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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 28, 2025

Principles of Toxicology, A. Wallace Hayes, University of South Florida, College of Public Health
Introduction to Drug Development Toxicology, Natalie Holman, Eli Lilly and Company
Introduction to Pharmacology for the Toxicologist, FDA Invited Speaker
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

Tuesday, April 29, 2025

General Toxicology, Lorrene Buckley, Eli Lilly and Company
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, Debra Tokarz, Experimental Pathology Laboratories, Inc.

Wednesday, April 30, 2025

Genetic Toxicology, Mark Powley, Merck and Co.
Evaluation of Potential Carcinogenicity, Timothy McGovern, US Food and Drug Administration
Reproductive/Developmental and Juvenile Toxicology, Alan Hoberman, Charles River
Nonclinical Safety Evaluation of Biotechnology-Derived Therapeutics, Melanie Hartsough, Hartsough Nonclinical Consulting, LLC

Thursday, May 1, 2025

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; and Natalie Holman, Eli Lilly and Company

Friday, May 2, 2025*

Cell and Gene Therapy, FDA Invited Speaker
Label Review of Drug N, Hanan Ghantous, US Food and Drug Administration
Review of Drug N Program: History and Outcome, Kenneth Hastings, Hastings Toxicology Consulting, LLC

*Course ends at noon.

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

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.

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 27, 2025 will not be accommodated.

Times:

Registration and Check-In: Monday, 7:30 AM–8:00 AM

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

Registration Fees:

Early-Bird Registration
(Received by January 9)
Regular Registration
(Begins January 10)
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

Fees are accessed according to the membership status at the time of purchase (there are no exceptions and there are no refunds.)

*Government Registration Policy: The government registration rate is specifically designated for federal, state, or local employees of government departments/agencies who are actively participating in the course as official government personnel. Employees of public academic institutions, nonprofit institutions, or government contractors do not qualify for the discounted government rate. To register under the government rate, individuals must use their government-affiliated email address for verification purposes. ACT may request further documentation of government employment before the registration is finalized. If you are unsure if you qualify for the government rate, please email ACT Headquarters before processing your payment online.

**Group Rate Registration: 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 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 1/9/25; 50% refund if canceled before 2/6/25; After 2/6/25, no fees will be refunded.

Safety Protocols: ACT expects that attendees use the CDC’s self-checker website daily. Evaluate your own health and that of people you are in close contact with. Should you feel unwell or suspect you have been in contact with someone who is sick, we ask that you isolate. Please visit CDC website for more information.


Registration Form

Course Location

Gaithersburg Marriott Washingtonian Center
9751 Washingtonian Boulevard
Gaithersburg, MD 20878

Hotel

Gaithersburg Marriott Washingtonian Center
9751 Washingtonian Boulevard
Gaithersburg, MD 20878
Tel: 301.590.0044
Hotel Reservations: 800.228.9290

Housing Deadline

Please refer to the ACT Room Block to make your housing reservation. The ACT TPRS meeting rate of $189 (plus tax) is offered over the dates of April 27–May 3, 2025, based on availability, and reservations must be made by March 27, 2025.

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