Continuing Education Courses

Continuing Educations (CE) courses are 3.5 hours each and are held either Sunday morning or Sunday afternoon. Preregistration is required and seating is limited.

Sunday, November 8

8:00 AM–11:30 AM

Beyond Study Directing, Understanding the Big Picture: Building and Executing a Toxicology Program in Drug Development

Session Chairs: Nancy R. Bordelon, Covance Inc., Greenfield, IN; and Robert F. Stachlewitz, Charles River, Reno, NV

The goal of this course is to provide early career toxicologists with the tools to better understand how nonclinical studies fit into the big picture of drug development for biologics and small molecules. We will discuss and present case studies on the regulatory framework in developing an IND enabling plan, including key questions and considerations for biologics and small molecules. Case examples for species selection for different classes of small molecules and biologics will be presented and we will discuss what types of studies should be conducted and appropriate study design, using data-based decision making on relevance. The third presentation will focus on approaches for target-based study design and reporting; including a discussion on consequences of development shortcuts. The fourth speaker will lead an interactive session on case studies for biologics and small molecules; groups will be provided with data sets and will work collaboratively with the speakers to define key messages. The final presentation will bring everything together and discuss the integration of multiple reports and data sets that are used in the regulatory submissions and for dose selection decision making. This course compliments the afternoon course “How to Be a Toxicology Project Leader—Scientific and Logistical Considerations Required for Participating on Pharma Multidisciplinary Project Teams.”

  • Planning an IND Program for Biologics and Small Molecules
    Nancy R. Bordelon, Covance Inc., Greenfield, IN
  • Species Selection for Biologics and Small Molecules
    Carol S. Auletta, Envigo, East Millstone, NJ
  • Keeping Your Eye on the Prize—Study Design and Reporting: Where Does It All Go?
    Robert F. Stachlewitz, Charles River, Reno, NV
  • What Does the Data Really Mean? Interpreting and Responding to the Data
    Noel D. Horton, MPI Research, Mattawan, MI
  • Bringing It All Together…How Does Your Toxicology Study Fit into the Big Picture?
    Jeffrey A. Handler, JAH Associates LLC, Wayne, PA

Fundamentals of Translational Neuroscience in Toxicologic Pathology: Optimizing the Value of Animal Data for Human Risk Assessment

Session Chairs: Alok Sharma, Covance Inc., Madison, WI; and James Morrison, Charles River Pathology Associates, Durham, NC

Extrapolation of animal data to predict possible human outcomes is an elemental conundrum in drug discovery and development. This problem often is of particular significance when investigating therapeutic candidates with neuroactive properties or that induce structural alterations in the central nervous system (CNS), especially when the portfolio management process and/or regulatory review are given to individuals with limited or no formal training in neurobiology. This session is designed to impart fundamental information on basic neurobiological principles necessary for pathologists, toxicologists, and regulators to gain confidence in their abilities to translate CNS structural changes in test animals for risk assessment in humans. The last talk is included as a practical example regarding the application of such principles to address a current issue facing many pharmaceutical companies and regulatory agencies.

  • Toxicological Significance of Rodent Neuroanatomy during Neuropathology Evaluation in Routine Toxicology Studies
    Deepa B. Rao, US Food and Drug Administration/CDER, Silver Spring, MD
  • Toxicological Significance of Non-Rodent Neuroanatomy during Neuropathology Evaluation in General Toxicology Studies
    Ingrid D. Pardo, Pfizer Inc., Groton, CT
  • Pathology Considerations in Rodent Developmental Neurotoxicity Testing
    Robert H. Garman, Consultants in Veterinary Pathology, Inc., Murrysville, PA
  • Neglected Factors That May Confound Translational Neuroscience
    Brad Bolon, GEMpath, Inc., Longmont, CO

Juvenile Toxicity Studies: Defining and Overcoming the Challenges

Session Chairs: Norman Kim, Biogen, Cambridge, MA; and Thomas Steinbach, Experimental Pathology Laboratories Inc., Raleigh, NC

Regulatory requirements for pediatric assessment in New Drug Applications and Biologics Licensing Applications have emphasized the importance of well-designed and effective juvenile toxicity studies. Successfully designing, conducting, and interpreting a juvenile toxicity study must consider a number of factors, including species selection and developmental differences in juvenile animals and adult animals. Factors unique to juvenile toxicity studies present a challenge to the drug development team. This session will focus on identifying and addressing challenges, particularly those associated with the species tested and those associated with histological evaluations of young animals. While the session pertains to juvenile toxicity studies of pharmaceuticals, many concepts will apply to other safety studies.

  • Introduction to Juvenile Toxicology, Rodents
    Robert M. Parker, Envigo, East Millstone, NJ
  • Non-Rodent Juvenile Toxicology
    Gerhard F. Weinbauer, Covance Laboratories Inc., Muenster, Germany
  • Challenges of Interpreting Histopathology in Juvenile Toxicology Studies
    Amera K. Remick, WIL Research, Hillsborough, NC
  • EMA Perspective on Nonclinical Support of Pediatric Programs
    Jacqueline Carleer, Belgian Federal Agency for Medicines and Health Products,
    Belgian representative on the Pediatric Committee (PDCO, European Medicine Agency), Brussels, Belgium

  • FDA Perspective on Nonclinical Support of Pediatric Programs
    Karen Davis-Bruno, US Food and Drug Administration/CDER/OND, Silver Spring, MD

1:00 PM–4:30 PM

How to Be a Toxicology Project Leader—Scientific and Logistical Considerations Required for Participating on Pharma Multidisciplinary Project Teams

Session Chairs: Melissa Rhodes, Roivant Sciences, Inc, Durham, NC; and Kenneth J. Olivier Jr., Merrimack Pharmaceuticals, Inc., Cambridge, MA

This CE course will provide participants with an overview of the scientific and logistical considerations that one should be aware of when serving as the toxicology area expert to a drug development project team. While the toxicology project team member (PTM) is responsible for determining the appropriate toxicology development plan and designing toxicology studies, there are multiple aspects across various scientific disciplines that must also be considered. The session will start with PTM considerations for a team in early development, including a discussion of determining appropriate formulations and drug supply and use of initial efficacy and DMPK data to determine doses for first toxicity studies. A core aspect of drug development for the PTM to understand is the ADME profile of an NCE or biologic, as both have very different considerations for the design of toxicity studies and key aspects will be presented. Logistical considerations involving CROs will then be discussed and will include lead times for conducting studies, calculating drug quantities requirements, and managing budgeting and reporting. Finally, an overview of potential API- and non-API-related issues that a toxicologist may be engaged in, such as impurities, degradants, and the container closure system will be provided.

  • Serving as a Toxicology PTM during Early Drug Discovery
    Melissa Rhodes, Roivant Sciences, Inc., Durham, NC
  • Core Aspects of DMPK Relevant for the Toxicology PTM
    Nicholas Buss, MedImmune, Gaithersburg, MD
  • Tasks and Timelines: The TnT of Supporting Clinical Trials in Drug Development
    Kenneth J. Olivier Jr., Merrimack Pharmaceuticals, Inc., Cambridge, MA
  • Fundamentals in Qualification of API- and Non-API-Related Impurities: A Review of Regulations, Guidelines, and Industrial Best Practices
    Douglas J. Ball, Pfizer Inc., Groton, CT

What You Always Wanted to Know about Immunotoxicology in Pharmaceutical Development…but Were Afraid to Ask

Session Chairs: Peyton Myers, US Food and Drug Administration, Silver Spring, MD; and Michael P. Holsapple, Michigan State University, East Lansing, MI

As evidenced by ICH S8, M3(R2), as well as S6(R1) Guidelines, the immune system has long been an important target in pharmaceutical development. Because of this attention, the science behind safety risks associated with the immune system has evolved, resulting in attention on immunotoxicology assessment tools. In recent years, as more pharmaceuticals are targeting specific immune targets, more immunotoxicology tools have been applied. This course will provide an overview of some of the most important immunotoxicology drug development platforms. Dr. Holsapple will set the stage by briefly reviewing ICH Guidelines and current paradigms in immunotoxicology. The next talks by recognized leaders in Immunotoxicology will focus on three important platforms. All of these talks will highlight how the data derived from these platforms are used to inform, highlighting strengths and limitations. Dr. Lebrec will consider the application of immunophenotyping to safety assessment. Dr. Burns Naas will describe the utility of the T-dependent antibody response (TDAR) as the “gold standard” in immunotoxicology. Dr. Prell will address the dichotomy of the role of cytokines, as “friend or foe.” The final talk by Dr. Myers will provide a regulatory perspective on immunotoxicology, and some unique insights into immunotoxicology study trends in FDA approvals.

  • Introduction—Setting the Stage: What You Always Wanted to Know About Immunotoxicology
    Michael P. Holsapple, Michigan State University, East Lansing, MI
  • Immunophenotyping: Application to Safety Assessment
    Hervé Lebrec, Amgen Inc., South San Francisco, CA
  • The “Gold Standard”: Utility of the T-Dependent Antibody Response (TDAR)
    Leigh Ann Burns Naas, Gilead Sciences, Inc., Foster City, CA
  • Cytokines: Friend or Foe?
    Rodney Prell, Genentech Inc., South San Francisco, CA
  • Immunotoxicology: A Regulatory Perspective
    Peyton Myers, US Food and Drug Administration, Silver Spring, MD

The Safeguarding of Your Vital Organ Systems Depends on Safety Pharmacology: What Is It?

Session Chairs: R. Dustan Sarazan, Data Sciences International (DSI), St. Paul, MN; and Michael K. Pugsley, Purdue Pharma LP, Cranbury, NJ

This continuing education course will include lectures that describe fundamental areas of safety pharmacology studies (CNS, Respiratory, Cardiovascular systems) for both new chemical entities (NCE) as well as biotechnology-derived products. It will also include some discussion of clinical issues (and methods) as well as novel non-clinical methods and approaches that may be added to the core ‘battery’ of tests used to explore the safety of novel therapeutic agents. Attendees will be introduced to discussion regarding the role safety pharmacology has as an integral component within the safety program for drug development. We will also introduce the Comprehensive In vitro Proarrhythmia Assay (CIPA) cardiovascular paradigm being developed for hazard identification, elimination and risk assessment that would help to obviate conduct of the clinical “Through QT” (TQT) study. This continuing education course will provide ACT scientists with a crucial resource that explains the important role safety pharmacology has in the overall pharmaceutical drug development process.

  • An Introduction to the Principles and Practice of Safety Pharmacology
    R. Dustan Sarazan, Data Sciences International (DSI), St. Paul, MN
  • Core Battery 1: The Cardiovascular System
    R. Dustan Sarazan, Data Sciences International (DSI), St. Paul, MN
  • Core Battery 2: The Central Nervous System
    Michael K. Pugsley, Purdue Pharma LP, Cranbury, NJ
  • Core Battery 3: The Respiratory System
    Simon Authier, CiToxLAB North America, Quebec, Canada
  • A Safety Pharmacology Evaluation of Biopharmaceuticals
    Michael Engwall, Amgen Inc., Thousand Oaks, CA

Selection and Use of Non-Rodent Species for Nonclinical Safety Assessment—Benefits, Pitfalls, and Caveats

Session Chairs: Binod Jacob, Charles River, Spencerville, OH; and Warren Harvey, Charles River, Edinburgh, United Kingdom

A non-rodent species is generally required for nonclinical safety assessment prior to and during clinical phase of drug development. The choice of species is driven by many factors that may include suitability related to pharmacology, pharmacokinetics and metabolism. Companies must make ethical decisions during the selection process while adhering to the 3Rs. In this continuing education course, the practical considerations of non-rodent species used in repeat-dose toxicity studies will be discussed. In addition the use of non-rodent species in reproductive toxicity studies will be the focus of one talk.

  • Non-Rodent Species Choice in Preclinical Safety Assessment: An Overview
    David O. Clarke, Eli Lilly and Company, Indianapolis, IN
  • The Translational Relevance of the Minipig for Modeling Human Cardiovascular Disease
    James R. Turk, Amgen Inc., Thousand Oaks, CA
  • Practical Considerations in Nonrodent Species Selection for Reproductive Toxicology Studies
    Alan M. Hoberman, Charles River, Horsham, PA
  • Experiences with the Beagle Dog in Preclinical Safety Assessment: Benefits and Pitfalls
    Bhanu Singh, Janssen Research & Development, Spring House, PA
  • Preclinical Models for Biologics: 3Rs Influence on NHP Use and Species Choice
    Lauren E. Black, Charles River, Reno, NV