spacer
home > ebr > autumn 2018 > rising to the challenge
PUBLICATIONS
European Biopharmaceutical Review

Rising to the Challenge

Advanced therapy medicinal products (ATMPs) represent one of the fastest-growing areas of clinical research due to their potential to cure severe chronic conditions. Despite the important health benefits that ATMPs are expected to bring, relatively few have reached the market, and several have been subsequently withdrawn. Oncology indications remain the largest sector in the UK, and, while Phase 3 trials have increased, most are still in early phase development. Therefore, it is likely to be several years before the full potential for ATMPs is translated into meaningful patient benefit and will be dependent upon researchers overcoming numerous challenges, including recruitment, operational, and safety considerations. Overcoming these challenges requires innovation, collaboration, and sound strategic development to ensure ATMPs are brought to market efficiently and without a prohibitive impact on drug budgets. This article will discuss how researchers in the UK are at the forefront of this scientific endeavour, with several exciting collaborations, backed by Innovate UK, generating optimism for future success.

The ATMP Market

ATMPs are a new generation of treatments that use gene therapy, cell therapy, and tissue engineering. They offer unprecedented promise for the treatment of diseases or injuries that currently have a high, unmet medical need, such as Alzheimer’s disease, cancer, muscular dystrophy, ophthalmology, and skin in burns victims. Given their curative potential in severe chronic conditions, ATMPs are, unsurprisingly, one of the fastest-growing areas of research, with an estimated global market opportunity of up to £14 billion by 2025, with predicted additional year-on-year growth potential of 25% to 2030.

While optimism may be justified for the future of ATMPs, the situation today is that this technology remains extremely complex and expensive and is only available to a small number of patients. Results from clinical studies have shown promise, but few products have yet to reach the market – only 10 have been approved in Europe, most recently being Alofisel (to treat anal fistulas in Crohn’s Disease) from TiGenix/Takeda. Of these, four have since been withdrawn. This is slow progress considering that the first ATMP, chondrocelect (to repair damage to the cartilage in the knee), was approved nine years ago, especially given the level of interest and investment in the field.

Read full article from PDF >>

Rate this article You must be a member of the site to make a vote.  
Average rating:
0
     

There are no comments in regards to this article.

spacer
Dr Fiona Thistlethwaite is a Medical Oncology Consultant within the experimental cancer medicine team at The Christie Hospital, UK, and Honorary Senior Lecturer at the Division of Cancer Sciences, Faculty of Biology Medicine & Health, at The University of Manchester, UK. Fiona is also the Director for iMATCH.

Dr Ian Thomas is a drug development expert with several decades of early and late phase oncology experience. In his role as Clinical Delivery Director for Aptus Clinical, a specialist CRO, Ian leads the company’s advanced therapy clinical development activities and is extensively involved in supporting iMATCH.
spacer
Dr Fiona Thistlethwaite
spacer
spacer
spacer
Dr Ian Thomas
spacer
spacer
Print this page
Send to a friend
Privacy statement
News and Press Releases

Pharmaceutical and Medical Industry Increasingly Demands Automated Testing Solutions

After the manufacturing processes in pharmaceutical and medical industries reached a high level of automation in recent years, manufacturers are more committed to automating their testing processes as well. Production-related tests as well as tests for product release are to be largely automated. In addition to higher specimen throughput, an increase in reproducibility through the elimination of operator influence is a main objective for manufacturers. Zwick Roell offers various levels of automation for testing syringes, insulin pens, and auto injectors.
More info >>

White Papers

The Flexible Factory Concept: A flexible bioprocessing platform to meet the changing needs of biomanufacturing

GE Healthcare Life Sciences

For the past several years, the biopharma industry has been buffeted by dynamic market conditions that are rapidly reshaping manufacturing requirements. These factors include: • The rise of small-market pharmaceuticals that do not require the production scale of the previous “blockbuster” drug model • Increased titers and process productivity that generate more bulk-product within a much smaller manufacturing footprint • The emergence of biosimilars and continued evolution of healthcare reform, which will increasingly pressure drug pricing and require greater cost discipline • Greater competition and shorter patent protection timelines, which will further ratchet up time-to-market pressures • Tighter capital markets that will create heightened scrutiny for all new investment projects
More info >>

 
Industry Events

Outsourcing Clinical Trials Nordics 2018

30-31 October 2018, Copenhagen, Denmark

Following on from the success of the 2017 Outsourcing in Clinical Trials Nordics conference, Arena International is pleased to announce that the event will return for its 6th year in 2018. The 2018 event welcomes biopharmaceutical and medical device companies from across the Nordic region to share knowledge and challenges of outsourcing and clinical operations.
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement