SLIDES & TRANSCRIPTS
Saturday, December 6, 2003

Highlights of GU SPORES

Jorge Gomez, M.D., Ph.D.

Slide 1:

Thank you, Marston. It is again an opportunity to be here this year to present some of the highlights of the GU SPORES, in particular with this very fine audience.

I want to take just five minutes, or seven, to give a synopsis of where we are and where we should be going with this program, as well as in general with some of the support that we have provided in the National Cancer Institute.

There is no question, in particular for those new investigators, especially those that are coming in and staying for the next afternoon session today, that we are moving investigator initiated research to multidisciplinary type of research.

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Slide 2:

There is also no question that the fundamental basis of how we spend the money and how we spend our dollars in research is coming through the R0-1, P0-1 and so forth, which is basic research. Certainly this is the basis of what we do at the National Institutes of Health, in particular also at the National Cancer Institute.

But also, we are increasing the funding that we do in preclinical research, in particular with the SPORES P0-1 and cooperative agreements. Not only the SPORES to support translational research; there are many other programs at the National Cancer Institute that support preclinical research and translational research.

Also, there is also an increment on the number of phase one and phase two clinical trials, in particular through the SPORES contracts and cooperative agreements and again through different divisions of the National Cancer Institute. But I think what I wanted to present is, hopefully we are moving from this direction, where we should increase the number of funding for preclinical research, translational research in Phase I and Phase II clinical trials. Hopefully that will trickle down to an increase in more definitive studies like phase three clinical trials.  

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Slide 3:

So we support a research concept that is aiming at impacting human disease. It is a group of experts that formulate objectives to the projects. This is the concept that right now is being also proposed by other National Institutes of Health when you look at the Roadmap presented by Dr. Zerhouni in our website.

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Slide 4:

There are many obstacles for this. For one, investigator-initiated research is still the name of the game. Intellectual property issues are very difficult to overcome. Scientific discoveries when you are approaching this from the P council level, who gets the credit, so it is very important also how institutions support investigators and the team concept. Institutional commitment is tremendously important to this.

But from our side, I think we need to also start addressing how our policies and procedures help multidisciplinary research or does not help multidisciplinary research. We need to switch the roles from regulators to facilitators of research, rather than emphasizing our role as regulators. We need to coordinate whenever possible with other programs within the NCI and with the rest of the NIH, how we support this research, so the program director's role is tremendously important.

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Slide 5:

In the SPORE experience, we have basic applied clinical investigators. It is a site driven program, and it has various approaches to human disease, prevention, early detection, diagnosis, treatment, et cetera. It is a bidirectional research, it goes from the lab to the clinic, from the clinical to the lab. It has a lot of flexibility, and we try to do tremendously flexible management in how we support the research.

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Slide 6:

As I already mentioned, therapy, diagnosis, prevention, risk assessment, early detection.

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Slide 7:

There are at the present time 11 prostate SPORES, and there are two genital urinary SPORES. There is a program announcement out on the street that is requesting applications for genital urinary SPORES with a receipt deadline of June 1, 2004. So we are accepting applications for kidney and bladder SPORES for June 1, 2004.

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Slide 8:

So again, the role of the NCI in particular in the SPORE program is to provide more information from the beginning to the applicants, and to facilitate this type of research.

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Slide 9:

We need to incorporate new technologies to patient oriented research. Many of you have witnessed today many of those opportunities. We need to create new ways of interacting with private industry. We are supporting many clinical trials in the SPORE program, where industry is playing a major role as well. We need to get patient advocates involved in research. We need to support clinical development and clinical interventions. We need to enhance drug development through appropriate mechanisms, and all this is part of our SPORE program. We need to enhance the career in development and translational research of new and established investigators, and attract them to the field to do research that really matters to patients.

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Slide 10:

We need to interact with our grantees from our point of view as NCI staff, and interact with other programs, as well within the NCI and NIH, and we need to facilitate our interactions with government agencies like DoD and so forth, that also support a lot of research. We really need to facilitate the research, and encourage investigators to continue to do patient oriented research.

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Slide 11:

We need to create resources to respond very quickly and efficiently to address the gaps, like every phase clinical interventions. We need to also support the coordination and intervention within the NCI and many other organizations with the research that we support.

So translational research is very complicated. We need to bring different players to the field, and we need to play a major role in organizing and coordinating these activities.

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Slide 12:

So the SPORE program right now is undergoing still an evolving program. It has already gone through a phase one or a step one, and is going right now to step two or multidisciplinary research. We have programs that were at the beginning in 1992, now they are well integrated.

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Slide 13:

We are right now in our phase two, where these programs are fairly integrated and are working more and more closely together. We have some very good examples of those, where we have multi-institution clinical trials and coordination of several infrastructures. We hope that we move into a phase three in the future where we will have several SPORES in different diseases, coordinating clinical interventions.

It is my pleasure today to introduce some of those SPORES that have been playing a major role in the National Cancer Institute. The first presenter for this will be Dr. Phillip Febbo from the Dana-Farber Cancer Institute.

Thank you.

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