key: cord-0752952-c91050zi authors: Lewin, Sharon R; Attoye, Timothy; Bansbach, Cathy; Doehle, Brian; Dubé, Karine; Dybul, Mark; SenGupta, Devi; Jiang, Adam; Johnston, Rowena; Lamplough, Rosanne; McCune, Joseph M; Nabel, Gary J; Ndung'u, Thumbi; Pottage, John; Ripin, David; Rooney, James F; Sikazwe, Izukanji; Nsubuga, Moses; Warren, Mitchell; Deeks, Steven G title: Multi-stakeholder consensus on a target product profile for an HIV cure date: 2020-11-30 journal: Lancet HIV DOI: 10.1016/s2352-3018(20)30234-4 sha: 1ae04c0a16efa59c5811dee6b67323383306cfe3 doc_id: 752952 cord_uid: c91050zi Developing a cure for HIV is a global priority. Target product profiles are a tool commonly used throughout the drug development process to align interested parties around a clear set of goals or requirements for a potential product. Three distinct therapeutic modalities (combination therapies, ex-vivo gene therapy, and in-vivo gene therapy) for a target product profile for an HIV cure were identified. Using a process of expert face-to-face consultation and an online Delphi consultation, we found a high degree of agreement regarding the criteria for the optimum target product profile. Although the minimum attributes for a cure were debated, the broad consensus was that an acceptable cure need not be as safe and effective as optimally delivered antiretroviral therapy. An intervention that successfully cured a reasonable fraction of adults would be sufficient to advance to the clinic. These target product profiles will require further discussion and ongoing revisions as the field matures. To receive input on the Target Product Profiles (TPP) from key stakeholders in the HIV and HIV cure field. Their feedback on the draft will be consolidated together with feedback from the first round of Delphi consultation, in preparation for the second round of the Delphi consultation with the aim of reaching consensus. 1. Reading the preamble, is the definition and purpose of a TPP clear? 2. What do you think of the intended use case scenario for the minimum and optimistic TPPs? In particular, what do you think about the described relationship between cure and ART? 3. Jumping into the TPPs themselves, we would like to discuss X, Y, and Z with you, given your expertise. Are there any other variables on which you would like to share your thoughts? This question will likely take up a significant portion of the interviews as we anticipate going into detail on the variables, but we should probably select specific variables to focus on for different interviewees. For example, while we may want to discuss efficacy and safety/toxicity with all of our experts, it may be particularly pertinent to focus on these topics with clinicians and patients. With regulatory experts, on the other hand, we may want to discuss the registration pathway in more detail. 4. Do you think they accurately take into account the predicted trajectory of the HIV field? 5. Do you think that the TPPs are designed to be applicable to all countries and income settings? 6. How helpful can this document be to you and your company/organization? 7. How do you think other stakeholders in the field can use this document? 8. What are your thoughts on the identified anticipated generations of cure TPP (ref. figure 2)? Are the definitions for each clear? 9. What do you think about the structure of the TPP document? 10. Do you see any significant gaps in the three TPPs? 11. Could you suggest improvements, both for the content and structure of the document? (Was the content clear and easy to digest?) Cells may be cryopreserved for future infusion as needed. Allogeneic "offthe-shelf" cells available (cells modified and expanded centrally, includes specialized cold chain for transport and storage as needed) Cells isolated and stored in GMPcompliant, closed systems (including specialized cold storage as needed). Cells may be cryopreserved and transported as needed. 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