The American College of Toxicology (ACT) is proud to introduce a new comprehensive course, Biologics Nonclinical Drug Development. The course offers an in-depth exploration of regulatory considerations and the toxicologic evaluation and development of protein biologics, modified protein biologics, and specialized biologics, including cell and gene therapies, and oncolytic viruses.
Participants will gain a thorough understanding of the key principles and methodologies employed in the nonclinical safety assessment of these advanced therapeutic modalities. The curriculum covers a wide range of studies essential for advancing biotherapeutic drug candidates through all stages of drug development from candidate selection to marketing authorization. These include general toxicity studies and a variety of specialized studies, including off-target assessment, safety pharmacology, carcinogenicity, and reproductive and developmental toxicity studies. Additionally, the course provides insight into pharmacokinetic and biodistribution assessments and the potential impact of immunogenicity for various of different therapeutic modalities. Several case studies will be used to highlight how specific strategies and issues are approached on a case-by-case basis.
The course is only being offered in-person. Virtual or hybrid participation is not an option.
Monday, June 16, 2025
Tuesday, June 17, 2025
Wednesday, June 18, 2025
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 by May 15, 2025. ACT will do its best to accommodate but cannot guarantee requests will be granted.
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
Course:
Monday–Wednesday, 8:00 AM–5:00 PM
Speakers, presentation topics, and/or in-person format are subject to change.
Course Organizers
Mary Ellen Cosenza, PhD, DABT, RAC, ATS, MEC Regulatory & Toxicology Consulting, LLC
Marque Todd, MS, DVM, DABT, Renaissance Consulting, Inc.
Deborah Novicki, PhD, DABT, DL Novicki Toxicology Consulting LLC
Joy Cavagnaro, PhD, DABT, ATS, Access BIO
Buay Permpoontaweesup , ACT Staff Liaison
Registration Fees:
| Early-Bird Registration (Received by April 23) |
Regular Registration (Begins April 24) |
|
| ACT Member | $1,350 | $1,450 |
| ACT Student or Postdoc Member | $ 895 | $ 995 |
| Nonmember | $1,650 | $1,750 |
| Government* | $1,350 | $1,450 |
| ACT Member Group Rate** (3 or more from same company) |
$1,250 | $1,350 |
| ACT Member Group Rate** (10 or more from same company) |
$1,150 | $1,250 |
| Nonmember Group Rate** (3 or more from same company) |
$1,450 | $1,550 |
| Nonmember Group Rate** (10 or more from same company) |
$1,350 | $1,450 |
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: $100 Processing Fee will be charged before 4/23/25; 50% refund if canceled before 5/21/25; After 5/21/25 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.
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 meeting rate of $199 (plus tax) is offered over the dates of June 15–19, 2025, based on availability, and reservations must be made by May 15, 2025.
