Clinigma| Sean O'Quinn (MPH)

Sean O'Quinn (MPH)

Scientific Lead

Role

Degree

MPH

Personal Info

so@clinigma.com

About

Sean brings over 15 years of specialized expertise in health outcomes research and Clinical Outcomes Assessment (COA) development to CLINIGMA®. As Scientific Lead, he leverages his extensive background in both industry and consulting environments to design and execute patient-centered research that generates compelling evidence for regulatory and commercial success.

Expertise

Clinical Outcomes Assessment Leadership

Extensive experience developing and validating Patient-Reported Outcomes (PRO) and Observer-Reported Outcomes (ObsRO) instruments using advanced qualitative and quantitative methods
Deep understanding of FDA guidance and EMA positions on COA instruments to support label claims
Proven track record building consensus between commercial and clinical stakeholders when developing research strategy and study design

Pharmaceutical Industry Expertise

Group Director of Patient Centered Science at AstraZeneca, leading respiratory therapeutic area initiatives
Director-level experience managing PRO aspects of clinical studies across multiple therapeutic areas
Strategic leadership in regulatory interactions, providing critical input on labeling strategy and formal FDA/EMA consultations

Orphan Drug Development Specialization

Comprehensive understanding of regulatory and reimbursement environments in US and EU for orphan products
Direct experience submitting orphan drug applications to FDA and EMA
Expert in developing condition-specific PRO instruments for rare diseases
Proven ability to conduct retrospective claims database analyses to evaluate disease burden

Health Economics and Market Access

Proven ability to develop payer evidence plans addressing evidentiary needs of payers and health technology assessment organizations
Experience building product value propositions and target product profiles
Strategic understanding of commercial implications of patient-reported evidence

Research Methodology Excellence

Master of Public Health with specialized focus in Health Outcomes Assessment and Epidemiology
Psychology background with expertise in behavioral medicine and psychophysiology
Extensive experience managing multiple simultaneous clinical studies with million-dollar budgets

Scientific Communication and Thought Leadership

Author of 30+ peer-reviewed publications in high-impact journals including New England Journal of Medicine and The Lancet
Regular presenter at major scientific conferences including American Thoracic Society and ISPOR
Demonstrated ability to translate complex research findings into actionable insights for diverse stakeholders

Sean's unique combination of academic rigor, regulatory expertise, and commercial understanding ensures that patient interview studies are designed to generate evidence that resonates with all key stakeholders. His proven ability to navigate complex therapeutic areas, from common conditions to rare diseases, makes him an invaluable strategic partner for any clinical development program seeking to capture authentic patient voices.

‍

Publications

Strand V, O’Quinn S, Furie RA, Morand E, Kalunian KC, Schwetje E, Abreu G, Tummala R. Clinical meaningfulness of a British Isles Lupus Assessment Group-based Composite Lupus Assessment response in terms of patient-reported outcomes in moderate to severe systemic lupus erythematosus: a post-hoc analysis of the phase 3 TULIP-1 and TULIP-2 trials of anifrolumab. Lancet Rheumatol 2022;4:e198–207. DOI: https://doi.org/10.1016/S2665-9913(21)00387-8.

Donald S, O’Quinn S, Williams B, Bean S, Schwetje E, Abreu G, Tummala R. Causal cascade of direct and indirect effects of anifrolumab on patient-reported outcomes: structural equation modelling of two Phase 3 trials. Rheumatology (Oxford). 2022 Nov 28;61(12):4731-4740. doi: 10.1093/rheumatology/keac138. PMID: 35274691; PMCID: PMC9707104.

Ho CN, O'Quinn S, Bailey J, Meyers O, Slagle AF, Dellon ES, Datto C. Development and content validation of a symptom assessment for eosinophilic gastritis and eosinophilic gastroenteritis in adults and adolescents. Orphanet J Rare Dis. 2021 Nov 24;16(1):495. doi: 10.1186/s13023-021-02107-6. PMID: 34819137; PMCID: PMC8611867.

Panettieri RA Jr, Chipps BE, Moore WC, Soong W, Carr W, Kreindler JL, O'Quinn S, Trudo F, Ambrose CS. Differing Perceptions of Asthma Control and Treatment Effectiveness by Patients with Severe Asthma and Treating Subspecialists in the United States. J Asthma. 2021 Aug 10;1-13. doi: 10.1080/02770903.2021.1963766.

Soong W, Chipps BE, Trevor J, Carr WW, O'Quinn S, Belton L, Trudo F, Ambrose CS. Health-related Quality of Life and Productivity Among US Patients with Severe Asthma. J Asthma Allergy. 2021;2021(14):713-725.

Silverberg JI, Guttman-Yassky E, Gooderham M, Worm M, O'Quinn S, van der Merwe R, Kragh N, Kurbasic A, Wollenberg A. Health-related quality of life with tralokinumab in moderate-to-severe atopic dermatitis: A phase 2b randomized study. Ann Allergy Asthma Immunol. 2021;126(5):576-583.e4.

Olech E, Stull D, Williams B, Bean S, Abreu G, Schwetje E, Tummala R, O’Quinn S. Patient reported physical health compared to clinician recorded BILAG-2004 musculoskeletal symptom scores: Discordance between patients and clinicians. Annals of the Rheumatic Diseases 2021;80:1171.

Corren J, Garcia Gil E, Griffiths JM, Parnes JR, van der Merwe R, Salapa K, O'Quinn S. Tezepelumab improves patient-reported outcomes in patients with severe, uncontrolled asthma in PATHWAY. Ann Allergy Asthma Immunol. 2021;126(2):187-193.

Soong W, Chipps B, Trevor J, Carr W, O'Quinn S, Trudo F, Ambrose CS. Health-related Quality of Life and Productivity Among a Real-World Cohort of Severe Asthma Patients in the United States. J Allergy Clin Immunol. 2020;145(2 Suppl):AB204.

O'Quinn S, Hirsch I, Cook W, Martin UJ. Improvements in SGRQ Total and Domain Scores with Benralizumab Treatment for Patients with Asthma. Ann Allergy Asthma Immunol. 2019;123(5 Suppl):S25.

O’Quinn S, Crooks P, New M, Slagle AF, Samant RM, Meyers O. Development and assessment of a novel nasal polyposis symptom diary. Poster presented at: the European Academy of Allergy and Clinical Immunology (EAACI) Congress; June 1-5, 2019; Lisbon, Portugal.

Criner GJ, Celli BR, Brightling CE, Agusti A, Papi A, Singh D, Sin DD, Vogelmeier CF, Sciurba FC, Bafadhel M, Backer V, Kato M, Ramírez-Venegas A, Wei Y, Bjermer L, Shih VH, Jison M, O’Quinn S, Makulova N, Newbold P, Goldman M, Martin UJ, for the GALATHEA and TERRANOVA study investigators. Benralizumab for the prevention of COPD exacerbations. N Engl J Med. 2019. DOI: 10.1056/NEJMoa1905248.

Celli BR, Criner GJ, Singh D, Bafadhel M, Backer V, Ramirez-Venegas A, Wei Y, Bjermer L, Shih VH, O’Quinn S, Makulova N, Newbold P, Goldman M, Martin UJ, on behalf of the TERRANOVA study investigators. A dose-ranging study (TERRANOVA) of benralizumab for moderate to severe chronic obstructive pulmonary disease. Presented at: American Thoracic Society (ATS) International Conference; May 17-22, 2019; Dallas, TX. Abstract A2625.

O'Quinn S, Xu X, Hirsch I. Daily patient-reported health status assessment improvements with benralizumab for patients with severe, uncontrolled eosinophilic asthma. J Asthma Allergy. 2019 Jan 23;12:21-33. doi: 10.2147/JAA.S190221.

O'Quinn S, Xu X, Hirsch I. Rescue medication use reduction with benralizumab for patients with severe, uncontrolled eosinophilic asthma [oral presentation]. Presented at the American College of Allergy, Asthma & Immunology meeting; November 15-19, 2018; Seattle, WA. Presentation 8052.

Corren J., Parnes JR., Wang L., Mo M., Roseti SL., Griffiths JM., O'Quinn S., van der Merwe R. Improvements in Asthma-Related Quality of Life Observed Within 4 Weeks of Treatment with Tezepelumab. Poster presented at: American Thoracic Society (ATS) International Conference; May 18-23, 2018; San Diego, CA.

Corren J., Parnes, JR., Mo M., Roseti SL., JM, O’Quinn S., van der Merwe R., Tezepelumab demonstrates clinically meaningful improvements in asthma control (ACQ-6) in patients with uncontrolled asthma: results from a phase 2b clinical trial. Journal of Allergy and Clinical Immunology. 141. AB80. 10.1016/j.jaci.2017.12.259.

Bacci ED, O'Quinn S, Leidy NK, Murray L, Vernon M. Evaluation of a respiratory symptom diary for clinical studies of idiopathic pulmonary fibrosis. Respir Med. 2018 Jan; 134:130-138.

O’Quinn S., Xu X., I. Hirsch I., Gopalan G. Improvement in Patient-Reported Activity Impairment, Stress, and Tiredness in Patients with Severe, Uncontrolled Asthma with Eosinophilic Inflammation: Pooled Results from Two Phase III Trials of Benralizumab. Poster presented at: American Thoracic Society (ATS) International Conference; May 18-23, 2012; Washington, DC.

Globe G, Currie B, Leidy NK, Jones P, Mannio D, Martinez F, Klekotka P, O'Quinn S, Karlsson N, Wiklund I. Development of the chronic obstructive pulmonary disease morning symptom diary (COPD-MSD). Health Qual Life Outcomes. 2016;14(1):104.

Esposito DB, Lanes S, Donneyong M, Holick CN, Lasky JA, Lederer D, Nathan SD, O’Quinn S, Parker J, Tran TN. Idiopathic pulmonary fibrosis in United States automated claims. Incidence, prevalence, and algorithm validation. Am J Respir Crit Care Med. 2015;192(10):1200-7.

Esposito DB, Lanes SF, Donneyong M, Holick CN, Lasky JA, Lederer DJ, Nathan SD, O’Quinn S, Tran TN. Incidence and prevalence of IPF in an insurance claims database: Assessing accuracy using medical records. Poster presented at: European Respiratory Society International Congress; September 6–10, 2014; Munich, Germany.

Murray L, Vernon M, O'Quinn S, Martinez F, Parker JM, Leidy NK. The EXACT in idiopathic pulmonary fibrosis (IPF): Content validity of an existing patient-reported outcome measure for use in a rare disease. Value Health. 2013;16(3):A238.

Erder MH, Wilcox TK, Chen WH, O'Quinn S, Setyawan J, Saxton J. A new measure of caregiver burden in Alzheimer's disease: the Caregiver-Perceived Burden Questionnaire. Am J Alzheimers Dis Other Demen. 2012;27(7):474-482.

McLaurin KK, Pokrzywinski R, O’Quinn S, Xu X, Hareendran A. Conceptualization of symptoms and symptom impacts among adults with inadequately controlled moderate-severe asthma. Poster presented at: American Thoracic Society (ATS) International Conference; May 18-23, 2012; San Francisco, CA.

Teschendorf B, Vernon MK, O’Quinn S, Van Rhee F. Development and Content Validation of a Multicentric Castleman’s Disease Symptom Scale. Poster presented at: the ISPOR 13th Annual European Congress, November 6–9, 2010; Prague, Czech Republic.

Norquist JM, Vernon MK, O’Quinn S, McQuarrie K, Dinges D, Roth T, Herring W, Brodovicz GH. Development of an Excessive Daytime Sleepiness Diary. Poster presented at: International Society for Quality of Life Research (ISOQOL) 17th Annual Conference; October 27–30, 2010; London, UK.

Wilcox T, Chen WH, O’Quinn S, Setyawan J, Saxton J, Erder MH. Effectiveness of memantine in patients with moderate to severe Alzheimer’s disease, as measured by the Caregiver Perceived Burden Questionnaire (CPBQ). Poster presented at: Neurological Association (ANA) annual meeting; September 12–15, 2010, San Francisco, CA.

Mody R, DeLeon MC, O’Quinn S, Dabbous O, Vernon M. Content Validation of a Daily Symptom Diary for Assessment of Heartburn. Abstract presented at: 16th Annual Conference of the International Society for Quality of Life Research; October 28–31, 2009; New Orleans, LA.

Erder HM, Wilcox T, Chen WH, Setyawan J, O’Quinn S, Saxton J. Reliability and validity of the Caregiver Perceived Burden Questionnaire (CPBQ) in Alzheimer’s disease. Poster presented at: International Conference on Alzheimer’s Disease; July 11–16, 2009; Vienna, Austria.

Vernon MK, O’Quinn S, McQuarrie K, Norquist JM, Dinges D, Roth T, Herring WJ, Brodovicz KG. Development of an excessive daytime sleepiness diary. Poster presented at: SLEEP 2008 – 22nd Annual Meeting of the Associated Professional Sleep Societies; June 8–11, 2008; Baltimore, MD.

Vernon MK, O’Quinn S, McQuarrie K, Norquist JM, Herring WJ, Brodovicz KG. Experiences with excessive sleepiness from patients’ perspectives. Poster presented at: SLEEP 2008 – 22nd Annual Meeting of the Associated Professional Sleep Societies; June 8–11, 2008; Baltimore, MD.

Stull DE, O’Quinn S, Vestenbaek U, Navaratnam P. Ceiling effects and discrimination of treatment benefit for patients with lower symptom severity: Measurement of health utilities in allergic rhinitis. Poster presented at: ISPOR Annual International Meeting; May 3–7, 2008; Toronto, Ontario, Canada.

O’Quinn SR, Larkin KT. Daily stress, coping, and nocturnal blood pressure dipping. Poster presented at: 63rd Annual Scientific Meeting of the American Psychosomatic Society; March 2–5, 2006; Denver, CO.

Parker B, Hernandez D, O’Quinn SR, Larkin KT. Assessing the construct of forgiveness: Relations between two scales of measuring trait forgiveness. Poster presented at: 39th Annual Conference of the Association for Behavioral and Cognitive Therapies; November 17–20, 2005; Washington, DC.

Larkin KT, Taylor BK, Hernandez, DH, Goodie JL, Doyle A, O’Quinn SR, Mihelic AM, Elnicki DM. Daily stress and coping in essential hypertension. Poster Presented at: 62nd Annual Scientific Meeting of the American Psychosomatic Society, March 3–6, 2004; Orlando, FL.