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Preclinical Consulting

Preclinical Consulting

With Preclinical Research Development, we help investigators gain access to the expertise and tools needed to prepare innovative ideas for human testing. We support and sustain novel technologies and methodologies through the early phases of development, when funding and expertise are most needed.

The overall goal of the Preclinical Research Development program is to accelerate new medical product development in the academic setting and to enhance the opportunities for their commercialization.  In order to compete effectively for translational research dollars and position inventions for future investment, academic investigators must now be able to clearly articulate viable commercialization, clinical, and regulatory strategies for their products.  In addition the investigator must assemble a nonclinical data package (e.g., pharmacology, pharmacokinetics, and product characterization), that will support the regulatory requirements for initiation of clinical trials.

Services

Services

ITHS is uniquely positioned to assist academic investigators with the development of these strategies and to thereby accelerate the testing and/or commercialization of technologies.  We can:

  • Link you to experts in drug and device development
  • Help you develop a regulatory strategy for your health-related project
  • Review and contribute to the scientific content of IND and IDE applications to FDA
  • Connect you to other educational and commercialization resources in the Pacific Northwest
  • Connect to other academic commercialization programs

Who can use the ITHS Preclinical Research Development program?

Who can use the ITHS Preclinical Research Development program?

We work with ITHS-affiliated researchers from academic institutions in the Pacific Northwest.

ITHS Programs

Programs

The Preclinical Research Development program has offers several resources and programs to facilitate development and commercialization of translational research. These programs are integrated into the regional ecosystem of parner programs supporting translational investigators. See Partnership tab.

ITHS Drug and Device Advisory Committee

ITHS Drug and Device Advisory Committee members have many years of industry experience in FDA regulatory requirements, product development, manufacturing, sales, and clinical implementation. The committee provides expert input for early stage academic innovators who aim to take their bench research to the clinic or industry setting. Learn more or schedule a meeting.

ITHS & WRF Commercialization Fellowship Program

ITHS and the Washington Research Foundation (WRF) support five $10,000 stipends for a 10-week summer fellowship program managed by the Buerk Center for Entrepreneurship. Each fellow works with an academic primary investigator to conduct a deep-dive business analyses on promising technology from that investigator’s research, looking at its intellectual propery status, regulatory path, potential business models, eventual impact, and likelihood of implementation. Learn more by visiting the Commercialization Fellowship Program web page.

Partnership Programs

Partnerships

ITHS Preclinical Research Development works with several partners to support researchers as they move toward clinical implementation of their innovations. Key programs:

  • UW CoMotion – CoMotion Innovation Managers support investigators at UW with intellectual property development and mentorship connections. The Innovation Gap Fund is a competitive opportunity to win $50,000 toward commercialization of a new technology. Training in entrepreneurship for faculty, students, and staff is provided through the CoMotion Regional NSF I-Corps program in partnership with the WE-REACH Biomedical Innovation Bootcamp.
  • WE-REACH Biomedical Entrepreneurship Hub  – Academic biomedical innovators in Pacific Northwest research institutions can benefit from training through the WE-REACH Biomedical Innovation Bootcamp which is partnered with CoMotion’s Regional NSF I-Corps Program. WE-REACH also has competitive funding and support for teams with advanced innovations, helping them prepare to spin out as a startup companies or licensed technologies.
  • UW Pharmacy Biomedical Regulatory Affairs Program (BRAMS) – Students in the BRAMS program work with their expert advisors to develop FDA regulatory analyses for selected biomedical technologies. These analyses support investigators in their preparation and planning for FDA requirements.
  • UW Law School – The Entrepreneurial Law Clinic works with selected biomedical technology teams, advising on intellectual property issues and providing company formation advice. UW Law School also has courses in FDA Law and Emerging Healthcare Technologies where the law students prepare advisory memos to technology teams covering FDA issues specifically relevant for each team’s innovation.
  • Life Science Washington Institute – Training and consulting programs support biomedical innovators in Washington and the greater Pacific Northwest. LSWI makes connections to mentors and prepares innovators to present their opportunities to funders such as Small Business Innovation Research grants, angel investors, and venture capital firms.
  • Washington Research Foundation/WRF Capital – Provides competitive opportunities in the form of nondilutive grants and seed venture funding to innovators and startups in Washington state.
  • Cambia Grove – Convenes innovators in healthcare systems, government, and communities to accelerate transformation toward a more patient-focused equitable system for all.
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