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.

link to full article

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