The Research Forum is designed to drive the research policy agenda for child and adolescent psychiatry by creating an environment that encourages scientific exploration and collaboration of investigators across disciplines. The primary audience for the 2011 Research Forum is researchers, although others are invited to attend.
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With the advent of new translational tools, biomarker identification and validation in psychiatry is poised to shift from a focus on establishing biological plausibility to translating insights about fundamental biology into tests for clinical use on regulatory pathways that guide their development and application. To speed this process, the 2011 Research Forum introduces participants to biomarker sciences as applied to the development of diagnostic, prognostic, and treatment biomarkers in pediatric psychiatry.

 

Biomarkers, which are clinically applicable quantitative measurements about biological processes, a disease state, or about response to treatment, are the foundation of stratified and eventually personalized diagnosis and treatment.
Presentations focus on the identification, validation, and clinical application of biomarker/biosignatures to stratified and personalized medicine in psychiatry. Specifically, the Research Forum introduces participants to the rationale for and practical application of -omics, MRI/PET, and QEEG/MEG technologies on regulatory pathways for developing diagnostics and companion diagnostics as applied to psychiatric/neurologic diseases from pre-clinical development through translational studies in humans.

Morning presentations focus on: 1) FDA, NIMH, and industry perspectives; and 2) Exemplar biomarker studies in major depressive disorder from industry and the NIMH. The afternoon session focuses on integrating biomarker studies into a neurodevelopmental framework, including a panel discussion and breakout groups that discuss and make recommendations regarding important principles for biomarker identification using three technology platforms: -omics, MRI/PET, and QEEG/MEG.
At the conclusion of the program, participants have a clear understanding of the rationale, experimental design, biostatistical, regulatory, and clinical exigencies involved in biomarker/biosignature identification, validation and clinical application in pediatric psychiatry, and how these unfold in a public-private partnership context. The goal of this year’s Research Forum is to help the field move from research designs emphasizing biological plausibility to focused experiments on regulatory pathways.

Presenters and their topics include:
John March, M.D., M.P.H.
Introduction to Biomarker Sciences

William Potter, M.D., Ph.D.
Alzheimer’s Disease as a Neurodevelopmental Model for Biomarker Identification and Validation

Kathleen Pajer, M.D., M.P.H.
Diagnostic Biomarkers

Tom Laughren, M.D.
Regulatory Guidance for Biomarker Development

Molly Oliveri, Ph.D.
The NIMH Perspective

Madhukar Trivedi, M.D.
Companion Diagnostics: The NIMH Biomarker Initiative

Magali Haas, M.D., Ph.D.
The Industry Perspective