This website uses cookies to store information on your computer. Some of these cookies are used for visitor analysis, others are essential to making our site function properly and improve the user experience. By using this site, you consent to the placement of these cookies. Click Accept to consent and dismiss this message or Deny to leave this website. Read our Privacy Statement for more.
Print Page   |   Contact Us   |   Sign In   |   Register
Community Search
DC Area Scientific Discussion Group - February 2020
Share |

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

CBER, FDA


VIEW SPEAKER SLIDES

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

FDA



VIEW SPEAKER SLIDES

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.



Schedule

 

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


Location

AstraZeneca
1 MedImmune Way
Gaithersburg, MD 20878

 

 

 
more Calendar

9/28/2020 » 10/1/2020
CE Pharm 2020

10/13/2020 » 10/15/2020
CMC Strategy Forum North America Fall 2020

Membership Software Powered by YourMembership  ::  Legal