TCW: January 2007

KansasBio Inks Deal with PRL Central Laboratory Services

Jan 29, 2007 12:05:01 PM

Overland Park, Kan,-based PRL Central Laboratory Services has signed an agreement with Kansas Bioscience Organization (KansasBio). The agreement will allow all KansasBio members to receive pricing deals for various laboratory testing and employee health screening services.

The deal also helps make Kansas an attractive place for young life-science companies. Part of KansasBio’s purpose is to foster pharmaceutical and biotech industry growth in the region.

Permalink | View comments (0) | View blog posts linking to this entry (0)

Medidata Solutions Launches Rave 5.6

Jan 29, 2007 9:58:00 AM

Posted by: Stephen DeSantis

Medidata Solutions has launched its newest version of its EDC technology platform Rave 5.6. The new version incorporates clinical trial management (CTM) functionality into its existing EDC product solution, allowing for one integrated clinical data management system.

The enhanced platform can maintain a global library of previously conducted studies to increase the speed of new study design. It can store images or documents as part of a case report form and can generate data clarification forms for sponsors using its double data entry capabilities.

The CTM functionality allows study designs to be edited and stored offline, and communicated internally within a sponsor. The new version also adds additional multilingual capabilities and a new module for local laboratory referencing.

Stephen DeSantis, Senior Associate Editor, Thomson CenterWatch.

Permalink | View comments (0) | View blog posts linking to this entry (0)

Bert Spilker's Pharma Principles of The Week

Jan 26, 2007 10:22:00 AM

Posted by: Bert Spilker

> To win the hearts and minds of regulators one must first establish the medical need for a new product, i.e., the public health message, and then establish the medical value of your product in terms of how well it addresses the medical need.

> It is legitimate to ask how much it costs to develop a drug when all failures and other costs are included. It is also legitimate to ask how much it costs to develop a single drug excluding other costs.

> Seek a balance between having too many projects where they slow each other and too few where a company risks its ability to survive on a few projects that may or may not succeed and achieve the company’s goals.

Bert Spilker, PhD, MD is an independent consultant who was most recently the Senior Vice President of Scientific and Regulatory Affairs for PhRMA. He is the founder of Bert Spilker & Associates (BS&A).

Permalink | View comments (0) | View blog posts linking to this entry (0)

Pfizer Under The Gun

Jan 23, 2007 11:46:36 AM

Posted by: Steve Zisson

Well,Pfizer made its big news official yesterday. The company plans to cut 10,000 jobs—about 10% of the company—by the end of 2008 and close some facilities, including three research sites in the United States. The job cuts and site closings are expected to save $2 billion a year.

To me, what is important is the company’s research plans. The three research sites set to close are all in Michigan, but don’t include a large manufacturing facility in the state and Animal Health. The company is also looking at shutting down research sites in Nagoya, Japan and Amboise, France.

Continue reading... »

Permalink | View comments (0) | View blog posts linking to this entry (0)

Bert Spilker's Pharma Principles of The Week

Jan 19, 2007 9:57:00 AM

Posted by: Bert Spilker

> Managing research scientists cannot be too heavy handed with the same control mechanisms in place that one uses for development of products. Medical product development and marketing activities can be more tightly planned and controlled than that of discovery.

> Good, fast, cheap. Choose any two. You can rarely ever have all three.
- If you want it good and fast, it won’t be cheap.
- If you want it good and cheap, it won’t be fast.
- If you want it fast and cheap, it won’t be good.

> Good data in a few patients are a far better basis to make a decision on, than mediocre data in many patients. This principle is often ignored by those who collect a great deal of uncontrolled data rather than collecting less data from a well-controlled trial.

Bert Spilker, PhD, MD is an independent consultant who was most recently the Senior Vice President of Scientific and Regulatory Affairs for PhRMA. He is the founder of Bert Spilker & Associates (BS&A).

Permalink | View comments (0) | View blog posts linking to this entry (0)

Covance Rings Closing Bell at NYSE

Jan 12, 2007 4:51:38 PM

Posted by: Stephen DeSantis

Chairman and chief executive officer Joe Herring of the Princeton, New Jersey-based CRO Covance ran the closing bell at the New York Stock Exchange (NYSE) on Thursday. The event was to honor Covance's tenth year as a publicly traded company. On the company 1st day of opening trading in 1997, Covance's stock was worth $19.25 per share. Ten years later, the stock is worth more than $60 per share; closing Friday at $63.36.

The company has annual revenues of more than $1.3 billion, operates in 18 countries and employs over 7,000 employees. The company was born in 1997 after being spun off, along with the global laboratory services giant Quest Diagnostics, from Corning Inc.

A video of the event can be seen on the NYSE opening bell schedule website. Or watch it here.

Stephen DeSantis, Senior Associate Editor, Thomson CenterWatch.

Permalink | View comments (0) | View blog posts linking to this entry (0)

Bert Spilker's Pharma Principles of The Week

Jan 12, 2007 3:08:28 PM

Posted by: Bert Spilker

> Exercise great caution in hiring academic or government employees into the industry as leaders, as you may have to spend years of “on the job training” to have them reach the state that many industrial managers are at today. Many academic and government managers or scientists never adapt adequately in industry, and a company takes a great risk when it hires these people.

> Are the company’s managers mainly living in the past, present or future? How many are in the present and keeping an eye on the future while planning how to get there? Where are you living?

> Professional talks and presentations are not like mystery novels where you build to a glorious climax and conclusion. Share the conclusions up front with your audience. Tell them what you will tell them, then tell them, and then tell them what you told them.

Bert Spilker, PhD, MD is an independent consultant who was most recently the Senior Vice President of Scientific and Regulatory Affairs for PhRMA. He is the founder of Bert Spilker & Associates (BS&A).

Permalink | View comments (0) | View blog posts linking to this entry (0)

CenterWatch Monthly: January 2007 Issue

Jan 12, 2007 1:57:00 PM

Phase I Market Consolidates

After a year of consolidation, facility building, and some controversy in the phase I market, expect additional acquisition deals in 2007 and growth to hold up in the low double digits. Industry experts estimate that the percentage of phase I work outsourced to CROs has increased to at least half of the phase I market. Several phase I units have been bought by large CROs as they increase their offerings and add global service.

2006 in Review: Industry Adapts and Adopts

CenterWatch reviews a year in which significant strides were made in the clinical trials industry even as it got past some hurdles of negative press concerning patient safety issues. 2006 may be looked back on as the year when the clinical research industry really took several big leap forwards with technology adoption including electronic data capture (EDC), electronic health records (EHR), electronic patient diaries and new approaches such as adaptive clinical trials that together will change the industry for a long time.

Romania and Bulgaria Join EU

This month marks the accession of Romania and Bulgaria to the European Union (EU), which gives both countries all the rights and obligations deriving from EU membership, including the implementation of the EU Clinical Trials Directive.

Eye On: Pain

The treatment of pain is a major healthcare and research priority. There are about 85 million people in the U.S. suffering from chronic pain conditions, and about 193 million new cases of acute pain annually. Despite recent advances in understanding pain physiology, currently available classes of analgesics have not changed significantly over the past few decades, and problems of limited efficacy, adverse effects and abuse potential remain.

Permalink | View comments (0) | View blog posts linking to this entry (0)

Quintiles Invests in Biotech

Jan 12, 2007 12:23:00 PM

Posted by: Stephen DeSantis

Quintiles Transnational’s strategic partnering unit, NovaQuest, funded a total of $342 million in 16 investments into emerging biotech companies. Quintiles will also provide marketing expertise, strategic development and possibly product development and commercialization. The unit of NovaQuest charged with funding emerging biotech companies is called eBio.

C.G. 'Chip' Gillooly, NovaQuest’s global vice president of eBio. said there were three things that are currently driving the booming biotech sector today:

"First, biotech’s continued progress in developing promising new medicines.

Second, private capital markets continue to value these companies more favorably than the global public equities markets, thereby altering investor exit strategies.

Third, the value NovaQuest brings – the experience and intellectual capital necessary to advance experimental programs, non-dilutive financing, alternatives to premature out-licensing and access to Quintiles’ global development and commercialization resources."

Read the full press release here.

Permalink | View comments (0) | View blog posts linking to this entry (0)

Going To The Dogs

Jan 11, 2007 5:37:00 AM

Posted by: Steve Zisson

In a week when the feds cracked down on some of those quick-loss diet companies with hefty fines for making false claims about their untested pills, it seemed just a bit odd that the FDA approved the first diet drug for dogs.

I can’t blame Pfizer Animal Health for going after this huge and growing market with Slentrol. There are about 62 million pet dogs in this country and more than 20 million are considered overweight or obese. I’d bet the very same owners of those 20 million dogs fit into those overweight and obese categories. Might be a good opportunity for Pfizer to cross-sell to the owners.

In a country where dog owners treat their animals as if they were their “babies”, it’s no surprise that their dogs are out-of-control eaters because most owners don’t train or control their dogs at all. Just watch an episode or two of the dog training show “Dog Whisperer” and see host Cesar Millan time and time again have to give owners basic dog training. His show should be mandatory for all new dog buyers...

Continue reading... »

Permalink | View comments (2) | View blog posts linking to this entry (0)

Bert Spilker's Pharma Principles of The Week

Jan 5, 2007 10:08:00 AM

Posted by: Bert Spilker

> Harmonizing regulations at ICH (International Conference on Harmonization) prospectively before any exist is a lot easier than retrospectively, where three different sets of regulations have to be harmonized into a single whole.

> When dealing with regulatory agencies and the public it is always best to try not to bury issues or problems, but to be transparent with them and discuss how you intend to deal with them.

> We have GCPs, GLPs, GMPs and others. Why do we not have GRRPs (Good Regulatory Review Practices) for how the regulators have to do their jobs in reviewing your applications?

Bert Spilker, PhD, MD is an independent consultant who was most recently the Senior Vice President of Scientific and Regulatory Affairs for PhRMA. He is the founder of Bert Spilker & Associates (BS&A).

Permalink | View comments (0) | View blog posts linking to this entry (0)

Enter Romania And Bulgaria

Jan 4, 2007 5:06:00 AM

Posted by: Sara Gambrill

The European Union (EU) will have two new member states next month: Romania and Bulgaria. Both countries are ready to implement the EU Clinical Trials Directive, but their membership may have broader implications for clinical research than just harmonized regulations.

Fast patient recruitment - one of the biggest drug development bottlenecks in the West - has been Eastern Europe’s trump card. Clinical trials that take only weeks to recruit patients for in Eastern Europe can take months or even a year in Western Europe.

The major difference between Western and Eastern Europe is the structure of their respective healthcare systems. Eastern European countries have very large hospitals, each dedicated to one therapeutic area where all patients with that disease go to seek treatment. These countries also only have one national healthcare system in which all patients are identified...

Continue reading... »

Permalink | View comments (1) | View blog posts linking to this entry (0)

Recent Articles

Categories

Healthcare Industry Blogs

Indispensable Sites

RECENT HEADLINES

Top Stories for the Week of Jan. 29th 2007

KansasBio Inks Deal with PRL Central Laboratory Services

Medidata Solutions Launches Rave 5.6

Bert Spilker's Pharma Principles of The Week

Top Stories for the Week of Jan. 22nd 2007

Pfizer Under The Gun

Bert Spilker's Pharma Principles of The Week

Top Stories for the Week of Jan. 15th 2007

Covance Rings Closing Bell at NYSE

Bert Spilker's Pharma Principles of The Week

CenterWatch Monthly: January 2007 Issue

Quintiles Invests in Biotech

Going To The Dogs

Top Stories for the Week of Jan. 8th 2007

Bert Spilker's Pharma Principles of The Week

Enter Romania And Bulgaria

Top Stories for the Week of Jan. 1st. 2007