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The Growing Trend of Patient-Led Clinical Research in Rare Disease

Conversations in Drug Development Trends

By: Juliane Mills, Senior Director, Therapeutic Strategy Lead, Rare Disease The rise of patient-led clinical research, particularly in rare disease, represents a significant shift in the clinical trial landscape. Why Is There an Increase in Patient-Led Rare Disease Research?

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Time for change: non-human primates in drug research

Drug Target Review

Non-human primates (NHPs), such as macaques and cynomolgus monkeys, have long served as a cornerstone in preclinical drug development due to their close genetic, anatomical and physiological resemblance to humans. Research using NHPs often requires detailed justification, approval by ethics committees and regular inspections.

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Altasciences at ARVO 2025: An Eye on the Future of Ophthalmic Drug Development by Gretchen Green

Alta Sciences

AI Innovations in Ophthalmic Research ARVO is one of the largest global conferences for ophthalmology research , attracting nearly 11,000 attendees from over 60 countries. Hosted by the Association for Research in Vision and Ophthalmology, it serves as a platform for exchanging cutting-edge research findings.

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Compliance Challenges in Generic Drug Development: Lessons Learned

Drug Patent Watch

The Unseen Hurdles of Generic Drug Development: Lessons Learned As the pharmaceutical industry continues to evolve, one thing remains constant: the pursuit of affordable, high-quality medications for patients worldwide. However, the journey to bringing a generic drug to market is often fraught with challenges.

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Regulator and Funder? FDA’s Orphan Products Grants Program awards significant funding to help move promising treatments through clinical development

FDA Law Blog: Drug Discovery

Background on the Grants Program Launched as part of the Orphan Drug Act of 1983, this program aims to encourage research and development of drugs, biologics, medical devices, and medical foods for rare diseases, defined as conditions that affect fewer than 200,000 people in the U.S.

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How FSP Models Help Biotech Companies Augment Their Clinical Development Needs

PPD

Its ability to maneuver persistent drug development challenges, like patient recruitment, trial complexity and rising costs, will ultimately determine its success. This blog explores the value of functional service provider (FSP) models and how they help biotech companies augment their clinical development needs.

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Applying Artificial Intelligence to Transform the Patient Enrollment Paradigm in Clinical Research

PPD

In today’s data-driven world, AI has become valuable and indispensable, enabling organizations to extract valuable insights from vast amounts of data, make informed decisions and drive innovation across different sectors — including drug development.