Biology as engineering
One of the most exciting technology developments of the last few years has been the evolution of biology from an empirical discipline to an engineered one. For the most part, this is because of the cross-over that has been made possible by network computing and big data.
For example, services like Patient Ping are deploying the kind of network effects we have seen large internet companies use to offer a coordinated healthcare experience to patients. By connecting primary care physicians with hospitals and home health administrators, the service is able to create a community of connected care providers that ensure the patient gets consistent treatment even after being discharged. Other organizations are leveraging social media to increase the number of volunteers for clinical trials, allowing drugs to go to market faster.
Some of the more fundamental changes are being witnessed in the drug discovery space. At present, medical research proceeds by establishing a hypothesis as to what might be the most appropriate point of entry to target a disease. Based on this hypothesis, molecules are developed through a long drawn out sequence of trial and error experiments. As soon as a viable molecule is discovered, it needs to be tested—first on animals and then on humans in order to see if it is effective in curing the disease and if there are any side-effects from using it. This process is cumbersome and the success rate is low.
We can now use computational techniques to do away with many of the uncertainties in this process. For some time now, we’ve known how to apply statistical algorithms to the identification of molecules, eliminating much of the trial and error that accompanies the process.
New techniques such as organ-on-a-chip allow us to use multi-channel 3D microfluidic cell culture chips to simulate the physiological response of entire organs such as the heart, the lung, kidney, artery, bone, cartilage and skin. We will, eventually, be able to simulate humans-on-a-chip, offering a safe and accurate way in which to test new drugs, without harming animals or human test subjects in the process.
Just as interesting are the developments in cell engineering—the process by which living cells from the immune system can be engineered to specifically target diseases—that offer a far more precise therapeutic solution than our current approach of carpet-bombing the entire body with drugs. New CAR-T cell therapies have made it possible for us to re-engineer human T Cells to specifically target certain proteins associated with cancer, offering a far more effective treatment of the disease than chemotherapy.
But perhaps the most interesting development is the extent to which we have managed to improve our understanding of proteins—to the point where we are now able to design proteins from scratch to perform a particular function.
Armed with this knowledge, scientists in the University of Washington have been able to design a protein that fits into a particular viral niche that would prevent the flu virus from entering the cells of its victims. Similar experiments are proceeding apace in engineering proteins that will break apart gluten molecules in food to help people with gluten allergies, or block the toxin that causes botulism.
These sorts of engineered cells are like programmable drugs. We will eventually be able to design them to have logic so that we can tell them where they have to go in the body, and what they have to specifically target. This will fundamentally change the way in which diseases are treated, allowing us to develop micro-cures that are specifically targeted at what ails us individually, rather than our current technique of applying generic drugs that have been developed based on the symptoms and response of a broad sample of the patient population. Combined with advances in human diagnosis, we are moving from broad-based diagnosis and therapies to much more targeted treatments that look to specifically cure the ailment of each individual.
All these advances are the result of the application of engineering techniques to the biological discipline. The results are solutions that can be scaled and replicated in ways that were not previously possible in the biotech space. It is also possible to re-purpose these results to apply in different circumstances, drastically cutting down the time it takes to arrive at these solutions.
The future direction of biology demands a review of the ways in which we regulate it. Existing laws that regulate drugs designed to work on large patient populations are of little use in the context of smart drugs and carefully targeted therapies.
Intellectual property protections that were supposed to apply to long-gestation drugs are over-kill in the context of rapidly scalable therapies. We need an end-to-end review of our regulations to make way for the future of medicine.
Rahul Matthan is a partner at Trilegal. Ex Machina is a column on technology, law and everything in between.
His Twitter handle is @matthan.