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Presented by Malcolm York, M.Phil. at the Nonclinical Studies Subcommittee of the

Presented by Malcolm York, M.Phil. at the Nonclinical Studies Subcommittee of the Advisory Committee for Pharmaceutical Science March 9, 2000. Accessible Toxicity Biomarker Morning Presentations.

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Presented by Malcolm York, M.Phil. at the Nonclinical Studies Subcommittee of the

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  1. Presented by Malcolm York, M.Phil. at the Nonclinical Studies Subcommittee of the Advisory Committee for Pharmaceutical Science March 9, 2000

  2. Accessible Toxicity Biomarker Morning Presentations Purpose: To hear from some of the technology leaders impacting the field - what is being done and what can be done…. Greg Downing, NIH Malcolm York, GlaxoWellcome Gordon Holt, OGS Leigh Anderson, LSP E.F. Petricoin, CBER Spencer Farr, Phase I Frederico Goodsaid, PEBio

  3. Accessible System Specific Biomarkers of Toxicity Goal: To establish a more optimal set of easily accessible biomarkers allowing progression with greater confidence from animal studies into, and through the clinic that herald the early onset of drug toxicities prior to morbidity and irreversibility.

  4. Accessible System Specific Biomarkers of Toxicity Impact: assess (ir)relevance of animal tox findings accurately assess doses associated with toxicity maximize favorable impact on public health minimize regulatory dilemmas/impasses improve selection of candidates for drug development/ reduce candidate attrition rates accelerate drug development/minimize resource consumption

  5. Accessible System Specific Biomarkers of Toxicity Hypothesis: Optimized panels of toxicity biomarkers exist in accessible biofluids (plasma, urine, circulating leukocytes) that we are not presently routinely measuring. These panels of biomarkers are measurable and can reliably herald the onset of drug induced system specific damage prior to visible morbidity or significant irreversible insidious damage.

  6. Accessible System Specific Biomarkers of Toxicity Objective: Define biomarkers with improved ability to profile a prioritized set of system specific damage endpoints covering a variety of mechanisms and drug classes.

  7. Advice from Research Subcommittee of CDER’s PTCC Tier1: Cardiac toxicity a) Cellular damage - resolve troponin usage b) Concensus approach to resolution of QTc / Torsades Vasculitis a) Biomarker need endorsed b) Encouraged growth into biomarkers of “immune system activation”

  8. Advice from Research Subcommittee of CDER’s PTCC Tier 2: Neurotoxicity Peripheral damage plasma markers? Central damage CSF markers? Coordinate with noninvasive imaging initiatives Hepatotoxicity Await upcoming FDA/PhRMA Conference advice Coordinate with ongoing ILSI initiative

  9. Advice from Research Subcommittee of CDER’s PTCC Tier 3 Skin photocarcinogenicity biomarkers Skin, in situ - different technologies Complex biology/timing/alternate models - hold off Renal toxicity Coordinate with ongoing ILSI initiative Coordinate with ongoing biofluids NMR collaboration thru Imperial College

  10. Proposal to NCSS Endorse expert working groups to derive specific implementation strategies Advise membership and facilitate formation of expert working groups Endorse or reprioritize targeted system specific toxicities

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