I gave a speech recently to an audience of professionals working in healthcare regulation for the invitation of the Consumer Healthcare Products Association in Washington. After the keynote, a guy raised his hand and asked me the following: how can a regulatory agency keep up with the speed of new technologies in pharma? I get a lot of questions like this one.
The medical community gradually acknowledges the importance of digital health, but they don’t yet embrace it enough or cannot get behind it with such a speed as it would require. For doing so, the first step is always getting to know what’s coming. So, here are the trends changing the pharmaceutical industry in the near future.
1) Have patients in the advisory board of pharmaceutical giants!
As patients take their health and through that their own future into their hands with the help of digital health, they also should be treated as equal partners in the hospitals, pharmacies – and even pharma companies. I believe that drug producers should have an advisory board including patients who have experience with the given company’s products. It would be easier to develop new products if the exact needs of the customers are well-known. Only with their help would it become possible to create a healthcare system that is futuristic even decades after the first plans were drawn.
Moreover, healthcare event organizers should include patients in the planning of their conferences. More and more healthcare conferences get the “Patients Included” badge. It means patients either speak at the event or are in the organizing committee.
2) Digital health “around the pill”
Pharma companies around the globe are realizing that it is not enough anymore if they are producing and developing drugs. The trends show they have to go beyond the physical appearance of the medicine itself and offer a complete package. These are called already the “around the pill” digital offerings: digital health apps, devices or services that could be prescribed by a doctor or bundled with a drug.
For instance, Partners Healthcare Center teamed up with Japanese drugmaker, Daichii-Sankyo to develop a “mobile wrap-around” for a Daichii Sankyo anti-coagulate drug prescribed for atrial fibrillation that will also work with other afib drugs. It involves a wearable monitoring device and an app, through which patients can receive positive feedback from their doctors and from the automated, personalized feedback generated by the app itself.
3) What if the drug sent you a message after swallowing it? Digestible sensors are coming!
With the amazing advancement of nanotechnology, one possible way for the future of drug making is to produce “digestibles“. These tiny pills or gadgets combined with a sensor could track digestion and the absorption of drugs after swallowing them.
In 2015, the FDA approved the first drug product combined with a digestible sensor. The Japanese Otsuka Pharmaceutical and Proteus Digital Health combined a digestible sensor with a type of drug against mental illness. With the patient’s approval, the ingestible sensor communicates with a wearable sensor patch if the drug is taken; then the information is transmitted to a smartphone or tablet of the caretaker or the patient himself. The ultimate aim is to measure drug adherence in the treatment of adults with schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder, and as adjunctive therapy for the treatment of major depressive disorders in adults.
4) What if we could test drugs on virtual organisms?
Testing drugs on humans and animals in the framework of costly and lengthy clinical trials are the past. Imagine that the characteristics of living organisms are so perfectly simulated that the clinical trial can be carried out in less time, with less money and still amazing results. This method is called an in silico trial. It is basically an individualized computer simulation used in the development or regulatory evaluation of a medicinal product, device, or intervention. While completely simulated clinical trials are not feasible with current technology and understanding of biology, its development would be expected to have major benefits over current in vivo clinical trials.
HumMod is one of the most advanced simulations in this respect. It provides a top–down model of human physiology from whole organs to individual molecules. It features more than 1,500 equations and 6,500 variables such as body fluids, circulation, electrolytes, hormones, metabolism, and skin temperature. HumMod aims to simulate how human physiology works, and claims to be the most sophisticated mathematical model of human physiology ever created.
5) With augmented reality (AR) for making drug descriptions more fun
AR has many exciting applications in healthcare: nurses can find veins easier with an AR vein scanner, AccuVein or describe their eye condition better to their doctor through EyeDecide. There are already great signs that AR will enter the field of pharma soon.
Look at drug descriptions, for example. Have you ever been curious about how a drug works in your body? Even if you got interested in discovering how the distant world of pills and medicaments work, I bet you lost all your enthusiasm after you read the boring and undecipherable drug description. Now, augmented reality is here to change it. With the help of AR, patients can see how the drug works in 3D in front of their eyes instead of just reading long descriptions on the bottle.
6) With Virtual reality (VR) against painkillers
AR’s counterpart, VR did also step forward from the pages of science fiction books into reality. As a doctor, you could assist in the OR without ever lifting a scalpel. If you are a medical student, you could study the human body more closely and prepare better for real life surgeries. As a patient with mental health problems, you could fight your possible fear of heights, schizophrenia or paranoia more successfully.
However, one of the most successful applications of medical VR is in the field of stress release and pain reduction for patients suffering from chronic pain. Perhaps pharma companies should consider stepping into the field instead of creating new types of painkillers. Brennan Spiegel and his team at the Cedars-Sinai Medical Center are experimenting with the technology and they found a significant drop in pain scores in case of VR therapies. Spiegel even believes the future will be VR pharmacies with specialists prescribing the appropriate VR treatment to patients.
7) Precision medicine through pharmacogenomics
As the National Institutes of Health (NIH) formulated it, precision medicine is “an emerging approach for disease treatment and prevention that takes into account individual variability in genes, environment, and lifestyle for each person.” There are various trends in precision medicine connected to pharma. On the one hand, researchers experiment with drugs for oncology that directly attack cancer cells without damaging other tissues; for example in treating cervical cancer. On the other hand, medical experts try to incorporate genetics into the process of creating targeted therapies and personalized treatments. Pharmacogenomics is one way to go about this.
Pharmacogenomics is defined as the study of variability in drug response due to the genetic code. It argues that despite general sentiments, medications do not have the same effect on people. There are already some, who expressly recommend genetic testing before any prescription of e.g. Warfarin, a type of anti-blood clotting drug takes place. Also, the team of myDNA promises to help you and your doctor personalize your treatment by selecting the most appropriate medications based on your genetic test.
8) 3D printing drugs
In August 2015, the FDA approved an epilepsy drug called Spritam that is made by 3D printers. It prints out the powdered drug layer by layer to make it dissolve faster than average pills. In June 2015, the UK’s Daily Mail reported that scientists from University College of London are experimenting with 3D printing drugs in odd shapes; such as dinosaurs or octopuses in order to make it easier for kids to take pills. The technology is closer to our everyday life as we think.
UK-based FabRx believes they will be able to commercialize printed tablets within the next 5-10 years, and 3D printing will probably become available in every major hospital in the next decade. Whether we will also print out drugs at home or at least at the pharmacy on the corner of the street? The latter is more imaginable, but maybe in 20 years, 3D printers as home-based pharmacies will also not be considered as elements of science fiction.
9) Medical decision making with artificial intelligence (AI)
I have no doubts about the potential for AI to revolutionize healthcare through mining medical records, designing treatment plans, speeding up medical imaging – or drug creation for that matter. As I mentioned before, developing pharmaceuticals through clinical trials take sometimes more than a decade and costs billions of dollars. Speeding this up and making more cost-effective would have an enormous effect on today’s healthcare and how innovations reach everyday medicine.
For example, Atomwise uses supercomputers that root out therapies from a database of molecular structures. In 2015, Atomwise launched a virtual search for safe, existing medicines that could be redesigned to treat the Ebola virus. They found two drugs predicted by the company’s AI technology which may significantly reduce Ebola infectivity. This analysis, which typically would have taken months or years, was completed in less than one day.
10) In dire need for new FDA and drug regulations
I believe that there is a consensus in the medical community that current regulations concerning drug production; moreover digital health devices or health apps are obsolete. Regulatory agencies are basically unprepared for the waves of digital innovation.
We could notice it with the appearance of the #wearenotwaiting Twitter-movement for patients suffering from diabetes. They started to use the so-called artificial pancreas without FDA or any other approval because the patients had the impression it works and they needed it. With the rapid innovation of digital health solutions, regulators need a more rapid response in order to get ahead of possibly dangerous DIY solutions.
Another example of regulations going after innovation is the case of direct-to-consumer genetic testing companies. They appeared approximately ten years ago on the market. However, in 2014 the FDA restricted 23andme’s operations saying that the health information services were not clear or complete enough for customers. So, the genetic testing company scaled back its activity mostly to provide data about ancestry. They have linked together long-lost family members and have built family trees. In April 2017, however, the FDA re-approved 23andme’s services, which aim to tell people to which diseases they are susceptible.
It’s time to embrace what is crystal clear. Digital health is changing care, the practice of medicine and how pharma innovations reach patients.