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Vinculaciones formales y efectivas con sectores clave para la Farmacia-
Industria
México, D.F. noviembre, 2017
VI Reunión de la Triple Hélice en
Farmacia
Jorge Paniagua PhD
Consultor Senior
Suiza
AMEFFAR
Disclosure
Consultor Senior
Laboratorios Silanes /
Instituto Bioclon
Jorge Paniagua PhD
Cómo desarrollar (1) y fabricar (2)
un antiveneno (3)
para tratar intoxicaciones (4)?
Índice
Cómo desarrollar (1) y fabricar (2)
un antiveneno (3)
para tratar intoxicaciones (4)?
Índice
A través de vinculaciones
efectivas
Diseño de un
antiveneno
• Soporte científico sólido.
• Epidemiological information
• Biological information
• Venom research
• Reactivity profile
• Venoms suppliers
• Immunization schedule
• Antibodies production
• Recognition profile
• Preclinical work
• Scale up production
• Regulatory strategy
Desarrollo
• Strong scientific support.
• Información Epidemiológica
• Biological information
• Venom research
• Reactivity profile
• Venoms suppliers
• Immunization schedule
• Antibodies production
• Recognition profile
• Preclinical work
• Scale up production
• Regulatory strategy
Desarrollo
Diseño de un
antiveneno
Sector salud y sector académico
Antivenom
design
• Strong scientific support.
• Epidemiological information
• Biología de las especies
• Venom research
• Reactivity profile
• Venoms suppliers
• Immunization schedule
• Antibodies production
• Recognition profile
• Preclinical work
• Scale up production
• Regulatory strategy
Desarrollo
Sector salud y sector académico
Antivenom
design
• Strong scientific support.
• Epidemiological information
• Biological information
• Componentes del veneno
• Reactivity profile
• Venoms suppliers
• Immunization schedule
• Antibodies production
• Recognition profile
• Preclinical work
• Scale up production
• Regulatory strategy
Desarrollo
Sector salud y sector académico
Antivenom
design
• Strong scientific support.
• Epidemiological information
• Biological information
• Venom research
• Perfil de reactividad
• Venoms suppliers
• Immunization schedule
• Antibodies production
• Recognition profile
• Preclinical work
• Scale up production
• Regulatory strategy
Desarrollo
Sector salud y sector académico
Diseño de un
antiveneno
• Strong scientific support.
• Epidemiological information
• Biological information
• Venom research
• Reactivity profile
• Proveedores de venenos
• Immunization schedule
• Antibodies production
• Recognition profile
• Preclinical work
• Scale up production
• Regulatory strategy
Desarrollo
Industria-Industria
Diseño de un
antiveneno
• Strong scientific support.
• Epidemiological information
• Biological information
• Venom research
• Reactivity profile
• Venoms suppliers
• Esquema de inmunización
• Producción de anticuerpos
• Recognition profile
• Preclinical work
• Scale up production
• Regulatory strategy
Desarrollo
Antivenom
design
• Strong scientific support.
• Epidemiological information
• Biological information
• Venom research
• Reactivity profile
• Venoms suppliers
• Immunization schedule
• Antibodies production
• Recognition profile
• Ensayos no-clínicos
• Scale up production
• Regulatory strategy
Desarrollo
Sector académico y/o CRO
Antivenom
design
• Strong scientific support.
• Epidemiological information
• Biological information
• Venom research
• Reactivity profile
• Venoms suppliers
• Immunization schedule
• Antibodies production
• Perfil de reconocimiento
• Preclinical work
• Scale up production
• Regulatory strategy
Desarrollo
Sector académico y/o CRO
Diseño de un
antiveneno
• Strong scientific support.
• Epidemiological information
• Biological information
• Venom research
• Reactivity profile
• Venoms suppliers
• Immunization schedule
• Antibodies production
• Recognition profile
• Preclinical work
• Scale up production
• Estrategia regulatoria
Desarrollo
Estrategia regulatoria
http://www.fda.gov/cder/handbook/develop.htm
Facility Inspection
Industria-Autoridad regulatoria
CTD
http://www.ich.org/products/ctd.html
Industria-Autoridad regulatoria
• Validación de procesos
• Planta de fabricación
• Good manufacturing practices (GMP).
• Reducción de cargaviral
• Validación de métodos analíticos
• Desarrollo de metodología analítica específica (niveles de veneno-antiveneno).
• Transferencia de tecnología y metodología analítica.
Manufactura
Sector servicios
• Process validation
• Manufacturing facility
• Good manufacturing practices (GMP).
• Registration process harmonisation.
• Safety issues: Viral reduction
• Analytical methods validation
• Analytical tools to detect venom-antivenom quantities in biological samples.
• Technology and analytical transfer from R&D to production
Manufactura
Producto
Time line
20
Phisalix, Bertrand
& Calmette
Immunization of horses
with venom of European
snakes and Asian cobras
1st Antivenom Generation 2nd Antivenom Generation
1894
1899
1905
1927
1938
USA
McFarland
1980
Brazil
Vital Brasil
Mexico
Venzor
MYN
LaboratoryZapata
mergeMYN
Behring & Kitasato
“Curative antibodies”
against diphteria1890
1900
Edelman
Sequence of
human antibody
Kohler & Milstein
Monoclonal
antibodies
1970
1975
1986 Jones
CDR Grafted
1990
1990
Smith &
McCafferty
Phage display
PR
OD
UC
TR
&D
Institu
Time lineP
RO
DU
CT
3rd Antivenom Generation1990
Instituto Bioclon®
ZamudioBCF2
NOM-SSA
“Fabotherapy”1994
1992
Alacramyn®
Aracmyn®
Antivipmyn®
MX Patent
230257
F(ab’)2 Antivenoms
FDA ORPHAN DRUGS
2000
2001
2003
2002
2004 USPTO 6,709,655
F(ab’)2 Antivenoms
Riaño, Posanni
& Becerril
Recombinat
human antibodies
Olvera & Alagón
Loxosceles
recombinant toxins
1986 Jones
CDR Grafted
1990
Smith &
McCafferty
Phage display
2005
2006
2008
R&
D
Olvera & Alagón
Loxosceles
recombinant toxins
Time line3rd Antivenom Generation
2009
FDA Inspection new
facility (Toluca)
2011
2008 USPTO 7,381,802
scFv Human Antibody
USPTO 7,485,303
Anascorp®
PR
OD
UC
TR
&D
New Antivenom Generation
Riaño, Posanni
& Becerril
Venom neutralization scFv
Rodríguez, Posanni,
Becerril & Riaño
Diabody
Riaño, Posanni
& Becerril
Human recombinant scFv
Marketing approvalSSA-MX
Reclusmyn®
First Antivenom
approved by
FDA
Anascorp®
USPTO 8,750,893
Anavip®2013 USPTO 8,512,706
Analatro®
USPTO 8,541,551
Reclusmyn®
2014
2015 Expected approval
Anavip®
2011
2012
2013
Picadura de alacrán en México
Scorpion sting mortality in Mexico
1979 -2003
Sector Salud
Conclusiones
• Las intoxicaciones por animales ponzoñosos
son un problema mundial: OMS*.
• Availabilitsy of the product.
• Physicochemical formulation.
• Safety and efficacy products
• Regulatory harmonisation.
• WHO suppliers prequalification.
• Venom standards
* Snakebite as a Neglected Tropical Diseases (WHO, 2017).
http://minutestodie.com/about-the-film/
Organismos Internacionales
Conclusiones
• Vinculaciones formales y efectivas con:
– Sector académico.
– Industria.
– Sector servicios.
– CRO.
– Sector Salud.
– Autoridades regulatorias.
– Organismos internacionales OPS/OMS.