Headline after headline, we hear about precision medicine and advances in the treatment of challenging diseases that were previously almost always fatal. And thanks to the accelerating scientific advancements in biotechnology, we’re successfully battling subsets of diseases that seemed unbeatable less than a decade ago.
Cancer is one example of this trend. No sooner did we get used to the idea of immunotherapy and checkpoint inhibitors – releasing the brakes on the the body’s own immune system against cancer cells – when we saw yet another breakthrough. The recent advance of chimeric antigen receptor (CAR)-T therapies that bypass natural immunity and turn a patients’ own T cells into living medicine to target some leukemias and lymphomas that were untreatable just a decade ago. At F1 Oncology, we’re raising the game further by leveraging our bioinformatics capabilities into new CAR-T designs to target other patient populations with limited or no treatment options.
Yet for all the progress that’s been made, there may be more that biotech could be doing.
Just as the precision afforded by CAR-T therapies lets us think differently about how we attack cancer cells, perhaps we need also to think differently about how we can more effectively and efficiently develop these therapies. The first goal of a new therapy is to ensure we maximize the benefit-risk equation for clinical trial subjects, yet at the same time we need to look at what we can do to hasten the process of bringing innovative products to the patients that need them the most.
It may be time for biotech to think more globally about drug development.
In a world of precision medicine, the end goal should always be the magnitude of clinical impact for the patient; getting the right medicine to the right patient. We need to escalate our understanding of the patients themselves that may become subjects in a trial but think globally about where the patients in need are. Look at cancer: of the 9.6 million[i] deaths from cancer across the globe in 2018, nearly 2.5 million were in China[ii] (more than a quarter of the total) – clearly there is an unmet need for cancer patients in China. Yet at the same time, of the approximately 3,700 phase I clinical trials for oncology initiated world-wide, only 170 were in China (less than 5%).[iii] We need to accept that diseases such as cancer don’t recognize borders and look at a more balanced approach of where early-stage trials can be initiated.
In an era where more and more countries around the world have adopted ICH guidelines as the standard for drug development and quality, the global barriers to getting the right investigational medicine to the most relevant clinical trial subjects are coming down. And with larger pools of eligibility, the hypothesis of a targeted medicine may be more rapidly evaluated, while allowing ineligible patients to become subjects in other investigational medicines where the benefit-risk equation may be more appropriate. There are tremendous opportunities for broader cooperation amongst academic centers and sponsors across the globe.
At the same time, a global biotech approach also means you can “expand your day,” taking advantage of advances in communication and the span of different time zones. Big Pharma has been operating in this manner for years, but thanks in large part to the radical advances in communications technology, smaller biotech companies can emulate this approach and work seamlessly and effectively across geographies, essentially passing work on from one time zone to another. F1 Oncology and other biotech companies already operate this way in drug development. When “time” is the greatest enemy of drug discovery and development, it’s a standard that could be replicated by more companies to accelerate the discovery and development process.
But innovative research can only become a transformative therapy when they reach patients. Once you’ve proven a therapy safe and effective, access is the key. Taking a more global view can make the process more efficient, more effective, and deliver on therapeutic promise to patients desperately in need of therapeutic options.
By: Gregory Frost
[ii] China National Cancer Center, cited by https://chinameddevice.com/seven-cancer-patient-diagnosed-every-minute-in-china/. (Accessed January 5, 2019)
[iii] ClinicalTrials.gov. Search conducted with global Phase I oncology trials initiated in 2018 vs. same parameters for China (Accessed January 5, 2019)