On the Horizon, Personalized Depression Drugs

The Human Genome should be providing more of this type of information...

Imagine that you are depressed and see a psychiatrist who explains that you have clinical depression and would benefit from an antidepressant. So far, so good. But then the doctor tells you there is a 60 percent chance that you’ll feel better with this antidepressant and that it could take as long as four to six weeks to find out, during which time you’ll probably have some side effects from the drug.

I have just described the state-of-the-art pharmacologic treatment of major depression in 2007. Don’t get me wrong; we have very effective and safe treatments for a broad array of psychiatric disorders. But in everyday clinical practice, we have little ability to predict which specific treatment will work best for you.

Laura is a case in point. A successful management consultant in her late 30s, she sought help for lifelong depression. Her treatment began with four weeks of the antidepressant Lexapro, a selective serotonin reuptake inhibitor, or S.S.R.I., without any effect. Next, I switched her to Zoloft, another S.S.R.I., since the chance of response to another member of the same drug family is about 60 percent. Again, no response. Then we moved on to Wellbutrin, an entirely different type of antidepressant, but this didn’t work either. Laura was now ready to call it quits, and who could blame her?

After nearly three months, I had still not found an effective treatment for her. Then she came in one day and said her father had recently revealed that he had been depressed and had done well on Prozac, another S.S.R.I., and she wondered if she could try it. Within three weeks, she felt markedly better, and the symptoms of her depression began to melt away.

Instead of the hit-or-miss approach I had to use with Laura, it will soon be possible for a psychiatrist to biologically personalize treatments. With a simple blood test, the doctor will be able to characterize a patient’s unique genetic profile, determining what biological type of depression the patient has and which antidepressant is likely to work best.

link to full article

Fun E Pharm

Fundamental Experiments in Pharmaceutical

check out the first episode...

the startling plot twist...

and the dramatic conclusion...

Counterfeit Toothpaste Imported From South Africa Recalled in 4 States

How difficult will this be?

WASHINGTON (AP) -- The Colgate-Palmolive Co. said Thursday that 5-ounce tubes of counterfeit toothpaste sold in discount stores in four states under a Colgate label are being recalled because they may contain a poisonous chemical.

A Food and Drug Administration official, Doug Arbesfeld, said Wednesday that testing had found the chemical in a product with the Colgate label, but said in the initial announcement that the FDA was unsure whether it really was Colgate or a counterfeit.

"We are aware that toothpaste is something that's been counterfeited in the past," he said. "We don't want to alarm people unnecessarily."

MS USA Trading, Inc. of North Bergen, N.J., the importer involved in the initial recall announcement, said the toothpaste may contain diethylene glycol, a chemical found in antifreeze.

The company said the toothpaste, imported from South Africa, was sold in discount stores in New Jersey, New York, Pennsylvania and Maryland.

"Made in South Africa" is printed on the box and includes Regular, Gel, Triple and Herbal versions.

The trading company said the problem was discovered in routine testing by the Food and Drug Administration. It said no illnesses have been reported to date.

link to full article

New Drugs Declining, Research Costs Increasing, GAO Says

less innovation is normally considered a bad thing...

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

Penn Researchers Find Potential New Target for Type 2 Diabetes

(PHILADELPHIA) – Researchers at the University of Pennsylvania School of Medicine have discovered a potential new target for treating type 2 diabetes, according to a new study that appeared online this week in Nature. The target is a protein, along with its molecular partner, that regulates fat metabolism.

“Over the last 10 years, we have begun to understand the importance of fat metabolism in diabetes,” notes lead author Morris J. Birnbaum, MD, PhD, the Willard and Rhoda Ware Professor of Diabetes and Metabolic Diseases at Penn and an Investigator of the Howard Hughes Medical Institute. “Type 2 diabetics are at a higher risk for cardiovascular disease because they also have disorders in fat metabolism as a result of obesity and abnormal insulin action.” Birnbaum is also the Associate Director of the Type 2 Diabetes Unit for Penn’s Institute for Diabetes, Obesity, and Metabolism.

When a person eats a meal, the pancreas usually responds by secreting insulin that signals the liver to stop making glucose and burning fat. When a type 2 diabetic eats a meal, insulin cannot stop the manufacture of glucose in the liver, but it can stop the burning of fat stores. This gives the diabetic person a “double whammy:” fatty acids accumulate from food and from the liver. Consequently, more fat is deposited in tissues and obesity worsens.

Until now there was no clear connection between insulin and the control of fat metabolism. This study shows that when insulin is present, as it is after a meal, the protein Akt2/PKB adds a phosphate group to its molecular partner PGC-1a. When this happens, PGC-1a cannot activate the genes needed for fat metabolism.

link to full article

US scientists discover new, potentially deadly bacteria

SAN FRANCISCO (AFP) - In a dramatic case of microbial sleuthing, US scientists said they have discovered a new, potentially deadly strain of bacteria previously unknown to medicine.

The bacteria was found in a 43-year-old American woman who had traveled across Peru for three weeks and suffered from symptoms similar to typhoid fever or malaria. The woman has since recovered.

Named Bartonella rochalimae, the new species is a close relative of a microbe that sickened thousands of soldiers during the First World War with what became known as trench fever, spread through body lice.

It is also related to a bacteria identified 10 years ago during the AIDS epidemic in San Francisco as the cause of cat scratch disease, which infects 25,000 people a year in the United States.

It was this previous work on cat scratch disease related to AIDS that helped experts at the University of California San Francisco (UCSF) and the US Centers for Disease Control and Prevention isolate the new bacteria found in the female traveler.

The findings are published in the New England Journal of Medicine.

Two weeks after returning to the United States from her trip to Peru, the woman experienced potentially life-threatening anemia, a rash, an enlarged spleen, insomnia and a high fever that lasted for several weeks.

link to full article

Philanthropic Roche shares manufacturing technology with Africa

04/06/2007 - Switzerland-based Roche is helping African nations fight the AIDS epidemic by sharing its coveted saquinavir drug-producing technology with two more manufacturers in Ethiopia and Zimbabwe.

As part of the drug giant's Technology Transfer Initiative, the Addis Pharmaceutical factory in Ethiopia and Varichem Pharmaceuticals in Zimbabwe will be provided, free of charge, with the technical expertise and guidance to manufacture generic HIV medicine, based on processes to produce saquinavir, Roche's second line HIV medicine.

The two companies join five others across Africa which have received the technology since the initiative's launch in January last year.

A Roche spokeswoman told in-PharmaTechnologist.com the scheme was like the analogy of teaching a man to fish so he could eat for a life time, rather than handing the man a fish so he can eat for the day.

By being locally manufactured, the dependency on western countries for treatment would be greatly reduced, she said.

Roche chief executive William Burns said in a statement: "These new agreements highlight the positive contribution that the Technology Transfer Initiative is making to help strengthen and expand local manufacturing capabilities for HIV medicines in Africa. Now entering its second year, the initiative reinforces Roche's commitment to find long-term, sustainable solutions to help increase access to healthcare in the world's poorest countries."

A team of Roche experts will work onsite at the manufacturing facilities in Ethiopia and Zimbabwe to help transfer the technology.

link to full article

Pa. hospitals, research groups split up $45M in tobacco funds

Everybody stop smoking!!!

Twenty-three area hospitals, research institutions and other health-care organizations were among the 38 Pennsylvania entities awarded a total of $45 million in health research grants from a portion of the state's tobacco industry settlement.

The money is being awarded under the Commonwealth Universal Research Enhancement program, which Gov. Ed Rendell said is designed to advance the work being conducted at Pennsylvania's leading medical and health research institutions. "This research will ultimately have a positive impact on the health of our residents," Rendell said.

The largest grant recipient was the University of Pennsylvania, which will receive $8.47 million for 10 projects that range from creating a health-services research data center to establishing a tumor tissue bank for cancer research.

Other large grants recipients include Thomas Jefferson University, which will receive $3.7 million for five projects including three aimed at developing new gene-based treatments for cancer; and $3.3 million awarded to the Children's Hospital of Philadelphia to discover and determine the underlying genetic causes of, and contributors to, a variety of childhood diseases.

link to full article

Scientist Gets Own Personal Genome Map

I want one!!!...

The Nobel Prize-winning scientist who helped discover the molecular structure of DNA has become the first person to receive his own personal genome map.

The map, a breakdown of his DNA that shows illnesses he is predisposed to contracting, is the first step in making the sequencing of individual human genomes quick, affordable and a routine part of medical care, according to researchers.

"I knew I was risking possible anxiety when I saw it," said 79-year-old James Watson, who was presented the map during a ceremony at Baylor College of Medicine. "But it's much more that if I don't sleep at night it's due to thinking about Iraq rather than about my genome."

Watson was chosen for the project because of his contributions to the field, and the map was completed after he submitted a blood sample.

link to full article

Cellular message movement captured on video

This stuff continues to amaze me...it could be, of course, that I am easily impressed...

Proper signaling step required for controlled cell growth -- otherwise, cancer and other diseases can result

Scientists have captured on video the intracellular version of a postal delivery service. Reporting in the journal Biochemical and Biophysical Research Communications (BBRC), bioengineering researchers at UC San Diego published videos of a key message-carrying protein called paxillin moving abruptly from hubs of communication and transportation activity on the cell surface toward the nucleus. Paxillin was labeled with a red fluorescence marker to make it stand out in live cells.

“It’s amazing to us. We thought the cell was so simple,” said Shu Chien, the senior author of the BBRC paper and a professor of bioengineering at UCSD’s Jacobs School of Engineering. “But it’s really very complex and I’m not sure we’re covering much as yet. We certainly don’t know all the interactions among these molecules that bring the cell into action.”

Examining living cells through a microscope, Chien and the paper’s co-author, associate project scientist Ying-Li Hu, filmed red-fluorescence-tagged paxillin molecules traveling from cells’ outer membrane along green-fluorescence-labeled traces of cytoskeleton. Even without video evidence, scientists have confirmed over the past 10 years that higher organisms use paxillin as a transmitter of locomotion and gene-expression signals from several classes of growth-factor receptors to the nucleus.


link to full article

link to University of California - San Diego

Massachusetts' biotech plan may top peers'

Specialists: Outline hints it may be more flexible, cost-effective

By Stephen Heuser, Globe Staff | May 31, 2007

Governor Deval Patrick's proposal to inject $1 billion into medical research and biotechnology is a complex plan whose details have yet to be worked out, and it depends on the Legislature's willingness to fund it over a decade. But his strategy could also be more flexible and cost effective than competing plans in California and other states, according to policy specialists and a Globe analysis.

Patrick unveiled his Life Science Initiative this month before a packed crowd in Boston at the world's largest biotech convention, saying it would combat "competitor states and foreign nations" trolling aggressively for a piece of the state's marquee industry. He promised money for a new stem-cell bank, job training, and biomedical research, as well as tax breaks for companies hiring new workers.

Behind the $1 billion promise is a stream of money that is far from guaranteed. The Senate and House would need to find $25 million in the state budget every year for 10 years. They would also need to authorize $500 million in new bonds and write a new law making life-science companies eligible for up to $250 million in tax benefits.

"This is an initiative that's probably just starting -- that's going to require a lot of moving parts to come together to make it go," said Patrick Kelly , a vice president at the national Biotechnology Industry Organization who tracks state biotechnology policies.

link to full article

China sentences former drug official to death

Holy Crap!!!...

29/05/2007 - China has today sentenced to death the former director of its State Food and Drug Administration (SFDA), on charges of corruption, according to reports in the Chinese media.

The hardline approach may be an attempt by the country to demonstrate to the world its seriousness in stamping out the corruption that is reportedly rife throughout the healthcare and pharmaceutical, among other industries, and has been muddying the country's reputation, causing it to miss out on billions of dollars of foreign investment.

The death penalty was slammed on Zheng Xiaoyu by a Beijing court for taking over $850,000 (€632,000) worth of bribes in the form of cash and gifts. Incidently he also received a sentence of seven years' imprisonment for dereliction of duty.

In addition, all Zheng's personal property was confiscated and he was deprived of his political rights for life, according to media reports. His wife and son are also implicated and are still being investigated, among others who are believed to be involved.

Zheng, who reigned as China's chief drug and food official between 1997 and 2006, does, however, still have the right to appeal.

link to full article

Google Invests In Bio-Tech Company 23andMe

(AHN) - Google Inc. recently invested in a bio-tech company in order to help consumers further take advantage of the features the company offers.

The company, 23andMe is owned by Anne Wojcicki who married Google co-founder Sergey Brin in early May. In a statement, the company said Google is one of many companies who invested.

23andMe co-founder Linda Avey said the funding these investors will bring to the table will allow them to connect people with their genetic information, allowing them to better lead their lives. The company got $3.9 million from Google alone.

The company identifies genetic makeup in their clients like inherent traits.

Avey said, "Achieving this significant funding milestone enables us to move forward with our core mission of connecting people with their genetic information."

link to full article

A new wrinkle in evolution -- Man-made proteins

what will people think!!!

Nature, through the trial and error of evolution, has discovered a vast diversity of life from what can only presumed to have been a primordial pool of building blocks. Inspired by this success, a new Biodesign Institute research team, led by John Chaput, is now trying to mimic the process of Darwinian evolution in the laboratory by evolving new proteins from scratch. Using new tricks of molecular biology, Chaput and co-workers have evolved several new proteins in a fraction of the 3 billion years it took nature.

Their most recent results, published in the May 23rd edition of the journal PLoS ONE, have led to some surprisingly new lessons on how to optimize proteins which have never existed in nature before, in a process they call ‘synthetic evolution.’

"The goal of our research is to understand certain fundamental questions regarding the origin and evolution of proteins," said Chaput, a researcher in the institute’s Center for BioOptical Nanotechnology and assistant professor in Arizona State University’s department of chemistry and biochemistry. "Would proteins that we evolve in the lab look like proteins we see today in nature or do they look totally different from the set of proteins nature ultimately chose" By gaining a better understanding of these questions, we hope to one day create new tailor-made catalysts that can be used as therapeutics in molecular medicine or biocatalysts in biotechnology."

The building blocks of proteins are 20 different amino acids that are strung together and folded to make the unique globular shape, stability and function of every protein. The mixing and matching of the amino acid chain like numbers in the lottery are what favor the odds in nature of finding just the right combinations to help generate biological diversity. Yet no one can predict how the string of amino acids sequence folds to make the 3-D functional structure of a protein.

To select the raw ingredients to create the proteins, Chaput’s group (which includes Harvard collaborator Jack Szostak, and ASU colleagues Jim Allen, Meitian Wang, Matthew Rosenow and Matthew Smith) began their quest by further evolving a protein that had been previously selected from a pool of random sequences.

link to full article

The pot is calling the kettle

"extremely inefficient and therefore expensive"

I think the FDA needs to look at themselves first...and right away...

Quality must be backbone of clinical trial process, says FDA deputy

22/05/2007 - Quality needs to be built into every step of the clinical trials process, insists a leading US Food and Drug Administration (FDA) official.

There is a need for extensive standardisation and clear accountability - but also for an acknowledgment that variations do occur and can be accounted for, says Dr Janet Woodcock.

The FDA deputy commissioner and chief medical officer was addressing a recent workshop in Washington on 'Defining and Implementing Quality in Clinical Investigations from Design to Completion', held jointly by the Drug Information Association (DIA) and the FDA's Office of Critical Path Programs.

The workshop was part of the Human Subject Protection and Bioresearch Monitoring Initiative, announced by the FDA in June 2006 and focusing largely on data quality and the oversight of institutional review boards (IRBs). The initiative comes under the broader umbrella of the US agency's Critical Path programme, which aims to modernise and streamline medical product development.

The context for improving quality throughout clinical research was that, while the process generally produced high-quality data, much of the evidence needed to support modern evidence-based medicine never came through, Woodcock noted.

This was the legacy of an "extremely inefficient and therefore expensive" system, in which regulatory burdens and the lack of a stable infrastructure limited the number of clinical questions that could be pursued. Fraud was rare, Woodcock claimed, but when it occurred it might go undetected for some time, tarnishing the reputation of "the research enterprise" and eroding trust when it was eventually discovered.

link to full article

Luck of the Irish brings new biologics base

The Irish job machine rolls on...

21/05/2007 - Proposals for the construction of a new small-scale biologics manufacturing plant in Ireland courtesy of pharma heavyweight Pfizer emerged late last week.

The company is considering investing in a site in Shanbally, County Cork, right next to its existing active pharmaceutical ingredient (API) plant in Ringaskiddy, at an estimated cost of €175m.

While the plans are still at a very early stage, with the company having only just applied for planning permission at the site, it will come as welcome news to the area which only three months ago was dealt a blow when Pfizer announced it would be cutting jobs and capacity at the Ringaskiddy API plant.

The new facility is due to be used for Phase III clinical trial products and initial product launches, and will follow the trend of many biologics manufacturers by using disposable technologies to ensure maximum flexibility in production.

Although the plans have yet to officially receive the seal of approval and proposals are technically still pending, the move would fit nicely with Pfizer's recent attempts to expand its presence in the growing biologics market.

The fact that the company has also pushed ahead with attempts to gain planning permission before the plant proposal has even been approved internally is perhaps somewhat telling, illustrating the urgency and importance the firm now lays on the role biologics could have in its future.

link to full article

Growing Nerve Cells in 3-D Dramatically Affects Gene Expression

PROVIDENCE, R.I. [Brown University] — When it comes to growing cells in a lab, technique matters. A new Brown University study shows that nerve cells grown in three-dimensional cultures use 1,766 genes differently compared to nerve cells grown in standard two-dimensional petri dishes.

The study, published in the May issue of Tissue Engineering, adds to a growing body of research showing that culture techniques can significantly affect cell growth and function. This research shows that cells grown in a laboratory in 3-D environments, not in flat petri dishes, are more like cells grown in the ultimate 3-D environment – the human body.

“More and more, we’re seeing evidence that cells cultured in three dimensions look and behave more like cells in your body,” said Diane Hoffman-Kim, the Brown bioengineer who spearheaded the new study, “so culture method is critical. If you want to better understand how the human body behaves or how new drugs might fight disease, 3-D may be a better bet.”

For more than 100 years, scientists have grown human cells in flat dishes. In these 2-D glass incubators, better known as petri dishes, cells stick to the bottom and spread out as they multiply. But in the body, cells don’t grow that way. They are suspended in fluids and gels and surrounded by other cells. And these cells aren’t stuck; they move.

As a result, some scientists suspect that hothouse cells do not behave like in vivo varieties. This means that the critical functions scientists are trying to understand by studying these cells – from the proliferation of cancer to the bacterial assault by antibiotics – may play out differently. Studies indeed show differences in behavior between cells cultured in 2-D and in 3-D. Cells cultured in 3-D, for example, grow faster.

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Vaccine grant to protect millions from yellow fever

Bill and Melinda Gates strike again...

GENEVA (Reuters) - More than 48 million people in West Africa will be immunized for yellow fever over the next four years under a new vaccine programme announced on Wednesday by the public-private GAVI Alliance.

Mass vaccination campaigns from the 1940s to the 1960s nearly wiped out yellow fever in Africa, but a drop-off in immunizations caused a resurgence in the hemorrhagic disease that health experts fear could trigger epidemics in urban areas.

Yellow fever, whose symptoms can include fever, vomiting and bleeding from the mouth, nose and eyes, infects some 200,000 people a year, killing around 30,000, mostly in Africa.

The $58 million grant from the Global Alliance for Vaccines and Immunization (GAVI) will support vaccinations against the viral disease spread by mosquitoes in the world's most-affected countries: Benin, Burkina Faso, Cameroon, Cote d'Ivoire, Ghana, Guinea, Liberia, Mali, Nigeria, Senegal, Sierra Leone and Togo.

It will also create a stockpile of 11 million doses of the vaccine to prevent outbreaks and manage epidemics, according to the Swiss-based GAVI, whose partners include governments, drugmakers, the World Health Organization, the World Bank and the Bill & Melinda Gates Foundation.

link to full article

Quality is free...

it's the non-conformances that cost money...

check out philip crosby...

do you think 634 million will get their attention?...

Purdue Frederick pleads guilty in OxyContin case

NEW YORK (Reuters) - Purdue Frederick Co. and three individuals pleaded guilty to charges of misbranding prescription painkiller OxyContin and will pay more than $634.5 million in penalties, the U.S. Justice Department said on Thursday.

The company pleaded guilty to felony misbranding of OxyContin with the intent to defraud and mislead, while its president, chief legal officer and former chief medical officer pleaded guilty to a misdemeanor charge of misbranding, the government said in a statement.

The Stamford, Connecticut-based company and the three admitted that they falsely claimed OxyContin was less addictive, less subject to abuse, and less likely to cause withdrawal symptoms than rival pain medications.

"Purdue (Frederick) put its desire to sell OxyContin above the interests of the public," Assistant Attorney General Peter Keisler said in a statement. "Purdue abused the drug approval process which relies on drug manufacturers to be forthright in reporting clinical data and, instead, misled physicians about the addiction and withdrawal issues involved with OxyContin."

link to full article

Senate Approves Bill On Drug Monitoring

I'm surprised this wasn't the FDA charter all along...

"The bill calls for a fundamental change in the philosophy and operations of the drug agency, requiring it to focus on the entire life cycle of a drug — not just the years before its approval — as well as the experience of patients who later take it."- Biospace.com

The Food and Drug Administration would have to establish new systems to monitor the safety of medicines after they hit the market and for the first time could fine drugmakers for false or misleading advertising under a bill approved yesterday by the Senate.

The provisions are part of a major bill to reauthorize the current system that charges drugmakers hundreds of millions of dollars in fees each year to pay for speeded-up reviews of prospective new drugs. The government's authority to levy those fees will expire Sept. 30 unless Congress acts before then. The House has not yet taken up similar legislation.

Senators approved the measure 93 to 1, with Bernard Sanders (I-Vt.) casting the dissenting vote

link to full article

Amgen opens Indian office

Amgen, the world's largest biotechnology company, is betting big on India. The California-based biotechnology company with sales in excess of $12 billion is setting up an office in India with the aim of testing its drugs in the country and exploring opportunities for tie-ups.

"Amgen is currently forming local affiliate companies in Mumbai and Hong Kong that will have the capability to conduct clinical trials in India and East Asia.

Amgen's affiliate in Mumbai will support the company's clinical trials to take place in India," Mary Klem, Associate Director, Amgen, told Hindustan Times in an e-mailed response.

Industry sources said the company, which banks on innovation to develop therapeutic drugs, is also looking at partnerships that might lead to potential takeovers, though the company refused to divulge details on future plans.

"Amgen is contracting with partners in India and China for services to support its R&D (research and development) operations, including research, pre-clinical development, data management support and statistical programming," the e-mail said. Amgen has an annual research budget of $1.3 billion.

link to full article from Hindustan Times

Biotech industry to touch $5 bn in three years

in India, that is...

NEW DELHI: The domestic biotechnology sector, which closed at $1.5 billion mark in 2005-06, is expected to touch $5 billion by 2010. The sector is growing at a CAGR of 35%. Biotechnology by definition is the exploitation of biological process for industrial and other purpose.

At present, India has over 300 biotech firms focusing on different aspects of value chain and their number is going to be more than double in next three to four years, says a release from Assocham.

In a Paper by Assocham on Biotechnology Future, it has been pointed out that although clearly much smaller in size than the IT and BPO sector, the domestic biotech sector is witnessing similar growth and growth prospects. For instance during FY 05-06, the sector closed at around $1.5 billion, and grew by 35% for the second year in a row.

According to a release, Assocham president Venugopal N Dhoot said, Bio pharma in 2005-06, the largest segment of biotech industry grew by 32% to $1 billion. Exports were at $763 million, and accounted for 52% share of total industry’s revenues. Bio pharma accounted for 75% of the total exports and 70% of domestic sales.

link to full article

The FDA is under a lot of pressure lately...

and rightly so…based on some of the news I've been reading lately...

Not only on the “Big D” side, drug safety, and efficacy, imports, but also on the “Big F” side of the house…, food imports, food safety…it goes on and on.

I really can’t comment on the food inspection functions as I have limited experience with those processes, and I will leave safety and efficacy to the experts…assuming there are any experts anyway…but that’s another whole issue.

It is my experience that overall the GMP manufacturing side of FDA regulation works pretty much as advertised…companies are supposed to manufacture products in a “state of control”…the FDA periodically inspects the process to spot check conformance with requirements…deviations are noted and addressed…it all sounds pretty much like that’s what should happen, and that’s a good thing…

When companies do not maintain control of the manufacturing process, they face an escalating series of comments and sanctions from the FDA…minor comments are addressed on an on-going basis, more serious issued are cited, companies find them selves facing consent decrees, serious fines, or even orders to cease and desist for serious violations.

I have two basic comments on the whole situation…

One, the process works, if you are out of control, the FDA will catch you…a glimpse at their websites will give you a listing of latest citations and descriptions of the situation…Companies respect, or more likely, fear FDA inspections and it keeps them on their toes…of course there are some horror stories to be told…most people working on the manufacturing side have their favorite “let me tell you how unreasonable the FDA is…” story…

Two, it is scary how out of control you have to be before the FDA catches you…

Follow-up: why don’t drug companies learn from big fines?

Big bucks for BMS Project

Construction has finally begun on Bristol-Myers Squibb's (BMS) new biologics manufacturing facility in Massachusetts, with the company upping its original investment estimates for construction from $660m (€485.7m) to $750m.

The project represents the single largest capital investment in the history of the company, according to BMS CEO Jim Cornelius, and is said to reflect the growing role the company believes biologics will play in the future of the company. The firm has previously estimated potential long-term investments in the site to reach as much as $1.1bn.

Despite the $90m jump in the budget, a spokesperson for the company said that there was no single factor responsible for the increase, and the it was always expected that original estimate would fluctuate somewhat once BMS had a better sense of the scope of the project.

Although original plans were for construction of the plant to begin in September last year, in February the company was still confident that its original time scales would still be met, with submission for regulatory approval timed for 2010 and operations at the site beginning in 2011.

The large-scale manufacturing plant in Devens, Massachusetts will be a multi-product bulk facility that is modular in design so as to accommodate any future expansion. The first phase of construction will involve four main buildings, including the manufacturing structure which will house six 20,000-litre cell culture vessels and one purification train. The facilities are due to be operationally complete in 2009.

link to full article

New hope for TB with nano drug delivery

"nanoparticles are submicron-sized polymeric colloidal particles within which the therapeutic agent is encapsulated, or adsorbed or conjugated into the surface..."

What? Oh, well, I'm just glad to see progress with a new technology...

South African researchers have provided a glimmer of hope for the millions of people in the developing world struck down by tuberculosis (TB) by developing a nano-sized drug delivery platform that could make all the difference in the battle against drug resistant forms of the disease.

The consortium of researchers, lead by the Council for Scientific and Industrial Research (CSIR), has successfully managed to encapsulate four first-line anti-TB drugs within a nano-sized polymeric shell, which could revolutionise the delivery of TB drugs and have a significant impact on the efficacy of therapeutic treatments in developing countries.

One of the major advantages of the new technique is that it would reduce the drug regimen for TB sufferers from four different drugs every day for up to six months, to a single treatment every seven days for just six weeks.

"The difficulty in treating TB results from patient non-compliance to the treatment regime," lead researcher on the project at CSIR, Dr Hulda Swai, explained to in-PharmaTechnologist.com.

link to full article

Folding@home Capacity Doubled by PS3

Finally getting some value out of all those game consoles...

Extra computing power from idle PS3s has helped the capacity of Stanford University's Folding@home project double in the last month.

The project, which aims to further the understanding of how proteins fold in order to limit the development of a number of diseases, was given a boost by the dramatically improved processing power acquired following a system software update made available to PS3 owners last month.

Mass uptake of an application within the update has enabled researchers to utilize the processing power of hundreds of thousands of dormant PlayStation 3 consoles.

“The PS3 turnout has been amazing, greatly exceeding our expectations and allowing us to push our work dramatically forward,” said Vijay Pande, associate professor of chemistry at Stanford University and Folding@home program lead.

“Thanks to PS3, we have performed simulations in the first few weeks that would normally take us more than a year to calculate. We are now gearing up for new simulations that will continue our current studies of Alzheimer’s and other diseases,” he added.

link to full article

Stem cell study zeroes in on ALS cause

Progress!!!

WASHINGTON (Reuters) - Cells that are supposed to nourish and support other nerve cells instead secrete the poisons that cause amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's disease, researchers reported on Sunday.

Two reports published in the journal Nature Neuroscience may show new ways to treat the degenerative nerve disease, which slowly paralyzes its victims until they die.

Both teams showed that the nerve cells called astrocytes, which support and feed neurons, turn toxic when they carry a mutated gene called SOD1, which has been linked with ALS in the past.

Dr. Serge Przedborski of Columbia University in New York and colleagues created mouse motor neuron cells that carried mutated versions of the human superoxide dismutase-1, or SOD1, gene. But these mutated cells did not cause the damage typically seen in ALS when grown in lab dishes of cells.

Then they created astrocytes carrying the mutated human SOD1 gene. Astrocytes are one of the types of glial cells -- support cells in the brain and nervous system that secrete various compounds that nourish neurons.

When SOD1 is mutated in these glial cells, Przedborski and colleagues found, one of the nourishing proteins apparently turns toxic. When they grew astrocytes with mutated SOD1, they killed the neighboring mouse motor neuron cells.

"It was previously thought that astrocytes were merely spectators watching their neighboring motor neurons die," said Przedborski. "With these results, we have learned they are not just spectators, they are major players."

link to full article

Stem Cell Bill Approved by Senate

WASHINGTON (AP) -- A stubborn Senate voted Wednesday to ease restrictions on federally funded embryonic stem cell research, ignoring President Bush's threat of a second veto on legislation designed to lead to new medical treatments.

The 63-34 vote was shy of the margin that would be needed to enact the measure over presidential opposition, despite gains made by supporters in last fall's elections.

"Not every day do we have the opportunity to vote to heal the sick," said Claire McCaskill, D-Mo., a senator less than 100 days following a tough 2006 campaign in which the stem cell controversy played a particularly prominent role. "It is a noble cause," she added.

link to full AP article

2007 FOY Winners!!!...

Check out the winners...

Interphex 2007

I haven't even finished up posting up stuff from the ISPE Annual Meeting...

and it's time for Interphex...

make your reservations!!!...

and plan your visit...

Astra Zeneca's new PR&D centre leverages Indian chemistry expertise

more off-shoring...this time research...

22/03/2007 - AstraZeneca is leveraging the process chemistry expertise accumulated in India's generics industry and universities by opening a $15m (€11.3m) process research and development (PR&D) laboratory next to its existing research centre for tuberculosis in Bangalore.

The newly inaugurated 8,000sq m facility on AstraZeneca's Hebbal campus can accommodate up to 75 process scientists as well as supporting office and engineering staff. The Bangalore laboratory will both consolidate the existing drug discovery programme for tuberculosis at the site and bolster the UK company's global PR&D network. This consists of one facility apiece in the UK and Sweden, plus a pending UK PR&D laboratory at AstraZeneca's Macclesfield site that is expected to start operating by mid-2009.

The company, whose research pipeline has come under critical scrutiny following a succession of damp squibs in late-stage development, has been investing heavily of late in new R&D resources, partnerships and acquisitions. At the same time, it has been making deep cuts to boost productivity and cost efficiency in its supply chain. The recent announcement that 700 manufacturing and supply jobs would go at Macclesfield contrasted pointedly with the £63.5m (€93.6 million) AstraZeneca is investing in its new PR&D laboratory at the same site.

link to full article

Two biotech firms to operate in Penang

more on the "Big World/ Small World" theme...

TWO major biotechnology companies in Penang – Progenix Research Sdn Bhd (PRSB) and Alpha Biologics Sdn Bhd (ABSB) – will be ready for business soon.

Chief Minister Tan Sri Dr Koh Tsu Koon said PRSB would begin operations this month and ABSB in September at Biotechnology Park in Bukit Minyak.

He said these companies, founded by Springhill Management Ltd (SML) - a biotech venture capital company - were the first to set up biotech facilities in Bukit Minyak.

“They have strategically positioned themselves in Penang, helping the state government to stimulate foreign investments in biotechnology industry.

“The state government has been striving to make Penang the hub for biotechnology and life sciences,” he said recently.

link to full article

India's biotech queen goes for global crown

BANGALORE, India (AFP) - When Kiran Mazumdar-Shaw founded Biocon India in 1978 with 10,000 rupees (225 dollars) and an office in a rented car garage, no banker was willing to give her a loan.

Back then, no one had heard of biotechnology, which uses micro-organisms such as bacteria or biological substances like enzymes to make drugs and synthetic hormones.

Women entrepreneurs were also rare and finding recruits willing to work under a female boss was difficult.

Mazumdar-Shaw, hailed in 2004 as India's richest woman with a personal fortune of 21 billion rupees, and Biocon, India's biggest biotech firm with 3,000 employees, have come a long way from the garage.

The businesswoman, who will turn 54 on Friday, is now setting her sights beyond the domestic market, despite the company's 29 percent annual growth rate, estimated to touch five billion dollars by 2010.

"I see myself and Biocon as being a biotech company in a leadership position on the global stage," Mazumdar-Shaw told AFP in an interview in Bangalore.

"We are on the right track to getting there," added the entrepreneur, who plans to double research spending every year to discover new drugs and enter the league of giants such as Amgen and Genentech.

link to full article

Small molecule derived from Rb2/p130 could act as cancer therapeutic

Go Temple...

Just ask Bill Cosby...

A small molecule derived from the spacer domain of the tumor-suppressor gene Rb2/p130 has demonstrated the ability to inhibit tumor growth in vivo and could be developed into an anti-cancer therapeutic, according to researchers at Temple University's Sbarro Institute for Cancer Research and Molecular Medicine.

The researchers reported their findings, "A small molecule based on the pRb2/p130 spacer domain leads to inhibition of cdk2 activity, cell cycle arrest and tumor growth reduction in vivo," in the March 22 issue of the journal Oncogene (http://www.nature.com/onc). Rb2/p130 was discovered in the early 1990s by Antonio Giordano, director of the Sbarro Institute (http://www.shro.org) and the Center for Biotechnology in Temple's College of Science and Technology, who headed the study.

see link to full article

although I found most of the article difficult to follow...

GM mosquito 'could fight malaria'

Who knew mosquito's get malaria?...

A genetically modified (GM) strain of malaria-resistant mosquito has been created that is better able to survive than disease-carrying insects.

It gives new impetus to one strategy for controlling the disease: introduce the GM insects into wild populations in the hope that they will take over.

The insect carries a gene that prevents infection by the malaria parasite.

Details of the work by a US team appear in Proceedings of the National Academy of Sciences journal.

The researchers caution that their studies are still at an early stage, and that it could be 10 years or more before engineered insects are released into the environment.

link to BBC article

More new links

I am impressed with the number of new blogs popping up...

check out these...

Pharm Aid

On Pharma

Pharmalot

Chemical 'may stop cancer growth'

We have got to get one of these that actually works...

Scientists in Glasgow have devised a new method of attacking cancer cells.
A team of experts from the Beatson Institute for Cancer Research gave mice a chemical which caused cancer cells to "commit suicide".

The chemical significantly slowed the growth of the tumours in the mice and could pave the way for a new agent to stop cancer developing.

The Cancer Research UK experts reported the findings in the Journal of Clinical Investigation.

In further laboratory studies the research team found that the chemical could kill several types of cancer cells - including bowel, cervical and bone cells.

Lead researcher Dr Kevin Ryan said: "Our study has shown for the first time that the selective activation of a gene called p73 can cause cell death in tumours.

"We think this approach has the potential to be developed into an effective treatment for cancer."

link to full article

Del., neighbors rally around biotech industry

I guess I need to cover this story...

State, federal money will help cultivate life sciences


PHILADELPHIA -- Political leaders from Delaware, Pennsylvania and New Jersey gathered in Philadelphia on Tuesday to discuss ways to improve the area's biotechnology and life sciences.

The emerging biotech industry, which supporters say needs more funding, is crucial for work force expansion, according to Delaware Gov. Ruth Ann Minner.

"One of the most important things we can do is prepare our work force for the future," she said at a news conference with Gov. Ed Rendell of Pennsylvania and David Socolow, New Jersey commissioner of labor and work force development.

"When companies are looking to relocate, the first thing they ask about is the work force," Minner said.

A pair of U.S. Department of Labor grants totaling $6.6 million will be used to train workers in biotechnology and the life sciences in a 13-county region that includes New Castle County, southeastern Pennsylvania and southern New Jersey.

link to full article

US aims to break drug industry's hold on pricing

This appeared under an "opinion" column...

In the land of the free market, the idea of the government influencing the choice and cost of medicines is heresy. But that's exactly what's in store for the US, as it tries to rein in its healthcare costs, which threaten to cripple the economy if left unchecked.

Other countries have already taken steps to deal with such problems. The UK set up the National Institute for Health and Clinical Excellence (NICE) in 1999 to decide which drugs the country's National Health Service could use (see "UK's gatekeeper has the final say"). Similar organisations operate in Australia and Canada, and all claim to be working successfully, allowing governments to just say no to ineffective drugs and haggle with pharmaceutical companies when prices are too high.

Now, at long last, the US is considering a similar proposal in the shape of a proposed Comparative Effectiveness Board (CEB), which would review the evidence on how well drugs work and whether they are cost-effective. If necessary, the CEB would carry out its own clinical trials. The idea is to break the pharmaceutical industry's stranglehold on drug prices and stop it peddling marginally effective medicines. The drug industry is already expressing its displeasure at the idea of a government body judging a drug's value for money.

link to full article

New vaccine technology holds double promise

Have you ever seen the term "ever-lasting gobb-stopper" in a serious medical story???...

05/03/2007 - A new nanotechnology-based vaccine delivery method could allow the development of single-dose vaccines as well as new vaccines in disease areas of unmet need.

Research presented at last week's ASM Biodefense and Emerging Disease Research Meeting revealed that a biodegradable polymer in a microsphere formulation could be used to develop time-released vaccines, thus reducing the need for vaccine booster shots, as well as stimulate an immune response that traditional vaccines do not.

"Current vaccines are good at producing antibodies that block entry into the cell. In the case of some diseases, such as malaria or tuberculosis, antibody vaccines just aren't effective," said Jenny Wilson-Welder, a lead researcher on the study conducted at Iowa State University.

The polymer, called polyandydride, is already being used as a delivery system for a brain cancer drug designed to inhibit tumor growth but this is the first time its application in vaccines has been shown.

"It's like an everlasting gobstopper or a bar of soap. It wears away slowly over time, delivering its payload," says Wilson-Welder.

link to full story

Prime Minister Tony Blair Opens Major Amgen (AMGN) (Jobs) Development Center in London; 300 New Jobs

Amgen in the UK...

Amgen (NASDAQ:AMGN) announced today that the Prime Minister Rt Hon Tony Blair MP opened Amgen's new European Development Centre in Uxbridge, London. The centre can accommodate more than 300 new staff and forms a key part of a significant Research & Development (R&D) investment in the UK by Amgen.

Amgen's biotechnology medicines have already improved the lives of millions of patients worldwide suffering from cancer, kidney disease and other serious illnesses. As of the end of 2006, nearly 41,000 patients in 39 countries were enrolled in Amgen clinical trials. Uxbridge, together with Amgen's expanded Cambridge, UK facilities, will support the company's largest ever international clinical trial programme. In 2007, Amgen expects that approximately 55,000 patients will be enrolled in more than 250 clinical studies worldwide. More than half of those studies will be coordinated by UK-based R&D staff across 31 European countries.

Commenting on his opening of the European Development Centre in Uxbridge, the Prime Minister said, "I am delighted that Amgen has chosen to locate its European Development Centre in the UK. The UK biotech industry is second only to the United States, and we lead Europe in this sector. Amgen's decision to locate here is another strong endorsement of our economy and our first-class research base.

link to full article

Cancer cells forming blood vessels send their copper to the edge

The level of machinations within a cell amazes me...(perhaps because I do not understand them...)

It's a good thing that there are people on the case...

ARGONNE, Ill. (Feb. 26, 2007) — New information about a link between the growth of blood vessels critical to the spread of cancer and the copper in our bodies has been discovered by researchers from the U.S. Department of Energy's Argonne National Laboratory and the University of Chicago, using a beamline at the Advanced Photon Source.

Growing new blood vessels from existing ones — a process called angiogenesis — is important in growth, development and wound healing. But it also enables the spread of tumors throughout the body, so researchers have been scrambling for ways to stop angiogenesis in the fight against cancer.

One element critical to blood vessel growth is copper, a vital nutrient that plays important roles in many life processes. Compounds that reduce copper in the body without disrupting the body's normal functions can inhibit the growth of blood vessels — and some of these compounds are even in clinical trials for use in cancer therapy. Yet, the biological basis for this sensitivity of angiogenesis to copper has been an enigma.

In search of an answer, researchers from the Biosciences and X-ray Science divisions at Argonne and the Department of Medicine, Section of Hematology/Oncology, at the University of Chicago, have used X-ray fluorescence microprobe imaging at the Advanced Photon Source at Argonne, the Western Hemisphere's most brilliant source of X-rays for research. The X-rays allowed the researchers to look at the distribution of copper in both a cell model of angiogenesis and sections of breast tumor tissue rich in blood vessels.

link to full article

$110m to set up Kiryat Shmona “Biotech Valley”

Biotech is truly part of the global economy...

The planners believe that an industrial park will be set up with an initial 20 start-ups.
Gali Weinreb 26 Feb 07 16:51

The Ministry for the Development of the Negev and Galilee and the Ministry of Industry, Trade and Labor together with the United Joint Israel Appeal (UJIA), the United Israel Appeals Federations Canada , Sacta Rashi Foundation, the Jewish Colonization Association, and the Jewish Agency are due to invest $110 million in establishing “Biotech Valley” near Tel Hai College. “Globes” broke the storey about the joint venture between the college, Meytav Technological Enterprises Innovation Center Ltd. in Kiryat Shmona, and the MIGAL - Galilee Technology Center, which is intended to attract top-quality biomedical researchers to live and work in the Upper Galilee.

link to full article

Pharmas to lose $100bn to generics

What does this tell us about the coming market?

22/02/2007 - A report to be published next week predicts that US and EU pharmas will lose up to $100bn in revenues over the next five years as generic products take advantage of major branded products losing patent protection.

The greatest impact will seen be between 2010 and 2012 as the patents covering Pfizer's blockbuster drug Lipitor (astorvastatin calcium) expire, according to the new report "Generic Competition 2007 to 2011 – The impact of patent expiries on sales of major drugs."

The drug achieved worldwide sales of almost $13bn (€9.9bn) in 2006, representing the biggest opportunity ever for the generics industry, according to the report.Patent expiration can cause revenues for the supplier to drop 10-fold over a period of just two years, said report author, Dr Peter Norman.

Eli Lilly experienced this first hand on expiration of Prozac's (fluoxetine) patent, and Bristol-Myers Squibb saw revenues for Plavix (clopidogrel bisulfate) drop 90 per cent within a quarter as generic clopidogrel hit the market following the branded product's patent expiry.

link to full article

Powerful anti-tumor compound created

Hopefully, this will be good news in the search for a cure...


PITTSBURGH, Feb. 22 (UPI) -- U.S. cancer researchers say they have synthesized a compound that works in a different way than existing agents to block tumor cell growth.
Kazunori Koide and colleagues at the University of Pittsburgh say the new compound is so potent that minute levels of 10 parts per trillion block the growth of tumor cells in laboratory experiments.

The parent compound, FR901464, inhibited the growth of cancer cells implanted into laboratory mice. Because of structural similarity between FR901464 and its analogue, meayamycin, the Koide group is cautiously optimistic meayamycin also will be effective against tumors in mice.
The amount that the Koide employed against cancer cells is equivalent to 10 seconds in 32,000 years or one packet of sugar in a coffee cup the size of 400 Olympic-size pools.

The report, which describes the compound as one of the most potent of all anti-cancer agents, is to appear in the March 7 issue of the Journal of the American Chemical Society.

link to article

Johns Hopkins leads in research spending

WASHINGTON, Feb. 21 (UPI) -- Johns Hopkins University was the fiscal 2005 leader in total research and development spending among all U.S. academic institutions, a report said.
Researchers at the Baltimore, Md.-based, school performed $1.44 billion in science, medical and engineering research during fiscal year 2005, which started Oct. 1, 2005, and ended Sept. 30, 2006.

The National Science Foundation said that makes Johns Hopkins the leading U.S. academic institution in total research and development spending for the 27th consecutive year.
The university also ranked first on the NSF's separate list of federally funded research and development, spending $1.277 billion during fiscal 2005 on research supported by such agencies as the National Institutes of Health, the National Aeronautics and Space Administration and the Department of Defense.

The University of Michigan was second in total R&D spending at $808 million. The University of Washington ranked second in federally financed R & D at $606 million.

link to full article

The Job Creation Machines Notices Biotech...

City's latest top job ranking recognizes biotech impact...

It's not just real estate that makes the Phoenix area one of the nation's hottest job markets.
This month's Forbes list of the Best U.S. Cities for Jobs also recognizes efforts in attracting technology firms -- biotech in particular -- in ranking the region No. 2 for the second straight year.

Top honors went to Raleigh, N.C., with the magazine noting its stable housing market and the presence of three major universities, which help in attracting an educated work force and technology firms. Detroit landed at the bottom of the pack among the nation's largest 100 metro areas.

Rounding out the top five were Jacksonville, and Orlando, Fla., and Washington, D.C., last year's No. 1. Tucson checked in at No. 20 on the list of Best U.S. Cities for Jobs, up from 41 last year. Las Vegas, a perennial winner on the job front landed at No. 8, down from third place.
To compile the rankings Forbes used five data points, weighted equally: unemployment rate, job growth, income growth, median household income and cost of living. The Phoenix area ranked 16th for unemployment, fifth in job growth, second in income growth, 34th in median household income and 64th in cost of living.

link to full article

Baxter FOY Presentation

The presentation topic for the ISPE meeting last Thursday night was the winning entry for last Year’s Facility of the Year competition, which was the Baxter project…

It looked like it was going to be a well-attended meeting due to the interest in the modular construction presentation topic…

I arrived early at the Holiday Inn…the traffic in North Jersey is such that if you want to get there at all, you have to get there early…I wandered around, admiring the nice collection of Beaux Arts architectural prints on the walls…everybody else was on their cell phone…

I had a bit of a chat with Mr. Inoue….see link to that post here…Mr. Inoue also noted that modular construction techniques were difficult implement in Japan due to over-the-road restrictions on module sizes, especially height. He indicated that the technique had been successfully used in remote areas that did not have similar restrictions.

I spent some time talking to some people from T+M Engineering…They are currently working on a pre-cast project in Northern NJ. In keeping with the theme of the evening, we all agreed that the construction speed of a pre-cast structure was something to be seen…

Conversations broke up when it was time for dinner to be served…given the crowd, it was difficult to find a seat… I tried to find a table with an open place to sit but it turned out to be like little kids playing musical chairs, and I wound up losing my seat while I was in the buffet line anyway…of course, by then, all of the other seats were taken… I eventually found a seat when they got more tables in place…Obviously, they weren’t keeping track of how many people were coming in the door as compared to how many places were set… other than that, dinner was fine…

When the presentation started, Mr. Signore of IPS made a brief introduction…

Mr. Ulrich Rudow, Vice President of World Wide Engineering & Real Estate for J+J provided a discussion regarding the judging process used in the competition…I think this was the most interesting part of the presentation, particularly if you are interested in submitting a project for consideration in future competitions.

I think he indicated there were 30 applications the first year and 50 this past year…Mr. Rudow joked about how many times he read about “world class”, fast-track”, and “best-in-class”…

He indicated the judges were looking for the “Ah hah” factor, or the “why didn’t I think of that?” type of reaction…

During the judging process, project applications were eliminated due to wrong data or data that was not internally consistent through out the presentation. Projects with only vague information also got the boot, or if the judges felt information was being concealed. Another important criterion was that the facility needed to be “ready to make product” and completely validated. He discussed issues involved in maintaining impartiality during the judging process and efforts to avoid any conflict of interest during the review process…

He indicated that size was not the determining factor in selecting the finalists, and pointed to the spectrum of project sizes among the five finalists as an example of other criteria being more important.

During the final judging, Mr. Rudow indicated that a point system was used to score the various entries and that he found that the judges all arrived at the same conclusions and had developed a solid consensus by the 3rd round of judging….

I thought it interesting that Mr. Rudow noted that we all provide engineering in pretty much the same way and only “tiny little differences” were all that ultimately separated the various entries…

Mr. Rudow concluded his remarks by noting that the judging effort was a lot of work and a lot of fun…


At this point the presentation was tuned over to Mr. Gordon Leichter of the Pharmadule, Inc.

Mr. Leichter presented briefly presented the five finalists and presented the winning entry in more detail…

The FOY Competition evaluates project entries against the following criteria:

- safety,
- significant contribution to industry,
- unique and innovative approaches
- quality
- project management techniques


The Baxter Project combined modular stick-built construction techniques with new construction of an addition and renovation of an existing structure.

Mr. Leichter indicated that a critical part of the project success was that the client had prior experience with modular construction with Pharmadule and understood the process of working within the requirements of this approach…

Mr. Leichter made a very interesting presentation, which included a lot of good pictures of the actual construction of both the module fabrication and field construction activities.…

The modular approach allowed site preparation activities to be undertaken while modules were being fabricated off-site…so far off-site, it was fabricated in another country…that’s off-site…

Modular construction does seem to go very quickly in the field. Mr. Leichter indicated that 6 modules were placed per day with the project being comprised of 62 total modules arranged in a three story layout…Overall module size was 14’-6” x 14’-6” x 45’ long, and this size was determined by over-the-road transportation restrictions…I found it interesting that Pharmadule also validated the facility as part of their project scope.

It appeared that more than one full year of conceptual and preliminary design time was not included in the reported project schedule for the competition… assuming I understood the presentation correctly…I am very surprised the judging committee did not focus on this issue more closely…

A young lady asked an interesting question regarding at what point in the project did the decision to apply to the FOY take place…I was also wondering if you start out the project with this as a goal in mind, or if you wind up realizing you have a candidate project after the fact…I didn’t quite follow Mr. Leichter’s answer…

Various other questions came up around other issues involved in modular approach to project execution and the trend toward this approach…Mr. Leichter indicated that modular execution would be a paradigm shift for most project teams…

It was noted that equipment layout must be coordinated with module layout in this construction technique…particularly for larger equipment like autoclaves or lyophilizers, and spread out equipment like the filling line set-ups …

The obvious question regarding cost premium came up and Mr. Leichter indicated it was quite a common question. He was understandably reluctant to quote an exact figure but indicated that a 10-15% premium could be expected after the completion of a conceptual layout.

Other issues came up regarding risk associated with this approach to project execution… Reaction at my table was that the risks involved in this type of approach were not discussed or addressed as part of the presentation.

In looking at the brochure material handed out as part of the presentation, there were more projects executed in this manner that I would have thought, although I am not sure how many have been successfully completed in the U.S…most seemed to be located in Europe.

Reaction from the audience indicated that most everyone felt it was an interesting presentation…

Clearly more answers to specific questions are needed to completely evaluate the modular approach to capital project execution…more than can be raised at a dinner meeting sales presentation… and more than can be covered here…

An interesting topic, which I am sure will be discussed in much more detail in the future…I am also sure other projects are being considered for execution in this manner and we should follow the progress of these projects carefully for more information.

Obviously, modular construction is a growing trend and is attracting a lot of interest, even if you only judge based on the size of the crowd in attendance…

More information can be found at the Pharmadule website at www.pharmadule.com

Lawmakers propose pathway for approving biosimilars

A group of lawmakers on Capitol Hill has introduced legislation that establishes a clear pathway for the approval of biosimilars. The bill has already attracted the wide support of a diverse group of lobbyists, including the AARP, health plans and pharmacy benefit managers, who would like to see the price of complex biotech drugs go down. BIO has long been on record that it isn't necessarily opposed to biosimilars--cheaper follow-on versions of branded biotech drugs--but insists that the complexity of biologics requires the FDA to insist on a separate set of expensive studies before any follow-on therapy can be approved. In Europe the EMEA has had a regulatory pathway in place for almost three years.

link to full article and related report

Astra Zeneca Pledges $10M to Cancer Society

Good news...I wish more pharma companies would step up like this...

ATLANTA (AP) -- A drug company is pledging $10 million to The American Cancer Society - one of the largest gifts in the organization's history - to help provide one-on-one support for cancer patients in U.S. hospitals, the organization announced Wednesday.

The unusual gift is from AstraZeneca PLC, an international pharmaceutical company.
It's earmarked for a program that stations specially-trained Cancer Society employees in 60 hospitals and cancer treatment centers. The "navigators" guide patients to social and emotional support, transportation, medical and financial assistance services.

The gift will allow the program to expand to 50 more locations in medically underserved areas, said Nancy Single, the Cancer Society's vice president for mission strategy.

link to full article

AIDS virus weakness detected

Progress???...

WASHINGTON (Reuters) - Scientists have captured an image of the AIDS virus in a biological handshake with the immune cells it attacks, and said on Wednesday they hope this can help lead to a better vaccine against the incurable disease.

They pinpointed a place on the outside of the human immunodeficiency virus that could be vulnerable to antibodies that could block it from infecting human cells.

U.S. National Institutes of Health researcher Peter Kwong said the study, published in the journal Nature, may reveal HIV's long-sought "site of vulnerability" that can be targeted with a vaccine aimed at preventing initial infection.

"Having that site and knowing that you can make antibodies against it means that a vaccine is possible," Kwong said in a telephone interview.

link to full article

Googling brain proteins with 3-D goggles

Cool new technology...

RICHLAND, Wash. — The Allen Brain Atlas, a genome-wide map of the mouse brain on the Internet, has been hailed as “Google of the brain.” The atlas now has a companion or the brain’s working molecules, a sort of pop-up book of the proteins, or proteome map, that those genes express.

The protein map is “the first to apply quantitative proteomics to imaging,” said Richard D. Smith, Battelle Fellow at the Department of Energy’s Pacific Northwest National Laboratory, who led the mapping effort with Desmond Smith of UCLA’s David Geffen School of Medicine.
“Proteins are the lead actors, the most important part of the picture,” PNNL’s Smith said. “They are the molecules that do the work of the cells.”

Fine-tuning such proteome maps will enable comparisons of healthy brains with others whose protein portraits look different. Contrasts in location and abundance of proteins may display the earliest detectable stages of Alzheimer’s, Parkinson’s and other neurological diseases. They hope such diseases might be curbed if caught and treated early enough.

The National Institutes of Health-funded study, performed at DOE’s Environmental Molecular Sciences Laboratory on PNNL’s campus, is published in the advance online edition of Genome Research and featured in current Nature online Neuroscience Gateway (http://www.brainatlas.org). PNNL staff scientists Vladislav A. Petyuk, Wei-Jun Qian and UCLA’s Mark Chin are co-lead authors.

To produce the map, the team characterized center-brain slices as several dozen 1 millimeter cubes, or “voxels,” to “show us where proteins appear in the brain and where they vary in abundance,” PNNL’s Smith said. “We labeled all the proteins so we would have reference points so we know we’re looking at the same protein between different parts of the brain and from one mouse to another.”

link to full article

What friends have been up to...

It’s always interesting to find out what friends have been up to …I have been in touch with a lot of friends and colleagues lately…

I heard from Mike Dockery the other day…he called in from the other side of the pond…

He has been in the US lately, and he indicated that he has been very involved in the Labs21 effort and in trying to bring a similar effort to Europe called Labs21 UK.

He was also interviewed for an article in the latest issue of Nature magazine in an article titled "Energy efficiency: Super savers: Experimenting with efficiency". The article covers energy savings as one of the most effective means to reduce greenhouse gases…He is quoted as saying “Europe can teach the US a thing or two…” about sustainable lab design.

I haven’t seen the full article…Nature charges a lot to read it’s articles on line…if anyone gets a look at the full article, let me know…

It was good to hear from Mike…I wish him well with his latest efforts…maybe I’ll try to get him to crank out a post or two…

My conversation with Mr. Inoue

While attending the ISPE meeting last Thursday night, I had the pleasure of meeting Mr. Mikio Inoue. We wound up having a pleasant conversation regarding his involvement with the competition and some other aspects of the pharm/bio industry.

We had both arrived at the meeting early and were waiting for the festivities to begin and I took the opportunity to introduce myself. We were exchanging pleasantries typical of being just introduced at a meeting and discussing the fact that it seemed like it was going to be crowded based on the Baxter FOY presentation.

Look for a review of that presentation coming shortly…


Mr. Inoue mentioned that he had been involved in the FOY competition (website link) and he was attending tonight to provide local representation for the project and his company.

I noticed he had a Facility of the Year sweatshirt on and we began to discuss his involvement with the competition.

It dawned on me that this was going to be a better conversation than the usual “Consultant meets Vendor at an industry function”... you know the type….we’ve all had a million of them…
With his permission I started scrawling some notes…I hope this captures the basics of our conversation, I do not have any actual training as a reporter, so bear with me…

Mr. Inoue had participated in a very successful project for the Daiichi Asubio Pharma Co., Ltd (website link). The project is a multi-product production facility located in Gunma Prefecture, Japan. Descriptions of the five finalist projects are available here at the FOY website (website link).

The project was a finalist in the 2006 Facility of the Year competition, which is how he got the sweatshirt. The competition is sponsored by ISPE, INTERPHEX, and Pharmaceutical Processing magazine.

He was very knowledgeable about the project and had a lot of detailed information regarding building layout, processes, and equipment involved in the project. The facility is capable of multi-product and multi-scale production and launch operations. The major pieces of process equipment were provided from a very geographically diverse set of countries. Mr. Inoue stated that part of the success of the project was having the architect understand the process to be supported by the facility.

Mr. Inoue indicated that the project was reviewed with the FDA in order to align the project with regulatory expectations. We both agreed that a Type C Meeting with the FDA is a very valuable step and allows for valuable input to be provided by the FDA in a more casual setting.


He was very knowledgeable about the project type and had some interesting rules of thumb regarding building size and process valve count. We also discussed the level of automation a project might have based on differences in approach between the level of automation between Japanese and US approaches to plant operation.

Mr. Inoue described the typical Japanese approach of using a high level of automation and centralized DCS systems in order to limit manual interaction of the operators in the production process. This approach also reduces labor costs associated with the plant operators and also addresses the difficulties of staffing a plant with operations personnel.

This approach is in contrast to the equipment specific PLC/ “islands of automation” approach that is often found in plants built here in the US. This results in less centralized control, beyond data gathering, and more manual interactions with the process. We discussed how the US approach may be driven by an operating company’s regulatory history, risk aversion, perceived complexities and costs of validation efforts associated with complex automation and control systems.

Both approaches are driven by the need to respond to the expense and availability of operator labor. While these are not hard and fast approaches, it represents a philosophical difference in each countries typical approach to the industry.


Mr. Inoue holds a PhD and is the General Manager of the Pharmaceutical & Biotechnology Project Division for the Fujikin of America Inc.

Mr. Inoue has recently moved to the US and is living and working in New Jersey. When asked how he found living in NJ, he replied “tough…” When I heard his response, my first thought was “well, it is New Jersey…” home of the Sopranos, the Jersey Turnpike, and the Attitude Capital of the World…

Mr. Inoue indicated he is very involved in the ISPE New Jersey Chapter activities. He had attended the Holiday Cruise party and would also be going to the Nets- Spurs game coming up on date.

Mr. Inoue can be contacted by phone at (201) 641-1119 or via e-mail at minoue AT fujikin.com. (substitute the "@" symbol for e-mail address...)


I guess I should try to introduce myself to more people more often when I go to ISPE meetings.
A lot of highly qualified and experienced people attend and I would probably be able to have a lot of interesting conversations.

I consider myself lucky to have met Mr. Inoue and to have had such an interesting conversation.

Males more prone to cloning

Prone to cloning???...It's a guy thing...

Cloning researchers who wish to boost their success rates should try using male cells, researchers say. The advice is based on a new study which showed that mouse embryos created from male adult cells were more than three times as likely to develop to term as those created from female adult cells.

Cloning an adult animal usually involves putting the nucleus from an adult cell into an egg that has been stripped of its chromosomes. However, progress has been hindered by the fact that "reprogramming" adult nuclei in this way has very low success rates.

To get around this problem, a team led by Peter Mombaerts and Elaine Fuchs at Rockefeller University in New York, US, tried using adult skin stem cells, which are less differentiated and so should be easier to reprogram.

The success rate was still very low, but they did find that 5.4% of embryos created from male cells developed to term, compared with 1.6% for comparable cells from females.
More tests are now needed to confirm whether this sex bias holds true for other cell types.

link to full article

When India is having trouble finding qualified people, we're all in trouble...

Noted scientist Dr. K Muniyappa has regretted that though the number of colleges offering biotechnology degrees in the country has grown by leaps and bounds during the last some years, the quality of the education imparted in these colleges is a subject for deep concern.

"The Indian biotechnology sector is facing an acute shortage of trained manpower and there is a lack of initiative for development of competent human resources," he said. There is an urgent need for the Union government to earmark a portion of the budget towards quality training of manpower in biotechnology.

The observation by the research institutes and the industry is that the present knowledge among biotech graduates makes them unemployable. In the post-graduate sector, many of the candidates are even unfit for on-the-job training.

"With the growing popularity of biotechnology among the students, there has been a spurt in the number of colleges offering biotechnology degrees, but the quality of training offered is a question," Dr Muniyappa, professor and chairman, department of biochemistry, Indian Institute of Science told Pharmabiz. "

Graduate students contribute the most, if not all to our research output in many disciplines. In India, the emphasis is on training rather than research productivity. This has led pharma-biotech sector to insist for candidates who have either studied or worked abroad only because of the quality of personnel in India are just not employable," Dr Muniyappa, who is also the founding coordinator, National DBT Post-doctoral Programme in Biotechnology and Lifesciences, added.

link to full article

Pharm Country ranks 3rd in bio jobs

A new national study ranked the Philadelphia area third in bioscience employment.
The nine-county region, with 53,036 biosciences jobs, trailed top-ranked New York and Los Angeles -- and finished ahead of Chicago and well-established biotech hubs Boston and San Francisco.

Battelle, a nonprofit independent research firm, conducted the study for the Biotechnology Industry Organization, a national trade group based in Washington, D.C. The report issued last week is the latest attempt to identify the leaders among the many regions in the country that have engaged in highly publicized attempts to lure sought-after life science jobs.

"This report illustrates that nearly every large metropolitan area in the United States is actively pursuing bioscience industry development," said Patrick Kelly, vice president of state government relations for BIO. "The biosciences not only have the potential to create high-skill, high-wage jobs, but the industry is also developing technologies that can improve the quality of health care and agriculture and help meet our nation's growing energy needs."

link to full article

Pfizer says to cut jobs and production in Ireland

more on the Pfizer situation...

DUBLIN, Feb 7 (Reuters) - Pfizer Inc. (PFE.N: Quote, Profile , Research) said on Thursday it planned to end or reduce manufacturing at three sites in southern Ireland, resulting in the loss of at least 65 jobs.

The U.S. drugs maker, which last month said it would cut 7,800 jobs in a bid to save $1 billion by the end of 2008, said the move was part of a plan to reduce Pfizer's global plant network by more than 50 percent over four years.

Failure to get potential new drugs onto the market, new technology, moving operations to countries where production is cheaper and lower sales due to higher competition had all contributed to the decision to cut capacity in Ireland.

The company's decision last December to end trials of its cholesterol drug, torcetrapib, due to safety concerns had been "by far the most significant factor impacting future capacity demand in Ireland," Terry Lambe, Pfizer's vice president of manufacturing for Ireland and Singapore, said in a statement.

Pfizer said it planned to close part of its Ringaskiddy site in County Cork by the end of 2007, resulting in the likely loss of 65 jobs.

link to full article

New international guidelines for stem cell science

The first international guidelines on human embryonic stem cell research, released on Thursday, echo public opinion in calling for a ban on human reproductive cloning. But they are already proving controversial in other angles.

Although the guidelines are not legally binding, they carry the weight of leading scientific opinion and are likely to be influential in many countries.
Written by a committee of leading stem cell scientists, the guidelines take a permissive stance on two key issues: paying women to donate eggs for research, and controls on projects involving human/animal chimeras.

Guidelines issued in 2005 by the US National Academy of Sciences (NAS) and laws in other countries, including the UK, prohibit using cash payments to induce women to donate eggs for research. But the new guidelines, issued by the International Society for Stem Cell Research (ISSCR), suggest that the question of payments should be left to local ethical committees.

link to full article

Altering Virus Coats May Halt Flu Spread

By LAURAN NEERGAARD AP Medical Writer

WASHINGTON (AP) -- Making a small change in the outer coating of the lethal 1918 flu virus was enough to stop it from spreading, a discovery that may help scientists monitor today's bird flu and other influenza strains for signs of the next pandemic.

The 1918 pandemic was triggered by a bird virus that mutated into one that could attack humans, going on to kill a staggering 50 million people worldwide in a matter of months.
To learn what caused that catastrophic bird-to-human transformation, scientists with the Centers for Disease Control and Prevention turned back the clock: They worked with recreated batches of the actual H1N1 flu strain that spawned the 1918 pandemic, but they altered two spots in a key protein to make that virus a little more birdlike again.

Then the researchers dripped the altered virus into the noses of ferrets, who catch and spread influenza like humans do.

The infected ferrets still sickened and died as the flu ravaged their lungs. But remarkably, they didn't infect healthy ferrets caged right next to them, the CDC team reports in Friday's edition of the journal Science.

link to full article

BioHealth Investor- Blog of the Week...

I don't usually focus too much on the financial side of the industry...and I think the biggest reason is there are other people out there doing a good job, way better than I could do...

BioHealth Investor- biotech stocks, news, and commentary

PPB Blog of the Week

check it out...

Small changes stop flu virus spread, study finds

WASHINGTON (Reuters) - Two little changes in the virus that caused the 1918 Spanish flu pandemic stopped it from spreading from one animal to another, a finding that may help determine what will cause the next pandemic, scientists reported on Thursday.

Researchers who have been studying a reconstructed version of the 1918 virus found it very easy to stop it from spreading from one infected ferret to another -- although the altered viruses still quickly killed the animals.

"Work on the 1918 virus is providing clues that are helping us evaluate other influenza viruses with pandemic potential, such as H5N1, that may emerge," said Dr. Terrence Tumpey, a U.S Centers for Disease Control and Prevention microbiologist who led the study.

"With this vital research, we are learning more about what may have contributed to the spread and deadliness of the 1918 pandemic," CDC' Director Dr. Julie Gerberding said in a statement.

"By better understanding how this virus spreads, we can be better positioned to slow down or stop the spread of the pandemic virus and hence be better prepared for the next pandemic."

link to full article

GSK invests in new Irish facility

New Construction...overseas, for OTC products...who's looking for work in Ireland?...

01/02/2007 - Major pharmaceutical player GlaxoSmithKline (GSK) has begun construction of a €23m facility in County Waterford, Ireland.

The new facility is already under construction at the company’s consumer healthcare manufacturing site in Dungarvan.The new plant will be a 2,700 square metre facility for granulation and compression for the company's over-the-counter (OTC) medicines, such as the firm's leading OTC analgesic, Panadol (paracetamol/acetominophen).

No one from GSK was available to comment on the new investment, but media reports state that the company believes the move highlights the strategic importance of the Dungarvan site to the global supply of the firm's OTC products.

Aside from Panadol, 6 billion tablets of which are produced by the company's factories annually, the company's other OTC products include a range of smoking control products, gastro-intestinal and dermatological products. In 2004, GSK also obtained the marketing rights to orlistat in the US, a prescription product for obesity management approved by the US Food and Drug Administration and currently marketed by Roche as Xenical.

In 2005 OTC medicines generated sales of around £1.4m for the company, almost 50 per cent of the total sales from the firm's consumer healthcare division.

GSK has manufacturing facilities at two sites in Ireland, one in County Cork in addition to the Dungarvan site.

link to full article

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

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