PHARMACEUTICAL & BIOTECHNOLOGY
R
ESEARCH
, DEVELOPMENT & COMMERCIALISATION 

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BioTarget Consulting provides research and preclinical development expertise to enable the efficient translation of biotechnology discoveries into commerically viable development projects.  The scope of the consultancy is broad and encompasses the following research and development areas:

  Discovery Research
  • Pharmaceutical discovery program assessment - tractability, commercial rationale, medical need, ease of development
  • Drug screening cascade development - decision points, criteria setting, hit to lead to development candidate planning
  • In vitro and in vivo model assessment and development
  • Gantt charting progress against milestones and targets
  • Pharmacology consulting - neuropharmacology and molecular pharmacology specialist
  • Disease target consulting - considerable expertise in psychiatry, autism-spectrum disorders, stroke, TBI, neurodegenerative disorders, obesity, diabetes, oncology, wound-healing and others
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 Preclinical Development
  • Early stage preclincal planning
  • Off-target screening
  • ADME studies - in vitro and in vivo pharmacokinetics (PK), PK-PD correlations, CYP enzyme screening, stability screens
  • Genotoxicity advice and contracting - Ames, chromosomal abberrations, micronucleus testing
  • Secondary pharmacology safety testing - e.g. cardiovasular and respiratory studies required by regulators
  • GLP safety and GLP toxicology - studies required by ICH / FDA / EMEA Guidance
  • Guidance on CMC requirements for drug substance manufacture to GMP
      
 Regulatory Advice
  • ICH requirements at different stages of development for ADME, safety and toxicology
  • Documentation advice for translation of preclinical projects into clinical programs
 Documentation
  • Medical writing of research discovery and preclinical development manuscripts
  • Preclinical and drug substance manufacture (CMC) material for IND submissions
  • Consultation and writing of Investigator's Brochures to support clinical trials


Bickerdike 2015