Cryoport talks compliance, biopharma expansion, and Brexit

Boasting a revenue of $555,000 (€489,000) this quarter from commercial agreements supporting Novartis’ Kymriah and Gilead-Kite’s Yescarta, cold chain logistics firm Cryoport continues to grow its presence in the temperature-controlled logistics space.

In addition, Cryoport announced a 91% increase in biopharma revenue for the three months ending September 30, 2018, compared to the same period last year.

This year alone, the firm opened two new logistics centres and cemented partnerships with McKesson Specialty Health​ and Be The Match BioTherapies​ for the delivery of supply chain services in the cell and gene therapy industry.

Add this to the recent regulatory approvals​ of key clients’ chimeric antigen receptor (CAR) T-cell therapies in Europe, and it would appear Cryoport is set to increase its presence across the pond.

We spoke with Cryoport’s chief commercial officer, Mark Sawicki, about the firm’s recent investments, partnerships, and compliance strategy – which Sawicki says is transforming from a ‘nice to have’ to a ‘need to have’ within the industry.

Cryoport recently announced two new logistics centres. What prompted these investments? ​

We opened two new facilities this year, one in New Jersey and the other in Amsterdam, to support our expanding clinical and commercial base. The average facility buildout costs between $2m and $2.5m and adds approximately seven staff members per site. Employee numbers are expected to grow as volume increases.

The site in Livingstone, New Jersey, is about three miles from Novartis’ commercial manufacturing facility and in close proximity to clients Johnson & Johnson, Celgene, and Bristol-Myers Squibb.

The facility enables these clients to execute almost on-demand unit orders, whereby they receive the unit for distribution within 90 minutes.

The European facility – based in Amsterdam, the Netherlands – has opened in conjunction with the increased launch and clinical trial activity in Europe. This includes broader biologics support, covering clinical distribution for testing and lab samples.

With a growing presence in Europe, does Cryoport anticipate logistical issues as a result of the UK leaving the European Union? ​

As our primary facility for distribution within Europe is in Amsterdam, everything that goes transcontinental passes through this hub or a similar region.

The primary issue that we foresee with Brexit relates to domestic distribution between the UK and European land. That goes for customs relationships that we see between the US and Europe, or between Europe and Asia – you just have to have the proper brokers and customs processes in place. It’s not a major concern, but may just add a bit of logistical paperwork.

Cryoport recently announced separate agreements with McKesson Specialty Health and Be The Match BioTherapies. How do these partnerships help secure the supply chain?​

The key behind both of these partnerships is the integration of our informatics platform with their systems. Clients want to automate more of their processes; full integration enables us to directly transition data between both systems, which will reduce manual re-entry and operator error.

It enables McKesson and Be The Match to pull distribution data from our site and provide it to physicians. It also means that we can pull material-specific information into our systems to collocate with any given distribution shipment, covering material ID numbers and randomised patient identifiers.

What gives Cryoport a competitive edge over other cold chain logistics firms?​

We have what we call ‘chain of compliance.’ This means that we apply the same standards of a biomanufacturing facility to the commodity being moved, including full traceability of the equipment, the processes, and environmental aspects.

We have the ability to track and trace these components for the entire usage cycle of our equipment. It provides a higher degree of visibility for the performance aspects of that piece of equipment.

One of the key elements relates to requalification. If you’re not requalifying the equipment every time it comes back into the facility, you introduce an element of risk. The hold times of these units can change dramatically between one use and the next, and if you’re not retesting and reconfirming their ability to hold temperature for a set period of time, you create risk.

Our platform also has near real-time track and trace, so we can identify where the commodity is, who has custody of the commodity, and monitor temperature in-the-field.

In addition, we know the orientation of the unit and if it has been mishandled. That provides a great degree of comfort to the risk management organisations within the partners we work with.

How might compliance be integrated into regulatory requirements?​

While right now, compliance is not a requirement of regulatory agencies, we believe things are moving in this direction.

If an entity doesn’t have full compliance – which is full traceability of all equipment and processes – we believe that creates significant risk. We have already seen from regulatory authorities, via some of our commercial relationships, that compliance is moving from a ‘nice to have’ to a ‘need to have.’

What should we expect from Cryoport in the coming years?​

We have focused heavily on the regenerative medicine space over the past 3.5 years. Our goal now is to leverage this strong industry position. We probably have 50% market share in this space, which is unheard of.

We will be leveraging that into broader temperature offerings, more complex logistics support offerings, and potentially storage and fulfilment services.

Mark Sawicki has held the position of chief commercial officer at Cryoport since 2015. Prior to this role, Sawicki was chief business offer at AAIPharma Services Corporation/Cambridge Major Laboratories and has also served in senior business development roles at CMC Biologics and at Albany Molecular Research Inc. ​​