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Welcome! All participants will be muted during the
presentation and discussion. Please use the chat for questions.
During the Q&A, please unmute for a question or comment,
and mute if you are not speaking. Thank you!
Live Webinar – Hosted by the IMPT Secretariat
Webinar Agenda
❑ Welcome & Introductions
❑ Presentations
➢ Next Generation 3D Printed Intravaginal Rings (IVRs) as a Multipurpose Prevention
Technology (MPT) for Prevention of HIV and Unplanned Pregnancy by Rahima
Benhabbour (UNC)
➢ MAPs for PrEP & MPT: Dissolving microarray patches (MAPs) for long-acting HIV and
pregnancy prevention (MPT) by Courtney Jarrahian (PATH)
❑ Facilitated discussion - Joseph Romano (NWJ Group)
❑ Wrap Up & Adjourn
Let’s Talk MPTs Discussion Series
30 June 2021
Multipurpose Prevention Technologies
MPTs combine protection against:
• Unintended pregnancy
• HIV
• Other STIs
MPTs have the potential to:
• Address overlapping risks
• Synergize prevention approaches
• Increase motivation for adherence
• Destigmatize HIV prevention
• Improve health & economic outcomes
Let’s Talk MPTs Discussion Series
30 June 2021
What is the Let’s Talk MPTs Discussion Series?
❑ A platform aimed to engage experts from diverse disciplines across the globe to help
address MPT and HIV prevention R&D priorities and gaps
❑ Past topics include:
❑ Recordings and upcoming webinars available at theIMPT.org
Let’s Talk MPTs Discussion Series
30 June 2021
MPTs in the R&D Pipeline (n=27)*
*As of June 2021
12
MPTs by Delivery Type
10
8 Explore at
MPTs101.org
6
4
2
0
Intravaginal Gels Fast Films Implants Injections Microarray Oral Tablets Enema
Rings (Vaginal & Dissolving Patches
Rectal) Inserts
Let’s Talk MPTs Discussion Series
30 June 2021
Today’s Discussants
S. Rahima Benhabbour, MSc. PhD Courtney Jarrahian, MS Joseph Romano, PhD
Let’s Talk MPTs Discussion Series
30 June 2021
All photos: PATH, unless otherwise noted
June 30th, 2021
3.71” h
MAPs for PrEP & MPT
Dissolving microarray patches
(MAPs) for long-acting HIV and 3.2” w
pregnancy prevention (MPT)
Courtney Jarrahian
Medical Devices and Health Technologies
Photo: PATH
Microarray patch (MAP): innovative drug
delivery system in development
• MAPs consist of hundreds or thousands of tiny
projections (microneedles) that deliver a drug or
Example of coated
vaccine into the skin. microarray patch for
vaccines (Vaxxas, early-
stage development).
• Some MAPs require applicators, others are manually
applied to the skin. An adhesive backing keeps the
MAP in place during drug delivery if needed for
intended wear time.
• MAP projections are typically shorter than 1mm Example of dissolving
Image: Queen’s University Belfast
MAP projections, viewed
(~50–900 µm in height) so they pierce only the top by microscope.
layer of skin.
• MAP drug delivery is less painful than an injection.
8
Dissolving MAPs for sustained drug release
Stratum
corneum When applied to the skin, MAP projections
dissolve to release the active pharmaceutical
ingredient (API).
Dermis
Once dissolved, the long-acting API slowly
enters the circulatory system; the backing is
Subcutaneous removed and discarded.
tissue
9
Photo: PATH
MAP delivery technology
Advantages
• Enables alternative delivery scenarios (self-
administration)
• Has potential to improve adherence
• Has potential to reduce burden on health
systems
Challenges
• Regulatory approval of a new delivery system
• Manufacturing hurdles
• Market challenges: introduction of new delivery
system; unknown potential
10Examples of MAP development status 11
12
PATH Microarray Patch Center of Excellence Goal: Advance the microarray patch as a technology platform for high-priority needs in low- and middle-income countries. 13 13
Center of Excellence strategy: Advancing MAP platform
Global health use cases Dissemination
and value propositions
• MAP resources
• Understand user needs website
• Prioritize global health • Newsletter
applications.
• Publications
• Evaluate business case
and cost-effectiveness
Manufacturing
Regulatory Working Group
• Readiness
• RWG website assessment
• Cochaired with Cardiff University • Cohosted
• Identify CQAs and test methods workshop with
• Assess risks of low- bioburden Harro Höfliger
manufacturing
14 Abbreviations: CQA, critical quality attribute; RWG, Regulatory Working Group.MAPs for pre-exposure prophylaxis and as a multipurpose
prevention technology
Objective: Advance development of dissolving MAP technology for delivery for an antiretroviral (ARV) drug
for long-acting HIV pre-exposure prophylaxis (PrEP) and assess feasibility of an MPT MAP that includes
pregnancy prevention.
• Made of biocompatible, water soluble polymers 4.5 mm
• High drug loading (60% w/w) Channel
• Short wear-time: targeting 20 minutes
• Weekly or monthly dosing
Diluent reservoir
• MAP could be administered by a health care
worker or by self-administration
• MAP has a feedback indicator to confirm
successful application pressure has been
applied Needle hub port
• Integration into reproductive health services
15MAPs for PrEP/MPT project partners
Formulation and preclinical
development
GMP manufacturing to prepare for a Phase 1 clinical
trial
Manufacturing advisor
User-centered User study advisor
design engineering
and cost analyses
CAB LA nanosuspension
Regulatory advisor
Country
assessments to
explore usability,
acceptability, and
programmatic fit
16
16PATH approach to product development Product development at PATH is conducted by multidisciplinary teams with a focus on user-centered design. The MAPs for PrEP/MPT team is conducting multiple activities led by staff who are experts in various disciplines. 17
MAP design and formulation
Dry reservoir
Image: Queen’s University Belfast
• Dissolving microneedles formulated
from cabotegravir or norelgestromin
4.5 mm
• Layered design that facilitates quick Channel
release of the microneedle
tips allowing shorter patch wear time
• Release rate assessed in vitro and in Diluent reservoir
Fast dissolving
preclinical pharmacokinetic studies drug-loaded hydrogel
Slow dissolving-
drug-free hydrogel
Needle hub port
18MAPs for PrEP/MPT user studies and evaluations in Kenya, South Africa, and Uganda 19
Summary of feature preferences
Product features/characteristics User preference of product characteristics
Size of MAP Small size is preferred, but some would trade for longer
duration of protection
Application site Upper arm or thigh
Duration of wear 30 minutes preferred; up to 60 minutes acceptable
Duration of protection Longer than one month, ideally two to three months
Feedback mechanism Both designs acceptable to some participants, but
refinements identified for both to improve confidence
Self-administration Self-administration acceptable, though want to learn first
from a provider Needle hub port
20Feedback indicator development
Technical design
User needs Next design steps
priorities
• Inspires confidence in • Cost • Minimize required number of
successful delivery • Manufacturability user actions
• Minimal training • Usability • Improve adhesive layering and
• Discreetness • Potential for self- release characteristics
• Speed/accuracy of delivery administration • Improve obviousness of
• Minimal impact on waste • Applicable to different feedback communication
stream MAP sizes and formats • Explore time indicators
Needle hub port
21MAPs for PrEP/MPT cost- effectiveness • Evaluated impact of various parameters to inform selection of product characteristics that will keep overall cost of goods to a minimum: • API • Drug delivery efficiency • MAP size • Duration of protection • Materials/packaging • Explored potential impact on service delivery through a preliminary cost effectiveness analysis relative to delivery of oral PrEP. • Self-administration highly valued by providers and potential consumers (potential to reduce cost and allows discreet use). 22
Challenges & opportunities • MAP development to date has focused on highly potent APIs (such as vaccines). ARVs likely require much larger dosages. Current MAP design aims for maximum drug loading and number of microneedles per array. • Trade-offs exist between patch size and duration of protection that will influence ease of use and acceptability. Smaller MAPs are preferred by users but longer protection is preferred by most potential user groups. • Use of more potent novel APIs could reduce dosage and patch size. • MAPs can deliver a progestin as well. Combining an ARV with hormonal contraception may better address the needs 23 for those who desire multipurpose protection.
Acknowledgements The MAPs for PrEP project is made possible by the generous support of the American people through the United States Agency for International Development (USAID) through the United States President’s Emergency Plan for AIDS Relief (PEPFAR), under the terms of Cooperative Agreement #AID-OAA-A-17-00015. The contents are the responsibility of PATH and do not necessarily reflect the views of USAID, PEPFAR, or the United States government. The Microarray Patch Center of Excellence is funded by UKaid from the UK government Foreign, Commonwealth & Development Office (FCDO); however, the views expressed in materials are the responsibility of PATH and do not necessarily reflect the UK government’s official policies. 24
Q&A
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Let’s Talk MPTs Discussion Series
30 June 2021IMPT Resource Center
Explore at
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Let’s Talk MPTs Discussion Series
30 June 2021Connect with the IMPT
theIMPT.org
@Initiative4MPTsThank You!
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 Cooperative Agreement
#AID-OAA-A-16-00045. The contents are the responsibility of the Initiative for MPTs (IMPT), CAMI Health, the Public Health Institute (PHI), and its partners and do not necessarily reflect the views of
USAID or the U.S. Government. The IMPT is a project of CAMI Health, an organization dedicated to women’s reproductive health and empowerment, housed at PHI.You can also read
