CLINIGEN
THE RIGHT MEDICINE AT THE RIGHT TIME
Shaun Chilton, CEO, Clinigen.
CLINIGEN
CLINIGEN, A GLOBAL PHARMACEUTICAL AND SERVICES COMPANY, PROVIDES ACCESS TO MORE INNOVATIVE AND DIFFICULT TO GET HOLD OF MEDICINES, IN MORE COUNTRIES, FOR MORE PATIENTS THAN ANY OTHER COMPANY.
THE RIGHT MEDICINE AT THE RIGHT TIME PROJECT MANAGED BY: ANDREW BOURKE
Clinigen’s mission is to deliver the right medicine to the right patient at the right time operating in three areas of global medicine supply: clinical trials, unlicensed and licensed medicines.
T
he company was formed in 2010 through the merger of Keats Healthcare, Clinigen Healthcare and Clinigen, and since then has grown progressively through organic growth supplemented by a number of corporate and product acquisitions in various parts of the world. Starting with only 30 people ten years ago, today the business employs a workforce of over 1,200 worldwide, with hubs in Europe, the US, Africa and the Far East.
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Following several acquisitions over the last few years, Clinigen is now the market leader in the supply of drugs for clinical trials and the distribution of unlicensed pharmaceuticals. The company has most of the world’s top 25 pharma companies in its customer base, and exclusive supply arrangements for more than 100 drugs. “Operating in a complex regulatory environment, we are the only company to globally manage access to medicine across all three routes worldwide - clinical trials, unlicensed and licensed medicines,” says CEO Shaun Chilton. “We delivered medicines to 135 different countries last year. We don’t just help make medicines available,
we get them to the people who need them.”
ACCESS TO SAFE MEDICINES
The company provides access to its own and other pharmaceutical companies’ products, whether to meet unmet medical needs or for use in clinical trials. This includes providing access to medicines that have received regulatory approval, but may not be available in a specific patient’s own country (‘unlicensed’ medicines). “The expression ‘unlicensed medicine’ is starting to appear more often now, and it is important that people understand what it means, and increasingly, why it is important. The term unlicensed medicine
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Digital Infrastructure, Operations & Service Management Digital Business & Programme Recovery Services Digital Programme & Product Management Digital Enablement, Optimisation & Transformation
Nothing stands still in today’s ever changing business landscape. If you’re not leading, you are simply following. At Step5 when the world zigs, we zag - putting our best foot forward and leading from the front. We realise our client’s ambitions, keeping them at the cutting edge. We see the bigger picture when others can’t, recognising that whilst every problem is different, every problem is there to be solved. Our clients and our teams are all individual pieces of the jigsaw, each as important as the next. When they come together, working in collaboration, we solve problems and make it happen. Because we don’t just believe in the power of dreams, we believe in making those dreams a reality. We work with leading FTSE 100 businesses, with central government and public sector organisations to scope, build, deliver or recover large scale transformational projects, on time and to budget. We are Step5 and together we can.
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STEP5 GROUP: THE EXPERTS IN DIGITAL TRANSFORMATION STEP5 IS A UK HEADQUARTERED TRANSFORMATION CONSULTANCY, WORKING WITH LEADING FTSE 100 BUSINESSES, WITH CENTRAL GOVERNMENT AND PUBLIC SECTOR ORGANISATIONS TO SCOPE, BUILD, DELIVER OR RECOVER LARGE-SCALE TRANSFORMATIONAL PROJECTS, ON TIME AND TO BUDGET. BLUE CHIP CLIENTS AND GOVERNMENT CONTRACTS With clients including Clinigen, the Department for Business, Energy & Industrial Strategy, Sopra Steria, Experian and BNP Paribas Personal Finance UK, Step5 brings together a wealth of experience, spanning the last 30 years, from architecture and design, to programme management and service management, and has delivered some of the most challenging programmes in both the public and private sector. AGILE AND EXPERIENCED With more than 70 staff deployed at any one time across the UK, Step5’s teams are highly experienced, flexible and agile and come handpicked from leading public and private sector organisations providing outstanding project skills and an innate understanding of Service Management. The result is unmatched diversity balanced by absolute unity of purpose. Every project team is carefully put together for their breadth of experience and sectoral insight, realising their clients’ ambitions, keeping them at the cutting edge, whatever business they offer. ACCOUNTABLE AND INTEGRATED Unlike most large-scale consultancies, Step5’s size and flexibility enables them to form strong, proactive relationships with their clients. This bond, combined with unique agility, equips them with the necessary skill-set to not only find the solutions but deliver them too. This means no standing on the sidelines finger pointing, rather Step5 is both accountable and responsible for delivering the required outcomes. AS A RESULTS STEP5 HAS HELPED CUSTOMERS TO BID, WIN AND DELIVER MAJOR TRANSFORMATION PROGRAMMES WITH A TOTAL CONTRACT VALUE IN EXCESS OF £1 BILLION, INCLUDING: • Olympics - London 2012: Members of the Step5 team ran the programme management and delivery of all telecommunications for the London 2012 Olympics. Joining a team of over 1,200 people to ensure one of the most successful global events in recent times ran smoothly. • Department for Business, Energy & Industrial Strategy: The merging of two key Government departments, The Department of Energy and Climate Change and The Department for Business, Innovation and Skills saw the creation of a single entity: The Department for Business, Energy & Industrial Strategy. With their extensive experience in Central Government, Step5 was asked to deliver an integrated solution for HR, Finance, Procurement and Payroll; a task they achieved in 3 months. • BNP Paribas Personal Finance UK: Over an 18-month period, Step5 played a central role in securing BNP Paribas Personal Finance UK’s entry into the £32 billion UK motor finance market. Working closely with the client, they successfully implemented an industry-leading digital platform capable of competing with some of the largest and most established competitors in the automotive market.
• Retail Environments: Step5 recovered a large-scale integration of front-end retail, logistics and back-end financial systems, including changing the financial point of record, for one of the top UK supermarket retailers. By working at every level of the organisation, from the executive board to walking the floor, Step5 was able to take full responsibility of the programme delivery; restructuring teams and working directly with suppliers to recover and deliver the programme successfully. • B2B Services: Providing the best outcomes for the client whilst keeping to strict timeframes is a common challenge faced by members of Step5. Finding this balance led to the development and delivery of one B2B customer’s transformation programme which moved their Customer Service interface to an online service. This included managing all aspects of the programme, from end customer engagement workshops, business change models, requirements definition, IT architecture, IT delivery and deployment to training and implantation. The first phase of this process was delivered in just 8 weeks with significant additional functionality delivered 12 weeks later. • Cloud Migration at Scale: Recently, Step5 successfully programme managed the delivery for a client migration from On-Prem Infrastructure to Oracle Cloud Infrastructure (OCI) — one of the biggest migrations in the world. Clients of Step5 can expect a bespoke service as Step5 is well aware that no two business are alike. As each vision and end-goal is unique, so is the puzzle that requires solving. To ensure the most cost and time efficient service, Step5 teams provide the appropriate best-in-class talent for the job to embed within the client’s organisation, remaining agile and flexible to the changing business needs. Partnership is a core Step5 value. However, it is recognised that this can only be achieved through trust and assured delivery; each of which is held in equal esteem. With a strong delivery focus, Step5 operates across management structures from the Boardroom, where they establish the strategic context, business ambition and delivery challenges, to their consultants working with, and within, delivery teams across the organisation. Identifying blockages, highlighting opportunity, setting out a plan of action and the tangibles of implementation are woven into their proven delivery frameworks. Tried and tested methodologies, combined with strong philosophies and unmatched experience allow Step5 to resolve issues and to embed new ways of working into clients’ programmes, teams or service organisations. TODAY, STEP5 RAISES THE BAR AND SETS THE STANDARD, OFFERING BUSINESSES A NEW WAY TO REALISE THEIR CAPABILITIES, OVERCOME CHALLENGES AND BE FIT FOR THE FUTURE.
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CLINIGEN
does not mean that the drug is unsafe, nothing could be further from the truth,” says Shaun Chilton. “What it means is that that the medicine that a physician or a pharmacist wants has not been approved commercially, i.e. has not been given a marketing authorisation, in other words a ‘license’ somewhere - yet! The regulatory pathway to obtain a marketing authorisation for a medicine is complex and expensive and sometimes, because there just aren’t
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enough patients or for other reasons, the company that owns the medicine does not wish to pursue and keep a licence in a given country, the cost of which is significant.” He points out that in all likelihood, even the most popular, widely used medicines will have a licence in only about 30 countries. “That means that in the vast majority of markets the medicine is technically unlicensed but it is an important, effective and safe treatment and so that does
not mean that people don’t want it. In today’s increasingly connected world, physicians and even patients are pushing to get access to medicines that are available elsewhere. That is what we do. We are probably the only company that can do this globally.”
“OPERATING IN A COMPLEX REGULATORY ENVIRONMENT, WE ARE THE ONLY COMPANY TO GLOBALLY MANAGE ACCESS TO MEDICINE ACROSS ALL THREE ROUTES WORLDWIDE - CLINICAL TRIALS, UNLICENSED AND LICENSED MEDICINES.” BUSINESS FOCUS MAGAZINE | 7
AT 3D IFS WE SPECIALISE IN EMPLOYEE BENEFITS AND WEALTH MANAGEMENT We have enjoyed working with Clinigen and Shaun in particular for the last five years. This has been an exciting time for both us and Clinigen. We look forward to continuing to support the Company and their employees for many years to come. We continually adapt the Employee Benefits Programme to cater for the rapid growth of Clinigen as a business and wish Shaun and the Company continued success in 2021 and for many years to come. Jon Isaacs MD
3difs, Unit 1 Elm Court, Meriden Business Park Copse Drive, Coventry CV5 9RG United Kingdom
Email: jenny@3difs.com Phone: +44 (0)1676 525 390 Web: www.3difs.com
3DIFS At 3Difs we are proud of our Chartered Status whether it is bespoke Personal Financial Advice or detailed relevant Employee Benefits Programmes that we deliver for our clients. Chartered Financial Planner status is regulated by the Chartered Insurance Institute (CII). It is awarded based on the organisations being competent, knowledgeable and ethical in their dealings. We go above and beyond the minimum standards required to act as Financial Advisers. As the CII say, Chartered status is the “gold standard for firms of financial planners.” It is equally important to us that we give all our clients value for money, especially in the times we find ourselves in at present. On the Wealth management side of our business we are passionate about helping you to achieve your goals. We don’t have a ‘one size fits all’ instead we tailor a bespoke solution for each and every client. Wealth creation and importantly preservation are at the heart of our recommendations. We offer advice on pensions, investments and our aim is to legitimately reduce client’s tax bills wherever possible by mitigating income tax as well as capital gains tax and ultimately inheritance tax. At the heart of every successful business is an effective Employee Benefits Strategy that seeks to balance the differing needs of employees with an employer’s desire to attract, motivate, retain and reward the best employees as cost effectively as possible. As a business you want to ensure that your costs are controlled and valued, and that your Employee Benefits Programmes are appreciated. At 3Difs, we are dedicated to providing, support and solutions by offering innovative and customised solutions. Our expertise, commitment and skilled workforce enable us to be at the forefront in design, implementation and management of Employee Benefits Programmes. In addition, our reputation of building strong relationships is second-to-none and we pride ourselves on the specialised and tailored service we provide. We provide Pensions, Group Income and Group Life Protection as well as Private Medical schemes. We also offer ‘one to one’ advice for employees on their existing benefits from previous employments.
Freight Trusted to deliver on time and in temperature Tek Freight specialises in the GDP transport of temperature-controlled Pharmaceuticals throughout the UK and Continental Europe. Our fleet of GPS tracked dual temp vehicles are some of the most technologically advanced on the road today. • Same-day and next-day delivery across Europe • GDP compliant • Door-to-door cold chain control (-30°c to +29°c) • 24/7 temperature and location tracking
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We advise clients with Mobile employees to help businesses make substantial cost savings by introducing cost effective travel and subsistence payments. Mobile employees cover different categories of employees such as: • Site-based workers • Engineers, maintenance workers and lorry drivers; • Outside Sales staff • Employees who work a substantial time away from their office. Introducing new travel and subsistence arrangements can be beneficial to both employees and the business providing they are introduced correctly. Any such arrangement must meet HMRC guidelines. Substantial savings can be made in excess of £1000 per mobile employee per annum. 3Difs offer a cost effective arrangement that ensures that businesses and their employees can benefit from significant savings safe in the knowledge that the robust processes and associated audit trails meet all HMRC requirements. 3Difs has introduced the arrangement to many different size organisations from those with 30 employees up to those with several thousand employees.
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www.3difs.com
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CLINIGEN
“ON ONE LEVEL, WE HAVE TO LOOK AFTER THE SAFETY OF OUR PEOPLE AND THAT WILL BE AN ON-GOING PROCESS IN OUR WAREHOUSES, HUBS AND OFFICES. ON THE OTHER, WE ARE DESIGNED TO HELP IN THIS SCENARIO.”
SPECIALTY DRUGS
In recent years Clinigen has spent tens of millions building up its own portfolio. One of the more recent additions was the metastatic melanoma drug Proleukin, that the company believes has promising potential. “Proleukin is a good example of what we try to do. It is an older drug, first launched in the US in 1991 to help the immune system by boosting its natural defences against cancer. 30 years on, the drug is still valuable, used and active; it has a very interesting mechanism of action and thus a number of potentially different uses,” explains Mr Chilton. “We are known for acquiring these older, but still very much in demand drugs, particularly from large pharmaceutical companies that tend to focus
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on developing and launching newer products. Proleukin has a lot of life left, and an extra potential use for autoimmune diseases, so that could be quite exciting in the next three to four years.” Being a pharmaceuticals supplier, surely Covid-19 must have brought an unexpected challenge? Shaun Chilton says: “On one level, we have to look after the safety of our people and that will be an on-going process in our warehouses, hubs and offices. On the other, we are designed to help in this scenario.” “We are involved actively in helping to distribute some of the newer medicines that are coming forward to deal with some aspects of Covid-19. To this end, we have also recently signed an agreement
with Synairgen to launch a Managed Access Program for Synairgen’s inhaled formulation of interferon beta (IFN-beta), SNG001, in the UK and the EU for the treatment of hospitalised Covid-19 patients.” “We are working with a number of companies who have products being tested against
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CLINIGEN
Covid-19 and are very pleased to be working with Synairgen to make this highly promising Covid-19 treatment available internationally. The early study results demonstrate that SNG001 may have a vital role in helping hospitalised patients recover more quickly from the disease.”
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CLINIGEN
MANAGED GROWTH
Asked about other potential challenges that the business is facing, Shaun Chilton says: “I think we are no different from any other company that is growing very quickly, as we have done consistently, in our combination of organic growth and acquisitions. Ultimately, it is about controlling this growth and effectively interconnecting things that we add on.” “It is also about people - to keep high-calibre people, we need to keep them happy, give them development opportunities and a sense of purpose. We can certainly give both - we spend a lot of money on training and development and what we do is genuine - we save lives.”
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CLINIGEN
He further points out that although Clinigen does not physically manufacture anything, sustainability is high on the agenda, as for any public company. The company is working with partners to encourage them to use novel packaging materials and has set up hubs in various parts of the worlds to reduce travel time and source and distribute drugs locally as much as possible Speaking about further development, Mr Chilton reflects that in the immediate future, the company will look at consolidating the business, improving the synergies and interconnecting the acquired capabilities. “Further ahead, we would look at further expansion, adding both products and capability to the business. That’s the strategy for the medium term.”
“FURTHER AHEAD, WE WOULD LOOK AT FURTHER EXPANSION, ADDING BOTH PRODUCTS & CAPABILITY TO THE BUSINESS. THAT’S THE STRATEGY FOR THE MEDIUM TERM.”
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CLINIGEN
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