DIA Europe 2023: De-Carbonizing Your Clinical Trials

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This panel at DIA Europe 2023 on Thursday was focused solely on addressing the issue of carbon emissions (CO2) “Creating an Impact for Patients and our Planet – Advancing Drug Development Towards a More Sustainable, Carbon-neutral and Circular Model.”

Setting the stage for the audience, Marc Philipp, partner and managing director at Kearney, explained the emissions issues related to pharma, as well as water pollution, which lead to extensive effects on the environment and quality of life. To measure effects on emissions, there are three levels or scopes. Scope 1 is direct, Scope 2 is indirect (owned and by the company) and Scope 3 indirect (not owned by the company). Accordingly, 90% of pharma emissions are from Scope 3, comprising 66% pharma suppliers, 12% of pharma itself, and 13% from customers.

At this point, two-thirds of large pharma have certified their CO2 ambitions, with Philipp noting that AstraZeneca is leading the pack.

ESG includes sustainability, where all ESG principles are being largely adopted, if not required, by large publicly-traded corporations globally. Sustainability related to pharma centers squarely in R&D where the needle on Scope 3 can be moved¾specifically the area of clinical trials. Questions around clinical trials emission drivers include, clinical facilities and partnerships (ex., which sites and CROs and why?); sponsor and participant travel, drug product logistics (ex., where to manufacture clinical trial supply, how to store and transport).

James Gallagher, lead Janssen Clinical Innovation, noted that Janssen is involved in the Digital Health in the Circular Economy (DHCE), a collaboration with NGOs, academia, etc. Based on the explosion of digital healthcare, the trade-off is eWaste. “Unlike traditional electronics, these contain unique contaminants that are not involved with traditional recycling,” said Gallagher.

Slawa Troubniakov, leader of strategic programs at the R&D department of Merck Healthcare, agreed that there is a negative impact to innovation and technology. But companies have to start somewhere. “It’s best to look at the whole value chain and identify the most relative/impactful,” he said. Then that should be measured and quantified to determine a baseline that allows decisions to be made from that baseline.

Neil Mackillop of AstraZeneca said the company looked at three of its Phase III trials and estimated between 1K to 4K tons of carbon emissions a year. “In our trials, the three big hot spots were travel, waste and samples.” Waste comes in the form of over-ordering of supplies “just in case.” But the big surprise was samples. Says Mackillop, “We are flying samples to central labs in dry ice, to shipping to other central labs, and then the samples sit around for 10 to 20 years. Why?”

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Juergen Wieland, Global Drug Development Environmental Sustainability Lead at Novartis Pharma AG, concurred that global clinical supply and the carbon footprint of medication shipments is a problem they are targeting. Novartis is asking questions such as, what does it mean to make three shipments a week to a site vs. using machine learning in IRT shipments to determine a more efficient quarterly shipment. “We also consider re-usable shipper boxes,” said Juergan. “We have to consider what is reasonable and what is waste.”

The basic challenge is where to start and how to measure it and do it scientifically. Roberto Rigobello, senior director, Sustainability, International Operations at Novo Nordisk, says the Sustainability Markets Initiative (SMI) taskforce has a goal to develop a methodology or tool to collect emissions data, and member companies will report their data for Phase II and III trials and in 2030, that data will be used to set targets. The goal, says Roberto, is to create a baseline and then track year over year. “You can’t improve if you don’t have the data.”

Fiona Adshead, chair of the Sustainable Healthcare Coalition noted the coalition was formed by the UK government to bring all of players in the systems together. As she said, “not one player in the system can solve this. We have to learn together to co-create in a pre-competitive approach. It’s a safe space for us to put processes in place to learn.”

And sustainability can be used positively, said Gallagher, for example in the common case of a single investigative site that is under-producing, maybe only enrolling one patient. “We can use sustainability to show that it doesn’t make sense to keep the site open and ship only to that site. Sustainability brings a new perspective. It’s a powerful lens,” he said.

Reference:

DIA Europe 2023, March 22-24, Basel, Switzerland. “Creating an Impact for Patients and our Planet – Advancing Drug Development Towards a More Sustainable, Carbon-neutral and Circular Model.”