Monday, February 28, 2005

GMP Design Reviews and FDA Type C Meetings

We will add content based on your comments...Let's go...


Abstract

Outline of Paper

Conclusion

Thursday, February 24, 2005

Ten Drugs to Watch

I thought I saw this previously on the forbes site, or somewhere...

http://biospace.com/news_story.cfm?StoryId=19181120

Friday, February 18, 2005

I am new to Blogging

I look forward to learning.

Scientists Map Important Gene Variation

link from AP News...

http://story.news.yahoo.com/news?tmpl=story&cid=534&ncid=534&e=5&u=/ap/20050218/ap_on_he_me/gene_map

Maybe this will finally drive the biotech revolution we've all been waiting for...

Could change campaign vs. batch thinking...

making drugs for a specific patient...now that's a small batch...

Thursday, February 17, 2005

The One Page Project Status Report

This industry has the one page Project Financial Report...

Some companies' analysis of these documents is so sophisticated that the health of an entire project can be determined by looking at several numbers, with comments like "this number should be .85, not .74..."

The blood, the sweat, the efforts of an entire project team, summed up in a page of numbers...

Great stuff...if you're interested in financial status...

Wouldn't it be cool if the ENTIRE status, of the ENTIRE project, could be contained in a

"One Page Project Status Report"

Only thing I need to is figure out what should go on the page...

Wednesday, February 16, 2005

Tuesday, February 15, 2005

FDA to create new Drug Safety Board

link from yahoo.com

http://story.news.yahoo.com/news?tmpl=story&e=3&u=/ap/20050215/ap_on_go_ca_st_pe/fda_chief

President Announces FDA Commissioner

Acting Commissioner Crawford gets the nod...

link from the White House...

http://www.whitehouse.gov/news/releases/2005/02/20050214-3.html

never posted a link to the White House web site before...

Friday, February 11, 2005

Thanks Jim Duffy

Thanks Jim for starting this blog. We have had many discussions in the past about advancing ideas for networking, building relationships and our careers. Check out www.cgmps.com - my wife now owns it and she is driving this site. Lets get some of our past ideas rolling and turned into action - I firmly believe there is information overload in the biopharm industry and that a small group of individuals, possibly the ones using this blog, will and should lead efforts in the industry to establish clear and concise methods for establishing better work processes - some of which are outlined on www.compliancebasis.com.

First off, I would like to assemble a group of people (no more than 5) for publishing a white paper on the GMP Design Reviews and Type C Meetings with the FDA and GMP Guarantees from A/E firms. Is anyone interested?

Thursday, February 10, 2005

Electronic System For Prescriptions Sought

Interesting bedfellows work on improving healthcare...

http://biospace.com/news_story.cfm?StoryId=18980420

India: New Biotechnology Policy To Boost Research

Link from Biospace.com...

http://biospace.com/news_story.cfm?StoryId=18980720

Pfizer Inc. Job Cuts Speculation...

Link from Biospace.com

http://biospace.com/news_story.cfm?StoryId=18981120

Engineering Measurement

Engineers love to measure things..."the complexities of specifics"...

We measure physical things like process equipment to fit them into a building...
We measure abstract things like loads in order to size systems to accommodate those loads...
We measure individual capacities to determine overall system throughput...

We also measure our progress during the design projects...

Most engineering systems are based on the earned value system using the engineering man-hour as the basic unit of measurement. Success is defined as the gaining exactly 1 hour of progress for each man-hour burned.

Welcome to the world of Project Controls...

Seems easy enough...earned versus burned...

and we know, that when the project controls measurement says we are 100.00% complete...
we can declare victory...
our work here is done...
not any sooner, and certainly not any later...

The project was obviously a success...it's time for the celebration!!!

What???!!!...

You had other concerns???...other issues???...

But we're finished!!!...Didn't you see the Status Report?


I think this leads directly to a whole 'nother topic...


Do engineers measure the right things?

Wednesday, February 09, 2005

the Next Big Thing???...

been hearing a lot about pre-built modules as an execution strategy lately...

a.k.a... "Superskids"...sounds cool, doesn't it?...

I think this may be one of those hot-button topics that is perceived to be "added-value"

you know, the kind that gets you on the short list, even if you don't belong there...
or gets you past the Procurement Department screening...
or even better, one you win the project with...

even if the rationale for using this strategy is questionable...

even if you don't actually execute the project this way...

Tuesday, February 08, 2005

Monday, February 07, 2005

Why rats don't have beer bellies...

Biospace.com article

http://biospace.com/news_story.cfm?StoryId=18946220

Post Superbowl Monday...

Ouch!!!

guess we'll chalk that one up in the "gaining experience" column...

Andy Reid and Donovan go through their growing pains on national tv...

bet that's one of the reasons for the delta between their salaries and the rest of us...

Thursday, February 03, 2005

Gregoire seeks $350 million biotech fund

An article from Biospace.com orginally published in the Seattle Times...

Big tobacco money gets rolled into Biomedical Research...

Wednesday, February 02, 2005

E-Procurement Training

I just went through some preliminary training for a web based procurement system at a major pharmaceutical company here in Philly. These new bidding procedures are intended to be used for all types of procurement activities; commodity purchase, equipment purchase, subcontracted construction work, and professional services.

Part of the training session was a mock bid for an equipment purchase as a “reverse auction” bid.

The session was very interesting…but the impression I was most left with was how much cost pressure this new approach will put on all aspects of our industry…

Although the stated aim of the company using this new technology is not just cost reduction, it is obviously having a significant impact on the bottom line…

Good for them…sound like good business practice to me…

But when I hear about reverse auctions for professional services it begins to hit home a bit more…

Big Pharma spends less…Consultants get less revenue…pretty simple…


We may be left with the Quick and the Dead…

the Quick being the companies that are able (and willing) to adapt to the new realities of our business world…