Fight Aging!

As the longevity industry grows, the need for investment grows with it. A big leap in funding is needed to move from preclinical to clinical development, and ever more companies are arriving at the point of making that transition. Raising the few million dollars in seed funding needed for a small lab team to produce proof of principle studies to demonstrate that a novel therapy works in mice is a very different prospect in comparison to raising tens of millions of dollars to conduct GMP manufacturing and phase II clinical trials in humans, never mind the even larger sums needed for later phase III trials. The types of investors to participate at early and later stages are very different, with very different ideas of risk. It is typically the case that larger the check, the more institutional and conservative the investor.

Institutional, conservative biotech investors care greatly about the way in which they are perceived, since their ability to raise funds from limited partners is very much affected by that perception. When it comes to investing in the longevity industry, conservative investors are attracted by the potential for profit, but bothered by the long-standing existence of a fraudulent "anti-aging" marketplace, alongside numerous groups claiming membership of the longevity industry while selling supplements or treatments via medical tourism with claims that are in no way backed by rigorous evidence. These investors have carefully cultivated reputations, and fear the loss of reputation that results from investing sizable funding into ventures that fail. And some fraction of ventures always fail. When those ventures were by-the-book, nothing-new-here, conservative endeavors that checked all of the proper boxes, that can be forgiven. But venturing out into the unknown? That is less forgivable.

Thus as the longevity industry matures, elements within it are creating industry associations and paving the way to a perception of the longevity industry as a by-the-book, rigorous, nothing-new-here endeavor, just like the rest of the medical biotechnology space. They draw a circle that excludes everyone who sidesteps the existing regulatory system for drug development: the supplement companies; the cosmetic companies; the companies focusing on medical tourism rather than the FDA; and so forth. Today's position statement is authored by the founders, investors, and leadership of a number of the longevity industry companies closest to clinical trials. This is a part of the process of laying the groundwork to make it easier to find the much greater funding needed for the phase II and phase III trials that lie ahead.

Defining a longevity biotechnology company

The Longevity Biotechnology Association (LBA) is a non-profit organization created to foster collaboration, propose guidelines for industry, educate stakeholders, and translate geroscience to prevent the diseases associated with aging and extend healthspan. Billions of dollars are being allocated to basic and translational research in aging biology, but parameters and guide rails for the longevity biotechnology industry remain undefined. The efficacy of a new intervention can only be rigorously demonstrated by a sufficiently powered clinical trial. Today, there are products on the market that claim to boost longevity but lack robust scientific evidence in humans to support these claims. Academic scientists, drug developers, and entrepreneurs developing new drugs arising from aging research need to direct their efforts toward elucidating the mechanisms of action of potential interventions and conducting human trials. Similarly, investors, regulators, members of the media and others require a framework to evaluate the claims made by translational longevity biotechnology projects and their potential to demonstrate effectiveness of an intervention in humans.

The LBA proposed framework for a longevity biotechnology company includes four pillars: (1) mission, (2) drug discovery approach, (3) initial clinical development and regulatory approval, and (4) targeting multi-morbidity and healthspan. By creating a framework that defines best practices in longevity biotechnology, we hope to facilitate communication with audiences that include drug developers, investors, regulators, policymakers, journalists and the general public. Clarification of the field's goals and approaches will help to direct resources to efforts with the greatest potential for trial success and regulatory approval, move innovations from the bench into clinical practice, and ultimately improve the lives of older adults.

Interest and investment into the longevity drug development space continue to grow, with the number of players in the sector expected to increase. Following the proposed framework by having a specific mission, generating a drug that targets known hallmark mechanisms, and going through the processes of early- and late-stage clinical trials will demonstrate to any scientist, investor, company, journalist or member of the public that a specific organization is positioned to contribute positively to the field of longevity biotechnology.

When a novel field of research captures the interest of academics, investors and the public, it is common for various approaches to proliferate. Some of these approaches will leverage novel science to yield patient benefit. However, as noted, less rigorous actors might exploit the public interest to sell products to consumers and patients. The onus rests with the experts within the new research field to help non-experts distinguish between the two. In the early 2000's this was done expertly for the stem cell field by the International Society for Stem Cell Research (ISSCR), which has helped maintain and update those standards in recent decades. We helped create the LBA as a non-profit entity to achieve a similar goal. Although the organization is still young, we have put forward this framework to identify those efforts that have a high likelihood of contributing to the goal of not just creating new interventions based on aging research, but also demonstrating that the interventions increase human healthspan in clinical trials.