Online Exclusives

The Growing Realm of Real-World Data

By Kristin Brooks, Contract Pharma | November 8, 2016

PPD's Evidera acquisition aims to help clients address the growing demand for evidence from regulators and payers

Pharmaceutical Product Development, LLC (PPD), a global contract research organization (CRO), has recently completed its acquisition of Evidera, a provider of evidence-based solutions to demonstrate the real-world effectiveness and value of biopharmaceutical products.

The acquisition creates opportunities for clients of PPD and Evidera to generate evidence of product value that helps optimize market access for new health technologies. The companies will create a set of services across the drug development continuum that aim to enhance biopharmaceutical companies’ ability to bring therapies to patients.

Evidera will operate as a wholly owned subsidiary of PPD and will continue to be led by its current management team and staff of scientific and consulting professionals. Also, Evalytica will continue to operate as a wholly owned subsidiary of Evidera, providing both Evidera and PPD clients with a technology-enabled analytic platform for transparent analysis of diverse data sources. 
 


David Simmons, chairman and chief executive officer of PPD, and Jon Williams, president of Evidera, share their insight on the acquisition, real-world evidence, and how it impacts clinical development. –KB
 
Contract Pharma: What was the strategy behind the acquisition?
 
David Simmons: I’m enthusiastic about Evidera joining our companies to offer services that will enable our clients’ success in today’s complex and rapidly evolving drug development and market-access landscape. The combined strengths of PPD and Evidera will provide clients not only comprehensive development strategies to achieve regulatory approval of new products, but also evidence to optimize market access. Our ability to provide broader access to real-world data and deeper disease modeling and analytical capabilities can provide value at all stages of drug development.
 
CP: What are some of the services that you've added with the acquisition?
 
DS: With Evidera, PPD gains real-world research expertise – an area of growing importance to our clients. We are combining our strengths to enhance clients’ efforts to bring therapies to patients. The addition of Evidera’s expertise and capabilities strengthens PPD’s drug development, laboratory and lifecycle management services by adding capabilities to address the growing demand for real-world evidence from regulators, payers and health technology assessment agencies. PPD gains access to an organization with strong health economics and outcomes research capabilities and an experienced team of nearly 400 scientists, consultants and thought leaders.
 
Jon Williams: As a member of the PPD family, Evidera will be able to leverage the operational capabilities of a large-scale CRO, which expands our global footprint and increases our ability to conduct larger and more diverse studies. Furthermore, we expect that the combination of two organizations – and the ability to work seamlessly across our collective offerings – will allow both companies to maintain their commitment to client service.
 
CP: In what areas will the combined companies gain scale?
 
JW: Together, PPD and Evidera will serve the large and growing market for Phase IIIb and Phase IV studies, observational research and registries. We also expect a number of unique opportunities to marry PPD’s regulatory expertise and capabilities with Evidera’s expertise in modeling and simulation, clinical outcomes assessment and payer research to develop novel solutions for our mutual clients.
 
CP: What services or areas do pharma/biopharma clients increasingly seek out?
 
DS: Evidera plays a critical role in helping pharmaceutical and biotechnology companies predict and demonstrate how their products may perform and benefit patients in real-world settings. This is a fast-growing area of need for our clients and an area where Evidera will significantly expand and build on PPD’s existing capability to deliver the evidence required by regulators, payers and health technology assessment agencies. Pooling the resources of our two organizations puts us in a leading position to support our clients’ needs. Demonstrating value of innovative medicines is becoming more and more critical to gain optimal market access. Evidera works to provide the evidence needed to support value assertions.
 
JW: The need continues to grow for biopharma companies to generate a better understanding and stronger evidence of how their products perform in the real-world. This evidence is becoming a requirement to obtain favorable access and reimbursement. In turn, that has led to our clients making additional investments in the development of real-world evidence. Jefferies, the global investment firm, estimates that the post-approval outsourcing market for CROs is roughly $6.8 billion, with growth outpacing overall development spend. This growth reflects the increasing needs our clients have to demonstrate real world effectiveness. And as a result they are looking for strategic partners who can work with them from early development through to loss of exclusivity to provide innovative and proven approaches to demonstrate the value of their products.
 
CP: How has the focus on real-world evidence impacted clinical development? 
 
DS: Our clients seek to include more real-world insights into their clinical development plans, so the outcomes of their clinical trials have greater relevance to regulators, payers and health technology assessment agencies. Having the ability to access and analyze real-world data and use this in the planning, design and execution of clinical trials is a critical success factor in current and future clinical development.
 
CP: What is your perspective on the future of pharma/biopharma R&D? Where do you see opportunities for advancement?
 
DS: Efficiency and relevance are two key drivers of current and future pharma and biopharma research and development. On the efficiency front, PPD is committed to bending the cost and time curve of drug development through innovations such as Preclarus, our clinical data solution that gives PPD teams and clients transparent, real-time access to all clinical trial operations and patient data. Now, with the acquisition of Evidera, we will offer capabilities to generate more relevant clinical trial outcomes supporting both regulatory approval and optimizing market access. At the same time, PPD has made significant investments in recent years to build an exclusive, global site and patient solution for our clients, allowing us to deliver access to patients, sites and data sources.
 
JW: Our clients are beginning to generate evidence in support of market access, earlier and earlier – often in early Phase II. Given the increasing evidence demands by payers and health authorities, we think the earlier the better to develop and implement a value/market access strategy. We also see tremendous potential in the use of multiple and often fragmented sources of patient-level data to improve health care decision-making. We’ve developed Evalytica, our next-generation data analytics software platform, to help address this need, and we’re working down a number of other paths, as well. We expect the combination of real-world data collection and more powerful data analytics to go from “nice to have” to an absolute requirement in the coming months and years.




 
David Simmons joined PPD in June 2012 to serve as chairman and chief executive officer. In this role, he establishes and supports the strategic direction of PPD and leads its global workforce of more than 18,500 employees, across 46 countries, in the design, implementation and execution of drug development programs on behalf of its biopharmaceutical clients. Simmons came to PPD following 15 years with Pfizer Inc. In his most recent position, he was president and general manager of the emerging markets and established products business units.











 
As president, Jon Williams oversees Evidera’s global team of scientists, consultants, and software programmers, providing strategic direction for the company in this rapidly changing health care environment. Williams joined UBC in 2010 and oversaw the building of Evidera as an independent company in 2013. He was previously senior vice president of strategy and business development at Medco-UBC, where he was responsible for business strategy, organic business development, and establishing partnerships with life sciences and other health care organizations.

  • CROs and Today’s  R&D Landscape

    CROs and Today’s R&D Landscape

    Kristin Brooks, Associate Editor, Contract Pharma||November 9, 2016
    John Lewis of ACRO discusses opportunities, challenges, and the future CRO

  • The Human Parts of Mouse Models

    The Human Parts of Mouse Models

    Julia Schueler, Head of in vivo Operations, Oncotest, a Charles River company ||October 11, 2016
    The PDX model system has come back into focus

  • Choosing Oral Formulations for First-in-man Clinical Trials

    Choosing Oral Formulations for First-in-man Clinical Trials

    Jon Sutch, Senior Manager of Formulation Development, Patheon||October 11, 2016
    Early formulations should be simple, but selecting a simple formulation isn’t as easy as it seems