape and ethical debate that has hampered research in countries such as the United States, South Korea is fast becoming a key center for stem-cell research.

Stem cells are master cells in the body that can develop into any cell type. Scientists are trying to learn how to manipulate them for transplants to treat diseases such as Alzheimer's or diabetes.

link to full article

stem cell

Cipla bird flu drug defies Roche

17/10/2005 - Cipla announced plans on Friday that will see it become the first company to sell a generic version of the anti-influenza drug Tamiflu.

The company claimed it was already making generic Tamiflu (oseltamivir phosphate) and should have its first batch of 1,300 treatments on the market in early 2006.
Tamiflu, which reduces the severity and spread of traditional flu, is already in short supply throughout the world, as countries gather stockpiles of the drug amid fears of a possible avian flu epidemic.

link to full article from in-pharmatech

tamiflu

Roche considers flu drug partners

Drug firm Roche may allow other companies to produce its antiviral drug Tamiflu under licence to help combat a potential flu pandemic.
The Swiss firm is considering ways of boosting output of Tamiflu, the main treatment for the deadly strain of bird flu which struck Asia last year.

Roche is now producing Tamiflu at 13 sites worldwide and has received orders for the drug from 40 countries.

The World Health Organization advised countries to stockpile supplies.

link to full article from BBC.com

tamiflu

More doubt on blood pressure drug

A large study has provided fresh evidence that a drug widely used to treat high blood pressure may not be the best option for many patients.
A Swedish team analysed data on more than 105,000 people and found beta blockers were not as effective as other drugs in reducing high blood pressure.

The Lancet findings echo a high profile international study last month which found modern drugs were more effective.

Beta blockers are used to treat more than two million UK

link to full story on BBC.com

Prof develops cancer nanobomb

Great Stuff!!! treating cancer with nanotechnology!!!

3:38 p.m., Oct. 13, 2005--University of Delaware researchers are opening a new front in the war on cancer, bringing to bear new nanotechnologies for cancer detection and treatment and introducing a unique nanobomb that can literally blow up breast cancer tumors.

Balaji Panchapakesan, assistant professor of electrical and computer engineering at UD, has recently reported on the discoveries in the journals NanoBiotechnology and Oncology Issues.

He is the lead investigator for a team that includes Eric Wickstrom, professor of biochemistry and molecular biology at Thomas Jefferson University in Philadelphia and his student Greg Cesarone, and UD graduate students Shaoxin Lu, Kousik Sivakumar and postdoctoral researcher Kasif Teker.

link to full article

Calif. court taking up motion to toss stem cell bonds

and bouncing...

SAN FRANCISCO (Reuters) - A California judge overseeing a lawsuit to prevent the state from issuing up to $3 billion in bonds for its stem cell research institute has scheduled a hearing on November 17 on a motion to dismiss the lawsuit, a spokesman for the state's lawyer said on Thursday.

The motion by California Attorney General Bill Lockyer aims to free the state to issue the voter-approved general obligation bonds, which could total $3 billion over 10 years, said Lockyer spokesman Nathan Barankin.

The debt would fund studies into using human stem cells for therapies or cures to various illnesses and ailments, an initiative backed by Republican Gov. Arnold Schwarzenegger.

His support for the work, which may include using stem cells from human embryos, is at odds with U.S. President George W. Bush's restrictive approach to the research.

Legal challenges to the debt sales for the California Institute for Regenerative Medicine have "effectively prevented the state from marketing the bonds," according to Lockyer's motion filed in Alameda County Superior Court.

link to full article

Mo. Groups Propose Stem Cell Amendment

The stem-cell issue keeps bouncing...

JEFFERSON CITY, Mo. - A coalition of researchers and patients groups proposed a constitutional amendment Tuesday to protect stem cell research in Missouri, where anti-abortion activists have tried to outlaw a particular type of research they say amounts to the taking of a human life.

Supporters of the amendment must gather at least 139,181 petition signatures from voters to get the measure on the November 2006 ballot. Anti-abortion groups want to "criminalize some of the most promising types of stem cell research," coalition chairman Donn Rubin said.

The coalition claimed its proposal was the first in the nation to protect patients' rights to be treated with any eventual stem cell-related cures. It would specify that stem cell research, therapies and cures allowed under federal law also are permitted in Missouri.

link to full article

Wyeth phases out NY facility

12/10/2005 - Pharmaceutical manufacturers, Wyeth, are to phase out manufacturing at its US facility as part of its consolidation plans, which will see the gradual phasing out of all operations at the New York facility by late 2008.

The three-year transition plan aims to phase out production of over-the-counter drugs as well as some of the best-selling ethical drugs currently on the market. The facility, located at Rouses Point, New York, manufactures and packages all dosage forms, from solid dosage to sterile fills.

pharmatech link to full story

ISPE Article of the Year Finalists...

2005 FINALISTS ANNOUNCED!!!

link to full list of articles...

FDA Adviser Resigns Over Plan B Handling

WASHINGTON - A consultant to a Food and Drug Administration advisory panel has resigned in protest of the agency's handling of the Plan B contraceptive.

Dr. Frank Davidoff, editor emeritus of the Annals of Internal Medicine, said the agency is ignoring science in favor of politics in delaying approval of the drug for over-the-counter sales.

He was a member of the FDA's Nonprescription Drugs Advisory Committee when it voted to approve Plan B for over-the-counter sales in 2003, and had served as a consultant to the committee since his term ended earlier this year.

Davidoff is the second person to publicly resign over Plan B. In late August, the top women's health official at FDA, Susan Wood, also resigned in protest. Former FDA Commissioner Lester Crawford has also since resigned.

Plan B, which can be used as emergency, morning-after contraception, is opposed by some religious conservatives.

The committee Davidoff was on is one of several scientific advisory committees that provide the FDA with an independent assessment of new drugs.

link to full story

Continuous Education- Part 3

and don't forget Interphex...

March 21-23
Jacob Javits Convention Center
New York, NY

and in case you have an extra presentation lying around that you have been dying to present...they're looking for speakers

SpeakerService: Interphex 2006

Continuous Education- Part 2

I'll be going to the ISPE meeting...see you there...

Celebrate 25 Years of Excellence!

Join your colleagues from around the world
for the pharmaceutical manufacturing industry's
number one educational event.

6-10 November 2005
Scotsdale, Arizona

ISPE 2005 Annual Meeting

Continuous Education- Part 1

got the following via snail mail, as the expression goes...

"In-Depth GMPs for Pharma and Biotech"

December 7-9 Las Vegas, Nevada

www.pharmaconference.com for more info

New Lifespan Extension Genes Found

New genes tied to lifespan extension in yeast have been identified by researchers from UC Davis and Harvard Medical School.

Drastically reducing calorie intake, or caloric restriction, is known to extend the lifespan of species including yeast, worms and rodents. Previous research linked a gene called Sir2 with lifespan extension due to caloric restriction, but worms and yeast that lack Sir2 also live longer when put on a tough diet, showing that some other genes must be at work.

Researchers led by David Sinclair at Harvard Medical School and Su-Ju Lin at UC Davis' Center for Genetics and Development and Section of Microbiology screened for other life-extending genes in yeast. They found a gene called Hst2 that accounts for most of the difference.

link from UCdavis.com

Liars' brains 'are not the same'

Habitual liars' brains differ from those of honest people, a study says.
A University of Southern California team studied 49 people and found those known to be pathological liars had up to 26% more white matter than others.

White matter transmits information and grey matter processes it. Having more white matter in the prefrontal cortex may aid lying, the researchers said,

But the British Journal of Psychiatry said there were likely to be more differences in the brains of liars.

Link to BBCnews.com

Genzyme unveils $540m expansion plan for manufacturing, R&D

27/09/2005 - US biotechnology major Genzyme officially opened four European facilities last week as part of a investment package eventually expected to cost $540 million (€449m).

The series of openings, which will see Genzyme become one of the largest biotechnolgy operations in Europe, with over 2,000 staff, includes.

a site in Geel, Belgium, for the production of recombinant monoclonal antibodies.
an $8 million centre at its UK manufacturing site in Haverhill, to carry out process development and clinical trial support for renal disease products;
a $157 million fill-and-finish plant for biologic medicines in Waterford, Ireland; and
a drug discovery research facility in Cambridge, UK, that will employ 150 people within five years.
The moves comes in the wake of a number of other large-scale investments in biological drugs production capacity, from the likes of Genentech, GlaxoSmithKline and Bristol-Myers Squibb.


link to full article in in-pharmatech.com

FDA Chief Wants Transformation in Medicine

WASHINGTON - The incoming head of the Food and Drug Administration says the agency must stay on top of emerging discoveries into the mechanisms of disease that may lead to new treatments that can be tailored to individual patients.

Dr. Andrew C. von Eschenbach, tapped by President Bush to at least temporarily head the regulatory agency, said Sunday that recent research will lead to a new kind of health care.

"We are discovering so much about diseases like cancer at the molecular level," von Eschenbach, a urologic surgeon by training, said in an interview with The Associated Press.

Based on these understandings, physicians will be able to devise treatments more effectively matched to a specific patient and his or her condition, he said. That's a fundamental shift: Doctors now treat illnesses based primarily on how well other people have responded to a given treatment.

Von Eschenbach has a reputation for optimism. As head of the National Cancer Institute, he outlined an ambitious goal of eliminating suffering and death due to cancer and turning it into a manageable disease by 2015 — an aim regarded by some as unlikely.


link to story

Crawford resigns as FDA Commissioner

Update- 28Sep05

FDA Chief's Resignation Comes As Surprise

WASHINGTON - Food and Drug Administration Commissioner Lester Crawford is out only two months after the Senate confirmed him to run the agency. President Bush designated Dr. Andrew C. von Eschenbach, the director of the National Cancer Institute, the acting replacement.


Crawford's surprise resignation, submitted Friday and effective immediately, gave no specific reason for his departure. "It is time at the age of 67, to step aside," he wrote in his resignation letter.

Crawford's tenure was marked by increasing criticism of the agency by those who contended it had become more interested in politics than in its mission to protect consumers.

Link to full article


26/09/2005 - The US Food and Drug Administration (FDA) has found itself once again without a permanent Commissioner after the current incumbent - Lester Crawford - resigned after 18 months in the post.

Crawford was appointed acting FDA Commissioner March 2004, after having stepped into the job on an interim basis on two prior occasions. He has been acting Commissioner since Mark McClellan departure left to head up the Centres for Medicare & Medicaid Services, and after a long, contentious and drawn-out appraisal process was finally granted the permanent position in July.

link from in-pharmatech

RABS Definition Paper Finalized

A restricted access barrier system (RABS) is a type of barrier isolation system that includes several specific characteristics; however, there is great confusion in the industry about RABS and how they differ from other forms of advanced aseptic processing.

In order to assist regulatory and industry professionals in reaching an understanding of the requirements for RABS, the FDA encouraged ISPE to provide a clearer definition of the elements that characterize RABS technology. Following ISPE's annual Barrier Isolation Technology Conference (part of the 2005 Washington Conferences in June), a group of attendees, speakers, and organizers met to create a definition white paper for RABS. The team posted the draft paper for public comment on the ISPE Web site during July and submitted a final version to the FDA. Released on 16 August, the positioning paper defines RABS for the industry and describes the "quality by design" and operational characteristics that must be present to constitute a RABS.

"I think this group's constructive work in describing RABS will be helpful to both industry and FDA. This appears to be the first, and certainly the most current and comprehensive, RABS definition offered by a technical organization," said Rick Friedman, Team Leader for Guidance and Policy at the FDA's Center for Drug Evaluation and Research. "Now, companies will be able to start sterile facility design discussions with a concrete definition to refer to. I expect this contribution to be an instrumental step toward reaching consensus on a formal definition."

link to ISPE.com article

Drug firms launch Web site to disclose trials data

LONDON (Reuters) - The global pharmaceutical industry launched a new Web site on Wednesday giving details of clinical trials on new medicines, in a bid to allay patient fears over drug safety.

The move follows criticism that companies manipulate or suppress results of clinical studies in order to come up with favorable conclusions.

link to full story at reuters.com

This could be a good thing...

just might be a bit boring to read.

Report sees boom time ahead for biopharma CMOs

good story...lot's to digest...

15/09/2005 - Pharmaceutical companies are increasingly looking to retain their internal focus on research and development (R&D) and marketing while outsourcing their manufacturing processes, thus fueling a growing demand for the manufacturing capacities of contract manufacturing organisations (CMOs).

This trend will drive a doubling in revenues in the pharmaceutical contract manufacturing sector from $12.38 billion (€10.13bn) in 2004 to $25.70 billion in 2005, according to a report from consulting firm Frost & Sullivan.

link from in-pharmatech.com

Sandoz takes issue with FDA over biogenerics

I didn't think you could sue the FDA...

15/09/2005 - Sandoz, the generic drug unit of Swiss pharmaceutical group Novartis, has filed a law suit against the US Food and Drug Administration (FDA) alleging that the agency is dragging its feet in a review of a ‘biogeneric’ drug filed by the company.

Sandoz is calling for a swift ruling on its pending application to market its human growth hormone product Omnitrope, based on an abbreviated approval route that does not require the conduct of extensive clinical trials

link from inpharmatech.com

Murdock Biotech Plan Valued At $1B; 5,000 Jobs In Bio NC

Its the job creation thing again!!!...

I sense a pattern...

but I still want to know what work is going to come out of all this...


California financier David Murdock's plan for establishing a biotechnology research campus in Kannapolis could grow to a $1 billion development that would create 5,000 jobs. Murdock, who owns Dole Food Co. Inc. and real estate development firm Castle & Cooke Inc., unveiled his proposal Monday for transforming a 250-acre former Pillowtex Corp. plant and an adjacent 100 acres in downtown Kannapolis into the North Carolina Research Campus. The campus, which Murdock wants to develop in conjunction with the University of North Carolina system, would create 5,000 jobs. But spinoff employment could eventually grow to 30,000, says John Cox, chief executive of the Cabarrus Regional Chamber of Commerce.

link from biospace.com

GSK continues apace with flu vaccine empire building

08/09/2005 - If there was any doubt that GlaxoSmithKline aims to become the premier world supplier of influenza vaccine, it should be laid to rest by yesterday’s news that the number two drugmaker is buying Canadian company ID Biomedical.

The move follows the company's decision to buy a facility from Wyeth in the US that will be turned over to flu vaccine production, as well as its announcement that it will double production at a flu vaccine facility in Dresden, Germany,
Until last year, the flu vaccine market was split mainly between two players – Chiron and Sanofi Pasteur – with other players lagging well behind the leaders. Now, the manufacturing problems that have beset Chiron and led to vaccine shortages in the 2004/5 flu season have opened up the market, and GSK itself has benefited with approval of its own Fluarix vaccine by the US Food and Drug Administration (FDA) under a special fast-track system.

link for full article

Biotech Firm May Bring 250 Jobs To Phoenix, Arizona

looks like biotech is the next job creation engine...

Phoenix beat out San Diego, San Francisco and Seattle as the new headquarters for a Canadian biotech firm that also is considering building a protein manufacturing plant in the Valley. InNexus Biotechnology Inc., which develops drugs from naturally occurring proteins, is consolidating operations and moving to Phoenix to conduct clinical trials for its cancer and heart drugs. Ultimately, the company could employ as many as 250 people here. Plans call for taking an initial 15,000 square feet within Mayo Clinic's 110,000-square-foot research complex at 136th Street and Shea Boulevard in Scottsdale. Written into the 10-year lease are plans for expansion. About 40 people will be employed at that lab to begin with, but as the company expands, as many as 100 will work there, said Jeff Morhet, InNexus chief operating officer.

link from biospace.com

Wyeth Pharmaceuticals Opens Ireland Plant

Wyeth Pharmaceuticals Opens $2 Billion Plant in Ireland, Expects to Employ 1,000 People

DUBLIN, Ireland (AP) -- Wyeth Co. officially opened a $2 billion Irish production facility Thursday, a move that will make the U.S. company the biggest pharmaceutical employer in Ireland.

The Madison, N.J.-based company expects to employ about 1,000 people, including 100 researchers developing new products, at its 1.2 million-square-foot campus south of Dublin within the next four years.

link from AP

Europeans launch $4 bln vaccines scheme

LONDON, Sept 9 - European countries launched a new scheme on Friday to provide $4 billion in life-saving vaccines to millions of poor children, but critics said the project was flawed and much more money was needed to address the problem.

link from reuters.com

Biogenerics market set to explode?

Regulatory obstacles to the development of the market for biogeneric drugs are falling down, and the first products are set to reach the markets of North America and Europe in 2006-7, according to consulting firm Frost & Sullivan.

The markets in Europe and the US alone have the potential to generate sales of $16.39 billion by 2011, according to the company.


yeah, but will this generate any work???...

link from in-pharmatech.com

Scientists strike gold in nanoparticle research

yeah, another nanotech post...

story from in-pharmatech.com

Scientists in the US have developed a way to rapidly generate libraries of gold nanoparticles that could have an array of applications in the pharmaceutical industry, from target and drug discovery studies to drug delivery.

The team, headed by Jim Hutchinson of the University of Oregon's Materials Science Institute, said their technique allows rapid incorporation of specific functionality into the gold nanoparticles and can be used to incorporate a wide range of functional groups. It can also provide access to new materials inaccessible by other methods, claims the group.

FDA Approves New Influenza Vaccine for Upcoming Flu Season

The Food and Drug Administration (FDA) today approved Fluarix, an influenza vaccine for adults that contains inactivated virus. Fluarix is approved to immunize adults 18 years of age and older against influenza virus types A and B contained in the vaccine. Influenza is also commonly called the flu.

from fda.gov

Illinois Lures Kansas City-Area Stem Cell Researchers

This seems like the next "Manufacturing Belt" job wave...

Illinois Gov. Rod Blagojevich and Comptroller Dan Hynes are asking some Missouri doctors and scientists involved in stem cell research -- including some in Kansas City -- to consider moving to the Prairie State. The Illinois officials said Monday that they had sent a letter to 30 doctors and scientists conducting stem cell research in Missouri, including some at the University of Missouri-Kansas City School of Medicine, the Stowers Institute for Medical Research, Kansas City University of Medicine and Biosciences, Midwest Research Institute and Saint Luke's Health System. Stowers Institute spokeswoman Marie Jennings said she doesn't know who at the institute received the letter. In a written release, the institute said that it has had a good home in Missouri and that it is "very concerned" about recent efforts to ban stem cell research in the state.

link to biospace story

Merck to Mull Settling Some Vioxx Suits

Merck to Consider Settling Limited Number of Lawsuits Over Withdrawn Painkiller Vioxx


TRENTON, N.J. (AP) -- Merck & Co. will consider settling a limited number of lawsuits over its withdrawn painkiller Vioxx, a spokesman said Friday. The drug's link to heart attacks and strokes has spawned thousands of lawsuits and last week's $253 million jury verdict in Texas.

link to yahoo AP story

More information on Virtual Neighbors...

this may seem to hometown to the rest of you, but here goes...

link from select greater philadelphia

In particular, check out this report from the Milken Institute entitled "The Greater Phildelphia Life Sciences Cluster"...it has a lot of good comparative information for major cities in the US...

End of the line looms for Able Laboratories

Another example of the cost of quality, or rather, the non-conformances...

So if you ever hear something along the lines of "yeah, but look at all the money we'll save...it's not like it's gonna bring the company down or anything..."; It's time to stop and wonder...

Troubled generic drug manufacturer Able Laboratories has conceded defeat in its bid to get products back onto the market and elected to sell off the assets of the business.

Able was forced to cease manufacturing and recall all of its products in May after serious questions were raised about quality control data used to obtain approval for products made at its manufacturing facility in New Jersey. The company has been in negotiations with the US Food and Drug Administration (FDA) for a ‘rescue package' that would allow it to start making and selling products again. But these have failed, according to a company statement released yesterday.

link from in-pharmatech.com

Contract manufacturing news in brief

Who's making what for whom? In-PharmaTechnologist provides its periodic round-up of new deals and developments in the pharmaceutical contract manufacturing sector.

link from in-pharmatech.com

Collaboration Key to Overcoming Obstacles to Drug Development

New AAMC/FDA Report Highlights Partnership Opportunities

link from fda.gov/aamc.org


Washington, D.C., August 15, 2005 - Industry, academic medicine, and government researchers are calling for new and increased collaborations among pharmaceutical companies, academic researchers, and regulatory agencies to strengthen the processes that move scientific breakthroughs to novel diagnostics and therapeutics that benefit the public. A January conference, sponsored by the AAMC (Association of American Medical Colleges) and the U.S. Food and Drug Administration (FDA), and part of the FDA's Critical Path Initiative, was the basis for a new report that describes an array of immediate opportunities for stakeholders to work together toward breakthroughs in the drug development sciences.

Smart’ nanotubes could have drug delivery uses

Check out the cool images at the bottom of the article...

A team of materials scientists and biologists in the US say they have developed ‘smart’ bio-nanotubes that could be used to deliver a drug or gene to a particular location in the body.


link from in-pharmatech.com

Seven Pharma Pipeline Picks

whose got stuff coming...at least what forbes thinks...also check out the related links for whose product line has moved on and whose product line has tanked...

NEW YORK - This month, we have added seven new experimental drugs to our watch list of New Drugs to Watch, a sampling of the most interesting medicines in development at pharmaceutical and biotechnology companies.

link from forbes.com

Pfizer Sets Guidelines on Its Advertising

first BMS...now Pfizer

maybe we can consider this a trend...

NEW YORK - Pfizer Inc. pledged not to directly promote any new product to patients for at least six months after putting it on the market and to target only adult audiences when touting impotency treatment Viagra on TV.

link to full article on yahoo.com

Mayor Bloomberg Anounces Developer To Build Largest Biotech Campus In New York City

[update] added picture from enr.com...


$700 MM private investment in a new Bioscience center in NY...

link to biospace.com

Mayor Michael R. Bloomberg today announced the selection of Alexandria Real Estate Equities Inc. to develop the East River Science Park into the largest commercial bioscience center in New York City. The new 870,000-square-foot-facility, which will be built on a City-controlled site on Bellevue's campus that the City will lease to Alexandria, is expected to jumpstart the City's commercial bioscience sector by attracting the world's leading healthcare and pharmaceutical companies, and providing needed expansion space for the City's existing companies. The privately-financed, $700 million project is expected to create more than 2,000 permanent jobs and 4,000 construction jobs over the next 10 years. The total economic impact of ongoing operations of the development project is expected to be more than $350 million a year. Deputy Mayor for Economic Development & Rebuilding Daniel L. Doctoroff, Economic Development Corporation (EDC) President Andrew M. Alper, Health & Hospitals Corporation Acting President Alan D. Aviles, Bellevue Hospital Executive Director Linda Curtis, Alexandria CEO Joel S. Marcus, and Kathryn Wylde, President & CEO of the Partnership for New York City, the City's leading business group that committed up to $10 million toward the project through its New York City Investment Fund, also attended the event.

FDA Alerts U.S. Residents to Recall of Counterfeit "Lipitor" Sold in the United Kingdom

Hopefully, this will not become the first of many...

The Food and Drug Administration (FDA) is alerting U.S. residents to the recent recall of a batch of counterfeit "Lipitor" (atorvastatin) sold in the United Kingdom (U.K.). The medicine is used to treat high cholesterol. The counterfeit Lipitor 20mg tablets were recalled in the U.K. on July 28, 2005. Health authorities in the U.K. stated that initial results of tests performed on the counterfeit drugs do not indicate that this product poses an immediate risk to patients, however, they are advising that patients stop taking the drug and return it to the pharmacy where they obtained it. U.K. pharmacies are being advised to return all remaining stock of this batch to Pfizer Ltd., the manufacturer of Lipitor.

link from FDA.gov

GSK to double flu vaccine production capacity

The world’s second largest pharmaceutical company, GlaxoSmithKline, is investing close to €100 million in a new manufacturing facility in Dresden, Germany, for flu vaccines.


link from in-pharmatech

Took a Break...

Sorry...no posts last week.

to busy judging sunsets over the bay...

I'll get back to it...

Millipore Acquires NovAseptic AB: Broadens Offering to Biotech and Pharmaceutical Industry

Now we can all get samples of those cool little plastic snap-in aseptic connections things....

link from biospace.com

Swedish stem cell researchers create new brain cells

Sign me up!!!


STOCKHOLM (AFP) - Swedish researchers have created new functioning brain cells from stem cells drawn from the brains of living adults, sparking hope that effective treatments for devastating illnesses like Parkinson's and Alzheimer's could be at hand, media reported.


link from yahoo

Frist Breaks With Bush on Stem-Cell Bill

The political football begins to bounce funny...

That's what happens when the ball, uh, I mean the issue, has a funny shape...


WASHINGTON - Senate Majority Leader Bill Frist on Friday threw his support behind House-passed legislation to expand federal financing for human embryonic stem cell research, breaking with President Bush and religious conservatives in a move that could impact his prospects for seeking the White House in 2008.

link from yahoo

Life science jobs on way

and another one!!!...

Bay Area office to move to Triangle

Arysta LifeScience, which has its global headquarters in Tokyo, will pick a new site by late August, spokeswoman Donna Uchida said Wednesday.

link from newsobserver

Biotech park opens at Searle campus

Labs likely to lure jobs, developer says

link from the Chicago Tribune

always good to see a story like this one...

Chiron vaccine facility will miss Begrivac production targets

problems continue for Chiron and the flu market...

25/07/2005 - Chiron says it will be unable to supply any Begrivac influenza vaccine to markets outside the US during the 2005/6 flu season, just days after admitting it has sterility problems at a manufacturing plant.

link from in-pharma-tech

New Sanofi plant increases vaccine production

21/07/2005 - Sanofi Pasteur is to increase US influenza vaccine capacity as plans to construct a new plant get underway. The new facility is expected to be up and running in time for the 2009 influenza season creating more than 100 new production jobs.

link from in-pharma-tech

we'll watch to see if they use the modular approach...

Senate Approves Crawford to Head FDA

July 19, 2005 -- The Senate confirmed President Bush's pick to head the FDA Monday evening, ending a series of drawn-out controversies that had left the post vacant for nearly a year and a half.

Senators voted 78-16 to confirm Lester B. Crawford as the agency's next commissioner, elevating the veterinarian and experienced Washington bureaucrat from his post as acting director.


link from WebMD

Gene discoveries, jobs promised with new biotechnology center

link from the Austin Statesman.com

A new Research institute in Texas...

New Leadership for Safer Drugs

FDA News

The Office of Drug Safety announced a nationwide search for a new director of drug safety with the Food and Drug Administration. "The person selected for this job will be in the center of critical issues facing the Nation on the safe and appropriate use of medications, and will have a profound impact on the future of both public health and the regulatory environment in assessing and managing the risks of marketed drug products." said Dr. Paul Seligman, M.D., Director of the Office of Pharmacoepidemiology and Statistical Science.

link to FDA News

Second Chiron plant has sterility problems

Get ready for flu season...or not...

US drugmaker Chiron is facing a significant shortfall in the volume of influenza vaccine it will be able to ship to markets outside the US as a result of sterility problems uncovered at another of its manufacturing plants, reports Phil Taylor.

Link from in-pharma-tech.com

Ill. Plans $10M for Stem Cell Research

This issue continues to be a political football...

No state wants to get left behind, but some of the legislatures are not ready to move forward...

CHICAGO - Illinois became the fourth state to support stem cell research after Gov. Rod Blagojevich circumvented the Legislature and ordered $10 million in tax dollars be used for the controversial research.

link from Yahoo news

FDA Says Drug Maker Altered Data on Pills

FDA Says Maker of Generic Drugs Altered Data So Drugs Would Appear to Meet Standards

Compliance is free, it's the non-conformances that cost money...

stock price goes from $26 to $1.50...

link from yahoo.com/AP

Biopure Study Is Held on Safety Concerns

FDA Holds Back Biopure Trial for Emergency Blood-Loss Therapy on Safety Risks

link from Yahoo/ AP News

another setback for Bpur...

More Interphex stuff

still finding posts regarding this past interphex

link from Mr. Cerro's blog

his main blog site is here

link for interphex 2006

More Virtual Neighbors...

link from bioadvance.com home page

Schering-Plough Corporation (SGP) Expands Its Presence In Asia Pacific; Commercial Operations Opened In Korea And Pakistan

Hey, for once it's not China!!!...

link from Biospace.com

Meeting New Neighbors!!!

Virtual neighbors, that is...

link to Science Center website

The Science Center is an incubator/ commercialization effort...
lots of good infromation on the site..

more to come...

BIO 2005

[UPDATE] 03Jul05

link to bioblog2005

for additional notes, infromation, reviews etc...



you would think we would be all over this...

been too busy...

here are the appropriate links...


BIO 2005

info

photos

Genentech unveils production capacity hikes

US biotechnology major Genentech has provided further detail on its plans to dramatically increase production capacity in the wake of its $408m acquisition of Biogen-Idec’s Oceanside facility.

link from in pahrma tech