We interviewed Hakim Yadi, Co-Founder and CEO of Closed Loop Medicine, and discussed his background and the future of precision dosing.
Hanna: Tell me about your background and what led you to founding Closed Loop Medicine.
Hakim: I am one of those people who was always fascinated by the natural world. I’ve always been interested in how things work. Since the age of four, I wanted to be a marine biologist. While many people don’t know what they want to do, I always knew I wanted to end up somewhere in life sciences. I earned an undergraduate degree in biology and was very fortunate that during my degree program, I spent a year in industry, working for a pharmaceutical company doing biomedical research. Specifically, I was researching the migration of inflammatory cells, T cells, to sites of disease and inflammation, particularly in conditions like multiple sclerosis and rheumatoid arthritis.
What I found fascinating about this research was a common thread: many autoimmune diseases go into remission during pregnancy. I thought, "Hang on a second—how can we bottle pregnancy and turn it into therapy?" I was really inspired by the idea that nature has had 3.6 billion years to solve problems, and I believe we should copy its solutions.
I started looking for a PhD in pregnancy and the immune system. I found that both research and funding for women’s health and especially pregnancy was sparse which stuck me as it’s a condition that can impact 50% of the population! However, I eventually found a PhD program studying preeclampsia, a condition that affects 5% of pregnant women globally. I would love to return to research in women’s health someday—it’s the reason I got into this field in the first place. But I quickly realized I was more interested in the application of research, and I needed to find a different path.
I became increasingly fascinated by the commercial side of life sciences and how technologies are brought to patients. After completing my PhD, I moved into management consulting, focusing on healthcare, life sciences, and innovation. I worked extensively with the NHS in the UK and eventually got seconded to the British government, where I worked in Downing Street and with UK Trade and Investment. My role involved helping to implement the life sciences strategy, giving me a rare combination of experience in science, business, and policy.
Later, I was recruited to run the Northern Health Science Alliance, a collaboration of teaching hospitals and universities in northern England. Sadly, the north of England faces much poorer health outcomes than the southeast—you’re 20% more likely to die before the age of 75 if you live in the north. Over the last 50 years, this disparity has resulted in one million premature deaths compared to the southeast. Our goal was to combine resources and expertise to address these inequalities and to foster innovation in healthcare.
Through this work, I noticed how fragmented healthcare innovations were. Drugs, devices, diagnostics, and data were all developed in silos, with little communication between them. I was looking for a way to start a company that would do drug device digital in combo and that is what led me to co-found Closed Loop Medicine to look at bringing modalities of care together around a particular aspect of medicine that is often forgotten, which is dosing. Dosing is an area of medicine that we knew was a problem 500 years ago. Paracelsus, the father of toxicology, famously said, "Only the dose makes the poison." The coffee you drank this morning, the alcohol you might have this evening, and the medicine you take can all be helpful or harmful depending on the dose. At Closed Loop Medicine, we’re tackling this issue by bringing precision medicine to all patients.
Hanna: Can you share an overview of Closed Loop Medicine and the underlying problem you’re addressing?
Hakim: An engaged patient working with the very best physician will, to the extent possible with available drug formulations, optimize their dose. In England, this might happen at a leading university hospital or on Harley Street with a top-end doctor; in the U.S., it could happen at Johns Hopkins. But a patient in rural America or rural England—who might be socioeconomically disadvantaged and visiting an overwhelmed outpatient clinic—won’t have access to that same level of personalized care.
What we’re doing at Closed Loop Medicine isn’t magic. It’s about taking what the best physicians and patients already do and democratizing it. That’s the beauty of software—it can democratize good. Our view on improving outcomes, cost, and disparity is that creating an environment where that very best physician is sat on your phone making the best decision for you as an individual based on the data that you provide. Regardless of your zip code or post code, you get the best, and by doing so, you reduce the number of appointments, the cost, and the side effects while raising everyone’s outcome regardless of their background.
Hanna: We saw a big wave of early players in digital precision medicine. How does Closed Loop see this field and its place in the market?
Hakim: I find it funny that we even call it precision medicine, as that implies the rest of medicine is imprecise. If we called it what it is—imprecise medicine—no one would want it. Think about it: I want to know precisely how much money is in my bank. I want precise recommendations for what to buy next on Amazon or which song to play on Spotify.
What we’re doing with our technology is bringing the ability to deliver precision medicine in a cost-effective way, linked to a drug, much like Spotify brings precision music recommendations. With support from partners like Black Opal, we’re pioneering this approach. Nothing I’ve said should surprise anyone—it’s obvious that we should be dosing someone correctly.
I was speaking with a physician recently who had a patient religiously taking their hypertension medication but hadn’t been monitoring their blood pressure. The dose was wrong. The patient was 100% compliant, but the treatment wasn’t effective. The ability to link drug plus digital precision dosing is obvious, but it has not been done with technology in a regulated way that physicians can trust. That is the role that CLM is taking – we are pioneering in making this possible.
What we’re doing is inevitable. My daughters, aged four and seven, will one day ask, “Did you really take medicine without knowing if it would work?” We’re leading the charge, protecting our innovations with patents, and bringing the obvious to medicine.
Hanna: How do you balance the very clinical aspects of what you’re doing with the commercial aspects of your business?
Hakim: Our foundation is clinical, and if anything, we’ve probably over-indexed on the clinical side because, without it, you’ll never gain physician buy-in. Ultimately, our products are prescribed, so we’ve focused on triangulating clinical needs, patient needs, and the drug’s flexibility.
From a commercial perspective, we’ve asked, “How can we create value for payers, providers, and pharma?” If you look at our team, it’s very scientific and clinical because we have got to get this right.
We started with pharma partnerships, such as those with Pharmanovia and Teva, and are now exploring GLP-1s, where dose optimization is desperately needed. Given the structure of U.S. healthcare, we’re also looking at other commercial opportunities, like enhancing precision in telemedicine or online pharmacy services. What we are doing now is building off the base of a pharma-based model and looking at other ways in which we can create clinical and commercial impact off the back of our technology.
Hanna: Shifting gears a bit to policy and regulation—how has that provided headwinds or tailwinds for Closed Loop Medicine?
Hakim: The U.S. is leading in this area with an initiative called PDURS, Prescription Drug Use-Related Software. The FDA published guidance in 2023 stating that software enhancing a drug or affecting its use should be included on the drug’s label. This guidance has created a clear path for software-enabled drugs, and we’re particularly interested in the concept of drug enhancement.
Historically, technology has been used for drug delivery—for example, converting intravenous drugs into subcutaneous formulations. Now, in the 21st century, everything is software driven. Why shouldn’t we have software-enhanced drugs? PDURS represents one of the most exciting healthcare policy developments we’ve seen. Pharma companies will need to adapt quickly to this shift, and we’re optimistic about the opportunities it creates. Whatever happens with the FDA in the new administration, we hope that this is a policy that moves forward at pace.
Hanna: What advice would you give to founders in this field?
Hakim: Think carefully before you jump into the world of SaMD.
The biggest lesson I’ve learned is that most people underestimate the complexity and cost of building Software as a Medical Device (SaMD). People often see an app and think, “It’s just an app.” But when you’re building SaMD, which in the U.S. is regulated under 510(k), you’re creating a medical device.
You must comply with standards like ISO 13485, ensure your data and cybersecurity meet ISO 27001, and achieve certifications like Cyber Essentials and SOC2. All these things are not only costly to do, but they require big teams with a lot of experience and a huge amount of work to be able to deliver them.
My advice to early founders is to look for models that allow you to achieve as many proof points as possible without immediately having to meet SaMD requirements.
Hanna: What has been the most rewarding and most challenging part so far?
Hakim: I often tell our team, “We’re doing something that’s never been done, with people who have never done it before.” That’s both the challenge and the reward.
It’s incredibly rewarding to ask new questions, develop new solutions, and work with a truly multidisciplinary team. Our team includes clinicians, scientists, regulators, quality experts, product engineers, and commercial leaders—a mix of people who wouldn’t typically interact. Seeing them collaborate to build new products for patients is very special.
Hanna: Looking ahead, what excites you most about the future of Closed Loop Medicine? What message would you share with patients, clinicians, pharma, and investors?
Hakim: It’s about knowing where the hockey puck is going.
Our lives are rapidly digitizing—movies, music, banking, shopping, friendships, and even dating. We now have electric and driverless cars, and robots can perform surgeries with surgeons on a different continent. Yet millions of people rely on medicines every day that are still stuck in a one-size-fits-all model. That’s unacceptable because we’re not one-size-fits-all.
The most exciting part of the future is how software can entangle with medicine to create truly individualized solutions.
Hanna: Is there anything I didn’t ask that you wish I had—or something you feel doesn’t get enough attention?
Hakim: One topic that isn’t discussed enough is how to make money in this field.
The real rate limiting step is figuring out how to monetize effectively and prove scalability in a short time. There should be more sharing of learnings on business models that worked and didn’t work, or business models that you collide to create something new because SaaS might not be right for all things. I would love to see more collaboration and understanding around the need for more innovative business models to drive the uptake of this technology.
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