Dr. R.J.M.M. Thoolen

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

Bob是全球病理学支持中心,简称(GPS) 公司的创始人和常务董事。他在病理学领域有超过30年的训练积累了丰富的工作经验。在人类和动物病理学方面的研究和培训使他对病理学的科学有了更广泛的认知。起初Bob在中央兽医研究所工作,后来又在苏威制药公司(Solvay Pharmaceuticals B.V.)担任毒理学病理学家。这些经验为(GPS) 在优良实验室规范(GLP)规范下进行毒理学病理研究奠定了坚实的基础。他还热爱运动,平时他喜欢健身、游泳。但是打高尔夫是他最钟爱的运动项目。

Working period at GPS: 19 years

专业经验
教育背景
会员资格
BOARD CERTIFICATION
著作
研究记录

专业经验和培训

培训和经验总年限:28年
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.
作为BSTP的代表,建立了Gobal INHAND肝脏命名法文件(分别是STP、ESTP和GSTP。Thoolen博士是作者之一(2007-2010)。

教育背景

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
关于非增殖性和增殖性肝脏病变的博士项目(乌特勒支大学医学中心(UMCU),病理学系,实验室和药学部)
1997 – 1999
在乌特勒支皇家大学医学系学习医学(1-3年级)
1996
由荷兰病理学会和荷兰皇家兽医协会联合设立的委员会认证的毒理学病理学家
1993
合格的实验动物病理学家,由荷兰病理学会和荷兰皇家兽医协会联合设立的委员会颁发
1989 – 1993
实验动物病理学家的研究生培训
1989 – 1991
显微镜病理学的研究生课程
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
在乌特勒支学术医院病理科进行医学普通和特殊病理学的考试和实践培训
1985
Bachelor of Science in Medical Biology
1981 – 1988
University of Utrecht.
1974 – 1981
Secondary school (Atheneum-B).

专业会员资格

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
欧洲毒物学病理学会(ESTP)理事会成员
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
被选为荷兰病理学会成员
1993 – now
被选为毒物学病理学家协会成员
1992 – 1993
查尔斯-刘易斯基金会的成员
1992 – now
荷兰毒理学会会员

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
合格的实验动物病理学家,由荷兰病理学会和荷兰皇家兽医协会联合设立的委员会颁发

著作

已批准的内部报告主要贡献;苏威制药公司提交的FDA、IDB、NDA、专家报告和评估报告--标题未呈现。
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 和 Bob Thoolen。病变分级。 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

研究成绩记录(1992-2021)

GLP-研究
研究类型
苏威制药 (1992 - 2004)
GLOBAL PATHOLOGY SUPPORT B.V. (2004 - 2022)
急性犬/鼠/小鼠/兔
+/- 800
+/- 95
亚慢性大鼠研究
+/- 200
+/- 180
狗的亚慢性研究
+/- 100
+/- 80
亚慢性猴子研究
+/- 50
+/- 65
致癌性研究
+/- 10
+/- 4
Reproduction/Developmental/ Toxicity studies (OECD 421,422 & 443)
+/- 10
+/- 30
同行评议(次)慢性研究
+/- 100
+/- 35
同行评议致癌性研究
+/- 10-20
+/- 6

对其他物种如:豚鼠、雪貂、仓鼠(慢性和致癌性研究)、小型猪(亚慢性和慢性研究)进行了若干(n=10-20)读数研究。
所有研究的应用途径包含:口服(灌服、饮食)、静脉注射、吸入、皮下注射、经皮、皮肤、皮内、输液、腹膜内和舌下给药等途径。
生殖/发育/毒性研究的组织病理学,涉及对生殖器官的详细研究(OECD 421和422)。在OECD的指导下,涉及特定脑部定位的专门的生殖和神经病理学调查(定性和定量)(OECD 443)。

全球病理支持(GPS.B.V)进行的所有研究均在GLP规范下进行。且都已获准提交

通过毒理学研究对药物、疫苗和化学品进行临床前病理评估,从而对产品的安全性做出评价。全球病理学支持中心为生物制药和化学工业处理基于毒理病理学研究基础上的临床前安全性问题。

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