Dr. R.J.M.M. Thoolen

Managing Director / Board Certified Toxicologic Pathologist (PhD, CRP/TP)

Bob is the founder and Managing Director of GPS BV. He has over 30 years education and/or experience in pathology. Training in human- and animal pathology gives him a broad perspective of the science of pathology. First working at the Central Veterinary Institute and later at Solvay Pharmaceuticals B.V. as Toxicologic Pathologist, is a sound basis of Toxicologic Pathology as performed up to now under GLP regulations at GPS BV. In his free time he like to fitness, swimming and play golf as much as possible.

Working period at GPS: 19 years

Professional Experience
Education
Memberships
BOARD CERTIFICATION
Publications
Studies track record

Professional Experience and Training

Total years of training and experience: 28 years
2004 – present
Toxicologic Pathologist PhD., CRP/TP / Managing Director / Test Site Manager
Global Pathology Support B.V., The Hague, The Netherlands.
  • Responsible for assessing the safety of drugs of preclinical toxicity studies in pharmaceutical or chemical safety development. The emphasis at Global Pathology Support is on the identification of pathological changes, the assessment of the relevance of these changes, and in particular the interpretation of animal tests in terms of human application. These activities are performed according to international accepted standards.
1992 – 2004
Principal Pathologist
Solvay Duphar B.V.
  • Giving management advice and guidance on chemically induced pathoses in the common laboratory animals by means of clinical examinations, necropsy, and histopathological examination.
  • To carry out and train subordinates in the necropsy and histopathology techniques.
  • To design and carry out and/or supervise oncogenicity tests in animals in such a way as to be able to report as soon as possible those results from the experiments which could prevent the safe use in man or its registration for use in certain countries.
  • To explain and discuss the results of oncogenicity studies and histopathological evaluation in other studies to third parties including government agencies.
  • To comment and/or prepare Investigational brochures, IND, NDA and Expert Reports for registration purposes.
  • Be involved in the preparation of electronic submission of tumour data from oncogenicity studies for registration purposes.
1989 – 1991
Pathologist
Central Veterinary Institute, Lelystad.
  • Responsible for diagnostic pathology and performing research on “pregnancy proteins” in cattle.
Formal examinations and practical training in General and Special Pathology of Medicine at the Academic Hospital Utrecht, Department of Pathology for one year (1985-1986) – Prof. Dr. J.A.M. van Unnik, Dr. C. Gielis.
Training program “Veterinary Pathology” (theory and practical training for Veterinary students. Studying Pathology of laboratory animals for one year (1988-1989) – Prof. dr. P. Zwart.
Pathologist and pathology training at the Central Veterinary Institute at Lelystad (1989-1991) – Prof. dr. J.E. van Dijk.
Formal post-graduate course in Microscopical Pathology for two years at the Veterinary Faculty, Department of Veterinary Pathology (1989-1991) – Prof. dr. J. Mouwen.
Formal post-graduate programme for Laboratory Animal Pathologist (1989-1993) – Prof. dr. J.E. van Dijk (Royal University Utrecht) and R. Dawes (Solvay).
Formal courses for certification as Toxicologic Pathologist (1993-1996) – Prof. dr. J.E. van Dijk and Prof. dr. J. Vos.
Formal examinations and practical training in General and Special Pathology of Medicine at the Academic Hospital Utrecht, Department of Pathology during study of Medicine (1997) – Prof. dr. van den Tweel.
Set up Gobal INHAND Liver Nomenclature document as BSTP representative (first author amongst representatives of the STP, ESTP, and GSTP respectively (2007-2010.

Education

2012
Obtained degree of Doctor (PhD) at the University Utrecht: “Global nomenclature of rodent liver lesions and comparative investigations of human and rat hepatocellular proliferative lesions”.
2009 – 2012
PhD project on non-proliferative and proliferative liver lesions (University Medical Center Utrecht (UMCU), Department of Pathology, Division of Laboratories and Pharmacy).
1997 – 1999
Study Medicine (1-3rd year) at the Faculty of Medicine, Royal University of Utrecht.
1996
Board Certified Toxicologic Pathologist, by the Committee set up jointly by the Pathological Society of The Netherlands and The Royal Netherlands Veterinary Association.
1993
Qualified Laboratory Animal Pathologist, by the Committee set up jointly by the Pathological Society of The Netherlands and the Royal Netherlands Veterinary Association.
1989 – 1993
Postgraduate training for Laboratory Animal Pathologist.
1989 – 1991
Postgraduate course in Microscopical Pathology.
1988 – 1989
Training program "Veterinary Pathology" (theory and practical training for Veterinary Students Studying Pathology of Laboratory animals).
1988
Master of Science in Medical Biology (B5*).
1987
Training program "Laboratory Animal Science" (Art. 9).
1985 – 1986
Examinations and practical training in General and Special Pathology of Medicine at the Academic Hospital Utrecht, Department of Pathology.
1985
Bachelor of Science in Medical Biology
1981 – 1988
University of Utrecht.
1974 – 1981
Secondary school (Atheneum-B).

Professional Memberships

2021 – now
Elected Member of the Society of Toxicology (USA).
2016 – 2017
President of the NL-STP for the International Federation of Societies of Toxicologic Pathologists IFSTP.
2016 – 2017
Elected Chairman Section Toxicologic Pathology of The Netherlands Society of Toxicology.
2015 – 2017
Chairman for the Section Animal Pathology (Toxicologic Pathologists, Laboratory Animal Pathologists, Veterinary Pathologists) of The Netherlands Society of Pathology.
2015
Scientific Organizer and Masterclass: Continuing Education Symposium Liver BSTP at Department of Pathology, Cambridge, UK, March 25th – 27th, 2015.
2005 – 2010
Member of the Board of the NVVP (educational committee) for the Toxicologic Pathologists.
2004 – 2010
Member of the Board of the European Society of Toxicologic Pathology (ESTP).
2009
President of the 7th European Congress of Toxicologic Pathology: “Drug Induced Toxicologic Pathology – Examples & Methods Used”. September 15th – 18th, 2009, The Hague, The Netherlands (>200 participants from 24 countries).
2007 – now
Elected Member of The British Society of Toxicologic Pathology.
2004 – now
Elected Member of the European Society of Toxicologic Pathology (ESTP).
1993 – now
Elected Member of The Pathological Society of the Netherlands.
1993 – now
Elected Member of The Society of Toxicologic Pathologists.
1992 – 1993
Member of the Charles Lewis Foundation.
1992 – now
Member of The Netherlands Society of Toxicology.

Board Certifications

2022 – 2027
Re-registration as CRP/TP Board Certified Toxicologic Pathologist.
1989 – 2023
Academic degrees and several courses on management, science and (toxicologic) pathology: N=122 certificates of education.
2003
Stralingsdeskundige Niveau 5 A/B.
1993
Board Certified Toxicologic Pathologist (see above).
1993
Qualified Laboratory Animal Pathologist, by the Committee set up jointly by the Pathological Society of The Netherlands and the Royal Netherlands Veterinary Association.

Publications

Major contributions to approved internal reports; FDA submissions, IDB, NDAs, Expert reports and Appraisals of Solvay Pharmaceuticals B.V. – Titles not presented.
Major contributions to approved internal reports; FDA submissions, IDB, NDAs, Expert reports and Appraisals of Solvay Pharmaceuticals B.V. – Titles not presented.
Bob Thoolen. The mouse renal system – A summary of histopathological findings. Dept. Veterinary Pathology, Div. Pathology of Laboratory and special animal diseases, November 1988; 16 pp.
Bob Thoolen. Rat – Histopathology of the renal system – A summary of histopathological findings. Dept. Veterinary Pathology, Div. Pathology of Laboratory and special animal diseases, November 1988; 18 pp.
BrdUrd labeling of S-Phase Cells in Testes and Small Intestine of Mice, Using Microwave Irradiation for Immunogold-Silver Staining: An Immunocytochemical Study. J Histochem & Cytochem 1990; 38(2):267-273.
Bob Thoolen. Malignant Fibrous Histiocytoma – a histogenetic study – J Comp Pathol 1990 (submitted). R.J.M.M. Thoolen, J.H. Vos, J.S. van der Linde-Sipman, R.A. de Weger, J.A.M. van Unnik, W. Misdorp and J.E. van Dijk. Malignant Fibrous Histiocytomas in Dogs and Cats – An Immunohistochemical Study – Res Vet Sci 1992; 53:198-204.
Bob Thoolen, Henk Koster, Anton van Kolfschoten & Martin de Haan. Gastric neuroendocrine tumours in a two-year oncogenicity study with CD-1 mice. Toxicol Pathol 2002; 30 (3):322-327.
Ben A.R. Lina, Ruud A. Woutersen, Joost A. Bruijntjes, Jan van Benthem, Jolanda A.H. van den Berg, Johan Monbaliu, Bob J.M.M. Thoolen, Rudolf B. Beems and Coen F. van Kreijl.
Evaluation of the Xpa-Deficient Transgenic Mouse Model for Short-Term Carcinogenicity Testing: 9-Month Studies with Haloperidol, Reserpine, Phenacetin, and D-Mannitol. Toxicol Pathol 2004; 32 (2):192-201.
Baras B, Stittelaar KJ, Simon JH, Thoolen RJMM, Mossman SP, et al. (2008) Cross-Protection against Lethal H5N1 Challenge in Ferrets with an Adjuvanted Pandemic Influenza Vaccine. PLoS ONE 3(1): e1401. doi: 10.1371/journal.pone.0001401.
Bob Thoolen, Robert R. Maronpot, Takanori Harada, Abraham Nyska, Colin Rousseaux, Thomas Nolte, David E. Malarkey, Wolfgang Kaufmann, Karin Küttler, Ulrich Deschl, Dai Nakae, Richard Gregson, Michael P. Vinlove, Amy E. Brix, Bhanu Singh, Fiorella Belpoggi1, Jerrold M. Ward. Nomenclature and Diagnostic Criteria for Hepatobiliary Lesions in Rats and Mice (INHAND) Toxicol Pathol 2010; 38:5S-81S.
Jerald M. Ward and Bob Thoolen. Grading of Lesions. Toxicol Pathol 2011; 39:745-746.
Bob Thoolen, Fiebo J.W. ten Kate, Paul J. van Diest, David E. Malarkey, Susan A. Elmore and Robert R. Maronpot. Comparative Histomorphological Review of Rat and Human Hepatocellular Proliferative Lesions. J Toxicol Pathol 2012; 25:189-199.
Bob Thoolen. Global nomenclature of rodent liver lesions and comparative investigations of human and rat hepatocellular proliferative lesions. 1-202. 12-11-2012. Utrecht, Department of Pathology, Division of Laboratory and Pharmacy, University Medical Center Utrecht. Dissertation. ISBN: 97 890 3935 8504
Bob Thoolen, Fiebo J.W. ten Kate, Domenico Castigliego, Paul J. van Diest, David E. Malarkey, Susan A. Elmore and Robert R. Maronpot. Comparative Immunohistochemical Research of Rat and Human Hepatocellular Carcinomas. J Histotech 2013; 36(3):75-85.
Strayer DR, Carter WA, Stouch BC, Stittelaar KJ, Thoolen RJ, Osterhaus AD, Mitchell WM. Protection from Pulmonary Tissue Damage Associated with Infection of Cynomolgus Macaques by Highly Pathogenic Avian Influenza Virus (H5N1) by Low Dose Natural Human IFN-α Administered to the Buccal Mucosa. Antiviral Res 2014; 110: 175-180.
Maronpot, R. R.,Thoolen, R. J. M. M., Hansen, B. Two-Year Carcinogenicity Study of Acrylamide in Wistar Han Rats with In Utero Exposure. Toxicological Sciences 2014 (Experimental and Toxicologic Pathology; Accepted 2014).
Thoolen, R. J. M. M., Chelur, Maronpot, R. R. Liver, Gallbladder and Exocrine Pancreas, Chapter 8, In S. Sahota: Toxicologic Pathology – An Atlas (2023). Eds. Pritam S. Sahota, Zbigniew W. Wojcinski, Robert H. Spaet, Jerry F. Hardisty (1st Ed., pp. 1-100). In Press

Studies Track Record (1992-2023)

GLP-studies
TYPE OF STUDY
SOLVAY (1992 - 2004)
GLOBAL PATHOLOGY SUPPORT B.V. (2004 - 2023)
Acute dog/rat/mouse/rabbit
+/- 800
+/- 95
Subchronic rat studies
+/- 200
+/- 180
Subchronic dog studies
+/- 100
+/- 80
Subchronic monkey studies
+/- 50
+/- 65
Carcinogenicity studies
+/- 10
4
Reproduction/Developmental/Toxicity studies (OECD 421,422 & 443)
+/- 10
+/- 30
Peer review (sub-)chronic studies-
+/- 100
+/- 35
Peer review carcinogenicity studies
+/- 10-20
6

Several (n >20) readings of studies with other species like: guinea pigs, ferret, hamster (chronic and carcinogenicity studies), minipigs (subchronic and chronic studies) were performed.
The application routes of all studies contained: oral (gavage, diet), intravenous, inhalation, subcutaneous, transdermal, dermal, intra-dermal, infusion, intra-peritoneal and sublingual administration routes.
Histopathology of Reproduction/Developmental/ Toxicity studies involving study of reproduction organs in detail (OECD 421 and 422). Specialised reproduction and neuropathology investigations (qualitative and quantitative) involving specific brain localizations under OECD guidance (OECD 443).

ALL studies performed by Global Pathology Support B.V. were under GLP and approved for submission/registration.

Pre-clinical pathology evaluation of drugs, vaccines and chemicals in toxicology studies for safety assessment. Global Pathology Support B.V. deals with preclinical safety – toxicologic pathology - for the (bio-)pharmaceutical and chemical industry.

Company Info

Churchillplein 6D
2517 JW Den Haag
the Netherlands

+31 (0)70 314 24 04
+31 (0)6 461 496 05

bob.thoolen@gpstoxpath.com

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