Safety Biomarkers

Using Advances in Toxicogenomics and Toxicoproteomics to Predict Drug Safety and Toxicity

Thursday, May 20, 2004

About

Dear Colleague:

Can you reliably predict the safety of your next development candidate?

According to a pharmaceutical industry survey, 20% of NCEs are abandoned during clinical development due to observed or suspected drug toxicity. An estimated $2 billion is spent yearly on toxicity-related drug failures. Recently, several potential blockbusters were withdrawn from the market because of adverse drug responses that may have been eliminated with more powerful tools for predictive toxicology.

Current advances in toxicogenomics and toxicoproteomics offer the potential for identification of novel biomarkers that can serve as surrogate endpoints of toxicity. Capturing the information held within the genome and proteome, in combination with an enhanced understanding of the mechanisms of drug related tissue damage, will enable more cost-effective drug development and safer clinical trials.

This timely American Conference Institute publication is devoted exclusively to safety biomarkers, and provides up-to-date case studies on how to optimize safety evaluation, as well as strategies for eliminating attrition of drug candidates due to toxicity.

Leaders from pharmaceutical and biotechnology companies, NCTR/FDA, NIEHS/NIH and other experts in the field provided information on:

  • Validation of pre-clinical biomarkers of safety and toxicity
  • Assessing organ- and system-specific toxic liabilities
  • Applications of genomics, proteomics and metabolomics in drug safety
  • Bridging markers - traversing the gap from pre-clinical to clinical toxicity
  • Mining toxicogenomics and toxicoproteomics databases for safety biomarkers
  • Guidelines for regulatory submission of genomic and proteomic data for toxicity
  • ILSI/HESI consensus on the applications of novel biomarkers
  • Legal, business and ethical issues of safety biomarkers

Contents & Contributors

About

Dear Colleague:

Can you reliably predict the safety of your next development candidate?

According to a pharmaceutical industry survey, 20% of NCEs are abandoned during clinical development due to observed or suspected drug toxicity. An estimated $2 billion is spent yearly on toxicity-related drug failures. Recently, several potential blockbusters were withdrawn from the market because of adverse drug responses that may have been eliminated with more powerful tools for predictive toxicology.

Current advances in toxicogenomics and toxicoproteomics offer the potential for identification of novel biomarkers that can serve as surrogate endpoints of toxicity. Capturing the information held within the genome and proteome, in combination with an enhanced understanding of the mechanisms of drug related tissue damage, will enable more cost-effective drug development and safer clinical trials.

This timely American Conference Institute publication is devoted exclusively to safety biomarkers, and provides up-to-date case studies on how to optimize safety evaluation, as well as strategies for eliminating attrition of drug candidates due to toxicity.

Leaders from pharmaceutical and biotechnology companies, NCTR/FDA, NIEHS/NIH and other experts in the field provided information on:

  • Validation of pre-clinical biomarkers of safety and toxicity
  • Assessing organ- and system-specific toxic liabilities
  • Applications of genomics, proteomics and metabolomics in drug safety
  • Bridging markers - traversing the gap from pre-clinical to clinical toxicity
  • Mining toxicogenomics and toxicoproteomics databases for safety biomarkers
  • Guidelines for regulatory submission of genomic and proteomic data for toxicity
  • ILSI/HESI consensus on the applications of novel biomarkers
  • Legal, business and ethical issues of safety biomarkers

Contents & Contributors

CHALLENGES IN TOXICOGENOMICS AND THE VALIDATION OF BIOMARKERS IN NON-HUMAN PRIMATES
Matthew Cooper, PhD, Biogen Idec

GENOMIC BIOMARKERS FOR NEPHROTOXICITY AND BILE DUCT HYPERPLASIA
Federico Goodsaid, PhD, Fluidigm Corporation

REGULATORY AND INDUSTRY INITIATIVES ON BIOMARKERS OF DRUG SAFETY AND TOXICITY
Steven McPhail, Expression Analysis, Inc.

TRACKING DIFFERENTIALLY EXPRESSED PLASMA PROTEINS ACROSS DRUG TREATMENT GROUPS
Eustache Paramithiotis, PhD, Caprion Pharmaceuticals, Inc.

IDENTIFICATION OF PREDICTIVE MARKERS FOR SAFETY USING PHARMACOGENETIC APPROACHES
Daniel K. Burns, PhD, GlaxoSmithKline
David A. Hosford, MD, PhD, GlaxoSmithKline

DEVELOPMENT OF PUBLIC TOXICOGENOMIC SOFTWARE FOR MICROARRAY DATA MANAGEMENT AND ANALYSIS
Weida Tong, US Food and Drug Administration

DRUGMATRIX™ - THE CHEMOGENOMICS PREDICTION SYSTEM
Kurt Jarnagin, PhD, Iconix Pharmaceuticals

THE CHEMICAL EFFECTS IN BIOLOGIC SYSTEMS (CEBS) KNOWLEDGE BASE
Michael D. Waters, PhD, National Institute for Environmental Health Sciences
Gary Boorman, National Institute for Environmental Health Sciences
Pierre Bushel, National Institute for Environmental Health Sciences
Michael Cunningham, National Institute for Environmental Health Sciences
Rick Irwin, National Institute for Environmental Health Sciences
Alex Merrick, National Institute for Environmental Health Sciences
Kenneth Olden, National Institute for Environmental Health Sciences
Richard Paules, National Institute for Environmental Health Sciences
James Selkirk, National Institute for Environmental Health Sciences
Stanley Stasiewicz, National Institute for Environmental Health Sciences
Brenda Weis, National Institute for Environmental Health Sciences
Ben Van Houten, National Institute for Environmental Health Sciences
Nigel Walker, National Institute for Environmental Health Sciences
Raymond Tennant, National Institute for Environmental Health Sciences

TO DO NO HARM: NAVIGATING ETHICAL CHALLENGES IN GENETIC BIOMARKER RESEARCH
Carol Isaacson Barash, PhD, Genetics Ethics & Policy Consulting Inc.

SOME INTELLECTUAL PROPERTY ISSUES ASSOCIATED WITH GENETIC MATERIALS
William S. Feiler, JD, LL.M, Morgan & Finnegan L.L.P.

PATENTING SAFETY BIOMARKERS
Melodie W. Henderson, Genaissance Pharmaceuticals



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