What’s All The Buzz? BioViva’s Platform For Expedited Drug Development

Blog Post Feb 2018

Aging is the root cause of the diseases of old age, and this disease burden causes an immense amount of suffering to individuals and society. It is a progressive pathology due to accumulation of damage over time at a cellular level.  This pathological progression has always been subjectively observable, but now we can objectively quantify it with increasing accuracy. As we get older our cells, tissues, and organs become progressively less able to maintain their functions, and in turn this gives rise to the diseases of aging and frailty.  

BioViva is a platform to expedite the development of drugs and treatments that affect human healthspan. To achieve this goal BioViva has developed a comprehensive set of biomarkers of aging, which include molecular, physiological, anatomical, clinical, and qualitative markers. BioViva also collaborates with clinicians, biomedical scientists, and statisticians to develop innovative protocols for adaptive clinical trials for gene and cells therapies. Finally, BioViva has built a bioinformatics pipeline to analyze the data generated from the biomarkers of aging in human trials, and validate the treatments that are effective for treating the aging process.

BioViva has recently partnered with a paid-for clinical trial company Integrated Health Systems (IHS). IHS connects doctors with patients who want to take part in paid-for clinical trials. During our collaboration with IHS they will utilize our adaptive clinical trial protocols to conduct gene and cell therapy trials. All patients will undergo pre- and post testing using BioViva’s comprehensive biomarkers of aging platform. Treatment efficacy, and patient well being will be assessed using our bioinformatics pipeline.

The goal of BioViva is to accelerate the development of products that will effectively, and cost-efficiently treat biological aging. Our platform is designed to provide expedited and reliable feedback to our clinical and manufacturing partners, so that they may rapidly iterate their products and services to help patients improve the quality and quantity of life.

Success for BioViva entails finding therapies that work quantitatively by reversing or slowing biological aging in humans as measured by DNA methylation, metabolic, physiological, anatomical, and clinical markers. In addition, we will qualitatively improve patient wellbeing by helping them achieve an optimal healthy life.

BioViva is a platform for anti-aging biotech development. BioViva is to biotech, what meta-analysis is to medical research. BioViva’s platform is designed to accommodate all forms of research and development that targets the aging process in humans. We  work with biotech companies and biologic manufactures, and help them conduct accelerated adaptive clinical trials to ascertain the efficacy of their products in treating the aging process.

According to FDA drug approvals between 2004 and 2014, there is a 15 percent chance of going from Phase 1 through to FDA approvals for biologics, and a 7 percent chance of success for small molecules. This high rate of failure highlights the problems with preliminary drug testing platform. BioViva is a cost-effective solution for biotech companies to rapidly test there drugs in humans to determine where to embark on the expensive and time-consuming FDA or EMA approval process.

In summary, we want to help humans live long and healthy lives, and we have built a platform to assess anyones products that can help us achieve that goal.

Over the next several years biotechnology will increasingly become an information technology. That is, it will improve consistently every 24 to 36 months, as will the cost-to-benefit ratio in favor of the customer.  

Over the next five to ten years, with our platform, we should be able to make substantial progress in tackling the diseases of aging.. We will start to see a more combinatorial approach, such as gene therapies given jointly with stem cell procedures, and small molecule drug  use between those therapies. Patients will be on a personalized and highly efficient health program to optimize their lives in meaningful ways. Gene therapies might become occupation specific, for example space travel will use therapies that protect against muscle loss and radiation.

The biggest challenge in evaluating the efficacy of anti-aging treatments are biomarkers of aging. Currently the best biomarkers of aging are loosely associated with biological aging especially in people aged over 50.

Some popular biomarkers such as Steve Horvath’s ‘epigenetic clock’ are able to predict biological aging in certain tissues within and error margin of about 3.6 years. But this ‘epigenetic clock’ has yet to be tested in a clinical setting with diverse population types. With today’s popular clinical grade biomarkers we would need at least 8 to 10 years before we can conclude that we have an anti-aging solution for humans.

This is clearly the biggest problem as we cannot wait for 10 years to test every treatment. Therefore at BioViva we have designed a comprehensive biomarker of aging platform that should be able to ascertain anti-aging treatment efficacy within a couple of years.