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DC Area Scientific Discussion Group - February 2020
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Thursday, February 20, 2020 (3:00PM - 5:30PM)

Location: AstraZenecaGaithersburg, MD

Thank you to everyone who joined us for an afternoon of discussion on

Antibiotic Resistance

Featured Speakers:

Cara Fiore



Regulatory Considerations in the Development of Bacteriophage for Clinical Use

The U.S. Food and Drug Administration, Center for Biologics Evaluation and Research, Office of Vaccines Research and Review (OVRR) regulates bacteriophage (phage) therapy when used for infectious disease indications. This presentation will focus on the Investigational New Drug (IND) regulatory review process and phage therapy development for studies under IND. Regulatory considerations for clinical studies and the chemistry, manufacturing and control (CMC) information will be reviewed, which may aid in preparation of an Investigational New Drug Application (IND) that is designed to collect clinical data to support marketing approval in the U.S.

Cara Fiore is a microbiologist and regulatory reviewer at the US Food and Drug Administration, Center for Biologics Evaluation and Research, Office of Vaccine Research and Review/Division of Vaccines and Related Products Applications (FDA/CBER/OVRR/DVRPA). Investigational New Drug applications (IND) and Biological Licensing Application (BLA) for vaccines for infectious diseases, bacteriophage therapy, allergenics and live biotherapeutic products when used to treat, prevent or mitigate a disease in humans are regulated in this Office for the US. She has been at the FDA in this capacity since 2007. Dr. Fiore is heavily involved in the regulation of bacteriophage therapy in DVRPA/OVRR.


Errol Strain



Whole-Genome Sequencing for Surveillance of AMR in Foodborne Bacterial Pathogens

In 2020 whole-genome sequencing (WGS) will completely replace legacy technologies for detecting, tracking, and characterizing common bacterial pathogens in the food supply and for surveillance of foodborne illness in the United States. The Food and Drug Administration, Centers for Disease Control, and the Food Safety Inspection Service at the United States Department of Agriculture work together to publicly share WGS data from product testing, inspections of food producing facilities, and clinical cases of foodborne illness. WGS provides a common platform for public health and agricultural laboratories to look for genetic matches between isolates from different sources, and to identify markers associated with virulence, pathogenicity, and anti-microbial resistance. This presentation will provide an overview of how microbial genomics is being used to improve food and feed safety in the United States. 

Dr. Errol Strain joined the Division of Animal and Food Microbiology in the Office of Research at the FDA’s Center for Veterinary Medicine in 2019 where he is responsible for bioinformatic analysis of drug-resistant pathogens for the National Antimicrobial Resistance Monitoring System. From 2010 to 2018 he was the Supervisor for the Biostatistics and Bioinformatics Staff in the Office of Analytics and Outreach at the Center for Food Safety and Applied Nutrition where he helped to create bioinformatics pipelines and workflows for the GenomeTrakr program. He received his Bachelor of Science degree in Biochemistry from Purdue University in 1998 and his Ph.D. in Bioinformatics from North Carolina State University in 2006. Dr. Strain’s research at the FDA has focused on the application of genomic methods for surveillance and prediction of antimicrobial resistance in foodborne bacterial pathogens. 

 Registration is now closed.

Pre-registration is required; there will be no onsite registration.



3:00 PM - Welcome
3:15 PM - Lectures
Networking and Discussion to Follow


1 MedImmune Way
Gaithersburg, MD 20878



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