Attendees

·         Jen Goode

·         Paul Bishop

·         Craig Bonsignore

·         Tina Morrison

·         Achim Zipse

·         Lisa Lim

·         Steve Brooks

·         Donna Lochner

·         Ahmet Erdemir

 

Won’t be able to participate today:

·         Alexander Nikanorov

·         Lindsay Pack

·         Ahmet is planning to call in, but may be late

 

Introductory Comments

• Tech Transfer Agreements
• CDAs
• Bard CDA is completed
• Abbott, Mass General Hospital CDAs are being negotiated
• Need comments from Boston Scientific, NDC
• BSC:  may be able to get CDA soon
• MTA:  may take 3 months (protocol 1^st and then images will be included in amended MTA)
• MTA for protocol first, then images
• CCF MTA – difficulty reaching CCF Tech Transfer contact (hasn’t been getting back to Michelle)
• Lori gave her to someone else
• Bill Palmer gets stuff ready for legal
• Paul will check with Bill, and then will email Michelle to let her know what is going on
• Collective – Need to complete CDAs first

 

Status of R01 Grant (Paul)

• February 5 submission
• Draft has been received from modelers; working on again later in the week
• Shared with FDA for a meeting (Th/F are pretty open for CCF)
• Wants to send it in next week – they like 10 days to review
• Paul is working on some modeling portions
• Separate section for the ASPECT goals (2 paragraphs)
• Collaboration:  industry, academia, regulatory
• Need to see that right up at the front of the grant
• ACTION:  FDA will propose some language for edits
• Letter(s) of Support
• FDA
• Letter will state that FDA approves of Bram’s participation (co-PI) in the study & what is important about the data being collected
• Companies
• Title, number, sample letter of support (if Vik is willing to share)
• May want to send by email since web-site is open to the public
• ACTION:  Paul will provide this information and guidance on desired content of letters.
• Data sharing
• Raw data, anonynomized, quality for modeling
• DICOM
• Release to public (data sharing required by FDA)
• Protect Vik’s right of publication?  Is he okay with providing data as it is collected?
• FDA/industry look at how data is documented so that it is useful for the field
• ACTION:  Paul will check in with Vik on this issue
• Time frame for NIH review of grant
• 6 months for reviews
• Funding starts December 2010
• First enrollment likely 1-2 months after IRB approval and nursing staff
• First patient enrollment Jan/Feb 2011
• IRB:  can’t submit until protocol acceptance
• Ahmet:  usually need IRB pending status (or will bounce out of consideration)
• Check NIH guidelines
• A few hours to get the project into the CCF IRB system can follow with more formal protocol

 

Outstanding ACTION Items

• Tech Transfer Agreements – in process; need comments from companies
• ACTION (Alexander):  Wedge discussion – Alex should FU with Paul to finalize how to fund and design what is needed;  Paul will coordinate a FU discussion with Alexander and other CCF folks who will be appropriate to build - ongoing
• ACTION (Paul):  estimation of costs (if dividing by multiple companies)
• <$500k/year direct costs; 5 year grants (CCF has additional indirect costs)
• 4 years collecting data; 1 year of additional data analysis
• Definitions of how data was derived, so end user knows how to work with the data
• Optimize how data will be shared and readily available
• Disseminate as data is available (DICOM) and then processed
• ACTION (Paul):  Provide a working image dataset for each of the imaging types that will be used in the study – on hold until after grant application is submitted
• ACTION:  Craig & Paul (early Feb) – offline discussion

 

Next Meeting:  1/20/10 – Lisa out; Jen will run meeting.