Merck KGaA of Darmstadt, Germany, and Quintiles have announced a new, five-year clinical development agreement. This strategic collaboration is the first-of-its-kind between a biopharmaceutical company or division and a biopharmaceutical services provider, creating a comprehensive process that integrates the expertise and experience from both organizations into a single, well aligned clinical development engine.
In a novel approach to clinical development that is founded on a shared commitment to cost-disciplined science, the collaboration is intended to optimize productivity in the design and execution of studies with a focus on quality, speed and efficiency.
Under this agreement, Merck KGaA will shape and lead the strategy of its clinical development programs, with Quintiles directing clinical trial planning and execution.
Quintiles also will be a key contributor to Merck KGaA’s future clinical trial design activities. In this capacity, Quintiles will focus on delivering superior performance based on optimized clinical trial design and execution strategies, using highly efficient processes and proven technologies.
To fully leverage the expertise of both organizations, leaders from Quintiles will collaborate in strategic decision-making processes affecting the development of the portfolio of Merck KGaA’s prescription medicines division.
“By combining the strengths of Merck KGaA and Quintiles, we are creating a new model in clinical development that will unlock the knowledge and insights of both companies,” says Annalisa Jenkins, Executive Vice President and Head of Global Development and Medical at the division.
Jenkins continued, “This is an innovative and unique collaboration that will help to 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.”
Moving forward, Quintiles will be the sole-primary provider of Merck KGaA’s outsourced clinical development services for its global clinical programs.
The agreement will span the full spectrum of clinical development, from Phase I through to post-marketing approvals.
Importantly, it will also allow the Merck KGaA division to expand its reach globally by leveraging the broad local expertise of Quintiles to implement development programs around the world.
“This agreement is built upon a long-standing commitment to trust and transparency between our two organizations, and I’m confident it will only be enhanced by this innovative relationship,” says Tom Pike, Chief Executive Officer at Quintiles.
Pike continued, “We are excited about the opportunities this collaboration provides as we work with Merck KGaA in a new and innovative manner that leverages the best of our combined capabilities. We view this as a key step forward not only for our two companies, but for the way the industry approaches the development of new therapies for the patients we ultimately serve.”
The agreement reflects a shared commitment between both organizations to delivering optimal performance in clinical development.
The objective is to expedite the delivery of new therapeutic options to patients with high medical need across the Merck KGaA division’s core research areas of neurology, oncology, immuno-oncology and immunology.