The Critical Path Initiative: The Division of Therapeutic Proteins’ Perspective. Amy S. Rosenberg, MD Director, Division of Therapeutic Proteins ACPS Meeting, October 19, 2004. Incentive for Critical Path: the Decrease in Novel Drug and Biological Product License Applications.
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Amy S. Rosenberg, MD
Director, Division of Therapeutic Proteins
ACPS Meeting, October 19, 2004
(Lee Babiss, Roche)
(Frank Douglas, Aventis)
Interferons Critical Path
Hematologic Growth Factors
Neurotrophic Growth Factors
Wound healing products
Enhance specificity and sensitivity of oligonucleotide microarraysfor multiple purposes
Principal Investigator: Serge Beaucage, Ph.D
detection and quantification of bacterial and viral nucleic acid contaminants in biologics including blood products
high-throughput screening of point mutations or single nucleotide polymorphisms in genomic DNA that predispose human to diseases.
gene expression assays to evaluate the safety and efficacy of drugs
The Immunogenicity Barrier Pipelines
CBER, DODP, DCRDP, DOTC, DPDP, DAVDP, DMEDP
CBER, DMEDP, DCRDP, DGCDP, OMP, OIM