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Behind the Insights

Behind the Insights

Written by: OM1 Inc.
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Welcome to Behind the Insights! A series where the industry’s top thought leaders share real-world data (RWD), artificial intelligence (AI), and evidence generation insights.

OM1, Inc.
Biological Sciences Science
Episodes
  • Behind the Insights: Ep 06 FDA Draft Guidance on Post-Approval Data for Cell & Gene Therapies
    Nov 4 2025

    In this episode of Behind the Insights, Rich Gliklich, MD, Founder and CEO and Michelle Leavy, MPH, Senior Director, Registries at OM1 unpack the FDA's new draft guidance on Postapproval Methods to Capture Safety and Efficacy Data for Cell and Gene Therapy Products. They'll discuss practical considerations sponsors need to know and provide expert insights on compliant, cost-effective postapproval data strategies.

    0:00 Intro

    0:33 What is the new FDA draft guidance about and why is it important?

    2:45 Main limitations of traditional real-world data sources?

    4:09 How do registries fill gaps?

    6:13 Decentralized data collection in practice

    8:22 What do sponsors need to keep in mind?

    9:22 Final thoughts

    📩 Stay updated on future episodes: https://go.om1.com/l/1071043/2025-02-10/bk8151

    🎯 Follow us! LinkedIn: https://www.linkedin.com/company/om1-inc./

    Facebook: https://www.facebook.com/profile.php?id=61573205886660

    X: https://x.com/Om1Inc

    🌐 Visit our website: https://www.om1.com/

    #fda #clinicalregistries #clinicalresearch #realworlddata #rwd #realworldevidence #rwe #pharma

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    10 mins
  • Behind the Insights: Ep 05 Rheumatoid Arthritis Remission with Chandra Gopalakrishnan, MD, MPH
    Nov 4 2025

    In this episode of Behind the Insights, Chandra Gopalakrishnan, MD, MPH, Principal Epidemiologist at OM1, discusses an award winning ISPOR poster that investigates predictors of low disease activity or remission in rheumatoid arthritis (RA). Despite the vast availability of therapies, many rheumatoid arthritis patients still fail to achieve remission, highlighting the need for more effective treatment strategies.

    0:00 Intro

    0:42 RA patients with prior inadequate response to biologic DMARDS

    1:37 Uncovering predictive trends with OM1's PremiOM RA dataset

    2:27 Comorbid insights, decision-making, and personalized treatment

    3:27 Capturing estimated Clinical Disease Activity Index (CDAI) for better capture disease control

    4:24 Effect on the treatment landscape and innovations

    📩 Stay updated on future episodes: https://go.om1.com/l/1071043/2025-02-10/bk8151

    🎯 Follow us! LinkedIn: https://www.linkedin.com/company/om1-inc./

    Facebook: https://www.facebook.com/profile.php?id=61573205886660

    X: https://x.com/Om1Inc

    🌐 Visit our website: https://www.om1.com/

    #rheumatology #rheum #rheumatoidarthritis #cdai #realworlddata #rwd #realworldevidence #rwe #clinicalresearch #pharma

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    5 mins
  • Behind the Insights: Ep 04 GLP-1s & Suicidal Ideation, Jessica Probst, MPH & Carl Marci, MD
    Nov 4 2025

    In this episode of Behind the Insights, Jessica Probst, MPH, Principal, Real-World Evidence at OM1 and Dr. Carl Marci, Chief Clinical Officer and Managing Director of Mental Health and Neuroscience at OM1, unpack a topic that’s made recent headlines and raised important questions for both clinicians and patients, suicidal ideation (SI) warnings on GLP-1 medications. While these labels have sparked concern, these experts will be discussing what the data has to say.

    0:00 Intro

    0:45 What inspired you to investigate potential ties between GLP-1 therapies and SI?

    1:18 How did you identify instances of suicidal ideation in RWD?

    2:08 Key findings

    2:45 How should clinicians should manage care going forward?

    3:08 Shaping future conversations

    📩 Stay updated on future episodes: https://go.om1.com/l/1071043/2025-02-10/bk8151

    🎯 Follow us! LinkedIn: https://www.linkedin.com/company/om1-inc./

    Facebook: https://www.facebook.com/profile.php?id=6157320588666

    X: https://x.com/Om1Inc

    🌐 Visit our website: https://www.om1.com/

    #mentalhealth #glp1 #glp1medication #suicidalideation #suicidalthoughts #ai #realworlddata #rwd #realworldevidence #rwe #clinicalresearch #pharma

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    4 mins
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