Clinigen BFM 83

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

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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.

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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.

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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.

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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.

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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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CLINIGEN

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