The Evidence Base®

In this captivating and important episode of Patti's People, from The Evidence Base®, Patti Peeples, PhD speaks with Emily Reuben OBE, CEO and Co-founder of Duchenne UK about Project Hercules and how a #patientadvocacy group can influence payer and provider stakeholders to enable change. A must watch. #heor #healtheconomics #outcomesresearch #hta #healthtechnologyassessment #healthdata #healthequity #healthpolicy #patientcentricity #patientengagement #duchenne #rarediseases

📢New article alert from the Journal of Comparative Effectiveness Research:   Title: The value of evidence and its role in driving product strategy   In the pharmaceutical industry, Integrated Evidence Plans (IEPs) are transforming how we approach evidence generation. By addressing gaps across the product lifecycle and aligning R&D, medical, regulatory, HEOR, market access, and commercial objectives, IEPs promote a collaborative and efficient strategy. But what truly drives the value of evidence?   In their latest editorial, Skip Olson and Gorana Capkun (Merck Healthcare) delve into the nuances of evidence's probative value and its impact on decision-making.   #Pharmaceuticals #EvidenceBasedStrategy #ProductDevelopment #HealthcareInnovation #Pharma #OpenAccess   https://lnkd.in/eEquH2F7

The FDA has released a report that summarizes submissions containing #RWD used to generate #RWE in support of #regulatory decisions regarding the effectiveness or safety of drugs or biological products. Read at The Evidence Base® #heor #healtheconomics #outcomesresearch #realworldevidence #realworlddata #pharma #biopharma #regulation #regulatoryaffairs #healthdata

Catch up on last month's key industry news with The Evidence Base® June 2024 Round-up. Including news from the European Union, Clarivate, HealthWise Data, NICE - National Institute for Health and Care Excellence, THREAD, SEQSTER, Parexel, , ISPOR—The Professional Society for Health Economics and Outcomes Research, HealthVerity and the FDA. #heor #healtheconomics #outcomesresearch #rwe #rwd #realworldevidence #realworlddata #marketaccess #pharma #biopharma #medicalaffairs #regulation #regulatoryaffairs #hta #healthtechnologyassessment #healthdata #healthequity #healthpolicy

The European Commission has introduced a third implementing act to streamline the exchange of information in EU-level assessments of new health technologies. Read at The Evidence Base® #heor #healtheconomics #outcomesresearch #rwe #rwd #realworldevidence #realworlddata #marketaccess #pharma #biopharma #medicalaffairs #hta #healthtechnologyassessment #healthdata #healthpolicy #JCA #jointclinicalassessment

Etranacogene dezaparvovec (HEMGENIX®) is the first and currently only #genetherapy approved for #hemophilia B in the UK and is made available under the #InnovativeMedicinesFund. Read at The Evidence Base® #marketaccess #medicalaffairs #hta #healthtechnologyassessment #ATMP #managedaccess #IMF

📢New article alert from the Journal of Comparative Effectiveness Research:   Changes in symptom burden and quality of life among women with uterine fibroids receiving relugolix combination therapy: a plain language summary   New Plain Language Summary of Publication highlights findings from clinical trials on relugolix combination therapy for women with heavy menstrual bleeding due to uterine fibroids. Women reported decreased distress and improved health-related quality of life after 24 weeks of daily relugolix combination therapy compared to placebo. Read more below!   Authors: Elizabeth A (Ebbie) Stewart MD FACOG, Andrea Lukes, MD MHSc FACOG, Roberta Venturella, Yulan Li, PhD VP, Head of Data Science, Elke Hunsche, Rachel B. Wagman, M.D., Ayman Al Hendy Mayo Clinic, CAROLINA WOMEN'S RESEARCH AND WELLNESS, Università 'Magna Graecia' di Catanzaro, Sumitomo Pharma America, Inc., UChicago Medicine   #QualityOfLife #WomensHealth #ClinicalTrials #PlainLanguage #PLSP #OpenAccess 🔗 https://lnkd.in/e4sxWzj7

The FDA has issued draft guidance to increase underrepresented population enrollment in #clinicaltrials, enhancing data relevance and patient representation. Read at The Evidence Base® #heor #healtheconomics #outcomesresearch #rwe #rwd #realworldevidence #realworlddata #pharma #biopharma #regulation #regulatoryaffairs #healthequity #healthpolicy #clinicaldevelopment

Here's this week's round-up from The Evidence Base®. This week we focus on ##ISPORAnnual. Read a compilation of our coverage to help you catch up on the insightful presentations from Atlanta, with content from the following people: - Danielle Gentile, PhD and Richard Scott Swain, PhD, MPH from Cardinal Health. - Aaron Cohen (Senior Medical Director, Machine Learning, Flatiron Health) - Qianyi Zhang (Flatiron Health) - Dr. Kuldeep Kumar Singh and Tijana Ignjatovic of Genesis Research Group - Suzanne M. and John Paul Ekwaru (Medlior Health Outcomes Research Ltd.), Mark van der Laan (University of California, Berkeley) and Stephen J. Duffield (NICE - National Institute for Health and Care Excellence) - Sreeram Ramagopalan (LCP Health Analytics), Alex Castanon (LCP), Stephen J. Duffield (NICE - National Institute for Health and Care Excellence) and Robert Reynolds (GSK) - Corey Ford (Cencora), Michael Drummond (University of York), Casper Paardekooper (Vintura, part of Cencora) and Kimberly Westrich (National Pharmaceutical Council) - Neil Johnson, Executive Director at Global Heart Hub - Ann Madsen (Aetion)  - Patti Peeples, PhD Plus, we look ahead to #ISPOREurope2024 #HEOR #WholeHealth

Here's this week's round-up from The Evidence Base®. This week we focus on ##ISPORAnnual. Read a compilation of our coverage to help you catch up on the insightful presentations from Atlanta, with content from the following people: - Danielle Gentile, PhD and Richard Scott Swain, PhD, MPH from Cardinal Health. - Aaron Cohen (Senior Medical Director, Machine Learning, Flatiron Health) - Qianyi Zhang (Flatiron Health) - Dr. Kuldeep Kumar Singh and Tijana Ignjatovic of Genesis Research Group - Suzanne M. and John Paul Ekwaru (Medlior Health Outcomes Research Ltd.), Mark van der Laan (University of California, Berkeley) and Stephen J. Duffield (NICE - National Institute for Health and Care Excellence) - Sreeram Ramagopalan (LCP Health Analytics), Alex Castanon (LCP), Stephen J. Duffield (NICE - National Institute for Health and Care Excellence) and Robert Reynolds (GSK) - Corey Ford (Cencora), Michael Drummond (University of York), Casper Paardekooper (Vintura, part of Cencora) and Kimberly Westrich (National Pharmaceutical Council) - Neil Johnson, Executive Director at Global Heart Hub - Ann Madsen (Aetion)  - Patti Peeples, PhD Plus, we look ahead to #ISPOREurope2024 #HEOR #WholeHealth