The FDA On Madison Avenue

Posted by: Steve Zisson

The Food and Drug Administration (FDA) has a deal in place that for the first time would allow pharma companies to pay fees for the FDA to review their drug advertisements. It is all being done in the hope of faster reviews. It’s not such a bad idea.

But I’ve got another idea to take it a step further that would help speed up review of drug advertising. Put together a citizen panel to check these ads before they go on air. We’ve all seen television ads for numerous new drugs, particularly the lifestyle drugs, that are simply laughable. The FDA can’t legislate good taste, I suppose, but maybe it should.

And many don’t believe some claims being made in a number of these advertisements. You’ know what I’m talking about - you’re in the middle of watching a football game, one of these ads comes on and everyone starts cracking jokes about it. One look at a proposed ad by a citizen panel would get an immediate reaction and give the FDA the feedback they really need. FDA staffers may not to able to really see an ad from the point of view of the public since they are dealing with the industry every day. The view from inside from a federal agency can get insular.

Pharmaceutical companies are expected to pay up to a $50,000 fee to the FDA for each TV ad campaign review. Throw a little more in the pot to set up a citizen panel, and the FDA and Madison Avenue may get better results.

Steve Zisson, managing editor of Thomson CenterWatch.

Top Stories for the Week of November 27th, 2006

Top News

Pharm-Olam Continues International Expansion with New Office in South Africa

Houston, Texas-based contract research organization Pharm-Olam International has opened a new office in Pretoria, South Africa.

Three Canadian Firms Set Up Research Consortium in Newfoundland and Labrador

Newfoundland-based medical research center NewLab Clinical Research has joined two Ottawa-based companies TrialStat, an eClinical firm, and BioTheraGene, a contract research organization, in establishing a consortium to conduct trials in Newfoundland and Labrador.

Other breaking news.....  

• Advinus Therapeutics signs partnership with Merck...
• etrials reports 40% growth in services revenue...   

Company Profile: An interview with Kenneth Borow, president and CEO, Encorium Group.

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

eClinical Market Has Strong Year

Posted by: Stephen DeSantis

In its third quarter, Morrisville, N.C.-based eClinical service provider etrials reported 40% growth in services revenue to $4.4 million.Net revenues during the same period in 2005 were $3.2 million. The company reported operating income of $178,331 compared with an operating loss of $148,618 in 2005 during the same period. etrials went public in 2005 in a reverse merger.

Major players in the eClinical market have seen high revenue growth in 2006, primarily due to an increase in EDC adoption and a less fragmented industry. Medidata Solutions reported the company’s 22nd quarter of consecutive growth. Medidata had a 189% increase in year-over-year revenue in the second quarter of 2006, and a 171% increase in year-over-year revenue for the first half.

United Kingdom-based ClinPhone released interim financial results for its six months ending Aug. 31. ClinPhone reported its revenue increased 32% to £20.7 million ($39.5 million) compared with £15.6 ($29.7 million) during the same period of 2005.One notable exception was eResearch Technology, which reported lower than expected earnings in its third quarter. The company’s share price dropped 22% to $6.04 on Nov. 9.

Stephen DeSantis, Senior Associate Editor, Thomson CenterWatch.

FDA Proposes New Regulations for Expanded Access to Investigative Drugs

The U.S. Food and Drug Administration (FDA) has submitted two regulatory proposals that would expand the rules concerning who has access to investigative treatments. The new proposals would provide a clearer pathway for certain critically ill patients so they can be considered for access to investigative drugs without enrolling in a clinical trial.Both proposals have been submitted to the Office of Management and Budget (OMB), where they will be reviewed for approval.

If the FDA’s two proposals clear the OMB review process, they would be released for public comment before taking effect.

Top Stories for the Week of November 20th, 2006

Top News

FDA Proposes New Regulations for Expanded Access to Investigative Drugs

The U.S. Food and Drug Administration (FDA) has submitted two regulatory proposals that would expand the rules concerning who has access to investigative treatments. The new proposals would provide a clearer pathway for certain critically ill patients so they can be considered for access to investigative drugs without enrolling in a clinical trial.

AtlantiCare Medical Center Joins Fox Chase Cancer Center Network

Atlantic City, N.J.-based AtlantiCare Regional Medical Center (ARMC) has joined the Fox Chase Cancer Center Partners network of community hospitals, giving AtlantiCare access to National Cancer Institute approved trials and also gain access to investigator initiated studies as well.

Other breaking news...      

•     Aptuit acquires SSCI...
•     DSG establishes data management division...   

Company Profile: An interview with Lydie Hazan, president and chief executive officer, IMPACT Clinical

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

Novartis Makes Big Play in China

Posted by: Sara Gambrill

Following in AstraZeneca’s footsteps, Novartis is investing $100 million in an R&D center in China. It’s a move I had alluded to in an earlier piece in this forum. Expect other big pharma companies to follow.

Those who look at a move like this as merely a cost-cutting measure are missing one of the more obvious reasons a drug company would go to China—it’s the largest potential market on the planet. China’s pharmaceuticals market grew 28.4% between 2003 and 2004 and is projected to grow another 18% this year, IMS Health estimates. In addition, the government has declared that biotechnology/life sciences make up one of China’s pillar industries.

Now is the perfect time to set up operations in China. The country adopted Good Clinical Practice in 1998 and became a member of the World Trade Organization in 2001, prompting it to tighten its intellectual property rights protection, which is still a concern. Most significantly, in 2003 China formed the State Food and Drug Administration (SFDA), a full cabinet-level agency, modeled after the U.S. Food and Drug Administration. That is when big pharma started taking a serious look at China for R&D.

Don’t Be Outfoxed By Dems' Win

Posted by: Steve Zisson

The Democrats’ decisive victory in Tuesday’s mid-term election put them in control of the House, but it is widely seen as bad news for the pharmaceutical industry. Dire predictions of drug price controls have many in big pharma concerned. Pharma should be worried—especially if it sticks to the old game plan.

But the Democrats’ moves against the drug industry are not likely to be as drastic as warnings suggest. So long out of power, the Democrats don’t want to revert to their old ways and to be seen as the anti-business party. They have a chance to take the middle road where they can be perceived as both pro-business and pro-consumer...

Top Stories for the Week of November 13th, 2006

Top News

UBC Buys Biostatistical and Medical Writing Firm BioCor

Maryland-based clinical trial design, and data management and consulting company United BioSource Corporation (UBC) has acquired BioCor LLC, a biostatistical, data services and medical writing firm based in Yardley, Pa. One of BioCor's specialties is designing trial protocols with advanced biostatistical methods for emerging biotech companies. It will be the first business unit in what is to become UBC's Biotechnology Solutions Group.

UK Aims to Speed up Trials with One-Stop NHS Review Process

Hospitals within the UK's National Healthcare System (NHS) can now benefit from a revision of the country's Model Clinical Trial Agreement rules, which include the trial site review process. Under the new system, only one review would be necessary for industry-sponsored trials taking place within the NHS network, where previously each site required individual clearance. The study must get approval from the Medicines and Healthcare products Regulatory Agency (MHRA) before the review process can begin.

Other breaking news...

• Qualia in strategic alliance with Tandem Labs...
• eResearch Technology reports lower than expected third quarter earnings...

    

Company Profile: An interview with Jordi Naval, managing director, Infociencia.

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

Bert Spilker's Pharma Principles of The Week

Posted by: Bert Spilker

> The state-of-the-art is often too advanced for the appropriate development level and approach to use.  This is often seen in the ability to measure blood levels at a far more precise level than can be used clinically to make decisions.

> When words like “compliance” or “risk” are being used does everyone know which definition you are using? These and many others have innumerable different definitions for people who approach discovery, development and marketing from many perspectives.

> Using higher medical and scientific standards than required often trumps the competition, as they will be trying to take some shortcuts, and the FDA and others will be likely to raise the bar for approval when they see the standards you are using.

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).

Can EU Regulators Keep Up with Innovation?

Posted by: Sara Gambrill

The now infamous TeGenero clinical trial - six patients fell critically ill from an investigational biologic — occurred, ironically, after the EU Clinical Trials Directive had been implemented in the UK in May 2004. Biotechs in the Netherlands, it seems, were adjusting to the adoption of the EU Clinical Trials Directive into national law on March 1, 2006 when the TeGenero incident occurred (March 13). Before that, healthy volunteer trials in the UK had been unregulated.

At the recent Applied Clinical Trials European Summit in Amsterdam, one speaker talked about the long shadow the TeGenero trial will cast not only on the Netherlands but on the entire European Union. Even though the Medicines and Healthcare Products Regulatory Agency’s (MHRA) final report from May identified some Good Clinical Practice discrepancies, the main cause of the severe reactions in the six trial volunteers was an “unexpected biological effect.”...

CROs Stand to Benefit from Dramatic Rises in Pharma R&D Spending

Posted by: Faiz Kermani 

A problem for the major pharma companies is that investors have become accustomed to double-digit growth performance and thus there is constant pressure on them to develop an ever-greater number of new products with high sales potential. However, the rising costs and risks of drug development combined with the lengthy drug development timescales and increasing competition have made it difficult for companies to keep pace with such expectations. Clinical trials are a particularly costly and time-consuming part of the R&D process, frequently accounting for over 40% of total R&D spending (1).

Recent figures show that pharma companies are increasing their R&D investment in their quest to improve productivity. Figures from Pharmbiosys reveal that this rise in spending is particularly evident among the top ten pharma companies - who dominate the industry’s R&D efforts. According to the analyses, by the end of 2006, the top ten companies will be investing a massive $54 billion, representing close to 60% of total industry R&D spend (1). By 2008, their investment could rise to $65 billion, representing over 80% of total industry R&D spend (1).

Top Stories for the Week of November 6th, 2006

Top News

Charles River Laboratories Acquires Phase I Company, Northwest Kinetics

Wilmington, Mass.-based Charles River Laboratories, a major player in the animal model supply and preclinical research market, has purchased Northwest Kinetics, a 150-bed early phase clinical pharmacology unit in Tacoma, Wash. The deal is worth $29.5 million.

Quintiles Establishes Central Lab in India

Raleigh, N.C.-based contract research organization (CRO) Quintiles is opening its first solely owned central laboratory facility in Mumbai, India.

Other breaking news...

    * Bilcare buys DHP Limited...
    * AAIPharma raises $30 million in new financing...

Company Profile: An interview with Malcom Sperling, medical director/principal investigator, Edinger Medical Group and Research Center.

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

Bert Spilker's Pharma Principles of The Week

Posted by: Bert Spilker

> Sunset clauses for all discovery projects are a useful means to insure the company reviews progress on the project to confirm it should be continued. These may occur every two years or at other pre-assigned times.

> The army has a motto that there is never enough time to do it right, but there’s always enough time to do it over.  A company’s motto must be: We must do it right the first time.

> The state-of-the-art is often too advanced for the appropriate development level and approach to use.  This is often seen in the ability to measure blood levels at a far more precise level than can be used clinically to make decisions.

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).