Wednesday, January 31, 2007

Bird flu claims first human life in West Africa

This can't be good...I was not aware this disease had made it to Africa...not the best environment for containing the spread of an infectious disease...

LAGOS (Reuters) - Nigeria confirmed the first human death from the H5N1 virus in sub-Saharan Africa on Wednesday after tests on a dead woman showed she had contracted bird flu.

The 22-year-old died after feathering and disemboweling an infected chicken. She was from Lagos, the commercial capital of Africa's most populous country, Information Minister Frank Nweke said.
Test on three other victims, one of them the woman's mother, were inconclusive.

Nigeria was the first African nation to detect the H5N1 virus in poultry last year and had conducted tests on 14 people suspected of having the virus.

Although bird flu remains essentially an animal disease, experts fear it could mutate into a form that could pass easily among humans, possibly killing millions

link to full article

Tuesday, January 30, 2007

Pfizer plans to double drug production outsourcing

more on the pfizer situation...

25/01/2007 - Pfizer’s latest cutbacks will provide a new outsourcing opportunity for contract manufacturing organisations (CMOs) in low-cost destinations as the drug giant announces plans to double its amount of drug production outsourcing.

The plans were revealed during an analyst meeting on Monday, when the world's biggest drug maker also announced that it would shut down two US manufacturing plants - one in Brooklyn, New York and one in Omaha, Nebraska - and try to sell a third plant in Feucht, Germany, culminating in the loss of 10,000 jobs.
The closures will also affect research and development, with three R&D sites in the US being deemed surplus to requirements and possibly two more, in France and Japan, under threat.

Pfizer's restructure comes in the face of patent expiries for some of its biggest drugs and a corresponding sharp dive in revenues – profits dropped 43 per cent in the fourth-quarter of 2006 as generic products began to make their presence felt – as well as the recent failure of a late-stage pipeline project, torcetrapib, upon which the firm was pinning its new financial hopes.

link to full article

Monday, January 29, 2007

Warning- Contents under pressure...

Update 29Jan07...

When I first started on this post, I was referring to operating companies and how internal politics can drive behavior that may have no other apparent explanation other than internal political pressure. The specific company presented below is representative of a company under such pressure, but by no means did I intend to single them out...the same issue applies to a good number of companies in the industry

I have found that even that was to limited a view...I think this same issue can also be applied to any large organization where ego and politics can drive behavior that would otherwsie be inexplicable...say at a large engineering company, for example...

Some thoughts on the pharma industry at large...

The recent Pfizer headlines provide ample opportunity to jump on, or rather off the bandwagon.

It's obvious that the announcements of cuts and closings will impact the near-term future for Pfizer as they do business going forward...they will continue to do business...the unfortunate impacts on their employees will also be obvious...

Less obvious will be the impact on the "corporate behavior"...

How much of Pfizer's business behavior will be driven by the fact that a lot of the corporation will be in "suvival mode"?

Internal politics is often a signficant source of impact to project success...

Other companies will find themselves in similar situations, with similar pressures...

The pressure caused by these hidden issues driving some companies behavior will only increase...

In between having all the fun, beware!!!...

Friday, January 26, 2007

Nanotech website for Bio/ Medicine

A website I just found with a page to focus on Bio/ Medicine aspects of the nanotechnology industry

the site also covers a lot of other aspects of nanotech...

Molecular Link between Inflammation and Cancer discovered

A team led by biochemists at the University of California, San Diego has found what could be a long-elusive mechanism through which inflammation can promote cancer. The findings may provide a new approach for developing cancer therapies.

The study, published in the January 26 issue of the journal Cell, shows that what scientists thought were two distinct processes in cells—the cells’ normal development and the cells’ response to dangers such as invading organisms—are actually linked. The researchers, who were also from the Salk Institute for Biological Studies and the La Jolla Institute for Allergy and Immunology, say that the linkage of these two processes may explain why cancer, which is normal growth and development gone awry, can result from chronic inflammation, which is an out-of-control response to danger.

“Although there is plenty of evidence that chronic inflammation can promote cancer, the cause of this relationship is not understood,” said Alexander Hoffmann, an assistant professor of chemistry and biochemistry at U.C. San Diego, who led the study. “We have identified a basic cellular mechanism that we think may be linking chronic inflammation and cancer.”

link to full article

Rexam unveils RFID-tagged pill bottles

A whole new effort in Qualification and "state of control"...

25/01/2007 - Packaging giant Rexam has fixed a radio frequency identification (RFID) chip in pharmaceutical bottles in response to Food and Drug Administration (FDA) recommendations to make use of the technology to track products through the supply chain.

Rexam has teamed up with RFID specialists Traxxec to develop the new tracking and anticounterfeiting system, which allows users to read and write information, such as batch releases, dates, product information and operational details, onto a chip. The firms promise that the fixed tags are 100 per cent reliable and faster to read than conventional bar codes.

The company explains that plastics, at the bottom of the pill containers encapsulate the chip, keeping it away from the dose forms to avoid potential migration of toxic materials. In addition, the chip is on the primary container – in keeping with the FDA's objective of eventually moving toward unit-level tagging of drug products – and kept distance from other chips in the product batch, which should help ensure a reliable read.

link to full article

Thursday, January 25, 2007

Scientists discover how to activate genetic 'switch' that stops cancer

A way of ridding the body of lethal tumours has been identified by scientists who have used a genetic "switch" to turn on a key gene for suppressing cancer.

The findings suggest there may be a way of re-activating a damaged gene that is normally involved in the natural suppression of the uncontrolled cell division that leads to cancer.

In a study on laboratory mice, the scientists demonstrated that it was possible to arrest the growth of tumours by activating the p53 gene, which is known to be involved in cancer suppression. In some of the animals the tumours shrank by between 40 and 100 per cent and the experimental technique appeared to work on two quite different kinds of cancer that are also known to affect humans.

link to full article

Tuesday, January 23, 2007

Chinese biotech firm 3SBio files for U.S. IPO

I don't normally post about the financial side of the industry, but this one caught my eye...

WASHINGTON, Jan 19 (Reuters) - Chinese biotechnology firm 3SBio Inc. said on Friday it is seeking an initial public offering of 7.7 million American depositary shares (ADS) for between $12 and $14 per ADS.

The company plans to sell almost 7.2 million ADSs and selling shareholders will offer more than 500,000 ADSs, according to a preliminary offering document filed with the U.S. Securities and Exchange Commission.

Each ADS represents seven common shares for a total offering of 53.9 million common shares.

The company will not receive proceeds from ADSs sold by the selling shareholders.
The company expects to use net proceeds from the offering for general corporate purposes, including funding clinical trials, research and development. The company may also expand manufacturing facilities and its sales and marketing network.

The company researches, develops, manufactures and markets products primarily in China. One of its principal products is EPIAO, an injectable medication used to stimulate the production of red blood cells in patients, according to the filing.

link to full article

Monday, January 22, 2007


The Big Ten marches on...where's Penn State?

COLUMBUS , Ohio – It's no secret why we shed tears. But exactly what our tears are made of has remained a mystery to scientists.

A new study sheds some light on the complex design of tears. What we think of as tears, scientists call tear film, which is made up of three distinct, microscopic layers. The middle, watery layer – what we normally think of as tears when we cry – is sandwiched between a layer of mucus and an outer layer of fatty, oily substances collectively called meibum.

It's in this outer layer that researchers describe, for the first time, a new class of lipids – a type of fat – that make up part of the film. They also identified one of these lipids, oleamide, which had not been known to be a part of tears before.

With each blink, meibum spreads over the surface of the eye. It keeps the watery middle layer in place, ensuring that our eyes stay moist.

Finding these lipids may help scientists better understand the causes of eye-related disorders such as dry eye disease, which affects anywhere from 12 to 14 million Americans, said Kelly Nichols, the study's lead author and an assistant professor of optometry at Ohio State University.

link to full article

Friday, January 19, 2007

Will Synthetically Engineered Immune Cells Stop AIDS?

I think we are all still waiting for the impact from unlocking the human genome...

USC biochemical engineer Pin Wang and his team explore new gene therapy to combat Human Immunodeficiency Syndrome

January 17, 2007 — Twenty years after its introduction, gene therapy still holds great promise as a way to harness the insidious power of viruses such as human immunodeficiency syndrome (HIV). But scientists have yet to solve a vexing problem: developing an efficient transport system that is capable of delivering therapeutic payloads to specific cells.

As challenging as the problem has been, researchers in the Viterbi School of Engineering may be turning a corner. With support from a $13.9 million grant from the Bill and Melinda Gates Foundation, a multi-institutional team of scientists, including Pin Wang of the USC Mork Family Department of Chemical Engineering and Materials Science, is exploring a completely new way of manipulating the body's natural defense system.

"Rather than focusing on conventional vaccines that boost the immune system, we are experimenting with a way to help the immune system produce antibodies that can neutralize the virus," says Wang. “If we can design a modified virus that will deliver these antibodies to chosen cells, we will be able to insert DNA that will help rather than harm cells.”

link to full article

Bird Flu Mutations Found

LONDON (AP) -- Mutations in the bird flu virus have been found in two infected people in Egypt, in a form that might be resistant to the medication most commonly used to treat the deadly disease, the World Health Organization said Thursday.
The mutations in the H5N1 virus strain were not drastic enough to make the virus infectious enough to spark a pandemic, WHO officials said. But more such mutations could prompt scientists to rethink current treatment strategies.
Samples taken from two bird flu patients in Egypt - a 16-year-old girl and her 26-year-old uncle - were not as responsive as regular H5N1 viruses to Tamiflu, a drug also know as oseltamivir that is used to treat the disease, the officials said.

link to full article

FDA Warns Doctor Over Stem Cell Implants

The research marches on...with or without the support of the government...

WASHINGTON (AP) -- A Las Vegas doctor has been implanting stem cells harvested from placentas into patients with multiple sclerosis, muscular dystrophy and other diseases in violation of federal law, according to a warning letter released by health officials Thursday.
Dr. Alfred Sapse failed to properly obtain, store, test and process the placentas, as well as screen both the suitability of the donors and the patients given the human tissue, according to the Food and Drug Administration letter. At least 16 patients received the stem cells, the FDA said.
Sapse also failed to obtain or even seek federal approval to carry out the procedures, done by at least one doctor under his direction, according to the FDA.

link to full article

Wednesday, January 17, 2007

Spitzer Wants New York to Enter Stem Cell Race

the job creation machines moves on...

ALBANY, Jan. 12 — Five years ago, the Bush administration decided to severely limit federal financing for embryonic stem cell research, a move that set off vigorous competition among the states to provide support for a research field that many scientists say could bring about major medical advances.

New Jersey was first out of the gate, pledging millions of dollars for stem cell research in the state. California raised the stakes with a huge $3 billion bond initiative, and other states followed with ballot initiatives or legislation to give scientists grants or to build research centers. Those efforts, supporters promised, would also bring in new jobs and tax revenue.

But New York — home to leading research universities, medical centers and biotechnology companies — has remained absent from the list. Legislative efforts in recent years to direct state money to embryonic stem cell research have stalled, and then fizzled.

Now, state lawmakers are preparing to move forward on what would be the most ambitious government-financed stem cell project on the East Coast.

link to full article

Cheap, safe drug kills most cancers

this does almost sound to good to be true...

It sounds almost too good to be true: a cheap and simple drug that kills almost all cancers by switching off their “immortality”. The drug, dichloroacetate (DCA), has already been used for years to treat rare metabolic disorders and so is known to be relatively safe.

It also has no patent, meaning it could be manufactured for a fraction of the cost of newly developed drugs.

Evangelos Michelakis of the University of Alberta in Edmonton, Canada, and his colleagues tested DCA on human cells cultured outside the body and found that it killed lung, breast and brain cancer cells, but not healthy cells. Tumours in rats deliberately infected with human cancer also shrank drastically when they were fed DCA-laced water for several weeks.
DCA attacks a unique feature of cancer cells: the fact that they make their energy throughout the main body of the cell, rather than in distinct organelles called mitochondria. This process, called glycolysis, is inefficient and uses up vast amounts of sugar.

Until now it had been assumed that cancer cells used glycolysis because their mitochondria were irreparably damaged. However, Michelakis’s experiments prove this is not the case, because DCA reawakened the mitochondria in cancer cells. The cells then withered and died (Cancer Cell, DOI: 10.1016/j.ccr.2006.10.020).

link to full article

Stem cells nurture damaged spine: study

BOSTON (Reuters) - Human embryonic stem cells can help regenerate damaged nerves in rats, producing compounds that nurture nerve cells and stimulate the growth of new ones, Geron Corp. said on Wednesday.
The company's stock rose on the news, published in the journal Stem Cells and Development.
Geron had earlier reported that human embryonic stem cells had helped replace myelin, a fatty covering on nerves that is vital to function.
Now, the company's researchers said, they had shown the cells produce multiple nerve growth factors, which are proteins that stimulate the survival and regeneration of neurons.

link to full article

Tuesday, January 16, 2007

Engineered chickens make cancer drugs

WASHINGTON (Reuters) - A team at the institute that cloned Dolly the sheep have made a genetically engineered chicken that produces cancer drugs in its eggs.

The chickens produce the cancer drugs in their egg whites, the team at the Roslin Biocentre in Edinburgh reported.

The drugs include a monoclonal antibody -- themselves lab-engineered immune system proteins -- and a human immune system protein used to treat cancer and other conditions, the researchers report in the upcoming issue of the Proceedings of the National Academy of Sciences.

These drugs are not easy to make in the lab. "Many human therapeutic proteins, such as monoclonal antibodies, are produced in industrial bioreactors, but setting up such systems is both time-consuming and expensive," the researchers wrote.

Scientists have been trying to find good ways to turn animals into factories instead -- given that animals naturally make such proteins anyway.

link to full article

Friday, January 12, 2007

House backs broader embryonic stem cell research

WASHINGTON (Reuters) - The new Democratic-led U.S. House of Representatives voted on Thursday to lift President George W. Bush's restrictions on federal funding for human embryonic stem cell research.

But the vote of 253-174, largely along party lines, fell short of the two-thirds majority needed to override a promised presidential veto.

The measure passed after an emotional debate in which supporters touted the research as the best hope for potential cures for ailments such as Alzheimer's disease, diabetes, Parkinson's disease and spinal cord injuries.

Opponents condemned it as unethical and immoral. Bush restricted funding for the research in August 2001.

Bush, whose support base includes conservative Christian voters who tend to oppose the use of stem cells taken from human embryos, in July used the only veto of his presidency to date to reject an identical measure.

The White House reiterated Bush's intention to use his veto power, saying American taxpayers should not pay for research involving the intentional destruction of human embryos.

link to full article

Wonder organ transplant solution

and here's another one...

Scientists and transplant surgeons in Edinburgh have developed a new preservative which should improve the success rate of organ transplants.

They have produced a new solution which prevents blood clots inside the organ, making it more likely that the transplant will work.

It is thought the liquid increases the length of time organs can be preserved.

This could make it possible to transport organs long distances and improve the chances of a good match.

Using a chemical, which contains nitric oxide, scientists have been monitoring the results of replacing the preserving liquid containing glutathione.

This could facilitate transporting organs internationally for specific donors, improving the chances of a good tissue match

Tests showed nitric oxide kept blood vessels open, which can also reduce clotting.

Cells lining blood vessels were also protected against harmful free radicals produced by oxygen in the recipient's blood after transplantation, they said.

The scientists said preserving this layer of cells - the endothelium - is vital to making sure enough blood flows to the organ after transplantation.

link to full article

New molecular pathway could reveal how cells stick together

I am always amazed at some of the stuuf that research delves into...

Troy, N.Y. -- Researchers at Rensselaer Polytechnic Institute have found a new pathway by which cells change their adhesive properties. With a $1.4 million grant from the National Institutes of Health, they plan to fill in the details behind how cells decide to stick to a surface, which could lead to a better understanding of the importance of this pathway to the physiology and development of organisms.

Cells must interact with each other to produce system responses, like the remodeling of a tissue during development or for orchestration of an integrated immune response. One way they do this is by physically attaching to one another and to surfaces. Andrea Page-McCaw, assistant professor of biology at Rensselaer and principal investigator for the project, has focused on matrix metalloproteinases (MMPs) -- proteins that play a role in development and immunity.

"MMPs have gotten a lot of attention primarily because of their regulation in a lot of disease states, most notably cancer and other inflammatory conditions," Page-McCaw said. Yet the normal function of these proteins is not well understood.

The job of MMPs is to cleave other proteins that reside in the space in between cells. Page-McCaw has previously identified a specific protein, called ninjurin, that gets cut by MMP. Now she is working out the interplay between MMPs and ninjurin, with the goal of characterizing this previously unknown pathway by which cells signal to each other.

Ninjurin is anchored to the surface of cells, but after being cut by MMP, a ninjurin segment travels to adjacent cells and signals them to alter their adhesive state. Page-McCaw published these findings earlier this year and was recently awarded an individual investigator research grant to extend her work from cells in a Petri dish to an organism. The grant, from the National Institute of General Medical Sciences, is for $ 1.4 million over five years.

"We're trying to figure out how it works in whole flies," Page-McCaw said. "When you take a cell out of the organism it behaves a little bit differently. So while you can work out cell mechanisms in cell culture, then you want to go back and demonstrate their relevance to the animal."

link to full article

Thursday, January 11, 2007

Another Theme for 2007

What kind of industry will we leave to the next generation?

We spend a lot of time trying to figure out what the current trends are affecting our industry...

We need to consider what we will leave behind for the people that will be coming behind us...

if, in fact, there actually will be anyone coming along behind us...

Wednesday, January 10, 2007

What's your theme?...

I was talking to Chad the other day about the state of the industry...

We were discussing differentiation in the engineering industry and how no one seemed to be making a real solid attempt to cretae any buzz in the industry...He wondered why no one has announced a "Theme for 2007"?

Good point...

My theme for 2007 will be "Themes"...

like the maturation and consolidation of the engineering industry, for instance...

Tuesday, January 09, 2007

New nanotech anti-cancer drug delivery system introduced

A new anti-cancer drug delivery system which allows more targeted treatment and helps avoid the unsafe and unpleasant side effects of chemotherapy is due to enter clinical trials in Europe and the US for use with anti-cancer drug paclitaxel.

Indian drug firm Dabur Pharma yesterday introduced Nanoxel, the first nanoparticle drug delivery system to be developed outside the US.
”Owing to its water insolubility, the widely used chemotherapy agent paclitaxel that is known to have substantial anti-tumour activity is now used with a castor oil based solvent, cremophor, which in turn is an agent for life threatening side effects,” said Dabur Research Foundation R&D president Dr Rama Mukherjee.

”The anti-cancer drug nanoxel, based on principles of nanotechnology, is a cremophor free soluble formulation – and is indicated as an effective and safe therapy for advanced breast, non-small-cell lung, and ovarian carcinomas.”

On of the major challenges with anti-cancer drug treatments is damage to surrounding healthy organs and tissue as many anti-cancer drugs are designed simply to destroy cells. The threat of severe side effects caused by random distribution of the drugs has meant that maximum dosages are necessarily restricted.

However, utilising nanotechnology to design new drug delivery systems is helping to tackle this problem. Nanoxel's polymeric nanoparticle drug delivery system is being touted as a ‘potential super generic' due to its increased safety and pharmacokinetic profile.

”Nanoparticle drug delivery devices like Nanoxel enable therapy to take a preferential course to the cancerous cells and directly interact with the tumour causing agents thereby throwing open a larger window for anti-tumour activity,” said Dr Advani, Director of Medical Oncology at the Jaslok Hospital and Research Centre.

”It also ensures that the patient receives the full measure of the therapy while limiting the adverse side effects and toxicity affected by the drug.”

link to full article

House Resumes Stem Cell Research Debate

WASHINGTON (AP) -- The author of a study on amniotic stem cells urged Congress on Tuesday not to consider his work a substitute for the search for disease-fighting material from embryonic stem cells.

"Some may be interpreting my research as a substitute for the need to pursue other forms of regenerative medicine therapies, such as those involving embryonic stem cells. I disagree with that assertion," wrote Anthony Atala of Wake Forest University, the author of a study published this week and widely seized upon by opponents of embryonic stem cell research as a more moral option.

Atala and other researchers reported Sunday that the stem cells they drew from amniotic fluid donated by pregnant women hold much the same promise as embryonic stem cells.

link to full article

Friday, January 05, 2007

Poll shows support for Democrats' stem cell agenda

All eyes are on Washington D.C. as Democrats regain control of Congress today, and one of the incoming party's top priorities will be making easier for Americans to buy cheaper prescription drugs from other countries. An Associated Press-AOL News poll found that 69 percent of respondents support legislation that would makes these inexpensive drugs easier to acquire. "Importing prescription drugs to the United States is illegal, but the FDA generally does not bar individuals from bringing in small amounts for personal use," explains the AP. Some medications cost significantly less in other countries than they do in the United States; however, officials don't think that this will force down the price of prescription drugs in the United States.

To a lesser degree, the poll found that Americans also support the Democrat's plan to relieve restrictions on federal stem cell research funding. In July President Bush used his first-ever veto to reject a bill on embryonic stem-cell research that would have lifted the 2001 ban on public funding of stem cell research. Democrats plan to revive the issue, which could force the Presdident to veto the bill again. Last time this bill was vetoed House lawmakers were unable to override his veto, falling just two votes short of the two-thirds majority it needed. The new Democratic majority promises to have a significant impact on the issue of federal funding for stem cell research.

link to full article

Looking forward in 2007...

I have been trying to determine a new direction for this blog for the new year...

I will try to focus on several areas, as follows:

- Industry events- ISPE Meetings, Interphex, and maybe others...
- Employment trends in the industry- outsourcing, off-shoring, etc...
- Interesting scientific topics or advances- DNA, Nanotech, Bird Flu, Stem cell issues, etc...

The intent is to provide a better focus for the content of the blog

and here's several articles which cover current topics...


Bird Flu


Stem cell research


Tuesday, January 02, 2007

FDA OK may spark 'clone-free' labels

WASHINGTON - Meat and milk from cloned animals may not appear in supermarkets for years despite being deemed by the government as safe to eat. But don't be surprised if "clone-free" labels appear sooner.

Ben & Jerry's, for one, wants consumers to know that its ice cream comes from regular cows and not clones. The Ben & Jerry's label already says its farmers don't use bovine growth hormone.

"We want to make sure people are confident with what's in our pints," company spokesman Rob Michalak said. "We haven't yet landed on exactly how we want to express that publicly."

For food that does come from clones, the Food and Drug Administration is unlikely to require labels, officials said.

The FDA gave preliminary approval Thursday to meat and milk from cloned animals or their offspring. Federal scientists found virtually no difference between food from clones and food from conventional livestock.

link to full article