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Desenvolvimento Pré-Clínico e Inovação 
João B. Calixto 
Centro de Inovação e Ensaios Pré- Clínicos (CIEnP) 
São Paulo, 18 de Agosto de 2014
Inovação tecnológica: 
"introdução de novidade no ambiente produtivo, seja ela produto ou processo, que traga melhoria significativa ou crie algo novo".
A inovação é o nosso lema. O único problema é que não a praticamos. Anônimo
ALGUMAS CARATERÍSTICAS IMPORTANTES DOS PAÍSES INOVADORES. 
Confiança nas instituições e nas pessoas. 
Cooperação com reciprocidade baseada em meritocracia. 
Mercados regulados e controlados com transparência (The role of law). Baixos níveis de corrupção. 
Respeito ao direito a propriedade e patentes. Pirataria é crime. 
Ética no trabalho e esforço pessoal. Promoção por mérito. 
Estímulo ao trabalho em equipe. 
Lideranças pragmáticas (pouca ideologia). 
Competição livre. Experimentar sempre e aprender com os próprios erros. 
Inovação nasce em função do ambiente existente. 
Países NÂOinovadores, apostam no curto prazo, tendem a se apegarem ao certo, evitam o risco e odeiam o incerto.
Avanços Recentes Nas Áreas de C,T&I No Brasil 
•12.000 Doutores e 41.000 Mestres em 2010 
•37.895 artigos publicados em revistas indexadas ISI em 2013 
•~ 2,7% da produção científica mundial 
•13 lugar no ranking mundial de publicações científicas 
•Maior produtor de grãos do mundo: papel da EMBRAPA 
•Domínio de exploração de petróleo de águas profundas: Petrobrás 
•Produção de aviões: EMBRAER 
•Sétima economia mundial 
•~1% das exportações mundiais baseada em commodities
NÚMERO DE CURSOS DE PÓS-GRADUAÇÃO NO BRASIL 
Ano 
Nível 
Doutorado 
Mestrado Profissional 
Mestrado 
Total geral 
1976 
181 
0 
518 
699 
1980 
260 
0 
680 
940 
1985 
332 
0 
784 
1.116 
1990 
469 
0 
993 
1.462 
1992 
537 
0 
1.083 
1.620 
1995 
682 
0 
1.289 
1.971 
2000 
903 
98 
1.620 
2.621 
2005 
1.099 
202 
1.923 
3.224 
2010 
1.602 
334 
2.706 
4.642 
2011 
1.738 
417 
2.925 
5.080 
Fonte: CAPES, dados atualizados em 08/05/2012.
Trabalhos Publicados Por Cientistas Brasileiros em Revistas Indexadas 
1.923 
2.329 
2.521 
3.597 
4.461 
5.482 
7.550 
10.839 
12.773 
16.950 
18.743 
18.998 
27.482 
29.125 
31.444 
33.783 
36722 
37895 
0 
5.000 
10.000 
15.000 
20.000 
25.000 
30.000 
35.000 
40.000 
1981 
1984 
1986 
1990 
1993 
1995 
1997 
2000 
2002 
2005 
2006 
2007 
2008 
2009 
2010 
2011 
2012 
2013 
Fonte: Web ofScience.
Patentes no USPTO 
Ano 
2010 
2009 
2008 
2007 
2006 
Brasil 
111 
71 
63 
61 
77 
Rússia 
82 
52 
45 
41 
39 
Rússia/Brasil 
0,74 
0,73 
0,71 
0,67 
0,5 
Índia 
363 
254 
267 
266 
257 
Índia/Brasil 
3,2 
3,58 
4,23 
4,36 
3,33 
China 
2.351 
1.415 
1.170 
800 
506 
China/Brasil 
21,18 
19,93 
18,57 
13,11 
6,57
Fonte: Folha de S. Paulo, 20/04/2014.
Importação de Fármacos 
Em US$ milhões 
Fonte: FarmaBrasil com base em dados da Funcex 
Importação de Medicamentos 
Em US$ milhões
Close Window 
•Using Images 
•Image Index 
Paul Erlich(1854-1915) 
“Corpora Non Agunt Nisi Fixate’” 
“A Substance will not work unless it is bound”or 
“A drug is efficacious only so long as it is bound to, and modulating the action of, its physiological target” 
Source: Lancet 182: 445-451, 1913 
1906, composto 606, Arsfenamina (Salvarsan).
Desenvolvimento de Novo Medicamento 
•Praticamente todas os novos medicamentos (novas entidades químicas), originaram de pesquisa básica inovadoras na academia e nos institutos de pesquisas. 
•O custo de desenvolvimento médio (incluindo todos os riscos) de um medicamento inovador (NCE), pode ultrapassar 1 bilhão de dólares. Ignorando as falhas, esse custo ficaria em torno de 200-300 milhões de dólares. 
•Isso significa que a taxa de sucesso para o desenvolvimento de um novo medicamento (NCE) está em torno de 0.6%, e de 6% para um medicamento cujo alvo já conhecido. 
•Doenças importantes como: câncer, psicoses, depressão, ansiedade, hipertensão, diabetes, dislipidemias, osteoporose, artrite, infecções, transplantes etc, são atualmente tratadas com sucesso, graça a essas descobertas.
Industry-funded academic inventions boost innovation 
BrianD.Wrightandcolleaguespresentdatachallengingtheassumptionthatcorporate- fundedacademicresearchislessaccessibleandusefultoothers. 
•Individualuniversitiesmaytrackpatentsandlicense'sattheirwoninstitutions,butthesedatasetsaregenerallysmallandconfidential; 
•Corporate-sponsoredresearchisvaluableforfurtherinnovation; 
•DatafromUniversityofCalifornia(15years)showthatcorporate-sponsoredinventionsarelicensedandcitedmoreoftenthanfederallysponsoredones(12.8versus5.6); 
•OfalldatainventiongeneratedattheuniversityofCalifornia,20%arelinkedtoatleastonelicense,andnear25%werepatented; 
•Corporate-sponsoredinventionsresultedinlicenses(29%)andpatents(35%)morefrequentlythanfederalsponsoredones(22%and26%,respectively); 
•Althoughacademicsmayactconservativelytogainacceptanceofpeers,papersandgrantproposals,he(she)writes,industrypartnershipdrawhigh-statusacademicsawayfromconfirmingestablishedtheoriesandtowardsspeculation. 
Nature,2014.
What testing is needed? 
•Usepreclinicaldatatoincreasetheoverallstrategicsuccessin 
–Pickingtherightcompound 
–Pickingtherightformulation 
–Pickingtherightdeliverymethod 
•Avoidcompoundslikelytocauseproblemsinclinicaltrials. 
•Useparalleloptimization:IntegrationofanalysisofbindingqualitiesandADME/Toxproperties. 
20
Good Lead Candidate for Drug Development 
•Adequate bioactivity; 
•Appropriate physical-chemical property to enable formulation development; 
•The ability to cross crucial membranes; 
•Reasonable metabolite stability; 
•Appropriate safety and efficacy (pre-clinical studies); 
•Efficacy in human (clinical studies).
Preclinical Study Design (Toxicology) 
•Essential for safety/start dose decision. 
•Toxicology studies should mimic the schedule, duration, formulation, and route as that proposed for the clinical trial. 
•Conform to standard toxicology protocols. 
•Conduct according to GLP.
Preclinical StudiesAcute Toxicity 
•Objective:To determine the Maximum Tolerated Dose (MTD) and No Observable Effect Level (NOEL) 
•Duration:Typically 14 days after single dose 
•Animals Required:2 species (rodent and non- rodent) 
•Parameters: 
•MortalityClinical pathologyGross necropsy 
Weight changeClinical observations 
•Points to consider: 
•Dose selection for repeat dose studies 
•Choice of the appropriated animal species
Preclinical StudiesSub Acute Toxicity 
•Objective:To determine toxicity after repeated administration of the test material 
•Duration:14 –28 days 
•Animals Required:2 species (rodent and non-rodent) 
•Parameters: 
•MortalityClinical pathologyUrinalysis 
HistologyWeight changeClinical observation 
•Points to consider: 
•Dosing regimen –similar to clinical use 
•Recovery period when indicated 
•Drug Toxicokinetics(TK) 
•Immunotoxicityin case biological products
Absorption, Distribution, Metabolism and Elimination (ADME) 
Advantages performing ADME testing early in the process, before a molecule gets into development: 
•Improvement of Pharmacokinetic (PK) properties. 
•Saves time and costs associated with progressing an unsuitable drug candidate through the pipeline. 
The ADME properties that are routinely measured are: 
•Solubility 
•Permeability 
•Plasma protein binding 
•Movement across transporters 
•Metabolism by liver enzymes
Local Tolerance 
•Dermal (skin) Irritation/Sensitization 
•Eye Irritation 
•Phototoxicity 
–The potential for sunlight (or other light frequencies) to transform a drug or a metabolite is: 
–a useful tool for activating some drugs and 
–A cause for a significant adverse effects for others (Quinolone antibiotics).
Genotoxicity 
•Minimum of 2 in vitro Assays: 
–Bacterial mutation Assay 
–Ames test (point mutations) 
–Chromosomal Aberration 
•Mammalian cells in vitro or in vivo 
•Dominant Lethal Tests in Rodents 
OR 
–Mouse Lymphoma Assay 
•If either of them positive or for Phase II 
–Micronucleus Assay (In vivo Assay). 
–Others Assays: Unscheduled DNA Synthesis 
•Not needed for Biologics
Carcinogenicity 
•Objective:To evaluate the potential tumorigenic effect in animals and risk to humans for continuous use of drug candidate in humans for 6 months or more. 
•Duration:12 to 24 months 
•Species:Mouse or Rat 
•Parameters: 
•Tumor developmentClinical pathology 
•Clinical observations and assessment 
•Points to consider: 
•Pharmacology, Pharmacokinetic or Toxicology (mechanistic in vitroand in vivo) data, 
•Structure-activity relationships, 
•Compound accumulation over long-term use,
Pharmacological Assessment of the Underlying Mechanism of Action 
•Molecular Level 
–Receptor binding, enzyme activity, molecular studies etc, 
–Cellular/Tissue Level 
–Cell function (tissue culture), isolated tissues. 
•Organ/System Level 
–Identify primary and secondary targets.
Safety Pharmacology 
•Objective:To investigate undesirable pharmacological effects of the test material; 
•Duration:Usually single dose; 
•Animals Required:2 species (rodent and non-rodent); 
•Core battery:Cardiovascular, Respiratory, CNS, Renal, Blood, Immunological etc.; 
•Telemetry ;
Preclinical Support for Phase I Clinical Trials 
•Acute/Sub-acute some time chronic Toxicity Studies; 
•Genotoxicity; 
•Pharmacokinetic/TK; 
•Studies about the mechanism of action of the compound; 
•Safety pharmacology (CNS; CV; Respiratory, Renal etc); 
•Local tolerance;
ToxicologyStudyDuractions 
Durations needded to support Phase I, II and III trials 
DuractionofClinical 
Trial 
MinimumDurationofRepeat 
Dose ToxicityStudies 
RodentsNon-Rodents 
Single dose 
2-4 Weeks 
2 Weeks 
Up to2 Weeks 
2-4 Weeks 
2 Weeks 
Up to1 Month 
1 Month 
1 Month 
Up to3 Months 
3 Months 
3 Months 
Up to6 Months 
6 Months 
6 Months 
> 6 Months 
6 Months 
9 Months 
Source: charles River
CENTRE OF INNOVATION AND 
PRE-CLINICAL STUDIES
Funding:Ministry of Health, Ministry of Science and Technology, FINEP and State Government of Santa Catarina 
Support: UFSC –Federal University of Santa Catarinaand CERTI Foundation 
Buildings: Scheduled for completion of infrastructure in December of 2012 
Executive and Scientific Director:Dr. João B. Calixto 
Built area:5.300 m2 
TheCenterInnovationandpre-clinicalstudiesistheresultofBraziliangovernmentinitiativefordevelopingpreclinicalstudiesindifferentareasofknowledgetomeetthedemandofpharmaceuticalindustries.
Infrastructure 
MainBuilding 
5.300m2ofconstructedarea,dividedinto: 
•Basement:parkingandsupportarea 
•Rodentfacility:600m2forthecreation/maintenanceofrodentsstandardSPFwithinternationalcertification 
•ResearchLabs:About20laboratorieswithhighlevelequipmenttoperformpreclinicalresearch 
•OfficeandAdministration 
•Auditorium:tohostsmallerevents~120people 
•Businessincubator:1,000m2fordevelopmentofnewideasandcompanies 
•Staffofabout60-80people,including15-20PhDs 
Non-rodentanimalfacility 
Secondarybuildingwithabout2,000m2onlyformaintenanceofnonrodentanimals(nonhumanprimates,dogs,rabbit,guineapig,pigsamongothers).
Objetives 
-Conductpreclinicalstudies:pharmacodynamics,safetypharmacology,pharmacokineticsandtoxicology(rodentsandnon-rodents),actinginaccordancewiththeguidelinesofgoodlaboratorypractices; 
-Supporttheresearch,developmentandinnovationtothepharmaceuticalcompanies,supportingdrugdevelopment; 
-Integratethenationalnetworkofdrugdevelopment, cooperatingwithcompanies,institutionsandtechnologicalmechanisms/agentstopromoteinnovation; 
-ContributetotheestablishmentofnationalcompetenceandthegenerationofpatentsinBrazilandabroad.
Location
Drug Discovery 
Desenvolvimento Pré-clínico 
Clínico 
Cadeia do desenvolvimento de medicamentos: atuação do CIEnP 
LNBio 
LassBio 
FIOCRUZ 
NPDM 
Universidades 
LAFEX 
Inst. Royal 
BioAgri 
Ciallyx 
Universidades 
Rede de pesquisa 
NPDM 
Universidades 
Nacionais 
Internacionais 
Nacionais 
Internacionais 
CIEnP 
Drug Discovery 
Clínica 
AGENCIAS DE FOMENTO 
GOVERNO/ EMPRESAS 
EMPRESAS 
FUNDOS DE INVESTIMENTOS 
Parcerias Estratégicas 
Parcerias Estratégicas 
Inc. Empresas 
Escalonamento 
Inc. Empresas 
CIEnP 
Inovação Radical 
Inovação Incremental 
Centro de Inovação em Medicamentos
Oportunidades em P&D 
Formação RH 
Indústria 
Patentes 
Publicações 
OPORTUNIDADES
“Se você não erra, provavelmentenão está trabalhando em problemas suficientemente desafiadores. E isto sim é um grande erro” Frank Wilczek, Prêmio Nobel de Física (1951-).
A Ignorância Gera Confiança Com Mais Frequência Que o Conhecimento. Albert Einstein (1879-1955)
www.cienp.org.br 
Contato: joão.calixto@cienp.org.br
FinanciamentoeApoio 
Centro de Inovação e Ensaios Pré-clínicos

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37º Congresso Brasileiro de Medicina Farmacêutica | Dr. João Batista Calixto

  • 1. Desenvolvimento Pré-Clínico e Inovação João B. Calixto Centro de Inovação e Ensaios Pré- Clínicos (CIEnP) São Paulo, 18 de Agosto de 2014
  • 2. Inovação tecnológica: "introdução de novidade no ambiente produtivo, seja ela produto ou processo, que traga melhoria significativa ou crie algo novo".
  • 3. A inovação é o nosso lema. O único problema é que não a praticamos. Anônimo
  • 4. ALGUMAS CARATERÍSTICAS IMPORTANTES DOS PAÍSES INOVADORES. Confiança nas instituições e nas pessoas. Cooperação com reciprocidade baseada em meritocracia. Mercados regulados e controlados com transparência (The role of law). Baixos níveis de corrupção. Respeito ao direito a propriedade e patentes. Pirataria é crime. Ética no trabalho e esforço pessoal. Promoção por mérito. Estímulo ao trabalho em equipe. Lideranças pragmáticas (pouca ideologia). Competição livre. Experimentar sempre e aprender com os próprios erros. Inovação nasce em função do ambiente existente. Países NÂOinovadores, apostam no curto prazo, tendem a se apegarem ao certo, evitam o risco e odeiam o incerto.
  • 5. Avanços Recentes Nas Áreas de C,T&I No Brasil •12.000 Doutores e 41.000 Mestres em 2010 •37.895 artigos publicados em revistas indexadas ISI em 2013 •~ 2,7% da produção científica mundial •13 lugar no ranking mundial de publicações científicas •Maior produtor de grãos do mundo: papel da EMBRAPA •Domínio de exploração de petróleo de águas profundas: Petrobrás •Produção de aviões: EMBRAER •Sétima economia mundial •~1% das exportações mundiais baseada em commodities
  • 6. NÚMERO DE CURSOS DE PÓS-GRADUAÇÃO NO BRASIL Ano Nível Doutorado Mestrado Profissional Mestrado Total geral 1976 181 0 518 699 1980 260 0 680 940 1985 332 0 784 1.116 1990 469 0 993 1.462 1992 537 0 1.083 1.620 1995 682 0 1.289 1.971 2000 903 98 1.620 2.621 2005 1.099 202 1.923 3.224 2010 1.602 334 2.706 4.642 2011 1.738 417 2.925 5.080 Fonte: CAPES, dados atualizados em 08/05/2012.
  • 7. Trabalhos Publicados Por Cientistas Brasileiros em Revistas Indexadas 1.923 2.329 2.521 3.597 4.461 5.482 7.550 10.839 12.773 16.950 18.743 18.998 27.482 29.125 31.444 33.783 36722 37895 0 5.000 10.000 15.000 20.000 25.000 30.000 35.000 40.000 1981 1984 1986 1990 1993 1995 1997 2000 2002 2005 2006 2007 2008 2009 2010 2011 2012 2013 Fonte: Web ofScience.
  • 8.
  • 9. Patentes no USPTO Ano 2010 2009 2008 2007 2006 Brasil 111 71 63 61 77 Rússia 82 52 45 41 39 Rússia/Brasil 0,74 0,73 0,71 0,67 0,5 Índia 363 254 267 266 257 Índia/Brasil 3,2 3,58 4,23 4,36 3,33 China 2.351 1.415 1.170 800 506 China/Brasil 21,18 19,93 18,57 13,11 6,57
  • 10. Fonte: Folha de S. Paulo, 20/04/2014.
  • 11. Importação de Fármacos Em US$ milhões Fonte: FarmaBrasil com base em dados da Funcex Importação de Medicamentos Em US$ milhões
  • 12. Close Window •Using Images •Image Index Paul Erlich(1854-1915) “Corpora Non Agunt Nisi Fixate’” “A Substance will not work unless it is bound”or “A drug is efficacious only so long as it is bound to, and modulating the action of, its physiological target” Source: Lancet 182: 445-451, 1913 1906, composto 606, Arsfenamina (Salvarsan).
  • 13. Desenvolvimento de Novo Medicamento •Praticamente todas os novos medicamentos (novas entidades químicas), originaram de pesquisa básica inovadoras na academia e nos institutos de pesquisas. •O custo de desenvolvimento médio (incluindo todos os riscos) de um medicamento inovador (NCE), pode ultrapassar 1 bilhão de dólares. Ignorando as falhas, esse custo ficaria em torno de 200-300 milhões de dólares. •Isso significa que a taxa de sucesso para o desenvolvimento de um novo medicamento (NCE) está em torno de 0.6%, e de 6% para um medicamento cujo alvo já conhecido. •Doenças importantes como: câncer, psicoses, depressão, ansiedade, hipertensão, diabetes, dislipidemias, osteoporose, artrite, infecções, transplantes etc, são atualmente tratadas com sucesso, graça a essas descobertas.
  • 14.
  • 15. Industry-funded academic inventions boost innovation BrianD.Wrightandcolleaguespresentdatachallengingtheassumptionthatcorporate- fundedacademicresearchislessaccessibleandusefultoothers. •Individualuniversitiesmaytrackpatentsandlicense'sattheirwoninstitutions,butthesedatasetsaregenerallysmallandconfidential; •Corporate-sponsoredresearchisvaluableforfurtherinnovation; •DatafromUniversityofCalifornia(15years)showthatcorporate-sponsoredinventionsarelicensedandcitedmoreoftenthanfederallysponsoredones(12.8versus5.6); •OfalldatainventiongeneratedattheuniversityofCalifornia,20%arelinkedtoatleastonelicense,andnear25%werepatented; •Corporate-sponsoredinventionsresultedinlicenses(29%)andpatents(35%)morefrequentlythanfederalsponsoredones(22%and26%,respectively); •Althoughacademicsmayactconservativelytogainacceptanceofpeers,papersandgrantproposals,he(she)writes,industrypartnershipdrawhigh-statusacademicsawayfromconfirmingestablishedtheoriesandtowardsspeculation. Nature,2014.
  • 16.
  • 17.
  • 18. What testing is needed? •Usepreclinicaldatatoincreasetheoverallstrategicsuccessin –Pickingtherightcompound –Pickingtherightformulation –Pickingtherightdeliverymethod •Avoidcompoundslikelytocauseproblemsinclinicaltrials. •Useparalleloptimization:IntegrationofanalysisofbindingqualitiesandADME/Toxproperties. 20
  • 19. Good Lead Candidate for Drug Development •Adequate bioactivity; •Appropriate physical-chemical property to enable formulation development; •The ability to cross crucial membranes; •Reasonable metabolite stability; •Appropriate safety and efficacy (pre-clinical studies); •Efficacy in human (clinical studies).
  • 20. Preclinical Study Design (Toxicology) •Essential for safety/start dose decision. •Toxicology studies should mimic the schedule, duration, formulation, and route as that proposed for the clinical trial. •Conform to standard toxicology protocols. •Conduct according to GLP.
  • 21. Preclinical StudiesAcute Toxicity •Objective:To determine the Maximum Tolerated Dose (MTD) and No Observable Effect Level (NOEL) •Duration:Typically 14 days after single dose •Animals Required:2 species (rodent and non- rodent) •Parameters: •MortalityClinical pathologyGross necropsy Weight changeClinical observations •Points to consider: •Dose selection for repeat dose studies •Choice of the appropriated animal species
  • 22. Preclinical StudiesSub Acute Toxicity •Objective:To determine toxicity after repeated administration of the test material •Duration:14 –28 days •Animals Required:2 species (rodent and non-rodent) •Parameters: •MortalityClinical pathologyUrinalysis HistologyWeight changeClinical observation •Points to consider: •Dosing regimen –similar to clinical use •Recovery period when indicated •Drug Toxicokinetics(TK) •Immunotoxicityin case biological products
  • 23. Absorption, Distribution, Metabolism and Elimination (ADME) Advantages performing ADME testing early in the process, before a molecule gets into development: •Improvement of Pharmacokinetic (PK) properties. •Saves time and costs associated with progressing an unsuitable drug candidate through the pipeline. The ADME properties that are routinely measured are: •Solubility •Permeability •Plasma protein binding •Movement across transporters •Metabolism by liver enzymes
  • 24. Local Tolerance •Dermal (skin) Irritation/Sensitization •Eye Irritation •Phototoxicity –The potential for sunlight (or other light frequencies) to transform a drug or a metabolite is: –a useful tool for activating some drugs and –A cause for a significant adverse effects for others (Quinolone antibiotics).
  • 25. Genotoxicity •Minimum of 2 in vitro Assays: –Bacterial mutation Assay –Ames test (point mutations) –Chromosomal Aberration •Mammalian cells in vitro or in vivo •Dominant Lethal Tests in Rodents OR –Mouse Lymphoma Assay •If either of them positive or for Phase II –Micronucleus Assay (In vivo Assay). –Others Assays: Unscheduled DNA Synthesis •Not needed for Biologics
  • 26. Carcinogenicity •Objective:To evaluate the potential tumorigenic effect in animals and risk to humans for continuous use of drug candidate in humans for 6 months or more. •Duration:12 to 24 months •Species:Mouse or Rat •Parameters: •Tumor developmentClinical pathology •Clinical observations and assessment •Points to consider: •Pharmacology, Pharmacokinetic or Toxicology (mechanistic in vitroand in vivo) data, •Structure-activity relationships, •Compound accumulation over long-term use,
  • 27. Pharmacological Assessment of the Underlying Mechanism of Action •Molecular Level –Receptor binding, enzyme activity, molecular studies etc, –Cellular/Tissue Level –Cell function (tissue culture), isolated tissues. •Organ/System Level –Identify primary and secondary targets.
  • 28. Safety Pharmacology •Objective:To investigate undesirable pharmacological effects of the test material; •Duration:Usually single dose; •Animals Required:2 species (rodent and non-rodent); •Core battery:Cardiovascular, Respiratory, CNS, Renal, Blood, Immunological etc.; •Telemetry ;
  • 29. Preclinical Support for Phase I Clinical Trials •Acute/Sub-acute some time chronic Toxicity Studies; •Genotoxicity; •Pharmacokinetic/TK; •Studies about the mechanism of action of the compound; •Safety pharmacology (CNS; CV; Respiratory, Renal etc); •Local tolerance;
  • 30. ToxicologyStudyDuractions Durations needded to support Phase I, II and III trials DuractionofClinical Trial MinimumDurationofRepeat Dose ToxicityStudies RodentsNon-Rodents Single dose 2-4 Weeks 2 Weeks Up to2 Weeks 2-4 Weeks 2 Weeks Up to1 Month 1 Month 1 Month Up to3 Months 3 Months 3 Months Up to6 Months 6 Months 6 Months > 6 Months 6 Months 9 Months Source: charles River
  • 31.
  • 32. CENTRE OF INNOVATION AND PRE-CLINICAL STUDIES
  • 33. Funding:Ministry of Health, Ministry of Science and Technology, FINEP and State Government of Santa Catarina Support: UFSC –Federal University of Santa Catarinaand CERTI Foundation Buildings: Scheduled for completion of infrastructure in December of 2012 Executive and Scientific Director:Dr. João B. Calixto Built area:5.300 m2 TheCenterInnovationandpre-clinicalstudiesistheresultofBraziliangovernmentinitiativefordevelopingpreclinicalstudiesindifferentareasofknowledgetomeetthedemandofpharmaceuticalindustries.
  • 34. Infrastructure MainBuilding 5.300m2ofconstructedarea,dividedinto: •Basement:parkingandsupportarea •Rodentfacility:600m2forthecreation/maintenanceofrodentsstandardSPFwithinternationalcertification •ResearchLabs:About20laboratorieswithhighlevelequipmenttoperformpreclinicalresearch •OfficeandAdministration •Auditorium:tohostsmallerevents~120people •Businessincubator:1,000m2fordevelopmentofnewideasandcompanies •Staffofabout60-80people,including15-20PhDs Non-rodentanimalfacility Secondarybuildingwithabout2,000m2onlyformaintenanceofnonrodentanimals(nonhumanprimates,dogs,rabbit,guineapig,pigsamongothers).
  • 35. Objetives -Conductpreclinicalstudies:pharmacodynamics,safetypharmacology,pharmacokineticsandtoxicology(rodentsandnon-rodents),actinginaccordancewiththeguidelinesofgoodlaboratorypractices; -Supporttheresearch,developmentandinnovationtothepharmaceuticalcompanies,supportingdrugdevelopment; -Integratethenationalnetworkofdrugdevelopment, cooperatingwithcompanies,institutionsandtechnologicalmechanisms/agentstopromoteinnovation; -ContributetotheestablishmentofnationalcompetenceandthegenerationofpatentsinBrazilandabroad.
  • 37. Drug Discovery Desenvolvimento Pré-clínico Clínico Cadeia do desenvolvimento de medicamentos: atuação do CIEnP LNBio LassBio FIOCRUZ NPDM Universidades LAFEX Inst. Royal BioAgri Ciallyx Universidades Rede de pesquisa NPDM Universidades Nacionais Internacionais Nacionais Internacionais CIEnP Drug Discovery Clínica AGENCIAS DE FOMENTO GOVERNO/ EMPRESAS EMPRESAS FUNDOS DE INVESTIMENTOS Parcerias Estratégicas Parcerias Estratégicas Inc. Empresas Escalonamento Inc. Empresas CIEnP Inovação Radical Inovação Incremental Centro de Inovação em Medicamentos
  • 38. Oportunidades em P&D Formação RH Indústria Patentes Publicações OPORTUNIDADES
  • 39. “Se você não erra, provavelmentenão está trabalhando em problemas suficientemente desafiadores. E isto sim é um grande erro” Frank Wilczek, Prêmio Nobel de Física (1951-).
  • 40. A Ignorância Gera Confiança Com Mais Frequência Que o Conhecimento. Albert Einstein (1879-1955)
  • 42. FinanciamentoeApoio Centro de Inovação e Ensaios Pré-clínicos