13.05.2022 Views

JNJ - GPH_MEDICAL_SCIENTIFIC_AFFAIRS

  • No tags were found...

You also want an ePaper? Increase the reach of your titles

YUMPU automatically turns print PDFs into web optimized ePapers that Google loves.

<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 />

n<br />

n<br />

n<br />

n<br />

n<br />

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

Hooray! Your file is uploaded and ready to be published.

Saved successfully!

Ooh no, something went wrong!