FW: Geneva meeting

Gates Package, p.47 · gates:email:00018

Date: 2014-10-17 18:03
Type: email · email
sender: Elizabeth Higgs
to: H. Clifford Lane
Topics: Biosafety and biosecurity Vaccines WHO and international investigation

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is) Hi Cliff, You must be exhausted. I am available if you wa one. a I'm appeal to a return of the old number! My work cell is . I know you wanted to touch base with me on the Geneva meeting. Having looked at the agenda I don't see where we (the USG) are supposed to specifically present the therapeutics protocol design. It looks like generic study design presentations followed by discussion. May be better not to discuss specifics beyond the basic Bayesian adaptive study design and we are not in a position to share a specific protocol as all there are still many decisions remaining on the protocol. I have reached out to colleagues in Geneva but I haven't had a response, but hope they will follow up tomorrow. My travel is set including the Oct. 23 Vaccine Development and Availability meeting. If tonight doesn't work, we can talk tomorrow or Sunday. I'm flying Sunday night. Best Libby Original Message-----

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2014-10-17 07:20 unattributed open

> > Thanks - I have copied Ed Cox and Lu Borio. I think they are both going and should be able to provide details. Laura can help facilitate getting the travel orders. Cliff > > On Oct 17, 2014, at 6:57 AM, "Higgs, Elizabeth (NIH/NIAID) [E]" EEO viaid.nib.gov<mailto {Ho niaid.nih.gov>> wrote: > > Sure > > Sent from my iPhone > > On Oct 17, 2014, at 2:33 AM, "Lane, Cliff (NIH/NIAID) [E]" EE viaid. nih. gov<mailto fOniaid.nih.gov>> wrote: > > Any chance you would want to go back to Geneva next week? I think Lu and Ed Cox are attending. >
2014-10-17 07:28 unattributed open

Let's discuss - given his involvement in the development of the protocol it might make more sense to have it be Ed but I understand the FDA sensitivities. Do you have an agenda? > On Oct 17, 2014, at 7:22 AM, "Borio, Luciana (FDA/OC)" <HR@ fa.hhs.gov> wrote: > > Sounds good. Would be nice for NIH to present the protocol. > > ----- Original Message -----
2014-10-17 18:03 Elizabeth Higgs

is) Hi Cliff, You must be exhausted. I am available if you wa one. a I'm appeal to a return of the old number! My work cell is . I know you wanted to touch base with me on the Geneva meeting. Having looked at the agenda I don't see where we (the USG) are supposed to specifically present the therapeutics protocol design. It looks like generic study design presentations followed by discussion. May be better not to discuss specifics beyond the basic Bayesian adaptive study design and we are not in a position to share a specific protocol as all there are still many decisions remaining on the protocol. I have reached out to colleagues in Geneva but I haven't had a response, but hope they will follow up tomorrow. My travel is set including the Oct. 23 Vaccine Development and Availability meeting. If tonight doesn't work, we can talk tomorrow or Sunday. I'm flying Sunday night. Best Libby Original Message-----
2014-10-17 21:20 H. Clifford Lane open

Thanks - we can talk virtually any time over the weekend. The main thing is to make sure that you and Ed and Lu are aligned. As per your note I think it is fine to hold off on specifics and focus discussion on the Bayesian approach. For the discussion regarding placebo controls I am not sure the water is as clear as it was to me for vaccines. While it is my preference and I know the preference of FDA I am not sure there is adequate equipoise within the investigator community. As an aside we do have a commitment from ZMapp to receive product for a stander RCT. In my ideal world the first paring in the RCT would be SOC v.s ZMAPP. with 40 doses of ZMapp you can treat 40 open label trial not be sure of what you have done or 80 in an RCT and have a chance at determining efficacy.

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