Ajan Reginald is a Co-founder and the Chief Executive Officer of Celixir in London UK, which he originally founded under the name Cell Therapy Ltd. in 2009 with Nobel Laureate Professor Sir Martin Evans. Ajan Reginald is a biotechnology entrepreneur with a medical & dentistry background.
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Celixir Confirmed US FDA approval of the IND Application Regarding Their Most Talked About Cell Therapy, Heartcel
Celixir, which comes as one of the most recognized and renowned firm and contributed big time in the discovery and development of certain life saving advanced therapies, recently released a statement regarding the US Food and Drug Administration (FDA)’s approval for its Investigational New Drug application (IND) for HeartcelTM. It must be mentioned that HeartcelTM comes on board as one of the most talked about immuno-modulatory progenitor (iMP) cell therapy which can be used to treat adult heart failure.
It must be mentioned that Celixir just announced the approval of their clinical trial application (CTA) from the renowned UK’s Medicines and Healthcare products Regulatory Agency which paved way to kick start their crucial Phase IIb human clinical trial with HeartcelTM. Same international trial will then be bringing around 250 patients and the IND approval will further ensure its reach to US trial sites.
Ajan Reginald, Chief Executive Officer of Celixir, placed his views on the same regards: “The FDA approval of our IND is a significant regulatory milestone, which follows UK clinical trial approval in January. Celixir is now well positioned to conduct potentially pivotal trials with Heartcel™ in Europe and the US.”
About Celixir
Celixir is one of the most renowned privately owned UK biotechnology companies that creates and develops many life-saving and life-changing advanced therapies to support global patients struggling with various health issues around. Celixir, which came into picture in the year 2009, brings along a team of specialized scientists and biopharmaceutical executives, which are further lead by the Nobel Laureate Professor Sir Martin Evans and former Roche Global Head of Emerging Technologies, Ajan Reginald.
About HeartcelTM
Heartcel can be termed as an allogeneic cell therapy which incorporates an off-the-shelf immunomodulatory progenitor (iMP) cells prearranged to redevelop the heart. It must be mentioned that the iMPs are tracked during the coronary artery bypass graft (CABG) surgery with the help and support of a direct injection around the cardiac scar, required to be regenerated. On the other side, the iMP cells have been pre-arranged as an Advanced Therapeutic Medicinal Product (ATMP) by the European Medicines Agency.
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The agenda covers gene therapy, gene edited cell therapies, stem cells & regenerative medicine.
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Heart disease, even while being curable comes as one of the biggest threats to one’s health in today’s world
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Heart disease is one of the biggest threats to your and my health. It’s the leading cause of death around the world, kills one in six men and one in six women, and afflicts 2.3 million people in the UK alone.
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As start-up ideas go, this has to be one of the best: Ajan Reginald wants to mend broken hearts.
Medically speaking, that is.
Heart disease affects about 30 million people globally, causes an estimated 4 million deaths per year in Europe, and is the primary cause of death in the developed world. Although modern medicines can provide a degree of relief, the harsh reality is that today there is no cure.
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Ajan Reginald was born in Kandy, Sri Lanka. When Ajan was five his family emigrated to England because Ajan’s father got a job as a doctor in NHS. His father is a Medical school lecturer (Warwick Uni) and his mother is a clinical psychotherapist. The family settled in Coventry and Ajan first gained entrance to King Henry School and then won a scholarship to Rugby School.
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How stem cell therapy is winning the medical world by its achievements?
Ajan Reginald comes as one of the co-founders of their firm Celixir, along with Professor Sir martin Evans. Ajan has earlier served as the global head of the emerging technologies and business development director at Roche. He has also served as the consultant at the Boston consultant group whilst being a bright scholar with an MSc in experimental therapeutics. He was recently been interviewed by one of the major online dailies and we present you with the excerpts of the same.
Phacilitate: Why does Celixir follow a non-traditional financing model?
Ajan Reginald: It’s driven by two things, I think: first of all, we are in a new cutting-edge area, i.e. regenerative medicine. The second thing is that we’re a very British company; we’re British investors, based in the UK and funded in the UK.
We, the founders, have put in a significant amount of the capital so far to get the company all the way to completing phase II trials. That’s quite unusual and I think that says a lot about our understanding and belief in the technology, and how we think it will be a paradigm-shifting technology. That might be based on the fact that we’re a little bit older and we’ve done a fair amount of time in biotech and pharma.
On the second point, the VC environment in Europe is a bit different to the US. There are some excellent VCs in Europe and there are some excellent VCs in the US; I just think the US has a larger number of VCs that have followed biotech, have done biotech deals, and who are therefore used to the high degree of uncertainty and volatility in biotech both from a technology perspective but also from a market perspective - so I think in Europe, the drivers to be more non-traditional are perhaps more apparent than in the US.
Phacilitate: In terms of the financing environment in Europe, many European biotechs consider the US to be much healthier in this regard; does this tally with your own experiences? What trends do you see developing in European private sector funding?
Ajan Reginald: In the US, you’ve seen better valuations for platform technology companies and for earlier-stage companies. I think Circassia last year is a great example of a company that has a platform technology having a very successful IPO in Europe, in London, so I do think that trend is changing.
Our own experience, which is relatively recent – we’re doing a large private funding now – has been pretty similar. We picked 20 of the top European institutions and 20 of the top US institutions, and our hit rate is about the same at both.
I think in that top tier of the very sophisticated funders in Europe and the US, they’re just top people; they understand it. It’s not necessarily that they’re going to invest in you, but they definitely understand what they’re doing and how quickly they understand it is pretty much the same.
Phacilitate: Did you consider Horizon 2020 as a potential financing source? What factors influenced your decision on whether or not to pursue this route?
Ajan Reginald: Yes, we did consider Horizon 2020. I think the key driver there is the specificity of the call from Horizon 2020. If Horizon 2020 has a call that really fits what you’re doing as a company anyway and you have some good European collaborators, I think it’s an excellent programme.
I think the secret to this, which is the same for this grant as it is with any other, is make sure that what you’re doing as a company is critical to you and then look for a grant that fits, not the other way round – don’t try to manufacture a project to fit a particular grant.
Phacilitate: Wales is becoming a force in the regenerative medicine space. What particular elements make it the ideal location for Celixir?
Ajan Reginald: For us, we’ve been in Wales from conception, so hopefully we’re the spark for some of that. Very simply, for us it’s where our scientific founder, Sir Martin Evans, was based; it’s where he won his Nobel Prize, it’s where we have a lab, it’s where we have fantastically skilled scientists and where we’ve had significant support from the Welsh Government. I think the Welsh Government for us has been a very strong supporter, they are committed to developing an innovation-based economy and I congratulate them on that.
Phacilitate: Tell us about Celixir's priorities for the remainder of 2015 and beyond, particularly for the lead product, Heartcel.
Ajan Reginald: 2015 is going to be a big year. We are focused on Heartcel, but we also have completed phase II for our second product, Tendoncel, and the results for that were presented in June at the International Society of Stem Cell Research. Then also Skincel, our third product, is probably going to report in Q4, so 2015 is a busy year.
For Heartcel, we are interacting with the regulators currently. We’re looking to get orphan designation in place for Heartcel in Europe and we may then also apply for some of the US regulatory pathways as well. So yes, it’s going to be hopefully a very positive year in terms of our interactions with the regulators.
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Scientists and researchers have been quite successful in identifying, growing and differentiating stem cells and developing effective stem cell therapies.
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Ajan Reginald Co-Founder & CEO
Ajan Reginald founded Celixir with Professor Sir Martin Evans in 2009 and has served as the company’s Chief Executive Officer since inception. Ajan Reginald is an inventor of Celixir’s core technology, discovered Heartcel and Tendoncel and designed and led the early clinical trials.
Under Ajan’s leadership, the company has grown from 1 employee in 2009 to ~70 FTEs in EU, US and Asia and has completed five successful funding rounds. These rounds include crowd funding in 2014 and successful institutional funding rounds in 2016 and 2017.
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Scientists and researchers have been quite successful in identifying, growing and differentiating stem cells and developing effective stem cell therapies. But now, especially as many clinical trials are moving beyond animal testing to human testing, it’s important to consider the best methods of delivery
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The Medicines and Healthcare Products Regulatory Agency has issued a green light allowing Celixir to carry out a potentially pivotal Phase IIb human clinical trial with its stem cell therapy Heartcel.
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Ajan Reginald A Recognized Hockey Player
Ajan Reginald, CEO and founder of Celixir, a stem cell research company holds its conception from the year 2006 when it was named Cell therapy ltd. The company was found by Ajan Reginald along with Nobel laureate Sir Martin Evans, it was later rebranded to Celixir in the year 2016.
The company is working in the fields of research on another level. The company has recently launched two of its supreme products Heartcel and Tendoncel and successfully run their trials. These products are a feather on the advancements made in the field of science and technology.
Ajan Reginald is one of the most successful entrepreneurs in the field of science and research and his extraordinary work can be seen in the form of his supreme products and results of research.
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Ajan Reginald A Cure for the Broken Heart ?
Ajan Reginald As start-up ideas go, this has to be one of the best: Ajan Reginald wants to mend broken hearts.
Medically speaking, that is.
Heart disease affects about 30 million people globally, causes an estimated 4 million deaths per year in Europe, and is the primary cause of death in the developed world. Although modern medicines can provide a degree of relief, the harsh reality is that today there is no cure.
But there may be. Ajan (Chicago, Zurich, 2003-2005) is the founder and CEO of Cell Therapy Limited (CTL), a biotech firm he started in 2009 to experiment with stem cells as a way to fix damaged heart tissue.
“It was my dream to start a company that melds great science with great business to produce great benefits,” said Ajan.
It doesn’t hurt that his cofounder is Professor Sir Martin Evans, a Nobel laureate who first isolated and grew embryonic stem cells at Cambridge University back in the 1980s.
“Martin has a vast depth of understanding, expertise, and intuition, all of which are fantastic leadership qualities. But he also brings strong contributory assets that make him a brilliant person to start a company with,” said Ajan.
For the first six months, it was only the two of them. “We were a genuine start-up, doing everything ourselves: designing experiments, registering the company, raising funds, and setting up the website. We were certainly unique in that we had a Nobel Prize winner answering the phones.”
CTL has since identified a way to treat people with the most severely damaged hearts—those whose only hope is to receive a transplant.
“We’re treating people who have a life expectancy of less than one year—with 70 percent one-year mortality,” said Ajan.
And this is where the “great science” part of his dream comes in to play.
CTL’s proprietary cell therapy claims unique properties. “It’s a paradigm-shifting technology. Today’s medicines can only keep a patient from getting worse. We’re looking, for the first time, at a medicine that is able to regenerate a damaged organ.”
Heart failure develops after a person has a heart attack or when the arteries of a person’s heart are blocked. The heart muscle gets damaged and forms nonfunctioning scar tissue. Without treatment, this scar tissue expands, leading to heart failure and a significant chance of death within a few years.
CTL’s stem-cell therapy can be injected into scar tissue to reduce the size of the scar, stimulate repair, improve the heart’s ability to function, and mitigate the likelihood of heart failure.
Although there are other biotech firms working to produce stem cells for the broad treatment of diseases—using the same stem cell for, say, the treatment of lung disease or a chronic joint problem—CTL is unique in that it has been able to identify and isolate heart-specific stem cells.
The firm has already completed successful clinical trials, which brings us to Ajan’s vision of a “great business.”
The fast-growing high-tech stem-cell market is projected to reach about $20 billion in five years, and CTL hopes to tap into that market. Last year, in what was an unusual move for a biotech start-up, the firm ran an external fund-raising campaign that included crowdfunding; the goal was to raise £1 million. Ajan anticipated it would take up to three months to hit his target.
It took just ten days.
“The fact that we met our goal in such a short time shows that exceptional science for the benefit of society is an exciting investment proposition. This outcome is consistent with my BCG experience: clients with a focus first and foremost on quality produced highly differentiated products with demonstrable benefits, and profits followed. BCG gave me the analytical skills to understand these important drivers of great companies; hopefully I can replicate these characteristics in our small firm.”
In CTL’s case, demonstrating benefits demands a meticulousness in the way it generates value for heart patients. “Scrupulousness in value-generation for our patients translates into value-generation for our shareholders,” Ajan says.
In addition to Sir Martin Evans, CTL’s leadership team boasts other prominent figures, including Rhodri Morgan, a former first minister of Wales, Mubasher Sheikh, a former transplant surgeon and the current head of Permira health care, and Lord Digby Jones, a former UK minister of state for trade and development.
“It’s important to surround yourself with smart, critical people and to listen to them. Again, this is something I learned at BCG. I’m fortunate to have an exceptional board and executive team, and I am careful to listen, but ultimately I’m responsible for the decisions, good or bad. And I’m happy to make those calls.”
Ajan likens his role among these iconoclasts to his position as a central midfielder in field hockey. (He currently represents the England Masters at the international level.) “In other words,” he says, “I’m expected to see everything, anticipate everything, and cover every inch of the pitch. I’ve got to be a total team player—attacking, defending, and fulfilling whatever role is required by the team.”
“CTL is like most biotech companies in that it requires a CEO to understand and connect the science with the biotech business,” says Ajan. “However, where CTL may be different is the dual-fold novelty and ambiguity of both our field of regenerative medicine and CTL’s unique approach. The novel approach in an unproven field and being at the fore-front. There is no path to follow. Therefore, we believe an in-depth level of science and business expertise is necessary to make these critical (and novel) decisions.
“BCG was the best preparation for this role. I found my BCG experience very challenging and the hardest job I’ve ever done. But in hindsight, it was great training. The intellectual capacity needed, the speed of thought and execution required, and the unrelenting pressure and ‘stretch’ is how I developed my capacity to perform critical operations under high stress. BCG trained me to think and to work in a high-performance team. I learned to be data driven and to recognize excellent analysis and the singular value of insight from that analysis. Ultimately, leaving BCG was right for me. But the hard-won BCG skills gave me the ultimate confidence to use data to make the most critical decisions.
“My experiences from high-performance sports teams and BCG are complementary. High-level hockey is fast and dynamic; tactical thinking on the fly is very hard. But for me, the single well-executed tactical decision that wins the game is compelling. In contrast, business is more strategic and tactical, and there’s more time to think. However, it’s much more difficult to produce ‘game winners’ in business, and it’s much harder to build a high-performance team. That may be because the time frames are longer, prolonged years of rigor are required, and the rewards are less connected with actions.
“When we started CTL, we decided to combine the teamwork of high-performance sports with the strategy and execution required to excel in business. Therefore, our team is nontraditional—perhaps to match our nontraditional scientific approach.
All of which, he says, is borne out in the success of CTL.
“If your high-performance team can work synergistically, excellence is a more likely outcome—be it at BCG, international hockey, or a biotech firm. I truly believe there are few limitations on the productivity of such organizations. You also need luck, however, and then you just might develop the world’s first regenerative medicine.”
CTL, which is based in Cardiff in the UK, now has 30 employees, holds more than 100 patents, and is affiliated with labs at leading universities in Oxford, Toronto, Denmark, Greece, and China.
“Our goal is to treat 100,000 critically ill patients within the next five years,” Ajan concluded. “Realizing the great responsibility of lifesaving medicines, we focus on bringing Heartcel to market rapidly. It’s an amazing time—simultaneously frightening, humbling, and awe-inspiring.”
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It was like two years back, when Ajan Reginald, the founder, CEO of Celixir, spoke to IntelligentHQ.com about all the present challenges and opportunities within the healthcare industry.
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It was like two years back, when Ajan Reginald, the founder, CEO of Celixir, spoke to IntelligentHQ.com about all the present challenges and opportunities within the healthcare industry.
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Ajan (Kellogg, 2014) is the highflying CEO and co-founder with Nobel Laureate Sir Martin Evans in 2009, of a stem cell health company called Celixir.
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