Don't miss the opportunity to connect with Meena Venkatachalam, Head of Global RWE Consulting, Lumanity at the 50th Annual European Society for Blood and Marrow Transplantation (The EBMT) Meeting, and be sure to catch the special session, Real World Evidence to Aid Decision-Making, on April 17. Reach out to contact@lumanity.com to set up time to meet at the conference in Glasgow. For more information, visit https://buff.ly/4cL0aVo #EBMT #EBMT24 #realworldevidence #RWE #HEOR #decisionmaking #bloodandmarrowtransplantation
Lumanity
Research Services
Bethesda, MD 48,746 followers
Incisive Thinking, Decisive Action
About us
Lumanity applies incisive thinking and decisive action to cut through complex situations and deliver transformative outcomes to accelerate and optimize access to medical advances. With deep experience in medical, commercial, and regulatory affairs, Lumanity transforms data and information into real-world insights and evidence that powers successful commercialization and empowers patients, providers, payers, and regulators to take timely and decisive action.
- Website
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http://www.lumanity.com
External link for Lumanity
- Industry
- Research Services
- Company size
- 1,001-5,000 employees
- Headquarters
- Bethesda, MD
- Type
- Privately Held
- Founded
- 2020
Locations
Employees at Lumanity
Updates
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Don't miss the opportunity to connect with our experts at the Academy of Managed Care Pharmacy (AMCP) annual meeting, and be sure to catch the Best Practices in Peer-reviewed Publishing session on April 17. This session will focus on how all stakeholders involved in producing peer-reviewed publications can ensure published research meets the highest ethical and quality standards and features Leslie Moody, PhD, ISMPP CMPP, Senior Scientific Director at Lumanity, Phil Schwab, Senior Director, Surveys and Observational Studies at RTI Health Solutions, and session moderator Laura Happe, Editor-in-Chief of the Journal of Managed Care and Specialty Pharmacy. To set up time to meet at the conference in New Orleans to discuss our industry-leading work, contact Bill, Josh, Lisa, and/or Leslie Moody directly or e-mail contact@lumanity.com. For more information, visit https://buff.ly/4cFveGe. #AMCP #AMCP2024 #marketaccess #medcomms #publishing #managedcare #pharmacy #managedcarepharmacy
2024 Academy of Managed Care Pharmacy (AMCP) Annual Meeting
https://lumanity.com
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It is critical that manufacturers are well equipped to deal with the potential obstacles and challenges they will face as they bring new products to the world’s two largest pharmaceutical markets with the implementation of the Inflation Reduction Act (IRA) in the United States and Joint Clinical Assessments (JCA) in the European Union. Join us during our upcoming webinar as we compare and contrast these two seismic changes to the value and access landscape and provide some best practices and experience-based key learnings to help manufacturers to prepare for the implications of these changes. Learn more and register at https://buff.ly/3U0E5ev #inflationreductionact #IRA #EUHTAregulation #EUHTA #JCA #HEOR #jointclinicalassessments #valueandaccess
Seismic Change: Preparing for the Practical Realities of the IRA and EU JCA
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Lumanity and PHARMO are collaborating to deliver long-term post-authorization safety studies (PASS). Between 2011 and 2020, PHARMO Institute for Drug Outcomes Research, Bayer, and partners conducted a large rivaroxaban PASS programme comprising of eight observational studies as part of the regulatory post-approval commitment to the European Medicines Agency (EMA). Check out the latest whitepaper, Challenges and lessons learned from a long-term post-authorisation safety study programme of rivaroxaban in Europe. This unique PASS program exemplifies an approach where the prescription of a medication and its safety and effectiveness can be evaluated in a single initiative, covering all indications to be assessed, and by using well-established and validated population-based European databases already familiar to researchers, industry, and regulators. Read the full paper at https://buff.ly/3VLWqNH #PASSstudies #postauthorizationsafetystudies #safetystudies #observationalstudies #EMA
Learnings from a long-term PASS study in Europe
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Be sure to check out our extensive library of content, including several new white papers, podcasts, articles, blogs, webinars, and case studies. Our perspectives provide illuminating insights, bold analysis, and transformative visions for decisive action. https://buff.ly/3VNqCYq #thoughtleadership #illuminatinginsights #wearelumanity #pharma #biotech #medicaldevices
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We are just one month away from Asembia's AXS24 Summit in Las Vegas! If you'll be at the summit, we invite you to join our market access experts, including Leeann Lui, PharmD, Lisa Cashman, William Renzo, and Joshua Phillips, for one of our two lunch-and-learn sessions: - Navigating the IRA: Are you playing chess or checkers? Tuesday, April 30, 12-1 pm - Unlocking Launch Potential: Sharing our recent learnings from 15+ launches over the past 18 months. Wednesday, May 1, 12-1 pm For more information and to reserve a spot at a lunch-and-learn, visit https://buff.ly/3J26HNO #Asembia #Asembia24 #AXS24 #marketaccess #drugdelivery #pharma
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In case you missed it, we recently shared the first in our series on real world evidence for regulators. The Food and Drug Administration (FDA) recently published draft guidance on the use of real world evidence (RWE) for medical devices. The guidance documents indicate both the importance of RWE to support regulatory approvals, but also the increase in its use cases. Our RWE experts have highlighted a few key areas about the recent medical device guidance making it clear that RWE is positioned as a useful tool to support with device innovation. Read the full piece at https://buff.ly/48OeJED and reach out to contact@lumanity.com to speak with one of our experts to learn more on how to prepare for FDA discussions on RWE and how Lumanity’s integrated approach can help you manage all aspects of FDA engagement. #RWE #FDA #realworldevidence #FDAguidance #regulatoryapproval #clinicaltrials #machinelearning #patientexperience
De-risk your Use of RWE for Regulatory Approvals
https://lumanity.com
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We are counting down to the Intellus Worldwide Summit in a few weeks! If you'll be at the summit, reach out to contact@lumanity.com to schedule time to meet with our on-site staff, including Michael Harris and Christopher Curtin and be sure to stop by exhibit booth 5! Learn more at https://buff.ly/3Vtcpjs #Intellus #intellusww #healthinsights #pharmamarketing #marketresearch #insights
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It's not too late to register for tomorrow's presentation and discussion, Charting a Path to FDA Advisory Committee Success in a Sea of Change. Register now at https://buff.ly/3Jeezw9 to ask your questions and get the recording of the discussion about areas for potential change in the FDA AdCom process and implications for drug companies seeking approvals. #FDA #RegulatoryAffairs #Biotech #Pharmaceutical #AdCom #FDAAdComMeetings
Charting a Path to FDA Advisory Committee Success in a Sea of Change
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