Obtaining funds: what to know, what to do. Esper G. Kallas, M.D., Ph.D.
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1 Obtaining funds: what to know, what to do Esper G. Kallas, M.D., Ph.D.
2 Funding sources Local funding agencies International funding agencies Pharmaceutical and biotech industries
3 Funding sources Brazil Brazilian Reais CNPq FAPESP Linear (CNPq) Linear (FAPESP) Year Source: &
4 Funding source NIH Billions of Dollars $30 $25 $20 $15 $10 $5 $13.7 $15.6 $17.8 $20.5 $23.3 $27.1 $28.0 $28.6 $28.6 $28.6 $0 FY 1998 FY 1999 FY 2000 FY 2001 FY 2002 FY 2003 FY 2004 FY 2005 FY 2006 FY 2007 DOUBLING Source:
5 Big Pharma Number of reports Year Source:
6 An overall general principle Clinical Applications Translational Research Basic Research and Technology Development
7 Institutional strategic view Discussion of strategies Fostering research in different levels Clinical application Translational research R&D Seed money Incentives for investigators Seek funding opportunities continuously Well organized structure
8 Well organized structure Infrastructure Administrative Finances Personnel Grant specialists Regulatory affairs Secretary
9 Experience background 1994 Started conducting Pharma-sponsored clinical research 1999 Started obtaining institutional funds Started applying for NIH grants in 2002 First Phase I trial in 2003, Merck HIV vaccine candidate HIV vaccine candidate study (STEP trial, Phase IIb) First NIH award (foreign component) in 2006 (R01 with UCSF, Dr. Douglas Nixon) U01 award: Sao Paulo Clinical Trials Unit at UNIFESP and CRT-DST/Aids 2007: R21 and R01 awards (as foreign component) 2008: Clinical Research Site at USP
10 Clinial Trials Unit Principal Investigator Esper Kallas Executive Committee Co-Principal Investigator Artur Kalichman CTU Administrator Maria Candida Dantas Finance Administrator Maria Aparecida Moreira Clinical Coordinator Ricardo Palacios NIH relationship Reporting Legal issues Accounting Accounts Payable Accounts Receivable Controlling Payroll Community Advisory Board Community Education Coord. Gabriela Calazans FAP-UNIFESP HVTU Vila Mariana Artur Kalichman (CRS HVTN) Community education Recruitment/retention Sirlene Caminada Ethics Regulatory issues Data management Volunteer safety Laboratory Management Helena Tomiyama Product Management Gustavo Mizuno
11 Clinical Research Sites HVTU Vila Mariana Artur Kalichman (CRS HVTN) Clinical specimens Clinical Laboratory CRT-DST/AIDS Routine & protocol tests CTU core Immunology Laboratories UNIFESP Imune assays Sample repository Shipment
12 Site expansion: USP University of Sao Paulo Division of Allergy of Infectious Diseases LIM-60 Laboratory Clinical Research Center
13 Other ongoing projects DAIDS (NIAID) sponsored trials Pharma sponsored studies
14 Structure Division PI Clinical Research Site Subinvestigators Study coordinator Administrator Nursing Pharmacy Admin Study nurse Pharmacists Receptionist Regulatory affairs Dada coordinator Recruitment and retention Community educator Assistant Recruiters Counselers
15 Laboratory Samples Central Laboratory LIM-60 Safety Repository Immune assays T cell counts Extended phenotype Immune function Molecular Biology
16 Clinical requirements Good clinical practices Training SOPs Documentation
17 Laboratories requirements Good laboratory practices ANVISA (includes ISO 9001) InMetro Training NIH compliance Safety: CAP proficiency GLP Guidelines Pharma compliance
18 Complexo Hospital das Clínicas 1 Instituto Central 2 Instituto do Coração 2 3 Instituto de Radiologia 4 Instituto de Ortopedia e 1 Traumatologia 5 Prédio da Administração 6 Instituto de Psiquiatria Instituto da Criança 8 Laboratórios de Investigação Médica 9 Divisão de Medicina de Reabilitação 10 Hospital Auxiliar de Cotoxó 11 Hospital Auxiliar de Suzano 12 Hospital Estadual de Sapopemba 22/10/07 Andréa Macorin Pinheiro
19 Central Institute 22/10/07 Andréa Macorin Pinheiro
20 Outpatient clinic building 22/10/07 Andréa Macorin Pinheiro
21 Centro de Pesquisas Clínicas ICHC FMUSP 22/10/07 Andréa Macorin Pinheiro
22 CPC Main hallway 22/10/07 Andréa Macorin Pinheiro
23 CPC Medical office 22/10/07 Andréa Macorin Pinheiro
24 CPC Monitoring room 22/10/07 Andréa Macorin Pinheiro
25 CPC Nursing room 22/10/07 Andréa Macorin Pinheiro
26 CPC Testing room 22/10/07 Andréa Macorin Pinheiro
27 CPC Testing room 22/10/07 Andréa Macorin Pinheiro
28 CPC - Pharmacy 22/10/07 Andréa Macorin Pinheiro
29 CPC - Pharmacy 22/10/07 Andréa Macorin Pinheiro
30 CPC - Pharmacy 22/10/07 Andréa Macorin Pinheiro
31 Identificação Protocolos 22/10/07 Andréa Macorin Pinheiro
32 The institution needs to be prepared Federal Wide Assurance (FWA) number Institutional Review Board (IRB) number Institutional registration at grants.gov Data Universal Number System (DUNS) number Central Contractor Registry (CCR) number Cage Code (Commercial and Government Entity Code) In Brazil: A NATO number, provided by the Navy!! era Commons registration
33 Site activation process Protocol approval Site evaluation by the NIH & CRO Compliance Quality management plan SOPs Training Pharmacy plan Community Advisory Board Laboratories NIH Laboratory Branch evaluation CRO evaluation Activation NIH & CRO
34 Regulatory process Translation (back translation may by required) In the US (if you are a foreign component) IRB submission in the primary institution In Brazil IRB and CONEP CNPq CIBio and CTNBio (when required) ANVISA (when required)
35 Time lag for regulatory approval Document portfolio: 2 weeks to 1 month IRB approval: 1 to 2 months CONEP approval: 3 to 4 months Anvisa approval: 1 month Total time: around 6 months.
36 Conclusions Brazilian funding agencies are investing more Funding opportunities in international agencies are within reach Clinical research in the country has increased Institutional preparedness and support are essential
37 Conclusions Conduction of clinical trials can be done in Brazil, under strict GCP and GLP standards Approval process can take a long time However, the Brazilian participation is usually successful and fast
38 University of São Paulo Site Clinical coordinator: Ricardo Palacios Administrator: Maria Candida Dantas Regulatory affairs: Zelinda Nakagawa, Issler Silva Investigators: Mariana Sauer, Fábio Leal, João Miraglia Nurses: Laís Magalhães, Maria Emília Campos Pharmacists: Lígia Correa, Maria Teresa Giret, Andréa Pinheiro Community educator: Ricardo Gambôa Counsellors: Flávia Penacchin, Daniel Bertevello Dada management: Ricardo Russo, Angela Lima Laboratory: Helena Tomiyama, Leandro Tarosso, Fernanda Bruno Team: 24 pessoas Laboratório Central: Marcelo Burattini Centro de Pesquisa Clínica: Décio Mion
39 Bob Grant, Uganda 1992 Merle Sande /10/07 Andréa Macorin Pinheiro
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