Participants

Jen Goode

Lisa Lim

Steve Brooks

Marilou Bastan

Donna Lochner

Lindsay Pack

Achim Zipse

Tina Morrison

Alex Nikanorov

 

Introductory Comments

• Tech Transfer Agreements
• CDAs
• Most organizations should have received CDAs already (whoever the legal contact is)
• GOAL:  finalize in next week or 2
• Need a tech transfer person for Abbott:  whoever handles legal agreements, patent issues (usually lawyers)
• Email Lisa their contact info, and FDA tech transfer person can contact them
• Company legal folks can make edits to FDA documents, if they want
• Bard almost done (waiting on final signature)
• BSC:  haven’t heard back yet if they want any changes
• NDC:  haven’t heard back yet if they want any changes
• Abbott:  will start ball rolling on this – should be able to get done quickly
• MTA for protocol first, then images
• 1 w/CCF
• 1 w/ rest of confidential folks
• Individuals who aren’t listed as confidential participants will not be included in distribution of protocol
• First:  will share protocol
• Then:  share images
• Can’t do this until we get all CDAs signed

 

Status of R01 Grant

• February 5 submission
• Paul is working actively on the drafting of this document
• Not sure if going to NIBIB, or NHLBI
• Solid Mechanics only
• Letter(s) of Support
• FDA
• Companies?
• Might help grant if each of the companies could also write a letter of support
• Do you guys do that?
• Jen:  summary of type of letter that FDA has sent in the past
• Grant title, institute and number being applied to
• Outline need for cardiovascular disease, discuss Critical Path Issues, need for data to help with testing, device design, FDA review of new product designs
• Bard:  willing to do this, who should sign?
• FDA:  center director signature
• Abbott:  they could do this as well, need who to send to
• Logistics:
• Send as a pdf letter to Paul – they submit electronically
• What address should letter be addressed to?
• What is title of grant?
• What institute will grant be submitted to?
• What is grant number that should be cited in the letter?
• Cost:  ~$500k/year; planning to apply for a 5 year grant, but NIBIB usually funds 4 year grants
• Don’t know where the modeling section is at (Ahmet out of country, Melissa may be working on this)

 

Outstanding ACTION Items

• Tech Transfer Agreements – in process
• ACTION (Paul):  give Achim a wish list for what sizes and how many stents they’d like to have  (Melissa will help)
• Achim:  got this from Paul, so will FU with him and then will let FDA know by email what they decide
• 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
• Alexander provided some drawings, so they should be able to make it very easily at CCF (2 blocks cut from polymer:  90/90 and 70/20 with adjustable height so it can work with every pt)
• ACTION (Paul):  estimation of costs (if dividing by multiple companies)
• Don’t have details
• ACTION (Lisa):  ask Paul if there is a working image dataset for each of the imaging types that will be used in the study
• Haven’t heard back on this yet, Paul has been focussed on writing the protocol

 

Next Meeting:  1/13/10