Transcript_of_Preproposal_Conference_Held_04272011.pdf

Alderson Court Reporting

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National Cancer Institute, Division of Cancer 4

Prevention 5

DCP Consortia Reissuance: 6

Pre-proposal Meeting and Teleconference 7

NCI Meeting, April 27, 2011 10

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The Contracting Officer, Donna Perry-Lalley, 1 opened the conference with introductions of 2

Contracting Personnel and DCP Program personnel. Along 3 with Donna Perry-Lalley, Contracting Officers Virginia 4

DeSeau, Jill Johnson, and Rachel Weiszer were in 5 attendance. The DCP Program personnel introduced were 6

Dr. Eva Szabo, Dr. Leslie Ford, and Mr. Don Johnsey. 7

Following introductions, general meeting 8 announcements were made to remind attendees to silence 9 their mobile phones, to use the mute button when not 10 speaking for teleconference attendees, to submit 11 additional questions in writing or by email to 12 perryd@mail.nih.gov during the meeting, and to let 13 attendees know the transcript would be posted as an 14 amendment to the RFP 15

Dr. Szabo: Can the people on the phone hear me 16 now? Absolutely clear? 17

Okay. Donna, can I first ask you a question? 18

Should we have the people on the phone introduce 19 themselves so we know who it is? 20

Ms. Perry-Lalley: They don't need to. 21

Dr. Szabo: They don't need to? Okay. That's 22

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fine. 1

Dr. Szabo: Okay, so this is why we have 2 three hours to do this. Okay, so we're going to go 3 ahead and get started. 4

So first of all, thank you to everybody who has 5 interest in this program. And so I wanted to keep my 6 comments fairly minimal. I think you've had a lengthy 7

RFP to read so you know exactly what we're looking 8 for. Just to give you a little bit of background. 9

DCP has had a program like this for many years, but 10 the current incarnation which is being re-competed now 11 was funded in 2003 and many of the people who are 12 present here have participated in one form or another. 13

The goal of the program is to do Phase 0, 1 and 2 14 trials, clinical trials in cancer prevention so that 15 we can identify agents that we should study further, 16 hopefully in Phase 3 or to bring to market eventually. 17

And as everybody knows, these are biomarker-heavy 18 clinical trials. 19

So the current program is reworked a little bit, 20 it's reworked primarily in its budget but as well in 21 its central administration. And I will want to make 22

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some comments about the budgeting because I assume 1 that many people have questions about how the budget 2 has been restructured. 3

But I do want to make one other additional 4 comment before, which I thought would come up in the 5 questions that were -- would be asked, it's about the 6 role of foreign sites and are foreign sites acceptable 7 or are they encouraged. 8

And my comment there is that the Government does 9 allow foreign sites, if they add something 10 significant, address a specific need. We have had 11 foreign sites in the previous contracts. We do want 12 them to be relevant to U.S. public health needs. So 13 when you're proposing foreign sites, keep two things 14 in mind. Number one, the cost that comes along with 15 that. And number two, different mechanisms of 16 carcinogenesis that may lead to diseases that are 17 somewhat different in certain populations than what we 18 see in the United States and weigh those factors 19 accordingly. But the answer is yes, we do allow 20 foreign sites. 21

I thought it would be worthwhile to actually talk 22

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a little bit about the budgeting and now I'm talking 1 about the complexity model that you will find on page 2

93, the subject costs. Okay? And this is a departure 3 from how we have done business in the past. Money is 4 not infinite, money is even tighter than it has been 5 in the past. And what we really want to go to is a 6 per subject reimbursement. And we are getting 7 there.But because prevention trials are complex- it's 8 not just a CT that you do every two cycles as you may 9 do in treatment trials (whole body CT)- since 10 prevention trials are more complex, our budgeting has 11 to be a lot more complex as well. 12

And so we're trying to make sure that there is 13 flexibility to allow for screening to identify the 14 appropriate populations and that there be flexibility 15 in the baseline screens. For instance, these can be 16 blood work versus invasive tests such as endoscopies, 17 bronchoscopies, etc. And this is why we have proposed 18 the screening one and screening two strata and then an 19 intervention at various levels of reimbursement to 20 allow for studies that are less complex or more 21 complex. 22

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We obviously recognize that a one month, Phase 1 1 pharmaco-kinetic study is very different from a six 2 month Phase 2b study with multiple bronchoscopies, for 3 instance. So, I gave an example in the RFP, if it's 4 unclear please ask me the question subsequently. 5

At this time I'd actually like to go through the 6 questions that have been submitted. Again, you are 7 going to have a verbatim transcript, but I will read 8 the questions, in some cases I'll paraphrase them, and 9 give you our answer and then if you have additional 10 questions please feel free to ask now, preferably, but 11 if a question comes up later we will most certainly 12 answer it. And all questions, as Donna said, should 13 go to her and, as appropriate, will come to us. 14

Okay. So the first question that was asked was 15 about the role of subcontractors and actually what 16 kind of information needs to be submitted about the 17 subcontractors. This refers to page 90 -#13f of the 18

RFP. Okay, and the question was, is it necessary to -19

- let me just look at it carefully. Is it necessary 20 to submit a complete cost proposal for subcontractors? 21

The answer is no. The information that we really need 22

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about subcontractors is what's in 13 A through E, 1 that's sufficient. 2

Do not submit a complete cost proposal for the 3 subcontractors, because their use will change 4 according to the specific study. However, we do want 5 a good description of their capabilities, what is 6 their strength- why are you using them, what can they 7 provide to the program. Okay, so I'm going beyond 8 that question a little bit. 9

Second question was regarding the business 10 proposal budget. Are we allowed to submit requests 11 for budgets for our participating organizations to 12 support them prior to submitting a study. In other 13 words, a core cost for the participating 14 organizations. 15

The answer is no. The core costs are really only 16 for the lead sites, not for the participating sites. 17

This has been tried by some organizations in the past, 18 it is a great way to lose money if the participating 19 orgs don't do anything. So, the answer is no. 20

With regard to the LOI budgets, when submitting 21 budgets for the LOI are you supposed to submit 22

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itemized budgets or budgets in the per patient 1 reimbursement? If you're supposed to submit itemized 2 budgets, does this apply only to the lead organization 3 or also to the participating organizations or should 4 you also provide a patient reimbursement for the 5 participating sites – in other words, do we want an 6 itemized budget for all the sites? 7

These itemized budgets in the RFP, the 8 sample LOIs in the RFP are meant to inform your 9 ultimate per patient reimbursement. So we actually 10 want an absolutely itemized budget for these sample 11

LOIs. That's not how we're going to do it once the 12 contract is awarded, then we're going to go to the per 13 patient reimbursements. But the goal of these 14 itemized budgets here in the sample LOIs is to allow 15 you to build those per patient reimbursements at the 16 various complexity levels and it will tell us what 17 assumptions you are making to get to those numbers. 18

Okay? So the answer is we want a fully itemized 19 budget for all the lead sites. Okay? 20

Another question with regard to the LOI budgets, 21 is there an approximate approvable range of budgets 22

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for LOIs beyond which the proposal will be cost 1 prohibitive, ie. should you stay within a certain 2 dollar range when proposing studies beyond which the 3

NCI will be unlikely to approve LOIs? 4

Money is limited. I don't need to tell you that. 5

I can't give you specific numbers beyond which we 6 would not approve an LOI. But I would recommend that 7 you be reasonable in what you propose. 8

Next question refers to additional technical 9 proposal instructions, page 75, items 2 and 3 and it 10 relates to previously performed studies. So in item 2 11 we are requested to document the completion and 12 reporting of at least two Phase 2 trials and at least 13 one Phase 1 trial if the Offeror wishes to be 14 considered for the Phase 1 studies under this 15 contract. And this refers to prior studies. And then 16 in item 3 you are requested to provide documentation 17 of ability to perform Phase 2 trials in at least two 18 different target organs. Can these be the same 19 studies? 20

And the answer is yes. You don't have to 21 document five different trials, just two or three. 22

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Next question. Additional technical proposal 1 instructions, page 75 with regard to the resumes. Are 2 full CVs required or are biosketches acceptable? 3

Biosketches are fine. 4

As you can see, a lot of these are very concrete, 5 yes-no kind of questions, which is good. 6

Next question, if we propose to involve several 7 investigators from one participating institution, 8 should we collect letters of commitment and resumes or 9

CVs from all the PIs or from just one PI at each 10 institution? 11

We would recommend that you collect documentation 12 from the multiple PIs at each institution, because it 13 will strengthen your proposal. For instance, a 14 urologist at an institution can't speak for the 15 pulmonologist at that institution. So if you have 16 commitment from two different departments, from 17 multiple PIs, working within different organ system 18 groups, we want to know that, it'll definitely 19 strengthen your proposal. 20

Okay. Next question. Patients in the Phase 0 21 and 1 studies require much more work than Phase 2. 22

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A.) will increased credit for patient accrual be 1 allocated per patient? In other words, would a Phase 2

0 or 1 patient count as 1.5 or 2.0 patients towards 3 the 75 patient per year expectation? And b.) is it an 4 acceptable expectation that the budgets for Phase 0 5 and 1 patients will be higher? 6

So I respectfully disagree, I think studies of 7 different phase differ in their complexity. My own 8 experience is that Phase 2b studies tend to be more 9 expensive than Phase 1. But in any case, different 10 studies have their own requirements and one 11 participant will earn one participant credit 12 regardless of what kind of study it is or how complex 13 it is. The budgets need to be realistic, based on the 14 individual study. 15

Next question. Do the biomarker studies have to 16 be done in a CLIA level facility? The answer is no, 17

CLIA is not required. We understand that a lot of the 18 biomarkers are, in fact, experimental. 19

Next question. Is imaging considered a marker 20 and will the cost be covered? At what level, ie. 21

Medicare versus full reimbursement? 22

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So, imaging is a marker. Costs will be 1 reimbursed at Medicare levels for approved imaging 2 modalities, you know, mammograms, CTs, MRIs. 3

Obviously novel imaging modalities that are not 4 approved are encouraged and if they're not approved 5 then we will reimburse at cost. 6

Okay. Next question. With regard to the two 7 required sample LOIs, if an LOI has been previously 8 submitted but review was not completed due to a lack 9 of preliminary data, are we allowed to redesign it and 10 resubmit for consideration? And b.) if we alter a 11 previously reviewed LOI addressing review concerns and 12 changing LOI endpoints or the administration of the 13 agent for instance oral to topical or disease site, 14 will this be reviewed as a new LOI? 15

So, this is actually a very important point. You 16 cannot submit an LOI that has been previously been 17 submitted to DCP and you have received some input 18 about it. I don't know what it means if the review 19 was not completed due to a lack of preliminary data. 20

I don't recall ever sending an LOI back unreviewed, 21 although the comments may have been minimal if we have 22

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decided to not accept it. But, if you have been 1 discussing a particular study, whether it was 2 officially submitted as an LOI or you've just been 3 discussing it with DCP staff and you've gotten some 4 input about that, you really cannot submit that as a 5 sample LOI for the RFP. 6

If you become one of the contract holders, then 7 that study can be submitted, you know, for actual 8 funding subsequently. So it's not a lost cause, 9 however it really cannot be submitted in the sample 10 where we're trying to assess your capabilities to do 11 work if you've gotten input from us. I think that's 12 sort of self-evident. 13

Frank: I'd like to ask --. 14

Dr. Szabo: Go ahead. 15

Frank: For example, an oral formulation and a 16 topical formulation because that's an entire different 17 sort of protocol or LOI that requires all sorts of 18 different things. The only similarity is that it's 19 the same drug. 20

Dr. Szabo: So you know, I can't tell you all 21 possible variations of how that can be different. Let 22

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me give you a couple of examples. If the issue was 1 that we didn't like an endpoint and suggested a 2 different endpoint, okay, and now you come in a 3 different formulation but using the endpoint where 4 you've already gotten input from us -- 5

Frank: -- even do the trial. 6

Dr. Szabo: Well, Frank, I think the only way I 7 can answer the question is that if you have gotten 8 sufficient input from us that will result in a change 9 in how you plan to do the study, okay, based on the 10 feedback, then I think it's really not fair to 11 resubmit. If it now goes in a completely different 12 direction and is not guided by what we said 13 previously, then I think that's acceptable. 14

But, you know, the issue is that if somebody were 15 to challenge the choice of contractors and they see 16 that you have gotten input on a particular study, I 17 think they would have a pretty good case to bar you 18 from getting the contract. That's the bottom line. 19

We're having difficulties-- you're fading in and 20 out, - I think you're saying that you can only come up 21 with so many studies, and I understand that. But it's 22

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an issue of -- 1

Frank: I don't understand why when it's totally 2 a difference, you know, an oral or topical there's not 3 definitely a difficult, I mean everything is 4 different, you know, topical compared to oral. 5

Dr. Szabo: I agree. Again, my comment was that 6 if the study that you are proposing, using a topical, 7 is sufficiently different from the original that any 8 fair individual looking at it would say that it was 9 not informed by the original review, then it should be 10 okay. But if a third party will look at the 11 discussions and say, well okay this new study was 12 informed by the previously discussion, then I think 13 it's not a fair thing to submit. 14

It's a risk you're going to take if somebody 15 challenges the outcome of this RFP. 16

Okay. I'm going to go on to the next question. 17

For our sample LOIs, can we propose data results that 18 have not yet been confirmed and assume data analysis 19 results? So the answer is it depends on the data. 20

For instance, if you're waiting for a Phase 2 21 dose and there's an ongoing Phase 1 study in progress 22

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and it's expected to be completed let's say within the 1 year, you could submit an LOI for a Phase 2 trial with 2 the assumption that there will be a Phase 2 dose 3 available. But if you are waiting for scientific data 4 to emerge from a study and it can go either way where 5 some of the results would most definitely argue 6 against doing a Phase 2 study, then it would be pretty 7 risky to assume a certain outcome is going to be shown 8 and that may not be the ideal Phase 2 study to 9 propose. Okay? 10

Next question. Is there an absolute limit on the 11 number of participants that will be allowed in each 12

LOI? What is the minimum number of patients expected 13 per LOI and what is the maximum? 14

So you should propose a participant number that 15 makes for a good study. There is no absolute minimum 16 or maximum. I guess I should say other than the 300 17 participants plus the options that are going to be 18 covered by the entire contract. I would urge you to 19 use common sense and your knowledge of how Phase 2 20 studies in the prevention field have been done to 21 date. Okay? 22

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Next question. With regard to expected accrual, 1 is the 75 per year across all studies or for each 2 study, including all study site? 3

It is 75 participants accrued in a given year 4 across all studies that are open. 5

Next question. Regarding the availability of a 6 drug for the sample LOI. Is it necessary to have 7 commitment from the pharmaceutical or biotech company 8 to actually provide drug or is potential availability 9 for clinical use sufficient? 10

Potential availability is sufficient, commitment 11 is not necessary. These are sample LOIs. 12

Regarding biomarkers and the sample LOIs. Is it 13 necessary to have the assay worked out in the tissue 14 of interest or is the expertise to perform the assay 15 sufficient? 16

So expertise is sufficient as long as it is 17 highly likely that you will be able to perfect the 18 study. So for instance, if you can do 19 immunohistochemistry but there's no antibody to the 20 protein under study, okay, don't propose to do 21 immunohistochemistry in that setting when it's 22

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completely unreasonable to think that that will be a 1 study available. 2

Next question is a specific one. Item 15 on page 3

51, section 508, EIT accessibility. Can you confirm 4 that this is applicable to deliverables only, only 5 items that will actually be delivered to the NIH, 6 correct? This applies to all electronic deliverables. 7

Okay. Page 11, under documentation required 8 during conduct of a trial. Could you please expand on 9 the section, specifically clarify who the official 10 database for trial funded by this contract would be. 11

I think that question is asking who -- where it would 12 reside and the frequency for submitting the minimal 13 data set transfers. 14

So the database of record, unlike in the current 15 program, will be at the sites. We will not have 16

Westat hosting RDC. RDC specifically is not part of 17 this acquisition. The minimal data set, which we will 18 post (we've been working on this), minimal data sets 19 will be sent to DCP on a monthly basis. These minimal 20 data sets may evolve over time so just to be aware of 21 that. And formats that are acceptable include XML, 22

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CSV and Excel, although XML and CSV are preferred. 1

And data will be submitted via SFTP site. Okay? And 2 we have been piloting this and hope to move it 3 forward. 4

Leslie may want to make a comment later about the 5

Metadata Rave and so on, but we don't need to get into 6 that right at this minute. 7

Next question. Page 75, number 4, the 8 solicitation requests that an Implementation Plan 9 accompany each of the two hypothetical LOIs. Does the 10

Implementation Plan count against the ten page limit 11 for each LOI and is there a template for the 12

Implementation Plan? 13

So please use the LOI templates that are found in 14 the DCP website, which are cited in the RFP. The 15

Implementation Plan that we're referring to is part of 16 this. It's the section on structures, facilities, 17 recruitment capability. That's what we're really 18 asking for. Everything asked for in the template 19 should be within ten pages, except for the references 20 and the budget, the itemized budget. So it’s very 21 similar to how current LOIs are being submitted, for 22

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those who are part of the program. 1

Next question. Can you identify which drugs are 2 available in the NCI repository so we know which 3 agents are readily available? 4

So the answer is actually, no. The way our 5 repository works, the way we work with our 6 pharmaceutical partners, is that in the majority of 7 cases we actually negotiate a drug on a study-by-study 8 basis. It's not like we've got some hoards of drugs 9 that are just waiting to use there. So we don't have 10 these stockpiles, especially not of the agents that 11 currently we are most interested in. 12

Okay. Next question. 13

Frank: Is there a question I can ask? 14

Dr. Szabo: Yeah. 15

Dr. Ford: Can we ask everybody who's not talking 16 to put their phones on mute? We're getting a lot of 17 feedback. And I don't know if it's coming from yours 18

Frank. It sounds like the ocean. 19

Dr. Szabo: Yeah, Frank you're coming in and out 20 so we're not hearing you. Can you please repeat your 21 question? 22

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Frank: The question is, is how about when it's 1 already worked out but still -- 2

Dr. Szabo: You know, so it's usually in clinical 3 trials agreements and they're done on a study-by-study 4 basis. So yes, one would think that it would be 5 easier to get a second study up and running if the 6 pharmaceutical party has given permission to do one 7 already-- so the question is, can we give a list of 8 the CRADAs that we have. We don’t have CRADAs, we use 9

CTAs. And again, although we think that it would be 10 easier to get a second study going if they've agreed 11 to give us drug for one, the specific CTAs always 12 refer to a protocol and therefore it's not fully 13 appropriate. 14

Frank: I understand that, but -- 15

Dr. Szabo: I think the only thing that we can 16 provide is a list of the studies that are ongoing. 17

Yeah, so we can provide you a list of the studies that 18 are ongoing, because that's public information. Okay? 19

Next question. Would LOIs using ablative therapy 20 be considered for this mechanism or are drugs a 21 required component for the proposed LOIs? Yes, 22

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ablative therapies and non-drug strategies are 1 acceptable. We are looking for, I'm putting this in 2 quotes, "interventions to reduce risk," end of quote. 3

And that actually covers all the questions that I had 4 from prior submissions, except we have two more 5 questions that were just submitted and then Donna will 6 address a couple of business questions. 7

So two more questions. Can you confirm that 8 individuals must be 21 years old to be classified as 9 an adult who does not require co-signature or consent 10

-- on a consent document. 11

Actually that apparently differs from state-to-12 state. In some states it's 18, in some it's 21. So I 13 cannot confirm, but you need to know what the rules 14 are in the states where you are working. 15

An additional question. Might there be a 16 mechanism to submit LOIs at times other than the 17 official solicitation times? 18

So in the past program we did LOI solicitations 19 three times a year and then two times a year at later 20 times. You know, the current plan is still to go with 21 defined solicitations, but we will address this when 22

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we see the abundance of work that is to be had by this 1 program. 2

So I'm going to turn the mic over to Donna who is 3 going to address a couple of other questions and then 4 we will take questions from the audience. Thanks. 5

Ms. Perry-Lalley: Okay, I just want to remind 6 the people on the teleconference line to mute their 7 phone. We are getting some feedback. It sounds like 8 maybe wind or breathing, I'm not sure what it actually 9

is. So, it's still going. So figure out if you have 10 that mute function and use it. Thank you. 11

I just want to reiterate something that Eva 12 touched on regarding budgets. We did have another 13 question that asked if there was a specific limit or 14 range for the budget and that was touched on regarding 15

LOIs. And again, no there is no specific limit range, 16 but funds are limited. Okay. 17

And as far as a central website or message board 18 for the solicitation, our central point of reaching 19 out to the public is FedBizOpps. So all amendments 20 regarding the RFP and all your questions that you've 21 asked and we answer, if not directly to you, will be 22

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posted on that website. Okay? 1

Now there were some other business related 2 questions. This question refers to the business 3 proposal instructions and specifically cost or pricing 4 data and data other than cost or pricing data. So the 5 question is, is there a specific dollar limit for 6 materials or supplies that require you to supply us 7 with quotes or invoices? And we would say for our 8 rule of thumb, what we use for your proposal purposes 9 is to submit quotes or invoices on anything over 10

$1,000. However, should your organization be entered 11 into the competitive range and we enter into 12 negotiations, we may ask for some additional 13 information that might be for lesser amounts. So just 14 use that little rule of thumb, if it's a thousand or 15 more send us some backup documentation. Okay? 16

The next question refers to the business proposal 17 instructions again. It says item 6d11, it's on page 18

84 of the RFP and it's in reference to the small 19 business subcontracting plan goals. These goals are 20 sent down to us by Health and Human Services, we don't 21 set these goals ourselves. So yes, you do need to 22

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strive to meet those goals. 1

There is one correction. When this RFP went out 2 the goal for the overall small business subcontracting 3 was 39.9 percent. That does sound a little high to me 4 even now reading it. That has been corrected since 5 then and it is now 28 percent. Okay? But we do have 6 the small business subtypes in there, the five percent 7 for small disadvantaged, five percent for woman owned, 8 three percent for HUB zone and three percent for 9 service disabled veterans. 10

Now we understand that doing clinical trials is 11 difficult to meet all these small business goals, 12 however zero percent goals will not be accepted by our 13 small business office. I've got to make that clear to 14 you. Please try to find ways, your materials and 15 supplies, any kind of subcontracts that are not 16 universities or hospitals, they may qualify. Check 17 them. Check to see if they are small business in any 18 way. And if they are small business, see if they 19 qualify under any of the subtypes for small 20 businesses. 21

Now if you're still hitting a wall and you're not 22

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getting something above zero, you can include your 1 indirects in your goals. Okay? And what I mean by 2 indirects is your housekeeping or your paper towels. 3

These are things that you might have to go to your 4

Contracts Accounting Representative, or your 5

Subcontract Plan Administrators to get that 6 information. You know, maybe there's a small business 7 who does the housekeeping and that's figured into your 8 overhead rate. So that's something that our small 9 business office also could help with, but go to your 10 people first, get the information, have them develop 11 the plans and then they can actually work with our 12 small business reps if needed. 13

Okay. The next question has to do with the 14 budget and this is -- they're planning on -- 15 everybody's going to be activating studies in years 16 two to five and they wanted to know if they can submit 17 one proposal for the options and one for the five year 18 proposal for the five year base. 19

But that's not how we want to see it. We want 20 one business proposal. Okay? And in your budget you 21 should budget for your base period of five years. And 22

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remember, in that base period you're accruing 1 approximately 75 patients per year in years two 2 through five for a total of 300. 3

And we're going to have two, one year options, 4 not one, two year option. Okay, it's two, one year 5 options that you can budget for, put in your proposal, 6 as well as in that base period we also have options 7 for subjects. And we've shown you how we kind of 8 foresee the breakdown of the option quantity, on pages 9 five to six of the RFP. And under B.2, Estimated 10

Cost-Option for optional quantities, subjects. And so 11 we've broken it down into small increments, 12, 12, 13 12 and 13 up to a total of 50 additional subjects. Okay? 13

So you should propose that in your business 14 proposal, as well as option quantities within that 15 base period only, not in the option years. Okay? 16

Is that clear? Did anybody not understand or 17 does anyone have a question? 18

Ms. Perry-Lalley: Base plus two, one year 19 options, but within the base there are optional 20 quantities for the subjects. 21

Anybody on the teleconference line? 22

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Female Speaker: Just one additional 1 clarification. Base is individual one year -- 2

Female Speaker: We can't hear you. 3

Ms. Perry-Lalley: You want to come up here? 4 can people hang up and call in again so that we 5 could hear better? There is interference… -- 6

Mr. Johnsey: -- we'd be calling into the same 7 line, and if that party didn't hang up and reconnect 8 there would still be interference-- 9

Male Speaker: Yeah, I know but there's no way to 10 disconnect that. 11

Dr. Szabo: No, but we don't know who is 12 responsible for the interference. No, there is no way 13 to disconnect. The only thing I could say is that 14 there will be a verbatim transcript, so if you miss 15 something it will be there verbatim next week. And 16 apologies. 17

Ms. Perry-Lalley: Yes. Okay, just to clarify 18 the base period. When you budget your base period, 19 even though it's a five year period, we want to see 20 each year individually. I think most of you are 21 familiar with that as well. 22

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Mr. Johnsey: -- cell phones should be put in the 1 other room. 2

Frank: Could I ask for a clarification of a 3 couple of the questions -- 4

Ms. Perry-Lalley: Okay. 5

Frank: -- as far as the transcript? 6

Mr. Johnsey: Can you hold that? We're right in 7 the middle of something now. We'll come back to it. 8

Frank: Well, that's fine so long as we can come 9 back to it. 10

Dr. Ford: We're all shutting off our cell 11 phones, Frank. 12

Mr. Johnsey: So Donna, why don't you finish your 13 thought and then we'll go back. 14

Ms. Perry-Lalley: Okay, regarding the base 15 period, please budget for each year individually and 16 then in the years two through five is where we would 17 foresee additional subjects, option quantities for 18 subjects. We're not going to exercise option years in 19 that base period, but we will exercise those option 20 quantities for subjects in that base period. So you 21 would want to put that in the years you think they 22

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might fall. I mean obviously we're estimating, these 1 are options, optional quantities for accrual purposes. 2

Was there additional clarity needed? I think 3 somebody -- okay. You've received a question? 4

Ms. Johnson: Do you want me to read it to you or 5 write it? 6

Ms. Perry-Lalley: Sure, you could read it. 7

Ms. Johnson: Can you repeat the response to the 8 question about would LOIs using ablative therapy be 9 considered within this mechanism or are drugs a 10 require component for the purpose of LOI. 11

Dr. Szabo: The question was whether ablative 12 mechanisms are considered responsive or do we have -- 13 do you have to use drugs. Yes, ablative therapies are 14 appropriate. We are looking for interventions to 15 reduce cancer risk, so it doesn't have to be a drug, 16 per se. 17

Ms. Johnson: A follow up question. Do the 18 biomarker settings have to be done in a CLIA level 19 facility? 20

Dr. Szabo: Okay, repeating the question about do 21 biomarkers need to be done in a CLIA certified lab. 22

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No, they do not. 1

Ms. Johnson: Another one. They may have not 2 heard this answer. Would DCP be interested in an LOI 3 that was drugs and its ability to show biological 4 changes in imaging techniques, for example, -- 5

Dr. Szabo: Okay, so the question was with regard 6 to using existing drugs with an imaging endpoint, I 7 folded that question in to say that imaging is an 8 appropriate endpoint. So yes, imaging is an 9 appropriate endpoint, we will accept that. 10

Are there other questions that are being sent or 11 that somebody here has that we can answer? 12

Dr. Brown: This is Powel Brown with a question. 13

We could not hear your response to the explanation of 14 option one and option two periods of the estimated 15 costs budget on page 5. 16

Ms. Perry-Lalley: Okay. Let me make sure I 17 understand your question. You want to know how to 18 budget for the option one and option two years? Is 19 that correct? 20

Dr. Brown: That's correct. 21

Ms. Perry-Lalley: Okay. When you submit your 22

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budget proposal you should include those as full 1 budgets for each year, individually, and then that 2 would be inclusive of your base period, in terms of 3 when we add it all up, but you would present your base 4 period as individual years for five years. And then 5 each option as an individual year also. 6

And it's intended that those option years would 7 cover the core costs that might be needed to proceed 8 and extend the finalization of protocols that were 9 started during the base period. It's not intended to 10 start new protocols. 11

Did that answer your question? 12

Dr. Brown: That's very helpful. Thank you. 13

Dr. Szabo: Are there additional questions from 14 anybody? If not again there will be a verbatim 15 transcript so if you miss the answer to a question it 16 will appear. And if you have additional questions 17 after this please send them to Donna and we will 18 answer them and those questions will be posted, the 19 answers will be posted. 20

Female Speaker: I have a question on page 5. 21

What options one through three and -- what does that 22

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mean? 1

Ms. Perry-Lalley: Good question. And that's 2 what I was referring to earlier when I was talking 3 about the option quantities for subjects. If your 4 organization feels they have the capability to accrue 5 additional subjects above and beyond the 300 total 6 that we have put into that statement of work that we 7 anticipate would be the minimum, you could put in 8 additional options for those subjects. 9

And we broke them down because with these options 10 we need to fully fund them. This just makes it easier 11 for us to fund, if they're in smaller increments. So 12

-- also, it helps to explain, I guess if you have a 13 study that goes beyond the 75 number say in one year 14 and you needed 85, this would allow you to do that. 15

So you might want to have five option quantities 16 within that base period of ten, but that just gives 17 you an idea of how we foresaw the breaking down the 18 additional subject accrual into option quantities. 19

Dr. Szabo: Are there any additional questions? 20

Male Speaker: I had a question that just 21 occurred to me. 22

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Dr. Szabo: Okay. 1

Male Speaker: I'm not sure if you answered it or 2 not, but I'm going to ask it. For someone who 3 currently has a contract, would it be seen as positive 4 to submit LOIs in areas that had not been intended 5 compared to doing more of the same with minor 6 variations? Does that sufficiently qualify? 7

Dr. Szabo: So the question is for people who 8 have an existing contract, should you be submitting 9

LOIs that are in different areas as opposed to more of 10 the same. That's a paraphrase. 11

I cannot tell you what would be viewed more or 12 less favorably. What I can urge you to do is to put 13 your best face forward and show us what your 14 capabilities are in as many areas as you're capable of 15 doing and that's what we're looking for. 16

Male Speaker: So an LOI -- and there's no 17 relationship to whether you had a previous contract or 18 not? 19

Dr. Szabo: That's correct. I mean we're 20 starting from scratch. Now obviously your prior 21 experience is going to be counted and will be used as 22

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one of the measures of what you're capable of. 1

However, the LOI which we would like to be realistic, 2 is an indication of what your capabilities are and 3 that's how it ought to be used. And in some cases if 4 the LOIs are good and the drug is available and you do 5 get the contract, it could be a fast track to protocol 6 approval, but that is not a guarantee. 7

Are there additional questions? Well, hold on a 8 sec. Yeah? 9

Female Speaker: We're seeing if there's addition 10

-- 11

Dr. Szabo: Oh, okay. Technology is rate 12 limiting and we lost Internet access and have now 13 regained it, so bear with us as we check whether you 14 have sent anymore email messages. Technology is 15 failing us. Okay. 16

If somebody who's on the telephone has sent a 17 question and I -- we have not addressed it, can you 18 speak up and tell us as we are internet-open right 19 now. 20

Male Speaker: I asked you a question regarding 21 the actual option budgets. Do you want that data in a 22

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separate budget section? 1

Dr. Szabo: Donna? Hold on one second. Okay, 2 can you repeat that question? And let me turn it over 3 to Donna. Hold on a sec. 4

Male Speaker: My question is, is that if you 5 want the option budget for the additional patient 6 segment, would we then submit a completely separate 7 budget to you in terms of how you wanted the per 8 subject budget per protocol and then you want an 9 option budget, is that what you'd like to see? 10

Ms. Perry-Lalley: No. I think what we want to 11 see when you develop your per subject costs for that 12 base period, those numbers are going to be the numbers 13 you would use then for your option quantities, for 14 those additional subjects. You're developing numbers 15 that are going to be per subject cost. So these would 16 just be per subject costs. And you would say ten 17 times whatever that number is that you anticipate your 18 per subject costs would be. That would be the amount 19 of the option. 20

Male Speaker: Is there going to be something 21 like we add to the existing form to say here's what we 22

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have? You know, as far as we would add it, say to the 1 budget we submit to you and say and our sample budget 2 plus 12 for option one? 3

Ms. Perry-Lalley: Correct. 4

Male Speaker: We would just show that one to 5 you? 6

Ms. Perry-Lalley: Yes. That would be in the 7 budget. You would have to show each of your options. 8

Generally you would have your base period with your 9 year one, two, three, four, five. Okay? And you'd 10 have your option years, your option year one, option 11 year two. Okay. But within your base period you're 12 also going to show I have options for these subjects 13 and I'm adding that dollar amount on but show that it 14 is an option. 15

Male Speaker: Okay. So we're also -- we're 16 going to use the same forms we used prior, correct? 17

Ms. Perry-Lalley: The same forms, right? Is 18 that what you said? 19

Yes. The what? 20

Male Speaker: -- for the budget, they're going 21 to be the same? 22

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Ms. Perry-Lalley: It's the Excel spreadsheet we 1 sent -- there's a link to it in the RFP under section 2

J, attachments. 3

Male Speaker: Yeah, I know but my question is -- 4 that we will add our own portion where we would pick 5 up option one? 6

Ms. Perry-Lalley: No, you would use the same 7 forms. 8

Male Speaker: Okay. 9

Ms. Perry-Lalley: When you're developing your 10 per subject cost you can use your own format if you -- 11 when you're describing to us how you've come up with 12 those costs. But then those numbers need to feed in 13 to that spreadsheet. 14

Male Speaker: Okay. 15

Dr. Szabo: Are we connected? Okay. 16

So there do not seem to be any additional 17 questions, so I think we will say thank you. And -- 18 hold on. 19

Ms. Perry-Lalley: We will be keeping the 20 teleconference line open until two o'clock, since we 21 said eleven to two, we have to keep it open. Someone 22

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-- probably a couple of us will be here in this 1 conference room as well during that time period, since 2 that time schedule was set to go until 2:00 p.m. 3

We will take a break, I guess a little early, 4 however and let people -- I mean if you're not coming 5 back we understand, but you can come back and ask 6 questions. Let's see, it's approximately twelve 7 o'clock. 12:15 I guess -- we will come back and be 8 available to answer questions. 9

We'd like to thank all of you, in case you're not 10 coming back, for your interest. We do appreciate you 11 taking time out of you day and we look forward to 12 seeing many excellent proposals come in on July 25th. 13

Thank you. 14

[Whereupon, at 11:57, the meeting recessed.] 15

Ms. Perry-Lalley: -- remaining in the room, just 16 wanted to let you know it's now 12:16 or so and we are 17 available for questions if you have them at this time 18 and we will be here until 2:00 p.m. 19

Mr. Johnsey: Is anyone on the phone? 20

Female Speaker: Yeah, hi. I do have a question 21 about RDC about whether that is going to be the manner 22

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in which data is communicated back and forth or not? 1

Ms. Perry-Lalley: At this time I think my 2 understanding is that we will not be using RDC. We 3 will have minimum data sets and whether that will be 4 modified slightly, I'm not sure at this time. But we 5 will not be using RDC is the word right now. 6

Female Speaker: Okay. So we should come up with 7

-- and I guess -- a way of being able to send our data 8 to you in a secure manner according to the 9 instructions? All right. 10

Ms. Perry-Lalley: Yes. 11

Female Speaker: Thank you. 12

Ms. Perry-Lalley: Is there anybody else on the 13 line? 14

Male Speaker: And we are still monitoring the 15 email address that we posted -- 16

Female Speaker: Hi. I have a question. 18

Ms. Perry-Lalley: Hold on just a moment, please. 19

Hold your question while we get our transcription 20 person ready. 21

Female Speaker: Okay. 22

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Ms. Perry-Lalley: Okay, thank you. We'll let 1 you know when we can start up. 2

Female Speaker: Okay. 3

Male Speaker: Okay, we're all set. 4

Ms. Perry-Lalley: Okay, he's ready. 5

Female Speaker: Well my question has to do with 6 article H.20 Information and Physical Access Security. 7

Ms. Perry-Lalley: Let me go to the article so I 8 will be able reference what you are referring to. Do 9 you have the page number of the RFP? 10

Female Speaker: Page 26. 11

Ms. Perry-Lalley: Thank you. 12

Female Speaker: At the bottom. 13

Ms. Perry-Lalley: Okay. I have it. Go ahead 14 with your question. 15

Female Speaker: Okay. So my question is, if we 16 are going to -- we're not going to use the RDC and 17 we're going to be submitting data, does the data need 18 to be encrypted and do we have to through all these 19 security channels in order to send this data to you? 20

Ms. Perry-Lalley: That's -- hold on a moment. 21

Mr. Johnsey: I think we'll have to get back with 22

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her on that. 1

Female Speaker: Hello? 2

Ms. Perry-Lalley: Hi. 3

Female Speaker: Hi. I have one more question I 4 was hoping to get answered. 5

Ms. Perry-Lalley: Hold on just a moment. Hold 6 on just a moment. We have another question. We're 7 talking. 8

Female Speaker: Oh, I'm sorry. 9

Ms. Perry-Lalley: It's kind of hard to tell when 10 you're on a teleconference line. I understand. 11

Mr. Johnsey: So regarding the data -- 12

Ms. Perry-Lalley: Data security. 13

Mr. Johnsey: -- question. Let's do our research 14 and we will add this and respond in writing. 15

Ms. Perry-Lalley: Okay. And I would ask that 16 the caller send your question to perryd@mail.NIH.gov 17 so we can reference that and make sure we answer it 18 correctly. We're probably going to have to talk to 19 our Information System Security Officer here at NCI 20 and we want to make sure we get the correct response 21 out to you. So having that question printed out will 22

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be helpful. 1

Female Speaker: Okay. Will do. 2

Ms. Perry-Lalley: Thank you. All right, there's 3 another caller on. 4

Female Speaker: We would like to propose -- we'd 5 like to make a proposal for an agent that's been 6 proposed in other areas of NCI but not relevant to 7 this chemo prevention consortium contract that we 8 currently have. Would that be disallowed based on not 9 having -- not submitting the study that had fact prior 10 review? 11

Ms. Perry-Lalley: It's had prior review under 12 the chemo prevention program or some other program? 13

Female Speaker: Not under the chemo prevention 14 program, under other programs at NCI. 15

Ms. Perry-Lalley: Don's going to answer that 16 question. Mr. Don Johnsey. 17

Mr. Johnsey: And again, is this in conjunction 18 with the Division of Cancer Prevention? Have you had 19 any, you know, discussions with -- 20

Male Speaker: -- one has gone to the Southwest 21

Oncology Group, that was reviewed somewhere within 22

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DCP. 1

Mr. Johnsey: Okay. Right. Well again, what 2 we'd like for you to do is submit that question and we 3 will talk to the right people and respond in writing. 4

Ms. Perry-Lalley: Okay, I have an email, is this 5

Jaclyn who actually asked that question? 6

Jaclyn: Um hmm. 7

Ms. Perry-Lalley: Okay. So that you already 8 sent the question in writing, correct? 9

Jaclyn: Yes. 10

Ms. Perry-Lalley: Okay. So we have that 11 question. 12

Male Speaker: There's two parts to the question, 13

I guess. Other areas in NCI, other areas in DCP. 14

Ms. Perry-Lalley: Okay. And then you will have 15 to clarify that and rewrite the question and make sure 16 that both areas are addressed. 17

Jaclyn: I will do that now. Thank you. 18

Ms. Perry-Lalley: Thank you. 19

Male Speaker: How long will it be before it's 20 answered? 21

Ms. Perry-Lalley: Well we anticipate that when 22

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we post a transcript of this meeting that we would 1 also post any responses to questions that we have to 2 tell you we'll need to get back to you on. So we're 3 hoping to have all those responses posted at the same 4 time in the same amendment. 5

Male Speaker: And when do you think that will 6 be? 7

Ms. Perry-Lalley: Oh, I'm sorry. In 8 approximately one week. 9

Male Speaker: Okay. Thank you. 10

Jaclyn: Thank you so much. 11

Ms. Perry-Lalley: You're welcome. Thank you. 12

[Pause.] 13

Ms. Perry-Lalley: Is anyone else on the line? 14

Female Voice: We're good for a while, Bernie. 15

Ms. Perry-Lalley: Hello, this is Donna Lalley, 16 is anyone on the line? Okay, there are no callers at 17 the moment. It's one o'clock. 18

[Pause.] 19

Male Speaker: -- had stepped away for a few 20 minutes, I had to go to the bathroom -- 21

Ms. Perry-Lalley: Oh, okay. Did you have any 22

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questions? 1

Male Speaker: No, I do not. Not at this point. 2

Ms. Perry-Lalley: Okay, and there are -- okay. 3

Male Speaker: No, I was going to say my partner 4 and I will be going over the -- all of the -- our 5 notes and the materials provided and then see where we 6 go from there. But we're very interested in this. 7

Ms. Perry-Lalley: Okay. Great. I -- there 8 weren't any other callers on the line, but I heard 9 some noises so I was just checking. 10

Dan: I actually just called in, this is Dan at 11

Northwestern. 12

Ms. Perry-Lalley: Oh, hi. 13

Dan: I was on actually earlier and then I broke 14 for lunch here. I do have some questions though that 15

I do have regarding first of all let's go through sub 16 sites. 17

Ms. Perry-Lalley: Okay. Can you hold just a 18 moment, please? 19

Dan: Sure. 20

Ms. Perry-Lalley: Greg, are you on? 21

Greg: Yes, it's being recorded. 22

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Ms. Perry-Lalley: Okay. Fine. Go ahead, I'm 1 sorry. 2

Dan: So regarding the sub sites, if we identify 3 a certain amount of sub sites that we would like to 4 have as part of our consortia, at what point will you 5 be requesting the certs and reps? Do you want them 6 upfront or as we subcontract out should they 7 participate? 8

Ms. Perry-Lalley: Well, when you submit your 9 proposal, you'll submit your reps and certs and we 10 won't need the reps and certs of any organizations 11 until you make those subcontracts with them. 12

Dan: I see. So that's what I was thinking. 13

It's going to be a -- identification, LOI approval 14 which you take at sub sites certs and reps? 15

Ms. Perry-Lalley: Correct. 16

Dan: Okay. I do see that for each 17 subcontracting site or proposed site for us you do 18 want our travel policy. And that's what I'm used to 19 in other NO1s. So you want ours and theirs, correct? 20

Ms. Perry-Lalley: Well, I think we identified 21 what we needed from the subcontractors in one of the 22

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previous questions. In addition to -- 1

Dan: Number 13 on page 90 talks about our 2 subcontractors. 3

Ms. Perry-Lalley: Right. 4

Dan: So, however I read later elsewhere when it 5 talked about travel, you would like subcontractor 6 travel policy. Item number 15. 7

Ms. Perry-Lalley: Oh, okay. If those 8 subcontractors would be traveling, and I understand 9 there's some travel related to participating 10 organizations, going to SCORE meetings or the PI -- 11 the lead PI for a protocol, if they're a subcontractor 12 than I think it would be appropriate to include their 13 travel policy, however again we're not certain -- or 14 you're not certain at this point they'd actually be 15 given a subcontract. Is that correct? 16

Dan: Yes, because it would be in the proposal 17 stage. I would list us as Northwestern and then sites 18

A, B, C through F. And let's say do I need sub site's 19

A through F's travel policy in my original business 20 plan? 21

Ms. Perry-Lalley: It might be safer to have that 22

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upfront. 1

Dan: Okay. Those are so easy to get these days. 2

Ms. Perry-Lalley: Yes. They're online. 3

Dan: It's not 2003 anymore, so that's a lot 4 easier to get. 5

Ms. Perry-Lalley: Um hmm. 6

Dan: But, you do say a complete cost proposal in 7 the same format as the offers. I know you said 8 earlier that that's something we wouldn't do, we would 9 not submit a budget because we're not going to give 10 them a core budget. Correct? 11

Ms. Perry-Lalley: Correct. That's correct. 12

Dan: Okay. Now, what is noticeably missing and 13…