An inviting beach in Nassau, Bahamas.
Dr. Conville Brown, a cardiologist-researcher in The Bahamas, is at the helm of a fascinating worldwide project: He's leading a movement to help accelerate innovation by providing scientists and patients from around the globe with a legal, cost-effective, and ethically rigorous place to conduct medical research, as well as to offer commercial therapies that are already approved in some jurisdictions, but not others. He recently spoke with Editor-In-Chief Kira Peikoff about The Bahamas' emerging ascendance in the scientific world. This interview has been edited and condensed for brevity.
"You don't want to take shortcuts from the perspective of not giving proper due diligence to the process, but you also don't want it to be overwhelmed with red tape."
Tell me about the work you do in the Bahamas – what is the research focus?
We have a couple research opportunities here. Several years ago, we established the Partners Clinical Research Centre, the idea being that we can partner with different people in different territories in the world, including the United States, and be able to perform ethical research as would be defined and adjudicated by an institutional review board and a properly constituted ethics committee. We do all of this with FDA rigor, but in a non-FDA jurisdiction.
By doing this, we want to look for the science behind the research, and want to know that there is a sound clinical hypothesis that's going to be tested. We also want to know that the safety of the human subjects is assured as much as possible, and of course, assess the efficacy of that which you're testing. We want to do this in the same manner as the FDA, except in a more accelerated and probably less bureaucratic manner. You don't want to take shortcuts from the perspective of not giving proper due diligence to the process, but you also don't want it to be overwhelmed with red tape, so that what could be 3 months takes 3 years. A jet ski turns around a lot faster than the Queen Mary.
Why do you think the clinical research process in other countries like the U.S. has become burdened with red tape?
The litigious nature of society is a contributing factor. If people are negligent, they deserve to be sued. Unfortunately, all too often, some things get taken too far, and sometimes, the pendulum swings too far in the wrong direction and then it's counterproductive, so the whole process then becomes so very heavily regulated and financially burdensome. A lot of American companies have gone outside the country to get their clinical trials and/or device testing done because it's too phenomenally expensive and time-consuming. We seek to make sure the same degree of diligence is exercised but in a lesser time frame, and of course, at a much lower cost.
The other aspect, of course, is that there are certain opportunities where we have major jurisdictions, as in Europe, that have determined that a therapy or device is safe. Those services and devices we can utilize in the Bahamas--not as a clinical research tool, but as a therapy, which of course, the United States is not able to do without FDA approval. That could easily take another five years. So there is an opportunity for us in that window to make available such therapies and devices to the North American community. I like to call this "Advanced Medical Tourism" or "Advanced TransNational Medical Care." Instead of somebody flying nine hours to Europe, they can also now fly to the Bahamas, as little as half an hour away, and as long as we are satisfied that the science is sound and the approvals are in place from a senior jurisdiction, then we can legally serve any patient that is eligible for that particular therapy.
Dr. Conville Brown
(Courtesy)
Are you seeing an influx of patients for that kind of medical tourism?
The numbers are increasing. The stem cell legislation has now been in place for two to three years, so we have a number of entities including some large international companies coming to the shores of the Bahamas to provide some therapies here, and others for research. The vast majority of our clientele are from abroad, particularly the U.S. We fully plan to increase the traffic flow to the Bahamas for medical tourism, or preferably, TransNational Medical Care, Advanced and Conventional.
How do patients find out about available therapies and trials happening there?
Advertising in the international arena for something that is perfectly legal within the confines of Bahamas is par for the course. But the marketing efforts have not been that heavy while all the processes and procedures are being fine-tuned and the various entities are set up to handle more than 100 people at a time.
"We were able to accelerate those programs, and do it a lot less expensively than can be done in continental countries, but just as well."
What kind of research is being done by companies who have come to the Bahamas?
We've been involved in first-in-man procedures for neuromodulation of the cardiovascular system, where we inserted a device into the blood vessels and stimulated the autonomic nervous system with a view to controlling patients' blood pressure and heart rate in conditions such as congestive heart failure. We have also looked at injectable glucose sensors, to continually monitor the blood glucose, and via a chip, can send the blood glucose measurement back to the patient's cell phone. So the patient looks at his phone for his blood sugar. That was phenomenally exciting, the clinical trial was very positive, and the company is now developing a final prototype to commercialize the product. We were able to accelerate those programs, and do it a lot less expensively than can be done in continental countries, but just as well. The Bahamas has also crafted legislation specifically for regenerative medicine and stem cell research, so that becomes an additional major attraction.
Do you ever find that there is skepticism around going to the Caribbean to do science?
When it comes to clinical research and new medical devices, one might be skeptical about the level of medical/scientific expertise that is resident here. We're here to show that we do in fact have that expertise resident within The Partners Clinical Research Centre, within The Partners Stem Cell Centre, and we have formed our partnerships accordingly so that when prudent and necessary, we bring in additional expertise from the very territories that are seeking to accelerate.
Have you seen a trend toward increasing interest from researchers around the world?
Absolutely. One company, for example, is interested not only in the clinical side, but also the preclinical side--where you can have animal lab experiments done in the Bahamas, and being able to bridge that more readily with the clinical side. That presents a major opportunity for parties involved because again, the financial savings are exponential without compromising standards.
"A person who is 75 and frail, he doesn't want to wait to see if he will make it to 80 to benefit from the agent if it's approved in five years. Instead he can come to our center."
Where are some of these researchers from?
The United States, the Czech Republic, Russia, Canada, and South America. I expect significantly more interest once we promote the idea of European products having a welcome niche in the Bahamas, because we accept federal approvals from the U.S., Canada, and the European Union.
What do you think will be the first medical breakthrough to come out of research there?
One of the biggest killers in the world is heart disease, and we have the opportunity to implement a number of cardiac protocols utilizing stem cell therapy, particularly for those with no options. We just completed a state-of-the art medical center that we fashioned after the University of Miami that is getting ready for prime time. The sky will be the limit for the cardiac patient with respect to stem cell medicine.
Second, we are extremely pleased to be involved with a company called Longeveron, which is looking at how one might age better, and age more slowly, particularly with the administration of young blood and mesenchymal stem cells to frail, elderly candidates. Healthy young men have their mesenchymal stem cells harvested, expanded, and then administered to frail, elderly individuals with a view to improving their Frailty Index and functionality (feeling younger). There is a lot of interest in this arena, as one could imagine.
And herein lies the classical scenario for the Bahamas: Longeveron is now recruiting patients for its phase IIB double blind, placebo-controlled clinical trial at multiple sites across the U.S., which will add some two to three years to its data collection. Originally this work was done with NIH support at the University of Miami's Interdisciplinary Stem Cell Institute by Dr. Joshua Hare, and published in the Journal of Gerontology. So now, during the ongoing and expanded clinical trial, with those positive signals, we are able to have a commercially available clinical registry in the Bahamas. This has been approved by the ethics committee here, which is comprised of international luminaries in regenerative medicine. Longeveron will also be conducting an additional randomized clinical trial arm of same at our Centre in The Bahamas, The Partners Stem Cell Centre.
Can you clarify what you mean by "registry"?
In other words, you still have to fit the eligibility criteria to receive the active agent, but the difference is that in a placebo-controlled double-blind clinical trial, the physician/researcher and the patient don't know if they are getting the active agent or placebo. In the registry, there is no placebo, and you know you're getting the active agent, what we call "open label." You're participating because of the previous information on efficacy and safety.
A person who is 75 and frail, he doesn't want to wait to see if he will make it to 80 to benefit from the agent if it's approved in five years. Instead he can come to our center, one of the designated centers, and as long as he meets the inclusion criteria, may participate in said registry. The additional data from our patients can bolster the numbers in the clinical trial, which can contribute to the FDA approval process. One can see how this could accelerate the process of discovery and acceptance, as well as prove if the agent was not as good as it was made out to be. It goes both ways.
"We would love to be known as a place that facilitates the acceleration of ethical science and ethical therapies, and therefore brings global relief to those in need."
Do you think one day the Bahamas will be more well-known for its science than its beaches?
I doubt that. What I would like to say is that the Bahamas would love to always be known for its beautiful beaches, but we would also like to be known for diversity and innovation. Apart from all that beauty, we can still play a welcoming role to the rest of the scientific world. We would love to be known as a place that facilitates the acceleration of ethical science and ethical therapies, and therefore brings global relief to those in need.
A company is looking to improve medicines by making them in the nearly weightless environment of space.
Microgravity research could potentially lead to many more discoveries like this one, or even the development of brand-new drugs, but ISS astronauts only have so much time for commercial experiments.
“There are many high-performance products that are only possible to make in zero-gravity, which is a manufacturing capability that cannot be replicated in any factory on Earth.”-- Will Bruey.
The only options for accessing microgravity (or free fall) outside of orbit, meanwhile, are parabolic airplane flights and drop towers, and those are only useful for experiments that require less than a minute in microgravity — Merck’s ISS experiment took 18 days.
The idea: In 2021, California startup Varda Space Industries announced its intention to build the world’s first space factory, to manufacture not only pharmaceuticals but other products that could benefit from being made in microgravity, such as semiconductors and fiber optic cables.
This factory would consist of a commercial satellite platform attached to two Varda-made modules. One module would contain equipment capable of autonomously manufacturing a product. The other would be a reentry capsule to bring the finished goods back to Earth.
“There are many high-performance products that are only possible to make in zero-gravity, which is a manufacturing capability that cannot be replicated in any factory on Earth,” said CEO Will Bruey, who’d previously developed and flown spacecraft for SpaceX.
“We have a team stacked with aerospace talent in the prime of their careers, focused on getting working hardware to orbit as quickly as possible,” he continued.
“[Pharmaceuticals] are the most valuable chemicals per unit mass. And they also have a large market on Earth.” -- Will Bruey, CEO of Varda Space.
What’s new? At the time, Varda said it planned to launch its first space factory in 2023, and, in what feels like a first for a space startup, it has actually hit that ambitious launch schedule.
“We have ACQUISITION OF SIGNAL,” the startup tweeted soon after the Falcon 9 launch on June 12. “The world’s first space factory’s solar panels have found the sun and it’s beginning to de-tumble.”
During the satellite’s first week in space, Varda will focus on testing its systems to make sure everything works as hoped. The second week will be dedicated to heating and cooling the old HIV-AIDS drug ritonavir repeatedly to study how its particles crystalize in microgravity.
After about a month in space, Varda will attempt to bring its first space factory back to Earth, sending it through the atmosphere at hypersonic speeds and then using a parachute system to safely land at the Department of Defense’s Utah Test and Training Range.
Looking ahead: Ultimately, Varda’s space factories could end up serving dual purposes as manufacturing facilities and hypersonic testbeds — the Air Force has already awarded the startup a contract to use its next reentry capsule to test hardware for hypersonic missiles.
But as for manufacturing other types of goods, Varda plans to stick with drugs for now.
“[Pharmaceuticals] are the most valuable chemicals per unit mass,” Bruey told CNN. “And they also have a large market on Earth.”
“You’re not going to see Varda do anything other than pharmaceuticals for the next minimum of six, seven years,” added Delian Asparouhov, Varda’s co-founder and president.
This article originally appeared on Big Think, home of the brightest minds and biggest ideas of all time.
Centenarians essentially won the genetic lottery, says Nir Barzilai of Albert Einstein College of Medicine. He is studying their genes to see how the rest of us can benefit from understanding how they work.
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Centenarians may have essentially won the genetic lottery, but that doesn’t mean the rest of us are predestined to have a specific lifespan and health span, or the amount of time spent living productively and enjoyably. “Aging is a mother of all diseases,” Dr. Barzilai told me. And as a disease, it can be targeted by therapeutics. Dr. Barzilai’s team is already running clinical trials on such therapeutics — and the results are promising.
More about Dr. Barzilai: He is scientific director of AFAR, American Federation for Aging Research. As part of his work, Dr. Barzilai studies families of centenarians and their genetics to learn how the rest of us can learn and benefit from their super-aging. He also organizing a clinical trial to test a specific drug that may slow aging.
Show Links
Age Later: Health Span, Life Span, and the New Science of Longevity https://www.amazon.com/Age-Later-Healthiest-Sharpest-Centenarians/dp/1250230853
American Federation for Aging Research https://www.afar.org
https://www.afar.org/nir-barzilai
https://www.einsteinmed.edu/faculty/484/nir-barzilai/
Metformin as a Tool to Target Aging
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5943638/
Benefits of Metformin in Attenuating the Hallmarks of Aging https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7347426/
The Longevity Genes Project https://www.einsteinmed.edu/centers/aging/longevity-genes-project/
