Reaching UNGA HLM on TB targets for ending TB in children and adolescents: First Paediatric Antituberculosis Drug Optimization Meeting (PADO-TB 1) Date: 14-15 February 2019 Meeting room CDS65, fourth floor of the WHO D-building/UNAIDS building, Geneva, Switzerland
49
Embed
Reaching UNGA HLM on TB targets for ending TB in children ... · that TB is preventable and treatable, 1 million children (0-14 years) develop TB every year, representing 10% of the
This document is posted to help you gain knowledge. Please leave a comment to let me know what you think about it! Share it to your friends and learn new things together.
Transcript
Reaching UNGA HLM on TB targets for ending TB in children and adolescents:
First Paediatric Antituberculosis Drug Optimization Meeting (PADO-TB 1)
Date: 14-15 February 2019
Meeting room CDS65, fourth floor of the WHO D-building/UNAIDS building, Geneva, Switzerland
2
Executive summary
To reach the UN General Assembly High Level Meeting on TB targets for treatment and prevention in
children, timely access to the most effective and safest medications in affordable, child-friendly
formulations is critical. Building on the experience in the WHO HIV programme, the first paediatric
antituberculosis drug optimization (PADO TB 1) meeting aimed to establish a formal transparent process
to reach evidence-based consensus among a variety of stakeholders regarding priority antituberculosis
drugs and formulations for children.
The meeting was attended by 45 participants with six additional attendees participating remotely and
included representatives from NTPs from TB high burden and priority countries, clinicians, scientists,
funding organizations, international organizations and technical partners.
The meeting objectives were to:
1. Discuss the PADO for TB platform and modus of operandi.
2. Develop a list of short/medium- and long-term priorities for paediatric TB drug optimization.
3. Agree on a way forward to accelerate development and uptake of the priority medicine
formulations.
During the first day, presentations covered the size and specifics of the paediatric anti-TB drug market,
the concept of paediatric antituberculosis drug optimization, experiences with antituberculosis drug
development and market-shaping and the current adult and paediatric TB research and clinical trial
landscape, priorities and overview of drug development. Participants engaged in discussions on the
PADO for TB mechanism and modus operandi in the context of complementary efforts in paediatric drug
optimization as well as the process to reach consensus on short/medium and long-term priorities for the
development of paediatric antituberculosis drugs and formulations.
On the second day, after providing additional background information on the PADO for HIV priority list,
participants broke up into three groups to discuss short/medium and long term priorities for a)
treatment of drug-susceptible TB; b) treatment of drug-resistant TB; and c) treatment of latent TB
infection (LTBI – both drug-susceptible [DS-TB] and drug-resistant TB [DR-TB]). A summary of the agreed
priorities can be found in the table below. The meeting also discussed how to best take these priorities
forward, taking advantage of existing structures.
Summary of agreed priorities:
Formulations: All scored dispersible
Short-term list DS-TB DR-TB LTBI Remarks
Rifampicin (RIF) √ √ Currently 4R is not a preferred LTBI regimen for children
Rifapentine (RPT) √ √
Bedaquiline (BDQ) (√) √ (√) Watch-list LTBI and DS-TB
3
Clofazimine (CFZ) √
Delamanid (DLM) √ √
Linezolid (LZD) √
Pretonamid (Pa) (√) √ (√) Watch-list LTBI and DS-TB
Watch list
Bedaquiline (BDQ) √ (√) √ Short-term list for DR-TB
Pretonamid (Pa) √ (√) √ Short-term list for DR-TB
RHZL FDC √ If SHINE not successful and if studies with short FQN based regimens are successful.
RHZE FDC √ To address barriers to use of ethambutol
Telacebec (Q203) √ Currently phase IIa
Sutezolid (PNU-100480) √ Currently phase IIa
Delpazolid (LCB01-0371) √ Currently phase IIa
OPC-167832 √ Currently phase IIa/IIb
Moxifloxacin (MFX) (√) √ Taste-masked
Next steps:
Meeting report with wide dissemination
Suggest establishment of sub-group of PADO TB and report to the Strategic and Technical
Advisory Group for Tuberculosis (STAG-TB)
o Show need for prioritization
o Learn more from PADO HIV experiences
o Make use of advantage of having GDF and UNITAID funding
o Work closely with WHO HIV and WHO MVP, in particular PQ
In future, involve more representatives from TB high burden countries as well as communities
affected by TB in PADO TB
Share outcome of PADO TB with the core team of the Child and Adolescent TB Working Group
Participate in IAS webinar 27 February 14:00 CET (15:00 SAST; 8:00 ET)
4
Day 1, Thursday 14 February 2019
Opening address – Tereza Kasaeva
TB has a visible and important place on the WHO agenda (GPW13). After UNGA HLM, the time for action
is now. Targets regarding treatment and prevention are ambitious, in line with End TB Strategy and its
milestones. We need to increase our prevention efforts at least 30 times to reach the target.
Overview of meeting objectives – Annemieke Brands
An overview of the meeting objectives and the agenda was provided. Participants were reminded
regarding the need to complete declarations of interest, and declare any conflicts of interests.
Pdf versions of the presentations given on day 1 have been uploaded in a Dropbox folder: https://www.dropbox.com/sh/b9ut6x94fxkrmgw/AAA5c5EkewQvl-AB7RuJ-PtKa?dl=0
Session 1 - An introduction to the size and specifics of the paediatric anti-TB drug market and to the
concept of paediatric antituberculosis drug optimization
The concept of drug optimization and the Global Accelerator for Paediatric Formulations (GAP-f)
framework: learning from experiences of the HIV programme - Martina Penazzato, WHO HIV
To reach SDG 3 (Ensuring healthy lives and promote wellbeing for all at all ages), drug
optimization is needed, as the best drugs or dosage formulations are not available to treat
children: Clinical evidence is lacking to define appropriate paediatric doses, paediatric
formulations do not exist for most drugs and time to market lags adult products by over a
decade.
Key challenges that hamper the rapid development and introduction of optimal paediatric
formulations include: Market fragmentation, lack of child-friendly formulations, complexity and
cost of the projects, internal prioritization within companies, lack of market incentives/small
markets, and difficult and slow market uptake.
Developing medicines for children requires addressing unavoidable complexities (e.g. natural
history, growth and puberty, drug metabolism, co-morbidities, palatability and ease of
administration) while promoting simplification and harmonization across the age spectrum.
In May 2016, the World Health Assembly called on WHO to take all necessary measures to
support access to quality, safe, efficacious and affordable medicines for children; encourage
research and development on appropriate medicines for diseases that affect children and
ensure that high-quality clinical trials are undertaken; and, strengthen national regulatory
systems including pharmacovigilance and post-market surveillance (Resolution WHA69.20)
HIV PADO has identified key priority products since 2013 to ensure a consistent clear message to
manufacturers regarding needs through collaborative and coordinated action: key formulations
are prioritised in the context of a public health approach; technical/research work is undertaken
to support development of the priority formulations; priority formulations are included in
identify non-severe disease but how to write up a definition of “non-
severe”?
HIV/TB DDI studies • DNDi: Ritonavir boosting of LPV/r in TB/HIV: completed
• NICHD PK: first-line TB drugs with ART: completed
• P1101: RAL-based ART with standard TB drugs: ongoing
• CS 5019: RFPT and DTG for TB prevention and treatment: development
TB prevention Phase I, II, II (DS AND DR-TB)
• A5300 PHOENIX: delamanid vs. INH for MDR-TB prevention: 2018 • TB-CHAMP: LFX vs placebo for MDR-TB prevention: 2016 • VQUIN: LFX vs. placebo for MDR-TB prevention: open • ACTG5279: 1HP daily for DS-TB prevention • Study 35: 3RH in HIV+/-children < 12 years of age: TBTC 2019 • P4v9 Trial: 4 months RIF vs 9 months INH for DS-TB prevention • TBTC 37: RPT 6 weeks vs. local SOC (4R or 3HP) • P1078: IPT in HIV-infected pregnant women • P2001: safety and PK of rifapentine in HIV+ pregnant women • 1 HP in children: CS 5109 (HIV+/-): planned
22
• 1 HIV vs. 3 HP in pregnant women: CS 5021 (HIV+/-): planned
o Data is already there that this can increase efficacy, and maybe lead to regimen
shortening
o Single rather than FDC because ratios will change across weight bands (for “top up”)
o Ideal dose of a dispersible tab to be determined but data already there
Rifapentine (RPT)
o Single rifapentine (same rationale as above for single need)
o Optimal dosage will come from PK study (not yet started/funded)
o Formulation should be dispersible (potentially scored) – dose TBD on PK study
Output 1 >5 years (Long)
Nothing if we can get to a 2-month regimen (especially if the same drugs can be used for LTBI
[broadening applicability of a single regimen/drug across the spectrum of disease])
Long-acting safe formulation that works across ages and disease spectrum appears
Possible watch list:
RHZL FDC short regimen – this FDC may be useful if SHINE not successful and if studies with
short FQN based regimens are successful. Lfx will be needed for CNS-TB, but we believe
currently available Lfx single dispersible will be sufficient for this.
HRZE dispersible FDC
HPZ(E) and HP dispersible FDC – depending on results of rifapentine PK study (if same ratio
between P and H are maintained across weight bands). Will also depend on harmonization of
this FDC between DS-TB disease and infection indications.
B6 dispersible FDC (in combination with first-line anti-tuberculosis drugs)
Bedaquiline, Pretonamid – If we cannot find a short regimen using currently used drugs (e.g.
RHZE or PHZE), a regimen containing B and Pa such as BPaMZ may be needed
Output 2: Additional research questions, funding gaps and advocacy needs:
Research gaps:
o PK of high-dose daily RPT (not yet started)
o PK/safety of antituberculosis drugs in malnourished kids
o PK of high-dose RIF and DTG (maybe DRV/r)
Funding gaps
o PK of high-dose daily RPT (not yet started) – study not funded
Advocacy needs
o Safety of Ethambutol
36
o Quality B6 supply
Next steps:
Convene subgroup of PK experts to work with available data and determine appropriate dosing
of rifampicin
Group 2: Drug-resistant TB disease treatment (Jennifer Furin + Martin Van Den Boom)
Output 1: Priority products for DR-TB treatment
Medicine Ped formulation Comments
Bedaquiline Trial formulation Short term
Clofazimine No Short term
Delamanid Trial formulation available for compassionate use
Short term
Could be used also for LTBI
Lfx/Mfx Yes/Yes Formulations exist. Could also be used for DR-LTBI and treatment of INH-mono-resistant TB
Linezolid Syrup (very expensive) 150mg dispersible tablet in development
Short term
Pretomanid No Short term
Watch list (based on new compounds in phase II):
Telacebec (Q203)
Sutezolid (PNU-100480)
Delpazolid (LCB01-0371)
OPC-167832
Preferred formulations:
Scored (functional) dispersible tablet
Under 5kg kids – compounded formulations, pragmatic use of dispersible tablets used for higher
weight group
FDC is not a priority
o Guidelines changing frequently
o Toxicity requiring stopping one drug
Long acting formulations (could be also injectable version) – for the future development
Output 2: Research questions
New delivery and administration ways
Ongoing PK/PD studies to optimize dosing (not to be based only on age and weight)
Understanding acceptability, adherence to administration instructions
Explore formulations to overcome food restrictions
37
Co-packing (e.g. with food)
Optimal dosing strategies for children under 5 kg
Flexible dosing
Is there a need for more than one agent from each drug class (e.g. FQs, nitroimidazoles)
Planning for paediatric studies should begin once a product is in phase II.
Use of drugs for other indications (FQ, Dlm) and maybe for adults – increasing market
Market estimations – how many children from different weight and age groups
Costing the research agenda to inform donors and manufacturers
Explore potential candidates for long acting formulations
Next steps and actions:
Follow up call to suggest the ideal strength tablet for paediatric bedaquiline and delamanid (<1
month)
Fill out the drug score sheet (identify knowledge gaps, prioritize drugs)
Advocacy to overcome Intellectual Property barriers and manufacturing insufficiencies
Facilitate, advocate, negotiate with manufacturers
Stimulate countries to collect/share data on children (disaggregated by weight and age). Provide
generic data collection tools, collaborate with partners (MSF, Union, KNCV, PIH, and others.)
Establish research HUBs in different regions (Belarus, Kyrgyzstan….), develop research capacity
Harmonize the needs with the preventive market
Regulatory harmonization (WHO+TAG+CSO) and advocacy enabling research, harmonized
registration
Orphan status of paediatric formulations (facilitate uptake in countries that require local
registration)
Group 3: Latent TB infection treatment (drug-susceptible and drug-resistant) (Lisa Obimbo +
Annemieke Brands)
Output 1: Short/medium term PADO TB drugs for prevention
Drug Formulation Comments
Short to medium term - All scored and dispersible
Rifapentine 150mg 150 mg DS TB
Isoniazid/Rifapentine FDC (HP)
unknown DS TB Evidence upcoming
Delamanid 50 mg DR-TB
(Pyridoxine) 50 mg Minimize INH toxicity. On essential medicines list (CTX/B6 FDC for HIV)
Notes on table:
Rifapentine stand-alone: has multiple uses and allows for flexibility to adjust dose as evidence
emerges on higher dosing for LTBI and active TB treatment.
38
HP FDC: Optimal ratio of H:P unknown, but preferred regimen is to optimize a 1 HP (HP once
daily for one month) short course regimen (Weekly HP for 3 months [3HP] would be the second
preferred short course): Multiple uses, both for LTBI and active disease.
Delamanid stand-alone: Current trials using 25mg trial formulation berry-flavoured mandatory
dispersible available. Taste is good. Not scored. Preferred for development: 50 mg scored
dispersible tablet (not restricted to mandatory dispersible, but also ok to dissolve on tongue for
older children).
Output 1: Long term PADO TB drugs for prevention
Drug Formulation Comments
Long term - All scored and dispersible
Moxifloxicin 100 mg DR TB Taste masked formulation required
Bedaquiline 20mg DR TB
Pretomanid Unknown Guided by research
Notes on table:
Levofloxacin: Lfx 100mg scored and dispersible tablet is already available, and it seems palatable
and acceptable in ongoing trials, but needs to be given for 6 months. So this formulation could
be scaled up for immediate use. No new formulation required, therefore not to be included in
PADO TB list.
Moxifloxacin: Long-term – consider development of taste masked formulation 100mg. However,
Mfx is inferior to levofloxacin in safety profile, so optional to include this.
Bedaquiline: Long-term – 20mg paediatric formulation for shortened regimens for DR-TB
exposed children.
Pretonamid: Long-term develop paediatric formulation for shorter course preventive regimens
for DR-TB exposed children (there is a paediatric formulation under development – remote
participant communicated). This will have multiple uses and may also be useful for treatment of
DR-TB disease.
Output 2: Prevention LTBI in Children: Remaining research questions to inform development and
optimal use
Shorter preventive regimens for children
o for DS TB (1HP, 3HP)
o for DR TB (fluoroquinolones, delamanid and possibly bedaquiline)
Acceptability and palatability to be assessed for all paediatric formulations early on in research
Levofloxacin – establish PK, safety and optimal dosing for children (emerging evidence –
bioavailability appears higher than expected in initial reports with 15-20mg/kg)
Moxifloxacin formulation: taste masking
Optimal ratio of isoniazid:rifapentine (HP) FDC
Long-acting novel formulations for children
39
Operations research to understand barriers and facilitators to uptake of treatment of LTBI in
children.
Discussions:
Discussion on pursuing FDCs versus single scored and dispersible formulations:
FDCs may pose a risk as long-term guidance and efficacy are not clear – therefore FDCs are not a
short-term priority
o More long-term priorities pending further research
o Single drugs most important but when deciding on formulations, the pill burden needs
to be kept in mind
Discussion on delivery strategies and flexible dosing: functionally scored dispersible
formulations are needed. Collect data from countries prior to updating guidelines.
Child-friendly versus patient-friendly formulations for both children and adults
TB/HIV:
A study on DRV/r with rifampicin seemed too unsafe and was just stopped in a study in adults
which showed grade 3 and 4 hepatotoxicity
Ethambutol barriers:
Evaluation of ethambutol safety (barrier to uptake of 4-drug regimens for first line treatment):
SHINE trial not powered to evaluate this. Currently not all sub-Saharan African countries using
additional ethambutol
E is protective in areas with increasing INH resistance. However, most children are not infected
with HIV and do not have severe disease and therefore do not need E.
Ethambutol containing regimens may not be needed as most children do not have severe
disease and are not infected with HIV
Prevention:
Data are needed on preventive therapy for children living with HIV on ARVs
We should not use “LTBI” but “treatment of TB infection”
Merging the spectrum of LTBI and DS-TB treatment: long-term possibility of treatment for all for
2 months?
Preventive treatment is given to children who are well and needs to be weight based, very safe,
tolerable and, as short as possible.
We need better data on how many children are eligible for preventive treatment to better
shape the market.
Prevention in youngest who are most at risk: precise dosing needed although they metabolize
medicines quicker
3HP versus 1HP: if companies can develop for trials, they can develop for markets even though
ratio H:P different in 3HP and 1HP
DR-TB:
40
Levofloxacin versus moxifloxacin: the choice used to be dependent on DST results. Currently,
levofloxacin is the drug of choice, as moxifloxacin causes more problems with QTc prolongation.
Reporting on adverse events is cumbersome
Recent publication on adverse events related to fluoroquinolones: advocacy needed on
levofloxacin
PADO lists of priorities and research needs:
The PADO priority consensus list should contain formulations that we think can be achieved and
that are better than we currently have (versus the perfect formulation)
PADO TB consensus priority list: realistic versus wish list of ideal formulations. Products can be
really expensive.
Within each area (DS TB, DR-TB and LTBI), try to prioritize within the list of consensus priorities
(try to delineate a bit more)
PADO TB 1: Summary of agreed priorities:
Formulations: All scored dispersible
Short-term list DS-TB DR-TB LTBI Remarks
Rifampicin (RIF) √ √ Currently 4R is not a preferred LTBI regimen for children
Rifapentine (RPT) √ √
Bedaquiline (BDQ) (√) √ (√) Watch-list for LTBI and DS-TB
Clofazimine (CFZ) √
Delamanid (DLM) √ √
Linezolid (LZD) √
Pretonamid (Pa) (√) √ (√) Watch-list for LTBI and DS-TB
Watch list
Bedaquiline (BDQ) √ (√) √ Short-term list for DR-TB
Pretonamid (Pa) √ (√) √ Short-term list for DR-TB
Telacebec (Q203) √ Currently phase IIa
Sutezolid (PNU-100480) √ Currently phase IIa
Delpazolid (LCB01-0371) √ Currently phase IIa
OPC-167832 √ Currently phase IIa/IIb
Moxifloxacin (MFX) (√) √ Taste-masked
41
Venn-diagram of agreed short-term priorities:
* BDQ and Pa on short-term list for DR-TB but on watch-list for LTBI and DS-TB
Session 6: Where do we go from here?
Discussion on ways to stimulate action towards the development of priority paediatric
antituberculosis drugs and formulations and agreement on next steps, including priorities for GAP-f –
facilitated by Jennifer Cohn
Summary of discussions:
What signals to communicate to manufacturers, researchers, funders, regulators, advocacy
groups
o Advocacy to create demand, regional and in-country; this should be more than usual
o Make use of existing and functional structures, for example, feed into communication
by GDF/TPMAT etc.
o It needs to be clearly communicated that rifampicin on short-term list is not necessarily
for 4R LTBI regimen as 3RH and 1HP or 3 HP are preferred options for children
Research gaps:
o Work on dosing based on (early) PK data – e.g. for rifapentine
o Also around patient, caregiver and healthcare worker preference (this would be done
early on in the development process ) – context does matter
Experiences with dissemination after HIV PADO:
o Meeting report
o Webinar sharing outcomes
o Scientific dissemination (general and specific)
o Community representation
Potential outputs:
o A subgroup of PADO TB 1 to anticipate dosing requirements based on what we currently
know and on early research results
42
o Explore funding to address research gaps and build capacity to develop and implement
appropriate research in multiple sites. Develop research protocols and make them
available for funding. Work towards sustainable funding for research.
o Engage the NIH (who are very active and have already expressed interest) to alert them
on the PADO priorities, research questions and gaps
o GDF to facilitate messages to manufacturers (involvement of CSOs and activists) and to
WHO PQ and GF ERP Expressions of interest (EOI), via established mechanisms
o GDF (through TPMAT) with WHO can provide signals to suppliers
o Advocacy role, including advocating with in-country regulatory authorities: Possible
opportunities through FDA/EMA/SRA approval (e.g. sharing review documents through
secure site)
o GDF can help assist with WHO PQ processes as TB medicines are almost always generics
(in that sense TB is different from HIV)
o Advocate for funding for patient preference surveys.
o Explore how best to build on existing initiatives and experiences.
o The revived paediatric regulatory network convened by WHO EMP, linked to GAP-f,
could convey messages on behalf of the TB community
o Medicines Patent Pool: can coordinate licensing agreements between innovators and
make them available to generic companies
o GF ERP can accelerate the process, next meeting on 8 April 2019: make use of the
current momentum and share the list of priorities
Next steps:
Meeting report with wide dissemination
Suggest establishment of sub-group of PADO TB and report to the Strategic and Technical
Advisory group (STAG TB)
o Show need for prioritization
o Learn more from PADO HIV experiences
o Make use of advantage of having GDF and UNITAID funding
o Work closely with WHO HIV and WHO MVP, in particular PQ
In future, involve more representatives from TB high burden countries as well as communities
affected by TB in PADO TB
Share outcome of PADO TB with the core team of the Child and Adolescent TB Working Group
Participate in IAS webinar 27 February 14:00 CET (15:00 SAST; 8:00 ET)
43
Annex 1: Meeting agenda
Day 1: Thursday 14 February 2019
Chair: Tony Garcia-Prats
08:30-08:55 Welcome and introductions Optimizing paediatric TB prevention and treatment in the light of reaching UNGA HLM on TB targets
Dr Tereza Kasaeva, Director WHO GTB
08:55-09:00 Overview of meeting objectives Declaration of interests
Annemieke Brands, WHO GTB
Session 1: An introduction to the size and specifics of the paediatric anti-TB drug market and to the concept of paediatric antituberculosis drug optimization Expected outcome: 1) An overview of the burden of TB, DR-TB and TB infection in children and recent policy developments; 2) An understanding of the current paediatric TB market and implications for drug development; 3) Review the concept of drug optimization and lessons learned from PADO for HIV; 4) An introduction to the Global Accelerator for Paediatric Formulations (GAP-f) framework.
10:00-10:20 The concept of drug optimization and the Global Accelerator for Paediatric Formulations (GAP-f) framework: learning from experiences of the HIV programme
Martina Penazzato, WHO HIV
09:00-09:20 The burden of paediatric TB (infection and disease), recent policy developments and targets
Malgosia Grzemska, WHO GTB
09:20-09:40 Paediatric TB medicines market overview and coordination
Brenda Waning, GDF
09:40-10:00 Paediatric TB market specifics and implications for drug development: a community and human rights perspective
Lindsay McKenna, TAG
10:20-10:30 Discussions
All
10:30-11:00 Group photo and coffee/tea break
Session 2: Experiences with antituberculosis drug development and market-shaping Expected outcome: 1) Sharing of experiences with paediatric antituberculosis drug development (first- and second line); 2) An understanding of regulatory and other barriers for drug development and market shaping; 3) Ongoing efforts to improve access to paediatric formulations; and 4) An understanding of child-friendly formulations.
11:00-11:20 Development of child-friendly TB Fixed-Dose Combinations: lessons learned
Shelly Malhotra, TB Alliance (remotely)
11:20-11:40 Development and introduction of TB medicines: the case of paediatrics
Brian Kaiser, GDF
11:40-12:00 Role of the WHO Access to Medicines, Vaccines and Health Samvel Azatyan, WHO
44
Products (MVP) cluster in improving access to and use of appropriate TB medicines for children
MVP
12:00-12:30 Discussion
All
12:30-13:30 Lunch break
Session 3: Current adult and paediatric TB research and clinical trial landscape, priorities and overview of drug development Expected outcome: 1) Overview of current adult and paediatric TB infection and disease, TB/HIV co-infection trials, drug pipeline and policy implications; 2) Ongoing efforts to improve access to paediatric formulations in other disease areas including HIV; and 3) An understanding of additional research priorities and needs.
Chair: Rina Triasih
13:30-13:50 An overview of the paediatric TB (infection and disease) trial landscape
Anneke Hesseling/Tony Garcia-Prats, Desmond Tutu TB Centre
13:50-14:10 An overview of the adult TB trial landscape and implications for paediatric TB drug optimization
Kelly Dooley, Johns Hopkins University (remotely)
14:10-14:30 TB/HIV-coinfection, ARVs and implications for paediatric TB drug development/Identifying synergies and alignment between TB and HIV
Helena Rabie, Stellenbosch University (remotely)
14:30-14:50 An overview of the current TB drug development pipeline and remaining research priorities
Lindsay McKenna, TAG
14:50-15:10 Discussion
All
15:10-15:30 Tea/coffee break
Session 4: PADO for TB Expected outcome: 1) Discussion on the PADO for TB mechanism and modus operandi in the context of complementary efforts in paediatric drug optimization; 2) Discussion on the process to reach consensus on short/medium and long-term priorities for the development of paediatric antituberculosis drugs and formulations.
15:30 -17:00 Discussions on the PADO for TB mechanism and modus operandi in the context of complementary efforts in paediatric drug optimization and to reach consensus on priorities for the development of paediatric antituberculosis drugs and formulations
Facilitated by WHO (Martina Penazzato and Martin Van Den Boom)
17:00 Summary and wrap-up Malgosia Grzemska, WHO GTB
45
Day 2: Friday 15 February 2019
08:30-09:00 Summary of day 1, objectives for day 2 and introduction to group work to define short, medium and long-term priorities for the development of paediatric antituberculosis drugs and formulations
Malgosia/Annemieke/Sabine, WHO GTB
Session 5: Group Work to define short/medium- and long-term priorities for the development of paediatric antituberculosis drugs and formulations. Expected outcome: 1) Agree on a list of short/medium- (2-5 years) and long-term (5-10 years) priorities for the development of paediatric antituberculosis drugs and formulations according to proposed methodology; and,
09:00-10:30 Group Work to define short/medium- and long-term priorities for the development of paediatric antituberculosis drugs and formulations:
Group 1: Drug-susceptible TB disease treatment
Group 2: Drug-resistant TB disease treatment
Group 3: Latent TB infection treatment (drug-susceptible and drug-resistant)
Brainstorming
Facilitators:
Group 1: Jen Cohn + Sabine Verkuijl (Main room CDS65)
Group 2: Jen Furin + Martin Van Den Boom (D46010)
Group 3: Lisa Obimbo + Annemieke Brands (D6007 -ground floor)
10:30-11:00 Coffee/tea break
11:00-12:30
Group work continued – formulations of priorities
12:30-13:30 Lunch break
13:30-15:30 Report back of group work and discussion and agreement on a final list of paediatric TB drug optimization priorities
Group facilitators
15:00 -15:30 Discussion
All
15:30-16:00 Tea/coffee break
Session 6: Where do we go from here? Expected outcome: Consensus on next steps
Chair: Jen Cohn
16:00-17:30 Discussion on ways to stimulate action towards the development of priority paediatric antituberculosis drugs and formulations and agreement on next steps, including priorities for GAP-f
All
17:30 Closing remarks Malgosia Grzemska, WHO GTB
46
Annex 2: List of participants
1. Jay Achar
HIV/TB/Hepatitis Advisor Médecins sans Frontières London United Kingdom of Great Britain and Northern Ireland Email: [email protected]
3. Grania Brigden Deputy Director TB and HIV Department The International Union Against TB and Lung Disease (The Union) Geneva Switzerland Email: [email protected]
4. Michael Campbell Clinton Health Access Initiative (CHAI) Bethesda USA Email: [email protected]
5. Martina Casenghi Technical Director CaP TB Project Elizabeth Glaser Pediatric AIDS Foundation (EGPAF) Geneva Switzerland Email: [email protected]
6. Thomas Chiang (unable to participate) Senior TB Technical Advisor USAID Washington, D.C. USA Email: [email protected]
7. Jennifer Cohn
Senior Director of Innovation Elizabeth Glaser Pediatric AIDS Foundation (EGPAF) Geneva Switzerland Email: [email protected]
8. Charlotte Colvin (unable to participate) Senior TB Technical Advisor USAID Washington, D.C. USA Email: [email protected]
9. Sarah Cook-Scalise Global Alliance for TB Drug Development New York USA Email: [email protected]
10. Kelly Dooley (through webex) Associate Professor of Medicine, Pharmacology & Molecular Sciences Co-Director, Fellowship Training Program in Clinical Pharmacology Faculty Leader, Janeway Firm of the Osler Residency Program Johns Hopkins University School of Medicine Baltimore USA Email: [email protected]
11. Gunta Dravniece TB Consultant KNCV Tuberculosis Foundation The Hague The Netherlands Email: [email protected]
12. Jennifer Furin The Sentinel Project on Pediatric Drug Resistant TB Boston USA Email: [email protected]
13. Anthony Garcia-Prats Stellenbosch University Cape Town South Africa Email: [email protected]
14. Lucia Gonzalez Fernandez Senior Manager International AIDS Society Geneva Switzerland Email: [email protected]
15. Anneke Hesseling Professor in Paediatric and Child Health Director, Desmond Tutu TB Centre Stellenbosch University Cape Town South Africa Email: [email protected]
17. Sandeep Juneja Senior Vice President, Market Access Global Alliance for TB Drug Development New York USA Email: [email protected]
18. Brian Kaiser Technical Officer, Global Drug Facility, Stop TB Partnership Geneva Switzerland Email: [email protected]
19. Alexander Kay (through webex) Baylor International Pediatric AIDS Initiative Mbabane Eswatini Email: [email protected]
20. Alexei Vladimirovich Kazakov Senior Scientist National Medical Research Center of Phtisiopulmonology and infectious diseases Ministry of Health Moscow Russian Federation Email: [email protected]
21. Linda Lewis Director Clinical and Regulatory Affairs Clinton Health Access Initiative (CHAI) Bethesda USA Email: [email protected]
22. Shelly Malhotra (through webex) Director, Market Access Global Alliance for TB Drug Development New York USA Email: [email protected]
23. Helen McIlleron (through webex) University of Cape Town Cape Town South Africa Email: [email protected]
24. Lindsay McKenna TB Project Co-Director Treatment Action Group New York USA Email: [email protected]
38. Brenda Waning Global Drug Facility Stop TB Partnership Geneva Switzerland Email: [email protected]
WHO Regional Office 39. Martin van den Boom, WHO EURO
WHO-Headquarters 40. Soumya Swaminathan, WHO DDG 41. Tereza Kasaeva, Director WHO GTB 42. Malgosia Grzemska, Coordinator, WHO GTB TSC 43. Annemieke Brands, WHO GTB TSC 44. Sabine Verkuijl, WHO GTB TSC 45. Dennis Falzon, WHO GTB THC/RTE 46. Matteo Zignol, Coordinator, WHO GTB THC & RTE 47. Avinash Kanchar, WHO GTB THC 48. Lice Gonzalez-Angula, WHO GTB LDR 49. Nebiat Gebreselassie, WHO GTB RTE 50. Kefas Samson, WHO GTB TSC 51. Martina Penazzato, WHO HIV 52. Samvel Azatyan, WHO MVP 53. Marina Plesons, WHO RHR 54. Vindi Singh, WHO HIV