In a first-of-its-kind agreement, Merck Serono (MS) and Quintiles announced a five-year clinical development partnership to create a comprehensive process that integrates the expertise from both organizations with the goal of optimizing productivity in the design and execution of studies.

Quintiles will serve as the sole primary provider of Merck Serono’s outsourced clinical development services for its global clinical programs, providing MS with expanded global reach to implement development programs around the world. MS will lead the strategy of its clinical development programs, with Quintiles directing clinical trial planning and execution. Quintiles will also contribute to MS’ future clinical trial design activities through optimized clinical trial design and execution strategies, and will collaborate in strategic decision-making processes affecting the development of MS’ portfolio.

How did this partnership emerge and where will it lead? We spoke with Kathy Ford, senior vice president of Global Clinical Operations at EMD Serono, and Paula Brown Stafford, president of Clinical Development at Quintiles, to provide some insight. –KB

Contract Pharma: What led up to the deal? What did previous partnerships between Merck Serono and Quintiles entail?

Kathy Ford: This agreement was created in part to address an increasingly competitive landscape in drug development, as well as an increase in costs and decrease in productivity in R&D that is being experienced industry-wide. As a result, we have selected Quintiles as the sole primary provider of Merck Serono’s outsourced clinical development services for our global clinical programs. This agreement will create a comprehensive process that integrates the expertise and experience from both organizations into a single, well-aligned clinical development engine. The ultimate goal — for both companies — is to help bring new therapies to patients in need faster and more efficiently while remaining steadfast in the commitment to quality and safety.

Previously, Merck Serono had a number of different CRO partners. Moving forward, Merck Serono intends to retain Quintiles for its new outsourced global clinical trial requirements, but will, of course, honor contractual commitments with other CROs.

Paula Brown Stafford: Building on what Kathy said, I also think it is important to highlight that Quintiles and Merck Serono do have a long history of working together on a variety of different clinical development and commercialization efforts.  Core to all of those efforts has been a strong, unwavering commitment to trust and transparency between our two organizations — commitments that we believe will only be enhanced by this collaboration between our two companies.

CP: In what areas do you expect to see the greatest efficiencies through the partnership?

KF: This collaboration is intended to optimize productivity in the design and execution of studies with a focus on quality, speed and efficiency.

CP: How do you anticipate this expanded partnership will help overcome drug development challenges and create long-term sustainability?

KF: We believe this is a first-of-its-kind agreement between a biopharmaceutical company and a biopharmaceutical services provider. This agreement will create a comprehensive clinical development process that integrates the expertise and experience of both organizations into a single, unified drug development team. There are a number of unique aspects to this collaboration, but most notably, Quintiles will be a standing member of a collaborative clinical operations team that will be responsible for clinical operations decisions related to the Merck Serono development portfolio.  

PBS: For Quintiles, we will have the opportunity to be involved with Merck Serono in a variety of clinical development activities throughout the development process — from strategic input in clinical development plan definition and trial concept sheet design to leading and coordinating the execution of most clinical operations activities, specifically clinical trials for their drug candidates. By combining the best of both the sponsor (Merck Serono) and provider (Quintiles) as well as working side-by-side and making decisions together, we believe we will be able to create a streamlined and more efficient approach to developing new therapies. It’s an approach we believe will benefit the patients we both ultimately serve.

CP: Where do you see the partnership going after the five-year mark?

KF: This is an innovative and unique agreement that will help translate the highest-quality science into efficiency and agility throughout our clinical trials, while enhancing our competitive position in an increasingly challenging environment of clinical drug development. We are very optimistic that this alliance will evolve beyond five years as we work together to bring new therapies to patients.

PBS: We see this agreement as a true shift in the biopharmaceutical industry. While it is impossible to predict the future, we all know that the pressures of the industry are not going to disappear. The entire biopharmaceutical industry must find more efficient ways of bringing safe, new therapies to market. Agreements such as this are one way to help do that. We’re hopeful this announcement is part of a broader shift to an even more collaborative approach to clinical development across the entire industry.