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Pharmaceuticals: Clinical Trials Management


www.chemicalsknowledgehub.com


Supporting pharma and biotech companies in the UK and worldwide


Leading European CRO Europital recently opened an office in Oxford, UK, which will seek to work with small and medium biotechs on new projects, particularly for First in Man, Phase 1 and Phase 2 clinical studies.


T


he UK is the largest life sciences market of all the countries within Europe and is an increasingly attractive and competitive location to perform clinical studies. In the year 2018 to 2019 alone, more than 870,000 people took part in clinical trials just in England alone. The Oxford Biotech Cluster, in particular, is a mature centre for life sciences research companies and one of the three closely situated regions in the UK known as the ‘Golden Triangle’, an area that accounts for more than a third of biotech companies in the UK and responsible for receiving more than 60% of the share of investment in the whole of the UK’s life sciences industry.


A growing biotech sector


According to Venture Valuations ‘UK Life Sciences Trend Analysis 2020’ report, since 2010 the number of therapeutically focused UK biotechs to be founded has grown steadily from 14 in 2010, to 29 in 2017. Whilst Brexit has caused a sharp decline in the number of newly founded biotechs, the amount of venture funding for UK based companies has remained steady over the past five years at about the $1.1 billion to $1.2 billion mark each year, with only last year seeing a more significant drop in funding to about the $716 million mark. In order to serve these small and medium biotechs by designing and executing their research projects, Europital has opened an office in Oxford, one of the most rapidly growing hubs for drug discovery and medical device development in the UK.Europital is an international, full-service contract research organization (CRO) and its new office is suitably located to serve the local


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research industry. Mohamed El Malt, Chief Medical Officer of Europital, comments: “It’s a really exciting time for innovators in the UK and the biotech hubs have a really vibrant pipeline of candidates. However, much of this cutting-edge innovation lies with smaller companies and spin-outs that really need the help of a science-driven CRO – not a volume- driven large CRO that usually won’t give the study the attention it needs. “You often hear ‘follow the molecule’ in CRO circles. What we are doing is following the innovator and looking at where we can best help our biotech partners advance their candidates through clinical trials,” Malt states.


He adds that it is widely known that these small innovators see, and experience, a large gap in the CRO industry and that what the small to medium-sized biotech companies need is a science-driven CRO that will support them closely with an experienced senior team but that also have a global trial network to offer. He says the difference Europital brings to sponsors is that the company’s senior teams stay with the sponsor’s trials from


contract to commercialization and that the same, experienced team is there throughout the lifecycle of the development plan, adding that as a science-based CRO, staffed primarily with physicians, Europital provides in-depth medical knowledge and industry knowhow.


The evolution of Europital


Europital has evolved from being a niche provider of medical management services to being able to offer the full range of services of a CRO whilst maintaining its original philosophy, ethics and driving force to put, not profit or expediency, but the scientific validity of study results and the safety of patients first. As, Malt says, “The scientific value of study results defines your ROI.” Small innovators in the UK have a clear need for a science- focused CRO that can provide detailed knowledge and therapeutic experience. Gaining access to senior medical CRO expertise can be extremely challenging for the smaller innovators as there is a real shortage of senior experience in the market because of the sheer number of trials underway. What they need is a partner that brings a


Meet Mohamed El Malt, MD,


PhD, Chief Medical Officer, Europital Dr Mohamed El Malt is an experienced oncology surgeon and scientific researcher with more than 35 years of experience as a medical doctor, including 20 years in clinical research and drug development experience in academic medical centres, the pharma and CRO sectors as an investigator, project leader, international medical director and chief medical officer, in addition to 15 years of clinical practice as an oncology surgeon. He has broad experience in different stages of drug


development and post-marketing activities in diverse areas of therapeutic areas including, but not limited to, oncology, immunology, infectious diseases, autoimmune diseases and respiratory diseases.


medical department with real-world trial experience to be a scientific driving force behind the project’s study design, execution and ultimate success.


Innovators developing therapies for oncology, infectious diseases, inflammatory and autoimmune diseases will be the major focus of Europital’s multi-functional and operational capabilities. Malt says that the type of biotech companies that would particularly benefit from these services are those that require a full range of CRO services for complex molecules and trial designs that necessitate senior medical and scientific oversight.


Strategic presence


As noted above, whilst investment in UK biotech has been affected by Brexit, the UK is still the largest country in Europe for life sciences research and that as the UK prepares to withdraw from the EU under uncertain terms and conditions, the presence of a Europital office in the country is also of strategic importance and a reassurance to the concerns of sponsors in the research industry. The UK office is expanding its operational team and will work with small and medium biotechs to design and execute projects, particularly for First in Man, Phase 1 and Phase 2 clinical studies while opening up direct access to UK investigational sites for existing European and North American partners with Phase 3 studies.


Further information Natalya Berdikyan


Public Relations Associate Europital


M: +34 605 046 415 E: natalya.berdikyan@ europital.com


Autumn 2020 Autumn 2020 25


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