Over the past few years, scientists have identified major challenges in moving from research discoveries in biomedicine, to actual products that improve human health. This gap is called the “valley of death.” This term derives from the perilous divide between research discoveries and medical treatments that become available to the general public. On one side of the valley you find a new research result with important implications, on the other side of the chasm stands a potential product capable of bettering or even saving human lives. In between these two milestones are numerous barriers that can keep the knowledge from reaching its full potential for humanity.

The redefined discipline of translational medicine seeks to improve the rate at which discoveries actually make it into the marketplace or from “bench to bedside,” as seen in Traversing the Valley of Death: A Guide to Assessing Prospects for Translational Success. The valley of death is so strewn with institutional and marketplace barriers, that experts believe we need to make changes in the support structure for translational research. By doing so, they hope that society will actually receive the benefits of science investments. Nature published a news feature on this topic in 2008, titled Translational Research: Crossing the Valley of Death.

These challenges for Earthbound researchers also apply to the biomedical research conducted on the International Space Station. Even the most compelling research findings on the space station have a long path ahead before that knowledge will have the opportunity to yield results—they, too, must traverse the valley of death.

Today, I want to share the status of three early research findings that you may have heard about. The results from these station investigations are just now starting to make their way across the chasm. The journey for these results may take as long as two decades to complete, if they are successful.

Salmonella Vaccine Development:

Spaceflight causes increased pathogenicity in Salmonella bacteria, which is a known cause of food poisoning. Investigators used space pathogenicity of salmonella infecting a model nematode (a type of worm used in research) as a screening model to evaluate candidate vaccines. The resulting data are leading to the development of a Food and Drug Administration application for an investigational new drug by Astrogenetix, Inc. A similar approach, using methicillin-resistant Staphylococcus aureus (MRSA), is also ongoing. Multiple research groups are now investigating mechanisms of virulence in other species of bacteria. The progress of this research depends on the future success of several stages of clinical trials, and the willingness of a pharmaceutical company to bring the vaccine to market. Given the global impact of food poisoning, the market is large. Even so, it will still depend on a pharmaceutical partner presenting a compelling business case for completing the development.

Eight syringe mechanisms filled with biological constituents
and loaded in a Group Activation Pack are used to test
bacterial pathogens for virulence and therapeutic potential.
(Image courtesy of BioServe Space Technologies)

Microencapsulation of Prostate Cancer Treatment Drugs:

Microcapsules—micro-scale capsules surrounding an injected medication to help it target a specific area of the body—were produced on the space station in 2002. The properties of the space-produced microcapsules were predicted to be more effective in treating prostate cancer; this was shown in ground models. In 2009, researchers were finally able to develop and patent a machine capable of producing quantities of similar microcapsules on the ground. NuVue Technology is now trying to raise the money necessary to fund the FDA-approved clinical trials at M.D. Anderson Cancer Center in Houston, TX, and the Mayo Cancer Clinic in Scottsdale, AZ. For obvious reasons, 2010 was not the best year for raising investor capital for new clinical trials. Global economic struggles and funding hurdles are just a few of many examples of the barriers to bridging the valley of death.

Micro-balloons containing antitumor drugs
and radio-contrast oil produced in
Microencapsulation Electrostatic Processing
System during International Space Station
Expedition 5.
(Image courtesy of D.R. Morrison)

A New Treatment For Duchenne’s Muscular Dystrophy:

Protein crystal growth on the space station allowed for the identification of an improved structure of human hematopoietic prostaglandin D2 synthase (HQL-79). The conditions in microgravity allowed for the development of a slightly better crystal than previously possible on the ground. This improved model provided investigators with new information on the structure of the enzyme. This protein inhibits an enzyme that is more active in patients with Duchenne’s muscular dystrophy. Based on this knowledge, investigators developed a new candidate treatment. It is now undergoing testing via animal models, with dramatic early success. This common and debilitating form of muscular dystrophy affects approximately 1 in 4,000 males, so the potential benefit and market are great. Barriers that could affect the eventual translation of the treatment to marketplace, however, include the possibility of an ineffective candidate drug in clinical trials, despite the successful animal model. Likewise, if the drug has unintended effects or if intellectual property makes the drug difficult to bring to market, the entire project could tumble into the valley.

Crystals of human hematopoietic prostaglandin D
synthase (H-PGDS) grown under terrestrial (a) and
microgravity (b) conditions. In the microgravity
experiment, plate-like crystals were grown with
good morphology. Scale bar corresponds to 100 μm.
(Image courtesy of Osaka Bioscience Institute)

In my role as Program Scientist, I talk frequently about these examples. This is because the advent of their success will validate the discovery potential of the space station as a laboratory. Critics be warned, however, that the converse is not true. If any or all of these examples do not make it to market, this only indicates that our society has not built the most reliable bridge across the valley of death. The National Institutes of Health, pharmaceutical companies, and universities continually seek better bridges so that scientific discoveries translate more directly into saving human lives. Space station researchers join their Earthbound colleagues on this journey to span the chasm for the benefit of all humanity.

Julie A. Robinson, Ph.D.
International Space Station Program Scientist