CET works collaboratively with its partners to carry out joint research that advances the therapeutic product candidate and adds value to the partners’ intellectual property. Each therapeutic product has a unique development path and requires a product and regulatory development plan appropriate for the product’s indication. Likewise, technology development activities at CET are governed by partnership agreements tailored to the type of product, developmental stage of the technology, and the needs of the individual partners and stakeholders, among other criteria. New development partnerships may follow this course:
Explore Technology Opportunities // We enter into discussions with potential partners, including intellectual property owners and assignees, to evaluate suitability of offered technologies and gauge mutual interests to enter into develop partnerships. Non-disclosure agreements are executed as appropriate.
Partnership Agreements // For selected technologies, an initial development plan is discussed and the parties reach consensus on major objectives, collaborative project teams and members, initial development steps and key milestones, assignments of major responsibilities, funding strategies and resources to be acquired and/or allocated. Appropriate Option, License and/or Research Agreements are executed that govern partner activities to advance technology development collaboratively.
The Parties // The product development and commercialization partner is comprised of professionals at CET and its parent company Cumberland Pharmaceuticals Inc.
The scientific development partner is comprised of scientific inventors and other subject matter experts including research investigators and clinicians and technology management officials.
Overarching Goals // The foremost goal is to establish proof-of-concept for the technology. For early stage technologies, collaborative work may include an efficacy study using an animal model relevant to the disease or medical indication.
With this milestone achieved, the parties work collaboratively to achieve next steps in the product development plan leading to the IND milestone (i.e., Investigational New Drug application is cleared by the U.S. FDA).
Strategic Approach // Small Business Innovation Research (SBIR) and Technology Transfer Research (STTR) grant mechanisms support proof-of-concept studies for early stage development projects. Significant value is added and risks to advancing the technology are reduced upon achieving SBIR/STTR Phase I and Phase II milestones under a peer-review system.
Later stage, nonclinical development programs fit a different model and utilize different funding strategies dependent on the type of product, indication, and stage of development among other factors.
Project teams meet regularly to review goals and work accomplished, identify factors for success, devise strategies to resolve problems, plan next steps, update the development plan and revise timelines to achieve the next “go/no go” decision point in the critical path.
Regulatory Approval and Commercialization // CET’s product development team creates a product & regulatory development plan for each product candidate and indication. We work to continually update the plan as new results are obtained and milestones achieved and manage all interactions with the U.S. FDA. We also design and implement commercialization strategies based on sales forecasts and market research intelligence. Inventor scientists continue to guide scientific direction during all phases of product development and typically carry out parallel, ongoing discovery research programs. The new knowledge generated is critical to understanding the product’s modes of action and advancing product development.
Development partnerships may be created around technologies at any stage of nonclinical development. When the IND milestone is achieved for a product candidate, the technology may be sublicensed from CET to its parent company Cumberland Pharmaceuticals Inc. In this case, responsibility for advancement through clinical development transfers seamlessly to Cumberland Pharmaceuticals. Alternative paths may include out-licensing to a third party.