CCMTR Executive Committee Minutes

March 28, 2008

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Present: Dean, Farin, Hammerberg, Horowitz, Olivry, Piedrahita, Sannes

Absent: Davidian

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Introduction of Char Farin

Dr. Char Farin has been appointed to the Executive Committee as an at-large member. Dr. Farin will be an important liaison between the CCMTR and CALS. She is filling the opening left by Dr. Greg Gibson.


Clinical Studies Core

Novartis has committed $625,000 over 5 years to support the Clinical Studies Core.

- This is a gift and as such will be non-reverting.

DoCS has agreed to be the administrative home for the clinical trials veterinarian. This will probably be a clinical assistant professor appointment.

- A search committee has been assembled.

Duncan Lascelles - Chair

Karen Munana

Maria Correa

Mark Papich

Clarke Atkins

- Position is at Human Resources

- It is a clinical non-tenure track position

Action: Continued the hiring procedure for the Clinical Assistant Professor position.

Budget

The vast majority of the CCMTR budget is in reverting accounts. It is critical that recipients of CCMTR grants spend out their account balance or it will mostly likely be lost. Some ongoing CCMTR activities bridge the fiscal year making budget management difficult. This year Dean Arden released the money from one FTE to be used by the CCMTR for Innovations Grants and Service Core Grants. This FTE will be filled by the clinical trials veterinarian. There is a second FTE that was committed to the CCMTR at its inception. The director has requested that money for this FTE be provided to the CCMTR for 08-09.

Action: Work with CVM administration to determine whether remaining budget can be rolled over to the next fiscal year and whether funds from the second FTE will be committed to the CCMTR.

Update on T32 and CTSA

T32 has been given a score of 131. We do not have a summary statement yet so we do not know if funding for all the requested slots was recommended by the study section. The proposal included, starting with two slots and by the end of the third year we would have eight.

The CCMTR partnered with UNC-Ch in the submission of a Clinical Trial Science Award (CTSA) which has received a score of 135 and was ranked second in the pool of proposals. The CTSA would provide the CCMTR with $100,000/year for five years. This money is to be used for pilot projects involving CCMTR faculty and faculty from other UNC system institutions. The CTSA requires us to match funds up to $100,000. If the CTSA is funded, the CCMTR must attempt to leverage these funds from central administration. Since the goals of the CTSA are in line with NCSU objective, it is anticipated that university administration would be supportive of this program. It was suggested that NC State write its own press announcement if the funding comes through.

May 14 is the date that the council meets on both the T32 and CTSA.

Action: Continue to monitor the progress of the T32 and CTSA through the NIH system.

Marketing Plan

We are in need of hard materials to distribute for various purposes. We have met with one person and we will need to meet with two others to design a general information brochure, a pocket folder with changeable inserts and a stand alone display.

Action: Decide on a design firm and develop marketing materials for Center use.

May workshop/Pilot Grant RFP

The workshop is set for May 15 at the Dorothy and Roy Parks Alumni Center beginning at noon. The recipients of 2007 Pilot Project grants have been reminded that they are obligated to present their research-in-progress.

As part of the 2008 Pilot Project Grant application, principal investigators must include a progress report for any CCMTR supported projects.

A “cite the CCMTR reminder” should be sent to the membership. We need a list of all publication resulting from our funding. We should receive acknowledgement of funding in the publication. Also, all members of the center are asked to acknowledge their affiliation in any of their publications or presentations.

Action: Send out the general announcement for the workshop. Send out a reminder to the membership to “cite the CCMTR” in all publications and to inform the center when they do so we can track the publications.

External Review Committee

We have assembled an external review committee

Joe Kornegay – University of North Carolina-Chapel Hill - CHAIR

Maria Ropoza – North Carolina Biotechnology Center

Jeffrey Everitt –Glaxo-Smith-Kline

Tom Rosol – Ohio State University

This committee will be here for two days.

-They will thoroughly evaluate the Center

-They will hold an exit interview on second day to review findings with

Dr. Gilligan, Dr. Arden and/or Dr. Dean.

This is possibly going to take place in August.

Action: Set date for External Review Committee to meet. Check with Dr. Gilligan’s office to find out if the university has any formal policy on reviewing centers and if there is an internal liaison person for the university who will direct the committee. Inform Service Core Leaders so that they are aware that they will be thoroughly evaluated in August.

FTE

There is a proposal that we should utilize part of our second FTE for a CCMTR-dedicated statistician. The question was raised as to whether the Center should pay for what appears to be CVM-wide need rather than a CCMTR specific need. The interest in this proposal seems to be primarily from DoCS faculty. Given that the CCMTR is comprised of faculty from 16 different departments, it should be considered whether this would have a beneficial impact on members center-wide. There is also a lack of hard evidence that a full or even a .5 FTE would be fully utilized by existing need. With the clinical studies service core we have learned that perceived need is not necessarily predictive of whether faculty will utilize a service, particularly if there is an associated cost. An alternative would be to establish a relationship with a statistician or a statistical group that would provide assistance on a fee-for-service basis. Center service core grants could be used for CCMTR members to access this service if they do not have the funds written into existing grants. This would provide insight into the actual demand for such a service as an intermediate step to investing the last CCMTR FTE. Another suggestion included talking with Kate Azizi regarding help approaching SAS, PPD, or Quintiles with a request to support a 0.5 position. This could be a good way of establishing a productive relationship with another corporate entity.

Action: Continue discussion with CCMTR members and CVM administration. Investigate possibilities with corporate partners.

Formal request for a translational research animal facility (animal housing)

It was proposed that the Center make a formal request for a translational research biounit as part of the NCSU response to the UNC-Tomorrow commission report. Such a unit would address desperate needs for animal facilities that are required to pursue current and future investigator initiated, animal-based translational studies. The CTSA provides a clear pathway for interactions that will need greater laboratory animal support. This will need campus-wide support to be successful, particularly from the CVM and CALS.

A short, convincing proposal would be needed for Dr. Bristol to include in his portion of the NCSU response. Such a proposal would need strong support from CVM administration.

Action: Jorge Piedrahita will head a sub-committee to prepare a brief request for support for a translational research biounit and determine whether Dr. Bristol would support its inclusion in the UNC-Tomorrow response.