Fresh from returning to public ownership with a US$947 million offering, Quintiles has made a significant addition to its roster of strategic alliances in the form of a five-year clinical development agreement with Merck Serono.

In fact, the agreement involves a level of co-operation beyond that usually seen in what is now a well established strategic-alliance model between biopharmaceutical companies and providers of outsourced clinical development services.

According to the new partners, the collaboration is the first of its kind between a biopharmaceutical company and a biopharmaceutical services provider, creating a “comprehensive process that integrates the expertise and experience from both organisations into a single, well-aligned clinical development engine”.

Sole primary provider

Under the arrangement, Quintiles will become the sole primary provider of Merck Serono’s outsourced clinical development services for its global clinical-trial programmes.

The agreement spans the full spectrum of clinical development, from Phase I trials through to post-marketing approvals.

One important factor, the companies noted, is that the partnership will enable Merck Serono to expand its reach globally by leveraging Quintiles’ “broad” local expertise in implementing clinical development programmes worldwide. 

Planning and execution

The distribution of responsibilities is that Merck Serono will shape and lead the strategy for its clinical development programmes, while Quintiles will direct clinical-trial planning and execution.

Quintiles will also become a key contributor to Merck Serono’s clinical-trial design activities, the companies said. 

In this capacity, Quintiles will focus on “delivering superior performance based on optimised clinical-trial design and execution strategies, using highly efficient processes and proven technologies”. 

To ensure the expertise of both organisations is fully leveraged, leaders from Quintiles will collaborate in strategic decision-making processes affecting the development of Merck Serono’s product portfolio.

Cost-disciplined science

The two companies described the agreement as “a novel approach to clinical development that is founded on a shared commitment to cost-disciplined science”.

The collaboration is aimed at maximising productivity in the design and execution of clinical studies, with a focus on quality, speed and efficiency.

The longer-term objective is to expedite the delivery of new therapeutic options to patients with high medical need across Merck Serono’s core research areas of neurology, oncology, immuno-oncology and immunology.

New model

“By combining the strengths of Merck Serono and Quintiles, we are creating a new model in clinical development that will unlock the knowledge and insights of both companies,” commented Annalisa Jenkins, executive vice president and head of global development and medical at Merck Serono.

“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,” Jenkins added.

Tom Pike, chief executive officer of Quintiles, said the agreement built on “a long-standing commitment to trust and transparency between our two organisations ... 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”.