Clinigen is a global pharmaceutical and services company focused on providing quicker and broader access to medicines to improve the quality of people's lives around the world. Our mission is to provide the right medicine, to the right patient, at the right time.
We are trusted by both pharmaceutical companies and healthcare professionals to provide access throughout the lifecycle of a medicine: pre and post launch. Through our Services and Products divisions, we provide access to our partners and our own medicines into licensed and unlicensed countries for use in both research and for treatment.
For over 30 years, Clinigen has been trusted by industry and healthcare providers to enable access to more innovative medicines, in more countries, for more patients than anyone else.
Our offerings at a glance
Clinigen support the running of efficient clinical trials through the provision of innovative logistics, packaging, distribution and biorepository solutions alongside global sourcing and supply of comparator medicines, ancillaries, and devices for use in clinical studies to both industry and investigator led researchers.
Design and implementation of global Managed Access Programs (MAPs – otherwise known as Compassionate Use, Named Patient, Early Access, or Expanded Access) to enable pre-approval access to innovative new medicines for the treatment of unmet medical needs.
Partner with Pharma and Biotech to provide access to their medicines in both licensed and unlicensed markets at a country, regional or global level through an exclusive access or licensing arrangement – ensuring maximum access as possible.
We source and supply unlicensed and short supply medicines in response to demand for access from healthcare professionals.
We provide global access to critical medicines that we have acquired or have developed in-house. Clinigen acquires products with the goal to maintain access to those that rely on them and growing access into new markets and disease areas through a targeted product revitalisation strategy. We also develop medicines in-house and provide these into licensed and unlicensed markets.
Whilst there are more medicines being approved every year the global roll-out of these medicines can take years and in some countries they will never be launched. Alongside this, pharma companies often re-allocate resource so that they can focus on different medicines or different geographies – something that could impact patients. Whether it be a recently approved medicine or a more mature established medicine, and whether it be in licensed countries where the medicines are approved and launched or unlicensed countries where the medicines are not commercially available, Clinigen is committed to ensuring critical medicines can be accessed by more people who need them.
Before a medicine becomes commercially available anywhere it needs to go through clinical development, something which can take 6-7 years on average and cost around £1bn. With the increase in more targeted and personalised therapies that address true unmet medical needs this clinical development is becoming more complex. Clinigen is committed to supporting pharmaceutical companies to run efficient clinical trials that reduce wastage, reduce cost and run on time, expediting their route to approval. We are also committed to making sure that alongside clinical trials patients with unmet medical needs can access new targeted unapproved medicines prior to them being approved anywhere in the world.
In developing countries there continues to be a huge issue accessing much needed medicines. It has been estimated that 2 billion people in low and middle income countries have no access to essential medicines. It has also been reported that of all specialty medicines used in emerging markets in the last 10 years only 0.1% of them are new medicines approved somewhere in the last 10 years. We believe we can play a huge role in enable better access to both new and established medicines in developing countries and will continue to work with all our stakeholders to ensure we support this important initiative.
Patients are at the heart of everything we do at Clinigen. They are the reason we exist and so it is critical the solutions we provide continue to focus on their needs and take into consideration their perspectives. It is vital we communicate effectively with patients and patient groups, vital we have solutions that focus on the patients needs and vital we understand how our day-to-day roles can have a positive impact on patients around the world.
How we will measure progress against our commitments
We will measure our progress against our stated commitments through by monitoring and reporting against a number of data points highlighted below. We have also highlighted recent initiatives with contribute towards making an impact against our commitments:
Our progress and actions
Clinigen is dedicated to solving an increasingly global healthcare problem - ensuring patients around the world have access to the critical medicines they need. Our mission gives Clinigen a clear purpose - to ultimately improve health outcomes and improve the lives of patients accessing our medicines whilst delivering greater value and sustainability to our stakeholders. We have summarised below our progress in contributing to improved global health outcomes:
- We support access to medicines right through the medicine lifecycle from phase I development through to approval and market exit.
- In the last 3 years we have provided access into 127 countries for patients with unmet medical needs.
- In the last 3 years we have provided access into 65 developing countries where access to important medicines can be hugely delayed and in some cases would never happen.
- More than 20,000 healthcare professionals across more than 5,000 different hospitals rely on Clinigen to provide access to approved and unapproved medicines.
- We currently partner with more than 400 pharma and biotech companies to run efficient and effective clinical trials to develop new medicines for the treatment of a broad range of diseases.
- We manage for than 140 Managed Access Programs which enable patients to access new innovative medicines that have not been approved anywhere in the world.
- We are providing access to medicines for patients with unmet medical needs more than 12 months in advance of their commercial launches
- Source and supply access more than 1,200 medicines on an on-demand basis.
- We have acquired and revitalised seven of our own medicines and provide access to these medicines in both licensed and unlicensed countries to ensure every request for access is responded to.
- We have developed 12 medicines in-house and now provide these into licensed and unlicensed markets.
Creating broader and quicker access to new medicines is an ethos we live by at Clinigen. It is the reason we come to work every day. At Clinigen we created a Patient Innovation Lab that helps us to think up new ways to be more patient focused and also to share real life stories about how what Clinigen does positively impacts patients around the world.
Our mission is to deliver the right medicine, to the right patient, at the right time and we regularly receive feedback on how our work has benefited patients directly.
We help HCPs to transform patient outcomes by enabling more patients in more places to access treatments to improve their condition. We believe every patient should have access to the medicine they need at the time they need it, with confidence in its quality.
Our digital platform, Clinigen Direct, is a globally available service which helps clinicians, pharmacists and pharmacy technicians to source hard to find medicines by connecting them with our specialist customer services team. By combining a passionate, multilingual customer service team and our in-house Medical Information, Quality, Pharmacovigilance and Regulatory experts, we aim to deliver real benefits to pharmacists.
Clinigen recognises the importance of balancing the interests of its customers, shareholders, employees, suppliers and the communities in which it operates. Management of the environmental and social issues that play a part in the business are key factors in the Group’s strategy for success and in the practice of good corporate governance. We expect our clients and customers to behave ethically and responsibly and to comply with their legal obligations at all times.
We have provided a number of case studies demonstrating our commitment to patients and how what we do has an impact in relation to the UN Sustainable Development Goal 3 ‘Good Health & Wellbeing’.
A patient with chronic tophaceous gout and particularly troublesome tophi on their hands had endured a 12-year battle to find satisfactory treatment. Having been treated with multiple different licensed and unlicensed treatment options, all had either proved ineffective or caused side effects. The consultant had a new product they wanted to try, so got in touch with the manufacturing company to find that the product was not marketed in the UK and they would not be able to import it. The manufacturing company did recommend using a specialist wholesaler, such as Clinigen, who might be able to support the hospital in obtaining the product.
What Clinigen did:
Following this, Clinigen’s Key Account Manager picked up this need and discussed using Clinigen’s expertise to import the product into the UK. This involved looking at the product’s detailed status and seeking specific approvals from relevant bodies, which was made more complicated by the fact that the product was centrally authorised, meaning that it was technically not considered “unlicensed” in the UK, despite not actually being available. Following many negotiations in the context of many competing priorities for the regulators with the COVID-19 pandemic ongoing, Clinigen secured a supply route for 3 months of stock.
How did this make a difference to the patient?
After the patient was successfully started on treatment, and within 1 month there were already signs of significant improvement. The Consultant advised that if the patient’s urate levels could be sustained at this level, the expectation would be resolution of tophi and ultimately cessation of gout attacks within the next 12 months.
It is hoped that that this treatment will have the potential to transform this patient’s life, after a long journey trying different treatments. A final happy ending to the story came a couple of months later when additional supply was granted and approved, based on the positive outcomes of the patient.
A physician at Dana-Farber Cancer Institute in the US decided to use Proleukin off-label for the treatment of chronic graft-versus host disease (GVHD) in a 4-year-old boy. The child was post stem-cell transplant and had developed chronic GVHD that was unable to be controlled with steroids or various other therapeutics.
With no Medicaid coverage for this, the Expanded Access route was the only option. Clinigen’s Medical Affairs team spoke with the physician to discuss this route.
What Clinigen did:
Within 48 hours, Clinigen had arranged the “Letter of Authorization” required by FDA. This was made possible because unanimous approval from the multiple Clinigen stakeholders was secured within 1 hour! The team then worked closely together to make sure everything proceeded smoothly and compliantly to enable drug to be shipped upon FDA approval.
How did this make a difference to the patient?
Clinigen teams instantly mobilized, with this young and very poorly paediatric patient in mind, so that the site received authorization to proceed with treating this little boy within 24 hours of them submitting the request.
Clinigen demonstrated that we exercise the same passion with our own medicines as when we are handling a partner’s medicine in a MAP, putting the patient at the heart of everything we do.
One of Clinigen’s partners had been let down by their existing suppliers for the Asia region. A medicine had not made it to the gate in time to get on the last flight. This meant a very ill young girl in China was left without the cancer medication that she needed, and her family had a further agonising wait. Other suppliers were saying they couldn’t help on the weekend and it wouldn’t be possible. The treatment was now extremely urgent, with only days to spare. The company turned to Clinigen late on a Saturday night, with a desperate plea to take over and try to secure delivery of the medicine for this young girl.
What Clinigen did:
Time was of the essence and the Clinigen team rose to the challenge, springing into action immediately, with each party playing their part to ensure that the medicine had the best chance of reaching the patient. At several points it was not clear whether it would be possible even for Clinigen to secure product and a route to China in time, but the team continued to prepare all documentation, approvals, and logistics, to make sure that everything was ready, in faith that a path forward would be found.
This coordinated response and effort was rewarded when stock and a logistical solution were confirmed, all against the odds. The “can-do” attitude, patient-focus and tenacity of Clinigen’s team set the tone for all parties within the process going the extra mile, which was a critical success factor in making this happen.
Operating in the context of global lockdowns and multiple extra COVID-related requirements, the team were faced with unexpected challenges and setbacks while the product (which required cold chain shipment) was on route from Belgium via Germany and on to China. At moments it seemed that all options were exhausted. Our out of hours team member was constantly watching over the process, researching alternatives and updating all sides over the weekend and throughout the week, to see it through. After a final tense delay while the vials were swabbed by virus control in China, we heard that the patient had received her first infusion in hospital.
How did this make a difference to the patient?
When supply routes seemed to be failing, when others had said it wasn’t possible, Clinigen’s team found a way through. This meant that the young girl could start treatment for her cancer without further delay and a desperate family were given hope and shown that they are not beyond reach.