Inflammatory genes linked to salt-sensitive hypertension

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

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

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

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

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

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

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

link to full article

Biotech industry surging in Maryland

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

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

link to full article

MIT creates 3-D scaffold for growing stem cells

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

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

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

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

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

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

link to full article

NNE scoops up Pharmaplan

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

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

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

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

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

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

link to full article

New Drugs Declining, Research Costs Increasing

This is not good news...

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

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

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

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

link to full article

Mistletoe for Cancer? Maybe Not

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

Mistletoe Extract May Be Harmful, British Doctors Say

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

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

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

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

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

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

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

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

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

link to full article

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

The job making machine continues forward...

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

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

link to red orbit article

Virgin process can produce stem cells

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

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

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

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

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

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

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

link to full article

stem cell research

"Inkjet" printer helps organize stem cells

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

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

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

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

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

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

link to full article

stem cell research

Senate approves Bush pick to lead FDA

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

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

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

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

link to full article

CROs – where is the money being spent?

another outsourcing/ offshoring issue...

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

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

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

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

link to full article

Pfizer manufacturing plant in question after torcetrapib blow

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

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

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

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

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

link to full article

Gates Foundation to separate assets from grant-making in January

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

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

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

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

link to full article

gates foundation

Red wine health locations found

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

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

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

The research is published in the journal Nature.

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

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

link to full article

Day 3- Tuesday- Socializing and taking off…

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

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

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

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

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

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

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

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

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

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

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

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


Review of Day 4 to come…

ISPE Annual Meeting

Ireland must lift its clinical trials game

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

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

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

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

link to full article

pharmaceutical outsourcing offshoring

Offshoring trend threatens Western employment

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

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

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

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

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

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

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

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

link to full article

pharmaceutical outsourcing offshoring

Singapore drives pharma industry forward

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

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

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

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

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

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

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

link to full article

pharmaceutical outsourcing offshoring

Merck tests India’s outsourcing capabilities

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

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

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

link to full article

pharmaceutical outsourcing offshoring

Day 2- Monday- Session Reviews

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

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


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

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

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

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

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

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

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

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

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

Reviews of Days 3 and 4 to follow…

ISPE Annual Meeting

California OKs $150 million stem-cell research loan

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

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

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

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

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

link to full article

stem cell funding

Day 2- Monday- Travelogue

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

Anywho, enough of the boring travel stuff…

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

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

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

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

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


Oh yeah, the meeting…

Day 2- Sessions Reviews

ISPE Annual Meeting

ISPE Argentina Affiliate blog

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

and they have a blog...

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

check out ISPE Argentina affliliate

ISPE Annual Meeting

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

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

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

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

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

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

Reviews of Days 2 and 3 to follow…

ISPE Annual Meeting

Drug counterfeiters changing tactics to bypass EU customs

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

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

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

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

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

link to full article

counterfeit drugs

Chocolate addiction leads to sweet discovery

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

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

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

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

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

link to full article

Vaccine 'tackles kidney cancer'

More vaccines for concer...

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

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

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

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

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

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

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

link to full article

cancer vaccines

Good things about the Annual Meeting...

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

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

ISPE Annual Meeting

Pharma abandons blockbuster for niche drugs, claims report

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

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

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

link to full article

Novartis to spend US$100m on Shanghai research centre

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


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

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

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

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

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

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

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

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

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

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

link to full article

U.S. under fire as WHO picks new leader

and the winner is...

Dr. Margaret Chan

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

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

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

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

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

link to full article

and Invensys takes the early lead...

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

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



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

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

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

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

ISPE Annual Meeting

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

Update 05Nov06

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

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


or other fun attire...

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

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

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

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

See you there...

ISPE Annual Meeting

Amgen to open Indian office...

Outsourcing hits R+D?...

The world's largest biotechnology company Amgen will start its wholly owned local affiliate companies in Mumbai and Hong Kong before the end of 2006 to tap the Asian market for clinical trials and drug development.

Apart from conducting clinical trials in India, Amgen will conduct R&D operations, including research, pre-clinical development, data management support and statistical programming, by partnering with pharma and biotech companies in India. Currently, Amgen is in talks with some of the leading pharma and biotech companies in India and China to form alliances and collaborations to undertake drug development and clinical trial operations in the Asian region.

"In our industry, R&D is a multi-faceted effort that requires partnerships and collaboration between industry and a variety of individuals and institutions - all committed to advancing human health with the most innovative therapies. In order to conduct clinical studies and apply science and innovation to help fight serious illnesses, Amgen will partner with leading clinicians, as well as academic, healthcare, government, research and patient organisations to better serve unmet medical needs in the region" Mary Klen, associate director, Amgen informed Pharmabiz in an e-mail interview.

However, she declined to share the details of the investment and the companies Amgen is in discussions with to form collaborations and partnerships.

She said under Amgen's global clinical development strategy, the company might decide to develop in Asia any of the molecules that are currently under development in the United States and other parts of the world.

The US$ 12.4 billion Amgen, which invested about US$ 2.3 billion in R&D alone in 2005, has about 26 molecules in the phase I to III stage for the treatment of cancer, asthma, Type 2 diabetes, obesity, pain management, rheumatoid arthritis, CVD and a host of other therapeutic areas.

link to full article

check out pharmabiz.com for a good view into India's pharmaceutical business...

CDC investigating salmonella outbreak

refer to the computer detection reference near the end of this post...sounds cool...

ATLANTA - A salmonella outbreak potentially linked to produce has sickened at least 172 people in 18 states, health officials said Monday.

Health officials think the bacteria may have spread through some form of produce; the list of suspects includes lettuce and tomatoes. But the illnesses have not been tied to any specific product, chain, restaurants or supermarkets.

No one has died in the outbreak, which stems from a common form of salmonella bacteria. Eleven people have been hospitalized, health officials said.

"We're very early in the investigation," said Dave Daigle, a spokesman for the U.S. Centers for Disease Control and Prevention.

Outbreaks of food-borne illness have repeatedly made headlines this year. Certain brands of packaged spinach, lettuce, carrot juice, beef and unpasteurized milk recently were recalled after they were found to be tainted with illness-causing bacteria.

The most serious outbreak, first reported in September, involved spinach tainted with E. coli bacteria that killed three people and sickened more than 200.

The CDC detected the salmonella outbreak two weeks ago through a national computer lab system that looks for patterns and matches in reports of food-borne illness. The U.S. Food and Drug Administration has joined the investigation and will try to help trace the outbreak to its origin.

link to full article

salmonella outbreak

Contract manufacturing biz to exceed $26bn

Always good to know who's growing...

30/10/2006 - The global contract manufacturing market is expected to exceed $26bn (€20bn) by 2011, according to new market research.


This growth is due to be driven largely by high potency sterile drugs, protein-derived drugs and specialised production methods, such as chiral chemistry – activities often not included in the core competency of pharmaceutical and biotechnology drug makers, the report said.

Pressured by stricter regulations and escalating costs, large pharmaceutical companies have traditionally opted to outsource their manufacturing process to contract manufacturing organisations (CMOs), only to improve efficiency in cost and productivity, as well as obtaining a specific expertise not available in house.

The research, conducted by Kalorama Information, publishing division of MarketResearch.com, suggests that today, these factors still play a role, but companies are now focusing on strategy and the most dynamic CMO driver is rapidly becoming the innovative processes and production technologies these companies offer.

According to the report, outsourcing manufacturing operations is a strategic imperative that provides not only a cost effective alternative, but also improved efficiency, speed and flexibility, and the market is therefore expected to exceed $17.5bn in 2006, an eight per cent increase from last year.

A fierce presentation...

Check out fierce biotech...a good industry site

Good webinars...I watched a recent presentation called "A Fierce Look at Venture Capital Trends in Biotech"... click here to download mp3 audio...I will try to get a link uploaded for the slides...

A good newsletter...focussed mostly on financial developments, lot's of good industry information...

I have found that Fierce Biotech provides quality information on a very consistent basis...more consistent than this site, but it's not like this is my full-time job or anything...

Check 'em out, I think you'll be pleased...

New biochip helps study living cells, may speed drug development

Some Big Ten Conference competition from Purdue...

WEST LAFAYETTE, Ind. — Purdue University researchers have developed a biochip that measures the electrical activities of cells and is capable of obtaining 60 times more data in just one reading than is possible with current technology.
In the near term, the biochip could speed scientific research, which could accelerate drug development for muscle and nerve disorders like epilepsy and help create more productive crop varieties.

"Instead of doing one experiment per day, as is often the case, this technology is automated and capable of performing hundreds of experiments in one day," said Marshall Porterfield, a professor of agricultural and biological engineering who leads the team developing the chip.

The device works by measuring the concentration of ions — tiny charged particles — as they enter and exit cells. The chip can record these concentrations in up to 16 living cells temporarily sealed within fluid-filled pores in the microchip. With four electrodes per cell, the chip delivers 64 simultaneous, continuous sources of data.

link to full article

The most interesting Engineering Sessions…

It will be interesting to see what sessions attract the most attention…

One that probably needs to be much better attended than it actually will be and is entitled “What makes a Good Client…”
This session is scheduled for Wednesday in the morning session

I think this will present two different views of a very interesting conversation…the panel hosts have indicted that they would like to see a “highly interactive” session…

The most productive discussion will not focus so much on what each wants from the other… for instance, what clients want from their consultants…or what do consultants want from personnel on the operations side.

The more interesting discussion (and probably most productive for all concerned) will be about how to communicate to the other party…what you need, what isn’t happening, what is missing…in such a way that the other party listens, understands, and has a chance to move these issues forward.

Let’s hope for a productive session…

ISPE Annual Meeting

Tests show DHEA supplement no "fountain of youth"

related reading here regarding Living Forever...
from Ray Kurzweil's website

BOSTON (Reuters) - The food supplement DHEA, touted as a "fountain of youth," does nothing to slow the damaging effects of aging despite widespread claims to the contrary, researchers said in a study released on Wednesday.

Extensive federally funded tests only uncovered "minimal and inconsistent" evidence that a daily dose of 75 mg may help strengthen thinning bones.

But even that benefit was far less dramatic than what doctors can accomplish with established medicines, said the study published in The New England Journal of Medicine.

"The conclusion is very clear," chief author Sreekumaran Nair of the Mayo Clinic in Minnesota, said. "There's no reason for older people to continue to take (DHEA)."

link to full article

Merck diabetes drug wins federal OK

Merck back on track?

WASHINGTON - Diabetics gained a new way of controlling their blood sugar levels Tuesday with federal approval of a novel pill for Type 2 diabetes, which affects about 20 million Americans.

The Food and Drug Administration said it approved Januvia, which enhances the body's own ability to lower blood sugar levels, after clinical trials showing the new pill works just as well as older diabetes drugs, but with fewer side effects like weight gain. The drug is made by Merck and Co. Inc.

Merck is expected to charge $4.86 for the once-daily tablet, a price tag that may limit its use. Older diabetes drugs can cost 50 cents a day.

Januvia, also known as sitagliptin phosphate, works with a one-two punch: It increases levels of a hormone that triggers the pancreas to produce more insulin to process blood sugar while simultaneously signaling the liver to quit making glucose. The pill does that by blocking production of an enzyme, called DPP-4, that normally inactivates that hormone.

Januvia is unlike any other oral drug for treating Type 2 diabetes. However, Novartis AG hopes to win FDA approval for a similar drug later this year.

link to full article

Ex-FDA chief to plead guilty

Mr. Crawford forgot what?

WASHINGTON - Former FDA chief Lester Crawford will plead guilty for failing to disclose a financial interest in companies his agency regulated, his lawyer said Monday.

The Justice Department accused the former head of the Food and Drug Administration with falsely reporting that he had sold stock in companies when he continued holding shares in the firms governed by FDA rules.

Crawford "is going to plead guilty to two misdemeanors tomorrow afternoon and he is going to admit his financial disclosures had errors and omissions, mostly with his wife's continued ownership of stocks," said Crawford's lawyer, Barbara Van Gelder.

"At the end of the day, he owned these stocks and he will admit he owned them while he was at the FDA and he will take responsibility for that," said Van Gelder.

Accused of making a false writing and conflict of interest, Crawford was scheduled to appear before a federal magistrate Tuesday afternoon. Each carries a maximum penalty of one year in prison.

The papers say Crawford failed to disclose his income from exercising stock options in Embrex Inc. of Research Triangle Park, N.C., an agriculture biotechnology company. Crawford had been a member of Embrex's board of directors, according to federal filings.

link to full article

Spinach E. coli outbreak linked to cow manure

Maybe this can now be solved?

WASHINGTON (Reuters) - Cattle manure from a ranch in California's Salinas Valley carries E. coli bacteria that match the strain that killed three Americans and sickened 200, U.S. health officials said on Thursday.

Samples taken from three cattle at a ranch precisely match the strain of E. coli 0157:H7 taken from patients and from bags of spinach linked to the outbreak, Dr. Kevin Reilly, deputy director of the Prevention Services Division at the California Department of Health told reporters.

"This is a significant finding and it is the first time that we have linked a ... E. coli 0157:H7 outbreak to a specific ranch in the Salinas Valley," Reilly said.

Reilly said the outbreak had been traced to four farms in San Benito and Monterey counties in central California.

"Not all of them have both livestock and production of fresh spinach or produce right there right next to each other. This particular ranch that we just talked about does have that."

He said cattle were between a mile and half a mile from the spinach fields on the ranch.

link to full article

E. coli outbreak

Top 10 Reasons for Attending

more to come...just like David Letterman...

5 - Learn How to Get the Most From Quality by Design

#6 - Listen to Industry Leaders Speak on Innovation

#7 - Get to Know More About RFID Trends and Solutions

#8 - Get the Latest on the Journal of Pharmaceutical Innovation

#9 - Learn How to Seal Your Career in Gold with the Certified Pharmaceutical Industry Professional (CPIPTM) Credential

#10 - The chance to take part in ISPE's first annual industry-academia colloquium on new approaches to education in the pharmaceutical manufacturing sciences

ISPE Annual Meeting

Researchers develop nanoparticle sensor

SOCORRO, N.M. - New Mexico Tech researchers have developed a sensor that uses the light-emitting properties of some nanoparticles to analyze and identify individual components of single strands of DNA and RNA.

Chemistry assistant professor Peng Zhang said team members hope they can refine the emerging technology and eventually adapt the tiny sensors to detect cancer cells in their early stages and to target and destroy cancerous cells and tissue.

"I am very excited about the potential for this new application, especially since the preliminary phase of this study has shown that we can identify cancer cells," Zhang said. "The next step will be to modify these nanoparticle sensors ... and actually kill cancer cells with them."

link to full article

nanoparticles

$10 million prize aims to inspire gene race

I really enjoyed the X prize space flight competition...hopefullt this one will be just as good...

WASHINGTON (Reuters) - The foundation that inspired a private sector race to space announced a new $10 million prize on Wednesday -- this time to inspire a race to sequence the human genetic map faster and cheaper.

Although scientists have mapped one person's genome -- by both public and private efforts -- it was time-consuming and expensive.

The X-Prize Foundation wants to inspire someone to map 100 different human genomes in just 10 days.

And just to spice things up, it is offering another $1 million if the team can decode the genomes of 100 more people, including some wealthy donors and celebrities such as Microsoft co-founder Paul Allen and Google co-founder Larry Page.

The effort could speed the era of personal genomics -- in which each person's propensity to disease, response to drugs, and other tendencies are individually mapped, said Dr. Francis Collins, director of the National Human Genome Research Institute.

link to full article

x prize foundation

Pack Expo

Upcoming industry event...

Pack Expo 2006

29Oct- 02Nov06
McCormick Place
Chicago, Illinois

Blogging the Annual Meeting- 2006

Get your witty quotes and session reviews ready...

The Annual Meeting will be having a dedicated blog this time around...

I'm really looking forward to this and I hope everybody gets involved with this...it should be a lot of fun...

the link is here...ISPE Blog

This is the official ISPE blog for the Annual Meeting

Anything I do will probably be a little more casual!!!...

ISPE Annual Meeting

Another Global Neighbor who is Virtually Next Door...

G-Town Radio

internet broadcasting from the suburbs of Philly...Germantown, to be specific...

heard a brief interview on WXPN the other day.

enjoy...

Women have mixed success at drug companies

they should try this study for engineering companies...

WASHINGTON (Reuters) - Top women executives do slightly better at U.S.-based healthcare and pharmaceutical companies than in other industries, but 35 percent of big drug companies do not have a single female director, according to a new survey.

The survey by Corporate Women Directors International found that 16 percent of directors at U.S.-based healthcare and pharmaceutical companies are women -- slightly more than the national average for all companies of just under 15 percent.

But nearly 36 percent of Financial Times 500 companies did not have any female directors, including industry giant GlaxoSmithKline, the report found.

"While we see promise among some companies -- particularly those based in the United States -- there is a shocking number of companies with absolutely no female representation at all," said Irene Natividad, co-chair of Corporate Women Directors International.

link to full article

Americans share Nobel Prize in medicine

NEW YORK - Two Americans won the Nobel Prize in medicine Monday for discovering a way to silence specific genes, a revolutionary finding that scientists are scrambling to harness for fighting illnesses as diverse as cancer, heart disease and AIDS.

Andrew Z. Fire, 47, of Stanford University, and Craig C. Mello, 45, of the University of Massachusetts Medical School in Worcester, will share the $1.4 million prize.

They were honored remarkably swiftly for work they published together just eight years ago. It revealed a process called RNA interference, which occurs in plants, animals and humans. It's important for regulating gene activity and helping defend against viruses.

It is "a fundamental mechanism for controlling the flow of genetic information," said the Karolinska Institute in Stockholm, which awarded the prize.

Since the discovery, scientists have already made RNA interference a standard lab tool for studying what genes do. And they're working to use it to develop treatments against a long list of illnesses, including asthma, cystic fibrosis, diabetes, flu, Parkinson's and Huntington's diseases, and age-related macular degeneration, a major cause of blindness.

link to full article

Sanofi breaks ground in cell culture-based vaccine production

28/09/2006 - With the first clinical trial of its cell culture-based seasonal influenza vaccine commencing in the US, Sanofi Pasteur has demonstrated the production scale potential of a cell line in a successful bioreactor run of 20,000L.

link to full article

Takeda Pharmaceutical Co. To Use $8.6 Billion On Drug Development

somebody else to do business with...

TOKYO, Sept 22 (Reuters) - Takeda Pharmaceutical Co., Japan's biggest drug maker, plans to spend more than 1 trillion yen ($8.6 billion) to develop new drugs over five years through 2010/11, the Yomiuri Shimbun daily reported on Friday.

Researchers get $100m to study cancer genetics

Somebody to do some business with...

A New York philanthropy is giving $100 million to the Broad Institute of the Massachusetts Institute of Technology and Harvard and four New York research centers to study the genetics of cancer, part of the push to transform the treatment of the disease by understanding its genetic makeup.

``There is just an extraordinary opportunity in cancer research right now," said Eric Lander, director of the Broad Institute, during a press conference yesterday announcing the award. ``The clinical and biological insights of the last decade and a half have really pointed us to where the problems are."

Executives at The Starr Foundation, established in 1955 by businessman Cornelius Vander Starr, said their only restriction for the money is that the five entities collaborate on projects, because they believe that scientists will find cures faster than if they work only with colleagues at their own institutions.

The other members of the consortium are Cold Spring Harbor Laboratory, Memorial Sloan-Kettering Cancer Center, The Rockefeller University, and Weill Medical College of Cornell University.

link to full article

Wal-Mart Stores offers $4 generic drugs in Florida

TAMPA, Florida (Reuters) - Wal-Mart Stores Inc., the world's largest retailer, said on Thursday it would cut the prices of nearly 300 generic drugs to $4 per prescription starting in the retirement haven of Tampa, Florida.

The move, immediately copied by rival Target Inc., slammed stock prices of drug retailers, with shares of No. 2 U.S. drugstore chain CVS falling 8.4 percent.

Wal-Mart characterized the program as "part of its ongoing commitment to provide affordable health care to America's working families," but critics called it a public relations move by a giant retailer accused of gobbling up mom-and-pop stores, relentlessly pressuring competitors and suppliers with discounted prices and refusing to provide insurance for many employees, forcing them to rely on government health plans.

Still, some consumer advocates said the move might drive down drug prices in general, and shares of generic drugmakers also fell.

link to full article

Roche hikes US Tamiflu production capacity

18/09/2006 - Roche has boosted annual manufacturing capacity for Tamiflu (oseltamivir phosphate) to 80m treatment courses, as demand for the flu drug shows no sign of abating.

The rise means Roche's global production network will be capable of producing 400m courses of Tamiflu annually by the end of 2006, a more than ten-fold increase since 2004.
The Swiss drug firm has predicted sales this year for Tamiflu will reach SFr1.1bn to SFr1.2bn (€7bn-€7.5bn), excluding sales as a treatment for regular influenza.

Amidst fears of a bird flu pandemic, the US Department of Health & Human Services (HHS) has been adamant that the US should be self-reliant in the supply of Tamiflu, so Roche and its external contractors have established all aspects of Tamiflu production in America, from synthesis of the initial starting material through all major steps of manufacturing to finished packs.

link to full article

FDA Statement on Foodborne E. coli O157:H7 Outbreak in Spinach

The U.S. Food and Drug Administration (FDA) will continue to provide the public with regular updates on the E. coli O157:H7 outbreak each day until further notice.

Case Reports
To date, 114 cases of illness due to E. coli infection have been reported to the Centers for Disease Control and Prevention (CDC), including 18 cases of Hemolytic Uremic Syndrome (HUS), 60 hospitalizations, and one death. Illnesses continue to be reported to CDC. This is considered to be an ongoing investigation.

States Affected
There are now 21 confirmed states: California, Connecticut, Idaho, Illinois, Indiana, Kentucky, Maine, Michigan, Minnesota, Nebraska, Nevada, New Mexico, New York, Ohio, Oregon, Pennsylvania, Utah, Virginia, Washington, Wisconsin, and Wyoming.

Consumer Advice
FDA advises consumers not to eat fresh spinach or fresh spinach-containing products until further notice.

link to full statement

related story...

Restaurant chains pull spinach from menus

Biotech Locations and the Job-creating Machine...

I have been noticing lately certain states are working to postion themselves in the life sciences markets...I believe this is because they see the biosciences as a new economic engine for creating jobs, etc...

see some recent posts regarding:

Maryland, California, and Indiana to name a few...

I had thought of getting these all together in a posting with a brief discussion of who, what, and where...

turns out, fiercebiotech.com has already taken a shot at this with an article titled "Top Five Regions Targeting Biotech Companies", enjoy...

other links regarding other locations to be posted shortly...

Gates Foundation gives $68 million to fight tropical diseases

SEATTLE -- The Bill & Melinda Gates Foundation announced Thursday four grants totaling more than $68.2 million to fight three tropical diseases that affect hundreds of millions of people each year in Africa, Asia and Latin America.

The diseases - hookworm, leishmaniasis and trypanosomiasis - are transmitted by parasites and worms. They can cause death or lifelong disfigurement or stunt children's growth and mental development.

No vaccines exist to prevent most of these diseases and the few drugs that are available to combat them are expensive and have serious side effects, foundation officials said.

"Many of the world's most debilitating illnesses are virtually unheard of in the rich world. But they're a fact of life for millions of people in poor countries," said Tachi Yamada, president of the global health program at the Gates Foundation.

The largest of the four grants will give $32 million to the Seattle-based Infectious Disease Research Institute to speed up development of a vaccine for leishmaniasis. This parasitic disease affects more than 12 million people worldwide and kills thousands each year, the World Health Organization said.

link to full article

gates foundation

More Pfizer plants axed as restructuring continues

15/09/2006 - Pfizer’s manufacturing reforms have claimed more casualties in two North American plants as the world’s largest drugmaker battles to realign production capacity with future product mix, new technologies and cost effectiveness.

The two sites in Arnprior, Ontario, and Lee's Summit, Missouri, have been dropped as part of Pfizer's multi-year review of all manufacturing operations that began in 2003 following the acquisition of Pharmacia.
After its merger with Warner Lambert in 2000, Pfizer acquired Pharmacia for $60bn (€47.1bn) in 2003 and has been trying to sort out its manufacturing network ever since.

Over the past three years Pfizer has announced plans to divest or close more than two dozen plants globally, reducing the number of its manufacturing facilities from 93 to 64.

“The company needs to transform its global manufacturing capabilities to match the type of new products emerging from our pipeline and overall product demand,” Pfizer spokeswoman Judy Sandlin Brooks told In-PharmaTechnologist.com.

“So there is an underlying trend, we are implementing a global initiative to adjust our production capacity.”

The Arnprior site manufactures and packages various prescription and over-the-counter products in tablet or capsule form, including Norvasc, Viagra, Reactine and Visine, but Pfizer says it can make these products now cheaper elsewhere and wants sites that can also make inhalable and injectable drugs.

link to full article

Alcohol use helps boost income: study

What? maybe little off topic, but we're all interested in what affects our income...

WASHINGTON (AFP) - People who consume alcohol earn significantly more at their jobs than non-drinkers, according to a US study that highlighted "social capital" gained from drinking.

The study published in the Journal of Labor Research Thursday concluded that drinkers earn 10 to 14 percent more than teetotalers, and that men who drink socially bring home an additional seven percent in pay.

"Social drinking builds social capital," said Edward Stringham, an economics professor at San Jose State University and co-author of the study with fellow researcher Bethany Peters.

"Social drinkers are out networking, building relationships, and adding contacts to their BlackBerries that result in bigger paychecks."

The authors acknowledged their study, funded by the Reason Foundation, a libertarian think tank, contradicted research released in 2000 by the Harvard School of Public Health.

"We created our hypothesis through casual observation and examination of scholarly accounts," the authors said.

"Drinkers typically tend to be more social than abstainers."

The researchers said their empirical survey backed up the theory, and said the most likely explanation is that drinkers have a wider range of social contacts that help provide better job and business opportunities.

link to full article

GSK opens vaccine plant in Hungary

07/09/2006 - GlaxoSmithKline (GSK), a major player in vaccine manufacturing, is set to inaugurate a €100m vaccine production plant on Friday in a Hungarian city 30Km northeast of Budapest.

According to a GSK spokesman, the new site in Godollo will be one of Europe's most advanced biotechnology plants and will manufacture two types of vaccines, though more details were not disclosed.
The company employs around 360 people in Hungary and had turnover of €106.8m in 2005.

GSK earlier said it plans to manufacture DPT, a combination of three vaccines to immunise against diphtheria, pertussis and tetanus, at the Godollo plant.

The drugmaker plans output in the order of 100m units a year to cover its entire world-wide needs.

link to full article

Red Cross Fined $4.2 Million Over Blood Safety

Uh-oh...

WASHINGTON (Reuters) - The U.S. government fined the American Red Cross $4.2 million for failing to ask blood donors proper screening questions and skipping other steps meant to keep the blood supply safe, officials said on Friday.

The fine, the largest ever levied by the Food and Drug Administration for a blood safety violation, follows a multiyear battle between the FDA and the Red Cross, which collects about 45 percent of the blood donated in the United States each year for transfusions.

The agency said it had no evidence that any blood collected by the Red Cross harmed people who got transfusions.


But FDA officials said the failure to follow multiple safeguards increased the risk that patients could receive blood tainted by an infectious disease.

"It is not acceptable that the quality systems failed in this way," Margaret O'K. Glavin, FDA associate commissioner for regulatory affairs, told reporters.

link to full article

Senators Denounce Scientist's Stem Cell Claims

The political football stem cell research takes another bounce...

Confusion Over Harm to Embryos In Study at Issue

By Rick Weiss
Washington Post Staff Writer
Thursday, September 7, 2006; Page A04

Two senators who strongly support human embryonic stem cell research lashed out yesterday at the scientist who recently reported the creation of those cells by a method that does not require the destruction of embryos, saying the scientist and his company have harmed the struggling field by overstating their results.

"It's a big black eye if scientists are making false and inaccurate representations," a combative Sen. Arlen Specter (R-Pa.) said during a hearing of the Senate Appropriations labor, health and human services subcommittee, which he chairs.

Sen. Arlen Specter: "It's a big black eye if scientists are making false and inaccurate representations."

Robert Lanza of Advanced Cell Technology (ACT) in Worcester, Mass., defended his work and the company's statements. "Our paper is 100 percent correct," said the visibly shaken scientist, referring to the highly publicized article that appeared in the Aug. 24 issue of the journal Nature.

link to full article

ISPE Blog at the Annual Meeting

I just got an e-mail today from Marsha Strickhouser who is the Public Relations Manager for ISPE...

The Annual Meeting will be having a dedicated blog this time around...

I'm really looking forward to this and I hope everybody gets involved with this...it should be a lot of fun...

Look for links and posts to be coming soon...

ISPE Annual Meeting
05-08Nov06
Orlando, FL

Maryland mulls 'vaccine manufacturing capital of the world' dream

some states really see the biosciences as an economic engine...It would be interesting to gather all this together into one package...


31/08/2006 - Bruised by Novartis’s snub over a $600m (€466m) vaccine plant, Maryland has commissioned a study on what more the state can do to attract a major cell culture vaccine manufacturing facility there.

Although the study has not yet been released, In-PharmaTechnologist.com has learned that in its findings the report suggests that the city of Baltimore and the state of Maryland will need to work much harder to attract biotech investment given the financial incentives that other states provide.
The state had been in the running with North Carolina and Georgia for Novartis's plant, which will be the first facility in the US to use novel cell culture technology, but Aris Melissaratos, Maryland's secretary of the Department of Business and Economic Development, said that other states were willing to give away free land and so Maryland couldn't compete with that sweetener given this region's high real estate prices.

Nevertheless, the state still has several firms that have committed to building manufacturing plants there, such as MedImmune and Emergent BioSolutions, yet the selection of North Carolina by Novartis stroke a raw nerve among those who have higher aspirations for Maryland.

“Maryland is doing exactly what it can and should be doing to attract more biotech firms and the vaccine feasibility study is a prime example,” Morgan Wallace, of the Economic Alliance of Greater Baltimore, the organisation behind the report, told In-PharmaTechnologist.com.

link to full article from in-pharma tech

'Virtually untreatable' TB found

Now here's the really scary story...


About 1.7 million people die from TB globally each year
A "virtually untreatable" form of TB has emerged, according to the World Health Organization (WHO).
Extreme drug resistant TB (XDR TB) has been seen worldwide, including in the US, Eastern Europe and Africa, although Western Europe has had no cases.

Dr Paul Nunn, from the WHO, said a failure to correctly implement treatment strategies was to blame.

TB experts have convened in Johannesburg, South Africa, to discuss how to address the problem.

TB presently causes about 1.7 million deaths a year worldwide, but researchers are worried about the emergence of strains that are resistant to drugs.

link to full article

Companies help schools produce bio-hires

Some states really do see the biosciences as an economic engine...

Biotech companies think globally about product development and marketing. But for their workforces, they need to hire locally.

What began in 2002 as a partnership between industry, government and local community colleges to retrain displaced Bay Area airline workers following Sept. 11 has turned into an award-winning, widely copied job-training program to build biotechnology's employment pipeline.

Skyline College in San Bruno was one of the first to begin working with Genentech to train workers specifically for entry-level biomanufacturing jobs.

Since its program began in 2002, 160 students have enrolled in the 12-week certificate program. Of 153 who completed it, 135 have taken full-time jobs and 20 are working toward their certificates. The average starting wage for certificate holders is $18.89 an hour.

Students who've completed a certificate program hold support positions like bioprocess technician, which involves preparing media and solutions for bioprocesses and reviewing documentation and calculations. Genentech would not say what percentage of its workforce holds such entry-level, biomanufacturing positions, but said this year it expects to increase its headcount by 15 percent company-wide. The 1,500 new employees will work in all departments at all levels.

Skyline's certificate program was created in close collaboration with Genentech to help the biotech giant meet its growing need for entry-level workers. Monica Poindexter, Genentech's associate director for corporate diversity and college programs, called the program "extremely successful."

Others in the industry have noticed. William Watson, director of the center for Workforce Development at Skyline, said that more than 25 local companies, from Applied Biosystems to Bayer to Chiron (now part of Novartis), now employ Skyline certificate holders.

link to full article

ICH Q8 & Q9- ISPE/ PDA Seminar

I always wondered when PDA was going to get together with ISPE

Challenges of Implementing ICH Q8 & Q9- Practical Applications

December 6-7
Washington DC
USA

Players storing children's stem cells as "repair kit": paper

LONDON (Reuters) - Some leading English soccer players are storing stem cells from their newborn babies as a potential future treatment for their own career-threatening sports injuries, according to a report in the UK Sunday Times newspaper.

Players are freezing the cells taken from the umbilical cord blood of their babies as a possible future cure for cartilage and ligament problems. Stem cells can be used to regenerate damaged organs and tissue because they are the earliest form of cells.

The paper quoted one unnamed Premier League player from a north west club as saying: "We decided to store our new baby's stem cells for possible future therapeutic reasons, both for our children and possibly for myself.

"As a footballer, if you're prone to injury it can mean the end of your career, so having your stem cells - a repair kit if you like - on hand makes sense."

link to full article

'Ethical' stem cell lines created

from our friends at BBC news...

Human embryonic stem cell lines have been generated without embryos being destroyed, according to researchers.
A US team created stem cell lines by removing single cells from embryos, a process that left them intact, they report in the journal Nature.

At present, growing this type of stem cell results in embryo destruction.

The researchers say their findings may remove some of the ethical barriers to this field and provide a way of bypassing current US legislation.

In 1995, the US congress passed an amendment stating that the government would not fund research in which human embryos were destroyed.

And in 2001, President Bush declared federal funding would only be available for research using the 61 human embryonic stem cells lines already in existence, where a "life or death decision had already been made".

This meant that no new lines could be created, whether from existing embryos or cloned embryos.

US stem cell researchers said the funding limits had ensured the US lagged behind in this field of research, limiting new studies to private companies, while pro-lifers hailed the decision.

Scientists believe stem cells may one day help to combat a range of diseases, such as Alzheimer's or Parkinson's disease, or to repair spinal cord injury.

link to full article

Proton Therapy Used More to Treat Cancer

HOUSTON (AP) -- Francis Maloy lay on his back on a narrow, metallic table, waiting for a giant machine to bombard the tumor in his chest with proton beams.

"The last time I heard about protons I was in college taking physics," said Maloy, a 68-year-old retired Army colonel from Stuart, Fla., just before the procedure.

Maloy, who has advanced lung cancer, is one of the first patients being treated at the University of Texas M.D. Anderson Cancer Center's new $125 million Proton Therapy Center.

It is the largest of the nation's four centers that treat cancer by targeting proton beams narrowly on the tumor itself, sparing the healthy tissue that with typical X-ray radiation would be blasted along with the cancer cells.

While newer forms of traditional radiation, with the help of computers, also allow doctors to precisely target a tumor, proton therapy allows higher levels of radiation. For a patient like Maloy, it could be his best hope at this stage of his cancer.

Dr. James Cox, chief of radiation oncology at M.D. Anderson, wasn't always a believer in the technology. But he said studies have shown proton therapy allows a higher level of radiation on the tumor, with less damage to healthy tissue and fewer side effects, such as loss of appetite, diarrhea and headaches. "That was the breakthrough, what changed my mind," he said.

"Anytime you have cancer in any location where it requires a high dose for control and it's close to sensitive normal structures (such as the eye, the skull, the spinal cord) that's an indication for proton therapy," said Cox. It also is useful for treating cancer in children, who are more sensitive than adults to the side effects of radiation.

Doctors at M.D. Anderson are using proton beam treatments mostly on patients whose cancers are so early in development that a cure is possible. But it is also being used on people like Maloy, who have relatively advanced cancers, Cox said.

Proton therapy has been around since the mid-1950s but was done mostly at research facilities, according to the National Association for Proton Therapy. The world's first hospital-based facility opened in 1990 at Loma Linda University Medical Center in California.

link to full article

Scientists hail breakthrough in bird flu drug quest

LONDON, Aug 16 (Reuters) - Scientists said on Wednesday they had made a breakthrough in the race to develop a drug for the H5N1 bird flu virus if it mutates into a form that can jump from human to human.

But they warned that it could take five years or longer to convert their discovery of a potential weak point in the N1 part of the virus into an effective drug.

So far the 238 cases of human infection have been from direct contact with infected birds, and scientists have said there is no evidence the virus is mutating towards making the leap between humans, though this could happen at any time.

Nearly 60 percent of those infected have died, and the best known drugs to tackle H5N1 infection in humans are oseltamivir known as Tamiflu and zanamivir known as Relenza, both originally developed to fight other forms of human 'flu. Now a team of scientists lead by John Skehel of London's National Institute of Medical Research say they have found a cavity in the N1 or neuraminidase part of the H5N1 virus that could be exploited as a potential weak point.

link to full article

Pfizer's Next Problem

Pfizer had a problem???...beyond my chloresterol medication going generic?...

Roche's competitor to Pfizer's much-anticipated "good cholesterol" pill torcetrapib may be more powerful than anyone thought, diluting the potential advantage for Pfizer's most important experimental drug.

Researchers who have seen data on the Roche drug say that it is far more potent when given with food, potentially complicating the gamble Pfizer has made on torcetrapib, which it is spending a record $800 million to develop.

Pfizer, the world's largest drug firm, is desperately in need of new firepower. Its $12 billion cholesterol pill Lipitor, the world's best-selling drug, is under siege from cheap generic copies of rival Zocor and the highly effective branded medicines Crestor and Vytorin. To make matters worse, an appeals court ruling just stripped a year of patent protection from Lipitor, meaning generics of the mega-blockbuster could be available in March 2010.

Torcetrapib is Lipitor's heir apparent. The drug is designed to boost high-density lipoprotein (HDL), nicknamed "good cholesterol" because it appears to actually clear plaque from the arteries and reduce the risk of heart attack.

In clinical studies alongside Lipitor, torcetrapib raised HDL by 60%. If everything goes as planned, a combination pill containing both torcetrapib and Lipitor will hit the market in the first half of 2008, and some analysts forecast 2009 sales of more than $1 billion. In a recent research note, analyst Barbara Ryan of Deutsche Bank called the drug "critical to Pfizer's future cash flows."

link to full article

Experimental RNA-Based Drug Kills Prostate Cancer Cells Effectively and Safely

I keep waiting for the breakthru, sort of like this...

DURHAM, N.C. -- Acting as a genetic Trojan horse, an experimental RNA-based drug -- the first of its kind -- tricks its way into prostate cancer cells and then springs into action to destroy them, while leaving normal cells unharmed.

The drug, developed at Duke University Medical Center, uses one type of genetic material, called targeting RNA, to enter cancer cells, and another type, called silencing RNA, to stop the expression of a protein that keeps the cells alive.

In tests in mice with prostate cancer, the drug shrank the size of their tumors by half, while the tumors in control mice that did not receive the drug continued to grow, said study co-author Bruce Sullenger, Ph.D., director of Duke's Translational Research Institute and chief of the Division of Experimental Surgery.

The mice showed no side effects from the treatment, Sullenger said.

"This study represents the first step in creating an RNA-based drug for cancer," said lead author James McNamara, Ph.D. a postdoctoral fellow in experimental surgery. "It provides a 'proof of principle' that an entirely RNA-based drug can work with minimal side effects, and it shows it is possible to overcome many of the obstacles that have hampered the development of RNA-based drugs."

link to full article

Bill and Melinda- Fund's $500M targets diseases

I haven't seen this info in any US new outlets...

TORONTO -- The battle against three diseases that are a scourge of sub-Saharan Africa and other developing regions -- HIV/AIDS, tuberculosis and malaria -- got a $500-million US boost from the Bill & Melinda Gates Foundation.

The couple will give the cash over five years to the Global Fund to Fight AIDS, Tuberculosis and Malaria.

"The Global Fund is one of the most important health initiatives in the world today," Bill Gates said in a statement announcing the gift ahead of the 16th International AIDS Conference in Toronto that starts Sunday.

Providing antiretroviral drugs to people infected with HIV/AIDS is a major feature of the fund's work.

Gates Foundation

update

link to full article

Vaccine slows hunger hormone, keeps rats slim

There may be hope for me after all...

WASHINGTON (Reuters) - A vaccine that slows down a key hunger hormone kept rats from gaining weight, even when they over ate, U.S. researchers reported on Monday.

The team at The Scripps Research Institute in California cautioned that such a vaccine is a long way from being tested in human volunteers, and that it may not work in people.

But the study shed light on how hunger and weight gain work, they reported in this week's issue of the Proceedings of the National Academy of Sciences.

The vaccine targeted ghrelin, a hormone discovered in 1999 that helps control appetite in animals and people.


"It appears that active vaccination against ghrelin is one avenue that can slow weight gain and fat build-up in the body," said Kim Janda, a chemistry professor who helped direct the study.

link to full article