The strategy of Exodos Life Sciences is to establish a clinical stage drug development pipeline and to move rapidly to proof-of-concept. Each topically formulated medication developed within our state-of-the-art medication research laboratory in San Diego, California, must impact human therapeutics by decreasing side effects, improving efficacy, and improving time to efficacy.
Exodos Life Sciences will build value by:
- Reformulating safe and approved products for new indications. Each new formulation will address a significant unmet medical need. This approach maximizes the probability of technical success, mitigates potential program cost overruns, and optimizes attractiveness of each project as a potential acquisition to a commercial entity.
- Pursuing approval of new medications and indications via the 505(b)(2) NDA or ANDA development pathways.
- Building a strong drug development product portfolio with patent-protected pharmaceutical products, compositions and/or method-of-use. Patent protection on topically delivered formulations will be derived through internally generated concepts and by in-licensing third party intellectual property (IP).
- Developing through a regulatory contract research organization (CRO) a US Food and Drug Administration (FDA)-acceptable streamlined drug development strategy to accelerate development of medical products and obtain clinical proof-of-concept (POC) in a timely fashion.
- Maximizing efficiency and quality of deliverables through program management techniques, including external providers for specific drug development and clinical support, and working with leading CROs to achieve first class submission documents and clinical results.
- Develop strategic alliances with major and mid-tiered pharmaceutical companies to achieve an early and clearly defined exit strategy upon completion of definitive proof-of-principle.
Note: A contract research organization is an organization that provides support to Exodos Life Sciences and the pharmaceutical, biotechnology, medical device industries in the form of research services outsourced on a contract basis. A CRO may provide such services as biopharmaceutical development, biologic assay development, commercialization, preclinical research, clinical research, clinical trials management and pharmacovigilance.