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 AM | Registration | |
| 8:00 AM - 8:10 AM | Welcome and Opening Remarks | |
| Rohan Kulkarni, MSc, PhD, ERT, Director- Toxicology | ||
| 101 | 8:10 AM - 9:05 AM | Introduction to Genetic Toxicology: Background, Laws, Guidelines, and Regulations |
| Rohan Kulkarni, MSc, PhD, ERT, Director- Toxicology | ||
| 102 | 9:05 AM - 9:55 AM | Bacterial Reverse Mutation Assays (Including Miniatured Versions) |
| Emily W. Dakoulas, BS, Senior Scientist/Study Director | ||
| 9:55 AM - 10:10 AM | Break | |
| 103 | 10:10 AM - 11:00 AM | Mammalian Cell Mutation Assays (Mouse Lymphoma and CHO/HPRT Assay) |
| Veronica Aquino, MS, Scientist/Study Director | ||
| 104 | 11:00 AM - 11:50 AM | In Vitro Cytogenetic Assays (including TK6 and 3D Skin) |
| Shambhu Roy, PhD, Principal Scientist/Study Director | ||
| 11:50 AM - 12:50 PM | Lunch | |
| 105 | 12:50 PM - 1:40 PM | In Vivo Cytogenetic Assays |
| Megan Young, PhD, Scientist/Study Director | ||
| 106 | 1:40 PM - 2:20 PM | In Vivo Comet Assay (Combo and 3D Skin Assays) |
| Shannon W. Bruce, MFS, Scientist/Study Director | ||
| 2:20 PM - 2:40 PM | Break | |
| 107 | 2:40 PM - 3:40 PM | A high-throughput genotoxicity assay using the transcriptomic biomarker, TGx-DDI |
| Al Fornace and HengHong Li, GeorgeTown University | ||
| 108 | 3:40 PM - 4:30 PM | Analytical Chemistry Support |
| Philip Aktins, Mchem/Li Tian, Ph.D, Principal Scientist/Study Director | ||
| 4:30 PM - 4:45 PM | Follow-up Q&A |
*Agenda subject to change.
Program* - May 15, 2019
| Session ID | ||
| 7:30 AM - 8:00 AM | Breakfast with BioReliance Scientists | |
| 8:00 AM - 8:05 AM | Welcome Back and Review of Agenda | |
| Rohan Kulkarni, MSc, PhD | ||
| 201 | 8:05 AM - 8:45 AM | Non-GLP Studies (QSAR, HTP Screening, Predictive Screening Assays) |
| Kamala Pant, MS, Principal Scientist/Study Director | ||
| 202 | 8:45 AM - 9:35 AM | In 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 AM | Break | |
| 203 | 10:00 AM - 10:50 AM | Toxicological Evaluation of Medical Devices —Tests for Genotoxicity (ISO 10993-3) and Risk Assessment (ISO 10993-17) |
| Hong Xie, Ph.D., Senior Scientist/Study Director | ||
| 204 | 10:50 AM - 11:15 AM | 3D Skin Micronucleus and 3D Skin Comet Assay |
| Shambhu Roy, PhD, Principal Scientist/Study Director | ||
| 205 | 11:15 AM - 11:55 AM | Dealing with Positive Genetic Toxicology Results |
| Rohan Kulkarni, MSc, PhD, ERT, Director- Toxicology | ||
| 206 | 11:55 AM - 12:25 PM | A Comprehensive Genetic Toxicology Testing Program: Workshop Summary and Panel Discussion |
| Rohan Kulkarni, MSc, PhD, ERT, Director- Toxicology | ||
| 12:25 PM - 1:25 PM | Lunch | |
| 1:25 PM - 1:55 PM | Depart for Lab Tours | |
| 1:55 PM - 4:55 PM | Lab 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