About Us

ABOUT THE SPEAC PROJECT

The Coalition for Epidemic Preparedness Innovations (CEPI) is a global partnership that develops vaccines to stop future epidemics. Brighton Collaboration is an international community of vaccine safety experts that provides standardized, validated, and objective methods for monitoring vaccine safety profiles and benefit-risk ratios.

In 2019, CEPI and Brighton Collaboration came together to launch the Safety Platform for Emergency Vaccines (SPEAC), a CEPI-funded project. SPEAC aims to enhance safety for CEPI-funded trials across multiple platforms for multiple priority pathogens, including vaccines for Lassa fever, Nipah virus, MERS, and Chikungunya.

In 2022, CEPI announced its 100 Days Mission to dramatically reduce the time it takes to deliver a vaccine against a pandemic pathogen. New priorities were added to SPEAC’s work to support CEPI in achieving this ambitious goal, including a focus on outreach to low- and middle-income countries and facilitation of rapid response.

Mission

SPEAC provides the best available scientific evidence on the safety of CEPI vaccines to support timely benefit-risk assessment during the vaccine life cycle. SPEAC provides a harmonized vaccine safety assessment and monitoring service for CEPI and its awardees in as many geographic regions where emerging pathogen vaccine studies will be conducted, with a focus on low- and middle- income countries.

Objectives

SPEAC builds a robust vaccine safety monitoring service with three objectives:

SPEAC provides tools and services for harmonized safety monitoring in vaccine studies of known epidemic and pandemic threats by supporting all stakeholders involved in vaccine safety monitoring.

SPEAC harnesses the learnings around safety monitoring of vaccines to improve the efficiency of safety data collection and knowledge sharing.

Through the Brighton Collaboration and CEPI network SPEAC connects vaccine safety experts and stakeholders on a global scale.

SPEAC activities

SPEAC experts’ activities contribute to building vaccine safety capacity and achieving project objectives to prepare, transform, and connect vaccine safety expertise.

Data Safety Monitoring Boards (DSMBs) for vaccines are typically composed of target disease experts, statisticians, and infectious disease specialists. Unfortunately, vaccine safety expertise is frequently missing.

SPEAC aims to contribute to that gap through DSMB support for vaccine developers and what SPEAC calls the Meta-DSMB:

DSMB Support for vaccine developers

SPEAC has created a pool of eligible candidates for DSMBs who are now available to CEPI-funded developers conducting trials in Africa and SE Asia contributing to the Research Preparedness Network initiative included in CEPI 2.0 plans for Clinical Development.

The pool has been continuously expanded through a training course conducted in priority geographic regions as one of the tasks within the SPEAC project.

Meta-DSMB

The meta-DSMB is a group of experts that monitors the safety profile of vaccines across all CEPI-funded clinical awardees by looking at patterns possibly related to vaccine platforms, antigens, adjuvants across trials.

The group comprises 16 global liaison members that attend the different awardees’ DSMBs as non-voting observers. They provide input on request and review reasons to stop/pause the enrolment of individual trials based on safety data and assess impact for similar vaccines/vectors.

A key task of the SPEAC project has been and continues to be the identification of ‘potential’ Adverse Events of Special Interest (AESI) that could occur during vaccine development of the he CEPI prioritized pathogens including Lassa Fever, MERS, Rift Valley Fever, Nipah, Chikungunya, COVID-19. These AESIs were identified based on based on vaccine safety evidence and target disease pathogenesis and the main objective is to

Once the AESIs have been identified, the work of the Standards and Tools work package in SPEAC focuses on ensuring the availability of the related resources below:

  • Brighton Collaboration case definitions
  • Risk factors for AESI occurrence to guide investigation & causality assessment
  • Population based background incidence of AESI to facilitate ‘expected’ vs ‘observed’ signal assessments
  • Medical codes (ICD, MedDRA, SNOMeD) to enable database searches for an AESI
  • Case report forms and algorithms to assist uniform application of available data to apply the case definition

The main goal of the above process that harmonized lists of prioritized AESIs together with their related standardized case definitions, resources and tools are available for global use across the vaccine life cycle, especially in the context of pandemics and/or outbreaks.

SEE ALL TOOLS

Effective communication of key information among key stakeholders including regulators, public health, and the general public is challenging due to highly subspecialized research with many acronyms, and the lack of specialized training in data supporting vaccine safety by many key stakeholders. That ends app leading to delays in regulatory approval and diminished public acceptance.  

In that context SPEAC started to develop standardized templates with key benefit/risk assessment considerations.  

Templates can function as a checklist for risk management of complicated activities and might help prioritize future research despite the inevitable gaps in current data. They can facilitate provision of key benefit/risk data for policymakers and for regulators to support the decisions for early authorization in case of emergency use. 

SEE THE PUBLISHED VACCINE TEMPLATES AND LEARN MORE

Digital Transformation (DT) is an industry best practice to advance vaccine discovery, clinical trials, regulatory approval, market distribution, and safety monitoring.  Effective DT results in modernization of technology platforms and emergence of science-based informatics tools for vaccine developers. 

In the context of SPEAC the project, one of the objectives is to create a SPEAC Safety Services Portal to accelerates the distribution and adoption of SPEAC best practice products and services to stakeholders. 

The team will also focus on building data-driven connections between SPEAC products to facilitate collaboration as well as synergy around development and deployment of products by SPEAC; and for distribution of products to partners.

There is a need for better understanding of the unique aspects of special populations in the life cycle of vaccines for emergent and epidemic/pandemic infectious diseases, as well as for the timely assessment of special populations’ disease burden to assess their risk in the early phases of a new disease emergence and for prompt inclusion of special populations in vaccine research and implementation as opposed to exclusion from early research, and late implementation 

The SPEAC project team activities related to special populations include: 

  • Identifying any special populations of relevance for the CEPI prioritized pathogens, and the workstreams of experts for each of the identified special populations.
  • Ensuring the inclusion of special populations in the process of vaccine development, evaluation, and implementation to contribute to CEPI’s objectives. 
  • Supporting key stakeholders throughout the process of vaccine development, evaluation, and implementation for special populations. Tools will be developed and made accessible to facilitate the timely inclusion of special populations in the development, evaluation, and implementation of vaccines for selected emerging pathogens.
  • Facilitating the interaction and integration of goals set up by SPEAC by providing special population level expertise.

The objective of this work package is to contribute to strategies for the generation of evidence of safety at CEPI Research Preparedness, as well as to strengthen the sustainability of such activities as it is critical for ongoing benefit-risk evaluation.  

The fulfil its objective the main tasks of this SPEAC work package will focus on: 

  • Planning for rapid landscape assessment that profiles the current state of current and planned active surveillance in LMICs identified by CEPI Research Preparedness Network sites, including identification of critical gaps and obstacles to sustainability.
  • Defining the requirements and the assessment of the capacity of these Network sites for active safety surveillance of vaccines.
  • Integrating the CEPI Research Preparedness Network sites into existing networks of vaccine safety, promoting coordination and leveraging the efforts of others. 

In the updated WHO R&D Blueprint list of priority diseases in February 2018, “Disease X” was included. “Disease X” is a term used to describe the possibility of a severe global epidemic caused by a pathogen that is not currently known to cause human disease and due to its unpredictable nature it is difficult to anticipate where it is likely to emerge or what it may be.

However, new diseases frequently arise from various parts of the world, particularly in developing countries with high levels of biodiversity. Such countries are at a greater risk of outbreaks due to their limited capacity for surveillance and response. COVID-19 is an example of “Disease X,” and as it has demonstrated, diseases do not respect borders. To respond to future outbreaks effectively, we must be prepared on a global scale.

SPEAC has funds that enable timely acute response to emergency vaccine safety issues; either ​ during the development of candidate vaccine(s) against a new Disease X, or ​during the rollout of such new vaccines to larger populations when new AESI X might first emerge.

OUR TEAM

Project Lead

Dr. Robert T. Chen

Scientific Coordinator

Prof. Dr. Miriam Sturkenboom

Research Director

Dr. Eileen Farnon

DSMB Support and Meta-DSMB Co-Lead

Dr. Steven Black

DSMB Support and Meta-DSMB Co-Lead

Dr. Cornelia Dekker

Standards and Tools Lead

Dr. Barbara Law

Vaccine Safety Templates Lead

Dr. Marc Gurwith

Vaccine Safety Templates Coordinator

Emily Smith

Digital Transformation Lead

Dr. Dale Nordenberg

Special Populations Lead

Dr. Flor Muñoz

Special Populations Co-Lead

Dr. Manu Chaudhary

Support for Vaccine Safety Surveillance Lead

Dr. Andy Stergachis

Quality and Continuous Improvement Lead

Dr. Wan-Ting Huang

MANAGEMENT TEAM

Task Force For Global Health (Program Management)

Program Manager

Anita Renahan-White

Project Manager

Adriana Gibby

Communications Manager

Caroline Cassard

Director for the Center for Vaccine Equity

Dr. Mark McKinlay

WeDo (Project Management)

Project Manager

Ángel Honrado

Project Manager

María Pía Aristimuño

Project Manager

Paz Aguirre

CEPI Members

CEPI Clinical Dev. Vaccine Safety Lead, PL for SPEAC

Rebecca E Chandler, MD


CEPI PM for SPEAC

Tom Cole

BOARD

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INVESTORS & PARTNERS

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CONTACT US

If you want to know more about SPEAC, its objectives, activities and/or partners you can contact us via email.

DSMB Support and Meta-DSMB

Data Safety Monitoring Boards (DSMBs) for vaccines are typically composed of target disease clinical trial experts, statisticians, and infectious disease specialists.  

Unfortunately, individuals with vaccine safety expertise are sometimes difficult to identify especially from LMICs. Additionally, safety signals may be missed in single small trials.   

SPEAC aims to help fill these gaps through DSMB support for vaccine developers and the availability of the SPEAC Meta-DSMB:  

SPEAC aims to help fill these gaps through DSMB support for vaccine developers and  the SPEAC Meta-DSMB:

DSMB Support for vaccine developers

SPEAC has created a pool of eligible candidates for DSMBs who are now available to developers conducting trials in Africa and SE Asia. The pool is being continuously expanded through a SPEAC DSMB training course focusing on qualified participants from priority geographic regions.  

Meta-DSMB

The SPEAC Meta-DSMB is a group that currently comprises 17 global vaccine safety experts who participate in sponsor DSMB meetings as non-voting observersThey meet as a group monthly and report on the safety profile of vaccines across all CEPI-funded clinical trials and look for patterns possibly related to vaccine platforms, antigens, or adjuvants across trials They also provide guidance on request, review reasons to stop/pause the enrolment of individual trials based on safety data and assess impact on similar platforms/antigens/adjuvants 

COMPLETION OF VACCINE SAFETY TEMPLATES

Effective communication of key information among key stakeholders including regulators, public health, and the general public is challenging due to highly subspecialized research with many acronyms, and the lack of specialized training in data supporting vaccine safety by many key stakeholders. That ends app leading to delays in regulatory approval and diminished public acceptance.

In that context SPEAC started to develop standardized templates with key benefit/risk assessment considerations.

Templates can function as a checklist for risk management of complicated activities and might help prioritize future research despite the inevitable gaps in current data. They can facilitate provision of key benefit/risk data for policymakers and for regulators to support the decisions for early authorization in case of emergency use.

DIGITAL TRANSFORMATION OF THE SPEAC TOOLS AND SOLUTIONS

Digital Transformation (DT) is an industry best practice to advance vaccine discovery, clinical trials, regulatory approval, market distribution, and safety monitoring. Effective DT results in modernization of technology platforms and emergence of science-based informatics tools for vaccine developers.

In the context of SPEAC the project, one of the objectives is to create a SPEAC Safety Services Portal to accelerates the distribution and adoption of SPEAC best practice products and services to stakeholders.

The team will also focus on building data-driven connections between SPEAC products to facilitate collaboration as well as synergy around development and deployment of products by SPEAC; and for distribution of products to partners.

INCLUSION OF SPECIAL POPULATIONS

The main goal of the above process that harmonized lists of prioritized AESIs together with their related standardized case definitions, resources and tools are available for global use across the vaccine life cycle, especially in the context of pandemics and/or outbreaks. 

There is a need for better understanding of the unique aspects of special populations in the life cycle of vaccines for emergent and epidemic/pandemic infectious diseases, as well as for the timely assessment of special populations’ disease burden to assess their risk in the early phases of a new disease emergence and for prompt inclusion of special populations in vaccine research and implementation as opposed to exclusion from early research, and late implementation. 

The SPEAC project team activities related to special populations include: 

DISEASE X

In the updated WHO R&D Blueprint list of priority diseases in February 2018, “Disease X” was included. “Disease X” is a term used to describe the possibility of a severe global epidemic caused by a pathogen that is not currently known to cause human disease and due to its unpredictable nature it is difficult to anticipate where it is likely to emerge or what it may be.

However, new diseases frequently arise from various parts of the world, particularly in developing countries with high levels of biodiversity. Such countries are at a greater risk of outbreaks due to their limited capacity for surveillance and response. COVID-19 is an example of “Disease X,” and as it has demonstrated, diseases do not respect borders. To respond to future outbreaks effectively, we must be prepared on a global scale.

SPEAC has funds that enable timely acute response to emergency vaccine safety issues; either during the development of candidate vaccine(s) against a new Disease X, or during the rollout of such new vaccines to larger populations when new AESI X might first emerge.

DEVELOPMENT OF STANDARDS AND TOOLS

A key task of the SPEAC project has been and continues to be the identification of ‘potential’ Adverse Events of Special Interest (AESI) that could occur during vaccine development of the he CEPI prioritized pathogens including Lassa Fever, MERS, Rift Valley Fever, Nipah, Chikungunya, COVID-19. These AESIs were identified based on based on vaccine safety evidence and target disease pathogenesis and the main objective is to  

Once the AESIs have been identified, the work of the Standards and Tools work package in SPEAC focuses on ensuring the availability of the related resources below:  

The main goal of the above process that harmonized lists of prioritized AESIs together with their related standardized case definitions, resources and tools are available for global use across the vaccine life cycle, especially in the context of pandemics and/or outbreaks.

SUPPORT FOR VACCINE ACTIVE SAFETY SURVEILLANCE AT CEPI RESEARCH PREPAREDNESS NETWORK SITES

SPEAC undertakes a series of activities aimed at facilitating the development of safety evidence at CEPI Research Preparedness Network Sites. In addition, SPEAC strives to enhance the sustainability of these activities, which are essential for continuous benefit-risk assessment.

The key activities of SPEAC in achieving this objective include:

Dr. Robert T. Chen

Project Lead

Dr. Chen is the Scientific Director of Brighton Collaboration and is an internationally recognized expert in vaccinology, pharmacoepidemiology, and vaccine safety.  

Dr. Chen played key roles in modernizing the vaccine safety infrastructure in the U.S. and elsewhere.  As Project Leader, he is responsible of overall scientific leadership of the Project. With the support of TFGH scientific coordinator, the Project Lead will provide strategic guidance and coordinate all efforts of the Executive Board for a successful project implementation. With the inputs of the Scientific Coordination Team (TFGH Coordination plus the Program Coordinator), he will assess the project scope adequacy, with a special emphasis on the alignment of the Service Orders with CEPI’s expectations based on progress evolution and actual needs of the various vaccine development programs. He will also be the main liaison point between SPEAC and both CEPI’s Project Lead and Steering Committee (SC) for periodic reporting and monitoring. 

Prof. Dr Miriam Sturkenboom

Scientific coordinator

Dr. Sturkenboom is a pharmacist (University Groningen) and epidemiologist (Harvard School of Public Health).

She worked at the department of Medical Informatics at Erasmus as professor in Observational Data Analysis for almost 20 years, and transferred to the Julius Center, Global Health group at University Medical Center Utrecht in 2017. She pioneered distributed data analytics in Europe and held several keynote lectures on Big Data in Pharmacovigilance. She is past-president of the International Society for Pharmacoepidemiology and was a Science Board member of the Brighton Collaboration from 2012-2018.

She coordinated several EU funded projects on drug safety such as SOS, ARITMO and SAFEGUARD, all of which used available health data across multiple countries. She established the EU Vaccine Safety Datalink for ECDC to study pandemic vaccine safety in EU, led data management and analysis for several global vaccine safety studies and led the IMI-ADVANCE project (47 partners in 19 countries). She is principal investigator on many EMA requested post-authorisation safety studies and expert for EMA, OHDSI, IMEDS, WHO, ECDC, CDC, FDA, ERC.

Eileen Farnon

Research Director

Eileen Farnon is the Director of Research for the Brighton Collaboration. Trained in clinical infectious diseases, tropical medicine, and applied epidemiology, Eileen worked in public health for 15 years at the CDC, the Philadelphia Department of Public Health, WHO, and Institut Pasteur; as well as clinically at Emory University and Temple University School of Medicine. She joined the industry in 2020, as a Clinician in Pfizer’s maternal and older adult RSV vaccine programs, then as Senior Director for Global Medical Affairs for HPV vaccines at Merck, and most recently as Executive Director for Clinical Development and Medical Affairs at a start-up vaccine company. Having responded to many international and domestic outbreaks of emerging and high-hazard infectious diseases, Eileen is passionate about developing and expanding access to vaccines to improve global health and ensuring their safety.

Dr. Steven Black

DSMB Support and Meta-DSMB Co-Lead

Dr. Steven Black received his undergraduate degrees in Biochemistry and Chemistry from the University of California Santa Barbara and his medical degree from the University of California San Diego. He completed a fellowship in paediatric infectious diseases at the University of California San Francisco.  

He then joined Kaiser Permanente where he founded the Kaiser Permanente Vaccine Study Center. During his 30-year career there, he served as principal investigator for five pivotal Phase III trials of paediatric vaccines, as well as multiple Phase II and Phase I studies. He was a charter principal investigator with the CDC sponsored Vaccine Safety Datalink and CISA projects where he published more than 200 articles on vaccine safety and effectiveness.  

Until recently, he served on the US National Vaccine Advisory Committee. He is currently an emeritus professor at the University of Cincinnati Children’s Hospital and Co-Director of the Global Vaccine Data Network, the goal of which is to foster collaborative international evaluations of vaccine safety.  

Dr Black has served on several DSMBs for the NIH, GSK, and Novartis. 

Dr. Cornelia Dekker

DSMB Support and Meta-DSMB Co-Lead

Dr. Dekker received her MD degree at Michigan State College of Human Medicine, did her Pediatric and Pediatric Infectious Diseases training at Duke University and Wellcome Research Laboratories.  She started her career in vaccine clinical development at Lederle Biologicals then Chiron Vaccines where she served as Vice President, Clinical Research and Medical Affairs. In this position, she was responsible for the clinical development of 18 vaccine candidates being developed in the US, Netherlands, Germany and Italy.  

She joined the Stanford University School of Medicine faculty in the Division of Pediatric Infectious Diseases in 1999 and was named Medical Director of the Stanford-LPCH Vaccine Program enrolling thousands of infants, children, adults and elderly participants into clinical trials.While at Stanford, she served as the Stanford PI on NIH-sponsored Vaccine and Treatment Evaluation Unit subcontracts to study new vaccine candidates, on a CDC-sponsored Clinical Immunization Safety Assessment Center contract evaluating safety of licensed vaccines and as PI of NIH grants to lead the Clinical Core in collaboration with Dr. Mark Davis’ large NIH Immunology grants. Dr. Dekker’s expertise in vaccines has been tapped by NIH, HVTN  and vaccine developers to serve on multiple vaccine safety and data monitoring boards. 

Dr. Barbara Law

Standards and Tools Lead

Dr. Law received BSc and MD degrees from the University of Calgary, completed a Paediatric residency (Dalhousie University, Toronto Sick Children’s Hospital) and Infectious Diseases Fellowship (McGill University, Montreal and University of Oklahoma) and was awarded a Medical Research Council research fellowship (U Oklahoma/Dalhousie).

Dr Law was Professor of Medical Microbiology and Paediatrics and Section Head of Paediatric Infectious Diseases at the University of Manitoba for 20 years. While there she was an investigator in several industry sponsored multi-centre phase 2 and 3 vaccine trials and led several epidemiologic studies of VZV and RSV.  In 2004 she left the University to become the Chief of Vaccine Safety for the Public Health Agency of Canada. She held this post until 2015 when she retired, but has continued to act as a consultant in vaccine safety related issues.  From 2005-2011 she served as a member of the WHO Global Advisory Committee on Vaccine Safety as well as the CIOMS-WHO Working group on Vaccines which published a report on Definition and Application of Terms for Vaccine Pharmacovigilance.  Dr Law was also part of a WHO Working Group that developed a new paradigm for Vaccine-Adverse Event causality assessment – currently used by WHO.

Dr. Marc Gurwith

Vaccine Safety Templates Lead

Dr. Gurwith eceived a BA in Philosophy at Yale College, an MD at Harvard Medical School, and a JD at Temple University. He completed residency in internal medicine and an infectious diseases fellowship at Stanford University.

He was an EIS Officer with the CDC, including one year in the WHO Malaria Eradication Program in Haiti. He was an Associate Professor at the University of Manitoba, UCLA and Michigan State University, where he was Head of Infectious Diseases. He then joined Wyeth as Head of Clinical Research for vaccines and antimicrobials.

Since 2002 he has been exclusively focused on vaccine development at VaxGen, then PaxVax; and has worked on the development of vaccines for rotavirus, influenza, HIV, cholera, small pox and anthrax.

He is currently consulting for a number of start-up biotechs including acting as Chief Medical Officer for Verndarii and for Jiangsu Atom Bioscience and Pharmaceutical Co. He has published more than 100 articles and has been PI for a number of NIH grants and contracts. His main research interests have been in the area of infectious diarrheal diseases and in vaccines. Hi is currently a member of the Brighton Collaboration Viral Vector Vaccines Safety Working Group. He is a reviewer for a number of journals including Vaccine.

Emily Smith

Vaccine Safety Templates Coordinator

Emily Smith received a BS in Microbiology, Immunology, and Molecular Genetics at the University of California, Los Angeles (UCLA) and an MPH at Emory University Rollins School of Public Health. 

She worked as a graduate student research assistant at the CDC and then an ORISE Fellow at the CDC. She currently works full time as an infectious disease epidemiologist at the Santa Clara County Department of Public Health, with a focus on HIV, STIs, and COVID. She is also currently the coordinator of the Brighton Collaboration working group Benefit-Risk Assessment of VAccines by TechnolOgy (BRAVATO; ex-V3SWG). 

Dr. Dale Nordenberg

Digital Transformation Lead

Dr. Nordenberg is a physician executive and medical epidemiologist with a focus on digital health and science innovation. He is the Founder and CEO of Thriive.ai, a population health company dedicated to safe medical technology, and is involved in several other healthcare initiatives. Thriive was recently awarded an Intel Innovations Fund grant for its COVID-19 Community Pandemic Response (CPR) Hub, which helps community-based organizations support their members’ health and wellness during a pandemic. Dr. Nordenberg is serving on the COVID-19 advisory board for Bronx Science High School and was a member of the CDC’s leadership team for the SARS-CoV-1 outbreak in 2003.

Dr. Nordenberg is the Co-Founder and Executive Director of the Medical Device Innovation, Safety, and Security Consortium (MDISS), the first public health initiative dedicated to cybersecurity in medical devices. He has advised numerous healthcare technology companies and venture firms, served on federal advisory committees for health information technology standards, and co-founded TBResist, a multinational genomics-based initiative to develop diagnostics and therapeutics for drug-resistant tuberculosis.

Dr. Nordenberg has worked in international settings, including China, and has received board certifications in pediatrics and medical informatics. He received his medical degree from Northwestern University, completed his training in pediatrics at McGill University, and his fellowship in epidemiology and public health at the Centers for Disease Control. Dr. Nordenberg’s notable accomplishments include being a co-principal investigator on the original Adverse Childhood Experiences (ACE) study and co-chairing the first Medical Device Security Information Sharing Council in the Health Information Sharing and Analysis Center (H-ISAC).

Dr. Flor Muñoz

Special Populations Lead

Dr. Muñoz obtained her MD from Francisco Marroquin University in Guatemala and did her Paediatric specialty and Infectious Disease subspecialty training at Baylor College of Medicine in Houston, TX where she is currently an Associate Professor in the Departments of Paediatrics and Molecular Virology and Microbiology, and Director of the Transplant Infectious Disease Program.   

She is a clinician-scientist who has dedicated the last 25 years to vaccine research and implementation, focusing on special populations including children, pregnant women and immunocompromised hosts. She has been an investigator in numerous vaccine clinical trials and epidemiologic studies of respiratory viruses. She has been involved in vaccine safety activities and pandemic preparedness, working with the US CDC, NIH and WHO to develop guidance documents on the safety evaluation of vaccines, and with the Brighton Collaboration to develop definitions for the assessment of safety in studies of vaccines in pregnant women and neonates. Dr. Munoz serves as Chair of the IRB at BCM and in several data safety monitoring committees of vaccines for children, pregnant women and adults. 

Dr. Manu Chaudhary

Special Populations Co-Lead

Dr. Chaudhary will co-lead the SPEAC activities related to the inclusion and consideration of special populations in vaccine development together with Dr. Flor Muñoz. She is an American Board Certified Pediatric Infectious Disease Specialist, and Fellow of the American Academy of Pediatrics. After completing her MBBS from Armed Forces Medical College, Pune, she pursued her residency and fellowship in the USA. Her externships were at Harvard Medical College & Mount Sinai School of Medicine.

She gained expertise in the most sophisticated and contemporary diagnostic methods and therapeutic modalities to assist in the care of healthy children with life-threatening to common infections as well as those immunocompromised patients with complex infectious diseases. Her outpatient training included general ID follow-up for inpatients, referrals from paediatricians, and specialty clinics for Tuberculosis, Travel, and HIV.

Her research focused on Group B Streptococcal prevalence in pregnant women in the USA and India and also genotyping its capsular subtypes, which may aid in future vaccine development. She was awarded the early career award from Thrasher Research Fund for this project. She has been practicing in India for the last seven years. During the COVID-19 pandemic, she led the COVID-19 task force for the largest Children’s Hospital group in India. She also specializes in Infection Control & Prevention and Antimicrobials.

Dr. Andy Stergachis

Support for Vaccine Safety Surveillance Lead

Dr. Stergachis earned his bachelor’s degree in pharmacy from Washington State University and his MS and PhD from the University of Minnesota. He completed a postdoctoral fellowship in health services research at the St. Louis Park Medical Center, Minneapolis, MN.

His research focus is mainly pharmacoepidemiology, global medicines safety, pharmaceutical outcomes research, and public health systems research. He directed a pharmacovigilance pregnancy registry study on the safety of first trimester antimalarials conducted in three sub-Saharan African countries. He has developed and evaluated novel approaches for safety surveillance of essential medicines and vaccines as well as for the evaluation of innovative pharmacy services in low- and middle-income countries. He has organized and conducted trainings and worked with strengthening pharmacovigilance systems with national regulatory authorities and public health programs in multiple LMICs.  As part of the SPEAC team he leads the activities related to the Support for Vaccine Safety Surveillance at CEPI Research Preparedness Network Sites.

Dr. Stergachis is also an elected member of the National Academy of Medicine. Previously, he was senior advisor to the Bill & Melinda Gates Foundation Safety Surveillance Working Group, a member of the US FDA Drug Safety and Risk Management Advisory Committee, and Chair of the Malaria in Pregnancy Consortium Safety Working Group. He is also a fellow of the American Pharmacists Association and of the International Society for Pharmacoepidemiology.

He is a Professor of Pharmacy and Global Health and Adjunct Professor of Health Metrics Sciences and Epidemiology. He is Associate Dean for Research and Graduate Programs in the School of Pharmacy, Director of the Global Medicines Program and Director of the Biomedical Regulatory Affairs Program at the University of Washington.

Dr. Wan-Ting Huang

Quality and Continuous Improvement Lead

Dr Huang guides the operation of monitoring the progress and quality of the work of the project to ensure SPEAC standards and tools are valid and applicable across global settings.

Dr Wan-Ting Huang obtained her MD degree from National Taiwan University and has worked at U.S. CDC’s Immunization Safety Office as an Epidemic Intelligence Service Officer.

She currently serves on the Brighton Collaboration Science Board and holds adjunct faculty appointments in the National Taiwan University Global Health program and Children’s Hospital. In her previous role as Chief Medical Officer at Taiwan Centers for Disease Control, she worked in broad areas of infectious diseases, field epidemiology, surveillance, and social science, with a primary focus of research on applying observational data to inform the use of vaccines from a clinical as well as public health perspective.

Anita Renahan-White

Program Manager

Anita Renahan-White received her BA, MPH, and Masters of Divinity from Emory University.

Anita’s professional experience spans more than 20 years with 13 years serving with the Public Health Informatics Institute at TFGH in a range of roles that included Director of Project Management, Deputy Director for Management and Operations and Sr. Associate Director of Programs. In 2015 Anita pursued a full-time opportunity with Northside Hospital in the metro Atlanta area as a palliative care hospital chaplain and served there for six years.

Anita joined Brighton Collaboration in August 2021 as a Project Manager and is currently the Associate Deputy Director for the Brighton Collaboration at The Task Force for Global Health (TFGH).

Adriana Gibby

Project Manager

Adriana has participated actively in different research projects at Emory University Rollins School of Public Health and the School of Medicine. Prior to joining Emory University, Adriana completed a Master of Science degree in Infectious Diseases at the University of Minnesota and a Veterinary Medicine degree in Colombia. While working at Emory University, Adriana earned a Master of Public Health degree from Rollins School of Public Health, with a focus in Applied Informatics. 

During the last three years, she worked as a Post-Award Administrator managing financial portfolios and monitoring grants and contracts at the Department of Pediatrics, School of Medicine. Before joining the Research Administration Services, Adriana was the Manager of Research Projects at the Child Health and Mortality Prevention Surveillance (CHAMPS) Network. During her first 12 years at Emory, Adriana collaborated closely with Emory Principal Investigators.

Caroline Cassard

Communications Manager

Caroline Cassard is a health communicator and writer based in Atlanta, Georgia. She led communications at the Global Partnership for Zero Leprosy, a program of the Task Force for Global Health, from 2020 to 2023. She now joins the Center for Vaccine Equity in Vaccine Safety as Communications Manager. Before joining the Task Force she served in the Peace Corps in East Java, Indonesia, and in AmeriCorps in Baltimore, Maryland. She has a B.A. in writing, literature, and publishing from Emerson College and is pursuing her Master’s in Public Health at Emory University.

Dr. Mark McKinlay

Director for the Center for Vaccine Equity

Dr. McKinlay received his undergraduate degree from Union College in Schenectady, NY, his master’s and doctoral degrees from Rensselaer Polytechnic Institute in Troy, NY and completed a postdoctoral research fellowship in molecular virology in the Division of Biophysics at The Johns Hopkins University School of Hygiene and Public Health. 

Prior to joining the Task Force, Dr. McKinlay was a member of the Poliovirus Antivirals Initiative Steering Team since its founding in 2008. Prior to the Task Force, Mark was co-founder, Chief Scientific Officer and Senior Vice President for Research and Development of TetraLogic Pharmaceuticals based in Malvern, PA from 2004-2012.  At TetraLogic, Mark led the team that discovered and developed a novel, best in class drug targeting the Inhibitors of Apoptotic Proteins for the treatment of cancer (licensed to Medivir).  From 1994-2004, Mark co-founded ViroPharma Incorporated (acquired in 2014 by Shire) and served as Vice President of R&D where he led the development of an antipicornavirus agent that was the first to demonstrate that an antiviral can affect the duration and severity of the rhinovirus common cold.  From 1980-1994 Mark served in varying roles including Senior Director, Virology and Oncopharmacology in the research group at Sterling Drug (acquired by Sanofi) where he discovered a novel class of antipicornavirus agents and advanced three of these agents into clinical trials.  While at Sterling Drug he demonstrated that oral delivery of an antipicornavirus agent was effective in treating poliovirus infections in mice.   

Mark McKinlay is currently Director for the Center for Vaccine Equity (CVE) based at the Task Force for Global Health. CVE programs include the Polio Eradication Surge Capacity Support team, Polio Antivirals Initiative, Partnership for Influenza Vaccine Introduction (PIVI), Global Funders Consortium for Universal Influenza Vaccine Development, COVID-19 Vaccine Introduction Program (CoVIP), the Coalition for Global Hepatitis Elimination, the Brighton Collaboration, the Safety Platform for Emergency Vaccines (SPEAC) and Voices for Vaccines.

Ángel Honrado

Project Manager

BSc Tourism Planning (2003), MSc in Local Development and Territorial Innovation (2001), and Postgraduate degree in Fundraising (2019).

17+ years’ experience as Project Manager with several organisations in planning, managing, and driving 20 collaborative and multidisciplinary research projects (including FP6, FP7, H2020, HEU, IMI-JU, Gates Foundation’s, and CEPI’s) for more than 100M€. He has been involved in the preparation and management of more than 80 research and innovation projects submitted to the European Commission, supporting different organisations and stakeholders across Europe.

He has been also responsible for the development and implementation of communication and outreach plans, as well as for the exploitation of results generated by EU-funded projects. He has experience in preparing and delivering workshops for project proposals preparation.

Since 2016 he is also co-founder and Public Funding Manager of FreeOx Biotech S.L., a start-up developing a neuro protective treatment preventing the damage caused by reperfusion after stroke.

Maria Pia Aristimuño

Project Manager

BSc in Biology (2013) and MSc. in Molecular biology & Genetics (2017). 

She worked as a scientific researcher in the Molecular genetics field in the public sector, and as part of the Project Management Office of a Non-Governmental Organization devoted to R&D&I projects in various areas of Biological Sciences. Also, she worked in the pharmaceutical industry as R&D project coordinator for the development of vaccines and other biological products.

She has experience in the development of scientific projects from various sides: scientific researcher, project manager and industry. She has supported the presentation of projects for financing, budget development, scientific coordination and project management, project reporting, and dissemination of results.

Paz Aguirre

Project Manager

BSc in International Business (2019), BSc in Banking and Finance (2020), MSc in Project Management (2023).

Paz has experience as a Project Manager for EU-funded research projects, supporting their planning, coordination, reporting, and dissemination. She has also developed tools for monitoring and managing project portfolios in the health and biosciences field.

Rebecca E Chandler, MD

CEPI Clinical Dev. Vaccine Safety Lead, Project Lead for SPEAC

Rebecca is a physician, educated and trained in internal medicine and infectious diseases in the USA. She discovered pharmacovigilance when she accepted a job at the Swedish Medical Products Agency in 2008 as a clinical safety assessor, reviewing both pre- and post-marketing safety data for a number of different types of medicinal products, including vaccines. Her passion for vaccine safety emerged with the narcolepsy/Pandemrix signal during the H1N1 influenza pandemic. She subsequently moved to the Uppsala Monitoring Centre where she was engaged in the development of new methods using spontaneous reports and building pharmacovigilance capacity throughout the world. As the vaccine expert for the UMC, she participated in many global vaccine safety groups, such as the CIOMS Working Group for Vaccine Safety and meetings of the Global Vaccine Safety Initiative.

Currently she works at CEPI as Clinical Development Vaccine Safety Lead and serves as Project Lead for SPEAC and INSIS.  In addition, is member of the WHO Technical Advisory Group for candidate vaccine prioritization and is an Associate Editor for the journal, Vaccine.

Tom Cole

CEPI Project Manager for SPEAC

Tom has a BA in Natural Sciences, a PhD in Microbiology, and a MSc in Science Entrepreneurship. Before starting at CEPI in August 2022 he worked for 17 years as a Project Manager and Clinical Project Manager at UK universities, first at St George’s University of London, and then at Imperial College London. He has managed vaccine development projects spanning the preclinical and early