Upload
drusilla-boyd
View
214
Download
0
Tags:
Embed Size (px)
Citation preview
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
Thank You For Joining Us! During the webinar please mute your line
using *6 if you are not speaking and unmute using *7 if you have a question or comment.
During the updates and presentations you can also use the chat feature to ask questions or make comments.
If you experience any technical difficulties during the webinar, please contact ReadyTalk Support.
Steering Committee & Supporting Agency Collaboration Committee
(SACC) Bi-Annual Status and Planning Webinar
18 November 2014 Live Webinar Hosted by CAMI Health
Steering Committee & Supporting Agency Collaboration Committee (SACC) Bi-Annual Status and Planning Webinar - 18 November 2014
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.
Steering Committee & Supporting Agency Collaboration Committee
Bi-Annual Status and Planning Webinar - 18 November 2014
Moderators:Joseph Romano
Bethany Young Holt
Update on Prioritized SAWG Activities
Steering Committee & Supporting Agency Collaboration Committee (SACC) Bi-Annual Status and Planning Webinar - 18 November 2014
SAWG Update
MPT Product Prioritization SurveyFY14 recommendationsNext steps for FY15
Dosage-form TPPs
Commercialization/Social-Behavioral TPP elements framework
Discussion
Steering Committee & Supporting Agency Collaboration Committee (SACC) Bi-Annual Status and Planning Webinar - 18 November 2014
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.
Steering Committee & Supporting Agency Collaboration Committee (SACC) Bi-Annual Status and Planning Webinar - 18 November 2014
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)
Steering Committee & Supporting Agency Collaboration Committee (SACC) Bi-Annual Status and Planning Webinar - 18 November 2014
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
Steering Committee & Supporting Agency Collaboration Committee (SACC) Bi-Annual Status and Planning Webinar - 18 November 2014
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.
Steering Committee & Supporting Agency Collaboration Committee (SACC) Bi-Annual Status and Planning Webinar - 18 November 2014
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?
Steering Committee & Supporting Agency Collaboration Committee (SACC) Bi-Annual Status and Planning Webinar - 18 November 2014
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
Steering Committee & Supporting Agency Collaboration Committee (SACC) Bi-Annual Status and Planning Webinar - 18 November 2014
Dosage-Form TPPs
Dosage-form Number of reviewers
Intravaginal Rings 8
Long Acting Injectables 7
On-demand Products 9
Steering Committee & Supporting Agency Collaboration Committee (SACC) Bi-Annual Status and Planning Webinar - 18 November 2014
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.
Steering Committee & Supporting Agency Collaboration Committee (SACC) Bi-Annual Status and Planning Webinar - 18 November 2014
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?
Steering Committee & Supporting Agency Collaboration Committee
Bi-Annual Status and Planning Webinar - 18 November 2014
Moderator: Anke Hemmerling
HC in MPTs Technical Meeting: Outcomes &
Recommendations
Steering Committee & Supporting Agency Collaboration Committee (SACC) Bi-Annual Status and Planning Webinar - 18 November 2014
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.
Steering Committee & Supporting Agency Collaboration Committee (SACC) Bi-Annual Status and Planning Webinar - 18 November 2014
Barriers to Conception
conception
Exposure
ovulation
Cervical mucus
Endometrial effects
Others??The Layers-of-Cheese
Model, courtesy of Kurt Barnhart
Steering Committee & Supporting Agency Collaboration Committee (SACC) Bi-Annual Status and Planning Webinar - 18 November 2014
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.
Steering Committee & Supporting Agency Collaboration Committee (SACC) Bi-Annual Status and Planning Webinar - 18 November 2014
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
Steering Committee & Supporting Agency Collaboration Committee (SACC) Bi-Annual Status and Planning Webinar - 18 November 2014
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
Steering Committee & Supporting Agency Collaboration Committee (SACC) Bi-Annual Status and Planning Webinar - 18 November 2014
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
Steering Committee & Supporting Agency Collaboration Committee (SACC) Bi-Annual Status and Planning Webinar - 18 November 2014
HC CYP (Induction)
Potential Sequelae from
Sub-Therapeutic Dose:
Pregnancy (P) and
BTB (E)
HC CYP (Inhibition)
Potential Side
Effects/Drug Toxicity
Drug level
Steering Committee & Supporting Agency Collaboration Committee (SACC) Bi-Annual Status and Planning Webinar - 18 November 2014
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
Steering Committee & Supporting Agency Collaboration Committee (SACC) Bi-Annual Status and Planning Webinar - 18 November 2014
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
Steering Committee & Supporting Agency Collaboration Committee (SACC) Bi-Annual Status and Planning Webinar - 18 November 2014
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
Steering Committee & Supporting Agency Collaboration Committee
Bi-Annual Status and Planning Webinar - 18 November 2014
FY15 IMPT Convenings
Moderators: Joseph Romano
Bethany Young Holt
Steering Committee & Supporting Agency Collaboration Committee (SACC) Bi-Annual Status and Planning Webinar - 18 November 2014
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
Steering Committee & Supporting Agency Collaboration Committee (SACC) Bi-Annual Status and Planning Webinar - 18 November 2014
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
Steering Committee & Supporting Agency Collaboration Committee
Bi-Annual Status and Planning Webinar - 18 November 2014
Moderators: Helen Rees (invited)Bethany Young Holt
IMPT Funding Optimization & Enhancement Strategy
Steering Committee & Supporting Agency Collaboration Committee (SACC) Bi-Annual Status and Planning Webinar - 18 November 2014
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
Steering Committee & Supporting Agency Collaboration Committee (SACC) Bi-Annual Status and Planning Webinar - 18 November 2014
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.
Steering Committee & Supporting Agency Collaboration Committee (SACC) Bi-Annual Status and Planning Webinar - 18 November 2014
[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
Steering Committee & Supporting Agency Collaboration Committee (SACC) Bi-Annual Status and Planning Webinar - 18 November 2014
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.
Steering Committee & Supporting Agency Collaboration Committee (SACC) Bi-Annual Status and Planning Webinar - 18 November 2014
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
Steering Committee & Supporting Agency Collaboration Committee (SACC) Bi-Annual Status and Planning Webinar - 18 November 2014
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
Steering Committee & Supporting Agency Collaboration Committee (SACC) Bi-Annual Status and Planning Webinar - 18 November 2014
Discussion Reminder:
Please mute your line using *6 if you are not speaking
Press *7 to unmute your line if you have a question or comment.
Thank you!
Steering Committee & Supporting Agency Collaboration Committee (SACC) Bi-Annual Status and Planning Webinar - 18 November 2014
Learn more about MPTswww.CAMI-Health.org & www.MPTs101.org
Steering Committee & Supporting Agency Collaboration Committee (SACC) Bi-Annual Status and Planning Webinar - 18 November 2014
Support for this project is made possible by the generous support of the American people through the United States Agency for International Development (USAID)
under the terms of the HealthTech Cooperative Agreement #AID-OAA-A-11-00051, managed by PATH. The contents are the responsibility of CAMI/PHI and its partners
and do not necessarily reflect the views of USAID or the US Government.
Thank You!