Sonali Kochhar

Clinical Professor, Department of Global Health, University of Washington, Seattle, and Medical Director, Global Healthcare Consulting

Dr Sonali Kochhar, M.D., has over 26 years of leadership experience for global vaccines and drugs development and implementation in the pharmaceutical industry, product development partnerships and international consulting organizations. This includes leading Phase I-IV clinical research, safety studies and implementation research for vaccines conducted in USA, Europe, Africa and Asia, in adult, maternal, adolescent and paediatric populations; vaccine for infectious diseases (including Ebola Bundibugyo, Tuberculosis, Mpox, Influenza, Lassa, MERS, Rift Valley fever, Nipah, COVID-19, HIV, Group B Strep, Respiratory syncytial virus, Malaria, Diarrheal, and tropical diseases); Maternal Immunization; pandemic and epidemic preparedness and response; safety and regulatory strategies for novel vaccines clinical research and implementation; introduction of new vaccines; increasing immunization coverage and acceptance; vaccine policy recommendations; translating research into impactful immunization programs by policy, strategy, capacity building of national committees, EPI leadership and National Regulatory authorities, building functional pharmacovigilance systems and healthcare systems strengthening; clinical trial data sharing and research with at-risk populations (including pregnant women and immunocompromised). Her work has shaped global and country specific vaccine policy recommendations.                                 

Dr Kochhar has led vaccine research programs in Kenya, Uganda, Zambia, The Gambia, South Africa, the United States, Belgium, Germany, India, Bangladesh and Nepal. She has led multi-country clinical development programs for vaccines, including the development and management of the clinical and regulatory strategies, clinical development plans, safety assessment, pharmacovigilance and benefit-risk assessment pre-and post-licensure.

She has co-authored internationally accepted guidance, research standards, protocol templates and over 30 case definitions for vaccine research, maternal immunization and safety. She has led the development of a standardised module for vaccine benefit-risk assessment, and vaccine safety templates which are being utilized by vaccine developers, funders and LMIC regulators for decision making. She helped lead the development of 26 novel Maternal and Neonatal case definitions and guidance for adverse event detection and evaluation. The definitions and guidance are being utilized in vaccines clinical research and pharmacovigilance globally.

For vaccine policy development, she co-led the development of the Evidence Considerations for Vaccine Policy (ECVP) framework, to help in early (pre-phase 3 trial design) alignment between regulators, policy makers and the national, regional and global stakeholders on the clinical trial and observational data or evidence needed for policy and program decisions for new vaccine classes, and help mitigate delays in post-licensure vaccine implementation. She helped lead the development of the ECVP for TB vaccines for adolescents and adults, and is helping in the development of the ECVP for GBS vaccines and Measles-Mumps- Rubella (MMR) Microarray Patches.

She is providing support for new vaccines implementation, Pharmacovigilance systems strengthening and setting up a pregnancy registry in LMICs. She has led work on increasing immunization coverage and acceptance in LMICs, and new vaccine introduction, working in close collaboration with the National EPI teams. 

She has helped set up vaccines R&D strategic partnerships, and advocacy with government partners and ministries of health, regulatory bodies (including the FDA, EMA, African and Asian national regulatory authorities), donors (including the Gates Foundation, USAID, Wellcome Trust, MRC), public health authorities, international organizations (including WHO, NIH, CDC, World Bank), pharmaceutical companies, local communities, and the media.

She serves on several international advisory panels including WHO Strategic Advisory Group of Experts on Immunization (SAGE), WHO Product Development for Vaccines Advisory Committee (PDVAC); Co-Chair WHO Technical Advisory Group on Evidence for Clinical and Policy Considerations for New Tuberculosis Vaccines; Gavi Independent Review Committee; Co-Chair WHO Expert Group on ethics and governance of infectious disease outbreaks and other emergencies of public health importance and Chair, Independent Review Panels for Clinical Study Data Requests. She is an Expert Evaluator for the European Commission, Medical Research Council, UK and Canadian Institutes of Health Research.

Kochhar serves as guest faculty for international vaccinology programs, and has published numerous publications and book chapters, with a h-index of 66. She has received multiple awards including the Yale World Fellowship (Yale University’s International Leadership Program) and the Vaccinology Fellowship Award from Fondation Mérieux and University of Geneva.