Lumanity

Alexander Fink and Ed Saltzman sat down together at the recent BIO-Europe conference and discussed why biopharma must better prepare for commercialization, even if the aim is to seek partnerships. In the video, they tackle common myths surrounding this topic and offer practical guidance on how teams can effectively approach the commercial thinking that is essential for success. Watch the full video at https://lnkd.in/ePJzByNd and be sure to read our white paper on the topic at https://lnkd.in/exUhg7rr #biopharma #biotech #commercialization #commercializationpartnerships #commercialsuccess #BIOEurope

We are counting down to the upcoming Pharmaceutical Launch Excellence Summit. Be sure to reach out to [email protected] or directly with our colleagues to connect with our experts, Keitel Suri and Jeff Hart. For more information about the summit, visit https://buff.ly/4esJP7r #LaunchExcellence #Biopharma #ClinicalDevelopment #CommercialLaunch #PharmaceuticalLaunch

We're just a couple weeks away from the upcoming 13th Annual Life Science Strategic Patient Advocacy Conference. Be sure to reach out to [email protected] to connect with Holli Kawadler, PhD who will be on-site in Philadelphia. For more information about the summit, visit https://buff.ly/3YJqadA #PatientAdvocacy #PatientEngagement #LifeSciences #PatientAdvocate

In this third episode of our podcast miniseries on integrated evidence generation planning (IEGP), our experts discuss key regional considerations when forming a strategy to address specific needs and challenges across diverse geographies, populations and health systems. Listen now: https://buff.ly/3AQ1PLo If you missed the first two episodes, make sure to check them out here: Episode 1: https://buff.ly/3Z0Pps4 Episode 2: https://buff.ly/3Zdcut4 #IEGP #IntegratedEvidenceGenerationPlanning #MAPS #MedicalAffairs #MedAffairs #PodcastSeries #PodcastMiniseries #PodcastEpisode #Pharma #PharmaStrategy

Our health economics, outcomes research, and real world evidence experts are on-site in Barcelona for ISPOR Europe. If you haven't yet, be sure to stop by booth 921 to catch up with our colleagues, grab some swag to take home, and participate in a short questionnaire at the stand! Learn more about our presentations and who is at the conference at https://buff.ly/3V0GOo2 #ISPOREurope #EUHTA #HEOR #HealthEconomics #OutcomesResearch #PatientCenteredOutcomes #RWE #RealWorldEvidence #ISPOR ISPOREU

In this article for QT9 QMS, Menaka Manokaran, Associate Director of Regulatory Affairs at Lumanity, reviews the FDA approval process for medical devices. The article examines Special 510(k) and Abbreviated 510(k) submissions, as well as premarket approval, the most stringent type of device marketing application required by the FDA. Read the article on the QT9 QMS site: https://buff.ly/4fLDaGx #QT9QMS #ClinicalAndRegulatory #FDA #MedicalDevices #MedicalDevice #FDAApproval #Regulatory #RegulatoryAffairs

In case you missed it, we recently discussed the use of real world data to guide precision oncology drug development. The discussion featured the topics of: - Strategic challenges in precision oncology - Approaches for navigating these uncertainties - The role of real world data and analytics and whether the use of real world evidence can be optimized to close gaps in target identification/biomarker discovery, indication prioritization, and disease & market understanding. Watch the recording of the webinar at https://buff.ly/3AV03bP #RWE #RWD #Oncology #DrugDevelopment #PrecisionOncology #RealWorldEvidence #RealWorldData #Biomarket #Cancer

A formidable group of experts are at #ISPOREurope this week! If you're in Barcelona for the conference, be sure to visit booth 921 and catch up with all of our colleagues on-site. For the full list of our presentations and experts in attendance, visit https://lnkd.in/eRTiSqhK #HEOR #HTA #HealthEconomics #OutcomesResearch #PatientCenteredResearch #ISPOR

Lumanity is committed to amplifying the voices of people living with a rare condition, and using our '29 stories' initiative, we seek to alleviate feelings of isolation, drive awareness for rare diseases, and facilitate more open and authentic conversations about the impact on patients and families. We invite you to submit your unique experiences and wisdom through a series of quick and insightful questions. In bringing your story into the spotlight, we help share information on rare diseases and support the community. If you or anyone you know would like to submit a story, visit https://buff.ly/3O6AyaN #rarediseases #raredisease #29stories #patientadvocacy #rarecondition #shareyourstory

We're counting down to the Cell Therapy for Autoimmune Disease Summit in a few weeks! If you're planning to be in Philadelphia during the summit, don't miss the chance to connect with our experts, including Kristin Abramo, Ph.D., David Lomb, and Danielle Marra. Reach out to our colleagues directly, email [email protected] to find time to connect during the summit, or visit our exhibit table on site. Learn more at https://buff.ly/4euVEtV #CellTherapy #AutoimmuneDisease #BioMarkers #ClinicalDevelopment