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