June 2, 2019

In the race to find new oncology treatments, solid tumor clinical trials are continuing to pave the way in the discovery and approval of effective new anti-cancer therapies, including combination immunotherapies and other forms of innovative targeted approaches.

Optimized Approaches to Immunotherapy

Syneos Health™ has been involved in supporting clinical and/or commercial services for six out of the seven checkpoint inhibitors currently on the market.

Our total solid tumor immunotherapy experience in the last five years spans 131 studies involving more than 17,000 patients in a variety of solid tumor subtypes.

This experience is diverse involving a breadth of immuno-oncology therapies and mechanisms of action, including 56 studies with checkpoint inhibitors (CPIs) and 14 studies with genetically modified organisms (GMOs).

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Our teams have the desired and necessary experience to operationalize your immuno-oncology studies across a wide range of disease settings and tumor types. Based on this deep experience, we can support sites with our experienced medical oncologists to ensure a robust evaluation of efficacy to obtain actionable data for registration studies.

Additionally, we are able to support studies in the search for effective vaccine therapies. We have conducted 21 clinical trials with cancer vaccines, enrolled almost 2,400 patients at over 600 sites worldwide.

Looking to the Future: Cellular and Gene Therapies

At Syneos Health, we are excited to be supporting our customers with these emerging technologies, which are often targeted as oncology, rare diseases and orphan indications and involve treatment aspects novel to investigators, site staff and patients. Our CRAs provide key support to sites through the many logistical complexities, which make these trials so unique in their requirements.

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Effective Trial Delivery in Immuno-Oncology Trials

Highly effective, personalized, novel therapies based on immunology targets are now being developed and used. Studies are now designed to include multiple immuno-modulators to optimize promotion and inhibition of immune-mediators in the disruption of the tumor biology.

Immuno-oncology treatment paradigms coupled with other targeted therapies and niche patient populations all require strong oversight to ensure appropriate safety management techniques, and focus on delivery of robust efficacy data. Our project teams concentrate exclusively on solid tumors and have developed the experience and skill required to provide exactly what is required.

Our clinical professionals are currently supporting the increasingly complex world of combination immunotherapy, along with the understanding of your study design. You will have access to expertise via our integrated Cross-Functional Consortia in a number of key strategic areas including cell and gene therapies, rare diseases and pediatric oncology. Additionally through our innovative Learning Solutions approach, we are able to leverage access to thought-leader led expertise in complex combination studies to ensure delivery of high-quality, actionable data in registrational settings.

Leveraging Real World Evidence (RWE) to Support Market Access and Life Cycle Management

Immuno-oncology drug development has already produced a number of products that have been approved on “thin” clinical trial packages supported by RWE programs.

As products move from trials into the clinic, our experts can offer advice on the optimized use of realworld data to differentiate products against competitors, supporting payers and reimbursement activities.

Additionally as RWE becomes more widely accepted by regulators, it can be used to support post authorization commitments. Our design team can assist you in planning and with the regulatory considerations of your RWE strategy. We will utilize our specific structure to apply the right operational approach, tools and technologies to ensure a successful delivery. Over the past five years we have successfully delivered eight global RWE studies in immuno-oncology at 375 sites with 5,300 enrolled patients.

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