Wednesday, November 30, 2005

Blogging the Annual Meeting- Day 4

Wednesday…last day here…can’t afford any more time away from the office…

Up…pack up, check out, etc, etc, etc… back to the resort for a last look around and some souvenir shopping…have to bring some good ones back since I’ve been gone for 4 days…

not very many people around… still lot’s of people coming out of the sessions at break time, but it seems that if you’re not there for a specific session, you went home…

Lunch in the resort, last stroll around, and off to the airport…

USAir and America west are merging and I’m stuck flying the day the computers won’t decide which airline is running the flight!!!

Whatever…back to Philly late, I had to be the last person out of the parking garage that night…have to be up early for work the next day, time zone change, traveling, now I know why they’re called “red-eyes”…

Blogging the Annual Meeting- Day 3

Tuesday…seminar day!!!

Bought the one day “a la carte” session pass…picked Tuesday for the Biotechnology session in the morning and the C and Q session in the afternoon…it would have been nice to be able to attend the full day in each, but that was the luck of the draw based on the schedule.

The Biotech session started the day off with a schedule adjustment to accommodate some of the speakers’ requirements…Tony Lubineicki gave a nice presentation on the progress made in the previous 25 years in the biotech industry…good background for some of us who weren’t there in the glory days of the industry. Another presentation was made to review possibilities for the next 25 years…maybe we will begin to realize the true power of the human genome…missed part of this for phone calls from the office…oh yeah, people back at the office are still working on the project!!!, should turned my phone off, not just on silent… the first part of the morning session finished up with a case study for a flash-track project presented jointly by a client and the consulting engineer...the remainder of the day seemed to be given over to discussion regarding development and production of generic biotech products, so I decided to give the rest of the session a miss.

So…over to the C and Q session which was continuing a good presentation of the new guideline document…some of the authors were available to present the overall intent and scheme…

Lunch was the ISPE working business meeting, but enjoyable nonetheless, given the number of speeches and sundry discussions regarding budget approvals, etc, etc, etc…out of that giant sea of people wandering in to the lunch hall, I still managed to run into someone I knew…

Spent the rest of the afternoon in the C and Q session…

Dinner that night was the big gala celebration…had to wear a jacket to dinner…lot’s of speechifying, good dinner, good entertainer…back to the hotel…

The presentations, or some of them anyway are available on the ISPE website…I’ll be reviewing the sessions in more detail as I get the time…look for more to come!!!

Live From The Lab, A Culture Worth A Thousand Words

They can do what???!!!...

Scientists have created living photographs made of bacteria, genetically engineering the microbes so that a thin sheet of them growing in a dish can capture and display an image. Bacteria are not about to replace conventional photography because it takes at least two hours to produce a single image. But the feat shows the potential of an emerging field called synthetic biology, which involves designing living cellular machines much as electrical engineers might design a circuit. "We're actually applying principles from engineering into designing cells," said Christopher A. Voigt, assistant professor of pharmaceutical chemistry at the University of California, San Francisco, and a leader of the photography project, which is described in a paper being published today in the journal Nature.

Monday, November 28, 2005

Blogging the Annual Meeting- Day 2

Monday!!!

up early, my body clock is still set on east coast time, breakfast at my dinky hotel...missed the delegates breakfast at the resort, oh well, my loss...

At the booth early, with a long day of "meet and greet" ahead...at least they serve coffee first thing...

nice to see people, surprising how many faces you know, walked around, looking at all the tabletop exhibits, good turnout...

lunch on the outside patio, delicious southwest style, good salsa, more spicy than I normally find...

back to the booth, waves of people hit the floor when the sessions come out, while the sessions are in sessions you get the impression that there aren't very many people in attendance...then suddenly it's packed...

Anyway, it seems about the same people mix, like there's 17 consultants circling the one client rep like sharks in bloody water...great fun!!!

At one point, about group of about seven of us found ourselves standing around a table chatting...not one of us was working where we used too last time we all saw each other, and not just on the consulting side either, client side too...so it was good to catch up with people...where are you now?

dinner on the back patio/ lawn...shook hands with the new ISPE director, seems like a nice guy...had to wear a jacket, but lots of entertaining southwest-type things to do, eat, band, rope a cow, etc, etc...some safety concerns were evident...like people doing the hatchet throw event after some number of drinks...but hey, nobody bounced anything off my head...

cut out after a while, though, another long day...

Merck Announces Initial Steps In Global Restructuring Program

Merck digs in...

WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Nov. 28, 2005--Merck & Co., Inc. (NYSE:MRK)

-- Initial Phase of Cost Reduction Program Expected to Yield Cumulative Pretax Savings of $3.5 Billion to $4.0 Billion in 2006-2010

-- Costs Associated with Restructuring Program Expected to be Substantially Complete by 2008

-- Elimination of 7,000 Positions Expected by End of 2008

-- Five of 31 Manufacturing Facilities Expected to be Closed or Sold

-- Full-Year 2005 EPS Expected to be $2.47 to $2.51 Excluding Charges, with Reported 2005 EPS of $2.04 to $2.10

-- Full-Year 2006 EPS Expected to be $2.28 to $2.36 Including Approximately $0.07 Impact from Stock Option Expensing but Excluding Restructuring Charges, with Reported 2006 EPS of $1.98 to $2.12


Merck & Co., Inc. (NYSE:MRK) today announced the first phase of a global restructuring program designed to reduce the Company's cost structure, increase efficiency, and enhance competitiveness. The initial steps will include the implementation of a new supply strategy by the Merck Manufacturing Division (MMD), which is intended to create a leaner, more cost-effective and customer-focused manufacturing model over the next three years.

"The actions we are announcing today are an important first step in positioning Merck to meet the challenges the Company faces now and in the future," said Richard T. Clark, chief executive officer and president of Merck & Co., Inc. "We are engaged in an ongoing effort to enhance efficiencies throughout the Company and improve the way we discover, develop, manufacture and market our medicines and vaccines and ensure that we get them to patients who need them as quickly, safely and efficiently as possible. Going forward, we also plan to pursue improved approaches to R&D, and marketing and sales. We look forward to discussing our initial plans at our Annual Business Briefing on December 15."

link to full article

Wednesday, November 23, 2005

Thanksgiving tips: Hold the bacteria

Enjoy your holiday!!!

WASHINGTON (AP) -- When Thanksgiving arrives next week, people should be groaning from full stomachs, not food poisoning.

More than 200,000 Americans get sick each day from what they eat, and turkey dinner with all the trimmings complicates it all. The government is offering some tips to keep holiday cooking from becoming an intestinal curse.

At the top of the list is washing your hands often, followed by keeping raw food separate from cooked food, using a food thermometer and storing leftovers in small portions in the fridge.

"It's a little bit more dangerous, obviously, when you have large gatherings and food laid out like this," said Richard Raymond, the nation's top food safety official. "We tend to feast and nibble and snack all afternoon."

During a food-safety demonstration at a food bank, the Agriculture Department's undersecretary for food safety walked along a table laden with raw and cooked turkey, stuffing, green bean casserole and pumpkin pie.

link to cnn.com for full article

Monday, November 21, 2005

Blogging the Annual Meeting- Day 1

Sunday- travel day!!! up at dawn, off to the airport...

crowded for a Sunday morning, where are all these people going? apparently, Phoenix...

typical travel hassles, long flight, driving in a strange city, getting lost...which way is east anyway?...found my hotel...eventually...some dinky little efficiency...everybody else got rooms at the main resort...oh well, off to find that...

arriving at the resort, it's so big I can't find the front door, oops, I mean main entrance, lobby, fountain/ reception area, etc, etc, etc...beautiful...

wander around a bit, check in with ISPE, no big lines...no problem...

off to the exhibit hall...it's booth central...trying to find my colleagues...

here we are, all set up and ready to go...It's "meet and greet" time... standing up for the rest of the afternoon, introducing myself to people I don't know...seems obvious, but it's a bit of a stretch for me, and others, I suspect...

dinner was out on the pool patio, hosted by DPR...very nice...

walked around the grounds, beautifully lit at night...fountains, pools, palm court...really very nice...

back to my dinky hotel room for some sleep, the time difference and the day's travels were catching up with me...

Life Sciences Short Of Workers, Threatened By Rivals

and I thought this was just on the engineering side of things

The life sciences industry in Northern California has grown from a collection of fledgling firms with potential into one that has commercialized hundreds of drugs and medical devices, but the region's regard as a world leader in the field is under threat, industry advocates warned Nov. 14. The warning came as BayBio, the region's life sciences trade and advocacy group, released a lengthy report that largely painted a positive picture of the state of the industry in Northern California. Life sciences firms in Northern California now have 240 products on the market to treat diseases such as cancer, and about 200 product candidates are in later stages of clinical trials. At least a third of all publicly traded domestic biotechnology firms are in Northern California, representing more than $150 billion in market value, and they are plowing nearly $4 billion annually into research, according to the report. The industry in Northern California employs some 85,000 workers. Hiring is proceeding at a rapid clip to fill nearly 8,000 more jobs that the sector is expected to generate by the end of 2006. Employment growth is expected to grow by 10 percent to 20 percent annually over the next several years, according to the report. But industry experts and advocates at the same time cautioned that the cost of living here, government bureaucracy, tax codes and an inability to supply enough trained workers to meet demand could hamper the region's ability to deliver new treatments and could cause some firms to leave the area. BayBio is taking the report on the road to Sacramento and Washington, D.C., and it hopes its message will resonate with lawmakers.

link from biospace.com

Saturday, November 19, 2005

Continuous Education

Great idea, this continuous education thing...

I see that ISPE is now pushing for an industry certification for "pharmaceutical Professional"...we certainly are an industry driven by "expertise"...

now all we have to do is make the time for it...on the consulting side, a week out of the office for the annual meeting means a week trying to get back in the loop and playing catch-up...the rest of the world kept going while I was out trying to continue my education

no one is sitting around waiting for you to become an expert...and I doubt anyone is scheduleling your training sessions...

that's up to us...

Thursday, November 17, 2005

Glaxo targets India for cancer drug research

I guess you can outsource anything...

LONDON (Reuters) - GlaxoSmithKline Plc plans to make India a major center for testing experimental cancer drugs, in a move highlighting the appeal of the country as a low-cost base for research.

Europe's biggest drug maker said on Thursday it had signed a collaboration with the University of Oxford's clinical pharmacology department to establish the first Indian cancer-trials network.

Glaxo, which has big ambitions in cancer, will outline its goals for tackling the disease at a research seminar for investors on November 30.

Its most important experimental cancer drug is lapatinib, a dual-action treatment which is being developed initially for breast cancer. It also has a promising vaccine to prevent cervical cancer, called Cervarix.

Glaxo said the new collaboration would enable the evaluation of new treatments in a range of cancer types, including gall bladder, liver and cervical cancers, which are more prevalent in India than in Europe or North America.

link to full articles from Reuters.com

Wednesday, November 09, 2005

Blogging the ISPE Annual Meeting...

Well, I had grand plans of blogging about the ISPE Annual Meeting and reviewing each day's activities...I had done a series of blogs for last year's Interphex meeting in NY...and had the same sort of thing in mind.

It turns out that the days have been so busy, along with extending into the nights, that this is the first time I have had a couple of minutes to sit down and gather my thoughts...

First things first, work is still going on in the office on East coast time...even if you get up early, they still have a 2 hour head start!!! like it's not hard enough to keep up when you're out of the office for three days...

I'll get back to it, maybe on the flight back...look for more to come...

Day 1

Day 2

Day 3

Day 4

Thursday, November 03, 2005

Demand growing for pre-fillable syringes

technology marches forward...

02/11/2005 - The Parenteral Drug Association (PDA) recently held a conference in Munich to fuel the further development of the growing pre-fillable syringe market.

The conference, spearheaded by Gerresheimer's PharmaSystems subsidiary, Blunder Glas, was designed to update pharmacists on the latest technology and development priorities for pre-fillable syringes, including the highly topical aspect of drug delivery.

The injectable drug market is growing strongly at present, driven by the rising number of biologic drugs coming though the biopharma industry's pipelines.

As patients live longer and are diagnosed with chronic and often debilitating ailments, the result will be a dramatic increase in self-administration of injectable drug therapies.

This trend is creating an increased interest in routes of administration that are user-friendly and cost-effective.

The availability of an increasing number of drugs in pre-filled disposable cartridges and syringes are fueling the growth of these administrative new devices, at the expense of traditional injectable drug delivery devices.

link to full article from in-pharma tech

Wednesday, November 02, 2005

Scientists offer new hope for rapid production of bird flu vaccine

More new technology progress...we'll wait and see if it is viable...
maybe the emerging crisis will really push new manufacturing techniques forward.

WASHINGTON (AFP) - A new genetic technique developed by US and Japanese scientists could help drugs firms produce a vaccine for the deadly strain of bird flu more quickly, researchers said in a specialized magazine.

The improved "reverse genetics" technique makes the disarmed viruses that are the seed stock for producing large quantities of flu vaccine, said the study's co-author, Yoshihiro Kawaoka of the University of Wisconsin.

It could assist in the rapid manufacture of a vaccine for the virulent H5N1 strain of avian flu, which has killed more than 60 people in Asia since late 2003.

link to full article

Tuesday, November 01, 2005

Bush Outlines $7.1B Flu-Fighting Strategy

lots of political statements, etc, etc, etc...

look at the last 2 paragraphs regarding domestic production and new cell culture production technology...

WASHINGTON - President Bush outlined a $7.1 billion strategy Tuesday to prepare for the danger of a pandemic influenza outbreak, saying he wanted to stockpile enough vaccine to protect 20 million Americans against the current strain of bird flu as a first wave of protection.

The president also said the United States must approve liability protection for the makers of lifesaving vaccines. He said the number of American vaccine manufacturers has plummeted because the industry has been hit with a flood of lawsuits.

Bush said no one knows when or where a deadly strain of flu will strike but "at some point we are likely to face another pandemic."

...portion deleted...

The government already has ordered $162.5 million worth of vaccine to be made and stockpiled against the Asian bird flu, more than half to be made in a U.S. factory.

But the administration plan, to be released in more detail on Wednesday, calls for more than stockpiling shots. It will stress a new method of manufacturing flu vaccines — growing the virus to make them in easy-to-handle cell cultures instead of today's cumbersome process that uses millions of chicken eggs — as well as incentives for new U.S.-based vaccine factories to open.

link to full article