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Title: The Brazilian experience: the role of national regulatory agency in technology development, production, importation and in the approval of future products


1
The Brazilian experience the role of national
regulatory agency in technology development,
production, importation and in the approval of
future products
  • Dr. Akira Homma
  • Diretor Bio-Manguinhos
  • Fundação Oswaldo Cruz
  • Ministério da Saúde
  • Brasília, DF, 4-5 Outubro 2006

2

Fonte Ministério da Saúde, SI-PNI.
3
Vacinas do Calendário Básico e Campanhas -
Aquisições do PNI - 2006
Vacinas Laboratórios Quant. TOTAL R Quantidades Quantidades Dispêndios Dispêndios
Vacinas Laboratórios Quant. TOTAL R Impor. Nac. Impor. Nac.
BCG-ID FAP 16.500.000 8.738.400,00 - 8,4 - 1,5
BCG-ID BUTANTAN 2.000.000 1.059.200,00 - 1,0 - 0,2
Febre Amarela BIO-MANGUIN 10.000.000 8.383.000,00 - 5,1 - 1,5
Poliomielite oral BIO-MANGUIN 20.000.000 34.320.000,00 - 10,2 - 6,0
Poliomielite oral GSK 27.000.000 8.127.000,00 13,7   1,4  
Poliomielite oral Sanofi Pasteur 9.000.000 2.902.500,00 4,6   0,5  
Poliomielite oral Chiron 9.000.000 2.709.000,00 4,6   0,5  
DTP BUTANTAN 13.200.000 4.620.000,00 - 6,7 - 0,8
Hepatite B BUTANTAN 11.000.000 15.876.000,00 - 5,6 - 2,8
Hepatite B LG 3.000.000 1.244.850,00 1,5   0,2  
Hepatite B Herber Biotec 1.000.000 473.000,00 0,5   0,1  
Tríplice Viral SCR BIO-MANGUIN 20.000.000 120.000.000,00 - 10,2 - 20,9
Dupla Adulto dT BUTANTAN 15.000.000 4.536.000,00 - 7,6 - 0,8
Tetra DTPHib BIO-MANGUIN BUTANTAN 12.000.000 109.784.400,00 - 6,1 - 19,1
Influenza BUTANTAN 19.000.000 120.460.000,00 - 9,7 - 21,0
Rotavírus oral GSK 8.670.000 130.483.500,00 4,4   22,7  
Total   196.370.000 573.716.850,00 29,4 70,6 25,4 74,6
Fonte MS / SVS Fonte MS / SVS Fonte MS / SVS Fonte MS / SVS
Domínio de todas tecnologias de produção de
vacinas do calendário básico de imunização
exceto rotavirus
4
REGULATION OF VACCINES IN PRODUCTION NEW
VACCINES - HIV
  • IN PRODUCTION - BRAZILIAN REGULATION (RDC 210
    315) INTERNATIONAL
  • PRODUCTION PROCEDURES
  • RAW MATERIAL
  • INTERMEDIATE PRODUCTS - PURITY
  • FINAL PRODUCT
  • EFFICACY POTENCY
  • CONSISTENCY OF PRODUCTION
  • STABILITY, THERMAL-STABILITY
  • PERSONNEL
  • OPERATION VALIDATION
  • PRODUCT VALIDATION
  • - PRE-CLINICAL STUDIES
  • - CLINICAL TRIALS PHASE 1, 2 AND 3
  • - POS-MARKETING

Facilities Equipments
BIOSAFETY ENVIRONMENT
  • ANTI- HIV/aids vaccines Prophylatic and
    Therapeutic - New and complex, requires new
    regulatory approach with early participation of
    regulatory authority

5
STEPS FOR VACCINE DEVELOPMENT
gt 10-20 years
Experimental Lots clinical studies - GMP - 4 -
Phase II - 6 -
Clinical Studies Phase I - 5 -
Fase III - 7 -
Discovery - 1 -
Pre-Clinical - 3 -
License - 8 -
Producion - 9 -

Characteristics multiples steps multiple
specialized teams each step, specific
requirement long period not linear --- need
strong coordination Early participation of
Regulatory Authority is essential !!!
Phase IV - 10 -

6
The scientific strategic plan of the Enterprise
identifies six key challenges to the development
of an effective AIDS vaccine, and proposes the
formation of consortia or centers to further
accelerate vaccine research. Adapted with
permission from a figure created by the Bill
Melinda Gates Foundation
7
DIVERSITY OF TECHNOLOGICAL APPROACH
8
Potential advantages and disadvantages of major
HIV vaccine design strategies.
9
Declan Butler - Nature 442, 610-611(10 August
2006)
HIV poses a formidable challenge for vaccine
developers it mutates rapidly, attacks immune
cells that might destroy it, An effective
vaccine will be two-pronged generating
antibodies, stimulate immune cells. Gates
Funding 11 consortia selected. five will seek
ways of generating effective antibodies when the
immune system is exposed to HIV. a consortium
led by Robin Weiss of University College London,
(25.3-million), will screen antibodies from
humans and animals that seem naturally active
against HIV, and then work backwards to see which
regions they target and design new vaccine
candidates. a consortium led by Leo Stamatatos
at Seattle Biomedical Research Institute
(19.4-million ) will use computers to design
molecules that might trigger antibodies against
the virus. six consortia will focus on
stimulating a cellular response. Timothy Zamb of
the International AIDS Vaccine Initiative (23.7
million) to try to modify other viruses to act as
vectors for the vaccine. Giuseppe Pantaleo at
the Centre Hospitalier Universitaire Vaudois in
Lausanne, Switzerland, (15.3-million ) hopes to
improve the ability of poxvirus, a known vaccine
vector, to trigger a response to HIV.



10
Lancet 2006 368 51121 Mother-to-child
transmission (MTCT) of HIV-1 is the major mode of
paediatric infection. The rapidly increasing
incidence of MTCT worldwide has resulted in an
urgent need for preventive strategies.
Antiretroviral regimens can prevent intrapartum
HIV transmission however, these regimens do not
prevent HIV transmission through breastfeeding.
Furthermore, children who escape MTCT are again
at risk of infection when they become sexually
active as adolescents. An infant vaccine
regimen, begun at birth, would hence be a more
attractive strategy and might also provide the
basis for lifetime protection. Unique features
of MTCT and paediatric HIV disease could be
helpful in understanding correlates of immune
protection and could facilitate rapid assessment
of vaccine e. cacy. Thus, there is compelling
rationale to develop safe, e. ective HIV vaccines
for use in infants and children.
11
ANTI-HIV UNDER DEVELOPMENTJULY 2006
  • CANARYPOX VECTOR
  • -ALVAC vCP 1452 (Sanofi Pasteur)
  • DNA PLASMIDIAL
  • -Clade C Gag-Env plasmids (Chiron)
  • -EP HIV-1090 (Epimmune)
  • -pGA2/JS2 DNA (Emory)
  • -VRC-HIVDNA-009 (NIH VRC)
  • -WLV003 (Wyeth)
  • -Gag and Env DNA/PLG microparticles (Chiron)

12
ANTI-HIV UNDER DEVELOPMENT JULY 2006
  • FOWLPOX VECTOR
  • -TBC-F357TBC-F349(Therion Biologics)
  • LIPOPEPTIDE
  • -LIPO-5 (Sanofi Pasteur/ ANRS)
  • MAV (Ankara)
  • -MVA pGA/JS2 (NIAID-LVD)
  • -TBC-M358 TBC-M335 (Therion Biologics)
  • ADENOVIRUS VECTOR NO REPLICABLE
  • -MRKAd5 HIV-1 Gag (Merck)
  • -VRC-HIVADV-010 (NIH VRC)
  • PEPTIDE
  • -Multi-epitope CTL peptide vaccine
    (Wyeth)

13
ANTI-HIV UNDER DEVELOPMENTJULY 2006
  • PROTEIN
  • -AIDSVAX B/B (VaxGen)
  • -Clade C Env subunit (Chiron)
  • -gp120 MN (VaxGen)
  • -AIDSVAX B/B (VaxGen)
  • -gp140 SF-162 -- oligomeric, V2-deleted
    (Chiron)
  • -gp120W61D (GlaxoSmithKline)
  • -NefTat (GlaxoSmithKline)
  • YEAST VECTOR
  • -HIVAX-GS (GlobeImmune)

14

15
CHALLENGES ANVISA FACING NEW VACCINES HIV
  • Variety of technologies used for anti HIV/aids
    vaccines
  • The establishment of ANVISA is relatively new -
    gaining experience
  • BIOLOGICAL AND IMMUNOLOGICAL COMPLEXITY OF
    HIV/aids
  • Each country has to establish their own
    regulations
  • RELATIVE SMALL NUMBER OF RESERCHERS INVOLVED IN
    HIV/aids

16
CHALLENGES ANVISA FACING NEW HIV VACCINES
  • For live attenuated virus vaccine there are
    general requirements established
  • For DNA vaccines there is FDAs guidance
  • For subunits and recombinant vaccines there are
    requirements established
  • For viral and bacterial vector vaccines there is
    no requirement established
  • Lack of information on technology aspects from
    developer laboratories.

17
SIX-SYSTEM INSPECTION MODEL
FDA Pharmaceutical CGMPs Sept. 2006
18
PROPOSAL FOR TECHNOLOGICAL DEVELOPMENT
STRENGTHENING
  • POLICY, LEGAL, ETHICAL
  • OPERATIONAL Organization of Technical Advisory
    Committee with participation of Anvisa, MoH,
    MCT, MRE, MF, RD institutions with following
    functions
  • Identification and selection of the most
    promising technological approach for development
    in Brazil
  • Identification of anchor institutions that must
    take part in RD of anti-HIV/aids vaccines.
  • Set out specific projects, with defined tasks and
    schedules, with participation of the
    correspondent authority, to follow, monitor,
    evaluate the steps up to production process.

19
PROPOSAL FOR TECHNOLOGICAL DEVELOPMENT
STRENGHTHENING
  • Establishment of technical cooperation among
    countries and companies that work with HIV/aids
    vaccine development
  • Establish specific technical projects dealing
    with improvement of regulatory issues involved
  • Networking/consortium should be organized in
    order to address different aspects of
    development
  • Globalization must contribute to facilitate the
    RD.

20
PROPOSAL TO STRENGTHEN TECHNOLOGICAL DEVELOPMENT
  • A strong coordination and project management
    procedures with definition of specific targets
    and timetable for each institution
  • Strengthen the administrative (professional)
    management
  • Integration of related RD activities Research
    institutiontechnological development
    regulatory authority Ministry of
    Finance/Science Technology/External Relations

21
  • THANK YOU FOR YOUR ATTENTION !!!
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