A 5-Step Approach To Strengthen Clinical Trial Partnerships In Low- And Middle-Income Countries
By Chantal Sarmanoukian, Bill & Melinda Gates Medical Research Institute
In many business circles, the procurement process is all about implementing systems so that most, if not all, procedures can be standardized. What we have found, as a virtual biotech organization working on clinical trials in low- and middle-income countries (LMICs), is that cultivating relationships is the “special sauce” that drives our procurement process. Procurement, in our case, refers to the three main components of running clinical research: clinical supply, laboratories, and contract research organizations (CROs), who run the research sites for our clinical trials.
Several decades ago, for U.S.-based biotech organizations, most clinical trials were based in the United States. U.S.-sponsored research then began to expand in Europe, eventually reaching Eastern Europe. Today, research efforts have expanded throughout the global south. This is especially important for our research, which aims to tackles diseases like malaria and tuberculosis that disproportionately impact LMICs.
Beyond The “Block And Tackle”
Procurement, for most organizations, follows a basic “block and tackle” process. We issue a request for proposals (RFP) that lists the services required and the capabilities that potential vendors must possess, and then receive information from prospective suppliers in response. Once we synthesize the information, we enter a selection process.
To find suppliers for our programs, however, we need to go beyond just selecting the best offer, contracting with them effectively, and then managing them. For a virtual organization like ours, to be successful in the marketplace of suppliers we have to strive to be the partner of choice. Relationships are key.
We have a five-step approach — to not just perform the basic mechanics of procurement but build relationships with partners.
1. Emphasize Your Organization’s Social Mission
We say to our targeted suppliers, “Come work with us in these countries that need your products the most, bring your knowledge and expertise, and let us work together to potentially help save lives.”
We bring our clinical research to where the patients are. We aim to address public health challenges where the incentives don’t exist for traditional pharmaceutical development companies. We do not need to consider the potential profits of the drugs we develop; our mission is to save lives.
Our mission immediately launches collaborations on a different track. Suppliers understand that we are not seeking to lower their fees beyond feasibility. Instead, they understand that we are invested in both parties flourishing — and this in turn inspires better contractual performance.
2. Codify Collaboration In Your Contracts
Our contracts have two levels of oversight. The first is in managing the work at hand. But our contracts also include a structure to oversee the relationship at the enterprise level, between our organization and the CRO. Typically, we have a joint steering committee, composed of senior leaders of both organizations, that maintains investment in the partnership over the duration of the contract and beyond. In this way, we can ensure that the work is mutually beneficial to both parties.
For us, it is not just about doing the work. These collaborations help us stay lockstep to make sure that, however the work gets done, we are still mutually supportive. This is important, as some of the clinical trial work we undertake lasts several years. We need to keep track of the vision that we decided on at the start and make sure that the relationship is still working.
At the start of every collaboration, there is a philosophical alignment that we codify in a governance structure. And we do this intending to come back to our vendors for potential investments and additional partnering. We want to grow together.
3. Emphasize The Strength Of Your Pipeline
Our mission — to develop drugs, biologics, vaccines, etc. for those in the greatest need — is important, but our suppliers also care about the amount of work coming in. We have a unique research pipeline, which means that a supplier can work on one project and make decisions based on the potential of other projects still in the discovery phase. Perhaps you have a similarly unique research pipeline?
We work with suppliers to understand their long-term needs. We help them grow so they can handle additional projects, expanding our partnership with them, and both parties appreciate the growing relationship. This is a key lesson.
4. Help Clinical Research Sites In Low- And Middle-Income Countries Build Capacity
Typically, biopharma organizations work with third parties in locations where they have conducted clinical research for years. Instead, we work in spaces where clinical research capabilities are less established, where the medical and patient infrastructure can vary depending on location.
Instead of disqualifying sites for missing certain elements, we find it helpful to review the public utilities — water, electricity, and internet bandwidth — after the selection process and provide solutions where necessary. For the medicines and experimental products used in the trials that require refrigeration we work with the supplier to ensure that backup power supplies are in place if the electric grid is unreliable. We also review the training protocols for the staff, the logistics of the trial itself, and security measures at all the research sites.
Recently, we established a relationship with a CRO in a middle-income country to provide five research sites for a Phase 3 clinical trial that we launched. When we went through our basic checklist, we found that all the sites needed pharmacy refrigerators, four of the five sites needed minus 20 degrees C refrigerators, and one of the sites needed an incubator. We also needed a separate partnership for lab capabilities, to enable clinical and bioassay development research. Helping the CRO meet these needs allowed us to partner with an organization that otherwise met all of our needs.
By helping to build capacity and capabilities as part of the study operations in low- and middle-income countries, you build a two-way relationship with suppliers. And, that way, leaving them with new infrastructure and capacity, they can work with other pharmaceutical organizations — public or private. They are now a venue for other organizations to consider. These investments, and the increased capabilities they bring, will be in place long after our work is completed.
5. Be Flexible With Suppliers
There is no “steady state,” no “one size fits all” for every single thing that you do. You have to be available and creative to figure out the needs that pop up and then address those needs in ways that are user-friendly to your stakeholders — which include your suppliers.
When the original plan includes getting all services from only one CRO or contract development and manufacturing organization (CDMO) but they aren’t able to deliver, we pivot and find additional third parties for support. We identify candidates, provide due diligence and audit, and then either contract directly with the new candidate or we work with the first supplier to have them contract directly and maintain oversight. This augments the supplier’s network of third parties that they can use for future work while also providing the necessary support for the study at hand.
The flexibility is not relying on a “one size fits all” strategy and accommodating with a fit-for-purpose approach to meet the study needs.
With this approach, we are not just aiming to save lives, but we may also contribute capabilities. We help build infrastructure and capacity, potentially creating jobs and opportunities for others. Our procurement processes matter — they are integral to the conduct of successful clinical trials.
About The Author:
Chantal Sarmanoukian is of head, strategic sourcing and procurement at Bill & Melinda Gates Medical Research Institute (Gates MRI) and is a pharmaceutical executive with close to 30 years of experience and expertise in operations roles spanning laboratory, clinical, clinical supply, travel, facilities management, and strategic sourcing and procurement across research and development and commercial categories. She is experienced in working with startups and well-established small and large pharmaceutical and biotech companies to drive and develop fit for purpose sourcing strategies and establish and enhance supplier relationships across the globe for lasting performance that benefit each organization she is a part of. Prior to joining Gates MRI, Sarmanoukian held various positions of increasing responsibility across R&D and business functions with Bristol-Myers Squibb, Shire, and AMAG.