Amgen to open Indian office...

Outsourcing hits R+D?...

The world's largest biotechnology company Amgen will start its wholly owned local affiliate companies in Mumbai and Hong Kong before the end of 2006 to tap the Asian market for clinical trials and drug development.

Apart from conducting clinical trials in India, Amgen will conduct R&D operations, including research, pre-clinical development, data management support and statistical programming, by partnering with pharma and biotech companies in India. Currently, Amgen is in talks with some of the leading pharma and biotech companies in India and China to form alliances and collaborations to undertake drug development and clinical trial operations in the Asian region.

"In our industry, R&D is a multi-faceted effort that requires partnerships and collaboration between industry and a variety of individuals and institutions - all committed to advancing human health with the most innovative therapies. In order to conduct clinical studies and apply science and innovation to help fight serious illnesses, Amgen will partner with leading clinicians, as well as academic, healthcare, government, research and patient organisations to better serve unmet medical needs in the region" Mary Klen, associate director, Amgen informed Pharmabiz in an e-mail interview.

However, she declined to share the details of the investment and the companies Amgen is in discussions with to form collaborations and partnerships.

She said under Amgen's global clinical development strategy, the company might decide to develop in Asia any of the molecules that are currently under development in the United States and other parts of the world.

The US$ 12.4 billion Amgen, which invested about US$ 2.3 billion in R&D alone in 2005, has about 26 molecules in the phase I to III stage for the treatment of cancer, asthma, Type 2 diabetes, obesity, pain management, rheumatoid arthritis, CVD and a host of other therapeutic areas.

link to full article

check out pharmabiz.com for a good view into India's pharmaceutical business...

CDC investigating salmonella outbreak

refer to the computer detection reference near the end of this post...sounds cool...

ATLANTA - A salmonella outbreak potentially linked to produce has sickened at least 172 people in 18 states, health officials said Monday.

Health officials think the bacteria may have spread through some form of produce; the list of suspects includes lettuce and tomatoes. But the illnesses have not been tied to any specific product, chain, restaurants or supermarkets.

No one has died in the outbreak, which stems from a common form of salmonella bacteria. Eleven people have been hospitalized, health officials said.

"We're very early in the investigation," said Dave Daigle, a spokesman for the U.S. Centers for Disease Control and Prevention.

Outbreaks of food-borne illness have repeatedly made headlines this year. Certain brands of packaged spinach, lettuce, carrot juice, beef and unpasteurized milk recently were recalled after they were found to be tainted with illness-causing bacteria.

The most serious outbreak, first reported in September, involved spinach tainted with E. coli bacteria that killed three people and sickened more than 200.

The CDC detected the salmonella outbreak two weeks ago through a national computer lab system that looks for patterns and matches in reports of food-borne illness. The U.S. Food and Drug Administration has joined the investigation and will try to help trace the outbreak to its origin.

link to full article

salmonella outbreak

Contract manufacturing biz to exceed $26bn

Always good to know who's growing...

30/10/2006 - The global contract manufacturing market is expected to exceed $26bn (€20bn) by 2011, according to new market research.


This growth is due to be driven largely by high potency sterile drugs, protein-derived drugs and specialised production methods, such as chiral chemistry – activities often not included in the core competency of pharmaceutical and biotechnology drug makers, the report said.

Pressured by stricter regulations and escalating costs, large pharmaceutical companies have traditionally opted to outsource their manufacturing process to contract manufacturing organisations (CMOs), only to improve efficiency in cost and productivity, as well as obtaining a specific expertise not available in house.

The research, conducted by Kalorama Information, publishing division of MarketResearch.com, suggests that today, these factors still play a role, but companies are now focusing on strategy and the most dynamic CMO driver is rapidly becoming the innovative processes and production technologies these companies offer.

According to the report, outsourcing manufacturing operations is a strategic imperative that provides not only a cost effective alternative, but also improved efficiency, speed and flexibility, and the market is therefore expected to exceed $17.5bn in 2006, an eight per cent increase from last year.

A fierce presentation...

Check out fierce biotech...a good industry site

Good webinars...I watched a recent presentation called "A Fierce Look at Venture Capital Trends in Biotech"... click here to download mp3 audio...I will try to get a link uploaded for the slides...

A good newsletter...focussed mostly on financial developments, lot's of good industry information...

I have found that Fierce Biotech provides quality information on a very consistent basis...more consistent than this site, but it's not like this is my full-time job or anything...

Check 'em out, I think you'll be pleased...

New biochip helps study living cells, may speed drug development

Some Big Ten Conference competition from Purdue...

WEST LAFAYETTE, Ind. — Purdue University researchers have developed a biochip that measures the electrical activities of cells and is capable of obtaining 60 times more data in just one reading than is possible with current technology.
In the near term, the biochip could speed scientific research, which could accelerate drug development for muscle and nerve disorders like epilepsy and help create more productive crop varieties.

"Instead of doing one experiment per day, as is often the case, this technology is automated and capable of performing hundreds of experiments in one day," said Marshall Porterfield, a professor of agricultural and biological engineering who leads the team developing the chip.

The device works by measuring the concentration of ions — tiny charged particles — as they enter and exit cells. The chip can record these concentrations in up to 16 living cells temporarily sealed within fluid-filled pores in the microchip. With four electrodes per cell, the chip delivers 64 simultaneous, continuous sources of data.

link to full article

The most interesting Engineering Sessions…

It will be interesting to see what sessions attract the most attention…

One that probably needs to be much better attended than it actually will be and is entitled “What makes a Good Client…”
This session is scheduled for Wednesday in the morning session

I think this will present two different views of a very interesting conversation…the panel hosts have indicted that they would like to see a “highly interactive” session…

The most productive discussion will not focus so much on what each wants from the other… for instance, what clients want from their consultants…or what do consultants want from personnel on the operations side.

The more interesting discussion (and probably most productive for all concerned) will be about how to communicate to the other party…what you need, what isn’t happening, what is missing…in such a way that the other party listens, understands, and has a chance to move these issues forward.

Let’s hope for a productive session…

ISPE Annual Meeting

Tests show DHEA supplement no "fountain of youth"

related reading here regarding Living Forever...
from Ray Kurzweil's website

BOSTON (Reuters) - The food supplement DHEA, touted as a "fountain of youth," does nothing to slow the damaging effects of aging despite widespread claims to the contrary, researchers said in a study released on Wednesday.

Extensive federally funded tests only uncovered "minimal and inconsistent" evidence that a daily dose of 75 mg may help strengthen thinning bones.

But even that benefit was far less dramatic than what doctors can accomplish with established medicines, said the study published in The New England Journal of Medicine.

"The conclusion is very clear," chief author Sreekumaran Nair of the Mayo Clinic in Minnesota, said. "There's no reason for older people to continue to take (DHEA)."

link to full article

Merck diabetes drug wins federal OK

Merck back on track?

WASHINGTON - Diabetics gained a new way of controlling their blood sugar levels Tuesday with federal approval of a novel pill for Type 2 diabetes, which affects about 20 million Americans.

The Food and Drug Administration said it approved Januvia, which enhances the body's own ability to lower blood sugar levels, after clinical trials showing the new pill works just as well as older diabetes drugs, but with fewer side effects like weight gain. The drug is made by Merck and Co. Inc.

Merck is expected to charge $4.86 for the once-daily tablet, a price tag that may limit its use. Older diabetes drugs can cost 50 cents a day.

Januvia, also known as sitagliptin phosphate, works with a one-two punch: It increases levels of a hormone that triggers the pancreas to produce more insulin to process blood sugar while simultaneously signaling the liver to quit making glucose. The pill does that by blocking production of an enzyme, called DPP-4, that normally inactivates that hormone.

Januvia is unlike any other oral drug for treating Type 2 diabetes. However, Novartis AG hopes to win FDA approval for a similar drug later this year.

link to full article

Ex-FDA chief to plead guilty

Mr. Crawford forgot what?

WASHINGTON - Former FDA chief Lester Crawford will plead guilty for failing to disclose a financial interest in companies his agency regulated, his lawyer said Monday.

The Justice Department accused the former head of the Food and Drug Administration with falsely reporting that he had sold stock in companies when he continued holding shares in the firms governed by FDA rules.

Crawford "is going to plead guilty to two misdemeanors tomorrow afternoon and he is going to admit his financial disclosures had errors and omissions, mostly with his wife's continued ownership of stocks," said Crawford's lawyer, Barbara Van Gelder.

"At the end of the day, he owned these stocks and he will admit he owned them while he was at the FDA and he will take responsibility for that," said Van Gelder.

Accused of making a false writing and conflict of interest, Crawford was scheduled to appear before a federal magistrate Tuesday afternoon. Each carries a maximum penalty of one year in prison.

The papers say Crawford failed to disclose his income from exercising stock options in Embrex Inc. of Research Triangle Park, N.C., an agriculture biotechnology company. Crawford had been a member of Embrex's board of directors, according to federal filings.

link to full article

Spinach E. coli outbreak linked to cow manure

Maybe this can now be solved?

WASHINGTON (Reuters) - Cattle manure from a ranch in California's Salinas Valley carries E. coli bacteria that match the strain that killed three Americans and sickened 200, U.S. health officials said on Thursday.

Samples taken from three cattle at a ranch precisely match the strain of E. coli 0157:H7 taken from patients and from bags of spinach linked to the outbreak, Dr. Kevin Reilly, deputy director of the Prevention Services Division at the California Department of Health told reporters.

"This is a significant finding and it is the first time that we have linked a ... E. coli 0157:H7 outbreak to a specific ranch in the Salinas Valley," Reilly said.

Reilly said the outbreak had been traced to four farms in San Benito and Monterey counties in central California.

"Not all of them have both livestock and production of fresh spinach or produce right there right next to each other. This particular ranch that we just talked about does have that."

He said cattle were between a mile and half a mile from the spinach fields on the ranch.

link to full article

E. coli outbreak

Top 10 Reasons for Attending

more to come...just like David Letterman...

5 - Learn How to Get the Most From Quality by Design

#6 - Listen to Industry Leaders Speak on Innovation

#7 - Get to Know More About RFID Trends and Solutions

#8 - Get the Latest on the Journal of Pharmaceutical Innovation

#9 - Learn How to Seal Your Career in Gold with the Certified Pharmaceutical Industry Professional (CPIPTM) Credential

#10 - The chance to take part in ISPE's first annual industry-academia colloquium on new approaches to education in the pharmaceutical manufacturing sciences

ISPE Annual Meeting

Researchers develop nanoparticle sensor

SOCORRO, N.M. - New Mexico Tech researchers have developed a sensor that uses the light-emitting properties of some nanoparticles to analyze and identify individual components of single strands of DNA and RNA.

Chemistry assistant professor Peng Zhang said team members hope they can refine the emerging technology and eventually adapt the tiny sensors to detect cancer cells in their early stages and to target and destroy cancerous cells and tissue.

"I am very excited about the potential for this new application, especially since the preliminary phase of this study has shown that we can identify cancer cells," Zhang said. "The next step will be to modify these nanoparticle sensors ... and actually kill cancer cells with them."

link to full article

nanoparticles

$10 million prize aims to inspire gene race

I really enjoyed the X prize space flight competition...hopefullt this one will be just as good...

WASHINGTON (Reuters) - The foundation that inspired a private sector race to space announced a new $10 million prize on Wednesday -- this time to inspire a race to sequence the human genetic map faster and cheaper.

Although scientists have mapped one person's genome -- by both public and private efforts -- it was time-consuming and expensive.

The X-Prize Foundation wants to inspire someone to map 100 different human genomes in just 10 days.

And just to spice things up, it is offering another $1 million if the team can decode the genomes of 100 more people, including some wealthy donors and celebrities such as Microsoft co-founder Paul Allen and Google co-founder Larry Page.

The effort could speed the era of personal genomics -- in which each person's propensity to disease, response to drugs, and other tendencies are individually mapped, said Dr. Francis Collins, director of the National Human Genome Research Institute.

link to full article

x prize foundation

Pack Expo

Upcoming industry event...

Pack Expo 2006

29Oct- 02Nov06
McCormick Place
Chicago, Illinois

Blogging the Annual Meeting- 2006

Get your witty quotes and session reviews ready...

The Annual Meeting will be having a dedicated blog this time around...

I'm really looking forward to this and I hope everybody gets involved with this...it should be a lot of fun...

the link is here...ISPE Blog

This is the official ISPE blog for the Annual Meeting

Anything I do will probably be a little more casual!!!...

ISPE Annual Meeting

Another Global Neighbor who is Virtually Next Door...

G-Town Radio

internet broadcasting from the suburbs of Philly...Germantown, to be specific...

heard a brief interview on WXPN the other day.

enjoy...

Women have mixed success at drug companies

they should try this study for engineering companies...

WASHINGTON (Reuters) - Top women executives do slightly better at U.S.-based healthcare and pharmaceutical companies than in other industries, but 35 percent of big drug companies do not have a single female director, according to a new survey.

The survey by Corporate Women Directors International found that 16 percent of directors at U.S.-based healthcare and pharmaceutical companies are women -- slightly more than the national average for all companies of just under 15 percent.

But nearly 36 percent of Financial Times 500 companies did not have any female directors, including industry giant GlaxoSmithKline, the report found.

"While we see promise among some companies -- particularly those based in the United States -- there is a shocking number of companies with absolutely no female representation at all," said Irene Natividad, co-chair of Corporate Women Directors International.

link to full article

Americans share Nobel Prize in medicine

NEW YORK - Two Americans won the Nobel Prize in medicine Monday for discovering a way to silence specific genes, a revolutionary finding that scientists are scrambling to harness for fighting illnesses as diverse as cancer, heart disease and AIDS.

Andrew Z. Fire, 47, of Stanford University, and Craig C. Mello, 45, of the University of Massachusetts Medical School in Worcester, will share the $1.4 million prize.

They were honored remarkably swiftly for work they published together just eight years ago. It revealed a process called RNA interference, which occurs in plants, animals and humans. It's important for regulating gene activity and helping defend against viruses.

It is "a fundamental mechanism for controlling the flow of genetic information," said the Karolinska Institute in Stockholm, which awarded the prize.

Since the discovery, scientists have already made RNA interference a standard lab tool for studying what genes do. And they're working to use it to develop treatments against a long list of illnesses, including asthma, cystic fibrosis, diabetes, flu, Parkinson's and Huntington's diseases, and age-related macular degeneration, a major cause of blindness.

link to full article