I'm Ron Evans. I'm an ophthalmologist from Placerville, and my wife has Parkinson’s disease. Specifically I was noticing in an earlier talk, I think Dr. Mills presented some of the funding schedules, and for 20 -- well, for this year and up to, I think, 2016, they had zero dollars slated to fund translational projects. Is there a reason why there's a delay in that and not moving of that $40 million forward?
(Randy) Mills (president of the stem cell agency, CIRM): Yes. So the funding for the $40 million here is on a -- starting as soon as it's approved by the board today. The numbers I put up on that slide were for the fiscal year 2016. So our fiscal year started July 1st and will end June 30th of next year. Between now and June 30th of next year, we will -- this program will be started, but we won't be through an entire cycle. Meaning we have to issue the program announcement, then there has to be time to complete the applications, and the applications come in and they go through the review process, and then after the review process, they come back to the board and the board approves them. We will not have gone through all of that cycle yet by June 30th. So the actual first awards that will come out of this will be in fiscal year 2017.
Evans: so essentially there has to be a certain legal process that it goes through before the funds are available or procedural if legal is not a good term.
Evans: And maybe an amendment someone might even think of is the president, if he sees an exceptional project, could seek to sidestep that or make an exception. Thank you.
(Agency) Chairman Jonathan Thomas: other comments from members of the public? Please state your name.
Roos: My name is Ben Roos. I'm a young onset Parkinson’s at age 31. I think I want to see some action. I understand the procedures and policies, but this is a billion dollars of money that I voted for and the public voted for, and I’d like to see translation put into effect ASAP. And I’ve waited 15 years. I'm tired of waiting. This is a golden opportunity. I think you guys should -- the people at Scripps (Research Institute) here have a program which is under way. Ten million, for example, would help them get into the next stage of translation. And I would give it to them this year, not in 2016. Also I would urge my fellow Parkies to speak up. This translation thing is where the rubber hits the road. So we've all come a long way. Speak up.
Hoover: Chris Hoover. I'm a Parkinson's patient. I've addressed the board twice before, but the last one was with Dr. (Jeanne) Loring (head of the Scripps stem cell program) at the Claremont (Hotel), and we were the only ones there because There was a rainstorm of the year. We call that divine intervention. But I think what I want to do is summarize. We kind of feel like we're a round peg in a square hole. We came to you and we had our discovery stage pretty much done by ourselves. We've raised the money, we've done the research, and we’ve got the science. So clearly we're in the translational stage, and that's where we're at. They suggested that we pull our old application because where we're at didn't fit the old CIRM and that it would fit the new CIRM 2.0 better. I was here almost every meeting, and CIRM talked about doing a 60-day turnaround on applications under the 2.0. So I’m not hearing anything about that now. We're talking now June of the following year. And that's kind of -- we've been waiting a while here. We've attended every meeting. So I’m wondering if there's any way, when you approve the translational, that we can speed that process up. And my question is what happened to the 60-day turnaround that you talked about initially with the 2.0 presentation.
Chairman Thomas: Dr. Mills.
Mills: So the 60-day funding decision is for the clinical stage programs, which includes the last part of translational and the enabling Studies that are done. There would be no way to do it for the high volume applications though.
Hoover: Where do we fit in your process because we didn't to come to you in the discovery stage? We're where we are now. Our science is done. We're need funding to get FDA approval. I guess my question to the board is: Is there any way to accelerate the process? Then you'd have us out of your hair. Thank you.
Chairman Thomas: Mr. (Jeff) Sheehy(a patient advocate, CIRM board member).
Sheehy: I think that's a question for Dr. Loring. I'm not sure where you would be in the science in terms -- we had our train analogy. I don’t know. I don't know what pieces need to be done and how that fits.
Hoover: I guess what I meant was when can we get our application in? We just want our application in to get reviewed. That's what we're looking to do. And we've been at this for about a year. Thanks.
Loring: So, Jeff, what's the question?
Sheehy: You don't qualify for the preclinical that's currently open?
Loring: It's not open now. There isn’t another round open right now. I'm sorry. I'm confused. There's no RFA (request for application) that I know of that is open right now that would be appropriate for us. If there is, I’ll apply it.
Sheehy: So there's not an RFA. So you’re really in the middle of the translation stage.
Loring: That's right. We are. We call it preclinical, but it really is translation as you define it.
Chairman Thomas: additional public comment?
Raub: I’m Ray Raub. My wife has Parkinson's, and we've been involved with Dr. (Melissa) Houser and Sherrie (Gould). At any rate, here's where we are. And if there's an exception that can be made, here's why we need it. We have scraped together almost $2 million. We've done it ourselves. We've done it on the backs of our friends. We don't have a lot of those left. They don't answer the phone anymore when we call because they know why we're calling. But we've done this and we've gotten awfully far. We've accelerated what we're doing. We're trying to get through the FDA. We've got functioning sets of dopaminergic neurons. We're ready to put them into a lot of the people that you've heard from today. We won't be able to do it without your help. We're tapped. And we've accelerated what we’ve been trying to get through the FDA. We've probably got about three months more of funding left. We need help, and we can't wait till the end of the fiscal year 2016, till next year. We'll find a way to do it. If you can't help, we'll find a way somehow. Anything you can do. And as I said, if there was ever a situation when exception was warranted, I swear this is it. Thanks.
(Marie) Duliege (CIRM board member): I just want to clarify. First of all, I just want to say how moved we are with all of your coming and your testimony about what you are going through and what you've done on your side to accelerate the process. But I want just to clarify one simple thing that I didn't get clear answer. Is there currently an opportunity to apply for a grant for the research that Dr. Loring is trying to do, or is there not? It's a very simple answer. In which court is the ball?
Mills: For translational activities, that's what we're voting on now.
Duliege: I’d like for everybody. Is there an opportunity for Dr. Loring to apply for a grant for the research that she's trying to do?
Mills: If we approve this, then there will be a program announcement issued, and that's what this funding is for.
Duliege: Thank you very much.
Chairman Thomas: Additional comments from members of the public?
Radunsky: My name is Mike Radunsky, and I’m involved in Dr. Loring's program. You've heard from me several times. And I feel a little bit like the counsel members' statements are a way to say, well, we gave you a chance to apply, but you’re telling us that we have to wait another year before the funding comes in. That's what we saw, a big zero in the 2016 funding. And there were three digits in all the columns for everything else. And the fact that it's going to take nine months to review a grant that we've been discussing with you for a long period of time is a little bit onerous. I think, again, as Ray Raub asked, if there's ever a time for an exception, this is it. I have two small children that I’m taking care of with Parkinson’s disease. And if I don't find something that's going to help me with this, I don't know if I'm going to get to the end of this without severe financial hardship. And I’m extremely lucky to be involved in this program, but I would like to ask you guys to help me stay lucky by getting there, Helping us get the money faster so that I can continue to work and supply for my family.
Chairman Thomas: additional comments from members of the public?
Raub : Hello. My name is Jenifer Raub, and my husband is going to make me cry. I just ask you to please speed this up. Tell us when we can apply, not September.
Chairman Thomas: Dr. Mills.
Mills: For the scheduling, so everyone knows, the concept plan that's before you for translation has the first application deadline, meaning the application would have to be in, is in March, which means the application would post this year. There would be time to obviously be responsive to the application and the application available in March.
Chairman Thomas: any other comments from members of the public?
Raub: Only me. My name is Jenifer Raub, and that's outrageous.
Burkes: My name is Dennis Burkes. I'm a patient, Parkinson’s patient. And this reminds me of the old saying, "Water, water everywhere and not a drop to drink." Down in San Diego we sit amongst other research institutes that are sitting on hundreds of millions of dollars. Guess what they're doing? They’re trying to figure out how they're going to dispense that money, and they’re just dragging that out and dragging that out. And it's so frustrating to all of us. If there's something wrong with the science here, if you know something or some reason this shouldn't proceed, then tell us. Don't let bureaucracy and policy and procedure stop this project from moving forward and taking another year because we're going to run out of money very soon. Ray is right. Maybe we can come up with more money, but we're not the most well-heeled group. And our list in our Rolodex has been used up. And it's going to be tough. And we've hired new people, we have new researchers at work now, and it would just be tragic to see that come to an end with all the funds that are there and with such a promising project as this one. So I just ask that you please take that into consideration. Thank you.
Chairman Thomas: Other comments from members of the public?
Roos: This -- I don't know which of you this is addressed to, but why was there zero dollars in this year's budget for translation?
Chairman Thomas: Dr. Mills.
Mills: So the schedule was set up because we were going to be launching all of these initiatives, not just the translational phase. So we have multiple discovery reviews to do, we have the translational review to do, we have the educational reviews to do, and we have all the clinical reviews to do. So we just have slots that we can have these things fall into. The reason that March was picked as the first application deadline for the translation phase was because we just did an award review in February. It was the most recent award that we had. We hadn't done a discovery award in a while. So when we were ordering them between discovery and translation, because we had just completed the translational phase award in February, we slotted discovery first.
Roos: And the follow-up question is why can't you approve a project like this now? Is this procedure really necessary, to wait a year?
Mills: I would just – James (Harrison) is legal counsel here.
Harrison: So Prop. 71 (the ballot measure that created the agency) requires that we go through a competitive selection process which entails review by the grants working group. And backing up, that involves releasing a program announcement, which will be done expeditiously assuming the board approves the concept proposal. We then need time to process the applications, Schedule a GWG (grant review group) meeting for the review, and then bring those recommendations to the board for its final consideration.
Roos: You guys (unintelligible). Can you do it in three months? I just don't understand why it has to wait a year. Thank you.