Preclinical Rethinking Webinar
Course Description
Preclinical research aims to develop potential therapies and to translate scientific discoveries into clinical applications for patients. This process requires rigorous hypothesis testing and experimentation in model systems to confirm treatment efficacy and safety before advancing to clinical trials. However, translational failures where clinical trials fail to replicate promising preclinical results are common, creating a significant gap with medical, economic, social, and ethical consequences.
Concerns about the low success rate of translating preclinical research into effective clinical interventions has grown within the biomedical community.
Learning Objectives
As part of the DECIDE II project, this seminar series brings together international experts to share insights on robust and efficient practices for responsible preclinical research, with the aim of bridging the translational gap and strengthening the research community.
If you were unable to attend a webinar session, you can access the slides and the recorded session here.
Target Audience
- Research fellows, early career researcher (postdocs, PhDs, students)
- Members of BIH, CHA, BUA and external institutions (academia, industry, other organizations)
Participation Requirements
None.
Upcoming Lectures
Join us for the first session of 2026, with a focus on research reproducibility. Our expert speaker Dr. Michèle Nuijten (Tilburg University, Netherlands) will present the R package and web app statcheck to automatically detect statistical reporting inconsistencies in primary studies and meta-analyses.
About the Speaker:
Michèle Nuijten is an Assistant Professor at the Meta-Research Center at Tilburg University, where she studies reproducibility and replicability in psychology. She obtained her PhD in Methodology and Statistics at Tilburg University in 2018.
Michèle received an innovation grant from the Dutch Research Council to develop an efficient protocol to assess and improve robustness of psychological findings.
Furthermore, as part of her research, Michèle co-developed the free tool statcheck; a “spellchecker” for statistics. Statcheck has gained popularity as a pre-publication check: since its launch in 2016, the web app was visited tens of thousands times, and two psychology journals have made statcheck a standard element in their peer review process.
Beside her research, Michèle serves on the Editorial Boards of several psychology and meta-science journals. She is on the advisory boards of several initiatives related to improving robustness in psychology and other scientific fields, such as the Institute for Replication, the ERROR program, and the Dutch Reproducibility Network. Throughout all her work, she is an advocate for open science an robust research methods.About the Talk:
Half of the psychology papers contain inconsistent statistical results in which the reported p-value does not match the reported test statistic and degrees of freedom. Most of these inconsistencies seem to be small and inconsequential, but in over 12.5% of the papers there are inconsistencies that might change the statistical conclusion. Such statistical reporting inconsistencies affect the reproducibility and quality of scientific findings.
We developed the R package "statcheck" and the accompanying web app https://statcheck.io to automatically find these inconsistencies. In my talk, I will briefly explain how statcheck works and discuss its potential in preventing statistical errors through self-checks and peer review. Finally, I will highlight some additional manual consistency checks that require only the information in the published article.
Nuijten, Michèle B, and Joshua R Polanin. ""statcheck": Automatically detect statistical reporting inconsistencies to increase reproducibility of meta-analyses." Research synthesis methods vol. 11,5 (2020): 574-579. DOI: 10.1002/jrsm.1408In this session, Dr. Marcus Meinhardt will share his insights on conducting multi-center preclinical trials, a novel approach in the drug discovery pipeline to enhance translation.
Meinhardt, Marcus W et al. "A new module in the drug development process: preclinical multi-center randomized controlled trial of R-ketamine on alcohol relapse." Neuropsychopharmacol. 50, 886–894 (2025). DOI: 10.1038/s41386-025-02071-w
About the Speaker:
Dr. Marcus Meinhardt is the head of the research group Translational Psychopharmacology, bridging preclinical research (Institute for Psychopharmacology) to clinical work (Department of Molecular Neuroimaging) at the Central Institute of Mental Health in Mannheim. His background is in biotechnology and neuroscience with particular expertise in the field of preclinical behavioral neuroscience, molecular biology, and neuroimaging research methods. Additionally, he has intensive pharmaceutical industry experience, including preclinical target development, CNS pharmacokinetics and quality management. The core vision of his research is to promote preclinical research data quality and integrity in order to develop novel therapeutic approaches in the field of substance disorders (SUD), ultimately providing go/no-go decisions for clinical development.
Previous Lectures
You can access the slides and recordings of all previous lectures here.
Previous Lectures
In this session, PD Dr. rer. nat. Steven R. Talbot of Medizinische Hochschule Hannover (Germany) will speak about the RELSA algorithm and its implementation in preclinical severity assessment of laboratory animals. The talk will focus on examples of where and how to implement the algorithm in animal research and routine monitoring. We will explore the idea of continuous quantitative severity assessment to more objectively identify animals at risk. Further, different applications such as forecasting and severity mapping will be discussed. The talk will illustrate how quantitative severity assessment informs research protocols and animal care practices, helping stakeholders make better informed decisions, supporting regulatory compliance while improving welfare outcomes and data quality.
About the Speaker:
Dr. Talbot is a biochemist, data scientist, and group leader (Preclinical Data Science) at the Institute of Laboratory Animal Science at Hannover Medical School (MHH), where he specialises in the intersection of artificial intelligence, statistics, and translational laboratory animal medicine. His research centres on developing data‑driven decision‑support tools that advance both scientific rigor and animal welfare in preclinical research. A significant contribution has been the development of the RELSA (Relative Severity Assessment) score, a quantitative framework for burden assessment in animal experiments that has also been successfully translated to pediatric clinical care as the Patient Vital Score (PVS). This work exemplifies his commitment to translational research that bridges veterinary and human medicine. As co‑founder of the GMDS “AI in Research” working group and an active member of the research groups R2N and FOR2591 – Severity Assessment in Animal‑Based Research, he continues to shape the integration of data science methods and artificial intelligence in biomedical research, working toward intelligent systems that enhance both scientific discovery and ethical standards in preclinical studies.
Talbot, Steven R et al. "RELSA - A multidimensional procedure for the comparative assessment of well-being and the quantitative determination of severity in experimental procedures." Frontiers in veterinary science vol. 9 937711. (2022) DOI: 10.3389/fvets.2022.937711
Ohland PLS, Jack T, Mast M, Melk A, Bleich A, Talbot SR. Continuous monitoring of physiological data using the patient vital status fusion score in septic critical care patients. Sci Rep. 2024 Mar 26;14(1):7198. doi: 10.1038/s41598-024-57712-9. PMID: 38531955; PMCID: PMC10965972.
In this session, Dr. Natasha Karp (Data Sciences & Quantitative Biology, Discovery Sciences, R&D, AstraZeneca, Cambridge, UK) will present the interactive Sex Inclusive Research Framework (SIRF) that supports the evaluation of in vivo and ex vivo research proposals to address the risk of sex bias in preclinical research.
About the Talk:
A culturally embedded practice of studying only one sex in health research introduces a bias into the scientific knowledge base and contributes to poor translation and irreproducible findings. It is also inefficient and unsustainable, resulting in an estimated overproduction of >25 million mice and rats globally.
Research has shown that scientists perceive sex as an important biological variable but believe sex-inclusive research represents an insurmountably difficult challenge. Despite this, funders and regulators are driving change in the research landscape by moving from encouragement to mandates, with key bodies now requiring a justification for exclusion.
Unfortunately, many of the perceived obstacles are rooted in misconceptions that permeate the entire research hierarchy. Frequently, these obstacles are rooted in statistical misconceptions and lead researchers to believe that inclusive designs will increase the number of animals needed and would thus be unethical and prohibitively expensive. Moving the dial to improve inclusive research practice requires a systematic approach to investigate and challenge these obstacles.
Here we present the Sex Inclusive Research Framework (SIRF) which supports the evaluation of in vivo and ex vivo research proposals from a sex inclusive research perspective by delivering a traffic light classification, indicating whether a proposal is appropriate, risky, or insufficient with regards to sex inclusion. This tool is designed for use by researchers, (animal) ethical review boards, and funders to generate a rigorous and reproducible assessment of sex inclusion at the proposal level, thus helping address the embedded sex bias in preclinical research.
Karp, Natasha et al. "The Sex Inclusive Research Framework to address sex bias in preclinical research proposals." Nat Commun 16, 3763 (2025). DOI: 10.1038/s41467-025-58560-5
About the Speaker:
Natasha is a Director of Hit Discovery and Biostatistics within AstraZeneca leading a team of statisticians and bioinformaticians supporting preclinical research. Natasha is an active researcher publishing papers with a focus on the challenges within preclinical research with a particular interest in improving replicability, reproducibility, and generalizability of the studies. In recent years, the research has focused on meta-research exploring how to enable and nudge scientists into better research practice.
Join us for the first session after the summer break with Dr. Manoj Lalu (University of Ottawa, Canada) and learn about patient engagement in preclinical research.
About the Talk:
Patient engagement in research, defined as “research being carried out with or by patients, caregivers, or the public, rather than to, about, or for them” ensures that those with lived experience of a health condition (and their families or caregivers) become active members of research teams. Because patients are the end-users of healthcare innovations, their perspectives help guide research design, conduct, and dissemination, making studies more relevant, meaningful, and impactful.
While patient engagement has gained significant traction in clinical research, its application in preclinical (laboratory-based) research remains relatively uncommon. Dr. Manoj Lalu will discuss the opportunities and challenges of preclinical patient engagement, sharing insights from his work on involving patients in laboratory studies.
About the Speaker:
Dr. Manoj Lalu is an Associate Professor in the Department of Anesthesiology and Pain Medicine at the University of Ottawa, with a cross-appointment to the Department of Cellular and Molecular Medicine and an adjunct appointment at the School of Epidemiology and Public Health. He serves as Lead of the Blueprint Translational Research Group and Associate Scientific Director of Training at the Ottawa Hospital Research Institute, where he is also a Scientist in the Acute Care Research and Regenerative Medicine Programs. His research focuses on cell therapy for perioperative medicine and critical illness, patient engagement in clinical and preclinical research, and preclinical multi-laboratory studies to reduce bias and improve rigor in preclinical science. Dr. Manoj Lalu is also active in meta-research and contributes to initiatives addressing predatory journals.Policy Brief: Engaging Patients as Partners in Preclinical Laboratory Research by The Blueprint Translational Research Group
Fox, Grace et al. "Patient engagement in preclinical laboratory research: A scoping review." EBioMedicine vol. 70 (2021): 103484. DOI: 10.1016/j.ebiom.2021.103484
Join the seventh session with Dr. Fanglian He (Bio-protocol) to learn about methods and practices that improve research reproducibility in preclinical research.
Reproducibility remains a critical challenge in preclinical research. The Reproducibility Project: Cancer Biology, as reported in eLife (Errington et al., 2021), reveals that inadequate protocols are a major factor critically impeding the replication of findings in preclinical cancer biology. In this talk, Dr. Fanglian He, co-founder and publisher of Bio-protocol, will discuss practical solutions for enhancing reproducibility, with a focus on open and reusable protocols. She will share recommended actions that stakeholders can take to address irreproducibility, as proposed by PRO-MAP, an initiative led by the EU's Joint Research Centre. Dr. He will also provide insights into how, over the past decade, Bio-protocol has supported the scientific community in improving reproducibility by publishing and sharing detailed, step-by-step life sciences protocols.
Attendees will gain a clearer understanding of the role of open protocols in addressing irreproducibility, and leave with actionable steps for fostering a more open and trustworthy preclinical research community.
About the Speaker:
Fanglian He is the publisher of Bio-protocol. She co-founded Bio-protocol in 2011 while at Stanford University, after experiencing firsthand the difficulties of reproducing published experiments. Motivated to help researchers share detailed, step-by-step protocols, she received strong support from the Stanford community. After completing her postdoc at the Carnegie Institution for Science at Stanford, Dr. He transitioned full-time to Bio-protocol in 2013, dedicated to improving the accessibility and reliability of protocols in the scientific community. She holds a PhD in Biology from the University of Pennsylvania.
In the sixth session, Dr. Nikki Osborne (Responsible Research) and Dr. Nathalie Percie du Sert (NC3Rs) will explore various resources that support researchers to improve the reliability of in vivo and in vitro experiments including the Experimental Design Assistant (EDA), ARRIVE guidelines, and DRIVER recommendations.
About the Speakers:
Dr Nikki Osborne is a developmental neurobiologist with over 25 years of experience in the lab animal science sector. She is the founding director of Learning Development & Research Training Ltd (trading as Responsible Research & Mindset Action) and works globally with research organizations, funders, regulators, and publishers. She is passionate about empowering researchers and institutions to improve the rigor and reproducibility of life science research.
Dr Nathalie Percie du Sert is the Director of Research Practice at the NC3Rs, where she leads efforts to improve research quality and reproducibility. She serves on the Advisory Board of the Swiss Reproducibility Network, the Steering Board of the Reproducibility by Design program at the University of Bristol, and the Scientific Advisory Board for the DECIDE project. She has played a central role in the development of key resources such as the Experimental Design Assistant (EDA), a free online tool for designing robust animal studies, and the ARRIVE 2.0 guidelines, which promote transparent reporting.
In the fifth session, Dr. Christoph Conrad and Dr. Michael Moles of the Regulatory Support Unit at the Berlin Institute of Health will provide an overview of the regulatory requirements for the preclinical stage of Gene and Cell Therapy (GCT) product development.
About the Speakers:
Dr. Christoph Conrad (Head of Staff Office Regulatory Affairs and Regulatory Support Unit, BIH) brings a wealth of regulatory and scientific expertise from a variety of fields. He was responsible for the evaluation of vaccines at the Paul Ehrlich Institute (PEI) for many years. Later he headed the Office for Scientific and Regulatory Advice (OSRA), an infrastructure of the German Center for Infection Research (DZIF) at the PEI. In addition to his regulatory work, Christoph Conrad gained several years of experience at the WHO in Geneva, the BMBF and the Federal Chancellery. In July 2022, he joined the BIH as Head of Staff Office Regulatory Affairs, and is also Head of the Regulatory Support Unit that has been established in June 2024.
Dr. Michael Moles (Regulatory Affairs Specialist for Biologicals) completed his PhD in Cancer Studies at the University of Glasgow, specializing in targeted therapy for chronic lymphocytic leukemia. He later pursued a Postdoc at the Max Delbrück Center, where his main focus was the development of CAR-T and CAR-NK cell therapies for blood cancer. In April 2024, he joined the Regulatory Support Unit at the Berlin Institute of Health as a Regulatory Affairs Specialist, where, alongside support for academic ATMP developers, he is participating in the EU Join4ATMP consortium and is a member of the International Rare Disease Research Consortium Task Force on regulatory convergence.
In the fourth session, Dr. Samuel Pawel (Epidemiology, Biostatistics and Prevention Institute, University of Zurich) will explore the concept of replicating null findings and present methods for evaluating their replication.
Pawel S. et al. (2023). Replication of "null results" – Absence of evidence or evidence of absence? eLife12:RP92311 DOI:10.7554/eLife.92311.2About the Speaker:
Samuel Pawel is a postdoctoral researcher at the University of Zurich specializing in (bio)statistics and meta-research. His work focuses on statistical methods for evaluating scientific evidence, with a particular interest in replication studies. He has contributed to methodological advances in statistical inference and methods for assessing replication success. Beyond research, he is involved in promoting open and reproducible science principles through his contributions to the Center for Reproducible Science at the University of Zurich and the Swiss Reproducibility Network.
In the third seminar, Dr. Vibeke Fosse (Department of Clinical Science, University of Bergen) will present a set of recommendations designed to enhance the robustness of preclinical methods in translational research for personalized medicine.
Fosse V. et al. (2023). Recommendations for robust and reproducible preclinical research in personalised medicine. BMC Med 21, 14. DOI:10.1186/s12916-022-02719-0
About the Speaker:
Vibeke completed a professional veterinary degree from the Royal Veterinary College, University of London in 2003, and specialized in companion animal oncology in 2019 from the University of Copenhagen, Denmark. Since 2016, Vibeke has also been working as an academic researcher at the University of Bergen, in a research group that focuses on the development of clinically relevant preclinical models for cancer, combined with the development of preclinical imaging modalities. From 2020-2022, Vibeke was involved in the PERMIT project funded by the European Clinical Research Infrastructure Network (ECRIN), to lead explorations into the optimal exploitation of preclinical research to drive personalized medicine trials.
In the second seminar session, Prof. Peter Loskill (Organ-on-Chip Research, University of Tübingen) will share his expertise on new approach methods (NAMs), with a particular focus on how microphysiological systems are advancing translational preclinical research.
About the talk:
Drug discovery and development to date has relied on animal models, which are useful, but fail to resemble human physiology. Technological advances at the interface of microsystem engineering and cell biology have provided an entirely new class of human relevant in vitro models – Organ-on-Chips (OoCs) – that have led to the emergence of a new paradigm of drug development using patient- and disease-specific models. OoCs integrate human µ-tissues into microfluidic devices tailored to create physiological microenvironments and recapitulate organ-level functionality. Moreover, OoCs provide the opportunity to mimic aspects of the human immune system, which is a multi-faceted challenge and a major opportunity at the same time: The complexity of the immune system, significant species-differences in immune response, and large population heterogeneities have created an immense need for human-relevant immunocompetent models.
Using microfabrication techniques, the team of Prof. Loskill has developed diverse OoCs with complex, immunocompetent 3D human tissues that remain viable and functional for weeks, including Tumor-, Retina-, Choroid-, Heart-, Pancreas-, Lymphoid-tissue-, and Adipose-on-chip models. The OoCs generally consist of three functional components: organ-specific tissue chambers; "vasculature-like" media channels enabling a precise and computationally predictable delivery of soluble compounds; "endothelial-like" barriers protecting the tissues from shear forces while allowing diffusive transport. To recapitulate human immune responses, Prof. Loskill’s team has successfully integrated components of the innate and adaptive immune system into the OoCs demonstrating the complex interplay of different cell populations as well as their importance for pharmaceutical safety and efficacy assessment.
About the speaker:
Prof. Dr. Peter Loskill is W3-Professor for Organ-on-Chip Research at the Eberhard Karls University Tübingen and the Natural and Medical Sciences Institute (NMI) as well as Past-Chair of the European-Organ-on-Chip-Society (EUROoCS). He graduated in 2012 from Saarland University with a PhD in Physics and thereafter worked as a postdoctoral fellow in the Healy Lab at UC Berkeley. In 2015, he was named as one of Technology Review’s "Innovators under 35 Germany" and awarded an ATTRACT starting grant. He now heads the interdisciplinary µOrgano-Lab and the 3R Center Tübingen for In vitro Models and Alternatives to Animal Testing.
Join the first seminar session with Randall J. Ellis, PhD, (Department of Biomedical Informatics, Harvard Medical School) and learn about the importance of pre-registrations and registered reports in preclinical research.
Ellis R. J. (2022). Questionable Research Practices, Low Statistical Power, and Other Obstacles to Replicability: Why Preclinical Neuroscience Research Would Benefit from Registered Reports. eNeuro, 9(4), DOI: 10.1523/ENEURO.0017-22.2022About Randall J. Ellis:
He completed his BS in Neuroscience at Florida Atlantic University in 2014, followed by a postbac at the National Institute on Drug Abuse, where he studied cocaine’s effects on behavior and developed computational biology skills. He earned his PhD at Mount Sinai in 2022, focusing on opioid use disorder and neurocognitive risks. Currently, he is a postdoc at Harvard Medical School, using statistical modeling to assess dementia risk and exploring metascience issues in biomedical informatics. A lot of his work focuses on the intersection of metascience and biomedical informatics, specifically how the performance of machine learning models can be reported in misleading ways.
Meet the Speaker:
If you'd like to meet our speaker in person outside of the webinar to discuss enhancing quality in preclinical research, Randall will be at the BIH QUEST Center from January 28–30, 2025. Feel free to contact decide@charite.de to set up a meeting.
