HESI VALUE: Translational Safety Biomarker Assessment of Neurotoxicity Proposal

Transcription

1 HESI VALUE: Translational Safety Biomarker Assessment of Neurotoxicity Proposal Jesse L. Goodman, MD, MPH US Food and Drug Administration Emerging Issues Session HESI Annual Meeting 12 June 2012 Prague, Czech Republic

2 Why a Good Fit for HESI? Relevant High Interest Right Expertise Opportunity to Progress Science Strengthens HESI s Portfolio

3 HESI COMBINED CHALLENGES MAP Relevance: Proposal fits into current map. Relative impact Animal use and welfare Vaccine development, use, and safety Genomics Human health: scientific evaluation of sensitive populations Sustainability Stem cell technology Food safety Communication and perception of risk versus benefit Improved risk assessment through biomonitoring and epidemiology Risk / benefit: regulation of chemicals in commerce Translational biomarkers Risk assessment of sensitive / vulnerable populations Environmental quality Emerging contaminants Safety of genetically modified organisms and foods Regulatory framework for new methods Computational tools / toxicology Use of science in setting public policy Omics in risk assessment Risk assessment of co-exposures Nanomaterials / nanotechnology Paradigm shifts in risk assessment / life cycle assessment Stem cell therapy Individual susceptibility Improved testing and assessment strategies Regulatory framework for carcinogenicity testing Alternatives to animal models Epigenetics in risk assessment Exposure-based risk assessment Improved biomonitoring through biomarkers Time: immediate (2010) to long-term (2020) Each axis appearing on the HESI Combined Challenges Map is a continuum. All issues on the map are of high importance/impact based on prioritization by the participants in the 2009 HESI mapping exercise. Relative impact is a qualitative measure of importance among high priority topics. The location of issues along the time continuum is an approximation of when the topic is likely to become a major issue in the timeframe from 2010 to 2020.

4 Interest Topic has relevance to all sectors involved with HESI. Project has potential to bridge academic, government, and industrial engagement.

5 Existing Expertise Opportunity for Synergy Benefit from organizational experience in related areas: Biomarker development and evaluation; Brain mapping project in imaging committee. Opportunity for HESI to facilitate interdisciplinary approach to define and address relevant issues.

6 Opportunity to Progress Science Development of translational biomarkers remains key focus for drug and chemical safety. Neuro program offers opportunity to bridge different disciplines (pathology, histology, chemistry, imaging, neurophysiology, electrophysiology, clinical diagnosis, etc.). HESI well positioned to advance this research.

7 Strengthens HESI s portfolio HESI has active programs in Cardiovascular Renal Developmental/Repro Immune Liver (evolving) Genetox Imaging Neuro would be a strong addition.

8 Relevance to FDA and Public Health Consistent with FDA s strategic goal to modernize toxicology in our 2011 Strategic Plan: Vision: Advances in life science and engineering transform product evaluation, better identifying and predicting what candidate is safe and what is harmful and reducing animal testing. Examples of related efforts include: FDA Guidance on Drug Development Tools FDA engagement with Predictive Safety Testing Consortium FDA engagement with EPA and NIH on Tox21 FDA grant support for developing new in vitro systems, e.g., heart-lung micro-machine, ocular and reproductive toxicology FDA collaboration with DARPA and NIH: human on a chip

9 What Would It Look Like? Year 1: Plan, gather data, and hold workshop to bring together expertise / input from relevant sectors and disciplines. Review case studies/experience driving consideration of initiative to build needed evidence to augment histological methods with emerging biomarkers. Review state of the art and identify promising biomarkers/technologies and potential candidate compounds for pilot collaborative testing. Examine opportunities to link biomarker development to other studies and methods, e.g., imaging. Determine whether there is sufficient interest and support for next steps to plan and build a consortium, and what its goals should be. Year 2: If answer is yes, identify support and bring together partners to plan and initiate a neurotoxicology biomarker consortium.