Dr Sonali Kochhar, MD, Medical Director

Dr Sonali Kochhar, M.D., Medical Director, Global Healthcare Consulting and Clinical Associate Professor, Department of Global Health, University of Washington, Seattle, has twenty-two years of leadership experience for global Phase I-IV clinical research, safety and epidemiology studies, and implementation research for vaccines and drugs conducted in USA, Europe, Africa and Asia in adult, maternal, and pediatric populations; Infectious diseases (including COVID-19, HIV/AIDS, influenza, TB, GBS, RSV, MERS, lassa, nipah, ebola, zika, chikingunya, pertussis, polio eradication, diarrheal diseases, and tropical diseases); maternal immunization (MI); safety, regulatory and ethical strategies for vaccines clinical research and implementation; pandemic preparedness and response; introduction of new vaccines; increasing immunization coverage and acceptance; translating research into impactful programs by healthcare systems strengthening and policy, strategy and communications development for immunization and maternal and child health programs; clinical trial data sharing; and research with vulnerable and at-risk populations (including pregnant women, children and immunocompromised). Her work has informed global and country-specific vaccine policy recommendations.

Dr Kochhar has led multiple research programs in Kenya, Uganda, Zambia, The Gambia, South Africa, the United States, Belgium, Germany, India, Bangladesh and Nepal. She provides expertise for vaccine research and safety (including for viral vectors, nucleic acid (DNA and RNA), inactivated, live-attenuated, protein vaccines and adjuvants).

She has led multi-country Phase I-IV clinical development programs, and the development and management of the clinical project strategy, clinical development plans, clinical and regulatory strategies, target product profile,  protocols, investigators brochures, informed consent, care and treatment guidelines, pharmacovigilance including risk management plans, risk evaluation and mitigation strategies and benefit-risk assessment, and study reports pre-and post-licensure.

She has co-authored internationally accepted guidance, research standards, protocol templates and case definitions for adverse events for vaccine clinical research and MI.  She has led the development of standardized templates for the benefit-risk assessment of vaccines. The templates have been recommended by WHO’s Global Advisory Committee on Vaccine Safety (GACVS), and are being utilized by COVID-19 and other vaccine developers. She helped set up and lead the Gates Foundation-funded multi-year Global Alignment of Immunization Safety Assessment in Pregnancy (GAIA) network, a critical program for vaccine safety, with partners in over 90 countries. She helped develop 26 novel Maternal and Neonatal Case Definitions for adverse events detection and evaluation, ensuring their applicability in LMICs. The definitions and guidance are being utilized in clinical research, epidemiological studies and pharmacovigilance for vaccines and MI globally.

Kochhar has helped led policy development, and advocacy with government partners and ministries of health, regulatory bodies (including the FDA, EMA, African and Asian National Regulatory Authorities), ethical committees, scientific organizations, international aid agencies (including the Gates Foundation, USAID, Wellcome Trust and MRC), public health authorities,  international and bilateral organizations (including WHO, NIH, CDC, World Bank), pharmaceutical companies, key opinion leaders, local communities, patient groups and the media. She has helped set up partnerships for vaccine R&D with international pharmaceutical companies, public-private partnerships and national governments.

She has led immunization programs strengthening by policy, strategy and communications development and healthcare systems strengthening (including evaluation, capacity building, supply chains strengthening, and new technology development and implementation). 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 serves on several advisory panels, including the WHO Strategic Advisory Group of Experts on Immunization (SAGE); WHO SAGE Working Group on COVID-19 vaccines; WHO Global Advisory Committee on Vaccine Safety (GACVS) Working Group on COVID-19 Vaccines Safety Preparedness; Co-Chair of the WHO ACT (Access to COVID-19 Tools)-Accelerator Ethics & Governance Working Group; Wellcome Trust’s Independent Review Panels for Clinical Study Data Requests, and Vivli (Centre for Global Clinical Research Data Sharing); international executive Committees and has published over 115 publications and reviews (including in the Lancet, Nature, JAMA, Annual Review of Virology), and book chapters on vaccine research, MI, safety, COVID-19 and health systems strengthening.

As the Medical Director for the International AIDS Vaccine Initiative earlier, she led the clinical development for several vaccine candidates (including AIDS Vaccine clinical trials in Europe and India; multi-country clinical trials in Africa, and the first AIDS vaccine clinical research in India). As the Clinical Research and Drug Development Specialist, PATH she provided leadership for phase I-IV clinical research in the USA and Asia, and introduction (including strategies for pipeline agents and product positioning). Prior to IAVI, she led teams in 11 South-East Asian countries for Eli Lilly and Company, providing technical expertise, strategies for pipeline agents, and new product launch planning.

As the Country Director for the USAID | DELIVER PROJECT for John Snow India Pvt. Ltd., an International Health Consultancy Organization, she led policy and strategy development and healthcare systems strengthening (including evaluation, capacity building, and supply chains strengthening) for Immunization and Maternal and Child Health programs in LMIC, working in close partnership with the National Government.

She has received multiple awards including the Yale World Fellowship for 2011 (Yale University’s International Leadership Program); Vaccinology Fellowship Award for significant achievements in Vaccinology from Fondation Mérieux and University of Geneva; Global Leadership Awards from Eli Lilly & Company, Indianapolis, U.S.A; Bharat Jyoti (Light of India) Award for medical achievements and the Serviers Young Investigator Award from Institut de Recherches Internationales, Servier, France.

Anurita K. Kapoor – Senior Director  

Anurita Kapoor, MSW, is a Social Scientist with over 20 years of experience working with women, children and youth with problems in LMICs. She has served in leadership positions for International Organizations working in the healthcare sector.

She has a Masters in Social Work with a Specialization in Family and Child Welfare and was with the Department of Social Work, Lucknow University.

Ms. Ritika – Communications Expert   

Ms. Ritika, MBA, is a Communications Expert with 15 years of experience and has led large national networks.

Harvinder Bhatia- Finance Consultant

Mr Bhatia, is a qualified Chartered Accountant and has over 25 years of broad financial experience. He has advised large international organisations. He is responsible for implementing a strong financial system for Global Healthcare Consulting and ensuring compliance with all legal and ethical requirements as mandated by the law of the country.