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

USG Supporting Agency Collaborating Committee (SACC) meeting

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?

Background

USG Supporting Agency Collaborating Committee (SACC) meeting

Value potential of MPTs

MPTs combine protection against:

• Unintended pregnancy
• HIV
• Other STIs

MPTs provide a unique and critical

• pportunity 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.

Current status of MPT field

Dosage Form Preclinical Phase 1 Phase 2 Phase 3 IVRs

BioRings IVR

BioRings LLC [Preg + HIV]

DPV + LNG IVR

IPM [Preg + HIV]

GRFT IVR

Pop Council [HIV + STIs]

TFV + IQP-0528 IVR

ImQuest [HIV + STIs]

TFV + ACV + EEE IVR

OakCrest [Preg + HIV + STIs]

ZC IVR

Pop Council [HIV + STIs]

TFV + LNG IVR

CONRAD [Preg + HIV + STIs]

TDF IVR

Einstein [HIV + STIs]

TFV IVR

CONRAD [HIV + STIs]

Gels

GRFT Gel

U Louisville [HIV + Preg]

GRFT + C Gel

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]

Amphora Gel

Evofem [Preg + STIs]

MIV-150 + ZC Gel

Pop Council [HIV + STIs]

The MPT Pipeline: IVRs & Gels

Dosage Form Preclinical Phase 1 Phase 2 Phase 3 Fast Dissolving Inserts (FDI)*

GRFT FDI

Pop Council [HIV + STIs]

HER102

Hervana [Preg + STIs]

TFV FDI

CONRAD [HIV + STIs]

TFV/FTC FDI

CONRAD [HIV + STIs]

Films

mapp66 Film

Mapp [HIV + STIs]

TFV Film

CONRAD [HIV + STIs]

Other

SILCS + MZC Gel

CONRAD/PATH/Pop Council [Pret + HIV + STIs]

Origami Female Condom

Strata [Preg + HIV + STIs]

The MPT Pipeline: FDIs, Films & Other Dosage Forms

*Vaginal capsules are included with the FDI category

USG Supporting Agency Collaborating Committee (SACC) meeting

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

Identify target populations End-user assessments Modeling R&D/ Technical issues Other??

What is the primary target

population(s) for MPTs?

What models will be help inform investment and product development decisions, what data is needed to populate models? What other technical issues or gaps need to be addressed? What are the underlying social-behavioral/market- based issues to ensure MPT uptake and ongoing use?

IMPT meetings convened in Fall 2016 successfully defined critical early next steps necessary to inform appropriate MPT investment:

Define here??

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

What is necessary moving forward?

USG Supporting Agency Collaborating Committee (SACC) meeting

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 Collaboration Committee (SACC) Meeting

MPT R&D is consistent with SRH priorities across the USG

Contraception

• Testing existing products in

new formulations

• New product development
• Testing—safety, biologic

impact, efficacy

• Regulatory &

Prequalification (FDA, EMA, WHO, etc.) HIV Prevention

• Product development
• Product formulation
• Product acceptability
• Product testing-safety,

biologic impact, acceptability, efficacy

• Regulatory & Prequalification

(FDA, EMA, WHO, etc.) STI Prevention

• Product development
• Product formulation
• Product acceptability
• Product testing—safety,

efficacy, biologic impact

• Regulatory &

Prequalification (FDA, EMA, WHO, etc.) MPTs

• Product Co-packaging
• Product Co-formulation
• Product acceptability
• Testing—safety, biologic

impact, acceptability, efficacy

• Regulatory & Prequalification

(FDA, EMA, WHO, etc.)

Conclusions

USG Supporting Agency Collaborating Committee (SACC) meeting

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 Collaboration 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

• btain 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

Role of the IMPT going forward

 To serve as the process manager in partnership with donors and other

stakeholders to move the process forward

 IMPT to convene/manage expert analyses of key issues so as to define

and recommend necessary actions to funders

• Recommendations in the form of relevant studies and activities

required to obtain the necessary data for informing MPT investments

• Recommendations in the form of data-based, specific product

development standards for MPT product investment

• Funding partners, experts, stakeholders for market assessments and the

development of technical development standards

 Funding required for the management of this process, and for the

implementation of the necessary studies and activities necessary to generate required data

Learn more about MPTs www.theIMPT.org & www.MPTs101.org

The Initiative for Multipurpose Prevention Technologies (IMPT) is a project of CAMI Health, an organization dedicated to women’s reproductive health and empowerment, housed at the Public Health Institute.