Section 18.6. Future Trends in Open Source Biology

18.6. Future Trends in Open Source Biology

Synthetic DNA appears poised to stimulate a new wave of genomic innovation, one closely aligned to software and using similar programming concepts. The decision of whether to support OSB will have long-term ramifications on the environment, the economy, and human health. There are thousands of biological products that could be designed collaboratively and produced inexpensively using open source synthetic DNAincluding vaccines, proteins, and gene therapies. If sufficient resources can be identified to bring these products to market without transferring them to proprietary interestsfor example, through open IP partnerships with generic drug manufacturers or HMOs, government loans, or the collection of personal donationsthe commercial sale of first-run therapeutics at generic prices could result, and not just for tropical medicines.

While real-world data and experiences will have to be collected before any conclusions can be drawn, the economics of open development may prove very attractive for synthetic genetics. Nature lends some support to this idea. DNA is openly shared in the physical world. The molecule is able to cross easily between species and is surprisingly plastic even within species or individuals. Not only this, but the grammar and syntax of the genetic language have remained conserved across all species throughout evolution. Nature doesn't waste energy with needless complications. If has retained a common genetic language and supported free exchange because this was less expensive than any other alternative.

If OSS proves any guide, synthetic DNA code will evolve fastest in the digital domain if allowed to be free. Efforts are underway in the scientific community so that a fair test of this idea can be made. Allies are being sought in government, law, finance, industry, and the general public to marshal support for open biological development projects. The idea is alluring to many people, in part because of the increasing awareness, use, and approval of open source software. Just as open software now provides individuals with greater software choice, OSB may one day offer individuals another source of safe and affordable gene-based technologies, therapeutics, and other bioproducts.

While OSB may not be immediately attractive, and perhaps may even be threatening, to some biotechnology companies, the benefits may be very appealing to others, especially those with limited resources. Given how few biotechnology companies can successfully produce and market any product, the value of proprietary IP may be considerably overvalued in life scienceespecially when sufficient R&D opportunities exist to prevent competitive overlaps. Companies may find that switching to open source allows them access to public information, institutions, and a scientific community usable or unapproachable by their closed peers. Open companies are able to exchange ideas or materials on core technologies easily, without threatening development within their particular specializations.

In addition to encouraging and amassing shared biological innovation, the decision to support OSB could produce immediate cost savings or benefits. Researchers, whether in academia or open companies, would conserve valuable research time not writing patent applications, while retaining the ability to freely publish and profit (albeit nonexclusively) from their innovations. Open companies would reduce legal costs, freeing cash to further develop programs. Universities would also save money on IP maintenance while retaining the ability to commercialize life science innovations. Meanwhile, government agencies involved in IPincluding the patent office, the FDA, and the courtscould find their workloads easier to manage if open source use grows. This will be particularly important with biotechnology IP if, as expected, synthetic leads to an acceleration of research discovery. In any case, the use of patent and strong IP would still remain available as an option if deemed more appropriate.

OSB could also appreciably shrink public distrust related to genetic development. The public is growing more aware of the issues that surround GM foods, genetic testing, stem cell technologies, gene doping, and gene therapies. While OSB will not solve the differences of opinion that make these topics controversial, open source ensures that each individual has equal access to information and also a voice in what products or technologies are developed. Open developments succeed because there is a demand for the product and sufficient community support, be it skill or money, to bring them to market. This shifts the agenda away from proprietary interests toward the needs and demands of consumersa shift likely to be strongly supported by those requiring new drugs or therapeutics.

OSB also fits nicely with emerging trends in health and medicine. Pharmaceutical development is expected to grow increasingly personalized in the future, drawing on recognition that individual variationgenetic, environmental, and behavioralplays a large role in human health and disease. Pharmacogenomic efforts are underway to allow better disease appearance prediction (facilitating preventative steps or treatments) and to determine how any particular patient will respond to a given drug. In time, therapies tailored to small patient subgroups, even individuals, will become favoredalthough present economic trends do not support this direction. Unable to make large-market drugs sustainable, personalized medicine cannot be accomplished by today's drug industry. However, gene-based medicine offers a tantalizing solution: change the informational content of each drug, not the drug itself. With DNA-based treatments, or gene therapies, the chemical entity remains the same, while the biological effects it can produce in cells changes. DNA may prove an efficient drug, inexpensive to make and modify, with a range of delivery options.

Synthetic design software, connected to an open, integrated dataset, could quickly evolve to facilitate the fabrication of custom health solutions for small populations or individuals. This capability will likely bring about large changes to the way drugs are currently tested in clinical trials: customized drugs could be tested only on the individuals for whom they were designed, who would presumably be agreeable to their use. New medicines could be quickly delivered to those in need. Even without broad clinical trials, gene-based drugs should prove very safe and reliable as test data is accumulated. Flaws with a genetic design would be excluded by software from happening again, and any complications would naturally be isolated to very small patient populations. Open source personalized medicine could also bring some legal relief to drug companies. With an open, software-based drug development system, class action lawsuits against synthetic drug manufacturers would be highly unlikely except in cases of outright negligence or fraud.

In summary, the concept of OSB is highly compelling. Focusing collaborative energies on the rapid and inexpensive development, synthesis, and testing of innovative biological products is a commanding vision. The potential of open genomics, with countless applications in medicine, agriculture, and environmental protection, is enormousbut so are the challenges to society. Familiar ideas and structures may need to be discarded before forward steps can be taken. Large changes in how scientific information is shared, new drugs are designed and tested, and knowledge is protected are sure to come. As we advance toward this future, tapped into a vast global web of information, we may find ourselves worrying much less about the ownership of old ideas and more about how to generate the next new one.