Behind the Insights: Ep 06 FDA Draft Guidance on Post-Approval Data for Cell & Gene Therapies

Behind the Insights: Ep 06 FDA Draft Guidance on Post-Approval Data for Cell & Gene Therapies

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Rich Gliklich, MD, Founder and CEO and Michelle Leavy, MPH, Senior Director, Registries at OM1 unpack the FDA's new draft guidance on Postapproval Methods to Capture Safety and Efficacy Data for Cell and Gene Therapy Products.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provide expert insights on compliant, cost-effective postapproval data strategies. 0:00 Intro 0:33 What is the new FDA draft guidance about and why is it important? 2:45 Main limitations of traditional real-world data sources? 4:09 How do registries fill gaps? 6:13 Decentralized data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 [https://go.om1.com/l/1071043/2025-02-10/bk8151] 🎯 Follow us! LinkedIn: https://www.linkedin.com/company/om1-inc./ [https://www.linkedin.com/company/om1-inc./] Facebook: https://www.facebook.com/profile.php?id=61573205886660 [https://www.facebook.com/profile.php?id=61573205886660] X: https://x.com/Om1Inc [https://x.com/Om1Inc] 🌐 Visit our website: https://www.om1.com/ [https://www.om1.com/] #fda #clinicalregistries #clinicalresearch #realworlddata #rwd #realworldevidence #rwe #pharma

Behind the Insights: Ep 05 Rheumatoid Arthritis Remission with Chandra Gopalakrishnan, MD, MPH

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 [https://go.om1.com/l/1071043/2025-02-10/bk8151] 🎯 Follow us! LinkedIn: https://www.linkedin.com/company/om1-inc./ [https://www.linkedin.com/company/om1-inc./] Facebook: https://www.facebook.com/profile.php?id=61573205886660 [https://www.facebook.com/profile.php?id=61573205886660] X: https://x.com/Om1Inc [https://x.com/Om1Inc] 🌐 Visit our website: https://www.om1.com/ [https://www.om1.com/] #rheumatology #rheum #rheumatoidarthritis #cdai #realworlddata #rwd #realworldevidence #rwe #clinicalresearch #pharma

Behind the Insights: Ep 04 GLP-1s & Suicidal Ideation, Jessica Probst, MPH & Carl Marci, MD

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 [https://go.om1.com/l/1071043/2025-02-10/bk8151] 🎯 Follow us! LinkedIn: https://www.linkedin.com/company/om1-inc./ [https://www.linkedin.com/company/om1-inc./] Facebook: https://www.facebook.com/profile.php?id=6157320588666 [https://www.facebook.com/profile.php?id=61573205886660] X: https://x.com/Om1Inc [https://x.com/Om1Inc] 🌐 Visit our website: https://www.om1.com/ [https://www.om1.com/] #mentalhealth #glp1 #glp1medication #suicidalideation #suicidalthoughts #ai #realworlddata #rwd #realworldevidence #rwe #clinicalresearch #pharma

Behind the Insights: Ep 03 Decoding Treatment-Resistant Depression with Carl Marci, MD

In this episode of Behind the Insights, Carl D. Marci, MD, Chief Clinical Officer and Managing Director of Mental Health and Neuroscience at OM1, explores the complexities of Treatment-Resistant Depression (TRD) and how OM1’s AI-driven models are reshaping the way we identify and treat patients. Discover how real-world data, clinician attestation, and unstructured clinical notes are unlocking hidden patterns in mental health care, and what the future holds for AI in mental health. 0:00 Intro 0:37 What is Treatment-Resistant Depression and why is it so challenging to define and detect? 1:13 How common is it for patients to experience failure with multiple treatments? 1:43 Highlighting “psychiatrist-attested TRD” with AI and unstructured clinical notes 2:38 Can you walk us through how you know which definition of TRD is correct? 3:35 How do you see AI evolving in the discovery and treatment of TRD? 4:05 How do we ensure trust, accuracy, and clinical relevance when using AI to identify patients? 4:38 The future of mental health and AI 5:04 Final Thoughts 📩 Stay updated on future episodes: https://go.om1.com/l/1071043/2025-02-10/bk8151 [https://go.om1.com/l/1071043/2025-02-10/bk8151] 🎯 Follow us! LinkedIn: https://www.linkedin.com/company/om1-inc./ [https://www.linkedin.com/company/om1-inc./] Facebook: https://www.facebook.com/profile.php?id=61573205886660 [https://www.facebook.com/profile.php?id=61573205886660] X: https://x.com/Om1Inc [https://x.com/Om1Inc] 🌐 Visit our website: https://www.om1.com/ [https://www.om1.com/] #mentalhealth #depression #treatmentresistantdepression #ai #realworlddata #rwd #realworldevidence #rwe #clinicalresearch #pharma

Behind the Insights: Ep 02 The Next Era of Evidence Generation with Rich Gliklich, MD

In this episode of Behind the Insights, OM1 CEO, Rich Gliklich, MD explores the groundbreaking advancements reshaping evidence generation in clinical research. From AI-driven automation in clinical trials to the power of passive data collection, discover how these innovations are reducing costs, accelerating research, and paving the way for personalized medicine. 0:00 Intro 0:46 Real-world data is reshaping how we generate evidence 2:26 Promising innovations addressing high costs and timelines in clinical trials 4:50 OM1 Center of Excellence 5:56 Automating evidence generation 7:49 Improving the speed and quality of data collection and analysis 8:55 Ensuring scalability and flexibility to meet diverse demands 9:30 Case Study: a unique approach with advantages over traditional methods 10:36: What's on the horizon? What advancements should we be paying attention to? 11:41 Final thoughts 📩 Stay updated on future episodes: https://go.om1.com/l/1071043/2025-02-10/bk8151 [https://go.om1.com/l/1071043/2025-02-10/bk8151] 🎯 Follow us! LinkedIn: https://www.linkedin.com/company/om1-inc./ [https://www.linkedin.com/company/om1-inc./] Facebook: https://www.facebook.com/profile.php?id=61573205886660 [https://www.facebook.com/profile.php?id=61573205886660] X: https://x.com/Om1Inc [https://x.com/Om1Inc] 🌐 Visit our website: https://www.om1.com/ [https://www.om1.com/] #om1 #behindtheinsights #evidencegeneration #ai #clinicalresearch #clinicaltrials #realworlddata #rwd #realworldevidence #rwe