PPD to acquire evidence-based solutions provider, Evidera

David Simmons, PPDChairman and CEO, told us Evidera’s real-world research​ services will further strengthen PPD’s peri- and post-approval capabilities, “positioning PPD to fully partner with biopharmaceutical customers across the development continuum in evidence generation and analysis for innovative medicines​.”

Additionally, Simmons explained, “PPD’s global scale and partnerships with multiple biopharma clients will provide Evidera a strategic partner to fuel its long-term growth and synergistic opportunities​.”

Now more than ever, the industry must demonstrate value and effectiveness in real-world settings, as it facing increasing scrutiny. “This is becoming increasingly critical to justify access to, and payment for, products,​” Jon Williams, President and CEO, Evidera, told Outsourcing-Pharma.com.

“It’s critical that evidence-based value demonstration start early and be well-integrated into the clinical development process​,” he added, as payers, health authorities, and providers are now demanding this as a condition for market access.

“No therapeutic area is immune any longer from these requirements​,” said Williams.

However, according to Williams, not all organizations are able to partner with biopharma companies to help them do this well. “Today that changes​,” he said.

“By marrying a best-in-class CRO with a best-in-class real-world research and market access company, PPD and Evidera can provide the evidence-based value demonstration that biopharma companies need. We believe this will be transformative​,” explained Williams.

Outpacing R&D​

Recently, the industry has recognized a need to generate stronger evidence for how products perform outside the setting of a clinical trial– “in other words, in a real-world setting​,” said Williams.

“Real-world evidence is needed​ to substantiate a product’s effectiveness and​ demonstrate its value to payers and health authorities to help optimize market access​,” he added – and the need for real-world evidence is increasing.

According to a Jefferies forecast, there is a $6.8bn post-approval outsourcing market for CROs.

“Investment growth in this area is outpacing overall R&D spend​,” explained Simmons. “This is 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​.”

The transaction is expected to close in the third quarter. In what it calls “a strategic differentiator​” to meet the needs of its clients, PPD does not plan to fully integrate Evidera into PPD.

“Evidera will operate as a separate business unit, serving as the late-stage business unit of PPD with the full ability to tap into the comprehensive capabilities of PPD as a global CRO​,” said Simmons. “We believe this unique approach will support Evidera in continuing to maintain its industry-leading reputation​.”