Merck Serono Audited

General

In 2013, R&D at Merck Serono evolved significantly. Starting in 2013 as separate functions – Global Research and Early Development, and Global Development and Medical – Merck Serono unified the two groups into one global R&D organization.

The guiding principle of the new organization at Merck Serono is to foster an environment of end-to-end research and development – from bench to bedside – with a resolute commitment to ensuring that the needs of the patient are the primary driver of Merck Serono’s efforts. Operationally, there is a strong focus on delivering the highest-quality science to clinical development with speed and efficiency, and translating that science into meaningful, differentiated new therapies for patients in need.

Discovery is structured across three distinct yet closely aligned Translational Innovation Platforms (TIPs): Oncology, Immuno-Oncology, and Immunology/Neurodegenerative Diseases. Each TIP integrates research, the early phases of development and biomarker strategies, and is now accountable for delivering promising discovery programs into development up to clinical proof of confidence. In order to achieve this, in-house teams of researchers and clinicians work closely together, while collaborating with leading academic institutes, research laboratories and industry organizations to complement their internal capabilities.

Merck Serono is implementing an open collaborative model in R&D and reflecting this, numerous collaborations were entered into during 2013. These included an innovative strategic collaboration with Quintiles creating a comprehensive process that integrates the expertise and experience from both organizations into a single, well-aligned clinical development unit. Several agreements were also signed with external partners in both research and development.

Across the continuum of R&D, Merck Serono is promoting a solution-oriented, collaborative and accountable culture that delivers value to the business and to patients. The Merck Serono R&D organization is boosting its efforts to advance a robust pipeline and achieve its launch ambitions.

Research & Development strategy

In 2013, Merck Serono R&D made considerable progress in simplifying its global operations structure. Today, a nimble and highly-experienced team of just over 2,500 R&D professionals is working towards adding value and bringing new therapeutic options to patients around the world.

With hubs in Darmstadt, Germany; Boston, Massachusetts (USA); Tokyo, Japan; and Beijing, China, the broad footprint of Merck Serono gives it access to innovation in its key markets. Across the spectrum of the biopharma ecosystem – from academia, to hospitals, to research institutions, and to other companies in the biopharmaceutical industry – Merck Serono complements its internal expertise by leveraging the experience and knowledge of others. In 2013, Merck Serono delivered clear examples of this strategic priority, announcing agreements with several companies and academic institutions around the world (for details see the overview compounds).

In April 2013, Merck and Quintiles, the world’s largest provider of biopharmaceutical development and commercial outsourcing services, announced a new, five-year clinical development agreement. This strategic collaboration is the first of its kind between a biopharmaceutical company and a biopharmaceutical services provider, integrating the expertise and experience of both organizations. This novel approach to clinical development is founded on a shared commitment to cost-disciplined science. The collaboration is intended to optimize productivity in the design and execution of clinical studies with a focus on quality, speed and efficiency. Under the agreement, Merck Serono is shaping and leading the strategy of its clinical development programs, with Quintiles directing clinical trial planning, design and execution, using highly efficient processes and proven technologies.

In the course of 2013, Merck Serono further strengthened its global presence. In Darmstadt, the division officially opened a biopharmaceutical R&D building. In Boston, the division’s R&D site was renamed the EMD Serono Research and Development Institute, and will accommodate more than 500 employees in the coming years across the full R&D spectrum. Merck Serono continues to build on its 80-year history in China and sees excellent opportunities to further strengthen its reputation as a partner in biopharma, a leader in R&D, and an employer of choice for top talent in this market. The division’s hub in Tokyo serves as a gateway to northeast Asia, allowing the delivery of scientific and medical innovation of its pipeline to patients with diseases that are of particular concern to this region.

Merck Serono strengthened its leadership team by appointing world-class physicians, scientists and health care professionals to senior positions, including the Global Chief Medical Officer, and the Head of Global Clinical Development, both of whom joined the organization in January 2014.

To further advance the field of medicine Merck sponsors research and advanced medical education globally, reflecting our commitment to science, education and patient care. For example, Merck Serono supports outstanding extramural research projects through its Grant for Fertility Innovation and its Grant for Multiple Sclerosis Innovation, which are both awarded annually and available to researchers and clinicians worldwide. Similar annual Grants for Innovation were launched in 2013 in Oncology and Growth Disorders and the first awards in these fields will be granted in 2014. Through contributions to multiple medical education providers, Merck Serono supports the development and delivery of independent advanced medical training for scientists, physicians, nurses, pharmacists, and other health care professionals. In 2013, Merck Serono invested more than € 13 million in independent medical education programs and in grants for innovation.

Overall, the global Merck Serono R&D organization is now well-positioned, with enhanced operational effectiveness, an unwavering commitment to exceptional science, and a focus on delivering a pipeline that will continuously bring innovation to the business and to patients.