Article: How Critical is Logistics to the Development of the Advanced Therapy Market?

There is growing awareness of how critical logistics is to the advanced therapy market. At the 2019 Phacilitate Leaders Europe Event (17 – 18 September in London), multiple logistics sessions reinforced this opinion. 

This article looks at the key takeaways and actions from Phacilitate.

Advanced therapy: a rapidly-growing industry

The industry is moving rapidly. In Europe alone, there are:

• more than 235 established companies
• over 3,000 advanced therapy medicinal products (ATMP) clinical trials
• estimates that the number of patients treated per year in the UK will increase from around 200 to 10,000 by 2028 [Cell and Gene Therapy Catapult]

But with this growth comes challenges…

Pressure to deliver excellence

Practitioners are under increasing pressure to provide patients with life-saving treatments as soon as possible. Treatments that are both cost-effective and affordable. At the same time, the entire value chain must perform flawlessly, ethically and honestly.

The pressure of delivering excellence with speed has meant therapy developers are rethinking their supply chain. Their aim? To create an overarching logistics platform, which is both robust and seamless.

Key trends in advanced therapy

During the conference, a number of key industry trends emerged.

• More therapies have been devised as allogeneic products (e.g. Alofisel by Takeda), as they attract lower COGS and simpler logistics
• Cryopreservation is a growing trend, as it ensures longer shelf-life. For example, World Courier has seen cryo-shipments move from 4% of all its advanced therapy shipments in 2004 to over 25% in 2019
• More companies (e.g. Glycostem, Cell Medica, TC Biopharm) are building their own in-house facilities, as a long-term investment that can decrease expenses related to third-party services and technology transfer, while safeguarding production expertise

Evolution of logistics strategy

ATMP shipments are time-sensitive and temperature-critical, meaning there are two critical logistics attributes that need consideration: facility location (centralized vs decentralized) and preservation method (fresh vs cryo).

Just as therapy developers are changing their approach to design and manufacture, they also need to start adjusting their logistics strategy. By planning and implementing the strategy ahead of time, potential risks that can lead to logistics failure can be identified from the very beginning of the development lifecycle.

Factors like increased employment of narrow-body aircraft and the ‘last 100 metres’ within the hospital ward imply the need for innovative and smaller packaging solutions, as well as seamless coordination between manufacturers and clinicians.

The lesson learned here is that companies can no longer focus solely on developing their product pipeline. They need to start addressing what happens outside of their R&D and manufacturing centers. Such considerations should be incorporated in their design thinking, which would ultimately support successful commercialization of their ATMP.