People have been trying to find the secret to eternal youth ever since the beginning of civilization. It has been well-documented in the annals of literature and history from the Epic of Gilgamesh to the conquest of the Spanish explorer, Ponce de Leon, respectively. While the concept of immortality has always been represented with an element of myth and alchemy, modern developments and intellectual enlightenment have made it more feasible to explore it through groundbreaking anti-aging approaches.
Right now, there are a myriad of products and services in the market that address the cosmetic aspect of aging. It’s a multi-billion dollar industry that is expected to grow some more in the next several years. Recent technological advances and increased awareness on the signs and symptoms of aging have contributed to its commercial growth. Despite success in that area, however, there seems to be a lack of approved therapies that address the pathological effects of aging, resulting in the rising incidence of age-related diseases. In the United States alone, at least 80% of adults 65 and older have one chronic condition brought about by aging; and at least 68% have two or more (National Council on Aging, 2017). In fact, the top three leading causes of death worldwide, particularly in industrialized countries, are age-related diseases—(i) Cardiovascular, (ii) Cancer, and (iii) Neurodegenerative.
The National Center for Biotechnology Information (NCBI) defines Aging as “the time-related deterioration of the physiological functions necessary for survival and fertility.” Anti-aging based therapies generally delay the onslaught of multiple factors that ravage biological processes associated with the decline of bodily functions as a result of aging. However, the challenges of developing those therapies are proving to be their ultimate paradox, especially for biotechnology companies.
There are a number of challenges that befall the anti-aging industry, but the most significant pitfall is that results won’t materialize until patients undergo the actual process of aging, which obviously takes time. Considering the sheer amount of time it usually takes to validate targets for clinical trials and obtain approval from regulatory boards, that only makes the process even more laborious for biotech companies focusing on anti-aging therapies. In that note, drugs that were developed for the purpose of slowing the aging process will make it more difficult to reach the conclusion of the trials due to their paradoxical indication.
Another hurdle is the inconclusiveness of the studies that have been carried out on model organisms, such as worms and mice. Whether or not the discoveries stemming from short-lived models are pertinent to humans are yet to be determined. Since we, still, lack complete biological comprehension of the aging process, determining sufficient and reliable biomarkers that can be used to designate limits or boundaries to clinical trials, it is not only going to be dragging, but costly, as well.
Even if there are voluminous amounts of data that have already been gathered due to the development of new technologies and approaches for extraction and collection, our capabilities of identifying suitable interventions that will succeed in clinical trials remain relatively poor.
All of these pose a big problem for biotech startups, more so than big pharmas, because of their primary focus on research and development. They are in the process of developing their pipeline of products; and having a lot of unknowns factored into the equation, which is having too many targets and an inestimable period to deliberate on the findings due to the very nature of the issue being tackled, makes it difficult to set an endpoint to a program’s drug discovery and development efforts
Time is a big consideration in mapping out and conducting clinical trials, so a direct-to-customers (DTC) approach can help in getting around federal restrictions and limitations. Nutraceuticals, as defined by Stephen De Felice (founder and chairman of the Foundation for Innovation in Medicines), are “foods, or parts of a food, that provide medical or health benefits, including the prevention and treatment of disease”. In the United States, and many other countries, they don’t fall within regulatory control, as long as they don’t incorporate health or therapeutics claims on their labels.
It is important for biotech companies to consider the trend of directly addressing aging as opposed to targeting age-related diseases individually as this would allow them to divert their resources to a single pathology that is the main precursor for other major causes of death worldwide. In doing so, however, they are going to have to, also, improve their capacity for target validation tenfold.
Want to explore this and other current trends in biotechnology further? Why not join the experts and decision-makers in a series of roundtable discussions in the field of Biology and Medicinal Chemistry on October 29 & 30 at the two-day Drug Discovery Strategy Meeting 2018 at the Hyatt Regency Airport in San Francisco, California.
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By Paula Mae Coronado
Content Strategist, Proventa International