Trine Schütt
Toxicologist
Hvidovre
Summary
I am a veterinarian with a strong clinical background, PhD degree and 9 years of training as a toxicologist covering experience from both discovery toxicology and regulatory toxicology. As preclinical lead, the responsibilities included both the study monitor role, strategic decision making in collaboration with the project and safety management teams and presentations for relevant stakeholders. I thrive by driving a project forward in connection with my colleagues!
Additionally, I also have comprehensive training as laboratory veterinarian and knowledge within the 3R's related to animals used for scientific purposes.
I am a veterinarian with a strong clinical background, PhD degree and 9 years of training as a toxicologist covering a broad experience in all stages of preclinical safety assessment of both small molecules and biopharmaceuticals. I've worked across all stages of drug development, from early discovery toxicology to Phase 3 enabling programs to post-approval work. My main experience comes from bringing candidate molecules to a successful IND/CTA.
In addition to my my role as a toxicologist, I have broad hands-on experience as designated laboratory veterinarian/Animal Welfare Officer.
With Astra Zeneca's focus on innovative science within multiple modalities and indications, I see my previous experience as an excellent match, and furthermore an great opportunity to build upon my current competencies.
I get motivated and thrive by working across disciplines to progress the molecules. I work with a structured approach and with focus on timelines, project needs and as a dedicated team player.
Overview
24
24
years of professional experience
2007
2007
years of post-secondary education
Work History
Senior Toxicologist and Animal Welfare Officer
NMD Pharma
10.2024 - Current
Drug modality and target indications:
- Small molecule for neuromuscular disorders
Main responsibiities:
- Study monitor for designing and conducting Phase 3-enabling studies, such as chronic repeat dose toxicity studies including implementation of special investigations, such as extended ophthalmoscopy, and outsourcing of both primary and peer-review pathology reading to experts within the field.
- Study monitor for specific metabolism studies (such as ADME study with radiolabelled compound, Placental and Lactal transfer study, and MetID study).
- Contribute in cross-functional team to deliver written statements to documents intended for interaction with Regulatory Authorities referring to preclinical issues constraining dose escalation in clinical trials.
- Provide input to strategy for disproportionate metabolite.
- Review of expert opinion statement reports primarily concerning histopathology findings.
- Toxicology lead for second generation project, which included assessment of relevant early toxicity screening.
Principal Professional/Developmental Toxicologist and Animal Welfare Officer
LEO Pharma
11.2022 - 09.2024
Drug modality and target indications:
Small molecules, including protein-protein interaction modulators (systemic and topical use) and monoclonal antibodies for inflammatory skin disorders and cancers.
Main responsibilities and learnings:
- Toxicology/Preclinical lead of Global Project Team for both early and late stage programs. Included contracting, planning, monitoring, and reporting of Phase 1-enabling programs or Phase 2 supporting studies (incl. reprotoxicity studies), in addtion to cross-disciplinary collaboration on strategy decisions for clinical development.
- Presentation of data to line- and project organisation such as presentation to Safety Review Board for approval of FiH trial and presentation of data and mitigation strategy to the Scientific Board of Directors.
- Responsible for providing and driving the preclinical input to regulatory documentation (such as IB, CTA/IND) and other interactions with Regulatory Health Authorities.
- Participate as preclinical expert in evaluations of potential in-licencing opportunities and Due Diligence projects, involving acquistion of a late stage project.
- Preclinical Lead in Divestment/Partnering of LEO projects to large-size Pharmacuetical companies.
- Full responsibility for securing compliance with animal welfare standards at external collaboration partners, which include full auditor rights of partners' premises, and continuous communication.
Principal Scientist/Toxicologist
Expres2ion Biotechnologies
05.2022 - 10.2022
Drug modality and indication:
Therapuetic vaccine for breast cancer.
Main responsibilities:
- Responsible for planning, designing, monitoring, and interpretation of exploratory and regulatory toxicology studies in both rodent and non-rodent species for a therapeutic vaccine. This included designing and evaluation of multiple immunoassays (ELISA, T-cell flow analysis and ELISpot, cytokine analysis etc.), assessment of effects from adjuvans and collaborating with project team for evaluation of species selection justification.
- Communicating data internally and contributing/authoring of nonclinical safety sections of relevant regulatory documentation.
Senior Scientist, Animal Welfare Officer
LEO Pharma
01.2019 - 04.2022
Drug modality and target indications:
Small molecules and monoclonal antibodies for inflammatory skon disorders and cancers.
Main responsibilities:
- Toxicology/Preclinical lead of Global Project Team for primailr early. Included contracting, planning, monitoring, and reporting of Phase 1-enabling programs supporting studies (incl. safety pharmacology studies) in addition to planning and initiation of the Phase2 program.
- Close cross-disciplinary collaboration on strategy decisions for clinical development.
- Presentation of data to line- and project organisation such as presentation to Safety Review Board for approval of FiH trial.
- Responsible for providing and driving the preclinical input to regulatory documentation (such as IB, CTA).
- Participate as preclinical expert in evaluations of potential in-licencing opportunities and Due Diligence projects, involving acquistion of a late stage project.
- Preclinical Lead in the full Divestment of a project including data transfer.
- Engage in continuously improving our collaboration with preferred CROs (such as governance board member).
- The role as Animal Welfare officer covers full responsibility for securing compliance with animal welfare standards at external collaboration partners (full auditor rights of partners' premises) in addition to cover for the Designated Lab Veterinarian if delegsated.
Research Scientist, Designated Lab Veterinarian
LEO Pharma
10.2016 - 12.2019
Drug modality and indications:
Small molecules (incl. PROTAC's) for inflammatory skin disorders.
Major responsibilities:
- Core team member of research project teams where I had full responsibility delivering on time execution of in vitro and in vivo data for early safety and risk assessment. This included evaluation in all stages of small molecule discovery toxicology from Lead selcetion, to superqualifier selection and to selection of Development Candiate molecule.
- Examples of assays included: in silico assessments for structural alerts, genetic screening assays (Ames and Micronucleus), cytotoxicity assays (HepG2 screening panel, Seahorse assay, PLD/Steatosis, phototoxicity), functional selectivity screens, hERG assay, in vivo PK/PD assays, 5-14 days rodent toxicology studies, CV telemetry studies etc.
- Responsible for the safety part of the written Candiadate Nomination Report
- Close collaboration wtih other disciplinces, primarily medicinal chemists, formulation scientists, PK experts and pharmacology leads.
- Study monitor for both in vitro and in vivo studies outsourced to external CRO's
- As Back-up Designated Laboratory Veterinarian, I functioned eiter as assitant to the the Designated Vet or was delegated the as fully accountable for animal welfare pertaning to both internal and external activities during one year of leave.
Post.doc.
University of Copenhagen
01.2015 - 12.2016
Ph.D student and teaching associate
University of Copenhagen
01.2011 - 12.2015
Senior Clinician With Teaching Responsibilities
University Hospital for Companion Animals
01.2007 - 12.2011
Clinical assistant in private practice for small animals
01.2002 - 12.2007
Education
Ph.D. -
University of Copenhagen
01.2011 - 01.2016
D.V.M. - Doctor of Veterinary Medicine
University of Copenhagen
Skills
- 9 years of experience from mid-size pharma and biotech covering both discovery and regulatory toxicology to post-approval work
- Worked with multiple platforms from small molecules, monoclonal antibodies to therapeutic vaccines
- In-depth scientific knowledge in working with immunologic targets where integration of immunoassays for understanding and evaluation of immunotoxicology is key
- Proficient in stakeholder management and strategic planning
- Focus on timelines and effective communication
- Excellent in cross-functional teamwork
- Solid knowledge and capabilities within assessment of Animal Welfare and the importance for securing better data quality
Publications Presentations
- 2017, Geriatric canine cognitive dysfunction/dementia, WSAVA/FECAVA (42nd congress)
- 2021, Barbara Blicher Thomsen, Cecilie Madsen, Katrine Tækker Krohn, Camilla Thygesen, Trine Schütt, Athanasios Metaxasb, Sultan Darveshe, Jørgen Steen Agerholm, Martin Wirenfeldt, Mette Berendt and Bente Finsen. Mild Microglial Responses in the Cortex and Perivascular Macrophage Infiltration in Subcortical White Matter in Dogs with Age-Related Dementia Modelling Prodromal Alzheimer’s Disease. J. Alzheimer’s Dis. 82, 572-592
- 2016, Schütt T, Helboe L, Østergaard L, Waldermar, G, Berendt M, Pedersen JT. Dogs with Cognitive Dysfunction as a Spontaneous Model for early Alzheimer’s Disease: A Translational Study of Neuropathological and Inflammatory Markers. J.Alzheimers. Dis. 52(2), 433-449.
- 2015, Schütt T, Toft N, Berendt M. Cognitive function, progression of age-related behavioral changes, biomarkers, and survival in dogs more than eight years old. Journal of Veterinary Internal Medicine. 29: 1569-1577.
- 2015, Schütt T, Toft N, Berendt M. A comparison of two owner-based questionnaires for clinical assessment of Canine Cognitive Dysfunction. Journal of Veterinary Behavior: Clinical Applications and Research. 10(6), 452-458.
- 2013, Fast R, Schütt T, Toft N, Møller A, Berendt M. An Observational study with Long-Term Follow-Up of Canine Cognitive Dysfunction: Clinical Characteristics, Survival, and Risk Factors. J. Vet. Intern. Med. 27, 822-829.
- 2003, Pedersen HD, Schütt T, Søndergaard R, Qvortrup K, Olsen LH, Kristensen AT. Decreased plasma concentration of nitric oxide metabolites in dogs with untreated mitral regurgitation. J Vet Intern Med.17(2), 178-84.
Professional Societies
- 2019-2025: Dansk Selskab for Toksikologi og Farmakologi (DSTF)
- 2019-2021: Safety Pharmacology Society (SPS)
- 2019-2025: European Society of Laboratory Animal Veterinarians (ESLAV)
Personal Information
Date of Birth: 01/17/73
Supplementary Education Training
- 2024, Primate Symposium, Labcorp
- 2024, Application of New Approach Methodologies, Labcorp
- 2023, DSTF annual meeting, DSTF, Denmark
- 2023, 11th Juvenile Toxicology Symposium, Janssen, Belgium
- 2023, Basic course in GLP, Key2Compliance AB
- 2022, The Danish 3R symposium, Danish 3R Center
- 2022, Drug Development Symposium, Early Clinical Development, Labcorp
- 2021, The Danish 3R Symposium, Danish 3R Center
- 2021, Congress of the European Society of Toxicology (virtual), EUROTOX
- 2021, Small size but big potential: the NHP marmoset in toxicology studies for Biologics and vaccines (Webinar), ERBC
- 2021, The Role of Dogs and Minipigs in DART Programs (Webinar), Charles River
- 2020, GLP Refresher Training, Mirabilitas Ltd.
- 2020, Welfare benchmarking in laboratory animals with a focus on mice and non-human primates (Webinar), Karolinska Institutet
- 2020, The Danish 3R Symposium, Danish 3R Center
- 2020, The Guidelines and Challenges of Performing NHP DART Studies (Webinar), Charles River
- 2020, ICH S5 Updates and Implications (Webinar), Charles River
- 2020, Drug Development Symposium, Immuno-Oncology, Covance
- 2019, Introduction to Pharmacokinetics for the Non-Specialist, PTI, UK
- 2019, Drug Development Symposium: Reproductive & Juvenile Toxicology Studies, Envigo
- 2019, Practical Reproductive and Developmental Toxicology, ACT, US
- 2019, Animal Welfare and Research: Reduce, Refine, Replace (Webinar), Covance
- 2019, Annual Biologics Symposium, Envigo
- 2018, Good Laboratory Practice for Study Directors, Principal Investigators, Study Staff and Management, RQA, UK
- 2018, Non-clinical Safety and Toxicology (Master of Industrial Drug Development), University of Copenhagen
- 2018, Annual Danish 3R Symposium, Danish 3R-Center
- 2018, Annual Primate Symposium, Covance
- 2018, Annual Biologics Symposium, Envigo
- 2018, Human focused in vitro toxicity models: from early stage screening to addressing clinical liabilities, Cyprotex
- 2017, De-risking Drug Development, Envigo
- 2017, 53rd Congress of the European Society of Toxicology, EUROTOX
- 2017, Annual Biologics Symposium, Envigo
- 2017, Credible communication for specialists, Rhetorica
- 2017, Annual 3R Symposium, Danish 3R-Center
- 2017, Annual meeting, Scandinavian Society for Laboratory Animal Science, Scand-LAS
- 2014, PhD workshop: The European Medicines Research Training Network (The whole life cycle of medicines research), EMTRAIN
- 2002, Laboratory Animal Science, FELASA, Category C, University of Copenhagen
Timeline
Senior Toxicologist and Animal Welfare Officer
NMD Pharma
10.2024 - Current
Principal Professional/Developmental Toxicologist and Animal Welfare Officer
LEO Pharma
11.2022 - 09.2024
Principal Scientist/Toxicologist
Expres2ion Biotechnologies
05.2022 - 10.2022
Senior Scientist, Animal Welfare Officer
LEO Pharma
01.2019 - 04.2022
Research Scientist, Designated Lab Veterinarian
LEO Pharma
10.2016 - 12.2019
Post.doc.
University of Copenhagen
01.2015 - 12.2016
Ph.D student and teaching associate
University of Copenhagen
01.2011 - 12.2015
Ph.D. -
University of Copenhagen
01.2011 - 01.2016
Senior Clinician With Teaching Responsibilities
University Hospital for Companion Animals
01.2007 - 12.2011
Clinical assistant in private practice for small animals
01.2002 - 12.2007
D.V.M. - Doctor of Veterinary Medicine
University of Copenhagen
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