11/12/2019 Celixir Confirmed US FDA approval of the IND Application Regarding Their Most Talked About Cell Therapy, HeartcelRead Now
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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. Many congratulations to our Club Coach, Dave Bryce, who has just been selected for England O35s for this summer's home nations tournament.
Congratulations to Ajan Reginald and David Harris who have been selected for England Masters for summer tournaments. Ajan Reginald selected for England Masters O45s. Ajan Reginald will play in the European Cup in August in Tilburg, you will be able to see info' here: https://www.ecmasters2017.eu/ Ajan Reginald played O40s last year in the World Cup in Australia and Home Nations in Scotland. Ajan Reginald is CEO of Celixir, who are the lead sponsor for Hockey for Heros this year, and Ajan will be participating in a number of the hockey events. Follow Hockey for Heros here: https://hockeyforheroes.co.uk/blog/opstretcher Well done Ajan Reginald! Ajan Reginald was born in the city of Kandy, Sri Lanka and while he was just five; his family got to migrate to England due to his father’s professional commitment as a doctor in the NHS. His father is a medical school lecturer in the University of Warwick and his mother works as a professional clinical psychotherapist. Their family shifted to Coventry and while Reginald Ajan joined King Henry School for his primary education, he secured a scholarship to the Rugby School. Ajan Reginald then went on to study dental surgery at the famous London Hospital School of Medicine and Dentistry (University of London) and finished up with his graduation in the year 1996. During his days in his school and university, Ajan Reginald went on to play hockey in England, Holland, and Germany and participated in the English Premier National League. Once finished up with his education at the university level, Reginald Ajan started his practice as dentist at a clinic in London and then moved to the Coventry city in the same profession. Unfortunately, Ajan Reginald has to take voluntary retirement from dentistry once he got diagnosed with a visual impairment out of a severe hockey injury. After taking retirement from dentistry, Ajan Reginald started his retraining in Business and Management and got rewarded with the UK Fulbright Scholarship in the year 2002. Ajan Reginald then completed his MBA from Kellogg Business School, Northwestern University in 2004 whilst securing a scholarship in Biotechnology. He then started working with the Boston Consulting Group (BCG) as a summer intern in 2003 and continued his part time work through Business school to further fund his education part. Whilst he was working at BCG, Ajan Reginald secured high end expertise in Pharmaceuticals and Intellectual Property in US and Europe regions. It was right then when one of his clients, Roche Pharmaceuticals based in Basel, asked Ajan Reginald to join them at their Business Development division. Ajan Reginald made his mark as a perfect deal maker whilst also winning the Roche Gold Olympiad in 2007. He then got promoted as a Global Head of Emerging Technologies for Roche Group Research, where his main focus was to identify the most significant new medicines, involving cell and gene therapies and other breakthrough technologies. Once he got through with his 5 years of re-training, Reginald Ajan got restarted with his passion towards hockey and gave training to some of the junior players in the process. He then played in many top-level national leagues and also represented England (over 40s) in 2014 whilst also playing the 2016 World Cup. EDUCATION
https://uk.linkedin.com/in/ajan-reginald-86a88512 https://twitter.com/ajanreginald https://www.crunchbase.com/person/ajan-reginald https://www.pinterest.co.uk/ajanreginald/ 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. While he discussed Celixir’s own Heartcel for being a cutting edge innovation as in life-saving, life-altering medicine, the role of artificial intelligence (AI) in healthcare was also been discusses. During this 40-minute interview, Ajan Reginald was largely excited about the fact that those robots with AI could possibly change genes and inject cells with more accuracy than humans. For Ajan Reginald, all these breakthroughs in medicine comes due to the benefits patients getting from these innovations along with the automation factor, which has played a key role in it’s implementation. This is happening when every third patient death is due to an error from the hospital’s end. Even though there are a number of benefits down the line, there are also hurdles that need to be overcome, specifically in regards to data privacy and encryption. This is where Scientists and researchers got to work hard in order to develop technology that would ensure the right medicine to the right patient, in the right dose, and at the right time. But the big question is, did we able to find the required advancements in the past 21 months? Marching towards AI-Dependent Healthcare Even when the big healthcare firms and tech companies are putting in billions to test AI-powered tools, most of the scientific and medical communities are still finding it hard to locate the required solutions for all the data and privacy concerns. Still it doesn’t mean that there hasn’t been any significant advancement in the same context and the medical and scientific communities have discovered much potential in regards to robotic surgery and image analysis. AI-Assisted Surgery As of now, the AI-assisted surgery is valued at around $40 billion as per a report from Accenture, but, if we have a look at the ability of robots to analyze various data from pre-op medical records, they can play a crucial role by guiding the surgeons’ instruments during the surgery process, which would ultimately lead to a 21% reduction in hospital stays for the patients. This is surely coming with a lot of benefits for the patients in the process as lesser time in hospital would cost less for all the insurance companies and hospitals, too. On the other side, AI-assisted surgery has proved to be more effective, with almost five times lower complications occurred than the surgeons operating on their own, as per a study published in The Spine Journal. Currently, the robots have a role to play in both eye surgeries and heart surgeries. The Da Vinci, which is been deemed as the most advanced surgical robot, has successfully operated with the human eye around seven months back. As Ajan Reginald Celixir predicted earlier, the robot has been able to successfully carry out the required processes with better control and expertise. Image Analysis Until June of 2018, image analysis was a process which used to consume a lot of time. That was simply because the fact that the humans need to do a detailed analysis which could take up to two hours or more in order to witness a change in the 3D medical scans. So we must thank the MIT-led research team, which has introduced a machine-learning algorithm that can easily analyze 3D scans up to 1,000 times faster than the past. All of the changes have been studied in real time which has further allowed the surgeons to react more promptly during the operations. AI is potentially been seen as a major help in improving all the radiology tools. This has ensured that instead of collecting the tissue samples via biopsies (which creates a situation causing infection to the patient) the AI-powered tool would analyze the images with a very close registration. All these tools are currently being piloted. AI’s future in Healthcare AI is still in its infancy period in the Healthcare domain but it’s still crystal clear that they have a crucial role to play in the same field with all the required tools and systems, which can help patients getting treated in a faster manner. As we are still utilizing the robots in many cell therapies, there’s every chance of seeing more advancements in the AI processes, along with their ability to interpret data in order to make the overall application and administration of medicine, much easier. 7/12/2019 Japanese firm secured a £12m licensing deal to market an inventive treatment for heart disease developed in WalesRead NowCelixir has agreed a deal with the Daiichi Sankyo that will see all of its advanced cell therapy medicine developed and distributed in the Japanese markets. The deal between the firms would allow the Japanese company with the license for Heartcel, one of Cell Therapy’s innovative cardiac regeneration medicines. Daiichi Sankyo will take care of all the development, regulatory and commercial activities for Heartcel in Japanese territory only, while Cell Therapy would take care of the same in rest of the world. As per the agreement, Cell Therapy will receive an upfront licensing fee of £12.5m along with additional royalties and payments. Talking in the same context, Cell Therapy’s chief executive Ajan Reginald said: “After a competitive process, we are delighted to partner with Daiichi Sankyo in Japan. The accelerated regulatory pathway for regenerative medicines in Japan enables faster patient access, making it a natural priority for us. A firm founded by a Nobel Laureate Cell Therapy was founded by Sir Martin Evans, a Nobel Prize winner for medicine in 2007 for his research into stem cells, along with Mr. Ajan Reginald, who has previously served as the global head, emerging technologies at Roche. The Firm is chaired by UK trade minister and CBI director general Lord Digby Jones along with former First Minister Rhodri Morgan also sits on the board. Speaking in regards to the license agreement, Sir Martin, Cell Therapy’s chief scientific officer, added: “This allows us to focus on US and European Phase 3 trials and accelerating the development of our pre-clinical pipeline. “[Our] in-house technology focuses on the discovery of novel tissue-specific cellular medicines. We are delighted that Daiichi Sankyo shares our belief in [Heartcel’s] potential in heart regeneration. Clinical Trials The Heartcel product includes the injection of modified cells into a patient’s heart tissue in order to repair the scarring out of a heart failure. The medical condition impacts more than 26 million people worldwide. During the Phase 2 clinical trial, the modified cells got injected into the cardiac scar during bypass surgery of 11 patients with severe heart failure. After duration of one year, the trial patients showed an improvement of 30% in heart functioning, along with a 40% decline in cardiac scar area and noteworthy improvement in quality of life. Moreover, all of the patients remained alive after three years of treatment. “This partnership is a validation of Cell Therapy’s novel approach and discovery technology.” It was last year when Cell Therapy secured the permission from the European Medicines Agency to initiate with the application process for “conditional approval of the treatment based on its early trial results”. This further allowed the company to market Heartcel while securing more evidence regarding its safety and effectiveness. Fast-track approval Japanese authorities have proposed for the fast-track approval for cell therapies in an effort to encourage the development of regenerative medicines. Mr. Ajan Reginald said he expected Heartcel to make its place in European or Japanese markets by late 2017 or 2018, depending on the results of further trials. Lord Jones further stated that the deal with Daiichi Sankyo would facilitate the Cell Therapy with more funds in order to expand and commercialize its product for the American and European markets. He quoted: “It validates our science and increases the confidence we have going into our next stage of development.” He also said that the company will be coming along with an initial public offering in the coming future but they still have enough cash to make it going for the next two years at least. 7/3/2019 Ajan Reginald, CEO of Celixir (formerly Cell Therapy Limited) - An Entrepreneur based in London, UKRead NowAjan Reginald, CEO of Celixir (formerly Cell Therapy Limited) is an entrepreneur based in London, UK. Ajan Reginald is a graduate in dental surgery and masters in Biotechnology with a combinational background in science and business. A vivid hockey player, Ajan has played at international levels and is actively involved in the work of Hockey. Ajan Reginald is currently the co-founder and the Chief Executive Officer of Celixir, which was founded by him in 2009 with Nobel Laureate Professor Sir Martin Evans. The original name of the company at the time of foundation was Cell therapy Limited. Celixir is a private British regenerative medicine company that discovers and develops life-saving and life-altering regenerative medicines for patient’s cell and gene therapies for patients with the greatest medical need. Celixir’s unique rational design approach drives in-house discovery and has created a broad pipeline of cell and gene therapy medicines, with seven of these currently being taken forward through the development cycle. At Celixir the pipeline is led by their investigational cardiac tissue engineered, cell therapy product, HeartcelTM which was designed keeping in mind to treat patients with heart failure undergoing coronary artery bypass graft (CABG) These HeartcelTM are injected during the bypass surgery surrounding the cardiac scar tissue in one single application. Another one of Celixir’s products is in late-stage clinical development called TendoncelTM, It is for tendon repair and is currently being tested in patients who suffer from tennis elbow. In its clinical stage pipeline, Celixir is also progressing three oncology products and two further cardiac products through the pre-IND stage.. Ajan Reginald before starting on with the entrepreneurial mode has served as the Global Head of Emerging Technologies and Business Development Director at Roche Pharma where he has overseen the identification, acquisition and development of the next generation of quantum leap of biopharma technologies and products. He joined Roche as a Business Development Director where he completed over 30 M&A and licensing transactions including a $1.3B licensing transaction with Alnylam. Before joining Roche, Ajan Reginald worked with the Boston Consulting Group (BCG) in the USA & Zurich as a member of both the Life Sciences Practice Area and Intellectual Property Group. Ajan Reginald was formerly a dental surgeon but he had to retire after getting injured during a hockey match which resulted in a visual impairment. Ajan Reginald is a Fulbright Scholar, graduate of the London Hospital School of Medicine and Dentistry (University of London) and holds an MBA from the Kellogg Business School at Northwestern University and an MSc in Experimental Therapeutics from Oxford University. He has also completed the Harvard Business School Advanced Management Program. |
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Ajan ReginaldAjan 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. ArchivesNo Archives Categories |