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TODAY’S CHALLENGE
Over the past 20 years or so, the pharmaceutical service industry has witnessed dramatic changes in the complexity of the compounds being developed and investigated. Along with this complexity came the rationalisation of resources and core competencies in the large and not-solarge pharmas and biotechs, increasing the need for outsourcing the development of speciality assays and biomarkers. With the rapid evolution of molecular biology, immunology and genetic science, finding a competent laboratory with the qualifications and experience to meet the R&D objectives for preclinical and clinical development is a challenge for most drug developers. During the current period of intense change, demand is also increasing due to mergers and acquisitions and the subsequent rationalisation of staffing to meet the economic objectives of the M&A. Conservation of cash by others is resulting in staff reductions and more and more outsourcing to speciality houses that provide the required expertise.
Once the decision to outsource has been taken, a number of additional steps must be considered. A general process would be to identify the types of assays needed (safety assessments, biomarkers, esoteric assays), build a relationship with an appropriate central laboratory that has the capacity to manage your R&D project, negotiate the project parameters so that communication and expectations are clear, and maintain clear communication channels throughout the project to help ensure success in its development.
TODAY’S ENVIRONMENT
Biomarkers and speciality or esoteric assays are today playing an increasingly important role across the clinical development spectrum. From large molecule pharmacokinetic assays and immunogenicity assays, to mutational analysis for subject selection to primary, secondary and exploratory endpoints, biomarker and speciality assays have become critical components in every phase of development. |
