Pathway USG MPT Supporting Agency Collaboration Committee (SACC) - PowerPoint PPT Presentation

Accelerating Action for A Successful MPT Pathway USG MPT Supporting Agency Collaboration Committee (SACC) Meeting November 9, 2016

Meeting Objectives  Define and initiate essential next steps to ensure that the most impactful MPT candidates enter Phase 3. • Priority areas for data needs • Ongoing projects to fill needs • Gaps – purview of each agency and planned funding  Identify funding opportunities to support realization of MPT value potential. USG Supporting Agency Collaborating Committee (SACC) meeting

Meeting format  Background • Value potential of MPTs • Urgency • Need for proper investment  Current status of MPT field  What is needed going forward? USG Supporting Agency Collaborating Committee (SACC) meeting

Background

Value potential of MPTs MPTs combine protection against: • Unintended pregnancy • HIV • Other STIs MPTs provide a unique and critical opportunity to leverage younger women’s need for (and willingness to use) contraception with prevention of HIV and other sexually transmitted infections (STIs). USG Supporting Agency Collaborating Committee (SACC) meeting

MPTs: The Urgency  Expanding, competitive prevention landscape  Funder commitment to other prevention interventions  Increasing challenges with HIV prevention trials • Changing SOC with prevention product roll out • Recruitment in the context of available products • Trial design in the context of approved products  Time USG Supporting Agency Collaborating Committee (SACC) meeting

Need for proper MPT investment Proper investment in: Technical aspects of product development (preclinical, • clinical, CMC, regulatory, etc.). Market-based/social-behavioral studies for data to • inform the technical development of MPT options for MPT Phase 3. Specific funding needs: Managing a process for defining the market/technical • data needs and how to get these data. Implementation of the studies to obtain data regarding • the critical market drivers for success. Investment in product development consistent with the • market data to achieve impactful MPT product. USG Supporting Agency Collaborating Committee (SACC) meeting

Current status of MPT field

The MPT Pipeline: IVRs & Gels Dosage Form Preclinical Phase 1 Phase 2 Phase 3 IVRs BioRings IVR TFV + LNG IVR BioRings LLC [Preg + HIV] CONRAD [Preg + HIV + STIs] DPV + LNG IVR TDF IVR IPM [Preg + HIV] Einstein [HIV + STIs] GRFT IVR TFV IVR Pop Council [HIV + STIs] CONRAD [HIV + STIs] TFV + IQP-0528 IVR ImQuest [HIV + STIs] TFV + ACV + EEE IVR OakCrest [Preg + HIV + STIs] ZC IVR Pop Council [HIV + STIs] GRFT Gel Amphora Gel Gels U Louisville [HIV + Preg] Evofem [Preg + STIs] GRFT + C Gel MIV-150 + ZC Gel Pop Council [HIV + STIs] Pop Council [HIV + STIs] NOV-1003 Gel Novicol [Preg + HIV + STIs] SAMMA Gel Yaso [Preg + HIV + STIs] SR-2P Gel SRI [HIV + STIs] VivaGel StarPharma [HIV + STIs]

The MPT Pipeline: FDIs, Films & Other Dosage Forms Dosage Form Preclinical Phase 1 Phase 2 Phase 3 Fast Dissolving GRFT FDI TFV FDI Pop Council [HIV + STIs] CONRAD [HIV + STIs] Inserts (FDI)* HER102 TFV/FTC FDI Hervana [Preg + STIs] CONRAD [HIV + STIs] Films mapp66 Film Mapp [HIV + STIs] TFV Film CONRAD [HIV + STIs] Other SILCS + MZC Gel Origami Female Condom CONRAD/PATH/Pop Council Strata [Preg + HIV + STIs] [Pret + HIV + STIs] *Vaginal capsules are included with the FDI category

Pipeline considerations  Does pipeline appropriately address needs of priority target populations? • How much STI vs HIV/contraception? • How much duplication/me too (e.g., TFV options) • How much duplication of dosage form? • What market data support these dosage forms? • How many early stage APIs vs. approved APIs?  Is there anything missing? USG Supporting Agency Collaborating Committee (SACC) meeting

Proposed MPT field-wide priority areas IMPT meetings convened in Fall 2016 successfully defined critical early next steps necessary to inform appropriate MPT investment: What is the primary target What are the underlying population(s ) for MPTs? social-behavioral/market- based issues to ensure MPT End-user Identify target uptake and ongoing use? assessments populations Define here?? What models will be help Other?? Modeling inform investment and product development decisions, what data is R&D/ needed to populate Technical issues models? What other technical issues or gaps need to be addressed? USG Supporting Agency Collaborating Committee (SACC) meeting

Ongoing efforts that can inform MPT market-based issues  Trio Study: Alternative dosage form acceptability- placebo injectable, oral, IVR  Quatro Study: 18-30 yr women with placebo film, insert, gel, IVR  Uchoose: 16-17 yr adolescents selecting contraception from IVR, oral, injectable options  DAP IVR OLE (HOPE, DREAM)  MTN 034: DAP IVR, oral Truvada  Dreams Initiative; USAID MPii programs  Data from other trials  Expanded MPT modeling USG Supporting Agency Collaborating Committee (SACC) meeting

What is necessary moving forward?

Within the next six months…  Agreement on priority areas.  Funder sanctioning/enabling of a robust process to appropriately support active progression of an MPT to Phase 3. Harnessing of non-biased, multidisciplinary expertise to frame • and inform the business case for MPTs.  Identification of data, on market and technical side, that can inform investment and R&D decisions. Target population end-user assessment data. • Data for modeling efforts (e.g., cost-effectiveness, demand • forecasting, etc).  Define process by which funders can most effectively and efficiently move forward to ensure impactful MPTs in timely fashion.  Define how this process will be funded. USG Supporting Agency Collaborating Committee (SACC) meeting

MPT R&D is consistent with SRH priorities across the USG HIV Prevention Contraception • Product development • Testing existing products in • Product formulation new formulations • Product acceptability • New product development • Product testing-safety, • Testing — safety, biologic biologic impact, impact, efficacy acceptability, efficacy • Regulatory & • Regulatory & Prequalification Prequalification (FDA, EMA, (FDA, EMA, WHO, etc.) WHO, etc.) STI Prevention MPTs • Product development • Product Co-packaging • Product formulation • Product Co-formulation • Product acceptability • Product acceptability • Product testing — safety, • Testing — safety, biologic efficacy, biologic impact impact, acceptability, • Regulatory & efficacy Prequalification (FDA, • Regulatory & Prequalification EMA, WHO, etc.) (FDA, EMA, WHO, etc.) USG Supporting Agency Collaboration Committee (SACC) Meeting

Conclusions

Key Summary Issues:  Do we agree? • MPTs are a valuable concept worth of effort and investment? • There is urgency in getting to an appropriate MPT product candidate for P3? • Market-based assessment data are needed soon to assure proper investment in appropriate MPT candidates? • Social-behavioral, end-user, target population, impact and cost effectiveness modeling, etc. are critical early steps in the process? • A formal process under objective management is necessary to assure the proper unbiased progression of this process?  How can the MPT process needs be funded? • Accessing existing funding  Possibly thru reprogramming? • Accessing new USG funding  How long and by what process? • Attracting to support proper study of MPT potential and appropriate product development USG Supporting Agency Collaborating Committee (SACC) meeting

Questions to the group  What is currently in your agency’s MPT portfolio?  Do you anticipate future funding for MPTs?  What is possible within your purview to work on in the MPT space?  What do you see as critical MPT funding gap(s)?  How should this group best proceed to ensure that the most impactful MPT candidates enter Phase 3? USG Supporting Agency Collaborating Committee (SACC) meeting

Elements of the process: proposed  Identify priority areas to inform investment and R&D decisions.  Assess extent to which current MPT pipeline is appropriate for prioritized target population.  Define what data are needed on the market side of MPTs (e.g., end- users, target population, impact modeling, social-behavioral issues, delivery channels, health system supports, health ministry policies, cost, etc.).  Define and implement studies and other relevant activities necessary to obtain the relevant market data  Use relevant market data to define preferred product characteristics necessary for an impactful MPT  Invest in specific product development consistent with the data-based preferred product characteristics Successful development of an appropriate MPT P3 candidate product USG Supporting Agency Collaboration Committee (SACC) Meeting