Picture this: a medicine targeting a particular disease is developed over 12-15 years from initial candidate selection, through to preclinical testing in the labs and to clinical testing in large numbers of people with that disease, at a cost of more than €1bn.1 That medicine is actively marketed for many years by the pharmaceutical company who made it, until the patent expires – effectively giving other companies the right and the recipe to make it themselves at substantially lower costs. At this point, the originating pharmaceutical company turns its attention back to the development of new medicines and the cycle continues.
All the while more people and their families are having their lives transformed by that original medicine. More and more health data is being collected in the real-world about how that medicine works in a wider population than that studied in the clinical trial. A wealth of information about any possible side effects, as well as unexpected benefits is being generated about a medicine that no longer has the same pharmaceutical company investment to harness that data and turn it into benefit for more people affected by disease.
This is where the traditional research and development (R&D) model can be challenged. Discovering brand new molecules and compounds that treat disease is always going to be important, but what if we haven’t discovered all that we can about existing molecules and compounds, that could treat more, if given the chance?
Through the availability of real-world patient data, we have the chance to re-examine, reuse and recycle existing medicines that – sometimes with minor adjustments such as enhancing the drug release profile of the medicine in the body to reduce side effects, or a new delivery mechanism to support better adherence – can breathe new life into ‘old’ drugs and turn them into new medical breakthroughs once again.
Real-world data also plays a crucial role in generating new clinical evidence, especially in discovering new therapeutic uses and benefits of the medicine in people with different medical conditions than the ones the medicine was initially tested for. With the safety profile of the medicine well established over many years – revamped medicines with new indications can get to the market much faster than the 12-year minimum period for a truly new drug.
In conclusion, as we venture beyond traditional development approaches and the use of randomised controlled clinical trials to provide evidence in limited subsets of patients, we have an opportunity to tap into the vast wealth of health data out there and transform our approach to healthcare. This information can empower us all to make smarter choices, elevating the quality of care and accessibility to medicines.
Therefore, it’s crucial for all of us to keep advocating for a better understanding of the advantages of sharing health data and using real-world evidence in shaping decisions for regulators, payers, pharma, HCPs and patients.
Pharmanovia is a global pharmaceutical company that revitalises, extends and expands the life cycle of already established medicines, designed to improve the experience and lives of patients globally.
References
1. Hughes JP Rees S, Kalindjian S, et al. Principles of early drug discovery. Br J Pharmacol. 2011 Mar;162(6):1239-49. doi: 10.1111/j.1476-5381.2010.01127.x. PMID: 21091654; PMCID: PMC3058157.
COR2024AR00233
Date Prepared: September 2024
