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<strong>GPH</strong> <strong>MEDICAL</strong> &<br />
<strong>SCIENTIFIC</strong> <strong>AFFAIRS</strong><br />
BULLETIN 001<br />
Profiling our team of dedicated staff and the<br />
excellent work they have been doing in the field.<br />
APRIL
Welcome to the J&J <strong>GPH</strong> Scientific and Medical<br />
Affairs bulletin. Here we will profile our team of<br />
dedicated staff and the excellent work they have<br />
been doing in the field.<br />
n<br />
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Team Profiles<br />
Paediatric Dr TB Training of Trainers<br />
Report on WAC-CREP Conference<br />
New Horizon Workshop<br />
Ebola Vaccine Preparedness Initiative<br />
Active Markets
MEET THE TEAM<br />
Our team includes members from Clinical Evidence Generation, Patient<br />
Engagement, Scientific Stakeholder Engagement, Evidence Dissemination and<br />
Medical Technical Support. Here they are:<br />
ABEDA<br />
WILLIAMS<br />
Abeda Williams is the<br />
Head of Scientific Affairs.<br />
She said: “Our team is<br />
more structured to support<br />
and execute the plans from<br />
the franchise team as well as<br />
achieve the <strong>GPH</strong> objectives.”<br />
“Under the leadership of Carlos, we are more<br />
aligned to support the franchise areas with defined<br />
roles and responsibilities.”<br />
“We have dedicated roles for example patient<br />
engagement, med info and medical education.”<br />
CLINICAL EVIDENCE GENERATION:<br />
Clinical insights and data generation to enable<br />
<strong>GPH</strong> Access goals under the leadership of Fafa<br />
Addo Boateng.<br />
and geographies.<br />
FAFA ADDO<br />
BOATENG<br />
Director for Data and<br />
Evidence Generation<br />
based in Accra, Ghana.<br />
In her role, she leads<br />
all <strong>GPH</strong> clinical research<br />
activities from PH3/B – PH4,<br />
across all priority therapeutic areas<br />
She said: “The Evidence Generation team is the 1st<br />
dedicated unit within <strong>GPH</strong> for clinical research. I am<br />
successfully shaping evidence generation and in<br />
collaboration with key internal stakeholders, developed<br />
and implemented the evidence generation framework<br />
which clearly outlines scope, processes and roles<br />
& responsibilities from design to close-out and<br />
publication of all clinical research projects.”<br />
FRIDAH<br />
MWENDIA<br />
Our Clinical Research<br />
Manager for Evidence<br />
Generation Program<br />
based in Nairobi, Kenya.<br />
She is responsible for providing<br />
scientific, technical and operational expertise in the<br />
planning, implementation and close out of all <strong>GPH</strong><br />
evidence generation activities across all relevant<br />
Therapeutic Areas (HIV, COVID 19, TB and Mental<br />
Health) and geographies (EMEA, Asia and LATAM).<br />
Mwendia said: “I have years of experience in<br />
managing clinical and epidemiology studies. I<br />
have worked in the non-profit and pharmaceutical<br />
sectors, as well as with research institutions, in<br />
reputable institutions like KEMRI and GSK Biologicals<br />
in Belgium. I have experience in management<br />
of stakeholders including partners, donors and<br />
government that is necessary in the planning,<br />
execution, analysis and reporting of clinical trials.”<br />
UKAH<br />
IDAHOSA<br />
Our Evidence<br />
Generation Program<br />
Manager for Medical<br />
Affairs, based in Lagos,<br />
Nigeria. In her role as<br />
Evidence Generation Program<br />
Manager, she is Project Lead for the ongoing<br />
studies in specified Therapeutic Areas within <strong>GPH</strong>.<br />
This means, she is responsible for ensuring that all<br />
activities related to these projects are conducted to<br />
specification and comply with company and other<br />
quality standards in accordance to agreed timelines.<br />
3 | J&J <strong>GPH</strong> Medical & Scientific Affairs Bulletin
EVIDENCE DISSEMINATION:<br />
Integrated communication plan for medical information<br />
and education contextualized to relevant audiences.<br />
RETHABILE<br />
LECHESA<br />
The Medical Information<br />
& Compliance Manager<br />
for Africa and has diverse<br />
experience spanning<br />
fifteen years in Medical<br />
Affairs gained in different<br />
pharmaceutical companies. Her vision is to ensure<br />
that we provide the best customer experience<br />
through well researched, fair and balanced medical<br />
responses, share meaningful insights and measure<br />
their impact and to compliantly enhance our service<br />
offering for patients.<br />
MERCY<br />
WALI<br />
Our Medical Education<br />
Lead <strong>GPH</strong> at Johnson<br />
and Johnson, based in<br />
Nairobi Kenya. Wali leads<br />
the medical affairs team in<br />
the Eastern African region,<br />
as a Medical Science Liaison and subsequently as<br />
a Medical manager. Medical Education was a key<br />
component of medical affairs and is anchored on<br />
good relationships with key opinion leaders, from<br />
who insights are obtained.<br />
She said: “I enjoyed impacting children through<br />
activities of the New Horizons Collaborative which<br />
was double pronged program.”<br />
“If anyone tries to tackle TB in isolation, it’s going to be<br />
a big challenge. I think South Africa is demonstrating<br />
that if we work together, you can make a difference.”<br />
– Abeda Williams –<br />
PATIENT ENGAGEMENT:<br />
Integrated and compliant patient engagement<br />
strategy and programs execution.<br />
MARK ANUM<br />
NORTEY<br />
is based in Accra-<br />
Ghana and works in the<br />
patient and community<br />
engagement team of the<br />
medical and scientific affairs<br />
department in Global Public Health (<strong>GPH</strong>), and with<br />
a focus on the New Horizon Collaborative.<br />
Mark joined <strong>GPH</strong> from the Janssen Medical<br />
Affairs (MAF) team in Near East Maghrib &<br />
Africa (NEMA) where he worked as a Medical<br />
Science Liaison responsible for driving the NEMA<br />
medical affairs strategy in Ghana, and with a focus<br />
on the Oncology & Neuroscience therapy areas.<br />
ROBERT<br />
KANWAGI<br />
Our Patient Engagement<br />
& Advocacy lead for<br />
<strong>GPH</strong> based in Nairobi<br />
Kenya. He joined <strong>GPH</strong> in<br />
May 2021 having worked on<br />
supporting the deployment of the<br />
J&J Ebola vaccine for 7 years on the Africa continent<br />
in Sierra Leone, DRC, Uganda, and Rwanda. His<br />
new role with <strong>GPH</strong> is to work with both internal and<br />
external stakeholders to enhance an integrated<br />
and compliant patient engagement strategy and<br />
programs execution.<br />
<strong>SCIENTIFIC</strong> STAKEHOLDER<br />
ENGAGEMENT:<br />
Regional and country field based medical<br />
engagement team for evidence generation and<br />
other med/scientific activities.<br />
ALMA-NALISHA<br />
CELE<br />
Medical Affairs Manager<br />
for Southern Africa –<br />
HIV and TB, based in<br />
Johannesburg.<br />
She heads up the medical affairs for <strong>GPH</strong> in<br />
Southern Africa and has launched a successful<br />
program that caters to junior doctors and young<br />
professionals by equipping them with skills for ease<br />
of treatment wherever they may be as well as a<br />
collaborative workshop with an excellent scientific<br />
partner that was well received by doctors.<br />
4 | J&J <strong>GPH</strong> Medical & Scientific Affairs Bulletin
SHAAKIRA<br />
ABRAHAMS<br />
Our Medical Science<br />
Liaison, based in<br />
Johannesburg, South<br />
Africa. Her primary<br />
responsibility is to connect with external<br />
stakeholders in order to communicate clinical<br />
data as well as gather information about the HIV<br />
treatment and care landscape. Shaakira said:<br />
“During my time as a research scientist, I was able<br />
to contribute to HIV therapy research by publishing<br />
scientific data in several peer-reviewed journals<br />
both nationally and internationally. I consider these<br />
to be one of my proudest achievements”<br />
WALTER<br />
MIBEI<br />
The vaccines medical<br />
manager for Eastern<br />
Africa based in Nairobi,<br />
Kenya. He works within the<br />
medical affairs team focused on<br />
the J&J COVID-19 vaccine and has been with<br />
J&J <strong>GPH</strong> for 7 months.<br />
Walter said: “For the last three months I have<br />
also been supporting COVID-19 vaccine related<br />
medical affairs work across the West Africa region<br />
pending arrival of a new colleague. The vaccines<br />
team has had many achievements and a key one<br />
is close collaboration of the larger <strong>GPH</strong> vaccines<br />
team in rolling out introduction and scientific<br />
update meetings with leadership of expanded<br />
program on immunization (EPI) teams in 18<br />
countries in sub-Sahara Africa over the last three<br />
months.”<br />
<strong>MEDICAL</strong> TECHNICAL SUPPORT<br />
JESSICA<br />
ABRAHAMS<br />
Medical Digital<br />
Excellence Manager<br />
for Johnson & Johnson<br />
Global Public Health,<br />
based in Cape Town, South<br />
Africa. She has Facilitated the<br />
successful integration of phase 1 ROA (Rest of<br />
Africa Countries) in iConnect and managing the<br />
data supply.<br />
THERESA<br />
DREYDEN<br />
Lastly, Theresa (Tracy)<br />
Dreyden is our Snr<br />
<strong>GPH</strong> Technical Support<br />
based in Midrand,<br />
Gauteng. In her role she<br />
provides high-level support and<br />
manages information, communication, logistics in<br />
the office to ensure regulatory functions, legal and<br />
compliance issues are in line with the requirement<br />
for <strong>GPH</strong> products.She also manages the <strong>GPH</strong><br />
Tender Management for SSA from end-to-end in<br />
partnership with Regional Access Leaders.<br />
Tracy said:“In the future I would like to streamline<br />
the processes with regards to processing of<br />
payments for the various teams as well as improve<br />
on the previous Tenders success rate.”<br />
“Future of the vaccines team looks bright and<br />
busy as we continue to roll out COVID-19 vaccine<br />
focused meetings with EPI teams in the remaining<br />
29 countries in sub-Sahara Africa and continue to<br />
focus on the Ebola vaccine.”<br />
5 | J&J <strong>GPH</strong> Medical & Scientific Affairs Bulletin
PAEDIATRIC DR TB TRAINING OF TRAINERS<br />
DATE: 24TH TO 26TH FEBRUARY 2022<br />
VENUE: RADISSON BLUE GAUTRAIN, SANDTON<br />
Paediatric DR TB remains a major public health<br />
problem. Paediatric DR TB case finding is low.<br />
This can be attributed to challenges in sample<br />
collection for TB DST and the lack of knowledge<br />
in managing DR TB in children. Contact<br />
management remains globally suboptimal,<br />
despite being a proven and easy to implement<br />
intervention for paediatric DR TB case finding.<br />
Unavailability of paediatric DR TB formulations<br />
presents a major challenge in the management of<br />
children diagnosed with DR TB. Children tolerate<br />
side effects of TB medicines better than adults,<br />
however, administration of adult formulations<br />
in children presents a major challenge to<br />
clinicians and caregivers in the preparation<br />
of the medicines and dosing of the prepared<br />
formulations as they are not always standard and<br />
thus the likelihood of over- or under-dosing.<br />
Health education to the caretakers is suboptimal<br />
due to the health care workers lack confidence in<br />
managing children with DRTB.<br />
Despite all the challenges, to the best of our<br />
knowledge, there is no training on DR TB<br />
specifically tailored for children aged less than 15<br />
years. Management of paediatric DR TB is largely<br />
extrapolated from the management of adults with<br />
DR TB.<br />
Aquity innovations NPC engaged two consultants<br />
to develop a curriculum specifically for DR TB in<br />
children based on the South African guidelines<br />
and other globally accepted guidelines. The<br />
consultants developed a draft curriculum that was<br />
reviewed by the South African paediatric DR TB<br />
technical working group based in South Africa, in<br />
October 2021.<br />
6 | J&J <strong>GPH</strong> Medical & Scientific Affairs Bulletin
This was a follow-up training of trainers using the<br />
material that was developed and facilitated by the<br />
TB experts and consultants.<br />
THE TRAINING WAS AIMED AT<br />
1) Training of the paediatric DR TB Trainers in line<br />
with current WHO and SA guidelines<br />
2) Reviewing the current updates on the M & E tools<br />
in use. This was a 3-day in-house training. It was<br />
well attended with representatives from the National<br />
DOH, the TB and DRTB heads from various<br />
provinces, AQUITY innovations staff among others.<br />
Nineteen participants undertook the pre-and<br />
post-test that demonstrated 15.7% knowledge<br />
increase. Key lesson learnt during the training is to<br />
allocate at least 4-5 days for the training. Some of<br />
the PAEDIATRIC TB Programmatic challenges to<br />
tackle:<br />
• Decentralization in some provinces is affected<br />
by low numbers of staff<br />
• Limited outreaches to communities is limited<br />
due to staff shortages<br />
• Some sites were closed as TB sites and<br />
converted to COVID-19 sites<br />
• Differentiating programmatic policies and<br />
advising participants what is the SA policy, and<br />
when to consult TB experts<br />
• Consider job aids on ordering of TB drugs, their<br />
side effects, the management of ADRs<br />
• Institutionalize programmatic contact<br />
management (including follow up) in DS TB and<br />
DR TB guidelines<br />
• Provide clear programmatic guidelines on TB<br />
screening (symptomatic vs CXR vs laboratory<br />
testing)<br />
• Include HIV experts in training<br />
Dr J Luiz<br />
Dora Nginza<br />
Hospital<br />
We are not nearly where we want to be but the first<br />
step has been taken and we believe we will reach<br />
a point where sample collection for TB DST and<br />
knowledge in managing DR TB in children is at<br />
100%.”<br />
Dr F Ismail (NICD),<br />
Dr S Nyathie (AQUITY),<br />
Dr T Njoroge (Consultant Paed.)<br />
7 | J&J <strong>GPH</strong> Medical & Scientific Affairs Bulletin
REPORT ON WAC-CREP CONFERENCE<br />
Johnson and Johnson <strong>GPH</strong> recently sponsored<br />
the 5th International Scientific Conference of the<br />
West African Consortium for Clinical Research on<br />
Epidemic Pathogens (WAC-CREP) from 17 to 19<br />
March 2022 in Yamoussoukro, Cote D’Ivore.<br />
The conference had approximately 100 researchers<br />
from Ivory Coast, Guinea, Mali, Sierra Leone, Liberia<br />
and the larger West Africa region in attendance<br />
to discuss and receive latest updates on topics<br />
of interest such as health, conducting research in<br />
epidemics, COVID-19 disease and Ebola Virus.<br />
Researchers from the region also presented<br />
abstracts on their studies.<br />
There was also a symposium and abstract<br />
presentation focused on the J&J Ebola Virus<br />
Vaccine. The symposium topic was ‘Updates on<br />
the Clinical Trial Program of the J&J Ebola Vaccine<br />
and Best Practices for conducting research in<br />
Africa’ and the symposium started with Walter<br />
Mibei introducing <strong>GPH</strong> and Prof Omu Anzala from<br />
University of Nairobi who shared from his wealth of<br />
experience in conducting research in Africa for over<br />
20 years.<br />
Our J&J colleague based in Uganda, Michael<br />
Katwere presented an abstract titled ‘Immune<br />
Response of a Two-dose, Heterologous Ebola<br />
Vaccine Regimen Using a ‘One Assay, One Lab’<br />
Approach: Summary of Three African Clinical Trials’.<br />
The research community mentioned they have<br />
challenges with certain aspects of research and<br />
were keen to continue collaborating with J&J to<br />
strengthen such aspects.<br />
NEW HORIZON WORKSHOP (LAGOS, NIGERIA)<br />
In April 2022, the New Horizons Collaborative<br />
(NHC) through its implementing partner Elizabeth<br />
Glaser Pediatric AIDS Foundation (EGPAF) and<br />
in collaboration with the National AIDS and STDs<br />
Control Program (NASCP) of the Federal Ministry<br />
of Health (FMOH) in Nigeria organized a 2 day<br />
technical workshop in Lagos – Nigeria.<br />
New Horizons is a collaborative initiative to build<br />
awareness, inspire action, and advance learning<br />
around the unmet needs of HIV treatmentexperienced<br />
children and adolescents globally.<br />
The workshop brought together several experts<br />
and stakeholders in pediatric HIV care to discuss<br />
treatment optimization in the management of HIV<br />
among pediatric and adolescent populations.<br />
Key topics discussed included the management<br />
of treatment failure in children and adolescents;<br />
challenges in 2nd and 3rd line management for<br />
children and adolescents and a training on the NHC<br />
Real World Evidence Study Protocol.<br />
The J&J and EGPAF team also conducted field<br />
visits to treatment centers such as the Abuja<br />
National Hospital (ANH) and the Lagos University<br />
Teaching Hospital (LUTH).<br />
The NHC in keeping with our promise of advancing<br />
pediatric HIV treatment and care in Sub-Saharan<br />
Africa (SSA), would continue to work together with<br />
our implementing partner and key stakeholders to<br />
provide capacity, enhance access to treatment and<br />
strengthen health systems.<br />
Prof Regina Oladokun (UCH, Ibadan) is seated first from the right, followed by Dr. Peter Nwaokenneya, Stacy Meyer is Dr Apollo<br />
Tiam, Prof Stephen Oguche (JUTH, Jos) and Dr Ijeoma Itanyi (UNTH, Enugu<br />
8 | J&J <strong>GPH</strong> Medical & Scientific Affairs Bulletin
EBOLA VACCINE PREPAREDNESS INITIATIVE<br />
The Ebola Vaccine Preparedness Initiative is a<br />
partnership between <strong>JNJ</strong> and the Kenya Paediatric<br />
Research Consortium(keprecon) with support from<br />
the Ministry of Health (moh) through the National<br />
Vaccines and Immunization Program (nvip), Kenya<br />
Paediatric Association (kpa) and the University of<br />
Nairobi’s (uon) Department of Paediatrics<br />
Ebola Virus disease (EVD), a viral haemorrhagic<br />
illness that carries a high mortality rate has been<br />
recognised as a significant health threat with the<br />
potential to cause large epidemics particularly<br />
in Africa. In recent years, outbreaks, which have<br />
previously occurred mainly in West and Central<br />
Africa, have been spreading to eastern Africa due to<br />
the increasing ease of cross- border travel.<br />
The World Health Organisation confirmed a new<br />
Ebola outbreak on the 24th of April 2022.<br />
Two vaccines were approved by the World Health<br />
Organization Strategic Group of Experts for Ebola in<br />
2020. The rVSV vectored vaccine has been used in<br />
outbreaks in West Africa and DRC since 2014 as a<br />
ring vaccination strategy.<br />
The second vaccine candidate consists of two<br />
components: Ad26.ZEBOV and MVA-BN-Filo and<br />
is administered in a heterologous prime-boost<br />
schedule.<br />
The vaccine has been used in DRC and in Rwanda.<br />
It is a prophylactic vaccine in a 2-dose schedule and<br />
is therefore suitable for populations at risk outside<br />
outbreak situations.<br />
Following the SAGE recommendations and in<br />
recognition of the high risk of rapid spread of Ebola<br />
to new countries, Janssen in 2021 approached the<br />
Kenya Paediatric Research Consortium (Keprecon)<br />
to partner in an Ebola Vaccine Preparedness<br />
Initiative.<br />
roll out can be accelerated and expanded to all<br />
countries allowing rapid containment.<br />
The educational activities planned were a series of<br />
4 monthly webinars. The first Webinar was held on<br />
2 March 2022and had 71 participants. The topic<br />
was “Description of the Ebola virus, epidemiology<br />
and pathogenicity”. The speaker was Dr. Daniel<br />
Mukadi who is the Regional Director of the P3/P2/<br />
P2 Rodolphe Mérieux INRB-Goma Laboratories from<br />
DRC Congo.<br />
The 2nd Webinar held on 23 March 2022 with 38<br />
participants and the speaker was Dr. Gaudensia<br />
Mutua from Kenya. She has worked for close to 20<br />
years as a principal investigator on various clinical<br />
trials including HIV and Ebola at the KAVI-Institute of<br />
clinical research (University of Nairobi). Dr. Mutua<br />
spoke on “Viral vaccine technologies, including<br />
vector-based vaccines”.<br />
The 3rd and 4th webinars are scheduled for April<br />
and May on the topics “Ebola vaccines research,<br />
including current Ebola vaccines” and “Ebola virus<br />
disease: prevention and treatment, including the<br />
SAGE recommendations”.<br />
Following positive feedback from participants<br />
and after discussion with Janssen, a 5th webinar<br />
has been proposed to address the challenge of<br />
improving vaccine uptake.<br />
To wrap up the webinar series, there will be a roundtable<br />
discussion bringing together all the speakers<br />
to address important highlights as well as brainstorm<br />
on the next steps with regards to the Ebola Vaccine<br />
Preparedness Initiative.<br />
This project has brought into focus the need to<br />
educate health professionals on the rationale for<br />
vaccination early enough outside of emergency<br />
need.<br />
Together, Janssen and Keprecon developed a<br />
proposal to conduct the Ebola Vaccine Preparedness<br />
Initiative project.<br />
The goal of the project was to prepare countries<br />
for effective introduction of the Ebola vaccine by<br />
educating members of National Immunization<br />
Technical Advisory groups as well as Immunization<br />
personnel from at-risk countries on key aspects of<br />
EVD and vaccines.<br />
This is with the aim of increasing awareness of<br />
vaccines as well as building up preparedness and<br />
capacity to ensure that during outbreaks, vaccine<br />
9 | J&J <strong>GPH</strong> Medical & Scientific Affairs Bulletin
ACTIVE MARKETS<br />
10 | J&J <strong>GPH</strong> Medical & Scientific Affairs Bulletin
LOCATIONS<br />
Southern Africa<br />
JC South Africa<br />
JC Botswana<br />
JC eSwatini<br />
JC Lesotho<br />
JC Mozambique<br />
JC Namibia<br />
JC Zambia<br />
JC Zimbabwe<br />
East Africa<br />
JC Kenya<br />
JC Ethiopia<br />
JC Rwanda<br />
JC Uganda<br />
JC Tanzania<br />
West Africa<br />
JC Nigeria<br />
JC Ghana<br />
JC Cameroon<br />
JC Democratic Republic Congo (DRC),<br />
Kinshasa<br />
JC Democratic Republic Congo,<br />
Brazzaville<br />
JC Senegal<br />
JC Ivory Coast / Cote d’ Ivore<br />
JC Burkina Faso<br />
J&J <strong>GPH</strong> Medical & Scientific Affairs Bulletin | 11
THANK<br />
YOU<br />
This <strong>GPH</strong> Scientific & Medical<br />
Affairs Bulletin 001 2022 was<br />
brought to you by our contributing<br />
editors, Robert Kanwagi and<br />
Rethabile Lechesa; sub editors,<br />
Fridah Mwendia, Ukeh Idahosa, Addo<br />
Boateng, Mercy Wali, Mark Anum<br />
Nortey, Shaakira Abrahams, Walter<br />
Mibei, Alma-Nalisha Cele, Abeda<br />
Williams, Jessica Abrahams, Tracy<br />
Dreyden; and, our agency<br />
of choice, Avatar Agency<br />
12 | J&J <strong>GPH</strong> Medical & Scientific Affairs Bulletin