THURSDAY MORNING

SEMINARS


From the FDA Trenches: So You Think You Can Design a GLP Animal Study?
8:00 AM - 10:15 AM/Room: Ballroom II
Leader: Annabelle P Crusan
Moderator: Judith A Davis
Facilitator: Elizabeth Katz

Why is FDA presenting on GLP animal studies that support medical device safety? We want to share our unique perspective as FDA animal study reviewers so that you and device manufacturers can design, conduct, and report on animal studies that effectively and efficiently support medical device clinical trials and marketing submissions. Whether you are already conducting GLP animal studies or want to expand your knowledge, join us for a discussion on what defines a successful study. We will provide an overview of the medical device regulatory framework and the skill sets required to effectively design and conduct an animal study to support device safety. We will share insights from the FDA reviewer’s perspective on good study design (hint: GLP compliance does not guarantee a good study design that will adequately address regulatory concerns); common GLP deviations and the problems they create; the importance of gross and histopathology; pertinent raw data; and how to prepare a final study report that effectively summarizes the study data. Along the way, we will present avoidable pitfalls we have encountered during our reviews. Finally, we will wrap up with a conversation about how we can work together to help you conduct efficient and effective GLP animal studies for medical device submissions to FDA.

Speakers/Topics:

8:00 Judith A DavisWelcome and Introduction
8:10 Kira MooreThe Animal Study Reviewer Skillset and Animal Model Selection
8:30 Natalie A MillerGLP Compliance and a Good Study Design
8:50 Diane CordrayCommon GLP Deviations and Problems They Create
9:10 Karen ManhartThe Importance of the Pathology Report and the Final Report
9:30 Annabelle CrusanGroup Discussion


Passive Electronic Data Collection Using RFID Technology: Improving Animal Welfare and Study Documentation Efficiency and Accuracy
8:00 AM - 10:15 AM/Room: Ballroom I
Leader: Brad Gien
Moderator: Craig Jordan
Facilitator: Ashley Cheetham

Accurate and timely data collection is critical when conducting any research projects. This seminar will focus on the importance of accurate data collection in a new innovative way. The goal is to create an individual animal record as part of the larger study documentation through passive electronic data collection from the time an animal is weaned through necropsy and tissue analysis. We will introduce advanced RFID microchips and custom software for tracking all elements of a research study from simple applications such as high throughput body weight screening, minor surgical modifications, major surgical disease models, medical device implants, PK/PD research, and short and long duration toxicology studies. The goal of this seminar is to demonstrate best practices for efficient, accurate data collection in many different laboratory settings and show the impact of good data collection and the cost of poor data collection. Participants will take away a better understanding of new innovative data collection techniques and the importance of efficient methods to complete this often monumental task. The target audience for this seminar will be research technicians, study directors, and investigators.

Speakers/Topics:

8:00 Brad Gien Welcome and Introduction
8:15 Matt Ruiter RFID: New Uses Beyond Simple Identification
8:45 Robert Ross Using RFID to Compile and Analyze High Throughput Body Weight Screening
9:15 Brad Gien Advanced Lab Animal Surgical Data Collection and Analysis
9:45 Matt Ruiter Electronic Data Collection—Improved Accuracy, Efficiency, and Animal Welfare from Start to End

The Laboratory Animal Medical Professional's Guide to How the 3Rs Enhance Rigor and Reproducibility

8:00 AM - 10:15 AM/Room: Ballroom III
Leaders: Kathrin Herrmann, Eric K Hutchinson, Kelly A Metcalf Pate
Moderator: Casey Kissel
Facilitator: Adam D Werts

Animal research has come under increased scrutiny recently due to a perceived lack of rigor and reproducibility. The laboratory animal research community has a unique responsibility to ensure the validity of animal research studies while also caring for the wellbeing of the research subjects themselves. This highly interactive seminar will focus on the importance of preparation, information gathering, housing and husbandry, analgesia and anesthesia, and reporting to assure high-quality, translational science. We will start with a discussion of the necessary steps to ensure effective research before a study even begins, and why pre-registering animal studies ensures better quality research outcomes. We will demonstrate and practice strategies for effectively searching existing literature and reports. We will make the connection between different housing, husbandry, analgesia, and anesthetic practices and rigorous science. We will lay out the importance of data-sharing and full reporting beyond the typical methods and results to the reproducibility of animal experiments. Throughout the seminar, attendees will have the opportunity to apply the concepts we present to real-world examples of animal research proposals. This seminar series is suitable for all laboratory animal professionals and will give participants a strong understanding of how the 3Rs impact rigorous and reproducible science.

Speakers/Topics:

8:00 Kelly A Metcalf PateWelcome and Introduction
8:05 Kelly A Metcalf PateHow the 3Rs Contribute to Rigor and Reproducibility
8:15 Kathrin HerrmannBe Prepared: Setting Yourself up for Success with Deliberate Study Planning
8:30 Kristina AdamsBe Informed: Searching the Literature for more than Alternatives
8:50 Kelly A Metcalf PateInteractive Exercise: Using the 3Rs to Enhance Rigor and Reproducibility
9:00 Eric K HutchinsonBe Refined: Harnessing Behavior for Better Science
9:15 Jennifer LofgrenBe Humane: Minimizing Pain as a Research Variable
9:30 Kathrin HerrmannBe Transparent: Comprehensive Reporting to Improve Reproducibility and Reduce Unnecessary Duplication
9:45 Kelly A Metcalf PateInteractive Exercise: Using the 3Rs to Enhance Rigor and Reproducibility—During and After the Study

This Seminar is sponsored in part by Johns Hopkins University Center for Alternatives to Animal Testing.

Trapped in a Bubble: In Managing Gnotobiotics, One Size Does Not Fit All
8:00 AM - 10:15 AM/Room: Ballroom IV
Leader: Carrie L Freed
Moderator: Judy M Hickman-Davis
Facilitator: Kate Nolan

Since the inception of gnotobiotics in the 1940s, research applications have evolved to include a wide variety of species. The role of microbiota in health and disease has far-reaching implications and such research, in the areas of immunology, cancer, and vaccine development, support the continued need for gnotobiotic housing. Available animal models come in very different sizes and therefore housing SOPs must be developed that fit both the needs of a particular species and any limitations of the facility. Due to significant financial burden and intense operational needs it is common for animals to be maintained as part of a core service, with dedicated personnel providing the day to day care for the animals. Delineating responsibility within the housing space and addressing fiscal responsibilities in advance is important to ensure expectations are clear. Depending on the species, veterinary support and technical needs may vary greatly. Once established, rodent models may be maintained long term with minimal direct veterinary involvement while larger models such as piglets or calves may require veterinary support for the initial derivation and ongoing blood collection or inoculations. Regardless of the species selected, attention to detail is important from start (the coordination of initial derivation procedures) to finish (breakdown of the isolator) for successful management of gnotobiotic housing to ensure high-quality research can be performed with animal welfare of utmost importance. This session will provide a better understanding of terminology related to gnotobiotic housing and the application of these concepts in an animal model. Attendees will become familiar with equipment and husbandry needs for mice, piglets, and calves housed within an isolator and will develop an appreciation for the veterinarian’s role for each model. The target audience includes facility managers, technicians, or veterinarians currently working in a facility that maintains gnotobiotic animals or those considering future plans. This will be valuable for any individual looking to improve their understanding of management of animal models in the field of gnotobiotics.

Speakers/Topics:

8:00 Carrie L FreedWelcome and Introduction
8:20 Judy M Hickman-DavisHistory of Gnotobiotics and a Review of Basic Terminology
8:45 Stacey M MeekerFrom the Researcher's Perspective, Application of Gnotobiotic Mouse Models for IBD and Colon Cancer Research
9:10 Carrie L FreedWorking in a Bubble: Coordination between Core Research Staff, Operations, and Veterinary Teams for Successful Management of a Swine Model
9:35 Juliette HansonThe Challenges of Working with Large Animal Models—Gnotobiotic Calves
10:00 All Panel Discussion/Questions

PLATFORM SESSIONS

8:00 AM-10:45 AM

Platform Session abstracts will be available on www.aalas.org in July. They will also be included in both the mobile app and the National Meeting Final Program.

SPECIAL TOPIC LECTURES


Animal Law and the Animal Research Community: What You Need to Know, What Your Need to Do
11:00 AM - 12:00 PM/Room: Ballroom II
Speaker: Jerrold Tannenbaum
Moderator: B Taylor Bennett
Facilitator: TBN

One of the most important threats to animal research has been the recent emergence of animal law. Typically, proponents of this field do not define it simply as the area of the law that deals with animals. Rather, animal law—often called “the animal law movement”—is viewed as legal advocacy on behalf of animals, which in turn is viewed as using the legal system to terminate or severely curtail many traditional uses of animals, including their use in scientific and medical research. This session will discuss how animal law so defined has become a central tool of animal activists in opposing animal research. We will look at how most of our country’s law schools are promoting this activist view of the law. We will discuss underlying foundations of this approach to animal law, including developments in academic philosophy and what colleges and universities now call “animal studies.” We will also look at the significance of a development in activist legal theory that has thus far been ignored by many in the research community: a focus on limited, pragmatic legal aims while the educational arm of the animal activist movement prepares the way for eventual achievement of the more fundamental general goals of legal standing for animals, animal rights, and animal personhood. The session will discuss why animal activist lawyers and legal theorists now have a significant head start over supporters of animal research. It will not be easy for the research community to develop legal tools that will be necessary to win current and future battles. There are some reasons for optimism. However, it is essential for supporters of animal research to understand how animal activists are attempting to use the law to achieve their aims and to think seriously about what the research community should do. The target audience will be all who involved in animal-based biomedical research.

This Special Topic Lecture is sponsored in part by National Association for Biomedical Research (NABR).


Exploring Acupuncture in Laboratory Animal Medicine
11:00 AM - 12:00 PM/Room: Ballroom III
Speaker: Jibing Yang
Moderator: Patrick Lester
Facilitator: Kelsey Cornelius

In laboratory animal medicine, clinical cases become challenging to manage when clinical care or treatment is limited by research objectives or species-specific pharmacotherapy options. Traditional Chinese veterinary medicine (TCVM), like acupuncture, can be used to complement or replace common veterinary management procedures in select cases. Benefits of acupuncture include analgesic effect and being a noninvasive approach, which can limit any potential research confounding effects. This lecture will provide a general overview of the history and basic principles of TCVM, its origins and evolution over thousands of years, and its current application in veterinary medicine. Specifically, the benefits and applications of acupuncture in general veterinary and laboratory animal medicine will be illustrated using case scenarios with dogs and rabbits. The lecture will conclude with a discussion on the safety of acupuncture and its scientific evidence in complementary medicine. The audience will gain a general picture of TCVM and the potential benefit of acupuncture in clinical care. The target audience includes veterinarians, veterinary technicians, research staff, and others who are interested in TCVM.


Gene Editing as a Path to More Informative Preclinical Research
11:00 AM - 12:00 PM/Room: Ballroom I
Speaker: Daniel F Carlson
Moderator: Amy G Andrews
Facilitator: Katherine LaVallee

There are an estimated 10,000 to 20,000 genetically inherited diseases in the human condition. Our ability to treat these genetic diseases is limited by several factors, but perhaps most notable is that many novel therapeutics that are effective in standard research models are not effective in human patients. The pig, physiologically and anatomically, is widely considered one of the closest matches to humans. Until recently, it was considered was too difficult to engineer pigs to model a variety of specific genetic diseases. Modern gene editing technology has changed that, and now several novel and innovative swine models of human disease are available. These models not only give us a new platform for testing therapies, but have also enabled discovery of new disease mechanisms that could guide the next generation of therapeutics. Our dilated cardiomyopathy (DCM) pig model is one such example. In addition to our DCM model, we’ll briefly discuss additional swine models of human disease and review the process to develop and utilize novel swine models of human disease for preclinical testing and discovery.


The Acheonomics—New Sports Medicine
11:00 AM - 12:00 PM/Room: Ballroom IV
Speaker: Tony Kaczowski
Moderator: Carmen Wilbourn
Facilitator: TBN

Within a demanding and clinically detailed workforce, the lack of efficient medical providers, and an estimated annual spend of over $52 billion dollars in direct health costs associated with work-related injuries in the U.S. alone, organizations have needed to look at cutting-edge solutions to solve the problem of employee health. The partnership between an organization and an industrial sports medicine team greatly aids in not only driving down work-related medical costs and injury statistics, but also provides a much-needed tool in preventing and intervening in potential employee health risks. The three components of a successful industrial sports medicine program combine early intervention and care of discomfort and injury through an on-site industrial sports medicine professional, effective ergonomic solution development, and proactive injury and illness prevention systems. Though these are the components required, the principles that drive success are less tangible but even more important. These principles include the ability to foster sincere relationships with those being cared for, operating as a team, and understanding that the only way to lead individuals down the path of better health is to educate them on why they need to be involved and that this involvement is for the ultimate good. Topics covered will include a general overview of the financial impact of musculoskeletal discomfort on an employer; discussion of the psychological, sociological, and economic barriers in accessing today’s health care systems; basic human anatomy and physiology; review of common injuries and early intervention tools to reduce severity; a demonstration of general stretching and strengthening exercises to address discomfort; a demonstration of biomechanical coaching tools and how they will assist in the prevention of the common injuries in a workplace; and a question/answer session. This interactive presentation is for all levels and will be in a lecture and group discussion format.

This Special Topic Lecture is sponsored in part by Covance and InSite Health.

PANEL DISCUSSIONS


In Pursuit of Better Research Outcomes: Influence of Veterinary Nurses on Patient Care, Reducing Animal Numbers and Institutional Compliance
12:30 PM - 2:00 PM/Room: 337
Leader: Chrystal L Montgomery
Moderator: Ann L Murray
Facilitator: Summer M Boyd
Panelist: Stephen J Cital, Victoria R Elam, Chrystal L Montgomery, Lawrence Young

As the realm of biomedical research expands and evolves, so has the focus on veterinary clinical techniques to improve efficacy and safety for animals and personnel. There is a trend of increasing emphasis on the role veterinary technicians are used in maintaining the integrity of the institutional animal care program and to streamline research efforts. The expertise of veterinary technicians is of value to IACUCs and investigators in this regard and is essential to preserving animal welfare. This panel discussion will explore various options available to veterinary technicians and researchers to preserve quality science by regularly applying the 3Rs. The refinement of study techniques will, in turn, improve animal health and welfare. The reduction of pain and distress with the use of anesthesia and non-invasive techniques, such as imaging, will reduce the number of animals needed. The replacement of historical procedures and the animals needed will be facilitated when opportunities for technicians and nurses are explored, and this knowledge is extended into managerial and compliance role use. The target audience is veterinary technicians, veterinarians, research technicians, animal care technicians, and animal resource managers.

This Panel Discussion is sponsored in part by Academy of Laboratory Animal Veterinary Technicians (ALAVTIN).


Joining Forces to Drive Laboratory Animal Science Harmonization
12:30 PM - 2:00 PM/Room: 339
Leader: Scott A Mischler
Moderator: Laura A Conour
Facilitator: TBN
Panelist: Laura A Conour, Judy Franco, Scott A Mischler, Ana Isabel Moura Santos

The laboratory animal science community represented by the Federation of European Laboratory Animal Science Associations (FELASA) in Europe and the American Association for Laboratory Animal Science (AALAS) in the United States have been working together to harmonize animal care and research recommendations. This session will provide an overview of the structure and relationship between FELASA and AALAS, and the value of this harmonization effort to the laboratory animal community. Brief updates on ongoing joint activities of the associations will be presented. Finally, there will be ample time provided for panel and audience participation to explore future collaborative efforts between the associations. Topics will include the history of the relationship between AALAS and FELASA, liaison body and working group establishment, updates on the transportation working group and zebrafish working group, the value of harmonization and how you can get involved, and an open microphone discussion on potential future collaborations and topics. The target audience will include AALAS and European researchers and laboratory animal scientists who are interested in learning about the joint efforts and accomplishments of AALAS and FELASA in harmonizing guidelines between the world regions. Additionally, audience participation will be critical in defining future directions and potential participants of the joint efforts.

This Panel Discussion is sponsored in part by American Association for Laboratory Animal Science/Federation of European Laboratory Animal Science Associations (AALAS-FELASA) Liaison Body.


Preparing for the Real World as a Laboratory Animal Vet: What We Know Now that We Wish We Knew Then
12:30 PM - 2:00 PM/Room: 343
Leader/Moderator: Victoria K Baxter, Kelly A Metcalf Pate
Facilitator: Jenny M Estes
Panelist: Cynthia D Cary, Dalis E Collins, Joshua Kramer, Joanna Walker

This panel discussion consists of veterinarians who have completed their specialty training in laboratory animal medicine in the last 10 years. The panelists represent diverse areas of the field, including academia, industry, and government, and serve in a variety of roles, including clinical medicine, teaching, research, and regulation. The purpose of this panel is to discuss topics related to transitioning from a training environment to a job. These topics include those related to preparing for and obtaining your first job post-training, such as capitalizing on opportunities during training that prepares you for your job; marketing yourself for a position; interview process peculiarities related to different areas in the field, and negotiating for the resources you need to succeed. The panelists will also share their experiences and give their insights regarding challenges commonplace in those first years following completion of training, including preparing for ACLAM boards while working, managing people, managing work-life balance, changing positions within the first couple of years, and navigating extenuating circumstances, such as being geographically limited due to family obligations. The target audiences for this panel discussion are veterinarians currently in or finishing their training, veterinarians who have recently finished their training and are transitioning to a first job, and LAM training program directors and faculty. The goal of the discussion is to provide tools and insight to navigating the transition from trainee to real-world vet so that newly-trained veterinarians find fulfillment and success in their career.


The Modern Vivarium—Digitally Enabled and Energy Efficient
Thursday, November 1, 12:30 PM - 2:00 PM/Room: 341
Leader: Clement Feng
Moderator: Michael Evans
Facilitator: TBN
Panelist: Gary L Borkowski, David W Brammer, Pete Hmelyar, Matt Moose

In this age of the IoT (Internet of Things) technologies, there is both insight for facilities that was previously not available, and at the same time opportunities for deep energy savings. This presentation will explore the technologies that enable the proactive management of a healthy vivarium environment, while also reducing energy use by up to 50% through demand control ventilation (DCV). Findings from a study conducted at the University of Houston will compare the use of DCV to constant flow in nonhuman primate and rodent rooms and review the resulting benefits of cost savings and a measurably better environment for both human and animal occupants. A representative from AAALAC International will address AAALAC's expectations regarding air exchange rates. The objectives of this panel are to learn about findings in a comparative study of a static air change rate to DCV in animal holding rooms, to gain a better understanding of the AAALAC standard relating to air change rates in the vivarium, and to understand a platform that helps proactively manage a healthy vivarium environment.