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Education Course
Toxicology for Pharmaceutical and Regulatory Scientists

This annual ACT course provides basic training in general toxicology. Participants will obtain an overall understanding of the principles of toxicology and nonclinical safety evaluation with a focus on pharmaceutical development. By popular demand, the course will include discussion of regulatory case studies and hands-on analyses of nonclinical data. The course is intended to benefit individuals working with small and large molecules from biotechnology and pharmaceutical companies, CROs, and regulatory agencies, or individuals interested in or currently practicing toxicology.

The ACT course is only being offered as an in-person format. Virtual or hybrid participation is not an option.

Monday, April 8, 2024

Principles of Toxicology, A. Wallace Hayes, University of South Florida, College of Public Health
Introduction to Pharmacology for the Toxicologist, Amy Avila, US Food and Drug Administration
Principles of Drug Metabolism and Toxicokinetics and Applications to Pharmaceutical Toxicology
Leanne Bedard, Bedard ADME-Tox Solutions
Safety Pharmacology for Human Pharmaceuticals, Simon Authier, Charles River


Reception

Please join us for a reception following the course on Monday. This light-fare reception, which is included in the registration fee, allows for fellow course attendees, course organizers, and speakers to interact and network in a casual atmosphere. Hors d’oeuvres, plus drink tickets for beer and wine will be provided to registered participants.

Tuesday, April 9, 2024

Nonclinical Safety Evaluation of Biotechnology-Derived Therapeutics, Melanie Hartsough, Hartsough Nonclinical Consulting, LLC
Toxicology of Organ Systems, Mary Beth Genter, University of Cincinnati
Clinical Pathology: Principles for Pharmaceutical and Regulatory Scientists, Lila Ramaiah, The Janssen Pharmaceutical Companies of Johnson & Johnson
Pathology in Toxicology Studies, Thomas Steinbach, Experimental Pathology Laboratories, Inc.

Wednesday, April 10, 2024

Genetic Toxicology, Mark Powley, Merck and Co.
Evaluation of Potential Carcinogenicity, James Popp, Stratoxon
General Toxicology, Lorrene Buckley, Eli Lilly & Company
Reproductive/Developmental and Juvenile Toxicology, Alan Hoberman, Charles River

Thursday, April 11, 2024

Immunotoxicology, Florence Burleson, Burleson Research Technologies, Inc.
Risk Assessment, Melissa Rhodes, Avalyn Pharma
Regulatory Toxicology—A Nonclinical Pharmacology and Toxicology Perspective, Hanan Ghantous, US Food and Drug Administration
Practical Application: Breakout Session and Case Outcome Reviews, Hanan Ghantous, US Food and Drug Administration, Natalie Holman, Eli Lilly and Company, Katie Sokolowski, Denali Therapeutics

Friday, April 12, 2024*

Cell and Gene Therapy, Sandhya Sanduja, US Food and Drug Administration
Label Review of Drug M, Hanan Ghantous, US Food and Drug Administration
Review of Drug M: History and Outcome, Kenneth Hastings, Hastings Toxicology Consulting, LLC

*Course ends at noon.

Speakers, presentation topics, and/or format are subject to change.

Daily continental breakfast, snack breaks, and lunch are provided as part of the registration. To disclose dietary restrictions, allergies, and/or accessibility needs please email ACT Headquarters. ACT will do its best to accommodate but cannot guarantee requests will be granted. Dietary requests submitted after March 18, 2024 will not be accommodated.

Detailed course handouts will be provided electronically. Participants must bring personal computer to view materials. Please ensure to download materials before arriving. Internet will not be provided.

Times:

Registration and Check-In: Monday, 7:30 AM–8:00 AM
Reception: Monday, 4:15 PM–5:30 PM

Course:
Monday, 8:00 AM–4:15 PM;
Tuesday, 8:00 AM–5:00 PM;
Wednesday–Thursday, 7:45 AM–5:00 PM;
Friday, 8:00 AM–12:00 Noon

Hanan Ghantous, PhD, DABT, US Food and Drug Administration

Timothy McGovern, PhD, US Food and Drug Administration

Natalie Holman, PhD, DABT, Eli Lilly and Company

Buay Permpoontaweesup , ACT Staff Liaison

Safety Protocols

ACT has continued to monitor the COVID-19 situation along with local and federal guidelines. Based on local current health mandates, ACT will not require proof of vaccination or proof of a negative PCR test. However, the local mandates could change; therefore, we ask that individuals bring a mask and proof of vaccination. You may also want to consider bringing an at-home COVID-19 test kit with you.

ACT expects that attendees use the  CDC’s self-checker website daily. Should you feel unwell or suspect you have been exposed to COVID-19, we ask that you isolate. Please stay home if you feel sick.


Registration Form

Registration Fees:

Early-Bird Registration
(Received by January 11)
Regular Registration
(Received January 12–April 5)
ACT Member $1,500 $1,600
ACT Student or Postdoc Member $995 $1,095
Nonmember $1,800 $1,900
Government $1,500 $1,600
ACT Member Group Rate**
(3 or more from same company)
$1,350 $1,450
Nonmember Group Rate**
(3 or more from same company)
$1,650 $1,750
ACT Member Group Rate**
(10 or more from same company)
$1,250 $1,350
Nonmember Group Rate**
(10 or more from same company)
$1,550 $1,650

**To take advantage of the group rate: Please send your completed registration forms to ACT Headquarters. You will not be able to select the group rate through the online registration. All three forms (or more) should be emailed at the same time.

Refund Policy: Refund Policy: $100 Processing Fee will be charged if canceled before 1/11/24; 50% refund if canceled before 2/8/24; After 2/8/24, no fees will be refunded.

Course Location

Hyatt Regency Dulles
2300 Dulles Corner Blvd.
Herndon, VA 20171

Hotel

Hyatt Regency Dulles
2300 Dulles Corner Blvd.
Herndon, VA 20171
Tel: 703.713.1234
Hotel Reservations: 402.592.6422

Housing Deadline

Please refer to the ACT Room Block to make your housing reservation. The ACT TPRS meeting rate of $149 (plus tax) is offered over the dates of April 7–12, 2024, based on availability, and reservations must be made by March 18, 2024.

Requirements

A personal laptop to view course materials and your computer charger are required. Please download all the course materials to your laptop prior to arriving at the course. Course materials will be provided approximately one week before the start of the course.

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