SOBP Training Workshop:
“Enhancing the Utility of Preclinical Animal Models for Advancing CNS Therapeutics”
April 27, 2022 – 8:00am – 5:00 pm – New Orleans, LA
Workshop Summary
Brain disorders are highly prevalent and substantially contribute to the overall global disease of burden. Over the past 10-15 years, hundreds of compounds have been advanced into clinical testing based, in part, on evidence from preclinical data. However, the vast majority of these compounds were later abandoned due to a lack of clinical efficacy. While there are multiple reasons for clinical failure, one of the most frequently cited is the translational validity and overall quality of the preclinical data used as the basis for clinical research. However, despite awareness and numerous efforts by publishers, funders, academic institutions, individual labs and other stakeholders to address the root causes, irreproducible research remains a challenge to R&D decision-making and limits the potential to speed new diagnostics and therapeutics for many brain disorders.
This workshop is aimed to early career researchers who seek training in the adoption and implementation of known tools to mitigate the causes of irreproducible research and thus enhance the translational relevance of preclinical research for clinical R&D. Topics include good research practices, strategies for effective experimental design, stringent statistical analyses, and transparent reporting and implementing a quality system in your laboratory. Further, to improve bi-directional awareness of the importance of preclinical research for R&D decision-making, this workshop will uniquely focus on the contribution of preclinical research to the drug development process and how all researchers can increase the likelihood of translational success by implementing good research practices.
Workshop Objectives
- Understand how the pharmaceutical industry utilizes preclinical data to inform drug development.
- Discuss key issues that contribute to poor rigor and reproducibility in preclinical research
- Introduce methods and tools that can maximize bidirectional translation between basic and clinical research.
Agenda
Time | Topic | Style | Presenter |
7:00 – 8:00 am | Arrivals and Breakfast | All | |
8:00 – 8:15 am | Welcome & Agenda | Chantelle Ferland-Beckham, PhD Senior Director, External Affairs Cohen Veterans Bioscience | |
8:15 – 8:45 am | How does Preclinical Research Contribute to R&D Decision Making? | Keynote | Allyson Gage, PhD Chief Medical Officer Cohen Veterans Bioscience |
8:45 – 9:30 am | Hidden Obstacles in Study Design | Lecture | Martin C. Michel, PhD Partnership for Assessment and Accreditation of Scientific Practice (PAASP) |
9:30-10:00 am | The Importance of Sex as a Biological Variable for Research Translation | Lecture | Jill Daniel, PhD Professor Department of Psychology, Director Tulane Brain Institute, Tulane University |
10:00 – 10:30 am | BREAK | ||
10:30 – 11:00 am | Developing a Statistical Analysis Plan BEFORE Experimental Conduct | Lecture | Lee Lancashire, PhD Chief Information Officer Cohen Veterans Bioscience |
11:00 – 11:30 am | Intentional Data Collection: The Role of Preclinical CDEs and their Benefits for Psychiatry | Lecture | Michelle C. LaPlaca, PhD Professor, Department of Biomedical Engineering Georgia Institute of Technology & Emory University |
11:30 – 12:00 pm | Learning from the Past: Search Strategies and Tools to Aid Study Design | Lecture | Nikolaos Kokras, MD, PhD Psychiatrist/Clinical Research Associate, Departments of Pharmacology & Psychiatry, University of Athens, Greece |
12:00 – 1:00 pm | LUNCH | ||
1:00 – 1:30 pm | Case Study: SPS | Lecture | Chantelle Ferland-Beckham, PhD Senior Director, External Affairs Cohen Veterans Bioscience |
1:30 – 2:00 pm | The Importance of Pre-registration for Replication | Lecture | Tim Errington, PhD Senior Director of Research, Center for Open Science |
2:00 – 2:30 pm | ARRIVE Guidelines & Other Checklists | Lecture | Penny Reynolds, PhD Assistant Professor of Anesthesiology University of Florida College of Medicine |
2:30 – 3:00 pm | BREAK | ||
3:00 – 3:30 pm | The Unique Challenges of Achieving Translation in Psychiatry (focusing on animal models) | Keynote | Magali Haas, MD, PhD CEO & President, Cohen Veterans Bioscience |
3:30 – 4:15 pm | Knowledge Management: The Role of QMS in Rigorous Research | Lecture | Malcolm Macleod, PhD GoEQIPD Guarantor Professor of Neurology and Translational Neuroscience Academic Lead for Research Improvement and Research Integrity University of Edinburgh |
4:15 – 4:45 pm | Translating Evidence into Policy | Lecture | Marc Avey, PhD Director of Standards Canadian Council on Animal Care |
4:45-5:00 pm | CLOSING COMMENTS & ADJOURN | Chantelle Ferland-Beckham, PhD Senior Director, External Affairs Cohen Veterans Bioscience | |
5:30 pm | EVENING SOCIAL (Cocktails & Hors d’oeuvres) | All |
Speakers
Chantelle Ferland-Beckham, PhD
Senior Director, External Affairs, Cohen Veterans Bioscience
Nikolaos Kokras, MD, PhD
Psychiatrist & Research Associate, National and Kapodistrian University of Athens
Malcom Macleod, PhD
Professor of Neurology & Translational Neurosciences and Academic Lead for Research Improvement and Research Integrity, University of Edinburgh