Steering Committee & Supporting Agency Collaboration Committee (SACC) Bi-Annual Status and Planning Webinar

Steering Committee & Supporting Agency Collaboration Committee (SACC) Bi-Annual

Status and Planning Webinar

Steering Committee & Supporting Agency Collaboration Committee (SACC) Bi-Annual Status and Planning Webinar - 18 November 2014

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Steering Committee & Supporting Agency Collaboration Committee

(SACC) Bi-Annual Status and Planning Webinar

18 November 2014 Live Webinar Hosted by CAMI Health


Webinar Objectives Provide brief a summary of prioritized

scientific agenda working group (SAWG) activities since April 2014;

Proposed Steering Committee and funding agency collaboration activities moving forward and discussion; and

Input on initiative funding.


Bi-Annual Status and Planning Webinar - 18 November 2014

Moderators:Joseph Romano

Bethany Young Holt

Update on Prioritized SAWG Activities


SAWG Update

MPT Product Prioritization SurveyFY14 recommendationsNext steps for FY15

Dosage-form TPPs

Commercialization/Social-Behavioral TPP elements framework

Discussion


MPT Product Prioritization Survey: Process

Round 1: Survey developed and sent to 12 SAWG members in February 2014.

Survey revised based on comments and feedback.

Round 2: Revised survey sent to 109 people identified by SAWG as key stakeholder informants.

Received 21 responses to survey.


5%

75%

5%

5%5%

5%

UK

USA

South Africa

Kenya

Netherlands

Switzerland

India

MPT Product Prioritization Survey: Respondent Demographics

Survey Respondents by Country (N=21)

5%

31%

33%

21%

10%

Consultant

Researcher

Funder

Developer

Provider

Survey Respondents by Professional Identity

(N=21)


Key Findings In 2013, the IMPT’s Scientific Agenda Working

Group (SAWG) prioritized prevention of HIV, unintended pregnancy and other STIs as the most relevant MPT indications.

Have there been any developments that justify changing the priority indications, drugs, or dosage-forms identified last year?Clear answer from responses is “NO”APIs: ARV and HC prioritized, STI lacking (gap) IVR = Injectable > on-demandViral STI > other STIsHSV > HPV


Key Findings – cont. Other priorities

Non-HC options for contraception Issues with surfactants, rProteins, polyAs Advantages with small molecules and approved drugs ARV options not used for treatment preferred

Is there adequate acceptability data for each dosage-form and product, and is there sufficient commercialization feasibility assessments for these products? “NO”

Strong acceptance of co-admin injectables as an MPT Films and tablets were favored over gels Inadequate data/knowledge on the use of HC and

ARV in on-demand products.


MPT Product Prioritization Survey: Plan for Moving Forward

Is prioritization exercise as currently configured of value?

Could modifications be made to make this a more rigorous, robust exercise?

Partnered with other market data?

Diversification of respondent pool?

Content/format of the survey?

IRB approval?

Size and statistical significance?

Frequency?


Dosage-Form TPPS: Process

Round 1: TPPs were distributed to SAWG/SACC members in the Spring 2014

Round 2: TPPs were distributed to non-developers and responses were received and reviewed.

Dosage-form TPPs were then revised based on feedback.

Round 3: Revised TPPs were distributed to developers for comments and feedback.

In total, received input from 12 stakeholders, 3 developers and 9 non-developers


Dosage-Form TPPs

Dosage-form Number of reviewers

Intravaginal Rings 8

Long Acting Injectables 7

On-demand Products 9


Commercialization & Social-Behavioral TPP Elements: Process

Framework sent out to 30 respondents to-date.

Feedback is being received and compiled for further discussion and refining of key elements for inclusion into the MPT TPPs.

Development of this framework is an ongoing and iterative process.

Purpose: Move beyond the technical feasibility and licensure issues to the acceptability and demand issues so that products can be killed if they do not meet critical socio-behavioral commercialization points.


Outcomes & Next Steps

1) Where does this leave us in terms of challenges?

2) What are your recommendations for actionable next steps, including possible meeting topics?



Moderator: Anke Hemmerling

HC in MPTs Technical Meeting: Outcomes &

Recommendations


Objectives of the HC MPT meeting

Unite experts in contraception and MPT development to discuss relevant contraceptive research to help guide MPT development and investment decisions.

Inform product developers and supporting agencies about expert recommendations for the use of hormonal contraception (HC) in MPT products.

Discuss appropriate strategies for including HC into MPT products between contraceptive experts and MPT developers.


Barriers to Conception

conception

Exposure

ovulation

Cervical mucus

Endometrial effects

Others??The Layers-of-Cheese

Model, courtesy of Kurt Barnhart


Current efforts in MPT Development CONRAD:

phase 1 safety and PK for Tenofovir and LNG reservoir IVR (polyurethane)

IPM: phase 1 dapivirine matrix EVA IVR with LNG to

start in 2015 Population Council:

partial reservoir/matrix EVA IVR for MIV-150 + Zinc + Carrageenan + LNG.


Summary of current knowledge and gaps in HC Research 1 Mechanism of Action

Systemic effects: HC plasma levels high enough for Anovulation have highest contraceptive efficacy

Topical effects: protection by endometrial thickness and cervical mucus as MoA independently of Anovulation unclear

LNG to date the HC with most dataProblems:

Low dose HC [LNG patch] with high level of ovulatory cycles and favorable mucus

Many ovulatory cycles with high BMI Other APIs may impact LNG levels


Summary of current knowledge and gaps in HC Research 2 Surrogate markers for effectiveness:

Many old HC studies with pregnancy as main outcome measure

To determine PK and PD and interaction with other APIs, new markers and meaningful thresholds for markers needed HC concentrations (e.g. LNG) not tightly correlated with ovulation and

other markers (progestin, SBGH, LH) Cervical mucus and endometrial thickness generally correlated with

ovulation, but antiquated measurement techniques

High acceptability only with methods that ensure regular bleeding patterns and cycle control High HC levels problematic combined HC with EE could be more effective with fewer side

effects Scarce data on IVR removal and expulsion during sex, sex

during menses, bleeding patterns


HC-MPT Drug-Drug Interaction Role of Cytochrome P450 Enzyme System for drug

metabolism for Protease inhibitors (PIs) and Non-nucleoside reverse transcriptase inhibitors (NNRTIs)

NNRTIs: Data on efavirenz suggests that LNG levels lowered by

60% (Perry 2014) Data on efavirenz suggests that ENG levels lowered by

60% (Vieira 2014) Nevirapine seemingly without effect No data on dapivirine

NRTIs:Tenovofir not affected


HC CYP (Induction)

Potential Sequelae from

Sub-Therapeutic Dose:

Pregnancy (P) and

BTB (E)

HC CYP (Inhibition)

Potential Side

Effects/Drug Toxicity

Drug level


Gaps for the MPT field Urgent need for more PK/PD data and research on

drug-drug interactions of ART (NNRTIs, PIs) and HC (LNG, ENG)

Research needed on MoAs other than anovulation, topical effects, impact of high BMI,

Look beyond IVRs to also consider on-demand and long-acting formulations for MPTs

Research needed on surrogate markers and thresholds for contraceptive and HIV effectiveness

Novel robust acceptability and commercial feasibility measures are needed for key MPT user groups


Issues for Discussion Risks of specific ARVs and/or HC strategies in

MPTs related to increased HIV acquisition

HC beyond LNG

Unknowns about drug-drug interactions

Appropriate dosing of HC and ART in combination

Surrogates of effectiveness for contraception or HIV beyond pregnancy and HIV+ infection

Justification of MPT - better than single indication


Outcomes & Next StepsRegarding the outcomes of the HC in MPTs Technical Meeting in September 2014:

1) Where does this leave us in terms of challenges?

2) What are your recommendations for actionable next steps, including possible meeting topics?

Comments from the Contraceptive Perspective

Comments from the HIV Perspective



FY15 IMPT Convenings

Moderators: Joseph Romano

Bethany Young Holt


FY15 IMPT ConveningsGoal: Plan and implement appropriate convenings over the next 12 months so as to better support funder needs in terms of managing current MPT investments and assessing new such investment opportunities.

Two major issues currently confronting the MPT field are: Verification of the hypothetical

advantages of MPT products Complexities of MPT Phase 2b/3 Clinical

Trials


Proposed FY15 Convenings Topics

Social-behavioral considerations for MPTs (with WHO)

HC in MPTs follow up (TBD) Regulatory Issues (TBD) Environmental impacts of MPTs MPT Cost-effectiveness modeling (with

WHO) Regionally-tailored MPT webinars (e.g. LAC) 2015 MPT Symposium Other



Moderators: Helen Rees (invited)Bethany Young Holt

IMPT Funding Optimization & Enhancement Strategy


Why the IMPT? Key Challenges Facing the Field:

ScientificSocial-behavioralClinical/RegulatoryManufacturing

How does the IMPT help address challenges?ConveningsTools & Guidances

TPPs, Prioritization Survey, Database, etc.Venue for multidisciplinary collaboration


Summary of Funding StrategyObjectives:

Optimization: To increase the effectiveness of existing resources by facilitating successful, well informed collaboration among existing and potential funders.

Enhancement: To engage new potential funding organizations on priority MPT gaps and needs in order to secure field-wide funding to advance the MPT field.

Fundraising: To generate sufficient core funding for the IMPT to serve as Secretariat of the IMPT, and continue its support to facilitate collaboration and organize around the many complicated questions in the MPT field.


[DRAFT] MPT Funding Opportunity Tool

1) Communications & Outreach [CO] 2) Access and Acceptability [AA] 3) Scientific Agenda [SA] 4) Technical Consultations & Convenings [TC] 5) Program/Project Evaluation [PE] 6) Core Support [CS] 7) Fundraising [F] 8) Regulatory Issues [RI]

DRAFT Categories


MPT Investment Tracking:

Process

Worked closely with AVAC to look at data collected in the 2013 HIV Resource Tracking Survey

Data from NIH grants database

Preliminary findings show close to $23 Million invested in the MPT field for 2013.

Goal: Monitor investment in the MPT field to measure progress and help inform investment prioritizations and gaps.


Partner with AVAC’s HIV Resource Tracking Data collection to incorporate more detailed MPT related information.

Distribution of survey to partners working outside of the HIV field.

Key findings will be summarized in an annual MPT Investment Tracking Report and compared to the baseline data.

MPT Investment Tracking: FY15 Plan for Moving Forward


Quick Secretariat Update Evaluation: CAMI Health is developing

metrics for tracking progress of the IMPT and the MPT field. Members of the SACC and Steering Committee

will be consulted once the evaluation plan is outlined.

CAMI Health Annual Report: Coming Soon!

CAMI Health Staff Update

Scheduling In-Person SACC Meeting


Discussion Reminder:

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Thank you!


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and do not necessarily reflect the views of USAID or the US Government.

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Steering Committee & Supporting Agency Collaboration Committee (SACC) Bi-Annual Status and Planning Webinar