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Blog
August 3, 2026 15 min read

Real-World Evidence in EU Joint Clinical Assessments: Strategic Use and Methodological Standards
With immature survival data, single-arm trials, and limited comparators common in early JCA submissions, real-world evidence is becoming a strategic necessity, not an afterthought. Learn how sponsors can plan and generate RWE that meets the methodological bar EU assessors expect.
Walid Shouman
M.Pharm, Associate Research Scientist
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Blog
July 30, 2026 16 min read

From Approval to Access: Adopting a “One Evidence Package” Mindset for Success in the EU Joint Clinical Assessment Era
The EU Joint Clinical Assessment is driving a new approach to evidence generation, where regulatory approval and market access considerations must be addressed together. Drawing on lessons from the first completed and discontinued JCA cases, this article explores how integrated evidence planning, comparative effectiveness evidence, proactive PICO management, and strategic use of real-world evidence can help organizations navigate evolving European requirements and support successful reimbursement and patient access outcomes.
Judy Lytle
Executive Director of Evidence Development Study Solutions
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Blog
July 27, 2026 11 min read

Navigating the AI Landscape: Expanding the Toolbox (Part 2) and Having a Little Fun Along the Way 
AI can support much more than drafting content. In Part 2 of our series, we explore practical tools that help teams organize information, improve communication, capture meeting insights, visualize complex concepts, and work more efficiently so experts can stay focused on what matters most.
Poonam Pathak
Manager, Pharmacovigilance

Posts by Date

Future of PV event, people in room
Blog
June 17, 2026 6 min read

Reality Check: AI in Pharmacovigilance Is Not What We Think
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.
Christopher Henry
Safety Scientist, Global Safety Writing
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Blog
April 14, 2026 4 min read

Key Insights from the 2026 REMS Industry Consortium Annual Meeting
AI, standardization, and a shifting FDA landscape. Here's what the 2026 RIC Annual Meeting revealed about the future of REMS.
Laura Fendler
Senior Clinical Project Research Manager, REMS Operations
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Blog
April 13, 2026 10 min read

How North American Privacy Frameworks Shape Real-World Evidence: A Comparison of Canada and the United States
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.
Samantha Gorun
Associate Research Scientist
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Blog
March 31, 2026 15 min read

EU Post-Marketing Compliance: What Regulation 2025/1466 Means for Your Pharmacovigilance Program
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.
Peter P. Psarologos
Senior QPPV
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Blog
March 27, 2026 7 min read

Access USA 2026: Key Takeaways on AI, Affordability, and Patient Support
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.
Diana Hampton
Senior Director, Strategic Relations
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Blog
March 26, 2026 19 min read

Getting from Taboo to Treatment: Understanding stigma and perceived gender differences in mental health and psychedelics
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
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Blog
March 17, 2026 18 min read

Oregon Psilocybin Service Centers are a Model for Patient-Centered Care
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
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Blog
March 9, 2026 17 min read

Breaking Barriers in Immuno-Oncology: Mechanistic Insights into Immune Checkpoint Inhibitor Resistance and Implications for Health Economics and Outcomes Research and Value Assessment
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.
Gaurang Nazar
Senior Associate Research Scientist
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Blog
February 26, 2026 16 min read

Redefining PV Skillsets in an AI-Driven World: Training the Next Generation of Safety Scientists
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.
Christopher Henry
Safety Scientist, Global Safety Writing
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Bekki Bracken Brown

President & Chief Executive Officer

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.