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Partners' Meeting | Dubai | 25 March 20141
G. Torelli, WHO, 25 March 2014
7th Meeting with International Partners on Prospects for Influenza Vaccine Technology Transfer
to Developing Country Vaccine Manufacturers
WHO Technology Transfer Initiative: supporting grantees through
the next phase
Partners' Meeting | Dubai | 25 March 20142
FLUBIOVacina
Influenza
FLU VAC
Green Flu S CANTGRIP
Green Flu S+
NASOVAC
SIX PANDEMIC VACCINES APPROVED
PREQUALIFIEDPANDEMIC VACCINES TWO
TWO SEASONAL VACCINES APPROVED
PRODUCTION FACILITIES
PRE- and CLINICAL STUDIES
Enzavac
THREE
Nasovac-S MOREbeing completed
LAIV H5N2 Ph II - immunogenic
WHAT HAS HAPPENED SINCE THE LAST MEETING in 2013
WHAT HAS HAPPENED SINCE THE LAST MEETING in 2013
Partners' Meeting | Dubai | 25 March 20143
� Desk review (reports, presentations, publications)� Assessment visits (9 sites Oct-Dec 2012) Assessment process:
Advance Questionnaire
Site visit with expert teams
Questionnaire covering:
Overall plansNational plansCurrent vaccines prodStaffing and structureProduction (process)FillingFacilityQA/QCSOPs
Training needsNational regulatory processProduct approval requirementsMarketing/business detailsBudgetary needsRsk analysis
2012 assessments
WHAT HAS HAPPENED SINCE THE LAST MEETING in 2013
WHAT HAS HAPPENED SINCE THE LAST MEETING in 2013
Partners' Meeting | Dubai | 25 March 20144
� 3-year workplans developed jointly with manufacturers,
based on the 2012 assessments
� New 3-year Cooperative Agreement with BARDA
� Collaboration with OGA-CDC
� 12 new grants issued
� Workshop on Enhancing Communication around
Influenza Vaccination (June 2013, Atlanta)
� Initiated work on conditions for sustainability
WHAT HAS HAPPENED SINCE THE LAST MEETING in 2013
WHAT HAS HAPPENED SINCE THE LAST MEETING in 2013
Partners' Meeting | Dubai | 25 March 20145
2016 TARGETS2016 TARGETS
Company / Country Vaccine Late stage** Licensed***
BCHT – China Seasonal LAIV X
Biofarma - Indonesia Seasonal X
Adjuvanted Pandemic [X]
Biovac – South Africa Seasonal* X
Adjuvanted pandemic* X
Birmex – Mexico Seasonal* X
Adjuvanted pandemic* X
Butantan – Brazil Adjuvanted pandemic X
Cantacuzino - Romania Seasonal X
Adjuvanted pandemic X
GPO - Thailand Pandemic LAIV (H5) X
Seasonal LAIV/IIV X
IVAC - Viet Nam Pandemic (whole virion) X
Seasonal (split) X
SII - India Seasonal LAIV (egg) X PQ?
Seasonal LAIV Tissue Culture X
Torlak - Serbia Seasonal (split) X
Pandemic (whole virion) X
• Fill-finish;
• ** includes vaccines in late stage clinical trials or regulatory dossier submitted;
• *** For pandemic vaccines outside of a pandemic, licensure = mock dossiers or other tentative approval;
11 7
Partners' Meeting | Dubai | 25 March 20146
2016 TARGETS2016 TARGETS
Company Current Predicted* NoteBirmex 0 120** Based on 15ug monovalent dose
Butantan 120 240 Based on adjuvanted7.5ug dose vaccine
Cantacuzino 9 36 Base on improved yields and adjuvanted 7.5ug dose
Torlak 0 6
Biovac 0 24** Based on target 8M seasonal supply.
SII 20 50** Based on submission TC LAIV and planned scale-up.
GPO 1.5 30** LAIV
IVAC 0 3**
Biofarma 0.1 16 Based on facility completion and adjuvant approval
BCHT 0 90** Based on strain-change approval
Green Cross 180 180 Has adjuvant technology, approved adjuvanted vaccine.
Total 330 795
.2016capacity by pandemicTable of maximum current and predicted
* to make estimations of predicted capacity we count vaccines that are licensed and also those that are in late stage development; ** unless company
has dose sparing technology approved or submitted for approval, we assume a dose of 15ug HA or a 107 PFU LAIV as experienced with H1N1,
enabling a conversion factor of 3 over the maximum annual seasonal capacity.
Total pandemic production capacity
at least 600 million
Partners' Meeting | Dubai | 25 March 20147
H7N9H7N9
� 4 grants for H7N9 development
– BUTANTAN, Inactivated � to Phase I
– SII and IEM, LAIV � to Phase I
– Bio Farma
� 2 other manufacturers working on H7N9 (IVAC, BCHT)
� Barriers:
– Reagents – a very long wait
– Ferret studies: costs, lab, availability of animals
� WHO CONDUCTING COORDINATED FERRET STUDIES
–
From Virology Down Under and Dr. Ian M Mackay
Partners' Meeting | Dubai | 25 March 20148
Meeting our targetsMeeting our targets
� A lot of progress has been made
– >300 million pandemic vaccine capacity already.
� A lot still needs to be made 2013-2016
– To bring candidates to approval, and
– To add another 300 million doses pandemic capacity
� Challenges
– Approval pathways for both seasonal and pandemic
– Sustainability
Partners' Meeting | Dubai | 25 March 20149
Animal studiesAnimal studies
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Activity A S O N D J F M A M J J A S O N D J F M A M J J A S O N D J F M A M J J A S O N D
Preclinical testing x x x x x x
Preclinical study x x x x x
Challenge in ferrets x x x x x x
Non-clinical mice study x x x x
Toxicology & ferret studies. x x x x
Preclinical immunogenicity x
Preclinical toxicology x x x x x
Repeated dose toxicity x x x x x x x x
Developmental toxicity x x x x x x x x x x
Immunogenicity study x x x x x
Single dose toxicity x x x x x
Immunogenicity x x x x x
Preclin immunogenicity (mouse) x x x
Toxicology (rat) x x x
Toxicology (mouse/rat) x x x x x x
Ferret challenge (conducted by WHO) x x x
Preclinical immunogenicity x x x
Preclinical toxicology x x x x
Immunogenicity (mice) x x x
Toxicology (rat) x x x x x x
Ferret challenge x x x x x x
Partners' Meeting | Dubai | 25 March 201410
Clinical TrialsClinical Trials
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Activity A S O N D J F M A M J J A S O N D J F M A M J J A S O N D J F M A M J J A S O N D
Phase I x x x xPhase II x x x x xPhase III x x x x x xPhase I x x x x x xPhase II x x x x xPhase III x x x x x x xPhase I x x x x x xPhase II x x x x x xPhase III x x x x x xPhase I x x x xPhase II/III x x x x x x xPhase I x x x x xPhase II x x x x x x x xPrime-Boost x x x x x xPhase I x x x x x xPhase II x x x x x x x x x x x xPhase I/II x x x x xPhase II/III x x x x xPhase I x x xPhase II/III x x x x x x x xPhase I x x x x x xPhase II/III x x x x x x xPhase I x x x x xPhase II x x x x x
Partners' Meeting | Dubai | 25 March 201411
Support to manufacturersSupport to manufacturers
� WHO technical support will continue
– Technical advice,
– Visits by TAG and consultants,
– Interactions with MoH
� In collaboration with PATH
� Particular focus on support for preclinical and clinical development:
– Study Protocol Templates being developed
– Workshop for manufacturers and NRAs the design, conduct and
regulatory review of non-clinical and clinical studies in support of
initial vaccine approval, annual strain change, process
modification, and prequalification (tentatively end June/early July)
Partners' Meeting | Dubai | 25 March 201412
Maintaining the gainsMaintaining the gains
� Sustainability of the capacity that you are establishing
needs to be addressed.
� The HHS/WHO Workshop Series has allowed the
stakeholders to comprehensively examine the different
factors and drivers involved.
� You will hear tomorrow how the knowledge that was
gained will be used to move this agenda forward.
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