Genomic Medicine

Applying genomics to enhance your drug development journey.

Parexel’s Genomic Medicine team helps its partners integrate genomic research into their global drug development programs for a smoother journey to market. Recognized by biopharmaceutical companies, peers and regulatory authorities as thought leaders and influencers in their field, Parexel’s Genomic Medicine team of scientists have a cumulative 300 years of experience incorporating genomics into drug target selection and validation, medicine development, registration, commercialization and differentiation from competitor medicines.

Genomic expertise to simplify the route to product approval and maximize patient access.

Parexel’s Genomic Medicine scientists apply expertise, innovation and state-of-the-art methodologies in the strategic and operational implementation of genomics services to help clients:

  • Better understand the genetic/genomic basis for the disease, drug, target and pathway
  • Differentiate their drugs from competitor medicines in development or on the market
  • Stratify drug responders/non-responders and enrich clinical trial design
  • Develop companion diagnostics strategies, where appropriate
  • Inform the benefit-risk profile of your medicine
  • Expedite regulatory and payer approvals
     

Our core services:

Data analytics and informatics Pharmacogenomics (PGx)
  • DNA Variation
  • RNA Variation
  • Microbiome
  • Proteome
  • Metabolome
  • Bacterial/Viral Phylogeny
  • Host-Pathogen Interactions
  • Mechanistic Pathway Analysis
  • Genotype Imputation
  • Database Mining
  • Database Development
  • Methods Development
  • Genomic strategy development from first-in-human (FID) through commercialization
  • Operationalize genomic strategy
    • PGx protocol and informed consent language
    • Sampling requirements
    • Sample and consent tracking and reconciliation
    • Qualify and manage genomics specialty labs
    • Genomic data management
    • Analysis & reporting of genomic results
    • Inclusion of PGx in regulatory submissions & labeling
  • Develop and support medicine companion diagnostic strategy
  • Improve sample collection rates
  • Inform understanding of drug mechanism of action
  • Inform drug dose selection with ADME PGx
Target validation and repositioning

Provide genomic evidence to:

  • Improve understanding of disease
  • Identify novel drug targets
  • Inform compound selection
  • Validate drug target: indication relationship
  • Identify potential alternative or new indications

Therapeutic area expertise includes:

  • Cardiovascular diseases
  • CNS/Neurology
  • Dermatology
  • Hematology
  • Immunology
  • Infectious diseases
  • Inflammatory diseases
  • Gastroenterology
  • Metabolic diseases
  • Oncology
  • Ophthalmology
  • Rare diseases
  • Renal diseases
  • Respiratory diseases
  • Reproductive/Urology
  • Rheumatology

We are always available for a conversation.

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