Although January is just another month and the 2020s are just another decade, big changes in the calendar give us pause. As another year unfolds, I marvel at how far biomedical research has come and where it will take us in the next year and beyond. With the advent of genomics, computing and massive biobanking projects, there’s never been a more exciting time for science and medicine. Here are five of the trends I’ll be watching closely in the early 2020s.
Real-world data accelerates medical progress
Clinical trials are the gold standard for determining drug safety and efficacy, but trials consume a lot of priceless time especially in the eyes of sick patients. Fortunately, the world has amassed so much real-world data from medical records that trials may be optional in some cases. The U.S. Food and Drug Administration has begun accepting real-world data as evidence that a drug is safe and/or effective. If the proof already exists, maybe a drug-maker doesn’t need to conduct multiple clinical trials. Real-world outcomes in many ways constitute a trial. They represent cohorts of patients who have received some sort of intervention and experienced corresponding effects that can be analyzed.
Real-world data can also help researchers discover and validate off-label drug uses. Think of discovering, through data on real patient outcomes, that, say, an asthma drug helps patients regrow hair. Or an anti-seizure medicine happens to relieve anxiety. Then think of finding more evidence to make these off-label uses standard care. What’s more, data collection will accelerate as voice-recognition technology helps clinicians talk vs. type their information into health records.
As providers of human biospecimens, which are a major source of critical medical information, we at iSpecimen play an important role in the development of real-world data (the key ingredient of real-world evidence). We also use real-world data (always de-identified) to power robust searching on the iSpecimen Marketplace).
Health care providers share their data
So where is the mother lode of real-world data? In patient records managed by health care organizations. Thus, in the 2020s we’ll see health systems increasingly sharing their data with partners who can make productive use of it. Google, for example, has been acquiring millions of health care system records, which not surprisingly, has raised a range of concerns. Data can become a revenue stream for health systems, but it has to be done right. Privacy needs to be paramount. As this column declares, “Tech and health care need their own ‘Hippocratic oath’ to make digital health work.” We believe iSpecimen sets a good example of protecting patient privacy (we actually prevent protected health information from entering our data center).
Liquid biopsies become standard of care
Largely experimental to date, a liquid biopsy is a prospective alternative to painful surgical or big-needle biopsies. Far less invasive, in addition to being quick and affordable, liquid biopsies under development use blood and other biofluids to screen for and possibly identify particular types of cancer through specific biomarkers. Liquid biopsies can also help dictate ongoing treatment for cancer patients. In this decade, we’ll see liquid biopsies migrate from the development lab to the doctor’s office. And hopefully, we’ll see a true “pan-cancer” liquid biopsy – a single test to detect all cancers earlier, or at least flag anomalies that trigger further investigation. At iSpecimen, we’re deeply involved with clients who are aggressively developing these exciting diagnostics, as they require large volumes of specimens in a steady volume to perform their work.
Immunotherapy two ways
Medical researchers are hard at work harnessing cells, genes and the immune system to attack cancer and other diseases. One way is extracting “T cells” (a type of white blood cell) from a patient, modifying them, and injecting the modified cells back into the patient. The first such CAR-T cell therapy was approved in 2017. Many other cell and gene therapies, often supported by CRISPR-based gene editing, will see approvals in this decade.
Another class of immune-related therapy will involve not activating, but rather shutting down, immune processes that have gone awry. I’m referring to autoimmune diseases like multiple sclerosis, lupus and rheumatoid arthritis. At iSpecimen, we provide expansive access to hematopoietic stem and immune cells for preclinical research in this area.
Mapping disease genomes
When scientists mapped the human genome, it was just the start. It revealed the structure, organization and function of the complete set of human genes, setting the stage for exciting new cures. Then came the Pan-Cancer Atlas at the behest of the U.S. government. Drawing on the analysis of more than 11,000 tumors from 33 of the most prevalent forms of cancer, “the Pan-Cancer Atlas provides a uniquely comprehensive, in-depth, and interconnected understanding of how, where, and why tumors arise in humans.” In the next decade, look for private companies to continue this push, mapping genomes for cardiovascular disease, renal disease and much more.
These are just some of the ways that the early 2020s promise to be eventful, to say the least, and full of progress in research, discovery, prevention, treatment and cures. We’re excited to be working in this era, and doing everything we can to help these miracles unfold.