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.