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33rd Annual Genotoxicity Workshop

Tuesday, May 14 and Wednesday, May 15, 2019

Johns Hopkins University, Rockville, Maryland

 

We are pleased to announce the premier genotoxicity event. In its 33rd year, this workshop features assay demonstrations, in-depth presentations by recognized experts, a government regulatory expert, a GLP regulations expert, and a facility tour. Admission is free.

Genotoxicity is complex and takes time to comprehend the myriad of assessment requirements. This workshop will walk through the regulations, assays and provide clarity on requirements for every type of product development and focus on gaining regulatory approval.

Course Content

  • Assay discussions on the theoretical basis for each test system.
  • Protocol design, assay limitations, data interpretation
  • Real life case studies
  • Screening/non-GLP versions, GLP regulatory-approved assays and follow-up assays to resolve in vitro positives

Learning Goals

  • Innovation and the Latest Assay Designs
  • Novel designs for the study of mechanism and mode of action
  • Designs of follow-up assays to rescue positive results
  • BioReliance® screening paradigms: in silico (QSAR) analysis, high-throughput screening assays, predictive screening assays, and more.

Who Should Attend

Ideal for anyone involved in product development. Those with less experience will appreciate the thorough investigation of every assay and the regulations those assays support. Experienced attendees will learn about the latest techniques in genotoxicity assessment.

What will you Receive

  • Course materials
  • This workshop Qualifies for CEU credits.

Course Content

Program* - May 14, 2019

Session ID  
   
 7:30 AM - 8:00 AMRegistration
   
 8:00 AM - 8:10 AMWelcome and Opening Remarks
  Rohan Kulkarni, MSc, PhD, ERT, Director- Toxicology
   
1018:10 AM - 9:05 AMIntroduction to Genetic Toxicology: Background, Laws, Guidelines, and Regulations
  Rohan Kulkarni, MSc, PhD, ERT, Director- Toxicology
   
1029:05 AM - 9:55 AMBacterial Reverse Mutation Assays (Including Miniatured Versions)
  Emily W. Dakoulas, BS, Senior Scientist/Study Director
   
 9:55 AM - 10:10 AMBreak
   
10310:10 AM - 11:00 AMMammalian Cell Mutation Assays (Mouse Lymphoma and CHO/HPRT Assay)
  Veronica Aquino, MS, Scientist/Study Director
   
10411:00 AM - 11:50 AMIn Vitro Cytogenetic Assays (including TK6 and 3D Skin)
  Shambhu Roy, PhD, Principal Scientist/Study Director
   
 11:50 AM - 12:50 PMLunch
   
10512:50 PM - 1:40 PMIn Vivo Cytogenetic Assays
  Megan Young, PhD, Scientist/Study Director
   
1061:40 PM - 2:20 PMIn Vivo Comet Assay (Combo and 3D Skin Assays)
  Shannon W. Bruce, MFS, Scientist/Study Director
   
 2:20 PM - 2:40 PMBreak
   
1072:40 PM - 3:40 PMA high-throughput genotoxicity assay using the transcriptomic biomarker, TGx-DDI
  Al Fornace and HengHong Li, GeorgeTown University
   
1083:40 PM - 4:30 PMAnalytical Chemistry Support
  Philip Aktins, Mchem/Li Tian, Ph.D, Principal Scientist/Study Director
   
 4:30 PM - 4:45 PMFollow-up Q&A

 

*Agenda subject to change.

 

Program* - May 15, 2019

Session ID  
   
 7:30 AM - 8:00 AMBreakfast with BioReliance Scientists
   
 8:00 AM - 8:05 AMWelcome Back and Review of Agenda
  Rohan Kulkarni, MSc, PhD
   
2018:05 AM - 8:45 AMNon-GLP Studies (QSAR, HTP Screening, Predictive Screening Assays)
  Kamala Pant, MS, Principal Scientist/Study Director
   
2028:45 AM - 9:35 AMIn vivo Mutation assays (Big Blue® Transgenic Rodent (TGR) Mutation Assay, Pig-A assay and Duplex Sequencing)
  Robert Young, MS, Program Consultant/ Study Director
   
 9:35 AM - 10:00 AMBreak
   
20310:00 AM - 10:50 AMToxicological Evaluation of Medical Devices —Tests for Genotoxicity (ISO 10993-3) and Risk Assessment (ISO 10993-17)
  Hong Xie, Ph.D., Senior Scientist/Study Director
   
20410:50 AM - 11:15 AM3D Skin Micronucleus and 3D Skin Comet Assay
  Shambhu Roy, PhD, Principal Scientist/Study Director
   
20511:15 AM - 11:55 AMDealing with Positive Genetic Toxicology Results
  Rohan Kulkarni, MSc, PhD, ERT, Director- Toxicology
   
20611:55 AM - 12:25 PMA Comprehensive Genetic Toxicology Testing Program: Workshop Summary and Panel Discussion
  Rohan Kulkarni, MSc, PhD, ERT, Director- Toxicology
   
 12:25 PM - 1:25 PMLunch
   
 1:25 PM - 1:55 PMDepart for Lab Tours
   
 1:55 PM - 4:55 PMLab Tours

 

*Agenda subject to change.

WHEN:

Tuesday, May 14 and Wednesday, May 15, 2019

WHERE:

Johns Hopkins University
Montgomery County Campus
9605 Medical Center Drive
Room 121
Rockville, Maryland
Follow the MilliporeSigma BioReliance® signs

ACCOMMODATIONS:

Participants responsible for his/her own accommodations and transportation.

REFRESHMENTS:

Light breakfasts, boxed lunches, coffee, and snacks

ATTIRE:

Business Casual

Free workshop includes facility tour and assay demonstrations

Register

Hotel: Reserve your room at a discounted rate.