Clinigen’s role in global specialty pharmaceuticals

Clinigen Group is a global specialty pharmaceuticals and services company headquartered in Burton on Trent in the UK. Started in 2010 by CEO Peter George merging the companies Keats Healthcare, Clinigen and Clinigen Healthcare, the organisation now provides services in over 130 countries. As well as the UK, the company has offices in the US, Japan, Australia, South Africa and Singapore.

Clinigen’s mission

The company’s mission is to enable patients across the world, with unmet medical needs, to receive medicines critical to their care without delays and to improve their quality of life. Clinigen’s mission is to deliver the right drug to the right patient at the right time to improve the quality of people’s lives around the world.

To enable this, Clinigen Group carefully navigates the ethical and regulatory landscape of the pharmaceutical and biotechnology industry, working within the set requirements for each country that it operates in.

The company provides medicines both licensed and unlicensed for the treatment of patients through a variety of different routes including commercial supply, clinical trials, managed access programs and unlicensed supply.

Responding to challenges

There are specific challenges that Clinigen is responding to through its services and products. Significantly, around 80% of patients in the world have minimal or no access to medicines to treat their diseases. In Africa, Asia and South America especially, access to treatments can be very limited.

Clinigen manages its business units by developing relationships with each of the key groups essential to successful delivery of the products to the patients such as customers and stakeholders including pharmaceutical and biotechnology companies, contract research organisations, healthcare providers and Key Opinion Leaders (KOLs).

Clinigen restructure

Through a process of growth and acquisition after it bought Idis, another organisation involved in patient access to medicines in April 2015, the company has now restructured into four business units which are complementary to each other - Clinigen Clinical Trial Services, Idis Managed Access, Idis Global Access and Clinigen Speciality Pharmaceuticals to provide its global network for improving the health of patients.

Clinigen has also recently acquired Link Healthcare/Equity pharmaceuticals that are based in Australia, South Africa and Japan. The acquisition is hoped to considerably strengthen the Group’s global leadership position in the AAA region with three key hubs in Singapore, South Africa and Australia and in Link’s local operations in Hong Kong, Japan and New Zealand.

Link’s well-established pharmaceutical and medical technology customer bases, along with access to key opinion leaders in this region, will provide the Group with excellent local knowledge and expertise.

Clinigen Clinical Trial Services (CTS)

Clinigen CTS combines expertise in sourcing and managing the flow of commercial medicines from pharmaceutical companies for use in clinical trials.

The company employs expertise and knowledge of the regulatory processes in different nations, customs operations as well as experience working in supply chain to deliver the compounds to their final destination.

Idis Managed Access

Working on behalf of pharmaceutical and biotech companies, including orphan and niche drug companies, Clinigen helps to provide physicians with early stage medicines for their patients that are not otherwise available in their country. This may be due to them not being eligible to part of the clinical trial but may still benefit from access to these medicines or the drug not having yet launched.

Idis Managed Access aims to carry out the service by operating ethically. Providing medicines through this route is known by different names in different nations such as expanded access, compassionate use, named patient and early access.

In 2015, the company was working with 19 out of 25 of the top pharmaceutical and biotech companies, particularly in the areas of high unmet medical needs. Unlicensed medicines were delivered to 95 countries throughout the year. The company was also actively managing 99 products.

Idis Global Access

This business unit provides pharmacists with on demand unlicensed access to medicines that are unavailable or in short supply. The organisation previously just operated in the UK and Europe but has expanded to include other global markets.

Understanding the local or regional environment that the pharmacists work in is key for Idis Global Access. The services available through this route also complement the services available through Idis Managed Access by providing unavailable medicines at a different point in the process.

Clinigen Specialty Pharmaceuticals

Clinigen is also able to market and distribute speciality niche hospital only pharmaceuticals which are no longer marketed by the original makers of the medicine. Clinigen SP acquires the rights to these medicines and revitalises them whilst maintaining the patients access to these essential medicines.

The medicines are usually for rare or critical diseases. It gains the rights to the drug for supply to specific markets using its unique global capability to supply these through both licensed and unlicensed routes.

Clinigen’s unique revitalisation model is key opinion leader and hospital driven and utilises its regulatory and logistical expertise to provide our partners with a single responsible owner with a global solution for divestment.

Clinigen SP currently has five products that are used in niche oncology and infectious disease areas that are provided through this route.

About The Clinigen Group plc

The Clinigen Group is a specialty global pharmaceutical company headquartered in the UK, with offices in the US and Japan. The Group is dedicated to delivering 'the right drug, to the right patient at the right time'. In April 2015, Clinigen acquired Idis, the market leader in the global supply of unlicensed medicines.

The Group now operates as four synergistic businesses; Clinigen Specialty Pharmaceuticals, Clinigen Clinical Trials Supply, Idis Managed Access Programs (this now includes the previously branded Clinigen Global Access Programs business) and Idis General Access.

The Managed Access Programs business develops and implements exclusive access programs for biotechnology and pharmaceutical companies and has provided physicians with an ethical solution to access unlicensed medicines for thousands of patients with an unmet medical need.

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Last updated: Apr 4, 2020 at 8:13 AM


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