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Dear All
Despite the challenges of the COVID pandemic, it is vital that
we do not lose momentum in addressing the full spectrum of global
health issues. GAP-f has continued to push forward the agenda for
better medicines for children and we have spent the last few months
strengthening and expanding our community of members, supporters and
thought partners and we have many of you to thank for your support.
Our goals remain ambitious and we are committed to making a positive
impact on the lives of children.
Here, we are sharing some snapshots of our work from the past few
months, to show you what has been keeping us and our members busy. Read
about us, follow us, question us – we are thrilled and humbled to be
working together with you in closing the gap in paediatric medicines.
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GAP-f has a new webpage on WHO website
GAP-f has unveiled a new webpage, hosted on the
Initiative section of WHO’s website, where we will
continue to provide updates and information. Please do
visit us
there.
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#BetterDrugs4Kids webinar series launched
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©Getty Images
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GAP-f’s new quarterly webinar series, #BetterDrugs4Kids,
features deep dives on paediatric drug prioritization,
evaluation, development, and delivery, and promotes
discussions to close the paediatric treatment gaps.
We kicked off the series with a webinar entitled
“Best practices in clinical research for the
development of paediatric formulations,”
organized and led by our Clinical Research Working
Group. The webinar provided an opportunity to reflect on
concrete innovations for optimizing efforts and more
rapidly generating the evidence needed to inform the
development and most appropriate use of new paediatric
formulations. The webinar recording can be accessed
here.
Our next webinar, led by the GAP-f’s Product Development
and Regulatory Affairs Working Group is scheduled for
June 16th. We hope to see you there. Please register
here
,
and we will send more details in due course.
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WHO publishes Good Reliance Practices and Good Regulatory Practices
documents
Reliance approaches are essential to facilitate the regulatory pathways
for paediatric medicines and the Good Regulatory Practices provide
advice to establish and implement sound, affordable, efficient
regulation of medical products.
The documents can be found as Annex 10 and 11 respectively in the
55th
WHO Expert Committee on Specifications for Pharmaceutical
Preparations.
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WHO Paediatric Regulatory Network (PRN) holds annual meeting
The meeting, held 14-15 April, convened regulators from 22 countries and
other
organizations to share regulatory information and achievements in the
field of paediatric medicines. The group discussed regulatory updates
from the different regions; results of a survey conducted between
members on the paediatric regulatory landscapes, challenges and
solutions; optimizing reliance and work-sharing between members;
experience from WHO-prequalification and WHO Collaborative Registration
Procedure for paediatric medicines; and regulatory activities for
Covid-19. More information on the PRN can be accessed
here.
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GAP-f@ CROI 2021
GAP-f’s Clinical Research Working Group of GAP-f performed a population
pharmacokinetic analysis to determine the lowest body weight for which
children could be treated using available DCV formulations (60 and 30
mg). The possibility to use currently available adult formulations of
DCV with SOF could help programmes accelerate expansion of HCV treatment
for children globally. This data was recently presented at CROI 2021 and
can be accessed
here.
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The PADO-TB interim review report now available
The Global Tuberculosis Programme at WHO recently published the report of
the Paediatric Antituberculosis Drug
Optimization (PADO-TB) interim review meeting. The
report
summarizes the discussions and decisions from the PADO-TB meeting held in
September 2020. In particular, meeting participants agreed to prioritize the
development of a child-friendly rifapentine formulation (150 mg scored
dispersible tablet) that is flexible, can serve multiple indications (e.g.
for TB prevention and possibly for TB treatment if recommended for all age
groups in the future) and can allow dosing across age groups. PADO-TB
meetings provide a forum for clinicians, researchers, financial and
technical partners and other relevant key stakeholders to work together and
ensure that priority optimal paediatric formulations of TB medicines are
investigated, developed and made available to children in a timely manner.
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Paediatric HIV partners launch the new Optimal Formulary and Limited Use List
The sixth edition of 2021 Optimal Formulary and Limited
Use List For Antiretroviral Drugs for Children was
launched on April 6th.
The Optimal Formulary and Limited- use list has been
published since 2011 and has provided clear guidance to
country programmes, procurement entities and funding
agencies on the essential antiretroviral therapy (ART)
dosage forms for children needed to deliver
WHO-recommended ART regimens to neonates and children
for all lines of treatment. The policy brief , which was
launched during a
webinar
,
can be accessed
here.
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GAP-f will support the Unitaid agility fund,
UnitaidExplore, during the development of their
finalists for funding
The valuable support will enable UnitaidExplore to
engage with a new technology partner in child-friendly
formulations, by contributing expertise to identify and
select the best-suited API for their platform
technology, with the highest expected impact.
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©MPP
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Watch
Dr Rachel Musoke
, a paediatrician working at
Nyumbani Children’s home in Kenya as she shares her
experiences as well as hopes for the future for
paediatric HIV treatment. Hear too from
Jacque
Wambui’s
and
Jerop
Limo’s
who both live with HIV as they speak on
why better paediatric options are still so important.
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DNDI have launched their 2021-2028
strategy
and children are at the forefront of the work they plan
to undertake. We look forward to working together in
realizing their strategy.
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PATH and Queen’s University Belfast launched a
collaborative effort to develop a microarray patch
(MAP), also known as microneedle patch, for long-acting
delivery of ARVs for children. This project is funded by
the National Institutes of Health through the Eunice
Kennedy Shriver National Institute of Child Health and
Human Development and the National Institute of Allergy
And Infectious Diseases, and includes partnerships with
the University of Liverpool and the Centers for Disease
Control and Prevention. It builds upon PATH’s ongoing
work developing MAPs for HIV PrEP and advancing MAPs for
critical public health needs through their
MAP
Center of
Excellence.
The aim is to develop a MAP
containing a
long-acting ARV for paediatric populations, with a focus
on the needs of the youngest age groups.
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MMV’s partner S Kant has received WHO prequalification
for its protective medicine for children. Read
here
to
learn more about Supyra® becoming the second seasonal
malaria chemoprevention medicine to be
prequalified.
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The Access to Medicines Foundation
released a publication on
Closing
gaps in access to medicine for children: how
R&D
and delivery efforts can be ramped up.
The analysis sheds light on a number of game-changing
new medicines that could dramatically improve the health
of children, provided they reach the patients that need
them most. The analysis also considers the immediate
opportunities for companies, governments and other
stakeholders to accelerate the speed at which new
products can reach children in low-and middle-income
countries. The findings are based on data collected for
the 2021 Access to Medicine Index.
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Copyright
© 2020 Gap-f, All rights reserved.
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