Past Events

Past Events

FDA/CDER-HESI Workshop on Preclinical and Translational Safety Assessment of CD3 Bispecifics

Silver Spring, Maryland, USA

With the emergence of CD3 bispecifics as a novel weapon in the fight against cancer, there is a growing need to share information and learnings about these compounds that range from strategies for target expression profiling to nonclinical safety assessment to clinical experience. This workshop is designed to engage with a multi-stakeholder group of experts that will present and discuss their case examples with the objectives of learning from each other through robust engagement and discussion to enable the best outcomes for patients

Read more

The Gut Microbiome Workshop

Alexandria, VA, United States

A 2-day workshop to address the state of the science and data gaps in gut microbiome research.

Read more

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				FAAM Workshop Logo_revised large 4
			
						REGISTRATION HERE
					
			
						DRAFT MEETING AGENDA
					
	

Details
Location: Tivoli Hotel and Congress Center - Copenhagen, Denmark
Dates: October 17 - 18, 2018

There will also be another meeting at the Tivoli Hotel and Congress Center in Copenhagen, Denmark, called FAAM 2018, a EAACI Focused Meeting. FAAM 2018 will take place from 18 -20 October 2018. Please consider attending both events! Find more information on the event here.

About
In the growing field of allergy research, scientists can approach protein characterization and allergy hazard assessment in diverse ways. The Health and Environmental Sciences Institute (HESI) Protein Allergens, Toxins, and Bioinformatics (PATB) committee supports original basic research that seeks to uncover the interplay between protein allergenicity and the physicochemical properties of allergenic proteins. The PATB also oversees the creation, maintenance and distribution of the Comprehensive Protein Allergen Resource (COMPARE) Database whose use in conjunction bioinformatic tools, offers an effective means for assessing allergenic potential of novel food proteins.  PATB’s focus on basic allergy research, coupled with bioinformatic methods for allergenic hazard assessment is unique within the scientific community as it supports an ever-increasing awareness of allergenicity among consumers and regulators. Topics to be covered in this workshop will include historic aspects of food allergy assessment, the evolution of bioinformatics as it relates to allergy assessment, and recent changes in regulations regarding novel food proteins.

This educational workshop will cover advances in protein allergy research and inform the use of novel approaches for the identification of potential food allergens. This event will be of interest to government regulators, those involved in food allergy and celiac disease research, and scientists involved in food safety and risk assessment.

dreamstime_xl_71979237

 

Objectives

Evaluate bioinformatics approaches to characterize the allergenicity potential of novel proteins and inform allergy safety assessment.

Discuss real-world examples of: 1) a product development case-study describing the utility of bioinformatics in protein characterization, and 2) a practical application of the EFSA 2017 Guidance.

Provide insights from new research, ranging from modifications of allergen epitopes at the single amino-acid level, to using protein structural modeling for allergenicity prediction, to the relation between enzymes and allergenic activity.

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The Gut Microbiome: Markers of Human Health,

Drug Efficacy and Xenobiotic Toxicity

 

June 25 - 26

Holiday Inn & Suites Alexandria - Old Town
625 First Street
Alexandria, Virginia

The gut microbiome is believed to play an important role in human health in areas as diverse as brain function and the immune system.  Exploring host-microbiome interactions will provide a mechanistic understanding and enable new insights in human diseases (i.e., their diagnosis, prognosis and treatment) and new perceptions of xenobiotic efficacy and/or toxicity. This workshop will review the science and initiate discussions on multiple topics, including a) identification of biomarkers of toxicity for alterations in gut microbial function, b) if changes in the microbiome can affect efficacy of medicines and c) if exposure to xenobiotics can eventually result in a disease state through changes in the microbiome.  Conclusions from his workshop will help determine where the data gaps are so that researchers can start answering these questions.

WORKSHOP GOAL
To identify data gaps that can be addressed to help determine if alterations in the gut microbiome have an effect on human health.

Microbiome

WORKSHOP AIMS
1.  To discuss and review the current science on the gut microbiome and identify areas of interest regarding its role in human health
2.  To discuss our understanding on how xenobiotic toxicity affects the microbiome
3.  To understand if there are biomarkers of disease or organ damage due to:
     -  Alterations of microbiome structure and function
     -  Endogenous microbial metabolites

Workshop Agenda [Download Agenda]

Plenary

 

Drugging Gut Microbial Enzymes for the Treatment of Cardiometabolic Disease
Mark Brown, Cleveland Clinic                                                                     

Session 1: Biotransformation

Overview of Biotransformation of Xenobiotics by Microbiota

Julia Cui, University of Washington [Download Presentation]

 

Gut Microbial Transformation – Endogenous and Exogenous Metabolites & Effect of Xenobiotics on Microbial Composition and Endogenous Functions

Gary Perdew, Penn State University

 

Modification of Chemical Effects by Microbiome?

Andrew Patterson, Penn State University

 

Session 2: Biomarkers of Adverse Effects

What is an Adverse Effect?

Rodney Dietert, Cornell University [Download Presentation]

 

Where to Look for Biomarkers?

Carrie Brodmerkel, Janssen [Download Presentation]

 

Challenges in Determining Sensitive Biomarkers of Dysbiosis When Assessing the Impact of Antimicrobial Drug Residues in Food on the Human Intestinal Microbiome

Carl Cerniglia, US FDA-NCTR [Download Presentation]

 

What are the Tools and Technologies Needed?

Joseph Petrosino, Baylor College of Medicine [Download Presentation]

 

Session 3: Biomarkers of Toxicity & Disease

Toxicity and Environmental Pollutants

Kun Lu, University of North Carolina Chapel Hill

 

Identification of Microbiome-based Biomarkers and Challenges Associated with their Application: Case Studies from Obesity, IBD, and Cancer

Emily Hollister, Diversigen [Download Presentation]

 

The Microbiome and Hypertension

Elaine Richards Sumners, University of Florida [Download Presentation]

 

Session 4: Human Susceptibility

Health Insights from Microbiomes in the Context of Personal, Dense, Dynamic, Data Clouds

Nathan Price, Institute for Systems Biology

 

Age – Early & Late Life

Eugene Chang, University of Chicago [Download Presentation]

 

Gender and the Gut Microbiome

Marijke Faas, University of Groningen

 

Session 5: Key Animal Models

Overview of Key Factors Known to Affect Composition of Laboratory Rodent Gut Microbiome

Aaron Ericsson, University of Missouri [Download Presentation]

 

Natural World Versus Laboratory World: Natural Gut Microbiota from Wild Mice Improve Host Fitness in Viral Infection and Carcinogenesis Models

Barbara Rehermann, NIH/NIDDK [Download Presentation]

 

Investigating Interactions Between Chemicals and Microbiota in Zebrafish

Tamara Tal, US EPA

 

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Details
Location: Tivoli Hotel and Congress Center - Copenhagen, Denmark
Dates: October 17 - 18, 2018

There will also be another meeting at the Tivoli Hotel and Congress Center in Copenhagen, Denmark, called FAAM 2018, a EAACI Focused Meeting. FAAM 2018 will take place from 18 -20 October 2018. Please consider attending both events! Find more information on the event here.

About
In the growing field of allergy research, scientists can approach protein characterization and allergy hazard assessment in diverse ways. The Health and Environmental Sciences Institute (HESI) Protein Allergens, Toxins, and Bioinformatics (PATB) committee supports original basic research that seeks to uncover the interplay between protein allergenicity and the physicochemical properties of allergenic proteins. The PATB also oversees the creation, maintenance and distribution of the Comprehensive Protein Allergen Resource (COMPARE) Database whose use in conjunction bioinformatic tools, offers an effective means for assessing allergenic potential of novel food proteins.  PATB’s focus on basic allergy research, coupled with bioinformatic methods for allergenic hazard assessment is unique within the scientific community as it supports an ever-increasing awareness of allergenicity among consumers and regulators. Topics to be covered in this workshop will include historic aspects of food allergy assessment, the evolution of bioinformatics as it relates to allergy assessment, and recent changes in regulations regarding novel food proteins.

This educational workshop will cover advances in protein allergy research and inform the use of novel approaches for the identification of potential food allergens. This event will be of interest to government regulators, those involved in food allergy and celiac disease research, and scientists involved in food safety and risk assessment.

dreamstime_xl_71979237

 

Objectives

Evaluate bioinformatics approaches to characterize the allergenicity potential of novel proteins and inform allergy safety assessment.

Discuss real-world examples of: 1) a product development case-study describing the utility of bioinformatics in protein characterization, and 2) a practical application of the EFSA 2017 Guidance.

Provide insights from new research, ranging from modifications of allergen epitopes at the single amino-acid level, to using protein structural modeling for allergenicity prediction, to the relation between enzymes and allergenic activity.

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