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 over 23 years of leadership experience for global vaccines and drugs development in the pharmaceutical industry, product development partnerships and consulting. This includes leading This includes leading Phase I-IV clinical research, safety studies and implementation research conducted in USA, Europe, Africa and Asia in adult, maternal, adolescent, and pediatric populations; vaccines for infectious diseases (COVID-19, TB, HIV/AIDS, influenza, GBS, RSV, MERS, rift valley fever, lassa, nipah, ebola, zika, chikingunya, pertussis, Shigella and other diarrheal and tropical diseases); maternal immunization (MI); safety, regulatory and ethical strategies for novel vaccines clinical research and implementation (including for epidemics, and pregnant women); introduction of new vaccines; increasing immunization coverage and acceptance; vaccine policy recommendations; pandemics and epidemics preparedness and response; translating research into impactful programs by policy, strategy, advocacy, building functional pharmacovigilance (PV) systems, and healthcare systems strengthening for immunization 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. She has been very involved in national, regional and global response efforts for COVID-19 including the development of COVID-19 vaccines, their safety assessment, policy development and implementation.

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 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 clinical development programs, including the development and management of the clinical and regulatory strategies, clinical development plans, target product profile, protocols, investigators brochures, informed consent, care and treatment guidelines, safety assessment, pharmacovigilance including risk management plans, risk evaluation and mitigation strategies and benefit-risk assessment. She has successfully built and led large international teams for clinical research, registration and post marketing support.

She has co-authored internationally accepted guidance, research standards, protocol templates and case definitions for vaccine clinical research, MI and safety. She is helping characterize the clinical risk factors and biomarkers associated with rare AEFIs. She is helping set up a Pregnancy Registry and determine background rates for vaccines in a LIC in Africa. She has led the development of a standardized module for vaccine benefit-risk assessment, which is being utilized by vaccine developers, funders and LMIC National Regulatory Authorities. She has led the development of standardized templates for the safety assessment of vaccines from different platforms, which are being widely utilized by vaccine developers and funders. She helped set up and lead the Global Alignment of Immunization Safety Assessment in Pregnancy (GAIA) network, a critical program for MI 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 lead vaccine 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 serves on several advisory panels, including the WHO Strategic Advisory Group of Experts on Immunization (SAGE); WHO Product Development for Vaccines Advisory Committee (PDVAC); Chair of the WHO SAGE Working Group (WG) on COVID-19 vaccines; Gavi’s Vaccine investment Strategy (VIS) Steering Committee; Co-Chair, Gavi VIS WG on Immunization Platforms; Advisory Board for Bill & Melinda Gates Medical Research Institute for the TB Vaccine Phase 3 trial; Co-Chair of the WHO Technical Advisory Group on GBS Vaccine Development; WHO Expert Steering Committee on Safety Surveillance in Pregnancy in LMICs; WHO Technical group for AESI background rate protocol development; Co-Chair of the WHO Expert Group on ethics & governance of infectious disease outbreaks and other emergencies of public health importance; Independent Review Panels for Clinical Study Data Requests, and Vivli (Centre for Global Clinical Research Data); International Executive Committees, serves as Guest Faculty for International Vaccinology Programs and has published over 145 publications and reviews (including in the Lancet, Nature, Annual Review of Virology), and book chapters on vaccine research, MI, safety and health systems strengthening.

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 18 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 mandated legal requirements.