RFP Informational Session: Pediatric DTG. November 10, 2017

Transcription

1 RFP Informational Session: Pediatric DTG November 10, 2017

2 The Optimal ARV project aims to generate demand for target ARVs in high-burden focal countries, driving rapid uptake and lowering global costs IMPACT: COST SAVINGS THROUGH 2023 GLOBAL COST SAVINGS THROUGH 2024 $1.6B and improved uptake of products and clinical outcomes for patients FOCAL COUNTRIES Optimal ARV Program Focus Accelerate time to market and optimal pricing on the supplier side by supporting key product commercialization activities; leverage an innovative incentive mechanism when necessary for niche products like adult 2L and pediatrics Identify opportunities for cost reduction through process chemistry improvements on DRV/r, TAF, and DTG Engage with MoH, civil society, and other stakeholders to support adoption and roll-out of optimal products, and drive uptake in focal countries which account for >50% of global HIV burden Cambodia, Kenya, Malawi, Nigeria, South Africa, Uganda, Zimbabwe and a peds focus in Francophone West Africa Adults EFV 400 DRV/r DTG TAF TARGET PRODUCTS Pediatrics LPV/r Pellet (uptake) DRV/r DTG ABC/3TC/EFV (uptake) Pipeline FDC (TAF/XTC/DTG, TBD) 2

3 Niche products will receive additional commercialization support When needed for niche products, the Unitaid-CHAI collaboration will mobilize an innovative incentive pool to support rapid development In an assessment of the uptake environment and commercialization timeline, CHAI will analyze the impact of an incentive on: Registration timelines in priority countries Launch pricing Cost-effectiveness/value for money of the incentive grant Potential complementary interventions being pursued by partner organizations Incentives will likely focus on pediatric ARVs and adult second- and thirdline ARVs 3

4 CHAI Priorities: DTG, 10 mg scored DT Product Presentation: DTG single, 10 mg scored dispersible tablet The public health case is strong for: Better clinical outcomes associated with a very favorable safety and efficacy profile versus current preferred regimens with substantial reductions in treatment-limiting adverse drug reactions Cost savings: Cost savings relative to the recommended first-line regimens that include LPV/r or EFV Reducing number of patients switching to 2L, therefore reducing costs of care CHAI has an ongoing collaboration with ViiV Healthcare, the innovator company for DTG, for technical support on development. 4

5 Request for Proposal (RfP) Purpose: To select generic manufacturer(s) that can accelerate the development and commercialization of a pediatric dolutegravir 10 mg scored dispersible tablet (DTG 10 mg scored DT). Consists of two documents: PDF and Excel files Available on CHAI s website: clintonhealthaccess.org Resource Center Instructions RfP Questionnaire 5

6 PDF document: RfP Document 6

7 Excel Document: RfP Questionnaire 7 tabs total 6 require information/attachments 7

8 RfP Required Components Completed RfP Questionnaire: Excel format Word Document, no more than 5 pages in length Outlining development plan and timeline for the activities described in the Statement of Work. Components include: Capacity to manufacture the DTG 10 mg scored DT Timeline (or Gantt chart) highlighting the milestones indicated in the Timeline tab of the RfP questionnaire Strategy for ensuring sustained supply in LMICs Form A: Response to RfP Form B: Anti-Bribery and Anti-Corruption Agreement Form C: Quality Audit Agreement Please send all forms together in a single by 5pm EST November 30 th No late entries will be considered 8

9 Selection Process 1. Upon receipt, proposals will be evaluated based on initial eligibility criteria, as outlined in the RfP (page 5). 2. CHAI will meet with generic manufacturers who passed the eligibility criteria in 1:1 meetings to discuss the proposed development plans. 3. Following 1:1 meetings, manufacturers will have the opportunity to submit an updated, final proposal response. 4. Internal CHAI panel will evaluate and rank manufacturers. 5. Award(s) will be contingent upon manufacturer(s) successfully passing quality and anti-bribery/anti-corruption audits. 9

10 Timelines for Selection Process RFP Posted on CHAI's Website 11/7/2017 Information Session for Manufacturers 11/10/2017 1:1 Meetings with Manufacturers Begin 12/11/2017 Manufacturers Submit RfP EST 11/30/ /05 11/12 11/19 11/26 12/03 12/10 12/17 12/24 RfP Revised Responses Due 12/29/ /16/2017 Q&A Response Document Posted on CHAI Website 11/15/2017 Questions Due Via EST Q&A Period RfP Response Period 1:1 Meetings with Manufacturers Revision of RfP Responses CHAI anticipates an award date in Q

11 Guidelines for Submission No phone calls for questions or clarifications. Only correspondence will be accepted. Questions must be received by November 15, EST via . All responses will be posted November 16, 2017 on the CHAI website ( Submission Guidelines: Deadline for submission is November 30, 2017 at 5pm EST via Late responses will not be accepted Make sure all components are submitted: Completed RfP questionnaire (Excel format) Supplemental project plan (Word format) Completed Forms A-C addresses: Sheetal Ghelani at Copy to Sunil Panicker at Copy to Ateen Paliwal at 11

12 Thank you! Acknowledgments: CHAI s work on accelerating access to optimal ARVs is made possible by the generous support and partnership of Unitaid

13 Questions? Please unmute telephone line by dialing *6 or use unmute feature on zoom After this call, please send any questions to and cc: Responses will be posted on Nov