Drug development has moved from measuring disease to measuring how patients feel and function. The next question is whether we are measuring what matters most to each individual patient.
Ask most people what inspection readiness means and you’ll hear about a scramble: pulling documents together, briefing colleagues, running mock inspections in the weeks before the real thing. That picture isn’t wrong, it’s just incomplete, and it puts the emphasis in the wrong place.
When the only view of the program is a static snapshot, the honest answer is often “we’ll know when the next report comes in.” That is the gap real-time dashboards close.
AI is everywhere in PV conversations, but far less mature in practice. Here's what stood out from Why Summit: Future of PV: validation bottlenecks, signal inflation, and why the real challenge isn't technology.
Canada's consent-driven data silos and the U.S.'s regulatory patchwork aren't just administrative hurdles — they're determinants of bias in real-world evidence.
Implementing Regulation (EU) 2025/1466 is in full effect — and it's the biggest change to EU pharmacovigilance rules in over a decade. Here's what your compliance team needs to act on right now.
Two phrases defined this year's Access USA conference: "calm the chaos" and "can't eliminate the human touch." As AI reshapes patient support programs, the question isn't whether to adopt it, but how to deploy it without losing what patients value most.
Women's depression is often framed as a hormonal imbalance of the body. Men's? A failure of will. These aren't just outdated ideas — they're active barriers to diagnosis, treatment, and survival. As treatment-resistant depression challenges conventional medicine, psychedelic-assisted therapy is emerging not only as a clinical option, but as a way to dismantle the very stigmas that keep people from seeking help in the first place.
Judy Lytle
Executive Director of Evidence Development Study Solutions
As psychedelics move toward potential FDA approval, Oregon’s psilocybin service centers offer early lessons in patient-centered care. This article examines real-world practices in preparation, dosing, facilitation, and integration—and what they may reveal about future clinical use.
Judy Lytle
Executive Director of Evidence Development Study Solutions
Immune checkpoint inhibitors deliver transformative outcomes, yet real‑world durability is often limited by primary and acquired resistance. This article explores the biological foundations of ICI resistance and outlines how integrating these insights into HEOR models can improve value assessment and real‑world decision‑making.
As AI becomes embedded across pharmacovigilance, the skills required of safety scientists are rapidly evolving. This article examines the shifting balance between human expertise and AI-enabled tools, outlining the competencies, training pathways, and cultural changes needed to prepare tomorrow’s hybrid PV workforce.
Bekki Bracken Brown serves as the President and CEO of UBC, guiding the company’s mission and values, including the improvement of access for patients to receive better outcomes. She oversees all aspects of UBC, such as operations, business growth strategy, sales and marketing, and acquisition support.
With over 20 years of industry experience, Ms. Brown brings knowledge from a successful career in senior management from her tenure at Quintiles, INC Research, and, most recently, with Syneos Health. She’s been a member of the North Carolina BIO Board of Directors since 2019. She is also a member of the Healthcare Businesswomen’s Association — Southeast Chapter and CHIEF, an organization that supports women executive leaders. Ms. Brown earned her bachelor’s degree at Duke University.