Patrick Donnelly Resigns From PRA

Posted by: Stephen DeSantis

PRA International announced the resignation of the company’s president and chief executive officer, Patrick Donnelly. He will work as a consultant for 18 months and will receive $2,000 for each day as a consultant. PRA went public, acquired 10 companies and increased its global operations during the past 13 years under Donnelly as CEO.

The company will pay the former executive a severance of $1 million. PRA has hired a global executive recruitment firm to find a permanent replacement for Donnelly. Terrance Bieker was put in place as interim chief executive officer and was appointed to the board of directors. Bieker has served as CEO of BioSource International, Axia Medical and Transfusion Technologies.

“After 13 rewarding years with PRA I have made the decision to leave the company to embrace new challenges and opportunities,” said Donnelly. “It is now time for PRA to be led by a CEO with a more scientific and therapeutic focus.”

Stephen DeSantis, Senior Associate Editor, Thomson CenterWatch.

Hitting For Power

There’s been so much written about Pfizer’s failure to get torcetrapib through clinical trials and big pharma’s outdated blockbuster mentality that it’s easy to overlook that pharma is finally making some progress in reducing the huge cost of drug development. And that sometimes going for the home run makes sense.

When Pfizer started studying this drug candidate about 10 years ago, the kinds of efficiencies available to drug sponsors did not exist. By doing more in early clinical trials—which cost far less than big phase III trials—drug companies will be able to decide much sooner if a drug has a chance to succeed. In the future, we should see far fewer of these late-stage blow-ups...

Bert Spilker's Pharma Principles of The Week

Posted by: Bert Spilker

> Data analysis and interpretation of the data are two separate processes, even if they are conducted 30 milliseconds apart by a single person.  Data analysis, however, is usually conducted by a statistician and data interpretation by a scientist or clinician.

> The regulatory cascade consists of laws leading to regulations, which lead to guidelines, which lead to points to consider, which lead to formal recommendations, which lead to informed comments and finally to gossip.

> Without pharmaceutical and biotech research, mankind has little hope of major advances in treating disease, but public support for clinical research is a mile wide and an inch thick.

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).

Radical Thinking On Oncology Funding

Posted by: Sara Gambrill

A deputy director from the National Cancer Institute (NCI) has proposed a radical overhaul of the way NCI allocates oncology clinical trial funding. His proposal would eliminate disparities in oncology clinical trial participation and health outcomes resulting from differences related to race, ethnicity and income. Dr. Jon Kerner, who works in the Division of Cancer Control and Population Sciences, shared his ideas at a recent roundtable held at Baylor College of Medicine.

Typically, only 3% to 5% of cancer patients participate in oncology clinical trials, a low percentage that slows down the drug development process. Most discussions about eliminating disparities in clinical trials focus on increasing the number of cancer patients among racial and ethnic minorities, but not on the overall percentage of cancer patients participating. So, more racial and ethnic minorities could participate, but the rate of cancer patient participation would still remain abysmally low.

Kerner has asserted that what’s actually needed to increase minority participation, overall participation and advance science is inclusion of 100% of all the patients who have the cancers that meet his three criteria: scientific opportunity, distinct disparity in terms of who gets them and/or who dies from them and high fatality rates...

Top Stories for the Week of Dec. 11th, 2006

Top News
      
Bridgetech Opens New Clinical Research Site in Hong Kong

Bridgetech Holdings International, along with The Chinese University of Hong Kong (CUHK), has opened a new oncology-focused clinical trial site in Hong Kong.


eStudySite Raises $6 Million to Expand with Additional Centers

San Diego, Calif.-based clinical trial management company eStudySite raised $6 million in its first round of institutional financing.

      
Other breaking news...

• etrials launches large wireless project...
• Prologue wins Bradmer contract...

Company Profile: An interview with Cecilia Huisman, director and research manager, Penthecilia.

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

India Needs More IRBs

Posted by: Lisa Marie Castro

Pfizer announced on December 5th that it was pulling the plug on torcetrapib, an investigational drug that raises “good” cholesterol and reduces plaque buildup in blood vessels that can cause heart attacks.

Pfizer had made an investment of nearly $1 billion on the development of torcetrapib. The investigational drug was three years into phase III clinical trials and had enrolled 15,000 patients. When more torcetrapib-related deaths than acceptable were identified by a Data Safety Monitoring Board after it had reviewed trial results, the 100 hospitals and medical clinics in three continents where the study was being conducted were notified to halt the study.

As India becomes increasingly preferred as a destination for the outsourcing of clinical trials, issues of informed consent and safety will become more significant. It is estimated that there are over 80 hospitals (government and privately owned) actively engaged in global and local clinical trials. Those numbers are expected to double or even triple each year by 2010, with 14,000 hospitals in the country...

CenterWatch Monthly: December 2006 Issue

Increasing Minority Participation in Clinical Trials

Ensuring that clinical trial participation reflects the racial and ethnic makeup of the U.S. population and the epidemiology of the particular diseases being studied is becoming more of a priority for industry, government and academia. The barriers—while not insuperable—are numerous. Over-coming them will take a multi-pronged approach. One four-year research program undertaken last year by the Chronic Disease Prevention and Control Research Center at Baylor College of Medicine and the Intercultural Cancer Council and funded by Genentech is attempting to tackle the issue of increasing participation by underrepresented populations, including racial and ethnic minorities.

CROs Taking Tentative Steps Toward Reform

CROs have a big opportunity to help lead any changes in the drug development process in the wake of two high profile patient safety issues involving CROs in the past year. Despite the run of bad publicity, CROs seemed to have weathered the storm with strong revenues gains and share prices. But the CRO industry isn’t about to become complacent as it takes steps to carve out a leadership role in any reform efforts.

Mandatory GCP Certification in The Netherlands?

Nearly two years past the deadline, The Netherlands passed the EU Clinical Trial Directive into national law in March. Some are wasting no time in attempting to make certification in Good Clinical Practice (GCP) mandatory for clinical researchers who want to conduct a study in The Netherlands. It is a trend that could well gain traction throughout the EU.

Eye On: Skin Conditions

The skin is the largest and most exposed organ of the body, and, not surprisingly, it is prone to a variety of diseases. Hand dermatitis, or hand eczema, popularized in television commercials as “dishpan hands,” is one of the most common work-related diseases, affecting 5% to 10% of the population. It is characterized by hand rash, redness, dryness, cracking and inflammation.

Bert Spilker's Pharma Principles of The Week

Posted by: Bert Spilker

> Business decisions for advancing or terminating an investigational drug in development or a compound in discovery are best made using “minimally acceptable standards.”  These are primarily established by marketing groups, with input from R&D.

> Do your best to eliminate fads and hype in management styles and be skeptical of all claims by vendors.

> Truly great scientists do not generally make great managers. Creative scientists must be encouraged, stimulated and rewarded so they are happy to remain creative scientists.

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).

Datatrak Forms Enterprise Relationship With GP-Pharm

Posted by: Stephen DeSantis

Cleveland, Ohio-based eClinical company Datatrak has formed an enterprise relationship with GP-Pharm, a Barcelona,Spain-based pharmaceutical company focusing on the development of hormonal and cytotoxic drugs. GP-Pharm is a part of the Lipotec Group, a Spanish-owned biochemical manufacturer and supplier of pharmaceutical, cosmetic and food ingredients. Initially, the contract calls for the company to use Datatrak’s EDC Version 4.0 product for a block of five clinical trials enrolling 730 patients and 145 sites. The trials are expected to be conducted in the next 14 months.

“The ordering of blocks of clinical trials under an enterprise business model structure represents another example of the stepwise progression of this market away from the inefficiencies and higher costs of the trial-by-trial behavior that had previously been the only means of contracting for electronic clinical trials,” said Jeffrey Green, president and chief executive officer at Datatrak.

Stephen DeSantis, Senior Associate Editor, Thomson CenterWatch.

Top Stories for the Week of Dec. 4th, 2006

Top News

AstraZeneca to Use Medidata's eClinical Solutions for All Clinical Trials

The New York, N.Y.-based eClinical company Medidata Solutions has been awarded a major contract from AstraZeneca to provide the company with its Medidata Rave electronic data capture (EDC), replacing AstraZeneca's present in-house system.

Covance Opens New Phase I Facility in Hawaii

Expanding to meet a growing demand to conduct special trials in specific ethnic patient populations, New Jersey-based contract research organization Covance has opened a new clinical research facility in Honolulu.

Other breaking news...

• Datatrak in enterprise relationship with GP-Pharm...
• ACM-Pivotal lab granted accreditation...

   
Company Profile: An interview with Federico Arturo Silva Sieger, Fundacin Cardiovascular de Colombia (FCV)

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

AstraZeneca to Use Medidata’s eClinical Solutions for All Clinical Trials

Posted by: Stephen DeSantis

The New York, N.Y.-based eClinical company Medidata Solutions has been awarded a major contract from AstraZeneca to provide the company with its Medidata Rave electronic data capture (EDC), replacing AstraZeneca’s present in-house system.

AstraZeneca initially will incorporate Medi-data’s platform on 50 to 55 phase II through IV global studies; however, its ultimate goal is to use Rave on all studies within the next several years.

“I think we are seeing a trend, where companies who had internal systems, like AstraZeneca, are making decisions to go with a product that is off the shelf. The other side of the equation for a company such as AstraZeneca, is what is the overhead of trying to maintain an internally developed product,” Ed Ikeguchi, co-founder and chief medical officer at Medidata told CWWeekly. You can read CenterWatch complete in depth coverage of the deal in the December 4th issue of CWWeekly.

You can read the company press release here.

Stephen DeSantis, Senior Associate Editor, Thomson CenterWatch.

Bert Spilker's Pharma Principles of The Week

Posted by: Bert Spilker

> Steps to shorten drug development lie primarily under the company’s control and the FDA’s role is much more modest in terms of further gains in shortening review times.

> There are three types of discovery or development standards to use as guides to judge data and results: ideal standards that describe the perfect product, realistic or desirable standards that describe what a company wants to have in a new product, and minimally acceptable standards which describe the least acceptable standards for a product that the company is willing to market.

> In theory, new drugs do not have to beat previous drugs in their degree of safety or efficacy, but regulators sometimes forget this and have to be reminded.  If one of the two is not equaled, the other must be far superior to existing therapy.

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).