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

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!!!...

Nanotech website for Bio/ Medicine

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

nanotechwire.com/biomedicine

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

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

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

TEARS REVEAL SOME OF THEIR DEEPEST SECRETS TO RESEARCHERS

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

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

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

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

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

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...

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...

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

nanotechnology

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

stem cell research

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...

China

Bird Flu

DNA

Stem cell research

enjoy...

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

Inflammatory genes linked to salt-sensitive hypertension

I can't wait to tell my cardiologist...

check out the part towards the end of the article where the cause of stress in the teenage subject's is playing video games for an hour...if my kids only knew...

One key to your high blood pressure might just be your inflammatory genes.

It may sound odd but mounting evidence suggests that inflammation, a part of the immune response implicated in diseases such as cancer, Alzheimer’s and diabetes, may also help translate stress into high blood pressure.

“There is a concept that hypertension is an inflammatory condition,” says Dr. Haidong Zhu, molecular geneticist at the Medical College of Georgia. She’s among the scientists who believe the connection between stress, inflammation and hypertension is the kidneys’ ability to release sodium.

When stress activates the sympathetic nervous system (the fight-or-flight mechanism), the body increases production of interleukin 6, a pro-inflammatory factor, which ultimately leads to production of other inflammatory factors such as C reactive protein.

Stress also prompts the body to hold onto sodium to help temporarily raise blood pressure so you can deal with the situation, says Dr. Gregory Harshfield, director of MCG’s Georgia Prevention Institute and an expert on what happens when the body doesn’t let go afterward. It’s called impaired stress-induced pressure natriuresis, which Dr. Harshfield has documented in young, healthy teens.

link to full article

Biotech industry surging in Maryland

Life Sciences as the job creation machine...look for more on this topic...

Maryland's bioscience industry is moving beyond its traditional research role and reaching for commercial success on par with the highly successful biotech sectors in San Francisco and Boston.
This year marked significant progress for the state's biotech industry as it starts to develop new drugs, increase venture capital investment and move out of the shadows of the region's powerful academic and federal research facilities, such as the National Institutes of Health and Johns Hopkins University.
"What we saw this year was more companies turn the corner, not in terms of drug approvals, but in terms of receiving significant money and the realization of new drugs coming to market," said Bob Eaton, president of MdBio Foundation, the trade association representing the biotech companies.
Biotechnology drugs are the most expensive drugs on the market and cost in the billions of dollars to produce and market. Biological drugs include antibodies, oncology treatments and vaccines and are created from living organisms, unlike pharmaceutical drugs that are synthetically manufactured.

link to full article

MIT creates 3-D scaffold for growing stem cells

CAMBRIDGE, Mass.-Stem cells grew, multiplied and differentiated into brain cells on a new three-dimensional scaffold of tiny protein fragments designed to be more like a living body than any other cell culture system.

An MIT engineer and Italian colleagues will report the invention-which may one day replace the ubiquitous Petri dish for growing cells-in the Dec. 27th issue of the PLoS ONE. Shuguang Zhang, associate director of MIT's Center for Biomedical Engineering, is a pioneer in coaxing tiny fragments of amino acids called self-assembling peptides to organize themselves into useful structures. Working with visiting graduate student Fabrizio Gelain from Milan, Zhang created a designer scaffold from a network of protein nanofibers, each 5,000 times thinner than a human hair and containing pores up to 20,000 times smaller than the eye of a needle.

The researchers were able to grow a healthy colony of adult mouse stem cells on the three-dimensional scaffold without the drawbacks of two-dimensional systems.

In addition to helping researchers get a more accurate picture of how cells grow and behave in the body, the new synthetic structure can provide a more conducive microenvironment for tissue cell cultures and tissues used in regenerative medicine, such as skin grafts or neurons to replace brain cells lost to injury or disease.

The scaffold itself can be transplanted directly into the body with no ill effects.

"The time has come to move on from two-dimensional dishes to culture systems that better represent the natural context of cells in tissues and organs," said Zhang, whose coauthors on the paper, in addition to Gelain, are from institutes and medical schools in Milan, Italy.

link to full article

NNE scoops up Pharmaplan

The consolidation of the engineering industry continues...and it includes our European collegues...

20/12/2006 - NNE and Fresenius ProServe yesterday announced they had reached an agreement by which NNE will acquire Fresenius’ subsidiary, engineering company Pharmaplan GmbH.

Fresenius ProServe has sold the company in a further step to focus its attention on the hospital and healthcare business, and its aspirations to participate in the privatisation of the hospital market.
Neither company are disclosing financial details regarding the acquisition, which is effective as of 1 January 2007. The companies will however have to wait for anti-trust approval from the relevant authorities before the deal can be finally implemented; this is expected no sooner than March 2007.

Pharmatec, a subsidiary of Pharmaplan that manufactures pure steam, pure water and sterilisation equipment, is not included in the transaction and will be divested by Fresenius at a later date.

Pharmaplan provides consulting, engineering and qualification/validation services for the pharmaceutical industry, supplementing NNE's business with delivery of turnkey facilities and key pharmaceutical processes. NNE contributes to the partnership with expertise in biotechnology, cleanroom and automation.

Operating under the name NNE Pharmaplan, the company will be headquartered in Copenhagen, Denmark, but will also maintain Pharmaplan's current site near Frankfurt, Germany, as an additional European hub.

link to full article

New Drugs Declining, Research Costs Increasing

This is not good news...

Drug companies are becoming less innovative, with the number of new drugs being developed failing to keep pace with the substantial increases in spending on research and development, according to congressional investigators.

A report released yesterday by the Government Accountability Office, the investigative arm of Congress, found that annual research and development spending by the pharmaceutical industry increased 147 percent, to $60 billion, between 1993 and 2004. At the same time, the number of new drug applications to the Food and Drug Administration grew by only 38 percent, and it generally has declined since 1999.

What is more, about two-thirds of the new applications were for drugs that simply represent modifications to existing medicines, while 32 percent were for potentially innovative new drugs.

"Over the past several years it has become widely recognized throughout the industry that the productivity of its research and development expenditures has been declining," investigators wrote in the 52-page report. "That is, the number of new drugs being produced has generally declined while research and development expenditures have been steadily increasing."

link to full article

Mistletoe for Cancer? Maybe Not

Don't get too caught up in the holiday spirit!!!...

Mistletoe Extract May Be Harmful, British Doctors Say

Dec. 21, 2006 -- Taking mistletoe for cancercancer may be ineffective and possibly harmful, British doctors report.

"I recommend mistletoe as a Christmas decoration and for kissing under, but not as an anticancer drug," writes Edzard Ernst, MD, PhD, FRCP, FRCPEd, in BMJ (formerly called British Medical Journal).

Ernst directs the complementary medicine department at the University of Exeter and Plymouth's medical school in England.

He points out that in Europe many cancer patients take mistletoe preparations and that Germany's insurance system covers mistletoe treatment.

In the U.S., the FDA hasn't approved any mistletoe cancer drugs.

Mistletoe studies have yielded mixed results and have often been "methodologically weak," Ernst says.

BMJ includes a report about a woman in Wales with inflammation under the skin where she had given herself mistletoe extract injections over the past year.

The 61-year-old woman previously had a type of cancer called lymphomalymphoma. With her cancer in remission, she began giving herself three weekly injections of mistletoe extract in her belly.

Ten months later, she had a breast tumor surgically removed. At a follow-up appointment, she complained that she had a mass in her abdomen.

link to full article

Second "Large Biotech" Interested In Devens, Massachusetts; More Jobs To Genetown

The job making machine continues forward...

-- What do a hummingbird and Magellan have in common?

State and local officials hope the answer is that they're both bringing lots of jobs to Massachusetts. Hummingbird and Magellan are both code names used this year for big, secret projects at Devens. The first one, Hummingbird, wasn't very secret for very long -- the news quickly broke that biopharmaceutical giant Bristol-Myers Squibb was considering Devens, among several other sites, for a large biomanufacturing plant.

link to red orbit article

Virgin process can produce stem cells

I'm going to guess that we'll be hearing about this subject again...

WASHINGTON (Reuters) - Mouse embryos created through a "virgin birth" process called parthenogenesis show that egg cells can be a source of valued embryonic stem cells, researchers said on Thursday.

The cells can be closely matched to the immune system of the recipient, making them a potential source for transplants, the researchers report in Friday's issue of the journal Science.

There are fewer obstacles to developing these stem cells than by using cloning technology, also called somatic cell nuclear transfer, researchers said.

"I think it is a much more real-world possibility than nuclear transfer," said Dr. George Daley of Children's Hospital and Harvard Medical School in Boston, who led the study.

If the experiment could be reproduced in humans, such cells might provide an alternative way to produce tailored tissues for transplanting, or for studying disease, Daley said in a telephone interview.

"We are aggressively trying to produce human parthenogenetic embryonic stem cells," Daley said.

link to full article

stem cell research

"Inkjet" printer helps organize stem cells

the second page of the article explains the process...

WASHINGTON (Reuters) - An "inkjet"-style printer for stem cells may help scientists put the precious master cells to good use, U.S. researchers said on Sunday.

A team of bioengineers at Carnegie Mellon University's Robotics Institute in Pittsburgh joined forces with stem cell biologists at the University of Pittsburgh School of Medicine to create the system, which they eventually hope will help them make stem cells grow into complex tissues.

Stem cells are like the raw clay of the body, undifferentiated into specific tissue types such as brain cells, skin cells or liver cells.

Doctors hope they hold the key to a whole range of regenerative therapies, but they are tricky to find and to work with. And it is not always easy to get them to mature into the desired cells.

Tissue is complex, made up of a variety of different types of cells, and they must be layered together in the right pattern to work properly.

link to full article

stem cell research

Senate approves Bush pick to lead FDA

WASHINGTON (Reuters) - The U.S. Senate on Thursday overwhelmingly approved the nomination of cancer expert Dr. Andrew von Eschenbach to run the Food and Drug Administration, despite objections from several Republican senators.

The urology surgeon and oncologist has served as acting FDA chief since September 2005. He was nominated earlier this year by President George W. Bush to take the job permanently.

The FDA regulates medicines, medical devices, most foods and other products that sustain about a quarter of the U.S. economy. The agency has lacked a permanent leader for all but 18 months of Bush's nearly six years in office.

Von Eschenbach was approved on a vote of 80-11.

link to full article

CROs – where is the money being spent?

another outsourcing/ offshoring issue...

05/12/2006 - The contract research organisation (CRO) industry is in full swing as the clinical trial outsourcing trend continues, but where is the money being spent?

Roughly 1,000 CROs are in operation across the world and this number continues to grow. The market is now worth $16bn (€12bn), according to research firm Datamonitor.
Giving a breakdown of this spending, 17 per cent of the total clinical research outsourced is preclinical work; six per cent is in Phase I; 14 per cent is during phase II-III and 16 per cent is postmarketing related.

Central lab services account for a further twelve per cent, while the remaining 28 per cent is being spent on other services such as data management and site management, according to figures from a 2004 Tufts University analysis.

Of the large global players, Quintiles is leading the pack, with 11 per cent of the global market share. Covance and Charles River laboratories share second spot, holding about eight per cent each, with PPD not far behind on seven per cent.

link to full article

Pfizer manufacturing plant in question after torcetrapib blow

sometimes even the best of planning can be "overtaken by events"...

how often are facility designs completed and then either scrapped or re-done for some other use?...more than most companies would like to admit, even if it's not very often...

05/12/2006 - A hefty investment by Pfizer in an Irish manufacturing facility could prove to be a waste after the potential blockbuster it was designed to make has been canned.

Pfizer announced that it will stop the development of its cholesterol drug torcetrapib after clinical trial results showed an increased risk of death in patients.
Since 2003 Pfizer has been undertaking a $90m (€68m) investment and expansion at an existing Irish manufacturing site in Loughbeg, Cork, so that it could make the new drug, a combination of torcetrapib – a cholesteryl ester transfer protein (CETP) inhibitor – and Pfizer's current blockbuster Lipitor (atorvastatin).

The company was touting the combination as a “major new cardiovascular treatment” and finished construction of the new extension in the middle of 2005, which included the design and installation of a fluid bed drier and granulation system over three floors, along with solids handling and management systems, specifically for the production of the new drug.

link to full article

Gates Foundation to separate assets from grant-making in January

SEATTLE -- The Bill & Melinda Gates Foundation will be altering its internal financial structure to cleanly separate its program work from investment of its assets, the foundation announced this week.

The reorganization plan, which takes effect in January, will also help the foundation accommodate an infusion of stock from Warren Buffett, the organization announced Wednesday. Buffett said in June he would be giving most of his money to the foundation in annual installments worth about $1.5 billion. His first gift was made in August.

Buffett has given the foundation a few years to ramp up before requiring that it distribute his entire donation each year, which will effectively double the dollar amount of grants the foundation makes.

In the same announcement, the foundation for the first time set a limit on its charitable work, saying it would spend all its money within 50 years of the death of Gates or his wife, whoever lives longest. The time limit gives the organization incentive to work harder to achieve more of its goals within the lifetimes of the Gateses and their children, officials said.

link to full article

gates foundation

Red wine health locations found

I'm partial to Australian and South African reds myself...

Those seeking a longevity-boosting tipple should turn their attention to red wines from Sardinia and south-west France, a study concludes.
UK researchers discovered chemicals called procyanidins were responsible for red wine's well-documented heart-protecting effect.

And they found traditionally made wines from these areas had more procyanidins than wines in other parts of the world.

The research is published in the journal Nature.

Previous studies have revealed regular, moderate consumption of red wine is linked to a reduced risk of heart disease and lower mortality.

A class of chemicals called polyphenols, of which there are many varieties, are thought to be responsible.

link to full article

Day 3- Tuesday- Socializing and taking off…

The main focus for today was walking the exhibit hall, socializing with some people, and getting out of town…

I recommend getting up early for the continental breakfast…imagine the scene…it seemed like dozens of engineers surrounding the bagel table…just keep your hands and feet away from anything that can be piled on a small plate and you should be ok…the coffee tables were just as bad, but we were all desperate for the caffeine so it didn’t get too ugly…

(I’m just kidding…it wasn’t just the engineers…it was the sales reps too…)

Speaking of sales reps…I was asking around and found that people felt that the exhibit hall was pretty empty until the educational sessions let out for coffee breaks…I have found this to be typical of the Annual Meeting…

Most of the exhibits are simple desktop displays…some vendors did make the effort with some nice product displays… but nothing as elaborate as Interphex, for example…although, I have heard that the Pack Expo makes Interphex looks small…

While walking the exhibit hall, you have to take note of the various booth give-aways…Invensys takes the coveted “coolest thing being given away” award…for the helicopter…

It was nice to be able to spend some time talking to people outside of the high pressure project environment and just have a conversation… catch up on who is up to what…it’s surprising who you might run in to…

A good example of this was running into CJ Sabol…I used to work with CJ some time ago…he and his wife now live in Puerto Rico and run Carribean Cleanroom Products… talk to CJ and Conchetta if you are in need of clean-room construction on the island…he was busy with a project bid right in the middle of the exhibit hall…

I introduced myself Jim Redenbarger from LS Planning Group…and had a brief conversation… So it is possible to meet some new faces at the meeting also…

I had to check out as I wasn’t going to be able to spend another day away from home, but I did manage to spend a bit more time walking around…checked out the student posters…no sessions today, unfortunately I was running out of time…

I was lucky to finally catch up with Marsha Strickhouser…Marsha is the Public Relations Manager for the ISPE…we had been exchanging e-mails about the inaugural edition of the ISPE Blog…it was good to be able to finally meet Marsha and put a face to the e-mail address…I got my picture taken with Marsha for being the “original” blogger for the Annual Meeting…I hope to get a copy or get to link to the posting…

Anyway, that about wraps up my time at the meeting…off to the airport in time to jet home…


Review of Day 4 to come…

ISPE Annual Meeting

Ireland must lift its clinical trials game

28/11/2006 - Ireland needs to lift its game if it is to compete globally and attract new clinical research business into the country, says a new report by the Irish government.

The report, released by Ireland's Advisory Science Council last week, said that Ireland is “uncompetitive” and losing clinical trials to other countries where securing ethical approval is less cumbersome.
“Ireland must develop and implement a new national health research strategy as a matter of urgency,” said the report, titled: "Towards Better Health: Achieving a Step Change in Health Research in Ireland."

"Our goal is to make Ireland the destination of choice when advanced technology for health is being conceived, tested or implemented," said the chairman of the advisory council, Mary Cryan.

Typically Ireland hasn't been a location where clinical research has been conducted by pharma firms and there are currently only three or four other contract research organisations (CROs) operating in the country, Icon Clinical Research being the largest. Quintiles did have a presence although have since moved their operations to the UK.

link to full article

pharmaceutical outsourcing offshoring

Offshoring trend threatens Western employment

23/11/2006 - Continual price pressures within the pharmaceutical industry are driving more Western firms to turn to offshore employment.

The practice is expected to increase 16 per cent annually to include 21,000 employees by 2008 – a doubling of the current figures, according to a report by research firm McKinsey & Company.
“Eighty per cent of the world's pharmaceutical industry employees are currently working in Western countries – 60 per cent of them for the top 20 firms,” said Dr Ajay Bakshi at the recent Association of Clinical Research Professionals (ACRP) conference in Brussels.

“The future will see a lot of opportunities for the industry to save money by basing some of their employees in low-cost offshore locations, although clearly this will have an impact on employees in the Western labour market.”

The sectors that are at most of risk at being deployed offshore are IT services, research and development (R&D), commercial analytics, and general and administrative back-office functions, said the report, titled: “The Emerging Global Labor Market: Demand for Offshore Talent in Pharmaceutical Services.”

The specific occupations under threat are associated with functions that are more amenable to global resourcing, including generalists, life science researchers, IT engineers, and support staff.

“The question is not how we can stop this from happening, but how we can manage it effectively,” said Bakshi.

“Companies need to avoid a goldrush mentality, and first decide how much globalisation is suitable for their needs and implement the changes under a three to five year plan.”

Meanwhile, roles such as sales, procurement, supply chain management, and those that require interactions with regulators are positions that still need to remain local and for now will largely be unaffected by the trend, said the report.

link to full article

pharmaceutical outsourcing offshoring

Singapore drives pharma industry forward

22/11/2006 - Singapore has successfully completed the first phase of its biomedical science (BMS) initiative and is now pushing the second phase forward in order to drive growth in its pharma industry further.

The first phase of Singapore's BMS initiative ran for the five years between 2000 and 2005 and exceeded expectations, Keat Chuan Yeoh, director of Biomedical Sciences Group at the Singapore Economic Development Board, told In-PharmaTechnologist.com.
“During this time the industry grew its manufacturing output to S$18bn (€9bn), exceeding the target of S$12bn by 50 per cent,” said Yeoh.

“Eight out of the top 20 pharmaceutical companies now have plants in Singapore – mainly for making bulk active ingredients and intermediates – although Schering Plough, Novartis and Merck all have tableting facilities.”

The first phase of the BMS initiative was designed to build up core capabilities in Singapore's biomedical research industry and introduce key foreign and local human capital and infrastructure initiatives.

The second phase currently underway aims to build on this and the government has set aside a S$1.4bn investment for the purpose.

“Our main focus now will be setting up infrastructure for translational research, such as imaging and animal testing facilities,” said Yeoh.

In addition, he said the country is investing heavily in training clinical scientists and putting in place ‘lab to clinic' research programs in oncology, cardiovascular disease, neuroscience, infectious diseases and optical medicine.

link to full article

pharmaceutical outsourcing offshoring

Merck tests India’s outsourcing capabilities

22/11/2006 - US-based drug maker Merck, has agreed to outsource some of its preclinical trial work to an Indian-based company, marking the first time the pharma giant has used an Indian company to conduct drug research.

The deal comes at a time when western pharmaceutical companies are increasingly shifting drug research and clinical trials to India to cut costs. India's heterogeneous population and new patent laws have added to the trend.

While pharma majors Roche, Pfizer and Eli Lilly have all announced plans recently to set up research units in China, Merck's agreement could be seen as a first step in testing the waters of the Asian outsourcing industry, currently experiencing major growth.

link to full article

pharmaceutical outsourcing offshoring

Day 2- Monday- Session Reviews

The Keynote Address lead off the meeting and several speakers provided their thoughts on our industry; Jane R. Brown, of GlaxoSmithKline, Ron Branning of Genentech, Nat Ricciardi, President of Pfizer Global Manufacturing, (first half) (second half), and finally, Bob A Spina of Walt Disney World.

I was talking to Marc Steinman about the sessions and he was very impressed with the Keynote Address by Mr. Spina…Marc noted that Disney employs more than twice the number of people who work for his company worldwide…and this was just at the Orlando site…here is the link to a review on the ISPE Annual Meeting Blog…Marc took note of the way Disney looks for new ideas from it’s front-line employees…the post captures some of this with some great points about the sources of innovation and new ideas in large organizations…good issues we should all be thinking about…


I spent the afternoon attending sessions…as usual, I tend to jump in and out of various presentations...trying to get my money’s worth, I guess...

Quality By Design - What the ICH Guideline Q8 Says About QBD6

I hadn’t planned on attending this session, but have been thinking that Q8 is an important issue...not worth all day, but the first session was noted as an FDA overview so I thought that might be worth a few minutes...

When I poked my head in, Elaine M. Morefield, PhD, FDA/CDER/ONDC was just being introduced. Her presentation was an FDA perspective on the Q8 Quality by Design program underway at the FDA. It is always good to get feedback from a regulatory viewpoint...A good presentation which was very well attended...Obviously, many questions still exist around the topic of "Design Space"...

From there I jumped to the Vaccine Facilities of the Futuresession, which was one of my main interests of the meeting...

Anand Ekambaram, Associate Director, Merck & Co Inc, provided a great presentation regarding a risk- based approach to definition of project requirements and doing both a thoughtful analysis and good job documenting the results…useful for future reference...this is a critical point...if it’s anything like my project work, the amount of turnover in the various organizations involved in executing a project can be quite extensive...

Both of these presentations deserve a more in-depth review, but I am running way behind as it is...when I can gather my notes and get some time I hope to provide a bit more information...

After the afternoon sessions finished up, I grabbed a quick bite for dinner...the evening weather was quite pleasant so I went out for a walk around the resort...

The combination of being up early to travel and the sessions make for a tiring day, so I was back in my room early...

Reviews of Days 3 and 4 to follow…

ISPE Annual Meeting

California OKs $150 million stem-cell research loan

SAN FRANCISCO (Reuters) - California officials approved on Monday a $150 million loan offered by the state to fund its stem-cell research institute in San Francisco.

In addition to the loan, the California Institute for Regenerative Medicine has sold $31 million worth of bond anticipation notes to raise money for research into medical applications of stem-cell technology.

Many scientists believe stem cells, either adult cells or ones from embryos, may be used to find treatments and cures for serious diseases such as cancer and diabetes.

Voters approved the creation of the institute by passing a statewide measure in 2004 that allows it to sell up to $3 billion in general obligation debt over 10 years, but that bond authority is currently being challenged in court.

To allow the research to move forward, earlier this year Gov. Arnold Schwarzenegger offered the $150 million loan, described by his budget planners as interim financing.

link to full article

stem cell funding

Day 2- Monday- Travelogue

I flew out of Philly Monday morning to a brief stop-over in Charlotte…(I needed the connecting flight to keep my travel cost as low as possible)…the plane pulled up to the gate and the jetway promptly got stuck for about 25 minutes…I was anxious about missing my connecting flight to Orlando and being late for the sessions I was looking to attend…no less anxious, I’m sure, than all of the families from New Jersey headed to Disney…it’s Teacher Convention week, and all of NJ traditionally heads for Disney…only had to go one gate over, caught the flight and made Orlando on time…

Anywho, enough of the boring travel stuff…

Getting off the plane, the weather was cloudy, with some brief rainy spots…The first thing I noticed, other than the palm tress, was that it was warm enough to feel humid…In November, no less…felt like back home in Jersey…

An easy cab ride ($60 + tip, 45 minutes) will get you to the resort, and the driver promised good weather for the rest of the week…It was fun driving through the gates of Disney. I know I sound like a kid, but I needed a break and Disney seemed like just the ticket…again, great choice by the event planners…

Hotel check-in was handled in the usual Disney manner…pleasant, quick, personable…

I learned from last year and had booked early enough to get a room right in the Dolphin where the event was being held…this makes a big difference…it’s very convenient to be able to bop back and forth to your room, and to have all of the resort amenities at your fingertips…well worth the price…

I guess I should make some comments on the Michael Graves design for the resort, but enough may already have been said. The interiors are great with lots of attention to detail…almost more so than the building exterior…the exterior grounds provide beautiful spaces for strolling …I just can’t resist noting the “Dolphin” really looks more like a bass…


Oh yeah, the meeting…

Day 2- Sessions Reviews

ISPE Annual Meeting

ISPE Argentina Affiliate blog

We aren't the only group having an Annual Meeting...

and they have a blog...

I can't read the posts, but it looks like it was fun...

check out ISPE Argentina affliliate

ISPE Annual Meeting

Blogging the Annual Meeting- Day 1- the Weekend...

I think I missed Day 1…maybe I should refer to this as Day 0…

Apparently, a lot of people looked at the schedule for the Annual Meeting and came to the same conclusion…
travel over the weekend and arrive in time for some fun Sunday afternoon/ evening/ night…
I talked to some people who were traveling with their families and it sounded like this really worked out for people…

The selection of Disney World as the meeting location made this a great option…great decision by the meeting planners…

I couldn’t make it for personal reasons, but it sounds like several good parties were held…
see previous post here…

Sunday sessions…I know some sessions were scheduled for Sunday…
Did anyone even go? Who can post a review?

Reviews of Days 2 and 3 to follow…

ISPE Annual Meeting

Drug counterfeiters changing tactics to bypass EU customs

I guess this is for real...scary...

16/11/2006 - Drug counterfeiters are changing their trafficking tactics to smuggle fake drugs into Europe.

According to new data released by the European Commission last week, in 2005, 148 counterfeit drug shipments were stopped at the EU borders, with three quarters of them originating from India.
With these statistics, it would appear on the surface that India has become a hub in the traffic of fake drugs. Interestingly though, India was only the origin of one per cent of the total amount of fake medicines seized – in terms of quantity, Indonesia is leading the way with 16 per cent of the 500,000 fake drugs seized originating there.

Furthermore, last year's statistics show that there has been an increase in the number of incidences of fake goods seized by European customs in general, however, the actual overall volume of goods seized has dropped.

“2005 is the first year a breakdown of this data for medicines has been made, so it is impossible to give a direct comparison with previous years, however it is clear that European customs have seen a shift in counterfeit drugs traffic with counterfeiters now splitting quantities of drugs and sending them via different routes,” Maria Assimakopoulou, a spokesperson for the European Commission told In-Pharmatechnologist.com.

link to full article

counterfeit drugs

Chocolate addiction leads to sweet discovery

WASHINGTON (Reuters) - They were so addicted, they just could not give up their favorite daily snack -- not even in the interest of science.

But chocolate lovers who flunked out of a Johns Hopkins University study on aspirin and heart disease helped researchers stumble on an explanation of why a little chocolate a day can cut the risk of heart attack.

It turns out chocolate, like aspirin, affects the platelets that cause blood to clot, Diane Becker of the Johns Hopkins University's School of Medicine and her colleagues discovered.

"What these chocolate offenders taught us is that the chemical in cocoa beans has a biochemical effect similar to aspirin in reducing platelet clumping, which can be fatal if a clot forms and blocks a blood vessel, causing a heart attack," Becker said in a telephone interview.

The 139 so-called chocolate offenders took part in a larger study of 1,200 people with a family history of heart disease. The study looked at the effects of aspirin on blood platelets.

link to full article

Vaccine 'tackles kidney cancer'

More vaccines for concer...

A vaccine which uses the body's immune system to attack an aggressive form of kidney cancer has completely eradicated one patient's tumour.
The TroVax vaccine, made by Oxford Biomedica, has been given to 150 patients so far in clinical trials.

Another two patients have seen their tumours shrink, and a further 15 have been stable for at least three months.

UK cancer experts said the data, presented at a conference in Prague, showed TroVax was effective.

The data so far suggests TroVax could be an effective treatment for several types of cancer

Around 6,600 people are diagnosed with kidney cancer each year in the UK. In 2004, 3,600 people died from the condition.

The TroVax vaccine is still going through the clinical trials process.

It works by harnessing the body's immune system to tackle a tumour.

link to full article

cancer vaccines

Good things about the Annual Meeting...

One of the good things about the Annual Meeting is the chance to see people socially, outside of the work environment...

Project work tends to be high pressure, and it's nice to see clients and colleagues in a more relaxed atmosphere...

ISPE Annual Meeting

Pharma abandons blockbuster for niche drugs, claims report

I just love the term "niche-buster"...

08/11/2006 - According to a new report, drug makers are shifting to ‘niche-buster’ drugs in an attempt to drive future sales growth. The niche-buster drug has become a viable alternative to the blockbuster drug model that has served the industry so well.

“The industry is turning increasingly to a niche-buster strategy by utilising increased licensing, R&D collaborations and small-scale M&A deals to harness innovation and provide access to markets with high unmet need,” said Datamonitor healthcare strategy analyst Dr. Mark Belsey.
With this switch from blockbuster to niche-buster, the dynamics of R&D activity and company strategy are changing. With greater focus on niche drugs, the industry is becoming increasingly R&D focused.

link to full article

Novartis to spend US$100m on Shanghai research centre

look at the end of the article for the reference to relative salary comparisons...


SHANGHAI : Swiss pharmaceutical giant Novartis said Monday it planned a US$100m research centre in China's largest city Shanghai, testimony to the Asian nation's growing scientific clout.

"This research and development centre is a milestone not just for Novartis' commitment to state-of-the-art biomedical and pharmaceutical research and development in China," Novartis chief executive Daniel Vasella said.

"It is also a signal and symbol of the ever growing importance of China and our willingness to trust the government and our associates to proceed with a long-term investment which entails the respect of intellectual property."

Construction of the 38,000-square-meter (410,000-square-foot) centre, the eighth in the company's global research network, will begin in mid-2007 and it will eventually employ about 400 scientists, the company said.

To serve Novartis' needs before the new centre begins operations, a 5,000-square-meter facility will open in May next year, the company said.

Cost is a key factor in prompting companies to locate their research facilities in places like China, according to observers.

"The main reason is that costs are lower in China," said Yuan Lu, a Shanghai-based analyst with Everbright Securities.

"In China, the salary of a doctoral candidate is about 100,000 yuan (US$13,000) a year, while abroad it's typically US$100,000," she said.

At the same time, however, the establishment of the centre reflects China's growing role in scientific research.

At the start of economic reform a generation ago, China produced almost no Ph.D. candidates but by 2003, a total of 13,000 doctorates were awarded, 70 percent of them in science and engineering, according to official data.

link to full article

U.S. under fire as WHO picks new leader

and the winner is...

Dr. Margaret Chan

GENEVA - The Bush administration's drug and sexual health policy is a key issue as the World Health Organization chooses its next leader, a post that wields great power in allocating billions of dollars in funds to alleviate misery around the world.

After two days of closed-door deliberations, WHO is set to announce its new chief Wednesday.

Contenders for WHO's top job include Dr. Margaret Chan, a bird flu expert and former Hong Kong director of health, Dr. Shigeru Omi of Japan, who heads WHO's Asia office, Mexican Health Minister Dr. Julio Frenk, Spanish Health Minister Elena Salgado Mendez and Dr. Kazem Behbehani, a veteran WHO official in Kuwait.

The United States has not declared a preference for any candidate.

Critics say the United States, WHO's largest donor, plays too large a role behind the scenes. They argue that the Bush administration is promoting the interests of its pharmaceutical industry — at the expense of poor AIDS patients who could be saved by cheap generic medicines — and has adopted an ideological line on issues like abortion.

link to full article

and Invensys takes the early lead...

in the "cool give-away at your booth" contest...

this radio- controlled helicopter has to be one of the cooler give-aways...



It's a DragonFly 36 Model helicopter...very cool...

stop by Booth #113 to meet with Invensys and drop off your business card...

we'll be checking out the other cool gifts and posting all the cool goodies...

can't say we're not keeping our eye on the priority issues...

ISPE Annual Meeting

Remember to pack your pirate outfit!!!...

Update 05Nov06

Another reason I hope you made travel plans for Sunday...

Perhaps you got the invitation...Biogen Idec Networking Reception at the Cabana Deck Walt Disney World Dolphin...


or other fun attire...

It seems like all of the fun receptions are scheduled for Sunday night...Unfortunately, due to personal reasons I will not be able to travel until Monday morning...I get the impression I am going to be missing all of the parties...

I got invited to this pirate-themed reception and dinner at the Living Seas Pavilion (followed by fireworks...Illuminations- Disney style) being hosted by Carter Burgess...If you stop by, tell Dave Wasson I said hi...

By the way, I still have the invitation...send me an e-mail and I forward it along to you...I'm sure Dave won't mind...

I guess I'll just have to settle for getting there in time for the work sessions and presentations...

See you there...

ISPE Annual Meeting

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