The Future of Drug Development?

Pharmaceutical company Eli Lilly & Co. is taking an unusual step to help advance two drugs in its pipeline for treatment of Alzheimer's Disease—it is allowing a hedge fund, TPG-Axon Capital, to invest directly in the drugs. The investments, totaling $325 million, will help cover the costs to finish development and conduct clinical tests on the two drugs. In return for its investment, TPG-Axon will receive milestone payments as the drugs progress through the pipeline and a percentage of revenues if either of the drugs makes it to market. This is not the first time Lilly has taken this type of investment. Lilly allowed NovaQuest, an organization that helps drug companies manage the risks of developing and launching drugs, to invest in Cymbalta, an antidepressant. Since then, NovaQuest has reaped 8.25 percent of Cymbalta's sales.

Lilly has a history of thinking outside the box when it comes to drug discovery, development, and marketing. In 2001, the company spun off its eLilly initiative as InnoCentive (which I've blogged about here and here), an organization that uses the power of crowds to solve problems for companies whose own researchers have struggled to solve them.

Could investing in individual drugs be the future of the pharmaceutical industry? Would structuring a drug company in such a way allow people who are victims of an illness or family members of victims to drive development of treatments? But more importantly, is it possible that this could lead to drug companies whose motivation is to keep researching drugs rather than marketing them? For instance, if an illness has a low incidence, could a drug company make more money by stringing along treatment in exchange for further investment, rather than releasing and marketing the drug?

Those are tough questions to answer now, but as this business model spreads, answers will be revealed.

Researchers Attacked By Animal Rights Activists

I've never understood people who are willing to kill human beings in order to protect animals. I do understand that people like animals and feel that they need to protect them, but scientific research conducted on animals is essential to advancing our understanding of biological processes. We can't very well test drugs in the earliest stages on human beings, now can we?

Fire-bombing a home with small children in it shows reckless disregard for human life, and I hope when the culprits are caught the jury gives them the maximum possible sentence. Not only that, the people who issued the pamphlets encouraging such attacks and including the names and home addresses of researchers should be arrested and charged as co-conspirators. The authors knew very well what the people who received the pamphlets would do with that information.

The people behind these attacks are violent terrorists who are not only trying to harm the scientists involved in this research, they are trying to harm anybody who could eventually be helped by this research. Without animal testing, we wouldn't have many of the drugs we have today that are helping people beat cancer and survive other devastating diseases. And we wouldn't have the many drugs that will be available in the next several years for treatment of such debilitating conditions as Alzheimer's disease.

I know the people who are doing this probably think they're trying to make the world a better place. But just once I'd like to see them take a walk through the pediatric intensive care unit at a hospital and realize who these researchers are trying to help.

Using Crowds to Solve Problems

The New York Times has an article today highlighting the growing trend toward prize-based science, especially highlighting InnoCentive, which I blogged about last year.

Award-based research turns out to be especially effective. Companies sponsoring the research only pay for research that delivers results, and they always come in at their budge—whatever value they place on the prize. In addition, you may get several competitors each performing research to attempt a solution to the problem at hand, but you only end up having to pay for the effort that succeeds.

The reason InnoCentive works is because often the best solution to a problem comes from somebody outside the field in question. Petroleum scientists, for example, specialize in their field and therefore do not have expertise that, say, a concrete chemist would have. But John Davis, a chemist specializing in concrete applied what he knew about keeping concrete from hardening to a problem set forth by the Oil Spill Recovery Institute in Alaska in order to keep oil in storage tanks from freezing.

The biggest organizer of research prizes right now is, of course, the X Prize Foundation, who currently has prizes active in genomics, automotive technology, and robotic lunar missions. But they're not the only ones. For several years now, the Defense Advanced Research Projects Agency has used monetary prizes to encourage outsiders to develop technology it can use for military purposes, most notably with regard to autonomous automobiles. And NASA has sponsored a number of challenges related to space exploration, such as the Lunar Lander Challenge, the Astronaut Glove Challenge (won by an engineer from Maine working at his dining room table), and a couple of competitions related to space elevator technologies.

If you have any scientific or technical skills, maybe it's time you took a look at some of these challenges facing us.

CNN Article About Volunteering for Clinical Trials

I wrote a post last year about volunteering to be a test subject for clinical research trials. Now CNN has an article on their website called Do you want to be a guinea pig (I think they left out the "Hey Buddy" part at the beginning), highlighting the increasing need for test subjects in clinical trials.

There are positives and negatives to participating in clinical trials. The biggest positives, in my mind, are that you generally get your medications and doctor's office visit paid for as part of the trial, and that you are helping to advance our knowledge of science and our ability to treat various medical conditions. Oh, and sometimes they actually give you money, too.

There are risks and drawbacks as well. For starters, if it's a blinded study (and they usually are), you don't know whether you're actually getting the test medication or a placebo. My local clinic sent me an offer to participate in a study of cholesterol medication, but it would have required that I stop taking the cholesterol medication I'm currently on, and only having a 50/50 chance of getting the study medication. That would have meant a 50 percent chance of not taking any cholesterol medication at all. Thanks, but no thanks. I'm more than willing to participate in the studies that are looking for "healthy volunteers" because those studies—usually earlier in the process—are designed to help figure out what tolerable, safe levels of the medication are. Basically, they're designed to compare any symptoms patients may get while taking various dosages of the medication to symptoms people who are taking the placebo get.

The CNN report has some tips you should ask before volunteering for any trials, so it's a good resource to take a look at if you've considered volunteering for any trials, maybe as a way to make a little extra cash in these tight times.

Shortage of Cadavers for Research and Education

The Los Angeles Times reports that organizations that distribute cadavers for medical schools and research are suffering shortages. It seems that more people are being cremated or donating their tissues piecemeal rather than donating whole corpses for research or educational purposes.

As a result, medical schools are not receiving enough corpses for students to practice and learn on, and are having to turn students away from important classes. The next time you're in the hospital for surgery and you see your young surgeon getting ready, think about whether or not he or she has had enough practice before getting to you.

For as long as I've been writing this blog, I've encouraged people to dedicate part of their time and/or resources to help advance science and technology. If you donate your body for research or educational purposes, you can continue to contribute to advancement even after your death. Plus, it could save your loved ones from having to spend money on burial.

Hey Buddy, Wanna Be a Research Test Subject?

Sometimes the easiest way to contribute to scientific advancement is not to be the scientist, but to be the lab rat. Research projects across the country and around the world need subjects for their test and control groups. The two means they have for getting subjects into their tests is by recruiting and by accepting volunteers.

Recruiting happens when the researchers target people with specific conditions, usually by working through a network of doctors who treat whatever condition they are trying to treat. The doctors recruit the patients and, if the patients consent, the doctors sign them up for the trials and are usually available to administer the treatments and provide follow-up care as part of the study.

Volunteers, on the other hand, take a proactive step to contact the research center or some agent in order to volunteer for the trial. I use the term "volunteer" loosely here, because in many of these studies, the volunteers are compensated (in cash, free medical care during the study, or both).

There are several ways to find out about opportunities for you to participate in a research study. The first (and best) is to ask your doctor. My doctor works at a clinic where they do clinical research, and she takes part in a couple of studies, one of which she considered signing me up for (until she discovered that the samples of a cholesterol medication she was giving me lowered my cholesterol by a massive amount in just two months).

You can also volunteer by checking with a local testing center, such as those run by Covance, or by searching for available studies at ClinicalTrials.gov, a site run by the National Institutes of Health. If you're looking for studies outside the U.S., Thomson Centerwatch maintains a list of actively recruiting clinical trials around the world.

Even if you volunteer directly, though, you should still check with your doctor before volunteering for any study.

Europe Launches 54 Billion Euro R&D Program

The European Union will launch the 7th Framework Program (FP-7) on December 22, a program that aims to increase Europe's growth and competitiveness, recognizing that knowledge is Europe's greatest resource. The seven-year (2007-2013) program has received 54 billion Euros (about $70 billion) in funding.

From the EU's FP-7 webpage:

What are the key research areas defined by the European Commission?

FP-7 comprises 4 programs:

The cooperation program accounts for over 60% of the available funding and allows European researchers to work together on collaborative research projects to advance knowledge, to propose solutions to some of the major issues facing us today and to develop new technologies for the future. It promotes cooperation among universities, industry and research centers across the European Union, as well as with the rest of the world. This program focuses on research in: health; food, agriculture and biotechnology; information and communication technologies; nanosciences, materials and production technologies; energy; environment; transport; social and economic sciences; space; and security.

The ideas program is implemented through a new body, the European Research Council (ERC), and provides on average 1 billion Euro per year for investigator-driven frontier research in cutting-edge, “risky” areas.  The first call for proposals focuses on early-stage independent investigators – those ready to set up their own team for the first time. Future calls will cater to all experience levels. Applicants do not have to be in Europe to submit a proposal – but the work must be done in Europe if selected.

The people program provides increased funding for Marie Curie actions, which promote the training and mobility of researchers at all research career stages. This includes fellowships for Europeans wanting to work in another European country; specific international activities to fund non-European researchers to work in Europe and to fund Europeans to work outside Europe; and reintegration grants for European researchers to return to Europe from abroad. European researchers in the US will be eligible for most actions.

The capacities program enhances research and innovation capacity in Europe through activities such as funding access for researchers to major European infrastructures; support for small and medium-sized enterprises (SMEs) to develop their research potential or to outsource their research; international cooperation and science and society.

In my opinion, this is a very positive thing for the European Union. It allows their scientists, including small research shops, better research opportunities across the whole of the EU. It will improve cooperation and competition in research endeavors, both of which have been shown to improve research results.

This program will also benefit more than just the EU, as the research results will be shared with the world, much like the research programs funded by the NSF. Cheers to the the EU for launching this initiative.

Project Profile: Einstein@Home

This week's profile is for the Einstein@Home project. Like last week's profiled project, Rosetta@home, Einstein@Home uses the BOINC software as a distributed computing platform.

The Einstein@Home project uses the idle resources of a distributed network of computers to search for pulsars, which are spinning neutron stars. The software analyzes data gathered by the LIGO and GEO gravitational wave detectors.

From the Einstein@Home Screensaver description:

The Einstein@Home Screensaver has a number of elements related to current efforts to detect gravitational radiation from periodic sources such as pulsars. The primary element of the screensaver is a rotating celestial sphere showing the known constellations, along with the current zenith positions of three gravity wave detectors. The positions of the detectors relative to the stars changes periodically over a 24 hour period. If you went to one of the detector sites, the stars visible directly overhead at any time are the same ones that appear next to the detector on your screensaver. (This assumes of course that your computer's time and timezone are correctly set!) Also shown are the positions of the known pulsars and supernovae remnants, and a marker indicating the positions being searched as the calculations proceed. When the graphics are shown in a separate window (not as a screensaver) the user can control the display with the mouse and keyboard.

Processing Power

While you sit reading this blog, your computer's processor is probably sitting mostly idle. Today's computer processors are monsters when it comes to number-crunching capability, and they have to be in order to process the multimedia explosion that drives our modern society. This is especially true when it comes to computer games, which continue to tax even the most powerful systems available today with their advanced graphics, positional and dynamic audio, and artificial intelligence.

But when you're not playing high-end video games, most of that processing power sits idle. It's like the difference between driving your computer down the interstate at (or close to) top speed versus sitting at a stop light waiting to go. Your engine is still running, but it's not accomplishing anything.

With computers, though, that doesn't have to be the case. Those spare CPU cycles can be put to use for any of a large number of tasks, including searching for signals from aliens, simulating the folding of proteins to better understand the causes of diseases (and find potential cures), simulating weather to help create better predictive methods, search for spinning neutron stars by processing data from LIGO and GEO gravitational wave detectors, or many other projects.

The software that runs these projects is called BOINC, and it is designed to run in the background, using only the spare processing power. It doesn't interfere with your computer's normal processes, because it sets itself up to run in the lowest priority setting on your computer.

It doesn't cost you anything to run BOINC, and it may just help some advance some research project toward curing a disease or furthering our understanding of the universe around us.