Global Healthcare Consulting (GHC)
GHC team members in GAIA PHASE II: Sonali Kochhar.
Dr Sonali Kochhar, M.D., Clinical Associate Professor, Department of Global Health, University of Washington, Seattle; Scientific Researcher, Department of Public Health, Erasmus University Medical Center, Rotterdam, The Netherlands; and Medical Director, Global Healthcare Consulting has twenty years of experience in a Leadership position for Global Phase I-IV Clinical Research, Epidemiology and Safety Studies for Vaccines and Drugs conducted in the USA, Europe, Asia, Africa and India in Adult and Pediatric populations, Infectious Diseases (HIV/AIDS, Diarrheal Diseases, Malaria, TB, Influenza, Group B Strep, RSV, Neglected diseases), Vaccines for Pregnant Women, Introduction of New Vaccines, Translating research into programs by Healthcare Systems Strengthening for Immunization and Reproductive, Maternal and Child Health programs, Pandemic Preparedness, HIV/AIDs Prevention and Treatment, Research Ethics for Vaccines, Epidemics, and New Technologies and working with vulnerable and at-risk populations.
Dr Kochhar has conducted multiple studies- including vaccine trials- in Kenya, Uganda, Zambia, The Gambia, South Africa, the United States, India, Bangladesh and Nepal. She provides expertise for Vaccine Research and Development (including for Viral Vectors (MMV, AAV, Ad-5 etc), DNA, Proteins, Inactivated, Subunit Vaccines, Adjuvants etc).
She has set up global International Strategic Partnerships and led Policy and Ethics Development, Institutional Strengthening, Strategy and Advocacy with Government Partners (across Asia-Pacific, Africa, and South America), Regulatory Bodies (including the FDA, EMEA, African and Asian National Regulatory Authorities), Ethical Committees, Scientific Organizations, International Aid Agencies (Gates Foundation, USAID, MRC, Basque Government etc.), Public Health Authorities, International and Bilateral Organizations (e.g. WHO, NIH, CDC, World Bank), Pharmaceutical Companies, Communities and the Media.
She has co-authored multiple internationally accepted Vaccine Safety Research Standards, Case definitions of Adverse Events for Vaccines Research, Guidelines for Vaccine Safety Research and Template Research Protocols. She is the Lead for the development of Maternal and Neonatal Case Definitions for Maternal Immunisation and has co-authored guidelines for vaccines in pregnant women clinical trials and studies. The definitions and guidelines are being utilized in clinical research, observational studies and AEFI surveillance for Vaccines and Maternal and Child Health Research globally. She has helped to develop Research Ethics for Vaccines, Epidemics, and New Technologies.
She is a member of International Steering Committees, serves on International Scientific Advisory Boards, was on the International Steering Committee of the WHO Consultation on Safety of Immunization in Pregnancy in Mothers and Newborn Children and served as the Session Chair for the WHO Pediatric Deliberative Session on neonatal events in maternal immunization, as Guest Faculty for International Public Health and Vaccinology Programs, and has published numerous peer-reviewed publications and book chapters in the areas of Vaccine Research, Maternal Immunization and Safety.
Dr Kochhar will lead Outcome 1 (Standard development). GHC will stay in charge of harmonizing case definition and guidelines development. Having harmonized over GAIA 21 case definitions, GHC brings its experience to translating the case definitions to CRFs. GHC will also participate in the development of the ORAT Tool, the SMQs and the case definition mapper. GHC main role is the integration and harmonization with the case definitions. GHC has actively represented GAIA at various occasions and will continue to do so. In the impact assessment work stream, GHC also has an outreach and crosslinking role, while actively contributing to protocol development and study implementation. GHC will remain member of the Coordination team and thus support project coordination and management.