Examining the biologics challenge in Clinical Trials

10th January 2017 (Last Updated July 16th, 2018 10:30)

CTA talks to Didier Basseras, Sanofi, who describes his thoughts on the cold chain and more

Examining the biologics challenge in Clinical Trials

Didier Basseras, Vice President Clinical Supplies, Sanofi, provides personal insight on how to overcome shortages of drugs within the cold chain, altogether maintaining continuity throughout the process.

Clinical Trials Arena: In your opinion, what are the top cold chain challenges?

Didier Basseras: When we talk about the cold chain we are talking about different families of drugs and patients. On the one hand, there are drugs for rare diseases and very few patients across the world, and on the other hand, there are thousands of patients needing vaccines sometimes concentrated in very specific areas. The combination of these factors with new regulations and geography is creating a huge challenge to deliver the drugs to all these patients.

We have to be able to maintain a high quality compound along the whole supply chain all the way up to the patient, from North to South and from West to East. That is, to guarantee that the product does not undergo any temperature excursions as set by the stability data. As most major pharma companies do, we have strong SOPs and processes covering and managing any excursions of time out of refrigeration. We also have a strong control and monitoring along the chain. So the challenge really is what about the last mile?

At this point, we must guarantee that we have stability and that it is robust enough to manage any excursion which can occur during the storage at home. This is to minimize the risk of wasting drug and treatment discontinuity. There are not any qualified refrigerated storages at patient homes covered by any QC yet, so pharma industries have to search for innovative approaches through devices and services to the patient. For example, developing e-training protocols that make the patients fully aware of the thermo sensitivity of compounds and also the best way to store and to use the drugs. This digital technology is applied as close as possible to the drug to help cumulate dynamically all the different excursions (if any) along shipping and storage, comparing them to the range of TOR acceptance and bringing to the patients the final green light securing the last step.

CTA: What would be the consequences of not doing so?

DB: With biologic products we are in a new paradigm. With small molecules, drugs were waiting for patients, but with bio compounds patients may wait for drugs. In case of mismanagement of the cold chain we may face a shortage of drugs, so having products that have been rejected because of time out of refrigeration directly affects the continuity of the business and the ability of the company to maintain patients in their treatments. The immediate consequence is the inability to treat patients. The ability of pharmaceutical companies to quickly provide new drugs to replace rejected products is not as flexible as it used to be in the past. We have a limited capacity, so any variance on the medical needs can create difficulties if there is not a proactive analysis on the robustness of the forecast.

CTA: What would you say Sanofi is doing to overcome the cold chain challenges?

DB: Whatever the tools and the technology are, the project team's behaviour is key. The interest of the patient is at the core of our way of working. Creating project centricity across the team and focusing on the same goal, accelerates the information flow, creates agility and flexibility to make quick decisions. Also, we are continuing to invest, to optimize our own facilities, to reengineer processes with the LEAN approach, and to innovate with devices measuring temperature excursions along the supply chain. We are developing the preferred carrier partnering model for premium services with efficient shippers and looking to incorporate new shipping models, such as Direct to Patient.

We are also considering new IT solutions for a better integration of data collection. Monitoring the variance of the clinical demand adjusted with the production and distribution master plan can offer opportunities to save drugs and resources with simulation tools helping across different scenarios to make the best decision. At this point we are considering partnering with a technology provider for a better forecast. It is a way not just to create savings, but also to maximize the value of what we do for the benefit of the patient.

CTA: What have been the results so far?

DB: By reducing the development cycle, we make it quicker to market to treat patients faster. We are more efficient in our operating model, which also means we quickly identify good sites for clinical investigation; we are more robust in our forecasts and conduct our trials effectively with the right quantity of drugs and minimizing the drugs wasted because of TOR.

CTA: What would you say are the challenges of reduced shelf life?

DB: A new regulation, which came into effect in 2016, declares that we should apply the shelf life at the lowest level of the packaging. This did not use to be the case. This is a difficult challenge for all pharmaceutical companies and it is creating a risk of treatment discontinuation for patients. In case of shelf life extension, we will not be able to manage the new labelling out of our GMP facilities, as future relabelling for extended shelf life means to unpack and repack. This means that some drugs might be rejected as unusable because of the expiration date on the label. We should have more discussions with regulators to have some flexibility because if not, patients will be affected.

CTA: What are Sanofi doing something about this?

DB: We are contributing in some ongoing discussions with IMP groups in the US and Europe. They are trying to influence the future regulation. There is not enough interaction between all the different regulators across the world. We should at least have a common approach between Europe and the US. There are now emerging differences with new markets, so we have to continue lobbying to influence new regulations through the different groups.

CTA: How optimistic are you about these discussions?

DB: I am very optimistic. I will put all my passion into promoting benefits for patients.