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DRAFT
21st century Drug Discovery, Drug Development & Drug Safety life sciences
business & finance strategies, informatics,
technologies & trends Map Research & finance Biology
molec & cellular Drug safety
& pharmacovigilance academic small molecules toxicology ADME
Absorption Distribution Metabolism Excretion Phase zero DOE NIH analytical chemistry biomarker assays AKA
microdosing SBIR DOD ADME/Tox biomarker validation Phase 1 drug safety friends &
families collaboration gene
networks media optimization toxicogenomics Pharmacogenomics basic collaboration project mgt protein
production scale-up &
manufacturing in vitro pharmacology hit to leads collaboration microarray data
analysis lead optimization haplotypes animal models seed capital applied finance A rounds cancer diagnostics
trends oncogenomics cancer finance venture capital cell
& tissue assays CROs Clinical
Research Organizations finance IPOs data
mining immunogenicity minimization finance M&A mergers & acquisitions cancer precompetitive finance clinical trial budgets Conducting
Clinical Trials in Europe finance risk management proteins toxicokinetics
optimization drug delivery mass spectrometry cancer legal NMR
legal patents in silico modeling RNAI
screening cellular
pathways clinical research
fraud legal trade secrets protein protein
interactions virtual screening Bayesian statistics
for Phase III outcomes:
clinical forecasting commercial potential legal patents expiration protein arrays GMP Good Manufacturing Practice clinical
diagnostics improving R&D
economics collaboratively RNAi therapeutics infectious diseases antibacterial drug dev HIPAA
Health Insurance Portability infectious diseases phage
display & therapeutic antibodies monoclonal
antibodies infectious diseases antibiotic
R&D: drug resistance infectious diseases molecular imaging
& informatics biodefense
diagnostics biodefense anthrax,
etc infectious
diseases R&D bio/pharma R&D immunology biotechnology integrated R&D
informatics metabolic electronic notebooks hepatotoxicity clinical protocols LIMs Lab info mgt
systems adverse effects reporting pathways analysis novel
therapeutics Alzheimers IND submissions
Inv New Drug Application CNS post -approval CNS novel
therapeutics pain metabolic
networks cells & tissues tissue microarrays cell therapies outsourcing drug dev Asia Bayesian statistics inflammation outsourcing outsourcing drug dev Latin America
markets
markets NDAs New Drug
Approvals markets drug repositioning
AKA drug repurposing DNA RNA
business/finance cells tissues biomarkers molecular medicine therapeutic areas latest revision 2009 25 June proteins technologies informatics chemistry bioprocessing drug discovery drug safety diagnostics drug development clinical trials regulatory Best
practices, lessons learned & ongoing challenges
Evolving Terminology for Emerging Technologies
Comments? Questions?
Revisions? Mary Chitty mchitty@healthtech.com
Last revised December 12, 2012
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