HESI Annual Meeting

HESI Annual Meeting
9 June 2021

Wednesday, 9 June 2021

10:30 AM
Welcome and Introduction to HESI
Dr. Ruth Roberts, ApconiX, HESI Vice Chair of Board

10:40 AM
Recent Highlights of HESI’s Impact on Global Health and Safety Science
Dr. Syril Pettit, HESI Executive Director

10:55 AM
New Science at HESI: A Window Into New Programming at HESI
Moderator: Dr. Jon Cook, Pfizer, Inc., HESI President of Assembly

Cell Therapy – TRAcking, Circulation, and Safety (CT-TRACS) Committee: Advance Sequencing Technologies for Identification of Off-Target Mutations Associated with Genome Editing (view recording or download presentation)
Dr. Mick Fellows, AstraZeneca

Read Abstract and Bio

Advance Sequencing Technologies for the Identification of Off-Target Mutations Associated with Genome Editing

Induce-seq is a novel sequencing technology that allows the unbiased detection of DNA double strand breaks (DSB) without the need for amplification. It has the potential to increase the sensitivity for DNA damage detection in many applications. The use of Induce-seq to detect CRISPR Cas9 off target DSB will be discussed and the proposal for a pilot HESI project will be introduced.

Dr. Mick Fellows, AstraZeneca

Dr. Mick Fellows is a Principal Scientist in Clinical Pharmacology and Safety Sciences at AstraZeneca. He earned his PhD in Pharmacology and Toxicology investigating topoisomerase II inhibition at Liverpool University. In the mid 1980’s, Mick joined Covance, where he developed and study directed a range of in vitro and in vivo genetox assays, becoming an authority on in vitro mutagenesis and phototoxicity. In 2001, Mick joined AstraZeneca, initially as a genetic toxicologist. However, over the last decade, Mick has focused on AstraZeneca’s advanced medicine safety platforms, including genome editing and modified RNA therapies. Mick’s current role is as the AstraZeneca biopharm cell and regenerative medicine safety lead. Mick has had the honour of serving as the president of the United Kingdom Environmental Mutagen Society and has worked on and chaired several international workgroups, including HESI, OECD, EFPIA and ICH.

Collaboration on Ototoxicity Risk Assessment (CORA): Understanding Ototoxicity Risk (view recording or download presentation)
Dr. Rick Neitzel, University of Michigan

Read Abstract and Bio

Understanding Ototoxicity Risk

HESI’s newest project from the Emerging Issues Committee is the Collaboration on Ototoxicity Risk Assessment (CORA). CORA is focused on finding a better understanding of the causes and risks of ototoxicity. This presentation will focus on the current state of the science, discuss the project plans and invite new participants to join.

Dr. Rick Neitzel, University of Michigan

Dr. Rick Neitzel is an exposure scientist whose research focuses on the characterization of exposures to noise, heavy metals and other ototoxins, psychosocial stressors, and injury risk factors, as well as a range of adverse health effects associated with these exposures. His work, and the work of his team in the UM Exposure Research lab, takes place in occupational and community settings both domestically and abroad. He is particularly interested in incorporating new methodologies and exposure sensing technologies into research, and also has a strong interest in translating his research findings into occupational and public health practice. He directs the UM Risk Science and Human Health Certificate program, and is also Director of the Pilot Project Research Grant Program of the UM Center for Occupational Heath and Safety Engineering.

Prior to his appointment to the faculty of the UM Department of Environmental Health Sciences, he worked as a Research Scientist in the University of Washington Department of Environmental and Occupational Health Sciences from 1998-2011. He has been a Certified Industrial Hygienist since 2003

Cardiac Safety Committee, Cardiovascular Biomarkers Working Group: Solving the Problem of Drug-Related Thrombosis (view recording or download presentation)
Dr. Marjory Brooks, Cornell University

Read Abstract and Bio

Solving the Problem of Drug-Related Thrombosis

The HESI Cardiovascular Biomarkers Working Group has been investigating biomarkers of cardiac injury for more than a decade, including early studies confirming the translational value of cardiac troponins. Hear about their latest projects developing preclinical models of thrombotic complications to prevent later phase drug attrition.

Dr. Marjory Brooks, Cornell University

Dr. Marjory Brooks is a Cornell DVM graduate who completed internship and residency training at the Animal Medical Center in NYC and is an ACVIM Diplomate in small animal internal medicine. She has more than 20 years of experience in hemostasis research and since 2009 has served as Director of the Comparative Coagulation Laboratory at Cornell University. The laboratory has a unique focus on advanced hemostasis testing for all animal species

12:10 PM
Science Foresight: Results of HESI’s 2021 Synthesis of Global and Organizational Trends That Will Drive New Health and Environmental Needs Over the Next Ten Years
Dr. Anthony Holmes, National Centre for the 3Rs, UK, HESI Vice President of Assembly, and Dr. Ron Hines, Yale University School of Public Health, HESI Chair of Emerging Issues Committee

12:30 PM
Break

12:45 PM
Panel Discussion: How Will the COVID-19 Pandemic Impact the Future of Human and Environmental Safety Assessment?
This interdisciplinary and cross-sector panel will address lessons learned and projected future impacts of the COVID-19 crisis as it relates to human and environmental health protection sciences.
Moderator: Dr. Donna Rivera, US Food and Drug Administration (FDA) Oncology Center of Excellence

Evolution of Nonclinical Safety Post COVID-19: A Pharma Product Development Perspective (download presentation)
Dr. Larry Updyke, Pfizer, Inc.

Read Abstract and Bio

Evolution of Nonclinical Safety Post COVID-19: A Pharma Product Development Perspective

Dr. Larry Updyke will discuss COVID-19 drug development as an example of a non-oncology, seriously debilitating or life-threatening (SDLT) indication, the excellent partnership that Pfizer had with global health authorities (FDA in particular but also UK and EMA), and the Pfizer experience in this space as well as the potential benefit of developing a global guidance (e.g., ICH) for SDLTs.

Dr. Larry Updyke, Pfizer, Inc.

Dr. Larry Updyke received a PhD in Toxicology from Purdue University in 1990 completed his postdoctoral research at Eli Lilly Labs and is certified as a Diplomate of the American Board of Toxicology (1996-present). He has more than 25 years of non-clinical safety drug development experience across multiple therapeutic areas including small and large molecule experience at all stages of development. He currently serves as the Drug Safety Research and Development Therapeutic Area Leader for Internal Medicine, Hospital Products, and Anti-Infectives for Pfizer managing all aspects of nonclinical safety for the entire drug development timeline.

Wastewater Testing for COVID-19: An Environmental Health Protection Perspective (download presentation)
Dr. Frederic Béen, KWR Water Research Institute, The Netherlands

Read Abstract and Bio

Wastewater Testing for COVID-19: An Environmental Health Protection Perspective

Dr. Frederic Béen will be presenting the work the KWR and it’s partners have been carrying out in the field if wastewater analysis for public health purposes, also referred to as wastewater-based epidemiology (WBE) or sewage surveillance. Before the pandemic, KWR was actively involved in the monitoring of chemicals in wastewater to assess human health and lifestyle. Through these activities, KWR acquired a lot of knowledge about wastewater monitoring and how to translate wastewater signals to public health and epidemiologically relevant information. The COVID19 outbreak triggered a rapid development in the field of microbiological monitoring of wastewater, which culminated in the development of the approach to track the circulation of SARS-CoV-2 in communities through wastewater analysis, which is being implemented on a large scale in numerous countries around the world. Finally, Frederic will briefly present his vision about how WBE will further be developed to help tackle the public health problems of the future.

Dr. Frederic Béen, KWR Water Research Institute, The Netherlands

Dr. Frederic Béen is a researcher at KWR Water Research Institute in The Netherlands. His research activities focus on (i) the implementation of analytical and sampling techniques to monitor emerging contaminants in the water cycle; (ii) advanced data analysis approaches to interpret chemical and environmental data and (iii) the further development of wastewater analysis to monitor human health at the population scale. He has been actively involved in the research around the monitoring of SARS-CoV-2 at KWR.

A Retrospective View on Urgent Preclinical Research Involving SARS-CoV-2
Dr. Simon Funnell, National Infection Service, Public Health England / World Health Organization

Read Abstract and Bio

A Retrospective View on Urgent Preclinical Research Involving SARS-CoV-2

Since the WHO R&D Blueprint global response to Pathogen X was activated for SARS-CoV-2, an unprecedented level of international collaboration has helped to reduce the timeline to approval and implementation of a broad range of vaccines, drugs and therapeutics. During this ground-breaking response, some of the traditional approaches of biological modelling and assessment have been challenging due to both the ability of the SARS-CoV-2 virus to mutate and adapt and weaknesses in methodology. Looking back at our experience, this is a good time to reflect on the strengths and weaknesses of the default approaches which were taken and consider ways in which improvements can be made for the future and any other emerging Zoonotic health threats.

Dr. Simon Funnell, National Infection Service, Public Health England / World Health Organization

Dr. Simon Funnell has 35 years of experience as a researcher in microbiology including translational research to develop vaccines, drugs and novel therapies against a wide range of infectious agents. As a study director and scientific leader, he has overseen 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, industry and international agencies. UK Health Security Agency (UKHSA) played a role in the global response to outbreaks of Influenza, EBOLA and SARS-CoV-2. Through secondment to the WHO R&D Blueprint team since February 2020, Simon has also assisted in the coordination of global collaboration aimed at reducing the time required for development and utilisation of new vaccines, drugs and therapies against SARS-CoV-2.

Population Data Insights and Lessons Learned from Publishing Up-to-Date Data to the General Public: Perspectives From the Israeli Experience (download presentation)
Dr. Meytal Avgil Tsadok, Deloitte Israel / Israeli Ministry of Health

Read Abstract and Bio

Population Data Insights and Lessons Learned from Publishing Up-to-Date Data to the General Public: Perspectives From the Israeli Experience

Dr. Meytal Avgil Tsadok will present insights from a project that she’s initiated, designed, and executed – the end-to-end process of publishing in-depth clinical and governmental data on the COVID-19 pandemic to the general public.

Dr. Metyal Avgil Tsadok, Deloitte Israel / Israeli Ministry of Health

Dr. Meytal Avgil Tsadok is an Epidemiologist with a PhD from the Hebrew University and did her post-doctoral fellowship in Clinical Epidemiology in McGill University, with specialties in pharmacoepidemiology and administrative databases. She is now working as a consultant in Deloitte Analytics, Israel. She has more than 20 years of experience in the health industry analyzing health datasets in both commercial and government sectors, with specialties in real world and big data. Prior to joining Deloitte, Dr. Avgil Tsadok worked in Clalit Research Institute as a senior epidemiologist and was the project manger of many health studies.

2:30 PM
Closing Comments from HESI
Dr. Martin van den Berg, Utrecht University, HESI Chair of Board

PAST ANNUAL MEETINGS

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