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.
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.”