Neurodegenerative drug development presents distinct scientific and regulatory challenges as innovation accelerates across Alzheimer’s disease, ALS, Parkinson’s disease. Sponsors are focused on generating meaningful evidence in alignment with evolving regulatory frameworks, emerging biomarkers and complex trial designs in areas where clinical endpoints and disease progression measures remain uncertain.

In this expert-led panel discussion, leaders from IQVIA Biotech and IQVIA share practical insights on regulatory strategy, protocol design and operational considerations shaping today’s neurodegenerative development programs. The conversation will focus on how sponsors can responsibly innovate, manage risk and advance evidence-generating studies in a rapidly evolving CNS landscape while balancing scientific rigor with the realities of regulatory ambiguity and operational complexity.

Key Takeaways

• Regulatory expectations in neurodegenerative development, including evidence requirements that support innovative and accelerated approval pathways
• Trial design and endpoint challenges unique to Alzheimer’s disease, ALS, Parkinson’s disease and related indications
• The evolving role of biomarkers, particularly in Alzheimer’s disease, and considerations for tracking disease progression in asymptomatic or early‑stage participants
• Strategies to position development programs for success across sponsor types, leveraging innovative trial designs to manage cost, feasibility and risk

For more information and to register, click here.

Speakers:

Joanna Pulawska, Ph.D., Therapeutic Area Head, CNS, IQVIA Biotech
Dave Podskalny, DO, MPH, Therapeutic Science and Strategy Unit, Design & Delivery Innovation, IQVIA