Connecting the dots along the supply chain: Interview with Catherine Coles
July 23, 2020
As Bayer Canada’s Director, Trade Relations & Strategic Partnerships, Catherine Coles manages Bayer’s partnerships with key drug distributors, pharmacies, and hospitals, enabling patients to access their prescriptions at the right time and place. At the best of times, distributors must manage daily deliveries to over 11,000 sites, many of them in remote locations.20 When the COVID-19 crisis created unpredictable deviations in pharmaceutical demand, Catherine’s role took on new urgency. Behind the scenes, she worked tirelessly with her partners to ensure the specialty drug supply chain remained intact.
Catherine is also using her regulatory and compliance expertise to help manage product supply for the global COVID-19 clinical trial program launched by the Population Health Research Institute with support from Bayer Inc.20 With Canadian operations housed in Hamilton, the program is evaluating the safety and efficacy of different combinations of drugs, including Bayer’s rivaroxaban and interferon beta-1b.
Tell us about the early days of the pandemic. How did things change in Trade Relations?
Remember the days when everyone was hoarding toilet paper? We realized the same thing could easily occur with pharmaceutical products. We couldn’t let that happen, because patients with serious conditions, such as heart disease or cancer, can’t go without their medications, not even for one dose. Anticipating large orders of certain medications, we put measures in place to ensure these drugs would reach all patients at the time of need. Because of this work, the shortages we might have experienced didn’t materialize.
Did you need to collaborate with stakeholders in new ways to ensure patients had access to their medications?
To ensure consistent distribution, we had to be quick on our feet and transparent. By the middle of March, our team was holding meetings with key players in the supply chain every other day, communicating our business continuity and response plan. We had to marry the demands of stakeholders with federal and provincial regulations, such as the maximum prescription duration of 30 days across the country. We continuously evaluated our inventory to ensure we could meet changing demands. None of this would have been possible if we didn’t already have strong relationships with stakeholders. You can’t wait until a crisis to establish good relationships. You have to build them from the ground up—brick by brick, as the saying goes.
Bayer has a number of drugs for serious and rare diseases. Has the pandemic impacted access to these specialty medications?
Understandably, many oncology patients didn’t want to risk exposure to Covid in infusion or injection clinics. This led physicians to re-evaluate their treatment plans and consider whether some patients could use oral medications for a time. Something similar happened in cardiology. New guidelines created during the pandemic enabled some patients to begin treatment on oral medications without the usual intermediary step of injected or infused drugs. This meant patients could pick up their medications at the pharmacy rather than receive therapy at the clinic. We dialogued with pharmacies and specifically our patient support programs to ensure they had enough inventory to support such patients. In the ophthalmology space, our medications can’t be taken at home, so we had to work closely with our partners to ensure continued supply as they spaced out clinic visits and stepped up safety protocols to minimize Covid risk.
Tell us about your experience contributing to the research collaboration between Bayer and the Population Health Research Institute for the Covid-19 clinical trial program.
I manage product sourcing and distribution of materials to the research sites. Clinical trials have regulations around inventory stock, and I make sure we’re complying. For example, you need to validate the products used in a trial and, as far as possible, use the same lot numbers. Interestingly, one of the most challenging issues was shipping product to a clinical trial site in times of COVID: coordinating receipt of product at sites with limited access, while working as quickly as possible to get product to a site so it could ultimately be delivered to patients.
One of the products used for the clinical trials is not available in Canada, so I had to arrange bringing this new brand into the country to the clinical trial site. This meant working with the global and local supply chain and with our regulatory team and Health Canada to determine quantities, timing, exportation, and importation. With all the regulations involved, this required mountains of collaboration. I was on the phone every day, sometimes late into the night because of time-zone differences. But we got the job done.
How might the pandemic transform Canada’s specialty pharmaceutical market?
In general, health care is moving toward more virtual consults, which speed up access and are especially convenient for patients in remote locations. I expect we will help all HCPs support patients virtually; we will have to ensure we are providing the right tools for our PSPs to support more telecommunication or virtual communication with patients. The pandemic has proven it can be done, though there will always be a place for face-to-face interactions. I also anticipate a greater emphasis on oral medications, which do not require as many “in person” clinic visits.
What role will Trade Relations have going forward?
The pandemic isn’t over and we can’t drop the ball. My main goal is to ensure timely, fair and reasonable distribution of all our products. This means patients in Northern Saskatchewan need to have the same access as those in downtown Toronto. We are also gathering data and will continue to collect data on the impact of the pandemic: what are the trends, where our patients are, who needs more or different drugs, and what types of PSP services are needed. This will help us serve our patients and distribute product throughout the pandemic and beyond.
References:
20. Covid-19 driving unprecedented demand. CAPDM News. https://www.capdm.ca/News/CAPDM-News/COVID-19-is-Driving-Unprecedented-Demand-(1).aspx