ACT Signature Webinars

March 12, 2024
Speaker: Marc Ellison
Educational Levels: Foundational, Practical

Since the FDA's adoption of the Standard for Exchange of Nonclinical Data (SEND) in 2016, it has continuously evolved, expanding beyond general toxicology to include disciplines such as Development and Reproductive...

December 11, 2024
Speakers: Timothy McGovern and Todd Bourcier
Educational Levels: Advanced, Emerging

The S1BR1 addendum expanded the evaluation process for assessing the human carcinogenic risk of pharmaceuticals. The addendum introduced a weight-of-evidence (WoE) approach to determine if a t...

September 18, 2024
Speaker: Paul McKellips
Educational Levels: Foundational, Practical

As toxicologists, we are often asked to present data in various forums and meetings, sometimes even presenting to an audience with varying levels of scientific knowledge. Mr. Paul McKellips is a dynamic speake...

May 22, 2024
Speakers: Elizabeth Neyens and Jay Stallons
Education Levels: Foundational, Emerging

Modern drug development is plagued by extremely high attrition rates when entering clinical trials. As many as 95% of drugs entering clinical trials fail, including almost 50% of those in phase III....

March 27, 2024
Speakers: Andrew Brown and Nataliya Sadekova
Educational Levels: Advanced, Emerging

Neuropathy refers to any condition involving peripheral nervous system damage and can develop as a side effect of certain classes of therapeutic compounds, from toxin exposure, or due to disease. ...

December 6, 2023
Speakers: Alex Eapen, Lorrene Buckley, and Ruth Roberts
Educational Levels: Foundational, Practical

- History and Overview of the American Board of Toxicology

Since 1979, the American Board of Toxicology (ABT) has served to encourage the study of the science of toxicology and ...

August 16, 2023
Speaker: Mary Beth Genter
Educational Levels: Advanced, Emerging

- So….. you want to be a peer reviewer?

This webinar will cover the basics of the peer review process. We will discuss different models of peer review, issues to consider when you are invited to peer review a manu...

July 19, 2023
Speaker: Rachel Tapp
Education Levels: Foundational, Emerging

Ototoxicity refers to the potential for certain chemicals or drugs to cause damage to the inner ear and result in hearing loss or balance problems. This type of ototoxicity can occur even in the absence of any clinical ...

May 3, 2023
Speaker: Ashley Frazer-Abel
Educational Levels: Advanced, Emerging

The complement cascade is a key component of our body’s innate immune system, protecting us from infection even at our first encounter. To act in this way complement must be nonspecific and strongly proinflammatory, ...

March 8, 2023
Speakers: Philip J. Kuehl and Jake McDonald
Educational Levels: Advanced, Emerging

The purpose of this webinar is to define the requirements for regulatory development of excipients used in respiratory formulations. As a part of the regulatory development pathway, pharmacology, tox...

September 14, 2022
Speakers: Carla Marashio and Amy Kim
Educational Levels: Foundational, Practical

Have you ever been the only toxicologist in the room or felt like all eyes were on you as the subject matter expert? Cross-functional collaboration is an important part of any successful program, ...

August 3, 2022
Speakers: Shayne C. Gad and Samantha Gad
Educational Level: Advanced, Practical

Over the last decade, testing requirements for medical devices have evolved immensely. Many device companies do not have internal toxicology or biocompatibility support to guide them through the testin...

March 2, 2022
Speaker: Madhav G. Paranjpe
Educational Levels: Advanced, Emerging

- Historical Control Database of Spontaneous Tumors in Transgenic TG.rasH2 Mice

The incidence of spontaneous tumors in control animals is important in understanding the background incidence of neoplasia in a model....

October 20, 2021
Speakers: Amit Chaudhary and David Woolley
Educational Levels: Advanced, Practical

- Safety Evaluation of Impurities in Generic Drugs

The FDA’s Office of Generic Drugs (OGD)-Division of Pharmacology/Toxicology (Pharm/Tox) Review (DPTR) conducts safety assessments to ensure that...

September 15, 2021
Speakers: Arianne Motter and Diana Lac
Educational Levels: Foundational, Practical

Congratulations, your team has a clinical drug candidate! Now what? Obtaining US FDA approval to begin clinical trials in the US requires the submission of an Investigational New Drug (IND) appl...

April 28, 2021
Speakers: Matthew Hartness, Brenda Finney, Emilyanne Leonard, and Ian Roman
Educational Levels: Advanced, Emerging

- Advances in the Measurement of Thyroid Hormones to Assess Endocrine Disruption Potential of Chemicals in the Rat

Endocrine disruptors are substances that can caus...

October 21, 2020
Speaker: Armin Wolf
Educational Levels: Advanced, Emerging

It is estimated that 90% of all compounds entering clinical trials fail, largely due to safety issues in clinical phases or drug efficacy issues in patients. This failure is because preclinical approaches that use in vi...

August 12, 2020
Speakers: Lisa M. Plitnick and Alan H. Stokes
Educational Level: Foundational

A systematic and regulated approach to the nonclinical safety assessment of vaccines is a relatively recent phenomenon compared to small molecule drugs even though the first vaccine was developed in the...

June 17, 2020
Speaker: Lisa A. Constantine
Educational Levels: Foundational, Practical

Human pharmaceuticals are routinely detected in wastewater, surface water, and aquatic organisms. Significant advances in instrumentation, analytical techniques, and methodologies have enhanced the ability to ...

April 22, 2020
Speakers: Kristina DeSmet, Amy Mihalchik-Burhans, and Saurabh Vispute
Educational Levels: Foundational, Practical

Strong communication is critical for the success of a toxicology program. Communicating effectively can keep your program on-track and help you establish long-lasting ...

February 17, 2021
Speaker: Laura Dill Morton
Educational Levels: Foundational, Emerging

Adeno-associated viral vectors are currently the most commonly used vectors for gene editing and gene replacement approaches in both CNS and ocular indications. The first part of the presentation will cover c...

February 12, 2020
Speaker: Carol M. Galvis
Educational Levels: Foundational, Practical

This webinar will provide an overview of safety assessment of metabolites in drug development. The speaker will discuss relevant guidance documents and will describe important considerations for the safety ass...

September 25, 2019
Speaker: John-Thomas Farmer
Educational Levels: Advanced, Practical

This presentation will present examples of common and uncommon immunological findings in nonclinical studies testing adeno-virus (AV) or adeno-associated virus (AAV) vectors expressing multiple cytokine transg...

July 24, 2019
Speakers: Michael V. Templin, and Scott E. Boley
Educational Levels: Foundational, Practical

The purpose of this webinar is to provide early career professionals with a general understanding of the design of Acute/Dose Range Finding (DRF) studies and identification/selection of a h...

May 29, 2019
Speakers: Pedro L. Del Valle and Michael A. Dorato
Educational Levels: Foundation, Practical

The purpose of this webinar is to provide early career professionals with a general understanding of the Good Laboratory Practices (GLP) involved in conducting nonclinical toxicology studies...

April 17, 2019
Speakers: Thomas Hudzik and Christina de Zafra
Educational Levels: Foundational, Practical

The misuse of prescription drugs has become an epidemic in the United States and a number of other countries, with consequently enormous socioeconomic impact. The manufacturers of new molecu...

December 21, 2018
Speakers: Simone Nicholson, Hervé Lebrec, Shawn Heidel, and Ken Hastings
Educational Levels: Advanced, Practical

Immune-Mediated Inflammatory Disease (IMID) encompasses a broad category of over 100 related diseases in which the person's immune system attacks his or her own tiss...

September 19, 2018
Speakers: Renee Hukkanen, Niraj K. Tripathi, and Sean P. Troth
Educational Levels: Foundational, Emerging

Veterinary pathologists are involved in study design and data interpretation for gross, clinical, anatomical, and histological pathology in the fields of pharmaceutical, i...

June 1, 2018
Speaker: Allen K. Wensky
Educational Levels: Foundational, Practical

The general content and format of pharmacology/toxicology information to be included in the submission of an IND can be found in 21 CFR 312.23 (a)(8). The regulation states that “The kind duration, and scope of ani...

March 7, 2018
Speaker: Janice Lansita
Educational Levels: Advanced, Practical

Productive industry interactions with regulatory authorities are critical for clinical development. However, it can be challenging to determine how much preparatory time and effort will be needed to accomplish the desi...

December 6, 2017
Speaker: Sherry J. Morgan
Educational Levels: Advanced, Emerging

Considerations for the use of animal models of disease will be discussed with specific examples of organ systems and/or responses that are generally either well or poorly predicted with the use of conventional anim...

September 20, 2017
Speakers: Jayanthi Wolf, David Clarke, and Karissa Adkins
Educational Levels: Advanced, Emerging

The approach for the nonclinical safety assessment of prophylactic vaccines for infectious diseases is well-established, with several regulatory guidelines and numerous examples o...

April 5, 2017
Speakers: Christopher J. Bowman and Wendy G. Halpern
Educational Levels: Foundational, Practical

Standard components of nonclinical toxicity testing for novel pharmaceuticals include clinical and anatomic pathology, as well as separate evaluation of effects on reproduction and deve...

October 26, 2016
Speaker: Roy Kerlin
Educational Levels: Advanced, Practical

Towards the end of 2012, The Society of Toxicologic Pathology (STP) sponsored a working group to address the concept of “Adversity” in regulatory documents through the auspices of the Scientific and Regulatory Policy Co...

September 9, 2016
Speakers: Aaron C. Ericsson and Julia Yue Cui
Educational Levels: Advanced, Emerging

The host-associated microbiota has a profound role in human health and disease susceptibility. Host microbiota has a strong influence on the phenotype of many animal models and should be consid...

April 27, 2016
Speaker: Michael Leach
Educational Levels: Advanced, Practical

There are currently many approved biologic products throughout the world, providing huge benefits across many therapeutic areas. At the present time, a number of biologics are coming off patent, which has opened the do...

December 16, 2015
Speakers: Jim Fikes and Dan Patrick
Educational Levels: Foundational, Practical

Pathology peer review is a fundamental process in nonclinical research that can help ensure the quality and accuracy of pathology results. Although there is no absolute requirement in the GLP princi...

September 17, 2015
Speaker: Kyle Kolaja
Educational Levels: Advanced, Emerging

The ability to make pluripotent stem cells from adult somatic cells has revolutionized cell biology, especially as access to differentiated tissues from induced pluripotent stem cells has improved. Differentiated cell...

May 20, 2015
Speaker: Russell Naven
Educational Levels: Foundational, Emerging

In recent years, computational toxicology as a discipline has received considerable attention as it offers the attraction of being able to provide rapid assessments of toxicological hazards and/or risks at a significa...

January 28, 2015
Speakers: Ikram Elayan and LaRonda Morford
Educational Levels: Foundational, Practical

Pediatric assessments are now required as part of every New Drug Application and Biologics Licensing Application in the US and every Marketing Authorization Application in Europe (unless a wai...

December 3, 2014
Speakers: Elizabeth A. Groeber and Andy Vick
Educational Levels: Foundation, Practical

Incurred Sample Reproducibility (ISR), also called Incurred Sample Reanalysis, has been a primary testing requirement according to FDA and EMA regulatory guidance since approximately 2008. Th...

September 10, 2014
Speaker: Raymond G. York
Educational Level: Foundational, Practical

February 12, 2014
Speaker: Adam D. Aulbach
Educational Levels: Foundational, Practical

December 4, 2013
Speaker: David Hobson
Educational Level: Advanced, Emerging