By Associate Professor Orin Chisholm

Book Chapters

Tong RKY; Chisholm O, 2025, 'How to Train University Students in Regulatory Affairs to Face the Medical Devices Market Growth in the Artificial Intelligence Era', in Medical Regulatory Affairs an International Handbook for Medical Devices and Healthcare Products Fourth Edition, pp. 1 - 7, http://dx.doi.org/10.1201/9781003611264-1

Martin D; Lesser N; Chisholm O, 2025, 'The Evolution of the Regulatory Professional: Perspectives on the Skill Sets and Capabilities That Will Define the Next Generation of Regulatory Professionals', in Medical Regulatory Affairs an International Handbook for Medical Devices and Healthcare Products Fourth Edition, pp. 11 - 20, http://dx.doi.org/10.1201/9781003611264-3

Chisholm O, 2023, 'Regulatory Landscape in Australia and New Zealand', in Handbook of Cell and Gene Therapy from Proof of Concept Through Manufacturing to Commercialization, pp. 233 - 242, http://dx.doi.org/10.1201/9781003285069-15

Chisholm O, 2023, 'Training Approaches to Build Cell and Gene Therapy Workforce Capacity', in Handbook of Cell and Gene Therapy from Proof of Concept Through Manufacturing to Commercialization, pp. 175 - 182, http://dx.doi.org/10.1201/9781003285069-10

Chisholm O; Carter M, 2021, 'Authorization Procedures for Pharmaceutical Products', in Hall G (ed.), Fundamentals of International Regulatory Affairs, Regulatory Affairs Professionals Society, USA, pp. 187 - 206, https://my.raps.org/online-store/merchandise-details/?id=0eeaf613-5fd3-eb11-ba5e-0003ff45124f&reload=timezone

Chisholm O; Carter M, 2018, 'Authorization Procedures for Pharmaceutical Products', in Jones P (ed.), Fundamentals of International Regulatory Affairs, Regulatory Affairs Professional Society, USA, pp. 91 - 108

Chisholm OT, 2017, 'Authorisation procedures for pharmaceutical products', in Jones P (ed.), Fundamentals of international regulatory affairs, RAPS, MD, USA, pp. 69 - 80, https://www.raps.org/ProductDetail.aspx?ProductId=131091030

Journal articles

Weekes A; Britland M; Saha C; McErlane S; Ansari N; Thurley D; Elegant V; Chisholm O, 2025, 'Development of a Competency Framework for Medical Affairs Professionals in Australasia.', Pharmaceut Med, http://dx.doi.org/10.1007/s40290-025-00585-8

Abbas R; Chisholm O; Elegant V; Susa S; Richards S; Tolman C, 2025, 'Evaluating the MAPA Medical Affairs Competency Framework: Insights from Amgen-Led Pilot Study in Australia, Japan and China', Pharmaceutical Medicine, http://dx.doi.org/10.1007/s40290-025-00590-x

Conway N; Chisholm O, 2024, 'Building a Competency Framework to Integrate Inter-disciplinary Precision Medicine Capabilities into the Medical Technology and Pharmaceutical Industry', Therapeutic Innovation and Regulatory Science, 58, pp. 567 - 577, http://dx.doi.org/10.1007/s43441-024-00626-5

, 2023, 'FIP Brisbane 2023: Industrial Pharmacy', Pharmacy Education, 23, pp. 295 - 302, http://dx.doi.org/10.46542/pe.2023.236.295302

Yoffe A; Liu J; Smith G; Chisholm O, 2023, 'A Survey of Industry Perceptions of Facilitated Regulatory Pathways in Drug Development in Australia', Pharmaceutical Medicine, 37, pp. 385 - 394, http://dx.doi.org/10.1007/s40290-023-00483-x

Yoffe A; Liu J; Smith G; Chisholm O, 2023, 'Regulatory Reform Outcomes and Accelerated Regulatory Pathways for New Prescription Medicines in Australia', Therapeutic Innovation and Regulatory Science, 57, pp. 271 - 286, http://dx.doi.org/10.1007/s43441-022-00465-2

Chisholm O; Critchley H, 2023, 'Future directions in regulatory affairs', Frontiers in Medicine, 9, http://dx.doi.org/10.3389/fmed.2022.1082384

Volckmar X; Vallejo M; Bertoldo MJ; Nguyen QN; Handelsman DJ; Chisholm O; Anazodo A, 2022, 'Oncofertility Information Available for Recently Approved Novel Non Cytotoxic and Immunotherapy Oncology Drugs', Clinical Pharmacology and Therapeutics, 111, pp. 382 - 390, http://dx.doi.org/10.1002/cpt.2254

Chisholm O; Sharry P; Phillips L, 2022, 'Multi-Criteria Decision Analysis for Benefit-Risk Analysis by National Regulatory Authorities', Frontiers in Medicine, 8, http://dx.doi.org/10.3389/fmed.2021.820335

Shaw B; Chisholm O, 2020, 'Creeping Through the Backdoor: Disruption in Medicine and Health', Frontiers in Pharmacology, 11, http://dx.doi.org/10.3389/fphar.2020.00818

Shaw B; Chisholm O, 2019, 'Australia's National Medicines Policy is outdated and in need of review', Medical Journal of Australia, 211, pp. 252 - 254, http://dx.doi.org/10.5694/mja2.50268

Chisholm O, 2019, 'Professional Development: Benefits of Obtaining Professional Qualifications', Regulatory Focus, https://www.raps.org/news-and-articles/news-articles/2019/8/professional-development-benefits-of-obtaining-pr

Chisholm O, 2019, 'Curriculum Transformation: From Didactic to Competency-Based Programs in Pharmaceutical Medicine', Frontiers in Pharmacology, 10, pp. 278 - 278, http://dx.doi.org/10.3389/fphar.2019.00278

Chisholm O, 2019, 'New Zealand’s new regulatory regime for therapeutic products', Regulatory Focus, https://www.raps.org/news-and-articles/news-articles/2019/3/new-zealands-new-regulatory-regime-for-therapeuti

Allen GM; Chisholm O, 2018, 'Postgraduate Education in Pharmaceutical Medicine in Australia: Evaluation and Evolution to a Global Program Over 20 Years.', Therapeutic Innovation & Regulatory Science, 53, pp. 1 - 7, http://dx.doi.org/10.1177/2168479018793129

Chisholm O, 2017, 'Program transformation: reimagining distance education in the digital world', Research and Development in Higher Education: Curriculum Transformation, 40, pp. 61 - 72, http://www.herdsa.org.au/research-and-development-higher-education-vol-40-61

Dauti A; Gerstl B; Chong S; Chisholm O; Anazodo A, 2017, 'Improvements in Clinical Trials Information Will Improve the Reproductive Health and Fertility of Cancer Patients', Journal of Adolescent and Young Adult Oncology, 6, pp. 235 - 269, http://dx.doi.org/10.1089/jayao.2016.0084

Chisholm OT, 2015, 'Proposed changes to US therapeutic products regulation', The Source Document, pp. 7 - 9

Badolato J; Chisholm OT; Holmes M, 2013, 'ARCS Australia University Partnerships.', The Source Document, pp. 34 - 34

Marsh IB; Whittington RJ; O''Rourke B; Hyatt AD; Chisholm OT, 2002, 'Rapid differentiation of Australian, European and American ranaviruses based on variation in major capsid protein gene sequence.', Molecular and Cellular Probes, 16, pp. 137 - 151

Ryan GR; Dai X-M; Dominguez MG; Tong W; Chuan F; Chisholm OT; Russell RG; Pollard JW; Stanley ER, 2001, 'Rescue of the colony stimulating factor 1 (CSF-1)-nullizygous mouse (Csf1op/Csf1op) phenotype with a CSF-1 transgene and identification of sites of local CSF-1 synthesis', Blood, 98, pp. 74 - 84

Sungaran R; Chisholm OT, 2001, 'Thrombopoietin gene regulation – a review', Haematology, 6, pp. 41 - 46

Sungaran R; Chisholm OT; Markovic B; Khachigian LM; Tanaka Y; Chong BH, 2000, 'The role of platelet ?-granular proteins in the regulation of thrombopoietin messenger RNA expression in human bone marrow stromal cells.', Blood, pp. 3094 - 3101

Holmes ML; Turner J; Fox A; Chisholm OT; Crossley M; Chong BH, 1999, 'hFOG-2, a novel zinc finger protein, binds the corepressor mCtBP2 and modulates GATAmediated activation', The Journal of Biological Chemistry, pp. 23491 - 23498

Cohen P; Chisholm OT; Arceci RJ; Stanley R; Pollard JW, 1996, 'Absence of colony stimulating factor-1 in osteopetrotic (csfmop/csfmop) mice results in male fertility defects.', Biology of Reproduction, 55, pp. 310 - 317

Chang M; Stanley ER; Khalili H; Chisholm OT; Pollard JW, 1995, 'Osteopetrotic (op/op) mice deficient in macrophages have the ability to mount a normal T-cell-dependent immune response.', Cellular Immunology, 162, pp. 146 - 152

CHISHOLM O; BERTONCELLO I, 1994, 'ALPHA-4-BETA-1 INTEGRIN EXPRESSION ON SUBSETS OF HEMATOPOIETIC STEM-CELLS', JOURNAL OF CELLULAR BIOCHEMISTRY, pp. 10 - 10, https://www.webofscience.com/api/gateway?GWVersion=2&SrcApp=PARTNER_APP&SrcAuth=LinksAMR&KeyUT=WOS:A1994MV41200025&DestLinkType=FullRecord&DestApp=ALL_WOS&UsrCustomerID=891bb5ab6ba270e68a29b250adbe88d1

Cecchini ; Dominguez MG; Mocci S; Wetterwald A; Felix R; Fleisch H; Chisholm OT; Hofstetter W; Pollard JW; Stanley R, 1994, 'Role of colony stimulating factor-1 in the establishment and regulation of tissue macrophages during postnatal development of the mouse.', Development, 120, pp. 1357 - 1372

CHISHOLM O; BERTONCELLO I, 1993, 'DOES EXPRESSION OF THE ALPHA-4-BETA-1 INTEGRIN CHANGE WITH THE PROLIFERATIVE AND DIFFERENTIATIVE CAPACITY OF MURINE PRIMITIVE HEMATOPOIETIC STEM-CELLS', JOURNAL OF LEUKOCYTE BIOLOGY, pp. 101 - 101, https://www.webofscience.com/api/gateway?GWVersion=2&SrcApp=PARTNER_APP&SrcAuth=LinksAMR&KeyUT=WOS:A1993ME18500405&DestLinkType=FullRecord&DestApp=ALL_WOS&UsrCustomerID=891bb5ab6ba270e68a29b250adbe88d1

Begg ; Radley JM; Pollard JW; Chisholm OT; Stanley R; Bertoncello I, 1993, 'Delayed haematopoietic development in osteopetrotic (op/op) mice.', Journal of Experimental Medicine, 177, pp. 237 - 242

BEGG SK; RADLEY JM; POLLARD JW; CHISHOLM O; STANLEY ER; BERTONCELLO I, 1992, 'MACROPHAGE DEVELOPMENT, AND AGE-RELATED-CHANGES IN HEMATOPOIESIS, IN CSF-1 DEFICIENT OSTEOPETROTIC (OP/OP) MICE', EXPERIMENTAL HEMATOLOGY, 20, pp. 826 - 826, https://www.webofscience.com/api/gateway?GWVersion=2&SrcApp=PARTNER_APP&SrcAuth=LinksAMR&KeyUT=WOS:A1992JA73400461&DestLinkType=FullRecord&DestApp=ALL_WOS&UsrCustomerID=891bb5ab6ba270e68a29b250adbe88d1

Chisholm OT; Symonds G, 1992, 'An in vitro fibroblast model system to study myc-driven tumour progression.', International Journal of Cancer, 51, pp. 149 - 158

Stanley ER; Wiktor-Jedrzejczak W; Pollard JW; Hunt JS; Chisholm O; Price LK, 1992, 'Biology and action of colony stimulating factor-1.', Journal of Cellular Biochemistry -Supplement-, 16C, pp. 57 - 57

Pollard JW; Arceci RJ; Chisholm O; Daiter E; Pampfer S; Stanley ER; Wiktor-Jedrzejczak W, 1992, 'Colony-stimulating factor-1 in the regulation of placental development', Journal of Cellular Biochemistry -Supplement-, 16F, pp. 75 - 75

Chisholm OT; Stapleton P; Symonds G, 1992, 'Constitutive expression of exogenous myc in myelomonocytic cells: acquisition of a more transformed phenotype and inhibition of differentiation induction.', Oncogene, 7, pp. 1827 - 1836

Bonham L; Kwok J; Chisholm OT; Symonds G, 1991, 'Inducible transformation of fibroblasts using a metallothionein-v-myc gene construct.', Oncogene, 6, pp. 1073 - 1077

Symonds G; Bonham L; Chisholm OT; Miller M; Stapleton P; Takayama Y, 1989, 'The use of retroviral vectors to study cell transformation and malignancy.', Transplantation Proceedings, 21, pp. 61 - 64

Chisholm OT; Symonds G, 1988, 'Transfection of myeloid cell lines using polybrene/DMSO', Nucleic Acids Research, 16, pp. 2352

Barry RD; Cowley JA; Chisholm OT; Richards SG, 1985, 'Structural and antigenic properties of human parainfluenza viruses', Virus Research, 3, pp. 78 - 78, http://dx.doi.org/10.1016/0168-1702(85)90408-3

Conference Papers

Yang M; Li K; Lam AC; Chui CMY; Yuen PMP; Chisholm OT; Chesterman CN; Chong BH, 1999, 'PDGF indirectly enhanced granulopoiesis.', in BLOOD, AMER SOC HEMATOLOGY, pp. 46B - 46B, https://www.webofscience.com/api/gateway?GWVersion=2&SrcApp=PARTNER_APP&SrcAuth=LinksAMR&KeyUT=WOS:000083790700200&DestLinkType=FullRecord&DestApp=ALL_WOS&UsrCustomerID=891bb5ab6ba270e68a29b250adbe88d1

Yang M; Hogg PJ; Chisholm OT; Li K; Chesterman CN; Chong BH, 1999, 'TSP1 inhibits PEG-rHuMGDF-induced mega karyocytopoiesis via TSP/TSP receptor interaction.', in BLOOD, AMER SOC HEMATOLOGY, pp. 41A - 41A, https://www.webofscience.com/api/gateway?GWVersion=2&SrcApp=PARTNER_APP&SrcAuth=LinksAMR&KeyUT=WOS:000083790300218&DestLinkType=FullRecord&DestApp=ALL_WOS&UsrCustomerID=891bb5ab6ba270e68a29b250adbe88d1

Chisholm O; Fahmy R; Tao H; Holmes M; Chong B, 1999, 'Transcription factor and cell surface protein expression during megakaryocyte differentiation.', in EXPERIMENTAL HEMATOLOGY, ELSEVIER SCIENCE INC, pp. 102 - 102, https://www.webofscience.com/api/gateway?GWVersion=2&SrcApp=PARTNER_APP&SrcAuth=LinksAMR&KeyUT=WOS:000081030100250&DestLinkType=FullRecord&DestApp=ALL_WOS&UsrCustomerID=891bb5ab6ba270e68a29b250adbe88d1

Sungaran R; Markovic B; Chong BH, 1999, 'The regulation of thrombopoietin mRNA expression - an in vitro and in vivo study', in Haematology Society of Australia and New Zealand - Annual Scientific Meeting, Hobart, presented at Haematology Society of Australia and New Zealand - Annual Scientific Meeting, Hobart

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