BioScience Experience

Edmond Scientific experience includes:

  • Conducting basic and applied R&D in Medical Countermeasure Systems (MCMs) to include biomarker, biological identification, and FDA-approved diagnostic systems,
  • Providing subject matter expertise (SME) in regulatory affairs supporting development pathways and FDA regulatory policy
  • Evaluation of 2nd generation vaccines and monoclonal antibodies
  • Providing scientific support and SME in clinical support of early stage drug development products optimized through Phase 1 for antimicrobials including nontraditional antimicrobial approaches to include:
    • Vaccines
    • Animal models
    • Assay development and validation; product potency, stability, immunogenicity testing in translational and clinical trials
    • Safety and efficacy evaluation of vaccines
    • Supporting nonclinical product development
    • Promoting public-private partnerships (PPPs)
  • Providing expertise in pharmaceutical manufacturing, including scale-up manufacturing of an R&D program in order to meet the emerging needs.
  • Providing scientific support in technology transfer and partnering with industry
  • Bioinformation systems and knowledge management to include integration of data repositories, data segmentation, and semantic search and support for knowledge retrieval.

Our expertise in Advanced Development and Manufacturing (ADM) includes:

  • Providing strategic and technical guidance on pr1ocess development, manufacture, and quality assurance across the portfolio of projects for new pneumococcal, rotavirus, enteric bacterial, and influenza vaccines,
  • Acting as the QA authority providing technical and regulatory guidance on the development, manufacturing, testing, GMP compliance, and CMC information, across a range of vaccine technologies, including, but not limited to, viral, bacterial, recombinant DNA, mammalian cell culture, and egg-based production.
  • Evaluating new technologies for upstream and downstream production of both bacterial and viral vaccines and assess their suitability for production of vaccine in the developing world.
  • Conducting technical (process development/manufacturing/quality assurance) due diligence of potential partners.
  • Providing technical review of pharmaceutical plans and technical documentation relative to vaccine manufacturing facilities.
  • Advising on all aspects of the project, for setting up a compliant Quality System in support of a new drug applications to the FDA.
  • Advising on the optimal process for developing scalable vaccine manufacturing process to support product pipelines.
  • Acting as government SME for licensing and commercial applications
  • Providing pharmaceutical portfolio management consulting, including analyses and strategy for partnering, contract negotiation, and in/out licensing.
  • Supporting government-industry contract negotiations: option agreements, strategic collaborations, manufacturing partnerships, CRO agreements, and discovery agreements
  • Developing compliance programs and quality improvement plans for pharmaceutical manufacturers and governance/oversight by the government.
  • Developing strategic regulatory plans for development of vaccines and biologics.