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Real-World Evidence Webinar

Realizing the Value of RWE Data… Faster Biopharmaceutical companies recognize the value of RWE and strive to make it a routine part of their decision-making process. Many face challenges, however, with optimizing their use of RWE data in the earlier stages of commercial planning and in life-cycle management. Disparate, error-prone, costly data coupled with a lack of time, resources, or experience generating insights lead to elongated project timelines.During this webinar, we will discuss barriers to RWE use in commercialization planning…

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Launching During COVID-19 Whitepaper

What is and isn’t working for drug launches amid COVID-19? Six months after COVID-19 lock-downs began, Trinity has uncovered some surprising (and some concerning) answers to key questions everyone is asking. In this paper, we examine the trajectory of new molecular entities (NMEs) approved in late 2019 and early 2020 to understand how to drive a successful drug launch (and avoid the pitfalls) in the age of COVID-19.…

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Systemic Literature Review to Characterize the Burden and Unmet Needs Associated with Cremophor EL

Cremophor EL (CrEL) is an additive (excipient) used to improve the solubility of hydrophobic drugs including certain anti-cancer drugs, like paclitaxel. Although the potential toxicities associated with CrEL are well known, the burden of CrEL-containing therapy is not well defined in the published scientific literature. Authors Brixner D, McKinley K, Gelder M, Oak B, Dehipawala S, Hadker N Journal ISPOR Meeting 2021 View publication…

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Evaluating Health-Related Quality of Life (HRQoL) in Patients with and without Crohn’s Perianal Fistulas (CPF) Using the Euroqol Five-Dimension (EQ-5D-5L) Questionnaire in a Real-World US Setting

Crohn’s disease (CD) substantially impacts HRQoL, with complications such as perianal fistulas potentially increasing burden of illness. We investigated HRQoL in patients with CD and CPF and those without CPF, and for patients with CPF with and without CPF-related surgery. Authors Jiang J, Kuharic M, Athavale A, Fan T, Silber A, Abilash V, Hadker N, Sharpe E, Cazzetta S Journal ISPOR Meeting 2021 View publication…

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Risk Factors Associated with Recurrence and Corticosteroid-Associated Adverse Events in Patients with Recurrent Pericarditis

Recurrent pericarditis (RP) occurs in up to 30% of acute pericarditis patients with some experiencing multiple recurrences and/or complications. Treating RP with corticosteroids can increase adverse events, risk of recurrence, and potentially healthcare resource utilization. This retrospective study examined risk factors for recurrence and corticosteroid-related adverse events (CS-AEs) among RP patients. Authors Schwier NC, Luis SA, Hu X, Athavale A, Skaar J, Magestro M, Lim-Watson M Journal ISPOR Meeting 2021 View publication…

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Clinical and Economic Impact of Primary Hyperoxaluria: A Retrospective Claims Analysis

Primary hyperoxalurias (PH; types 1, 2, and 3) are rare genetic disorders resulting in the overproduction of oxalate in the liver and that manifest in renal complications. This study sought to quantify the healthcare resource utilization (HCRU), costs, and clinical characteristics of PH patients. Authors Bernd Hoppe, Abigail Silber, Gavin Miyasato, Tom Koenig, Jeffrey Skaar, Craig Langman Journal American Society of Nephrology; ASN Kidney Week 2020 View publication…

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Effect of New-Onset Gout on Kidney Transplant Outcomes: A Retrospective Cohort Analysis of the United States Renal Data System

This investigation assessed if the development of new-onset gout after KT was an independent risk factor for loss of graft function, as assessed by the need for maintenance hemodialysis following KT. Authors J. Li, D. Yin, M. Brigham, B. Lamoreaux, J. Kent, M. Francis-Sedlak, R. Johnson, N. Hadker, K. Francis, H. Sanchez, G. Miyasato Journal EULAR 2020 View publication…

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The Burden of Familia Chylomicronemia Syndrome in Canadian Patients

Familial chylomicronemia syndrome (FCS) is a rare autosomal recessive disorder characterized by persistent extreme hypertriglyceridemia as a result of lipoprotein lipase deficiency. Canada is an important region for FCS research due to the high prevalence rates. The burden of illness and quality of life of Canadian patients, however, have been inadequately addressed in the literature. The objective of this study is to understand the burden of illness of FCS on Canadian patients’ lives. Authors Daniel Gaudet, Michael Stevenson, Nelly Komari,…

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Hypoactive Sexual Desire Disorder (HSDD) is not ‘Female Erectile Dysfunction (ED)’: Challenges with the Characterization of HSDD in Women Based on a Systematic Literature Review

Hypoactive sexual desire disorder (HSDD) in women has been viewed inaccurately by some in the medical and payer community as analogous to erectile dysfunction (ED) in men. This literature review aims to highlight the distinctions between HSDD and ED. Authors Sheryl Kingsberg, Shruti Nambiar, Swagata Karkare, Nandini Hadker, Michelle Lim-Watson, Laura Williams, Julie Krop Journal National Library of Medicine; Current Medical Research & Opinion; June 2020 View publication…

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