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Rich Gliklich, MD, Founder and CEO and Michelle Leavy, MPH, Senior Director, Registries at OM1 unpack the FDA's new draft guidance on Postapproval Methods to Capture Safety and Efficacy Data for Cell and Gene Therapy Products.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0:33 What is the new FDA draft guidance about and why is it important?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

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

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

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

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

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