American College of Toxicology


= Members Only

2020 Educational Course Postponed—
Tentative Dates: September 28–October 2, 2020

Toxicology for Pharmaceutical and Regulatory Scientists

Course Description

This annual ACT course provides basic training in general toxicology. Using pharmaceutical development as an example, participants will obtain an overall understanding of the principles of toxicology and nonclinical safety evaluation. 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.

Course Flyer

Course Schedule


8:10 AM–10:00 AM

Principles of Toxicology, A. Wallace Hayes, University of South Florida, College of Public Health

10:15 AM–11:45 AM

Introduction to Pharmacology for the Toxicologist, Amy Avila, US Food and Drug Administration

1:00 PM–2:30 PM

Principles of Drug Metabolism and Toxicokinetics and Applications to Pharmaceutical Toxicology,
Debie Hoivik, Akebia Therapeutics

2:45 PM–4:15 PM

Safety Pharmacology for Human Pharmaceuticals, Mary Jeanne Kallman, Kallman Preclinical Consulting

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.


8:00 AM–9:45 AM

General Toxicology, Lorrene Buckley, Eli Lilly and Company

10:00 AM–12:00 Noon

Toxicology of Organ Systems, Mary Beth Genter, University of Cincinnati

1:00 PM–2:30 PM

Clinical Pathology: Principles for Pharmaceutical and Regulatory Scientists, Lila Ramaiah, Pfizer, Inc.

2:45 PM–4:15 PM

Pathology in Toxicology Studies, Thomas Steinbach, Experimental Pathology Laboratories, Inc.


8:15 AM–9:45 AM

Genetic Toxicology, Mark Powley, Merck & Co., Inc.

10:00 AM–12:00 Noon

Evaluation of Potential Carcinogenicity, James Popp, Stratoxon LLC

1:00 PM–2:50 PM

Reproductive/Developmental and Juvenile Toxicology, Alan Hoberman, Charles River

3:00 PM–4:30 PM

Nonclinical Safety Evaluation of Biotechnology-Derived Therapeutics, Melanie Hartsough, Hartsough Nonclinical Consulting, LLC


8:15 AM–10:15 AM

Immunotoxicology, Florence Burleson, Burleson Research Technologies, Inc. (BRT)

1:00 PM–2:30 PM

Risk Assessment, Melissa Rhodes, Aerami Therapeutics

10:30 AM–12:00 Noon

Regulatory Toxicology—A Nonclinical Pharmacology and Toxicology Perspective, Hanan Ghantous, US Food and Drug Administration

10:30 AM–12:00 Noon

Cell and Gene Therapy, Sandhya Sanduja, US Food and Drug Administration

2:45 PM–4:15 PM

Practical Application: Nonclinical Case Studies, Hanan Ghantous, US Food and Drug Administration


10:45 AM–11:45 AM

Preparation of Nonclinical Documents for Regulatory Submission, Paul Nugent, Pfizer, Inc.

8:00 AM–9:30 AM

Review of Drug K: History and Outcome, Kenneth Hastings, Hastings Toxicology Consulting, LLC

*Course ends at noon.

Daily continental breakfast, snack breaks, and lunch are provided as part of the registration. Detailed course handouts will be provided electronically. Participants must bring personal computer to view materials.


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

Course: Monday–Thursday, 8:00 AM–5:00 PM;
               Friday, 8:00 AM–12:00 Noon

Course Organizers

Joseph A. Francisco, PhD, Charles River
Hanan Ghantous, PhD, DABT, US Food and Drug Administration
Timothy McGovern, PhD, US Food and Drug Administration
Jordan Ballance, ACT staff liaison


Registration will reopen pending an improvement in the COVID-19 situation.

Registration Fees:

  By Feb. 3 Feb. 4–March 27
ACT Member $1,295 $1,395
ACT Student and Postdoc Member $   995 $1,095
Nonmember $1,595 $1,695
Government $1,295 $1,395
ACT Member Group Rate**
(3 or more from same company)
$1,145 $1,245
Nonmember Group Rate**
(3 or more from same company)
$1,445 $1,545

**To take advantage of the group rate: Please send your completed registration forms to You will not be able to select the group rate through the online registration.

Refund Policy:

In the event this face-to-face course needs to be canceled due to COVID-19, registration fees are refundable.

Dietary and Special Services Accommodations:

Accessibility, dietary needs, or allergies must be indicated during registration to arrange for accurate service and preparation. The college will try to accommodate these requests. There is no guarantee that requests can be honored.

We strive to work with our partners and vendors to provide safe and delicious meals for all attendees. Despite taking every precaution, we cannot guarantee that menu items are free of trace amounts of allergens or other ingredients.

Course Location

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


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

Housing Deadline:

Housing information will be available in June.


A personal laptop to view course materials and your computer charger are required. We also suggest downloading 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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