2025 NORD Rare Disease Summit: Advancing Evidence and Partnerships for the Rare Community
UBC attended the 2025 NORD Rare Diseases & Orphan Products Breakthrough Summit, where patient voices, scientific innovation, and regulatory expertise converged to shape the future of rare-disease research. Learn what inspired us and how we’re advancing real-world evidence, patient partnerships, and innovative trial designs to accelerate progress for the rare-disease community.
High-Touch, High-Impact: Optimizing Patient Support in Cell & Gene Therapy
As cell and gene therapies reshape treatment paradigms, patient support programs must evolve to meet new challenges. Discover how strategic alignment, payer advocacy, and innovative solutions can optimize the patient journey.
Registry feasibility assessments for post-authorization safety studies (PASS): Learnings and Challenges
UBC recently completed a multi-country feasibility assessment to identify disease registries capable of supporting a PASS for a novel therapy targeting a hereditary muscular disorder. The study evaluated registry data elements, quality, and governance to ensure fit-for-purpose real-world data (RWD) for generating reliable RWE.
Making the most of real-time pharmacovigilance oversight: Applying operational data analytics across diverse use cases
Learn how companies are making the most of their oversight capabilities by leveraging real-time data to improve the health of their pharmacovigilance program.
Putting a Seatbelt on AI: How Risk-Based Integration is Transforming Drug Safety
AI is revolutionizing drug safety, but without proper guardrails, it can introduce new risks. Learn how risk-based integration strategies are helping life sciences companies harness AI’s power while maintaining trust, transparency, and compliance.
Operational Data On Demand: Overcoming Barriers to Effective Pharmacovigilance Oversight
Platforms designed specifically for the collection and communication of operational pharmacovigilance data are breaking down long-standing barriers to real-time PV oversight.
Drug Repurposing in Rare Diseases: The Impact of Natural History Studies
Drug repurposing is transforming the landscape of rare disease treatment by leveraging existing medications for new uses. With significantly lower development costs and faster timelines, this approach is gaining traction—especially when supported by natural history studies that provide deep insights into disease progression and real-world treatment patterns.
EMA Issues Guidance on Risk Minimisation Measures for Medicinal Products with Embryo-Foetal Risks
The EMA’s August 2025 guidance on embryo-foetal risk minimisation marks a pivotal step in harmonizing safety protocols across the EU. This blog breaks down the new Addendum I to GVP Module XVI, clarifying what constitutes a Pregnancy Prevention Programme and how risk minimisation tools can be effectively implemented without compromising patient access to essential treatments.
To Rescue or Not to Rescue Your Study: How to Spot Trigger Points in Strategic Partnerships
Instability is woven into our industry’s DNA. We operate daily in a high-stakes, high-risk environment where financial pressures, regulatory changes, and patient lives hang in the balance. The CRO selection process reflects this tension, few other sectors require competitors to both challenge and collaborate with one another, often for the same client. Our ecosystem is […]
