Impatient Optimists, Bill and Melinda Gates Foundation

The Bill and Melinda Gates Foundation (BMGF) invited Dr Sonali Kochhar, Medical Director, Global Healthcare Consulting to write on Safety Monitoring for Immunization in Pregnancy – The GAIA Project for their blog, Impatient Optimists. GHC co-led the scientific coordination of the international project along with BCF.

For more information, please visit- http://www.impatientoptimists.org/Posts/2017/03/Harmonized-Safety-Monitoring-of-Immunization-in-Pregnancy-the-Global-Alignment-of-Immunization-Safety-Assessment-in-Pregnancy-GAIA-project

Special Issue of Vaccine Published

Global Healthcare Consulting co-led the scientific coordination of the international Global Alignment of Immunization Safety Assessment in Pregnancy (GAIA) project with the Brighton Collaboration Foundation. The multi-year Bill and Melinda Gates Foundation (BMGF) funded GAIA project consisted of 13 partners from 8 countries (including the National Institute of Health, WHO, Erasmus University Medical Centre, St George’s University of London, Baylor College of Medicine etc). The GAIA project outputs are being utilized in Interventional and Observational studies and AEFI surveillance for Vaccines and Maternal and Child Health Research for adverse maternal and perinatal birth outcomes assessments globally. They include a core set of over 21 globally standardized case definitions of selected key obstetric and neonatal terms, a glossary of enabling terms critical to these obstetric and neonatal case definitions (e.g., an algorithm for the determination of gestational age) to support stakeholders using the definitions, guidelines for the standardized conduct of clinical trials of vaccines in pregnant women (including a landscape analysis of regulatory guidance available for immunization in pregnancy from the Food and Drug Administration (FDA), European Medicines Agency (EMA) and International Conference on Harmonization) and guidance on study design and the standardization of data collection etc. These have been published in a special issue of Vaccine (http://www.sciencedirect.com/science/journal/0264410X/34/49). A standardized approach to safety data collection and reporting is likely to improve the acceptability and implementation of immunizations in pregnancy and subsequently help reduce illness and death among pregnant women and young infants globally.

Global Healthcare Consulting part of Business Delegation to New Zealand

Global Healthcare Consulting was invited to be part of the Business Delegation to New Zealand. The GHC COO and Medical Director were part of the Delegation in October 2016. They met with the New Zealand High Commissioner to India in New Delhi and then traveled with the delegation to New Zealand where there were Business Women Conclave meetings in Ackland, a meeting with the Mayor of Wellington at the Parliament and then a visit to the Masssey University in New Zealand.

Global Alignment of Immunization Safety Assessment in Pregnancy develops a new case definition addressing Zika

Zika is a mosquito-borne virus that was first identified in 1952 in Uganda and the United Republic of Tanzania. The Zika virus is transmitted to people through the bite of an infected mosquito (Aedes aegypti in tropical regions). This is the same mosquito that transmits yellow fever, dengue, and chikungunya. Sexual transmission of Zika virus has also been described. Outbreaks of Zika virus disease have been recorded in Africa, the Americas, Asia and the Pacific.

Health authorities have observed an increase in Guillain-Barré syndrome (a potentially fatal neurological condition that can cause paralysis) and an increase in babies born with microcephaly (a birth defect characterized by abnormally small heads associated with severe cognitive disorders, intellectual disability, and possibly death). These coincide with Zika virus infections in the general public. Scientists believe Zika can potentially spread into the brain of a fetus through a pregnant woman’s amniotic fluid, attacking the neural cells and stunting the baby’s brain development. On Feb 1, 2016, WHO declared the cluster of microcephaly cases and other neurological disorders as a health emergency. The Zika infection is spreading rapidly globally. There is currently no vaccine available and a number of new vaccines are under development.

In order to respond to the global epidemic, the Global Alignment of Immunization Safety Assessment in Pregnancy (GAIA) consortium (with Global Healthcare Consulting as an Executive Committee and Coordination Team member and leading the case definitions development) has developed a globally standardized case definition of microcephaly (along with the definitions of other key obstetric and neonatal outcomes, guidelines and tools). The case definitions, guidelines and tools have been extensively review by peers and stakeholders to ensure their applicability, usefulness and acceptability in developed and low and medium income countries.

The use of these definitions, guidelines and tools will be useful in pre-and post-licensure safety and pharmacovigilance surveillance systems and help support enhanced surveillance and collection of safety data that can be consolidated and compared across sites, countries, and programs worldwide.

 

Plenary Presentation at the 10th Euro Global Summit on Vaccines and Vaccination, Rome, Italy by Global Healthcare Consulting

Dr Sonali Kochhar from Global Healthcare Consulting was invited to make a plenary presentation on Vaccines for pregnant women- challenges and opportunities for harmonized safety monitoring at the 10th Euro Global Summit on Vaccines and Vaccination held in Rome from June 16-18, 2016. . The presentation was really well received by the audience which consisted of regulatory representatives (including from the FDA), Industry, Private sector, and academia.

For more information about the conference, please visit:http://vaccines.global-summit.com/europe/abstract/2016/vaccines-for-pregnant-women-challenges-and-opportunities-for-harmonized-safety-monitoring

Global Healthcare Consulting presentation at the Harmonized Safety Monitoring of Immunization in Pregnancy International Consensus Conference, USA

Dr Sonali Kochhar from Global Healthcare Consulting presented on Challenges and Guidance for Immunization in Pregnancy Safety Monitoring at the “Harmonized Safety Monitoring of Immunization in Pregnancy International Consensus Conference” held on the NIH Campus (Bethesda, MD, USA) on March 29-30 2016.

Global Healthcare Consulting was also part of the Scientific Committee for the conference.

The conference, supported by the Bill & Melinda Gates Foundation, Sanofi Pasteur, Novavax and GSK, aimed to highlight progress in harmonizing safety monitoring of immunization in pregnancy and to develop consensus recommendations for a globally concerted approach. It brought together 142 stakeholders from around the world (including representatives from theFDA, NIH (National Institute of Health), CDC (Centers for Disease Control and Prevention), the Pharmaceutical Industry, Maternal Immunization Trial Investigators from both low and high resource settings, the Gates Foundation, National Vaccine Program Office, and Pan American Health Organization (PAHO) etc).

For more information about the conference, please visit: http://immunization-in-pregnancy-2016.iabs.org/index.html

Dr Sonali Kochhar part of Wellcome Trust’s 5 member international Independent Review Panel for Clinical Study Data Requests

Dec 2015

Dr Sonali Kochhar is part of Wellcome Trust’s 5 member international Independent Review Panel for Clinical Study Data Requests. The panel is responsible for the scientific and ethical review of Research Proposals from researchers requesting access to patient-level data from clinical trials conducted by pharmaceutical companies (including Astellas, Bayer, Boehringer Ingelheim, Daiichi Sankyo, Eisai, GSK, Lilly, Novartis, Roche, Sanofi, Takeda, UCB,  and ViiV Healthcare).

For more information, please visit https://www.clinicalstudydatarequest.com/Members-of-the-Independent-Review-Panel.aspx

Scientific Committee for the Harmonized Safety Monitoring of Immunization in Pregnancy International Consensus Conference

Global Healthcare Consulting (GHC) is part of the Scientific Committee of the Harmonized Safety Monitoring of Immunization in Pregnancy International Consensus Conference to be held on March 29-30, 2016 at the Natcher Conference Center,National Institute of Health, Bethesda, USA.

The conference aims to highlight progressin harmonizing safety monitoring of immunization in pregnancy and to develop consensus recommendations for a globally concerted approach.

The conference is held in collaboration with the Eunice Kennedy ShriverNational Institute of Child Health and Human Resources, the National Institute of Allergy and Infectious Diseases, the National Cancer Institute, the Bill and MelindaGates Foundation, the World Health Organization, the International Alliancefor Biological Standardization (IABS) and the Brighton Collaboration Foundation.

This meeting will bring together regulators, scientists, academia and industry experts to help resolve existing challenges of safety monitoring of immunization inpregnancy and to reach conclusions that will be valuable to a globally concerted approach.

Call to Action Summit 2015 for ending preventable child and maternal deaths

Global Healthcare Consulting (GHC) attended the Call to Action Summit 2015 for ending preventable child and maternal deaths. This was co-hosted by The Ministry of Health and Family Welfare, Government of India along with Ministry of Health Government of Ethiopia, USAID, UNICEF, Bill & Melinda Gates Foundation, and Tata Trusts in New Delhi on August 27-28, 2015.

The two-day Leadership Summit was a confluence of health ministers from 24 priority countries that committed to the Global Call To Action for Child Survival in June 2012, international health experts, health practitioners, and global leaders from the corporate, civil society and media.

The New Delhi Summit was a prelude to the United Nations Sustainable Development Summit in New York from September 25-27, 2015 for the adoption of the Sustainable Development Goals post-2015.

The Call to Action Summit enabled countries to take stock of progress, share best practices, and forge alliances for ending preventable child and maternal deaths. Key topics such as health financing, corporate partnerships, innovations, accountability, and cross cutting areas such as water, sanitation, and nutrition that play a pivotal role in the success of program delivery and impact were discussed.