AstraZeneca Bets More Chips On China

Posted by: Sara Gambrill
 
AstraZeneca is investing $100 million more in China over the next three years to build the AstraZeneca Innovation Centre China, an R&D facility to study the benefits of new drugs to Chinese patients. Already one of the most heavily invested in China among big pharma companies, AstraZeneca is further distinguishing itself as the leader there with this new commitment.

The Innovation Centre, expected to open by the end of 2009, will focus on translational science by building knowledge of Chinese patients, biomarkers and genetics. Initially, research there will target cancer, a major cause of death in China. AstraZeneca’s lung cancer drug, Iressa, has proved more effective in Asian patients than it has in Caucasians, and China is becoming an important market for sales...

ICON Steers Toward Integrated Oncology Service Model

Posted by: Stephen DeSantis

During DIA 2006, CenterWatch got the inside scoop on ICON's new The Oncology Solution service model during an interview with imaging CRO Beacon Bioscience’s David LaPoint, Vice President of Business Development. Beacon Biosciences was acquired by ICON Clinical in July 2004. According to LaPoint, the solution will allow ICON to bring together their full range of clinical service offerings, including imaging, central laboratory, IVRS and CRF data services.

Here are a few excerpts from that interview:

CW: Can you tell us about your Oncology Solutions offering?

It is really looking at trying to change the conversations with clients about their oncology studies. So instead of going in and talking about traditional clinical CRO services such as the number of sites, CRF pages, etc we are changing the dynamic of the conversation to talk about what their trial endpoints are. What we are trying to do with the Oncology Solution is to begin talking about the outcomes of their studies and bring that conversation in early, then fill in the traditional clinical CRO pieces behind that.

CenterWatch’s 42nd Annual DIA Round Up

Posted by: CW Editorial

This year’s Drug Information Association (DIA) 42nd annual industry conference, held in Philadelphia, Penn attracted nearly 10,000 attendees from across every sector in the drug development industry. Presenting at the show were over 400 U.S. and close to 200 international companies, from both developed markets and emerging regions around the globe. Nearly 1,000 delegates from 50 countries were scheduled to attend.

While attending last week’s conference, CenterWatch gathered an abundance of exciting news, conference highlights and emerging trends from across the industry. Here is a quick summary of just a few of the many notable events during the show:

• Further acknowledging the growth in the phase I trial sector, PRA International announced the acquisition of Dutch, Pharma Bio-Research, a 300-employee, early-phase clinical development company based in Zuidlaren. During an interview at DIA Pat Donnelly, chief executive officer of PRA, said that the new acquisition was "very aggressive in replicating what they currently have in the Netherlands not only in Europe but also in the United States, and five years from now, or even less than that, hopefully in Asia and Latin America." When asked about how the PRA and PBR relationship arose Donnelly commented: "We were looking first and foremost in Europe and I've been having conversations with PBR for three years now. We've always liked that business and been trying to figure out how long the courtship needed to be."

• Emerging markets remains one of the hottest topics in the clinical trials industry with nearly a dozen sessions specifically centered on conducting clinical trials in counties like China, India and Latin America. Among the many countries covered, India was a topic of high interest. During a unique session entitled “How to Assure Quality When Clinical Trials Are Conducted in Developing Countries” industry professionals and government officials from India discussed issues regarding best practices for clinical trial conduct in India. The session was chaired by James Utterback, MS, CEO of Scirex Corporation and included speakers from Wyeth (Robert Maguire, MD Vice President of Clinical R&D), Clinigene (Head of Clinical Operations) and India’s Drugs Controller General Ashwini Kumar, MPHARM.

• Post-approval outcome studies are certainly on the rise since the increased emphasis on safety over the year and a half. Apparently recognizing this high growth area, ICON Clinical announced the acquisition of Ovation Research Group, an Illinois-based patient registries, outcomes research and health economics firm. The company conducts prospective pharmacoeconomic and quality-of-life analysis, statistical analysis, disease and product registries and health outcomes research.

• In a similar step towards the collection of post-approval outcomes data, recently gone public etrials announced a partnership with Relsys International, an adverse event reporting software provider based in Irving-Calif. The partnership will allow etrails to integrate Relsys’ Argus Safety Web into their own eClinical suites. "Being able to identify and report critical patient safety data is more important than ever," said etrials chief executive officer John Cline.

• During the show, the Ft. Lauderdale, Florida-based EDC company, OmniComm Systems, announced the launch of version 4.0 for their eClinical software suite called TrialMaster. The new version was not just the standard update to prior releases, but incorporates some major enhancements. The software suite now includes better data and trial management functionality, and promises to provide increased flexibility in working within clients’ own systems.

• And finally, eClinical software provider Datalabs’ big ‘booth give away’ could arguably be the most impressive of the event. A free 2-year lease on a Toyota Prius hybrid. The winner was Michael K. Olchaskey of Forest Research Institute, a division of Forest Labs.

Time To Embrace Paperless Clinical Trials

Posted by: Steve Zisson

When it comes to efficient drug development, pharmaceutical companies have a lot to learn. Recent research we conducted at Thomson CenterWatch suggests, however, that they might just be getting t he message, at least when it comes to clinical trials In a recent survey, we polled users of electronic data capture (EDC) software – the folks on the front line of research who conduct their clinical trials using this software – for their views on the factors most likely to prevent future drug development delays.

Their top answer: EDC software. When we c onducted the same survey in 2003, EDC software came in fourth.That’s not to say that the industry has embraced the technology yet – only about 10% of clinical trials are currently done electronically. But the results of our survey certainly show a readiness to embrace an electronic trials process, unsurprising given the immense pressures on pharma companies from the courts, regulators, investors and the public at large. Paper trials, it seems, must end.Two recent quarterly reports from small EDC companies support the idea that biopharma is getting serious about efficient drug development...

Who Owns the Rights to Human Tissue?

Posted by: Sara Gambrill

A recent Boston Globe article reported on a National Institute of Health (NIH) senior scientist selling human tissue to drug giant Pfizer, for Alzheimer’s disease research. The news was released by the House Energy and Commerce Committee, along with details of a nearly $300,000 collaboration involving the NIH’s National Institute for Mental Health and Pfizer, spanning several years. The government spent $6.4 million to obtain 3,500 samples that went to Pfizer to study how Alzheimer's disease progressed in 538 patients. An interesting point of contention related to tissue samples that this article doesn't address is whether subjects have property rights to their tissues or products developed from their tissues. As the editor of Thomson CenterWatch's book Protecting Study Volunteers in Clinical Research, I know it would be valuable to share a passage about this issue here...

Challenges in Communication

Post by: Stephen DeSantis

Recently, the well known industry chemist and blogger Derek Lowe, PhD discussed an important issue plaguing the drug development industry; a general lack of public knowledge with regard to how drugs are brought to market. Given the need for direct patient involvement in clinical trials, the issue is especially of great concern for our industry. The challenges and complexities of drug development are not easy tasks to relay to the layperson, but a greater attempt to bring public clarity to this process, would only benefit our shared goals: finding new therapies to treat disease...

Check out his post here.

NPR Interviews David DeMets on Drug Safety Monitoring Boards

Posted by: Stephen DeSantis

In the wake of Vioxx and the recent events during the German biotech TeGenero AG’s trial, involving a severe immune reaction in six British subjects given an investigative monoclonal antibody, the industry has made a major effort to review trial safety precautions. Among other areas under scrutiny, the work of independent review boards (IRBs) has received much attention. Recently, the roles and challenges of Data Safety Monitoring Boards (DSMBs) have also been discussed in preventing further safety issues during clinical trials AND after market approval...

MDS Pharma Services Top CRO in CenterWatch's 2006 European Site Survey

Posted by: CW Editorial

The Thomson CenterWatch 2006 European Investigative Site Survey marks the fifth time CenterWatch has surveyed investigative sites—those front-line researchers conducting clinical trials in Europe. MDS Pharma earned the top score for contract research organizations, improving from third place in the 2004 survey.

The factors rated most important by sites concerning CRO performance include being organized and prepared for a study, knowledge level of CRAs/monitors, quality of protocol design, timeliness of availability of the study drug, and simplicity of the case report form—critical aspects of study success.

-The complete article appears in CenterWatch Monthly's June 2006 issue and was written by Sara Gambrill, Senior Editor and Paul Dewberry, Research Analyst at Thomson Centerwatch.

-To read this article, or any other CenterWatch stories, visit our publications area.

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