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Open - SBMF
Obtaining funds: what to know, what to do Esper G. Kallas, M.D., Ph.D. Funding sources • Local funding agencies • International funding agencies • Pharmaceutical and biotech industries Funding sources – Brazil 1.400.000.000 Brazilian Reais 1.200.000.000 1.000.000.000 CNPq FAPESP Linear (CNPq) Linear (FAPESP) 800.000.000 600.000.000 400.000.000 200.000.000 0 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 Year Source: www.fapesp.br & www.cnpq.br Funding source – NIH $30 $27.1 Billions of Dollars $25 $28.0 $28.6 $28.6 $28.6 $23.3 $20 $20.5 $17.8 $15 $13.7 $15.6 $10 $5 $0 FY FY FY FY FY FY FY FY FY FY 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 DOUBLING Source: www.nih.gov Big Pharma 1000 Number of reports 800 600 400 200 0 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 Year Source: www.anvisa.gov.br An overall general principle… Clinical Applications Translational Research Basic Research and Technology Development 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 Well organized structure • • • • Infrastructure Administrative Finances Personnel – Grant specialists – Regulatory affairs – Secretary 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 Clinial Trials Unit Principal Investigator Esper Kallas Co-Principal Investigator Artur Kalichman Executive Committee CTU Administrator Maria Candida Dantas Clinical Coordinator Ricardo Palacios Finance Administrator Maria Aparecida Moreira NIH relationship Accounts Payable Reporting Accounts Receivable Legal issues Controlling Accounting Payroll FAP-UNIFESP Community Advisory Board Community Education Coord. Gabriela Calazans 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 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 Site expansion: USP • University of Sao Paulo – Division of Allergy of Infectious Diseases • LIM-60 Laboratory – Clinical Research Center Other ongoing projects • DAIDS (NIAID) sponsored trials • Pharma sponsored studies Structure Division PI Clinical Research Site Subinvestigators Nursing Pharmacy Admin Study nurse Pharmacists Receptionist Regulatory affairs Assistant Study coordinator Dada coordinator Administrator Recruitment and retention Community educator Recruiters Counselers Laboratory Samples Central Laboratory Safety LIM-60 Repository Immune assays T cell counts Extended phenotype Immune function Molecular Biology Clinical requirements • • • • Good clinical practices Training SOPs Documentation Laboratories requirements • Good laboratory practices – ANVISA 17025 (includes ISO 9001) – InMetro • Training • NIH compliance – Safety: CAP proficiency – GLP Guidelines • Pharma compliance Complexo Hospital das Clínicas 1 Instituto Central 2 Instituto do Coração 3 Instituto de Radiologia 2 4 Instituto de Ortopedia e Traumatologia 1 5 Prédio da Administração 6 Instituto de Psiquiatria 7 Instituto da Criança 3 4 8 Laboratórios de Investigação 5 6 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 Central Institute 22/10/07 Andréa Macorin Pinheiro Outpatient clinic building 22/10/07 Andréa Macorin Pinheiro Centro de Pesquisas Clínicas ICHC FMUSP 22/10/07 Andréa Macorin Pinheiro CPC – Main hallway 22/10/07 Andréa Macorin Pinheiro CPC – Medical office 22/10/07 Andréa Macorin Pinheiro CPC – Monitoring room 22/10/07 Andréa Macorin Pinheiro CPC – Nursing room 22/10/07 Andréa Macorin Pinheiro CPC – Testing room 22/10/07 Andréa Macorin Pinheiro CPC – Testing room 22/10/07 Andréa Macorin Pinheiro CPC - Pharmacy 22/10/07 Andréa Macorin Pinheiro CPC - Pharmacy 22/10/07 Andréa Macorin Pinheiro CPC - Pharmacy 22/10/07 Andréa Macorin Pinheiro Identificação Protocolos 22/10/07 Andréa Macorin Pinheiro 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 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 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) 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. 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 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 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 Bob Grant, Uganda 1992 22/10/07 Merle Sande 1939-2007 Andréa Macorin Pinheiro
MARÇO | MARCH / 2016 - Ed. 5
