The Benefits of the Alliance for Longevity Initiatives?
The Alliance for Longevity Initiatives was founded in 2022 and advocates for policies and initiatives that extend human healthspan by ending the harm of age related diseases like Alzheimer’s, cardiovascular disease, and cancer. It also promotes biomedical technology and to increase its assessibility to the general public.
Longevity Science Caucus
The Alliance for Longevity Initiatives aims to bring about collaboration between longevity scientists, biotechnology companies, and health policy advocates. Its goal is to ensure that there is legislative support for scientists. The Alliance for Longevity Initiatives helped form the first Longevity Science Caucus which is a bipartisan group of Congressional House members. The caucus was formed to increase appropriations for aging research, support aging and longevity biotechnology, and streamline regulations to bring new therapeutics to the market quicker.
An example of the Longevity Science Caucus is its white paper on The Advanced Approval Pathway for Longevity Medicine which is a fast-track approval pathway to bring anti-aging therapies to the market sooner.
The Alliance for Longevity Initiatives worked with the state of Montana to pass its Senate Bill 422 which expanded access to treatment under its existing Right to Try federal law. Under this bill and as of October 1, 2023 all patients (not just terminally ill) in Montana have the right to access therapeutics that passed Phase 1 safety trials (first of four phases).
Fast-tracking Drug Approval
According to PhRMA (an industry group) it takes 10-15 years to develop a new medicine from initial discovery to FDA approval. The mean cost to bring a drug to market can be up to $2.8 billion dollars. This is the cost to bring a drug from discovery to development and through the four phases of drug clinical trials onto the approval process.
A faster way to get a drug through the regulatory process faster is through drug repurposing. With drug repurposing, drugs already proven to be safe and effective and approved for another indication are studied to see if they may be effective for another condition. This process has increased gained interest since the onset of the COVID pandemic with the exploration of use of invermectin and hydroxychloroquine being examples..
Drug repurposing can be accomplished in as little as two to three years since the drugs have already been proven safe and effective and the initial drug development has already been done.
Montana’s Senate Bill 422 is an even faster way for patients to try new therapeutics for their condition or disease. Montana’s Senate Bill 422 allows a manufacturer of an investigational drug, biologic product, or device to provide treatment to an eligible patient who has requested it.
Phases of Drug Development
There are five steps to drug development.
- Discovery and Development
- Preclinical research
- Clinical research
- FDA review
- FDA post-market safety monitoring
With the clinical research step there are four phases of clinical trials.
- Phase 1. The purpose of phase 1 is to assess safety of a drug and the proper dose for the specific indication. The trial consist of 20 to 100 healthy individuals or individuals with the disease or condition. The trial typically lasts several months. Approximately 70% of the drugs will move on to phase 2 clinical trials.
- Phase 2. The purpose of phase 2 is to study efficacy and side effects. This phase typically involves several hundred individuals with the disease being studied. This phase lasts several months to 2 years. Approximately 33% of the drugs will move onto phase 3 clinical trials.
- Phase 3. Is a more in-depth phase 2 clinical trial involving up to 3,000 volunteers who have the medical condition. The trial assesses efficacy and monitors for adverse reactions. Appoximately 25% to 30% of the drugs move onto the next phase.
- Phase 4. Phase 4 trials are carried out once the drug has been approved by FDA during the Post-Market Safety Monitoring. Some adverse reactions take years to become evident and phase 4 monitors for such events.
Some drugs are very promising but many individuals with life=threatening conditions will never get the opportunity to try these promising drugs due to the lengthly approval process. The Alliance for Longevity Initiatives strives to remedy that but for all patients and not just those with terminal conditions.