Bio Job Blog : Bio Jobs : Biotechnology Jobs : Biopharmaceutical Jobs : Bioscience, Biotech Jobs : Bio Job Blog : Biocareer : Bio-Business Training, Biotechnology Training : Jobs in Biology : Internships in Biology : Internships in Biotechnology

The clinical trial phase of the drug development process is labor intensive, costly and usually takes the largest amount of time to complete. In the past, most human clinical trials for new molecular entities discovered by American scientists were conducted in the US. However, growing healthcare costs and shortages of “treatment-naive” trial participants have forced drug makers to take the effort global. To that end, many companies now routinely conduct Phase I (safety) and Phase II (proof of principle) trials in Eastern Europe, Latin America and Asia. Moreover, a growing number of pharmaceutical companies are beginning to conduct pivotal Phase III trials in which a majority of participants come from outside of the US.

Last year, a report from the inspector general of the Department of Health and Human Services revealed that in 2008 a whopping 78 percent of all subjects participating in trials to support drug applications submitted to the US Food and Drug Administration were enrolled in foreign sites. Likewise, in Europe, approximately 61 percent of patients in human trials submitted to the European Medicines Agency (EMA) from 2005-2009 were from developing countries. Additionally, 11 percent of the participants were enrolled in studies conducted in Eastern Europe. Poland and Hungary appear to have benefited the most from this trend; the number of Poles involved in trials rose fivefold over the period while Hungary was up almost fourfold.

According to a recent article from Reuters, ClinicalTrials.gov—a public website managed by the National Institutes of Health that tracks current US clinical trials—lists roughly 106,000 human clinical trials that are underway around the world. Approximately 50 percent of these trials are being conducted in the US. Interestingly, at present, only 43 percent of all pivotal Phase III trials are being conducted in the US.  Not surprisingly, China is the beneficiary of the trend and is experiencing exponential growth in the number of clinical trials conducted within its borders. To date, over 2,700 clinical trials have been performed in China and that number is likely to drastically increase over the next five years as Chinese medical and healthcare infrastructure continue to improve.

While outsourcing human clinical trials may be favorable to drug makers, the trend is beginning to anger many American physicians who previously benefited from managing US-based clinical trials. These physicians blame their misfortune on the life sciences industry’s endless pursuit to lower costs and the increasing regulatory bureaucracy and red tape surrounding clinical trial procedures in the US.

In addition to physician anger, outsourcing human clinical trials poses several other problems. First, there is a question of ethics. For example, is it right to test an expensive new drug in a country where locals may never be able to afford it if approved? And, are foreign patients always adequately informed or educated about the potential risks and side effects associated with experimental medicines? Second, can ethnic differences between patients contribute to differences in drug effectiveness and safety? In other words, will Caucasian patients respond to a new drug in the same ways as Asian patients? Finally, in the absence of rigorous regulatory inspections can Good Clinical Practices be routinely maintained across all global clinical trial sites? To that end, as pointed out in the Reuters article from 2005 to 2009 EMA inspectors only conducted 44 good clinical practice inspections (outside of the US and Europe) from a total of 44,034 clinical sites. Meanwhile, during the same period, the US FDA inspected only 0.7 percent of foreign clinical trial sites as compared with 1.9 percent of domestic sites.

Like it or not, outsourcing of human clinical trials in emerging markets is a trend that is likely here to stay. Hopefully, in the future, regulatory agencies will be able to better oversee foreign human clinical trials to insure that the drugs that they approve continue to be safe and efficacious.

Until next time...

Good Luck and Good Job Hunting!!!!!!!!!

• Email This
• Print
• Comments
• Trackbacks
• Share Link

Pharmaceutical,biotechnology and other companies that sell prescription drugs and devices are deathly afraid of adverse events (AEs) associated with their products. For those of you who may not know, companies with approved prescription drugs and medical devices are required to track and report any adverse events associated with their products to regulatory agencies like the US Food and Drug Administration (FDA). If FDA receives enough AE complaints about a product, the agency will investigate to determine whether or not there may be efficacy, safety or tolerability issues with it. And, if FDA thinks that the AEs are legitimate, it may ask a company to conduct Phase IV clinical trials with the product in question or require that changes be made to the product’s label. Not surprisingly, these outcomes can be time consuming and perhaps more importantly, costly. Label changes—especially for blockbuster products—frequently lead to changes in physician prescribing habits which can translate into a loss of revenue. Despite the fact that ALL drugs exhibit AEs, many companies falsely cling to the hope that there will be few, if any, AEs reported for their products.

While drug makers are very familiar with the range of possible AEs associated with their drugs—all AEs for a drug are identified and reported during clinical trials—pharmaceutical executives are concerned about social media activities, because they fear that than the number and frequency of AEs reported for their products will increase. This, in turn, would prompt FDA and other regulatory agencies to investigate and more closely scrutinize their marketed products. As Jonathan Richman, author of the Dose of Digital Blog points out in an excellent post entitled the “Myth of Adverse Event Reporting” AEs are a fact of life for prescription drugs. And, that social media may help to improve adverse reporting. Like Jonathan, I contend that social media might allow drug makers to more effectively identify potential safety issues with a product earlier in its lifecycle and thereby minimize possible deleterious effects of the drug on certain patient populations. I think that drug manufacturers ought to begin to consider how they might effectively use social media to improve AE reporting rather than ignore the potential upside of this new medium.

The Myth of Adverse Event Reporting

Adverse Events are nothing more than negative reviews. If you want people to genuinely talk about your brand, they are going to say negative things. But how often do posts include adverse events? Nielsen decided to take a look at this rather than simply assume it was ” a lot,” which of course is a difficult number to manage. Nielsen looked at Yahoo Health boards and took 500 postings. Of these, only 1 contained enough information to qualify as an adverse event that needed to be reported. That’s 0.2%. Why so low? Turns out that someone simply saying that your drug caused them to have a headache isn’t enough to qualify as an adverse event. Nielsen summed up the pieces of information required to report an adverse event and there are four pieces: “(i) an identifiable patient; (ii) an identifiable reporter; (iii) a specific drug or biologic involved in the event; and (iv) an adverse event or fatal outcome.” (Hat tip to Pharma 2.0 for the summary). The study showed that one or two of these pieces were often available, but not all four. In addition, they found that it would be impossible to get all four even with some effort. In fact, the FDA says, “[Without these pieces] a report on the incident should not be submitted to the FDA because reports without such information make interpretation of their significance difficult, at best, and impossible, in most instances.”

This is because people often don’t register or leave their personal information in a post, so there is no way for a company to follow up and fill in the blanks. Naturally, if there is something significant, every effort should be made, but on the often anonymous Internet, this is usually difficult. Suppose for a moment there were several adverse events that need to be reported. How often do they need to be reported? The FDA is pretty clear on this. For new drugs, reports need to be filed quarterly for three years. After that, it’s annually. For “serious and unexpected” events, these have to be reported within 15 days. However, there’s a pretty high threshold for an adverse event to be considered “serious and unexpected.” Every company already has these reporting channels in place, so it is simply a matter of including adverse events received from social media into the workstream. 

Yes, it’s a balance. The fact is adverse events should not be the reason why healthcare shies away from social media. These risks can easily be mitigated and, if done right, can actually be used in a positive way. So, don’t use adverse events as an excuse anymore. You’ve got the data. 1 in 500 posts include a reportable event. You report quarterly at most (which you’re doing anyway). How much ongoing effort do your other marketing programs require? Probably quite a bit more than this. Next time you hear this excuse, you’ve got the data to dispel the myth of adverse event reporting.

Until next time...

Good Luck and Good Job Hunting!!!!!!

• Email This
• Print
• Comments
• Trackbacks
• Share Link

Optimer, a San-Diego, CA-based biopharmaceutical company, reported positive Phase III clinical trial results for OPT-80, its lead treatment for Clostridium difficile gastroenteritis. C. difficile gastroenteritis is caused by exotoxins secreted by clostridia that have colonized the colon following prolonged antibiotic treatment for other bacterial infections. If left untreated, patients can die from a pseudo-membrane that forms in the colons of C. difficile-infected people. The incidence of C. difficile gastroenteritis has drastically increased over the past decade because of prolonged treatments with multiple antibiotics that are often necessary to eradicate infections caused by multiple drug resistant bacteria.

Historically, CHO-based drugs (with a few notably exceptions like heparin) have not fared well as therapeutic agents. To my knowledge, OPT-80 is the first synthetic carbohydrate (CHO)-based antibiotic to demonstrate anti-bacterial efficacy in a Phase III clinical trial. Having worked for Transcell Technologies (now defunct) and Alchemia,Pty—both of which attempted to develop CHO-based antibiotics—Optimer’s clinical success with OPT-80 is certainly noteworthy. I wish the company continued success in the future—mostly because I have always thought that carbohydrates would make good antibiotics!

Until next time…

Good Luck and Good Job Hunting!!!!!!

• Email This
• Print
• Comments
• Trackbacks
• Share Link