Stablepharma taking steps to bring a vision into reality

A interview with Dr Bruce Roser – Inventor and Chief Scientist Stablepharma Ltd – lays out the reality of the world of vaccines, the problems with the ‘cold chain’ and the ultimate impact on humanity and wasted lives.

Q: Given the years of research to find a solution to stabilise vaccines, what has motivated you to identifying the technology that will solve the current vaccine wastage?

Dr Bruce: A child dying every 20 seconds is an unacceptable statistic. The World Health Organization report that over 50% of vaccines are wasted around the world each year. Being both a doctor and a research scientist, has given me two different motives for my work. As a scientist, I have always been driven by curiosity. Having discovered the remarkable properties of the sugar trehalose in preserving even the most fragile of medical products, I tried to explore all the areas where this could be applied.

As a doctor, it was obvious to me that simple but powerful medical advances can be made with this technology. This continues to drive my commitment to find a way to avoid the wastage and change the lives of those most in need. My vision is for a world where lives are no longer destroyed by vaccine preventable diseases. This has been the focus of my attention over the last 20 years.

Q: What was your big breakthrough moment?

Dr Bruce: In 2017, we celebrated proof of concept for our StablevaX™ product - it worked perfectly in protecting a living creature and therefore, could benefit society, especially those people living in the developing world, where refrigeration is a luxury. It is satisfying to think that, after all this research, we are bringing to market a solution to eradicate vaccine wastage, reduce costs and stabilise lifesaving vaccines. This has been an incredible journey.

Q: What will happen next to achieve your vision?

Dr Bruce: Our next important milestone is to complete clinical trials in Humans next year. This is a complex project in a highly regulated area that requires considerable effort towards satisfying the necessary regulatory requirements, related to efficacy and safety.

Once the GMP (Good Manufacturing Process) batches of StablevaX™ have been produced, and before it’s administered to humans, Stablepharma will be required to conduct formal pre-clinical trials, in two species of animals. These trials will be similar to the tests that Stablepharma successfully conducted at NIBSC. This is an exciting and intense time for us, as we move towards the next stages of production, post clinical trials.

Q: Given the rigid regulatory process around any new pharmaceutical product, how prepared are you?

Dr Bruce: This is always a challenge but happily we have a great team in place to support and guide us. To ensure that we adhere to all elements of the regulatory approval process, Dr Arcadio Garcia De Castro at Stablepharma’s R&D facility in Madrid is driving this forward, and we have the considerable benefit of help from our Advisory Board especially from Professor Alan Boyd, a very respected expert in the field.

Q: And finally, what does the future look like for Stablepharma?

Dr Bruce: It looks pretty good, we are moving at a steady pace to achieving our vision, implementing the correct regulatory procedures and consolidating our management team. We aim to bring our StablevaX™ product to market, which will significantly change the way vaccines are used globally. We believe this to be a truly disruptive invention that within 3 years can enter the c. $36 billion human vaccine market.