Looking Beyond Symptoms in Psychiatric Drug Development - Report - MDSpire
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Looking Beyond Symptoms in Psychiatric Drug Development

  • October 15, 2026

  • 10 min

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Clinical Report: Looking Beyond Symptoms in Psychiatric Drug Development

Overview

Tanya Wallace, PhD, describes a shift in psychiatric drug development from reliance primarily on symptom clusters and clinical observation toward integrating human genetics, circuit biology, biomarkers, and imaging. She highlights EEG and brain imaging approaches as tools for assessing target engagement and translating findings from preclinical research into early clinical studies, while noting that substantial work remains.

Background

Psychiatric conditions are complex and heterogeneous, and symptom-based diagnosis has provided limited insight into the biology underlying different patient experiences and treatment responses. Unlike many other therapeutic areas, researchers cannot routinely biopsy the brain to investigate disease biology. Wallace describes advances in genetics, circuit biology, translational biomarkers, and imaging as expanding the ways researchers can study these conditions. The interview also notes closer coordination between discovery and development, including earlier attention to target engagement and patient selection.

Data Highlights

The interview reports no numerical trial results. It describes translational methods used or under investigation: EEG assessments carried from preclinical studies into early clinical studies; receptor-occupancy imaging to assess whether drugs reach intended brain targets and to support dose selection; resting-state fMRI to examine neuronal networks; and task-based fMRI as a potential way to assess modulation of circuits associated with psychiatric symptoms.

Key Findings

  • Wallace says psychiatric R&D has shifted from greater dependence on symptom clusters and clinical observations toward use of human genetics, circuit biology, and translational biomarkers.
  • Discovery and development are more closely connected, with target-engagement questions raised earlier and clinical teams involved earlier in development.
  • EEG can be used preclinically and in early clinical studies, including in healthy volunteers and, in some cases, patient populations, to compare observed effects across settings.
  • Receptor-occupancy imaging has been used in drug development, particularly for antipsychotics; Wallace says it is also used with novel mechanisms to assess brain target access and support dose selection.
  • Resting-state fMRI is being explored to assess drug effects on neuronal networks identified in preclinical species, while task-based fMRI is described as a developing approach for examining symptom-related circuit modulation.
  • The related article “It’s In The Blood” reports that neuropsychiatric drug-development programmes declined by 70 percent over the preceding decade and identifies limited understanding of disorder diversity and a dearth of relevant preclinical models as challenges.

Clinical Implications

The interview describes EEG and imaging as translational tools that may provide evidence about target engagement, dose selection, and patient biology during development. Wallace presents task-based fMRI as a potential early-development method for assessing whether therapeutics modulate circuits associated with psychiatric symptoms; the source does not report clinical trial outcomes establishing its effectiveness.

Conclusion

Wallace characterizes psychiatric drug development as increasingly informed by biological and imaging approaches alongside symptom-based assessment. She also emphasizes that these methods are still developing and that further work is needed to understand patient biology in greater depth.

Related Resources & Content

  1. The Medicine Maker, n.d. — Looking Beyond Symptoms in Psychiatric Drug Development (interview with Tanya Wallace, PhD)
  2. The Medicine Maker, 2019 — It’s In The Blood
  3. FDA, 2025 — Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments
  4. ACNP position paper, 2026 — Toward actionable biomarkers in psychiatry: a collaborative roadmap for precision clinical trials
  5. the medicine maker — Why Drug Development Still Lacks Integration
  6. Drug Safety — Exploring the Impact of Drug-Induced Impulsivity: A Network Analysis Utilizing the FDA Adverse Event Reporting System
  7. Frontiers in Psychiatry — Psychiatry and the unknown future: the period of hope
  8. Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments | FDA
  9. Toward actionable biomarkers in psychiatry: a collaborative roadmap for precision clinical trials. An ACNP position paper
  10. A Decision-Support System to Personalize Antidepressant Treatment in Major Depressive Disorder: A Randomized Clinical Trial | JAMA | JAMA Network

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