CET partners with inventor scientists, affiliated technology transfer officials and entrepreneurs seeking a corporate partner to assist in navigating complex biopharmaceutical pathways to commercialize new therapeutic products. Partnerships are created mainly around innovative biopharmaceutical products addressing critical unmet medical needs. Agreements govern activities of the parties to collaboratively advance the product along its critical path towards first-in-human studies and ultimately marketing approval for a commercial product. CET brings a wide breadth of product development expertise to the partnership and offers an array of services.
- Project management
- Grant application preparation and submission and management of grant awards
- U.S. and international biopharmaceutical development expertise
- Product development
- Formulation & manufacturing
- Clinical & regulatory development
- Commercial development infrastructure
- Core management team consisting of pharmaceutical & biotechnology industry veterans and a network of medical directors and advisors
- Marketing strategies for commercialization
Technology Evaluation // Our senior management team understands the risks and benefits of developing early stage technologies, pathways to create marketed products that improve therapeutic outcomes, the needs of the marketplace and the regulatory environment governing biopharmaceutical products. Our Advisors and Directors inform the technology evaluation process and development strategies. Information is gathered to assess technology opportunities in terms of the stage of development, feasibility to address unmet medical needs, strength and competitiveness of the scientific foundation, partner-organizational profiles and core strengths, intellectual property assets, commercial potential, and strategic fit with CET’s project portfolio among other factors. Non-disclosure agreements are executed as appropriate.
Product & Regulatory Development // We have proven expertise creating and commercializing new therapeutic products in the U.S. and working with international partners for global product development and distribution. We excel at preformulation, analytical support, formulation development, manufacturing, nonclinical study design and implementation, and navigation through U.S. FDA regulations. These strengths are critical to advance early stage technologies and create new products.
Project & Grants Management // We provide logistical support for the collaborative project teams through coordinating communications and team meetings, planning next steps and resolving problems, preparing and archiving reports and other management activities. We compete for development support from external sponsors, including private organizations and governmental agencies such as the National Institutes of Health. We identify appropriate funding opportunities, prepare and submit proposals for joint research projects and support partner-initiated proposals. We have a track record of winning awards through the Small Business Innovation Research (SBIR) and the Technology Transfer Research (STTR) granting programs, which are designed to advance innovative early stage technologies. We manage grants awarded to Cumberland for joint research with our partners, with a commitment to assure compliance with sponsors’ terms and conditions of the award. Click here to view our corporate Objectivity in Research policy.
Commercialization // We support formulation and manufacturing of product candidates through all stages of non-clinical development. At later developmental stages, we offer expertise in sourcing and manufacturing GMP-grade drug substance and clinical trial material, stability testing, process development and scale-up towards commercial manufacturing. We develop sales forecasts and strategies for marketing and distribution, and provide assistance with in-licensing and out-licensing of intellectual property.