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Research Newsletter
January 20, 2015  

Shipping Abroad in Compliance with Export Regulations

The federal export control laws can apply when regulated items are being shipped abroad. Before shipping a device, materials, or other items abroad, CWRU personnel should contact either the Environmental Health and Safety Office or the Compliance Office so that an employee trained in export compliance can determine whether an export license is needed prior to making the shipment.

These are the steps that all CWRU researchers should follow when planning to make an outgoing international shipment of items or materials:

  1. The CWRU Principal Investigator works with the CWRU Technology Transfer Office (“TTO”) to determine whether a Material Transfer Agreement (“MTA”) is needed prior to the shipment. The CWRU PI initiates this by submitting a completed MTA Review Form found at https://research.case.edu/forms.cfm#tech_mgt.
  2. If the Technology Transfer Office determines that an MTA is needed between CWRU and the overseas organization to receive the items or materials, the Principal Investigator and TTO work together to put it in place. Once the MTA is completed and signed by CWRU and the recipient organization, the Technology Transfer Office will forward a copy of the final contract to the PI. The PI should keep a copy of the final MTA for easy reference. Note that MTAs not only help to ensure compliance with the federal export laws, but they also protect investigators’ intellectual property rights.
  3. Before making the shipment overseas, the PI should contact the CWRU Environmental Health and Safety Office. This step is necessary so that the Environmental Health and Safety Office can analyze the contents of the shipment in light of the export regulations and determine whether the shipment can proceed immediately, or whether federal pre-authorization is needed. If the Technology Transfer Office determined that an MTA was needed, then the PI should provide Environmental Health and Safety with a copy of the signed MTA so that it can match the requested shipment with the formal contract.
If you have questions on how the export regulations impact specific international shipments, contact the Compliance Office: Lisa Palazzo, Director of Export Control and Privacy Management, at 368-5791, or Boyd Kumher, University Chief Compliance, Export Control and Privacy Management Officer, at 368-0833; or email exportcontrol@case.edu.

For more information on the export control regulations, including the full text of CWRU’s Export Control Policy Statement, visit http:www.case.edu/compliance/exportcontrol/.

Questions regarding Material Transfer Agreements (MTAs), should be addressed to Andrew Jarrell in the Technology Transfer Office, Andrew.jarrell@case.edu, 368-1401.

 
eRA Information: Ext-UAT and Commons Demo Will be Unavailable Wednesday, January 21, 2015

The External User Acceptance Test (Ext-UAT) and the Commons Demo environments are scheduled to be offline Wednesday, January 21, 2015 from 9 am to 5 pm in preparation for the winter system-wide software release. As part of their standard practice before each quarterly software release, eRA Commons updates the Ext-UAT and Commons Demo environments with the changes that will take place in production the following week.

Please note that this process will not affect the production environment.

 
NIH Center for Accelerated Innovation at Cleveland Clinic (NCAI-CC)

The NIH Center for Accelerated Innovation at Cleveland Clinic (NCAI-CC) Announces the Request for Applications (RFA) for the third funding cycle.

Funding is available for promising emerging technologies directed towards diagnosis, treatment or management of cardiovascular, pulmonary, blood or sleep-related disorders. NCAI-CC is seeking projects such as therapeutics (e.g. drugs, biologics), preventatives, diagnostics, devices, tools, etc., in order to facilitate their translation to commercialized products that improve patient care and enhance health. The NCAI-CC will provide funding and project assistance to advance the development of high priority early-stage technologies within the mission areas of the NHLBI (cardiovascular, lung, blood and sleep disorders). Expert assistance will be provided in areas required for early technology development, including commercial opportunity assessment, intellectual property, clinical and regulatory, reimbursement, business, legal and project management.

Eligibility: Investigators from the Cleveland Clinic, Case Western Reserve University, The Ohio State University,Cincinnati Children’s Hospital, and University of Cincinnati

Letter of Intent Deadline: February 10, 2015

For more information visit the NCAI-CC website.

 
Case-Coulter Translational Research Partnership (CCTRP)

This is the fourth year of the second phase of the Case-Coulter Translational Research Partnership to support collaborative translational research projects that address unmet or poorly met clinical needs. The CCTRP seeks to reduce the market risk of promising new clinical products arising from the research programs of BME and other Case faculty. Successful projects will thus often focus on the development of prototype products, building relationships with companies, performing clinical feasibility studies, obtaining regulatory approval, and other activities that companies or business experts indicate are the essential last steps before a license can be negotiated or a startup launched. An overarching goal of the program is to foster research and development work likely leading to commercially relevant translational technologies within a three- to five-year horizon. Because the goals of all Coulter projects are to reduce market risk, all proposals are expected to reflect genuine business input, and all projects must include a “business advisor” as an important member of the decision making team.

Awards up to $200,000 will be considered if well justified.

Letter of Intent Deadline: February 13, 2015

For more information visit the BME website.

 
NIH Center for Accelerated Innovation at Cleveland Clinic (NCAI-CC)

The NIH Center for Accelerated Innovation at Cleveland Clinic (NCAI-CC) Announces the Request for Applications (RFA) for the third funding cycle.

Funding is available for promising emerging technologies directed towards diagnosis, treatment or management of cardiovascular, pulmonary, blood or sleep-related disorders. NCAI-CC is seeking projects such as therapeutics (e.g. drugs, biologics), preventatives, diagnostics, devices, tools, etc., in order to facilitate their translation to commercialized products that improve patient care and enhance health. The NCAI-CC will provide funding and project assistance to advance the development of high priority early-stage technologies within the mission areas of the NHLBI (cardiovascular, lung, blood and sleep disorders). Expert assistance will be provided in areas required for early technology development, including commercial opportunity assessment, intellectual property, clinical and regulatory, reimbursement, business, legal and project management.

Eligibility: Investigators from the Cleveland Clinic, Case Western Reserve University, The Ohio State University,Cincinnati Children’s Hospital, and University of Cincinnati

Letter of Intent Deadline: February 10, 2015

For more information visit the NCAI-CC website.

 

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