Thursday, November 30, 2006

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

Wednesday, November 29, 2006

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…

Tuesday, November 28, 2006

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

Monday, November 27, 2006

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

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

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

Saturday, November 25, 2006

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…

Monday, November 20, 2006

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

Sunday, November 19, 2006

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 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

Thursday, November 16, 2006

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…

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

Wednesday, November 15, 2006

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

Tuesday, November 14, 2006

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

Thursday, November 09, 2006

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...

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

Wednesday, November 08, 2006

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

Sunday, November 05, 2006

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...

Thursday, November 02, 2006

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...