A conversation with Donna Libretti Cooke, director, contracting & budgeting & Kits4Life project lead, and representatives from Bayer, Sanofi, Eli Lilly, and Roche
Corporate sustainability efforts have been the hot topic since this decade began. However, some clinical operational professionals think that there's no place for sustainability in their role of conducting clinical trials. However, there is one simple way to implement a sustainability initiative within your organization's clinical trial conduct.
Kits4Life is a nonprofit program that enables clinical trial sites to donate unused clinical trial supplies for humanitarian aid. Several sponsors cofounded the program and serve on the Advisory Council for Kits4Life. Bayer was the first pharma organization to fully implement the platform with their sites and it has now been fully operational for the past two years. Sanofi and Eli Lilly have successfully donated bulk medical supplies from surplus inventories and are currently working on pilot donation programs with their sites. Meanwhile, Roche is the newest partner working on a site pilot as well.
We sat down with clinical operations representatives from Bayer, Sanofi, Eli Lilly, and Roche to learn more about their ventures into sustainability and the programming support they are receiving from MedSurplus Alliance and Kits4Life’s founder. Let's explore their efforts:
To Bayer: How did you get involved and did you have any challenges in corporate buy-in and/or implementation?
Donna Libretti Cooke, Director, Contracting & Budgeting & Kits4Life Project Lead: We learned about Kits4Life at the 2019 SCRS Site Solutions Summit. Our head of site management for the Americas, Mark Ryan, sponsored the initiative at Bayer and I became project lead. There were no barriers to corporate buy-in; we promptly joined the Kits4Life Advisory Council and offered to chair the onboarding workstream. The only learning curve was understanding Bayer’s corporate donation policy so it could be approved and then clin ops could implement the program while continuing its collaboration with corporate social responsibility and site management teams. We worked with all internal stakeholders and new Kits4Life partners to implement it in 2020 within eight months of initiation. Colleagues have been thrilled with the program, eager to reach out and implement it for their studies. Expansion efforts are in development, with Australia being the first country outside the U.S. to start donations in 2022. Finally, in Q4 2022, the onboarding workstream rolled out a sponsor onboarding toolkit to ease the way when new sponsors join.
To Sanofi: What’s the status of your Kits4Life programming, and who champions it within your organization?
Julie Diaz, Clinical Learning & Development Project Manager & Kits4Life Project Manager: Sanofi R&D is one of the founding Kits4Life partners since 2018. We coordinated our first Kits4Life bulk product and biomedical equipment donations from U.S. study sites in July 2020. The COVID-19 pandemic slowed down the implementation of this initiative at our clinical sites, but we are now extending Kits4Life to more countries and clinical trials. Our 2023 pilot is about to start. This initiative is a joint collaboration effort between our R&D corporate social responsibility and our clinical sciences and operations teams across the globe.
To Roche: Roche is the newest sponsor to join Kits4Life. Did you have any challenges, or has this been an easier lift for acceptance and implementation?
Marcel Hollenstein, Senior Clinical Operation Leader: We first heard about Kits4Life at the 2019 SCRS Site Solution Summit, and my manager brought this to my attention, knowing my passion for sustainability. Before I continued to drive the initiative forward toward the end of 2020, we started a small working group to identify key questions and contacts. The main challenge was to find the right internal stakeholders to provide the answers we needed to be compliant and legally covered. In addition, it took some efforts to identify an internal funding partner. Engaging with a suitable medical surplus recovery organization (MSRO) and setting up all final agreements also took some time. The acceptance was never an issue; the initiative was considered as highly important and beneficial from the start. The implementation, once all documentation was in place, went quickly. The first donation was made only a month after signing final agreements.
To Bayer: What have you learned over the past few years in implementing Kits4Life and working with new partners?
Donna Libretti Cooke: The most eye-opening experience has been learning about the efforts of the MSROs and the amazing work they do to extend the useful life of medical supplies. In fact, clinical trial supplies were an unknown and untapped resource until the past few years. I’ve loved learning about this industry, and the role MedSurplus Alliance plays in providing standards and accreditation to the MSROs, running the platform, and hearing the stories of global health impact from all sponsor donations. The knowledge sharing involved with other sponsors in the workstreams and the advisory council has enabled us to make it all happen. The collaborative spirit cannot be emphasized enough. There is no lack of political will in these efforts; when there’s an excellent cause that makes true, tangible impact, no other motivation is needed. Last, sharing this internally has sparked tremendous interest that continues to spread. Anyone internally can touch this just by raising their hand. We all have unused supplies; how can we donate?
To Lori Warrens, director of MedSurplus Alliance (MSA): What is the role of MedSurplus Alliance in Kits4Life programming?
Lori Warrens, Director: Our primary role is to engage cross-sector medical product donation partners to help protect the health of populations by providing medical supplies and equipment when and where they are needed. To accomplish this, we provide Kits4Life members with governance, legal, standards, education, consulting, implementation tools, and a tested online platform that enables donors to repurpose supplies and equipment safely.
Are there plans for expansion?
MSA and Kits4Life have a three-part approach to expanding and improving the program.
- All but one MSA-accredited MSROs partner with one or more sponsors. The MSA will work with these MSROs to identify new last-mile recipients, including labs and education and research institutions, enabling them to accept an increasing number of supplies and equipment.
- MSA also will explore and pilot a Kits4Life certification program to enable non-accredited MSROs to qualify for Kits4Life donations.
- MSA is currently piloting accreditation in Australia and will actively promote accreditation of MSROs outside the U.S.
To Kits4Life Founder Greg Folz: You and your site staff generated this idea almost five years ago. What are your thoughts today of where it has gone and your vision for the next five years?
Greg Folz, Founder: It’s humbling to see so many sponsors now on board sharing the same vision and already seeing the amazing results of their humanitarian work. In my nearly 30-year career in clinical research, I have never experienced the level of sincere collaboration and sharing of expertise among so many life-sciences stakeholders to impact the lives of those in need around the world. What started out as an idea to repurpose surplus lab kits has transformed into a secure international distribution platform, supported by accredited MSROs. It’s a platform to not only donate medical supplies but to now also safely donate medical devices, lab equipment, iPads, and any other medical-grade items utilized for clinical trials. I’m excited for the future of the program, as we expand globally and hopefully see the donation of such surplus medical supplies and equipment become an industry standard. Why, one may ask? I believe Mark Ryan, from Bayer said it best. "Because it’s the right thing to do."
Visit kits4life.com for further information and check out the MedSurplus Alliance’s and sponsors’ short videos on making a global health impact.