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Why Attend?

Establishing whether a CNS drug reaches the brain, engages its target and produces functional effects is a critical challenge in early development. In this webinar, Dr Graham Wood and Dr Denisa Wilkes will explore how to select and combine CNS assessments to answer these questions and inform development decisions.

Drawing on three decades of experience and practical case studies, the session will examine CSF sampling, PET, fMRI and qEEG, alongside complementary biomarkers and functional assessments. We will discuss the scientific and operational considerations that shape successful protocols, including imaging selection, sampling strategies and participant recruitment.

The webinar will also explore how adaptive and multipart designs can integrate populations, dosing stages and assessments within early development programmes. Discussion of psychedelic trials will address their distinct regulatory, clinical and operational requirements. Attendees will gain practical insights into aligning trial objectives, assessment methods and delivery strategies to design more informative early-phase CNS studies.

Learning outcomes:

  • Select the right CNS assessments: Understand how CSF sampling, PET, fMRI and complementary techniques can assess brain exposure, target engagement and functional effects.
  • Translate scientific objectives into practical protocols: Explore key design and delivery considerations for CSF sampling and imaging studies, including radioligand selection, receptor occupancy and radiation exposure.
  • Build flexibility into early development: Discover how adaptive and multipart protocols can integrate populations, dosing stages and CNS assessments to improve programme efficiency.
  • Prepare for complex study delivery: Understand recruitment strategies for healthy participants and CNS patient populations, alongside the distinct regulatory, clinical and operational requirements of psychedelic trials.

Speakers

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Dr Denisa Wilkes
VP Medical Operations & Medical Director UK | Nucleus Network London | Hammersmith Medicines Research

Dr Denisa Wilkes brings more than 18 years of experience in clinical research and pharmaceutical medicine to her role as VP Medical Operations and Medical Director UK at Nucleus Network London | Hammersmith Medicines Research. An MHRA-accredited First-in-Human Principal Investigator, she has led more than 100 studies across diverse therapeutic areas and participant populations, providing strategic, medical and scientific leadership throughout early-phase development.

Dr Wilkes trained in Medicine and Surgery at Oxford and completed specialist training in Anaesthesia and Critical Care in Oxford and London. She holds an MD, an MSc with Distinction in Clinical Pharmacology, and UK and European Diplomas in Pharmaceutical Medicine.

A Fellow of the Faculty of Pharmaceutical Medicine, she serves on the UK HRA Phase 1 Advisory Group and the MRC Medicines Development Fellowship Programme Board. Her work combines scientific rigour, participant safety and multidisciplinary collaboration.

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Dr Sally Dowen
Vice President of Operations UK | Nucleus Network London | Hammersmith Medicines Research

Dr Sally Dowen is Vice President of Operations UK at Nucleus Network London | Hammersmith Medicines Research, bringing more than 20 years of experience in early-phase clinical development, regulatory strategy and operational leadership. She has overseen more than 200 Phase I and II trials across therapeutic areas including CNS, cardiovascular disease, oncology and infectious diseases.

Sally holds an MA in Natural Sciences and a PhD in Molecular Oncology from Cambridge University. Following postdoctoral research at Cambridge and Cancer Research UK, she moved into clinical development, holding senior roles including Head of Clinical Trials at the MHRA and Director of Clinical Science and Regulatory Affairs at a leading UK CRO.

Her expertise spans adaptive trial design, regulatory submissions and operational delivery. Combining scientific knowledge with regulatory insight and practical problem-solving, Sally works collaboratively with sponsors and clinical teams to deliver efficient, high-quality early-phase trials.

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