Orphan Drug Prices Facing Increased Scrutiny
With the US Food and Drug Administration (FDA) approving an all-time record number of orphan drugs during 2014, the pricing of these treatments is set to come under increased scrutiny.
Research and consulting firm GlobalData says the FDA approved an all-time record number of 17 orphan drugs during 2014. This out of the total of 41 new molecular entities approved by the FDA last year. The report from GlobalData further stated that while the rare disease sector may appear to be increasingly lucrative for pharmaceutical companies, some orphan drug prices have recently reached new unprecedented levels and their affordability has become a significant issue for payers.
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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.
