PRA Announces Strategic Relationship with Amgen
PRA announces a new agreement with Amgen for a series of Phase III studies to develop several biosimilar drugs on a worldwide basis. It is intended that PRA will serve as the sole provider of CRO services for these studies. A global leader in the biotechnology space, Amgen conducted a thorough search process to identify a CRO for Amgen’s biosimilar development program and selected PRA. Amgen and PRA signed the agreement in April 2012.
Under the new agreement, Amgen and PRA will work together to execute Phase III studies related to Amgen’s current biosimilar portfolio. The agreement is intended to govern the entire anticipated scope of Amgen's global biosimilar portfolio.
“This agreement reflects and confirms PRA’s commitment to providing full service support to our clients’ development pipelines,” said Kent Thoelke, PRA’s Executive Vice President of Scientific and Medical Affairs. “Our mission is to assist our clients across all phases of biotech drug development by combining therapeutic and operational expertise with local knowledge to help them meet their development goals. As such, this relationship represents a key milestone in PRA's commitment to supporting our clients’ biosimilar development programs. Amgen is a blue chip company and a world leader with a global reputation for excellence in bringing biologic therapies to patients with grievous illnesses. PRA has a strong track record in executing our clients’ global registration trials and helping to bring new drugs to market. We are delighted to announce this strategic relationship with Amgen.”
Improving Relationships and Diversifying the Site Selection Process
April 17th 2025In this episode of the Applied Clinical Trials Podcast, Liz Beatty, co-founder and chief strategy officer, Inato, discusses a number of topics around site engagement including community-based sites, the role of technology in improving site/sponsor relationships, how increased operational costs are impacting the industry, and more.
Behind the Buzz: Why Clinical Research Leaders Flock to SCOPE Summit
February 7th 2025In this episode, we meet with Micah Lieberman, Executive Conference Director for SCOPE Summit (Summit for Clinical Ops Executives) at Cambridge Innovation Institute. We will dive deep into the critical role of collaboration within the clinical research ecosystem. How do we bring together diverse stakeholders—sponsors, CROs, clinical trial tech innovators, suppliers, patients, sites, advocacy organizations, investors, and non-profits—to share best practices in trial design, program planning, innovation, and clinical operations? We’ll explore why it’s vital for thought leaders to step beyond their own organizations and learn from others, exchanging ideas that drive advancements in clinical research. Additionally, we’ll discuss the pivotal role of scientific conferences like SCOPE Summit in fostering these essential connections and collaborations, helping shape the future of clinical trials. Join us as we uncover how collective wisdom and cross-industry partnerships are transforming the landscape of clinical research.
FDA-Approved Gene Therapy Beqvez Shows Sustained Efficacy, Safety in Long-Term Hemophilia B Trial
April 17th 2025Beqvez (fidanacogene elaparvovec), an FDA-approved one-time gene therapy for hemophilia B, demonstrated sustained factor IX expression, low bleeding rates, and a favorable safety profile over long-term follow-up.
