In today’s ACT Brief, we examine who decides what trials measure, how designing for human thinking improves site execution, and how the FDA extended an immunotherapy to a new bladder cancer population.
News|Podcasts|August 12, 2026
ACT Brief: Efficacy Ceiling Breakthrough in Autoimmune Disease, Early-Career Retention and Burnout Prevention, and PRV Program Catalyzing Rare Disease Investment
Author(s)Andy Studna, Senior Editor
In today's ACT Brief, we examine new strategies for breaking efficacy plateaus in IBD through combination approaches, why clinical research teams lose talent at the early-career stage, and how FDA's Priority Review Voucher program is reshaping rare disease capital flows.
This is the Applied Clinical Trials Brief—your fast track to the latest insights shaping clinical operations and drug development.
- In a
new video podcast , Kori Wallace, MD, PhD, vice president and global head of immunology clinical development at AbbVie, discussed efficacy plateaus in inflammatory bowel disease and how they're driving a shift toward stringent tissue-based targets and complementary mechanism combinations. In vivo CAR-T and B-cell depletion strategies designed to reset the immune system could enable deep, durable remission rather than incremental symptom improvement. - In a
new contributed article , Mario Alejandro Castellanos Urdaibay, MD, MSc, examined how clinical research coordinators face early burnout from expectation-reality gaps, inadequate mentorship, and fragmented technology platforms. Structured orientation, formal mentorship programs, and leadership training for supervisors are retention strategies treating early-career preparation as workforce sustainability rather than HR afterthought. - The
FDA's Priority Review Voucher program renewal is driving US rare disease biotech investment, with vouchers selling for $150 million to $200 million in non-dilutive capital, while the UK lags without an equivalent mechanism. Orphan therapies represent roughly one-fifth of global prescription revenue, making rare disease assets attractive to pharma seeking de-risked, clinically validated programs with higher Phase I approval likelihood.
That's all for today's ACT Brief. Join us tomorrow for more updates shaping clinical operations and drug development. Thanks for listening.
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