Charles River Laboratories Acquires U.S. Phase I Unit

Posted by: Stephen DeSantis

Wilmington, Mass.-based Charles River Laboratories has stepped up its clinical research presence with the purchase of Northwest Kinetics, a 150-bed unit early phase clinical pharmacology unit in Tacoma, Wash. The deal is worth $29.5 million and may signal that Charles River has interest in expanding its clinical development business, after selling off much of that to Kendle last year. Watch for the in depth story in an upcoming issue of our CW Weekly newsletter.

Read the press release here.

Top Stories for the Week of October 30th, 2006

Top News

Synexus Clinical Research Buys South African SMO

Manchester, England-based Synexus Clinical Research has bought South Africa-based site management organization (SMO), Clinical Research Centers SA (CRC) for at least $1.52 million in cash and shares, and up to $3.4 million, depending on performance targets.

ClinPhone Acquires EDC Company DataLabs

Nottingham, U.K.-based ClinPhone, a clinical technology company, acquired DataLabs, an electronic data capture (EDC) vendor in a deal that could be worth nearly $69 million if DataLabs meets performance targets.

Other breaking news...

Phase Forward reports increased third quarter revenues...
AAIPharma completes CAC acquisition...

Company Profile: An interview with Howard Schwartz, medical director, Miami Research Associates; Ella Grach, executive medical director, Wake Research Associates; and Chris Hoyle, director of business development, Elite Research Network.

To read the full articles for this issue or for more information on these and other breaking stories, please click here!

Phase Forward reports 26% increase in third quarter revenue

Posted by: Stephen DeSantis

Waltham, Mass.-based Phase Forward reported a 26% increase in third quarter 2006 revenues compared with the same period in 2005. The company reported third quarter revenues of $28 million, up from $22.2 million last year. For the fourth quarter of 2006, the company reported it expects revenues to be between $29.2 and $30.0 million. Income from operations was $4 million, showing a margin of 14.2% and an increase of 66% from the prior year period. The company reported expected revenues for the entire 2006 fiscal year to be between $105.6 and $106.4 million. On non-GAAP basis, the company expects EPS between $0.37 and $0.38.

Thomson Scientific Reports on ACT's - 13th Annual European Summit

Posted by Claire Veryard, Thomson Scientific Ltd, London, UK

The Applied Clinical Trials – 13th Annual European Summit, Amsterdam, the Netherlands meeting held October 17th - 19th was attended by approximately 200 delegates from pharmaceutical companies, device manufacturers, CROs, data capture providers, logistics services and consultancy firms.

Topics covered at the meeting included regulatory and safety issues, trial design and management, electronic data capture, outsourcing, and offshoring. This summary of the report will highlights from of this year's event...

You can view the full event report here: Download act_2006_euro_summit_meeting_report.pdf

Bert Spilker's Pharma Principles of The Week

Posted by: Bert Spilker

> The perception of medical value of most new products goes through a series of stages from unrealistic optimism to unrealistic pessimism and eventually to a balanced view.

> Time is generally viewed in drug development as the single most precious resource you have to spend.

> There is a spectrum for discovering drugs that ranges from purely rational to that of pure chance or serendipity.

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).

Top Stories for the Week of October 23rd, 2006

Phase I Doesn’t Faze Them

Posted by: Steve Zisson

It was interesting to see Waltham, Mass.-based Parexel, a global contract research organization (CRO), remaining unfazed in the hot phase I clinical research market. Earlier this month, Parexel agreed to acquire California Clinical Trials and Behavioral and Medical Research for $65 million. A key part of the deal is a 51-bed phase I unit that would boost Parexel’s presence in the phase I market.

Parexel could have become gun shy about phase I last March, when it took some heat after a phase I trial it was conducting for biotech company TeGenero in a London hospital resulted in six cases of serious illness. TeGenero has since gone bankrupt...

Underwriting Investigator Training in China

Posted by: Sara Gambrill
 
Eli Lilly and Novartis have made substantial investments in investigator training in China recently. Both companies are planning to make a big play there. Novartis has already said that it’s opening an R&D center in Shanghai this year. Lilly has not made its plans public.

With a population of 1.3 billion and a centralized healthcare system with access to millions of treatment-naïve patients per day, China has certainly attracted the interest of top 20 pharmaceutical companies. AstraZeneca has by far the largest presence in China. The country’s pharmaceutical market has been growing at a double-digit clip, dwarfing the growth seen in Western markets.

To further their goals, Lilly and Novartis have each donated tens of thousands of euros to the Vienna School of Clinical Research (VSCR) to fund the organization of investigator courses. VSCR seeks funding from industry and government to fulfill its mission of raising the level of professionalism in clinical research in Central and Eastern Europe and developing countries...

Top Stories for the Week of October 16, 2006

Smaller EMR Companies Could Push Integration

Posted by: Stephen DeSantis

The use of electronic medical records (EMR) technology to enhance the conduct and efficiency of clinical trials has been highly touted of late. The ability to utilize hospital medical records in patient recruitment is seen as a promising solution to costly subject recruitment delays. Companies operating in the EMR space are looking for ways to integrate their systems to work togther with established eClinical infrasture. Aside from a few of the global IT giants such as Siemen AG and Oracle Clinical, GE Healthcare and McKesson, some of the smaller players in EMR may be the ones to watch out for. Being smart, quick and nimble has a big advantage in the IT idustry.

CenterWatch Monthly: October 2006 Issue

NIH Pushes Academic Collaboration vs. Competition

Posted by: Stephen DeSantis

The National Institutes of Health (NIH) has begun the development of a unique translational research consortium composed of some of the most well renowned top academic health centers (AHC) in the U.S. This is somewhat unique in a research community that has become extremely competitive for NIH grant money.

The 12 initial research centers to be networked into the group received NIH awards totaling around $100 million to fund the project through its first year. The NIH hopes to create a network of 60 AHCs by 2012 receiving a total of $500 million per year.

Top Stories for the Week of October 9, 2006

In India, A Pairing Born Of Necessity

Posted by: Sara Gambrill

India’s clinical research market entered a new era in January 2005 with the signing of the Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement. TRIPS requires the country to honor all product patents issued after 1995.

A paper published by the U.S.-based National Bureau estimates that in the antibiotic sector alone, TRIPS will result in a $713 million loss to the Indian economy; $50 million of this amount represents foregone profits of domestic drug companies. To avoid these losses, Indian pharmaceutical companies are looking for new revenue streams. Increasingly, large domestic—formerly generic—pharmaceutical companies are focusing on new drug development.

A partnership deal made last week reflects the changes going on in India’s domestic pharmaceutical market. A contract research organization (CRO) called ClinTec International, based in the UK with operations in 27 countries in Europe, South Africa, the Middle East and India, has formed a co-development partnership with Hyderabad, India-based Dr. Reddy’s Laboratories. The risk-sharing agreement involves co-development of DRF 1042, a topoisomerase inhibitor that has shown potential as an anti-cancer treatment.

Painless Growth?

Posted by: Steve Zisson
 
Big Pharma continues to expand into the vaccine market as Pfizer purchased privately owned PowderMed this week, hoping for an ouch-free entry into this segment. The vaccine market is suddenly looking golden to Big Pharma when just a few years ago it seemed that most drugmakers wouldn’t go near vaccines.

Now with government encouragement and the promise of fairly predictable growth, Big Pharma is into vaccines in a big way. With U.K.-based PowerMed, Pfizer is getting a company developing needle-free, DNA-based vaccines.

The Psychology of Clinical Trials: Understanding Physician Motivation and Patient Perception

The clinical trials industry has been at the center of public scrutiny following recent news reports of unethical patient recruitment and manipulated trial results.  Are these well-publicized stories causing doctors and patients to shy away from experimental treatment?  What are the key factors that drive physicians to refer patients into clinical trials and what are patients’ biggest concerns?

To gain a better understanding of the psychology of the clinical trials patient and referring physician, Thomson CenterWatch conducted a series of in-depth doctor and patient surveys.  The results and related observations, which were presented this June at the Drug Information Association Annual Meeting, are outlined in this Thomson CenterWatch Research Brief...

Top Stories for the Week of Oct. 3rd 2006