Achieving Data Quality and Integrity in Maximum Containment  Laboratories — Nonclinical CourseFDA-UTMB Collaborative Education Program

Medical Affairs Scientist/Chief Medical Officer
Frederick National Lab/NIAID Integrated Research Facility at Fort Detrick

Presentation Title: 

1. Clinical research at the (evolving) Ebola virus disease bedside: Lessons from a steep learning curve
2. BSL-4 in the Field

Ian Crozier is an infectious diseases clinician-scientist at the Frederick National Lab providing chief medical officer support to NIH/NIAID’s Integrated Research Facility (IRF) at Fort Detrick. His position enables bidirectional agility between the BSL-4 animal models of high-threat or emerging infectious diseases and the human outbreak bedside, including in clinical and research efforts in Ebola virus disease (EVD) in Western and Central Africa. Research interests are informed both by extensive clinical experience and a prior personal experience of EVD that included critical illness and severe sequelae. In addition to filoviral diseases, current work at the IRF includes the development of non-human primate models of SARS-CoV-2/COVID-19 and Lassa Fever as well as leading clinical management efforts in an ongoing clinical trial of therapeutics for mpox in DRC. Previous work with the World Health Organization and an Emory University Eye team focused on EVD survivors, targeting their clinical care needs, the management of residual risk related to viral persistence, and scientific questions newly emerging at EVD survivor bedsides. Prior to 2014, he spent many years based at the Infectious Diseases Institute (Kampala, Uganda) training African clinicians in complex decision-making in patients with HIV/AIDS, tuberculosis, another other common tropical illness. He completed his infectious diseases and medical training at Vanderbilt University. He is originally from Bulawayo, Zimbabwe.

Scientific Leader
United Kingdom Health Security Agency (UKHSA)

Presentation Title:

1. Development, Characterization and Standardization of Bacterial and Viral Stocks
2. Regulatory in Vivo: U.K. Perspective 
3. Global Responses to the COVID Pandemic

Dr. Simon Funnell has almost 40 years of experience as a researcher in microbiology. Simon's postgraduate and postdoctoral training focused on vaccine research and his career has included translational research to develop vaccines, antibiotics and novel therapies against a wide range of infectious agents including many Select Agents and public health threats. As a study director and scientific leader, he has overseen the bidding, planning, design, execution and reporting of many complex projects involving the development and utilization of in vivo models using aerosols and other routes of infection with Select Agents and public health pathogens funded by several US government agencies as well as UK government and international agencies. He is also working to develop ways to refine, reduce or replace animals in this field.

The challenges of conducting studies aimed at replacing human clinical Phase III efficacy trials are familiar to him and his colleagues at the UK Health Security Agency (UKHSA). UKHSA’s ABSL3 and ABSL4 facilities have been used to conduct a wide range of studies including a GLP study with NHPs. UKHSA (and its predecessors) has been involved in the global response to outbreaks of Influenzae, EBOLA and SARS-CoV-2. Through secondment to the WHO R&D Blueprint team since February 2020, Dr Funnell has also assisted in the co-ordination of global collaboration aimed at reducing the time required for development and utilisation of new vaccines and therapies against SARS-CoV-2. This has resulted in unprecedented co-operation of international scientific groups and the sharing of data in real time where a focus on quality and integrity of data is critically important.

Global Health Science Advisor
Division of Clinical Research, NIAID, NIH, HHS

Presentation Title:

1. Conducting Clinical Research in the Setting of an Outbreak: From HIV to Ebola to COVID-19

Elizabeth Higgs (Libby) is a global health science advisor, clinical scientist, and pandemic policy advisor for the National Institute of Allergy and Infectious Diseases’, Division of Clinical Research (DCR) at the National Institutes of Health. Dr. Higgs provides expertise, interagency and multilateral engagement for DCR’s health emergency response research activities which have included SARS-CoV-2, Ebola outbreaks in West Africa and the DRC, and the 2018 Nipah outbreak in Kerala, India. She serves on a variety of global health security, multilateral, and USG policy groups for emergency response and preparedness. She serves as an investigator on a variety of EID protocols and is the NIAID Division of Clinical Research liaison and SME for emergency response research to World Health Organization. She is trained in internal medicine and infectious diseases. She holds a doctorate in medicine, a master’s degree in International Affairs, an interdisciplinary bachelor’s degree in bioethics, and a Diploma in Tropical Medicine and Hygiene.