Clinigma| Louise Newton (MSc)

Louise Newton (MSc)

Chief Scientific Officer

Role

Degree

BSc Psychology (First with honours), MSc Social Psychology (Distinction)

Personal Info

[email protected]

About

Louise brings two decades of expertise in COA research and measurement science across both consultancy and pharmaceutical settings. As Chief Scientific Officer at CLINIGMA®, she leads the scientific strategy behind every in-trial patient interview, ensuring patient experience data is collected with the rigor, structure, and regulatory credibility needed to generate meaningful insights and strengthen clinical development decision-making. Her unique combination of pharmaceutical industry experience, measurement science expertise, and regulatory insight helps ensure patient voice data is generated to the highest standards—while bringing energy, curiosity, and a highly collaborative approach to every partnership.

Expertise

Deep Clinical Trial Experience

Former Senior Director of COA Measurement Science at AstraZeneca / Evinova, leading COA strategy across oncology and digital health trials
Extensive experience supporting regulatory-focused evidence strategies aligned with FDA and EMA expectations
Specialist expertise in oncology, including hematology and cellular therapies
Published author in of peer-reviewed articles, plenary speaker at international scientific congresses, and recipient of Publication of the Year from the Journal of Patient-Reported Outcomes

Therapeutic Areas

Oncology & Hematology: Breast cancer, prostate cancer, head and neck cancer, and pancreatic cancer as well as lymphoma, leukaemia and multiple myeloma
Rare disease & Immunology: Angelman syndrome, Eosinophilic Esophagitis, Pancreatic ductal adenocarcinoma (PDAC), Systemic lupus erythematosus
Dermatology & Rheumatology: Atopic dermatitis, Fibromyalgia
Neurology & Sleep: Parkinson’s disease, insomnia
Women’s health & Urology: Dysmenorrhea, Menopause, Interstitial Cystitis, Bladder pain,
Gastrointestinal & Cardiovascular: Ulcerative colitis and Heart failure

Methodological Excellence

Trained in patient-centered outcomes research and measurement science
Specialist in qualitative interview design, concept elicitation, and cognitive debriefing methodologies
Conducted qualitative interviews with patients, caregivers, and healthcare professionals across diverse therapeutic areas for over 20 years
Extensive experience in the development and psychometric validation of COA instruments
Author of methodological publications in peer-reviewed journals, covering conceptual model development, implementation of PROs in clinical practice, and digital/eCOA measurement equivalence research

Regulatory Success

Extensive experience supporting and participating in FDA and EMA regulatory interactions
Successfully developed (COA) evidence packages and dossiers to support FDA and EMA submissions

Quality Assurance

Systematic approach to interview protocol development based on 20+ years of research
Rigorous data analysis methodology ensuring scientifically robust findings
Experience training and supervising international research teams

Publications

Oncology / Hematology

George, D. J., et al. (2026). Patient reported outcomes (PRO) and tolerability of capivasertib (capi) plus abiraterone (abi) versus placebo (pbo) plus abi in patients (pts) with PTEN-deficient metastatic hormone-sensitive prostate cancer (mHSPC): CAPItello-281. Journal of Clinical Oncology, 44(7 Suppl), 14. https://doi.org/10.1200/JCO.2026.44.7_suppl.14

Newton, L., Mannix, S., Marshall, C., et al. (2025). CO72 development of a preliminary conceptual model to capture the adult patient experience of follicular lymphoma. Value in Health, 28(12 Suppl), S56. https://doi.org/10.1016/j.jval.2025.09.174

Theodore-Oklota, C., Humphrey, L., Wiesner, C., Schnetzler, G., Hudgens, S., & Campbell, A. (2016). Validation of a treatment satisfaction questionnaire in non-Hodgkin lymphoma: Assessing the change from intravenous to subcutaneous administration of rituximab. Patient Preference and Adherence, 10, 1767–1776. https://doi.org/10.2147/PPA.S108489

Rare Disease / Neurology / Pediatrics

Connor-Ahmad, S., Tjeertes, J., Chladek, M., Newton, L., Symonds, T., Clinch, S., Vincenzi, B., & McDougall, F. (2023). Developing Angelman syndrome-specific clinician-reported and caregiver-reported measures to support holistic, patient-centered drug development. Orphanet Journal of Rare Diseases, 18, 156. https://doi.org/10.1186/s13023-023-02729-y

Staunton, H., Kelly, K., Newton, L., Leddin, M., Rodriguez-Esteban, R., Chaudhuri, K. R., Weintraub, D., Postuma, R. B., & Martinez-Martin, P. (2022). A patient-centered conceptual model of symptoms and their impact in early Parkinson’s disease: A qualitative study. Journal of Parkinson’s Disease, 12(1), 137–151. https://doi.org/10.3233/JPD-202457

Chehade, M., McCann, E., Spergel, J., Yaworsky, A., Lamoureux, R. E., Litcher-Kelly, L., Burbridge, C., Sutter, C., Newton, L., Liu, R., Tilton, S. T., Kamat, S., & Dellon, E. S. (2026). Validation of the novel Pediatric Eosinophilic Esophagitis Sign/Symptom Questionnaire-Caregiver Version in EoE KIDS. Journal of Allergy and Clinical Immunology: In Practice, 14(4), 899–906. https://doi.org/10.1016/j.jaip.2026.01.001

Gastroenterology / Immunology / Dermatology

Dubinsky, M. C., Newton, L., Delbecque, L., Hunter, T., Guobyte, A., Naegeli, A. N., McFadden, S., Donaldson, J., & Symonds, T. (2022). Exploring disease remission and bowel urgency severity among adults with moderate to severe ulcerative colitis: A qualitative study. Patient Related Outcome Measures, 13, 287–300. https://doi.org/10.2147/PROM.S378759

Holloway, L., Humphrey, L., Heron, L., Pilling, C., Kitchen, H., Højbjerre, L., Strandberg-Larsen, M., & Hansen, B. B. (2014). Patient-reported outcome measures for systemic lupus erythematosus clinical trials: A review of content validity, face validity and psychometric performance. Health and Quality of Life Outcomes, 12, 116. https://doi.org/10.1186/s12955-014-0116-1

Humphrey, L., Heron, L., Pilling, C., Holloway, L., Højbjerre, L., Strandberg-Larsen, M., & Hansen, B. B. (2013). PRM146 patient-reported outcome measures for systemic lupus erythematosus clinical trials: A content validity and psychometric performance review. Value in Health, 16(7), A600–A601.

Newton, L., DeLozier, A. M., Griffiths, P. C., Hill, J. N., Hudgens, S., Symonds, T., et al. (2019). Exploring content and psychometric validity of newly developed assessment tools for itch and skin pain in atopic dermatitis. Journal of Patient-Reported Outcomes, 3, 42. https://doi.org/10.1186/s41687-019-0128-z

Sleep / Pain / Musculoskeletal Disorders

Hudgens, S., Phillips-Beyer, A., Newton, L., Seboek Kinter, D., & Benes, H. (2021). Development and validation of the Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ). The Patient, 14, 249–268. https://doi.org/10.1007/s40271-020-00474-z

Burbridge, C., Symonds, T., Humphrey, L., Arbuckle, R., Hirsch, I., & Whelan, L. (2013). Validation of the Daily Diary of Fatigue Symptoms—Fibromyalgia (DFS-Fibro). Open Journal of Rheumatology and Autoimmune Diseases, 3(2), 92–103. https://doi.org/10.4236/ojra.2013.32014

Burbridge, C., Symonds, T., Humphrey, L., Arbuckle, R., Hirsch, I., & Whelan, L. (2013). PND48 evaluating fatigue in fibromyalgia: Development and validation of the Daily Diary of Fatigue Symptoms in Fibromyalgia (DFS-Fibro). Value in Health, 16(7), A626. https://doi.org/10.1016/j.jval.2013.08.1846

Humphrey, L., Arbuckle, R., Mease, P., Williams, D. A., Samsoe, B. D., & Gilbert, C. (2010). Fatigue in fibromyalgia: A conceptual model informed by patient interviews. BMC Musculoskeletal Disorders, 11, 216. https://doi.org/10.1186/1471-2474-11-216

Mease, P. J., Arnold, L. M., Crofford, L. J., Williams, D. A., Russell, I. J., Humphrey, L., Abetz, L., & Martin, S. A. (2008). Identifying the clinical domains of fibromyalgia: Contributions from clinician and patient Delphi exercises. Arthritis & Rheumatism, 59(7), 952–960. https://doi.org/10.1002/art.23826

Urology / Women’s Health

Humphrey, L., Arbuckle, R., Moldwin, R., Nordling, J., van de Merwe, J. P., Meunier, J., et al. (2012). The bladder pain/interstitial cystitis symptom score: Development, validation, and identification of a cut score. European Urology, 61(2), 271–279. https://doi.org/10.1016/j.eururo.2011.10.004

Nguyen, A. M., Humphrey, L., Kitchen, H., Rehman, T., & Norquist, J. M. (2015). A qualitative study to develop a patient-reported outcome for dysmenorrhea. Quality of Life Research, 24(1), 181–191. https://doi.org/10.1007/s11136-014-0755-z

Nguyen, A. M., Humphrey, L., Kitchen, H., & Rehman, T. (2015). A qualitative cross-cultural exploration of breast symptoms associated with hormonal therapy. Health and Quality of Life Outcomes, 13, 182. https://doi.org/10.1186/s12955-015-0370-4

Cardiology

Humphrey, L., Kulich, K., Deschaseaux, C., Blackburn, S., Maguire, L., & Strömberg, A. (2013). The Caregiver Burden Questionnaire for Heart Failure (CBQ-HF): Face and content validity. Health and Quality of Life Outcomes, 11, 84. https://doi.org/10.1186/1477-7525-11-84

Blackburn, S., Humphrey, L., Maguire, L., Deschaseaux, C., Kulich, K., & Strömberg, A. (2012). PCV90 a novel conceptual model of caregiver burden in chronic heart failure: A qualitative study. Value in Health, 15(7), A374. https://doi.org/10.1016/j.jval.2012.08.1019

Measurement Science / PRO Methodology

Humphrey, L., Willgoss, T., Trigg, A., Meysner, S., Kane, M., Dickinson, S., & Kitchen, H. (2017). A comparison of three methods to generate a conceptual understanding of a disease based on the patients’ perspective. Journal of Patient-Reported Outcomes, 1, 9. https://doi.org/10.1186/s41687-017-0013-6

Chan, E. K. H., Edwards, T. C., Haywood, K., Mikles, S. P., & Newton, L. (2019). Implementing patient-reported outcome measures in clinical practice: A companion guide to the ISOQOL user’s guide. Quality of Life Research, 28(3), 621–627. https://doi.org/10.1007/s11136-018-2048-4

Hudgens, S., Newton, L., Eremenco, S., Crescioni, M., Symonds, T., Reasner, D. S., Byrom, B., O’Donohoe, P., & Vallow, S., on behalf of the Patient-Reported Outcome (PRO) Consortium and Electronic Clinical Outcome Assessment (eCOA) Consortium. (2022). Comparability of a provisioned device versus bring your own device for completion of patient-reported outcome measures by participants with chronic obstructive pulmonary disease: Quantitative study findings. Journal of Patient-Reported Outcomes, 6, 116. https://doi.org/10.1186/s41687-022-00526-y

Newton, L., Knight-West, O., Eremenco, S., Hudgens, S., Crescioni, M., Symonds, T., Reasner, D. S., Byrom, B., O’Donohoe, P., & Vallow, S., on behalf of the Patient-Reported Outcome (PRO) Consortium and Electronic Clinical Outcome Assessment (eCOA) Consortium. (2022). Comparability of a provisioned device versus bring your own device for completion of patient-reported outcome measures by participants with chronic obstructive pulmonary disease: Qualitative interview findings. Journal of Patient-Reported Outcomes, 6, 86. https://doi.org/10.1186/s41687-022-00492-5

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