Podcasts about biologics

Episode is based on a talk Subhi Saadeh gave at CPHI. In this episode, Subhi Saadeh breaks down the three levels where true harmonization must happen for drug-device products to succeed:-Global regulatory alignment-Effective sponsor-CXO collaboration-Cross-functional teamwork between drug and device stakeholders inside companiesSubhi covers why regulatory misalignments across countries create uncertainty, how disconnected sponsor-CXO relationships lead to delays and inefficiencies, and how internal friction between pharma and device functions can stall programs even when the science is sound.Timestamps:00:00 – Introduction: The Reality of Drug-Device Combination Products00:39 – Identifying the Core Issues in Combination Product Development01:38 – What Are Drug-Device Combination Products?02:05 – Common Types of Combination Products05:00 – Market Growth & Regulatory Landscape07:26 – Challenges and Silos That Slow Progress10:01 – Practical Strategies for Harmonization and Collaboration14:56 – Final Thoughts: Why Harmony Beats SamenessSubhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

Ever wondered who's really behind the regulations you follow in pharma and medical devices? In this episode of Let's ComBinate, Subhi Saadeh breaks down the five categories of organizations that influence how we develop, test, and release products:Regulatory Authorities (like FDA, EMA, PMDA)Harmonization Bodies (like ICH, IMDRF, and PIC/S)Standards Organizations (ISO, ASTM, etc.)Pharmacopoeias (USP, JP, Ph. Eur.)Industry Groups (like PDA, MDIC, PhRMA, and more)Subhi dives into how each type contributes to the rules, expectations, and gray areas that define your work — and how to figure out which ones really matter when you're reviewing SOPs, guidance docs, and regulatory submissions.00:00 – Intro01:23 – Regulatory Bodies04:03 – Harmonization Organizations10:01 – Standards Organizations12:07 – Pharmacopoeias13:59 – Industry Groups16:11 – Wrap-up and TakeawaysSubhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

Mikkel Wandahl Pederson, CEO and chief scientific officer at Commit Biologics, discussed the company's mission to harness the powerful complement system for the treatment of serious diseases.

In this episode of Let's Combinate, Subhi Saadeh—an ISO 13485 certified lead auditor, CQA, and CQE—dives into the evolving role of auditing in the medical device and pharmaceutical industries. He reflects on his journey to becoming a Certified Quality Auditor and asks a timely question: in the age of AI, will audits—and auditors—still matter? Subhi outlines what separates good auditors from great ones, shares lessons from his own audit experiences, and breaks down how AI might streamline parts of the audit process. But he makes a clear case: while AI can assist, it can't replace the critical thinking, real-time risk judgment, and systems awareness that human auditors bring. The episode wraps with practical advice on how to embrace AI as a tool—without losing the edge that only people have.00:00 Introduction to Auditing and Certification00:43 My Auditing Journey and Experience02:40 The Importance of Technique in Auditing03:26 Real-World Auditing Insights04:59 The Value of Certification07:16 Key Qualities of a Great Auditor10:48 The Role of AI in Auditing12:18 Why AI Won't Replace Human Auditors15:26 Conclusion and Future OutlookSubhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

Peyton Greenside, co-founder and CEO of BigHat Biosciences, on machine-learning guided biologic drug discovery.

Not sure what Minimal Disease Activity or MDA is and how it relates to psoriatic arthritis and your joints? Listen as rheumatologist Dr. Arthur Mandelin explains what MDA means. Join hosts Jeff Brown and LB Herbert as they discuss minimal disease activity in psoriatic arthritis with nationally recognized rheumatologist Dr. Arthur Mandelin who identifies what it is, factors that influence achieving MDA, how long it takes to reach, and the impact on selection of treatments. Dr. Mandelin also addresses fatigue associated with inflammation, and what the future holds for minimal disease activity in psoriatic arthritis. Whether you have psoriasis or psoriatic arthritis, this episode offers information to help you understand management goals set by your doctor and the importance of attaining minimal disease activity. Timestamps: (00:00) Intro to Psound Bytes & guest welcome rheumatologist Dr. Arthur Mandelin (02:23) What is minimal disease activity (MDA) (04:32) MDA in comparison to ACR response criteria (07:36) Criteria for reaching MDA (09:20) Positive and negative factors of MDA (11:25) Importance of reaching MDA within a specific time frame (17:34) Length of time to reach MDA (18:48) Selection of treatment options and psoriatic arthritis domains (23:51) Inflammation and fatigue (26:59) A look at the future of minimal disease activity in psoriatic arthritis: Reaching ACR 90 (29:09) Advancements in psoriatic arthritis: Finding disease markers (33:40 ) If you have psoriasis, be aware of your risk for psoriatic arthritis 4 Key Takeaways: There are various ways to measure minimal disease activity in psoriatic arthritis to assess how the disease impacts quality of life.   Attaining and keeping minimal disease activity low through use of different therapy options offers a chance for better bone and joint outcomes. Advancements in psoriatic arthritis include attaining ACR90 and the potential for identifying key markers that make treatment selection more targeted and individualized. Those who have psoriasis need to realize bone and joint pain, and swelling in the joints may be related to their psoriatic skin disease and seek appropriate help.  Guest Bio: Dr. Arthur Mandelin is an Associate Professor of Medicine at Northwestern University Feinberg School of Medicine and the Department of Medicine Division of Rheumatology. Dr. Mandelin launched Northwestern University's first training program in musculoskeletal ultrasonography for rheumatology fellows. He is an active participant in the REASON Group which is a multi-center research collaboration devoted to using ultrasound guidance to obtain minimally invasive synovial tissue biopsies. Dr. Mandelin is a past member of the National Psoriasis Foundation's Medical Board where he served on consensus panels for the development of a variety of practice guidelines.  Resources Mentioned: National Psoriasis Foundation: https://www.psoriasis.org PEST Screener: https://www.psoriasis.org/psoriatic-arthritis-screening-test/ PsA Action Month 2025: https://www.psoriasis.org/psa-action-month/ NSAIDS  for Psoriatic Disease: https://www.psoriasis.org/advance/nsaids-for-psoriatic-disease-psa/ AMP (Accelerated Medicines Partnership): https://www.psoriasis.org/advance/progress-and-success- through-collaboration/  Tags: psoriasis, skin, psoriatic arthritis, minimal disease activity, ACR20, ACR50, ACR70, tender joints, bone erosion, joint swelling, enthesitis, inflammation, pain, fatigue, axial disease, spinal involvement, treatment, NSAIDS, biologics, personalized medicine, dermatology, National Psoriasis Foundation, AMP, Psound Bytes podcast, Soundbites podcast

Pink Sheet Executive Editor Derrick Gingery, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs consider early excitement and concern about Vinay Prasad's potential impact on product development as director of the US Food and Drug Administration's Center for Biologics Evaluation and Research (:20). They also consider the consequences of the FDA missing product-specific guidance publication deadlines (14:59) and its potential impact on the upcoming user fee reauthorization negotiations (20:00). More On These Topics From The Pink Sheet Tougher Approval Standards May Follow Vinay Prasad's Appointment To Lead US FDA's CBER: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/tougher-approval-standards-may-follow-vinay-prasads-appointment-to-lead-us-fdas-cber-WEULXI5EJRE43BWU752PGDGE44/ US FDA Guidance Roadblock: Writing Continues, But Publication Has Slowed Or Stopped: https://insights.citeline.com/pink-sheet/biosimilars-and-generics/generics/us-fda-guidance-roadblock-writing-continues-but-publication-has-slowed-or-stopped-TZF4DMPEMVHT3JJPRUX7LJJIHU/

Join us for this two-episode mini-series featuring lead study authors, Mario Castro and Njira Lugogo, as they discuss key findings from the VESTIGE trial and their implications on asthma care.  Uncover: ·      The importance of patient phenotyping: How can biomarkers and imaging improve asthma management? ·      Mucus plugging and airflow obstruction: What does the latest research reveal? ·      Biologics and airway remodeling: What did the VESTIGE trial reveal about biologics and airway remodeling? ·      The role of imaging in clinical practice: How can CT scans provide new insights into asthma care? Speakers Mario Castro, University of Kansas School of Medicine, United States Njira Lugogo, University of Michigan, Ann Arbor, Michigan, United States Disclaimers: ·      This program is non-promotional and is sponsored by Sanofi and Regeneron Pharmaceuticals, Inc. ·      The speakers are being compensated and/or receiving an honorarium from Sanofi and Regeneron in connection with this program ·      The content contained in this program was jointly developed by AMJ, the speakers, and Sanofi and Regeneron, and is not eligible for continuing medical education (CME) credits ·      See full US Prescribing Information for dupilumab ·      MAT-US-2412937 v2.0 - Pro1 Expiration Date: 04/21/2026 Speaker disclosures: ·      MC reports research support from the American Lung Association, AstraZeneca, Gala Therapeutics, Genentech, GSK, NIH, Novartis, PCORI, Pulmatrix, sanofi-aventis, Shionogi, and Theravance Biopharma, consultancy fees from Allakos, Amgen, Arrowhead Pharmaceuticals, Blueprint Medicines, Connect BioPharma, Genentech, GSK, Merck, Novartis, OM Pharma, Pfizer, Pioneering Medicines, sanofi-aventis, Teva, Third Rock Ventures, and Verona Pharmaceuticals, speaker fees from Amgen, AstraZeneca, Regeneron Pharmaceuticals Inc., and Sanofi, and royalties from Aer Therapeutics. ·      NLL reports research support paid to institution from Amgen, AstraZeneca, Avillion, Genentech, Gossamer Bio, GSK, Regeneron Pharmaceuticals Inc., Sanofi, and Teva, consultancy fees from and participation on advisory boards with Amgen, AstraZeneca, Genentech, GSK, Novartis, Regeneron Pharmaceuticals Inc., Sanofi, and Teva, travel support from AstraZeneca, and honoraria for non-speaker bureau presentations from AstraZeneca and GSK. References: 1.        Castro M et al. Effect of dupilumab on exhaled nitric oxide, mucus plugs, and functional respiratory imaging in patients with type 2 asthma (VESTIGE): a randomised, double-blind, placebo-controlled, phase 4 trial. Lancet Respir Med. 2025;13:208-20. doi: 10.1016/S2213-2600(24)00362-X.

Join us for this two-episode mini-series featuring lead study authors, Mario Castro and Njira Lugogo, as they discuss key findings from the VESTIGE trial and their implications on asthma care.  Uncover: ·      The importance of patient phenotyping: How can biomarkers and imaging improve asthma management? ·      Mucus plugging and airflow obstruction: What does the latest research reveal? ·      Biologics and airway remodeling: What did the VESTIGE trial reveal about biologics and airway remodeling? ·      The role of imaging in clinical practice: How can CT scans provide new insights into asthma care? Speakers Mario Castro, University of Kansas School of Medicine, United States Njira Lugogo, University of Michigan, Ann Arbor, Michigan, United States Disclaimers: ·      This program is non-promotional and is sponsored by Sanofi and Regeneron Pharmaceuticals, Inc. ·      The speakers are being compensated and/or receiving an honorarium from Sanofi and Regeneron in connection with this program ·      The content contained in this program was jointly developed by AMJ, the speakers, and Sanofi and Regeneron, and is not eligible for continuing medical education (CME) credits ·      See full US Prescribing Information for dupilumab ·      MAT-US-2412937 v2.0 - Pro1 Expiration Date: 04/21/2026 Speaker disclosures: ·      MC reports research support from the American Lung Association, AstraZeneca, Gala Therapeutics, Genentech, GSK, NIH, Novartis, PCORI, Pulmatrix, sanofi-aventis, Shionogi, and Theravance Biopharma, consultancy fees from Allakos, Amgen, Arrowhead Pharmaceuticals, Blueprint Medicines, Connect BioPharma, Genentech, GSK, Merck, Novartis, OM Pharma, Pfizer, Pioneering Medicines, sanofi-aventis, Teva, Third Rock Ventures, and Verona Pharmaceuticals, speaker fees from Amgen, AstraZeneca, Regeneron Pharmaceuticals Inc., and Sanofi, and royalties from Aer Therapeutics. ·      NLL reports research support paid to institution from Amgen, AstraZeneca, Avillion, Genentech, Gossamer Bio, GSK, Regeneron Pharmaceuticals Inc., Sanofi, and Teva, consultancy fees from and participation on advisory boards with Amgen, AstraZeneca, Genentech, GSK, Novartis, Regeneron Pharmaceuticals Inc., Sanofi, and Teva, travel support from AstraZeneca, and honoraria for non-speaker bureau presentations from AstraZeneca and GSK. References: 1.        Castro M et al. Effect of dupilumab on exhaled nitric oxide, mucus plugs, and functional respiratory imaging in patients with type 2 asthma (VESTIGE): a randomised, double-blind, placebo-controlled, phase 4 trial. Lancet Respir Med. 2025;13:208-20. doi: 10.1016/S2213-2600(24)00362-X.

Send us a textIs an Indian CDMO the right move for your biologics CMC development?Pulling back the curtain on what might be your next strategic manufacturing advantage, this episode reveals the hidden capabilities emerging from India that leading biotech companies are racing to access. As supply chain vulnerabilities continue to expose risks in traditional manufacturing models, could the solution lie halfway around the world?Joining us to reveal the inside story is Abdelaziz Toumi, CEO of Lupin Manufacturing Solutions and veteran of global pharma giants like Bayer, Merck and Lonza. With over 20 years in biotech, Abdelaziz brings unique insights on when and why you might want to look beyond traditional Western manufacturing partners. Our host, David Brühlmann, leverages his 15+ years of biotech industry experience to extract the practical insights you need to make informed decisions about your manufacturing strategy.In this second segment, we'll dive deeper into the Indian CDMO and biomanufacturing landscape. Then we'll explore Lupin's specialized capabilities and finally extract Abdelaziz's most valuable leadership insight from his role as a CEO.Key insights from this episode:The One-Stop Solution Advantage: Discover how Lupin is building rare end-to-end manufacturing capabilities for complex modalities like Antibody-Drug Conjugates (ADCs) - potentially eliminating the headache of managing multiple manufacturing partners across continents.Beyond Labor Cost Advantages: "Digitalization plays a key role, especially if you are operating in a cost-competitive space," explains Abdelaziz. Learn how Indian CDMOs are strategically automating key processes to drive both efficiency and quality, challenging Western perceptions.Leadership Across Cultures: "Listen, listen, listen," emphasizes Abdelaziz when discussing cross-cultural leadership. Understand the subtle communication dynamics that can make or break a global manufacturing partnership, especially when navigating hierarchy-sensitive cultures.Whether you're actively evaluating Indian manufacturing options or simply preparing for the shifting global biotech landscape, these next several minutes deliver insights you can't afford to miss.Listen to the full episode to extract the specific capability indicators that will help you determine if and when an Indian CDMO partnership makes strategic sense for your unique biologics pipeline.Want to find out more about the CDMO selection? Here's what one of our distinguished guests had to say about it:Episodes 103-104: One-Stop Shop vs. Specialist CDMO: A Scientist's Guide to CDMO Selection with Sigma MostafaConnect with Abdelaziz Toumi:LinkedIn: www.linkedin.com/in/abdelaziztoumiLupin Manufacturing Solutions: www.lupin.comNext step:Transform your process development strategy with a complimentary consultation. Schedule your expert session: https://bruehlmann-consulting.com/callReady to scale up? Join our exclusive 1:1 Strategy Call and learn proven methods to reduce development and manufacturing costs while maintaining product quality. Our bioprocess experts will help you navigate complex bioprocessing challenges and regulatory requirements. Limited spots available: https://stan.store/SmartBiotech

What's the difference between Quality by Design (QbD) and Design Controls—and why should you care if you're developing drug-device combination products?In this episode of Let's Combinate, Subhi Saadeh breaks down the key distinctions between QbD, used in pharmaceutical development, and design controls, the regulatory framework guiding medical device design. Learn how these two approaches tackle product realization, why they're not interchangeable, and how both are essential when building safe, effective, and compliant combination products.Whether you work in drug development, medical devices, or the space in between, this episode will help you:-Understand the regulatory foundations of QbD (ICH Q8) and design controls (FDA 21 CFR 820.30)-Learn the core tools and deliverables (like CQAs, QTPP, design verification & validation, and risk assessments)-See how each system addresses user needs, therapeutic effects, and process control-Apply both systems effectively in combination product developmentTimestamps:00:00 – Intro: Why Compare QbD and Design Controls?01:31 – Philosophical Differences: Process vs. Product Control03:10 – Practical Examples: Drugs vs. Devices05:13 – Origins and Frameworks: ICH Q8 and Design Controls Regulation06:46 – Deep Dive: What Are Design Controls? (Inputs, Outputs, DHF, V&V, Transfer)11:51 – What Is Quality by Design (QbD)? (QTPP, CQAs, Design Space, DOE)15:39 – Final Takeaways: How to Use Both in Combination ProductsSubhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.------------------------ICH Q8, Q9, Q10, and Q12ISO 14971 Risk ManagementDifferences between usability engineering and clinical trialsThe role of control strategies and process monitoring in pharmaRelevant for:Regulatory affairs professionalsQuality engineers in pharma and medtechDrug/device development teamsAnyone preparing for combination product submissions or audits

How do we approach a patient with rheumatic diseases who have cycled through multiple high cost drugs? In this pod, Dr Roz Benson, BSR Digital Learning Editor chats with Dr Arti Mahto, a consultant rheumatologist. They talk through some challenging cases discussed in the virtual biologics clinic and the role of the MDT in complex decision making.Thanks for listening to Talking Rheumatology! Join the conversation on X using #TalkingRheum or tweet us @RheumatologyUK.BSR is the UK's leading specialist medical society for rheumatology and MSK health professionals. To discover how we can support you in delivering the best care for your patients, visit our website.

Psoriasis in high impact sites like the scalp, nails, genitals, palms, and soles is challenging. Hear views on living with such difficult to treat areas, and how appropriate treatments offer patient centered care from internationally recognized dermatologist Dr. Andrew Blauvelt, chair of the NPF Medical Board, patient advocates Brittany Murray and Crystal Gatlin, with moderator Corinne Rutkowski. This episode is provided with support from AbbVie. 

Send us a textIs an Indian CDMO the right move for your biologics pipeline?As Western biotech companies seek new strategic advantages, one question keeps surfacing: Is India truly becoming the next biotech manufacturing powerhouse? And what hidden capabilities are emerging that leading companies are racing to access?In this episode of the Smart Biotech Scientist Podcast, Abdelaziz Toumi, CEO of Lupin Manufacturing Solutions and veteran of global pharma giants like Bayer, Merck, and Lonza, joins host David Brühlmann to reveal the inside story on when and why you might want to look beyond traditional Western manufacturing partners.Here are three key insights from their conversation:The Post-Pandemic Manufacturing Revelation: "During the pandemic, we realized how vulnerable our supply chain truly is," explains Abdelaziz. Discover why diversifying manufacturing partnerships isn't just smart—it's becoming essential for resilience in an unpredictable world.Beyond the Cost Advantage: While Indian CDMOs can deliver up to 80% cost savings compared to Western counterparts, Abdelaziz reveals the unexpected advantages that make the most strategic partnerships about far more than budget considerations.The Trust Factor: "This is a business of trust," emphasizes Abdelaziz. Learn the critical questions that separate world-class Indian CDMOs from the rest, and the cultural nuances that can make or break your manufacturing partnership.Ready to discover if Indian CDMOs could be the missing piece in your biologics development strategy? Tune in for expert insights on IP protection, talent access, and how to navigate the cultural dynamics that determine success in this emerging manufacturing powerhouse.Listen to the full episode to unlock the strategic advantage that could transform your pipeline's journey from lab to market.Want to find out more about the CDMO selection? Here's what one of our distinguished guests had to say about it:Episodes 103-104: One-Stop Shop vs. Specialist CDMO: A Scientist's Guide to CDMO Selection with Sigma MostafaConnect with Abdelaziz Toumi:LinkedIn: www.linkedin.com/in/abdelaziztoumiLupin Manufacturing Solutions: www.lupin.comNext step:Transform your process development strategy with a complimentary consultation. Schedule your expert session: https://bruehlmann-consulting.com/callReady to scale up? Join our exclusive 1:1 Strategy Call and learn proven methods to reduce development and manufacturing costs while maintaining product quality. Our bioprocess experts will help you navigate complex bioprocessing challenges and regulatory requirements. Limited spots available: https://stan.store/SmartBiotech

Rinvoq approved for giant cell arteritis; telehealth companies collaborate with Novo Nordisk for Wegovy access; epidermolysis bullosa wound healing treatment approved; Imaavy approved for gMG; New nasal powder approved for migraine treatment.

In this episode of Let's Accommodate Drugs and Devices, host Subhi Saadeh shares four pieces of timeless career advice inspired by Morgan Housel's book, 'Same as Ever'. This episode is particularly aimed at bioengineering students and early-career professionals. The tips include: publishing early to build visibility, understanding how industry regulations and processes work, developing interdisciplinary skills, and finding mentors for guidance. Subhi emphasizes the importance of learning for its own sake and seeking out diverse experiences to enhance one's career prospects in the highly regulated field of bioengineering.00:00 Introduction and Purpose of the Episode00:36 Tip 1: Start Publishing Early04:26 Tip 2: Learn How Industry Really Works06:14 Tip 3: Build Skills Across Disciplines09:00 Tip 4: Find Mentors and Network12:08 Conclusion and RecapSubhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

Is the future of nasal polyp treatment right under our nose? In this episode of Backtable ENT, Dr. Martin Citardi, a world-renowned rhinologist and skull-based surgeon at UTHealth Houston, discusses the latest advancements in the management of nasal polyps with hosts Dr. Gopi Shah and Dr. Ashley Agan.---This podcast is supported by:Medtronic ENT---SYNPOSISDr. Citardi shares insights from his comprehensive career, spanning patient care, device, and drug development. The surgeons discuss the evolving treatment landscape, challenges in managing recurrent nasal polyps, the role of steroids and biologics, and the importance of correctly identifying the type of polyps. Additionally, Dr. Citardi emphasizes the need for a better understanding of healthcare economics, particularly concerning the high costs of new treatments. The discussion also touches on the future of research and the need for a system to deploy treatment options effectively.---TIMESTAMPS00:00 - Introduction04:39 - Nasal Polyps: Patient Presentation and Initial Examination10:25 - Detailed Examination and Endoscopy Techniques17:26 - Imaging and Lab Workup20:11 - Treatment Strategies and Patient Management31:08 - Managing Patients with Allergies, AERD, and Asthma34:09 - Biologics vs. Surgery: A Comparative Discussion42:50 - Steroid Delivery Methods and Their Effectiveness52:24 - Follow-Up, Long-Term Management and Future Research57:01 - Conclusion and Final Thoughts---RESOURCESDr. Martin Citardi's Profile:https://www.utphysicians.com/provider/martin-j-citardi/Medtronic ENT:https://www.medtronic.com/en-us/healthcare-professionals/products/ear-nose-throat

"It's an exciting time. We're not just managing chronic disease. We're reimaging its trajectory" per dermatologist Dr. Mona Shahriari, Central Connecticut Dermatology and NPF Medical Board member as she discusses the latest from the AAD Annual Meeting like head-to-head studies between IL-17 and IL-23 inhibitors, early intervention for psoriasis, use of GLP-1's, new TYK2 and oral IL-23, and high impact sites with moderator Archie Franklin. 

 "The emergence of biologics has really significantly transformed the management of these patients for me." — Dr. Yvonne ChanWhen it comes to nasal polyps, the landscape is shifting fast. On this episode of The Allergist, Dr. Mariam Hanna is joined by otolaryngologist Dr. Yvonne Chan to talk about how biologics, surgery, and multidisciplinary care are working together to reshape care for this stubborn condition. From recognizing key symptoms to navigating the latest therapeutic options, Dr. Chan shares practical insights to help physicians better support patients with nasal polyps.On this episode:How to differentiate nasal polyps from other causes of chronic nasal obstructionWhen imaging should be ordered and what findings are suggestive of polypsThe role of allergy testing and comorbid conditions like asthma and AERDHow biologics have changed the game—and which patients are ideal candidatesWhen surgery is still needed, even in the era of advanced medical therapiesThe importance of long-term follow-up and multidisciplinary collaborationListen now, because when it comes to managing nasal polyps, the right team and the right tools can make all the difference.Visit the Canadian Society of Allergy and Clinical ImmunologyFind an allergist using our helpful toolFind Dr. Hanna on X, previously Twitter, @PedsAllergyDoc or CSACI @CSACI_caThe Allergist is produced for CSACI by PodCraft Productions

How One Leader Came Out of Retirement to Transform Home Healthcare Jasper Freeman, Director of National Accounts at SC Pharmaceuticals, didn't just return to medical sales—he came back with a mission to change it. In this episode, Jasper shares how he helped launch Ferosix, a revolutionary heart failure treatment designed to keep patients out of the hospital and improve care at home. But that's just the beginning. We dive into: The untold story of Pharmacy Benefit Managers (PBMs) and their massive influence over drug pricing and access Why the insurance-sales-patient triangle is the key battleground in healthcare innovation What the U.S. can learn from other countries about lowering costs and improving care Bold reform ideas—from slashing med school tuition to rethinking drug distribution This is a rare, behind-the-scenes look at the business of healthcare, guided by someone who's lived it at the highest levels. If you're in medical sales—or trying to break in—this episode is a masterclass on what's next and how to lead the change. Connect with Jasper: LinkedIn Connect with Me: LinkedIn Love the show? Subscribe, rate, review, and share! Here's How » Want to connect with past guests and access exclusive Q&As? Join our EYS Skool Community today!

Documentation Hierarchy and Best Practices in Quality Systems with Aaron SnyderIn this episode of Let's Combinate, host Subhi Saadeh is joined by Aaron Snyder, the creator of Quality Systems Explained and a seasoned consultant in regulated quality systems. The discussion revolves around the critical role of documentation in quality systems, which serves as the backbone of compliance. Key topics include the hierarchy of regulations, document management best practices, the intricacies of quality manuals, and the critical distinctions between SOPs and work instructions. Additionally, they explore the interconnectedness of document control and training, emphasizing the importance of defined roles and responsibilities within organizations. Listeners are provided with insights into establishing and maintaining effective documentation systems while ensuring adherence to regulatory requirements.00:00 Introduction and Guest Introduction00:37 The Importance of Documentation in Quality Systems01:30 Hierarchy and Structure of Documentation02:44 Standard Operating Procedures (SOPs) vs. Work Instructions11:22 Document Control and Change Management15:52 Roles and Responsibilities in Quality Systems18:20 RACI Matrix and Its Importance20:47 Common Issues in Documentation and Training25:25 Conclusion and Where to Find More InformationAaron Snyder is a quality management systems expert and the founder of Quality Systems Explained. He previously served as VP of QA at Allotex and has held roles at Fresenius Kabi, Molnlycke, Waters Corporation, Covidien, Cardinal Health, and General Electric. With extensive experience across pharmaceuticals, medical devices, and combination products, Aaron is also a member of the AAMI Faculty, teaching several courses on various QMS topics. An avid content creator, he dissects, presents, and teaches QMS and cGMP topics on his YouTube channel, Quality Systems Explained.Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

Today, we continue our review of the Global Initiative for Asthma (GINA) guidelines on asthma. We've covered asthma diagnosis and phenotyping, and the initial approach to therapy. On today's episode we're talking about biologic therapies for asthma and will cover … Continue reading →

Interview with Benjamin N. Rome, MD, MPH, author of Use and Cost of First-Line Biologics to Treat Plaque Psoriasis in the US: Use of and Cost of First-Line Biologics to Treat Plaque Psoriasis in the US. Hosted byAdewole S. Adamson, MD. Related Content: Use and Cost of First-Line Biologic Medications to Treat Plaque Psoriasis in the US

Interview with Benjamin N. Rome, MD, MPH, author of Use and Cost of First-Line Biologics to Treat Plaque Psoriasis in the US: Use of and Cost of First-Line Biologics to Treat Plaque Psoriasis in the US. Hosted byAdewole S. Adamson, MD. Related Content: Use and Cost of First-Line Biologic Medications to Treat Plaque Psoriasis in the US

In this episode, we sit down with Dr. Jeffrey Gross—a former neurosurgeon who has become a leading voice in regenerative medicine. He shares his journey from traditional surgery to cutting-edge biologics, explaining how tools like stem cells, exosomes, peptides, and hormone optimization are transforming patient outcomes. Dr. Gross discusses the limitations of conventional healthcare, the importance of healthspan over just lifespan, and how a functional, root-cause approach is essential for true healing. Whether you're managing chronic pain, exploring anti-aging strategies, or seeking science-backed solutions to avoid surgery, this conversation offers a compelling look into the future of medicine. Connect with Dr. Jeffrey GrossWebsite- https://recellebrate.com/back-pain-doctorInstagram- https://www.instagram.com/ifixspinesChange Life & Destiny is a movement to excite, engage, and educate communities about the importance of taking control of our health and wellness. We highlight the latest and greatest technologies that can restore health, prevent disease, and promote wellness, as well as practitioners who are using cutting-edge technology to help patients take control of their health.Learn more about us here:Website: https://www.changelifedestiny.com/Instagram: https://www.instagram.com/changinglifedestiny/LinkedIn: https://www.linkedin.com/company/changelifedestiny/YouTube: https://www.youtube.com/@changelifedestinyFacebook: https://www.facebook.com/changelifedestinyWant to learn more? Visit our website or follow us on Instagram, Facebook Youtube, and LinkedIn.

After 23 years of being on a biologic drug, Matt has been able to discontinue medications by following the Paddison Program For Rheumatoid Arthritis. Book Your RA Reversal Strategy Session Here https://www.rheumatoidsolutions.com/book-a-call/ 1. Learn how you can reverse your RA symptoms here: https://www.rheumatoidsolutions.com/training-2024 2. Follow me on Instagram to get daily pain-reduction insights: www.instagram.com/paddisonprogram

Understanding GXPs: Essential Good Practices for Bioengineering ProfessionalsIn this episode of Let's Combinate, host Subhi Saadeh, a seasoned bioengineer with ten years of experience in the pharma and medical device industries, provides an in-depth exploration of good practice guidelines (GXPs). Subhi covers various GXPs including GMP (Good Manufacturing Practice), GLP (Good Laboratory Practice), GCP (Good Clinical Practice), and GDP (Good Distribution Practice), explaining their roles, regulations, and importance in ensuring the safety, efficacy, and quality of medical devices and pharmaceuticals. He discusses how these frameworks integrate to form a comprehensive approach that governs the lifecycle of medical products from preclinical research to post-market surveillance. Additionally, Subhi delves into GAMP (Good Automated Manufacturing Practice) and GVP (Good Pharmacovigilance Practice), emphasizing their significance in maintaining data integrity and patient safety. This extended episode aims to provide early professionals with a robust understanding of these critical regulatory standards and their real-world applications in industry.00:00 Introduction to GXP02:22 Understanding GMP: Good Manufacturing Practice09:21 Exploring GLP: Good Laboratory Practices17:57 Diving into GCP: Good Clinical Practices24:00 Ensuring Quality with GDP: Good Distribution Practices29:32 Overview of GVP and GAMP33:48 Conclusion and Final ThoughtsSubhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

In this episode of Let's Combinate, Subhi Saadeh shares personal insights and seven crucial lessons on finding the right mentors in the pharmaceutical and medical devices sectors. Subhi emphasizes the transformative impact mentors have had on his life and career, breaking down the types of mentors one can have, such as teachers, sponsors, and peer mentors. He provides practical advice on lowering your expectations, focusing on value and repetition, being mentor-able, and leveraging non-traditional forms of mentorship, like books and advanced tools. Subbi concludes that mentorship is about being open, curious, and willing to learn from various sources.00:00 Introduction: The Power of Mentorship02:06 Lesson 1: Different Types of Mentors05:04 Lesson 2: Lower Your Bar for Mentors07:51 Lesson 3: Focus on Value and Repetition09:37 Lesson 4: Be Mentor-able11:37 Lesson 5: Look Sideways, Not Just Up12:58 Lesson 6: Don't Wait for a Formal Title15:01 Lesson 7: Mentors Can Be Dead16:41 Conclusion: Recap and Final ThoughtsSubhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.

Alissa Coram and Ed Carson analyze Tuesday's market action and discuss key stocks to watch on Stock Market Today.

The Forbidden Documentary: Doors of Perception official trailer

Discover how ampoule(ampule) drug delivery systems could revolutionize the pharmaceutical industry in this eye-opening video. Learn about the potential impact of this innovative technology on drug administration and patient care.In this episode of 'Let's Combinate Drugs and Devices,' host Subhi Saadeh is joined by Eric Suglalski, Founder and CTO of Archimedic, to discuss the often-overlooked role of ampules in drug delivery. Eric highlights the stability and contamination resistance benefits of ampules, despite the industry's shift towards vials and pre-filled syringes. He elaborates on the time and cost factors that make transitioning to pre-filled syringes challenging for pharmaceutical companies. The discussion also covers Eric's work on the Ampule Filled Syringe (AFS) system, which aims to combine the usability of pre-filled syringes with the stability of ampules. They delve into the historical context of ampules, global usage patterns, and the hurdles faced in implementing ampule-based technologies. Eric invites interested pharma companies to explore potential collaborations with Ampulous.00:00 Introduction and Guest Welcome00:17 The Overlooked Potential of Ampoules02:11 Challenges with Vials and Prefilled Syringes05:01 The Cost and Time Barrier to Prefilled Syringes08:29 Introducing Ampulous: A New Solution10:36 Technical Details of Ampule Filled Syringes14:39 Historical Context and Global Use of Ampoules16:38 Addressing Concerns and Resistance18:01 Human Factors and Usability19:44 Conclusion and Contact InformationEric Sugalski is the Founder and CTO of Archimedic, a contract design and development organization (CDMO) specializing in drug delivery devices and combination products. With over 25 years of experience in medical device development, he has worked extensively on early-stage concept development, human factors engineering, and commercialization strategies. His work spans life-support systems, remote monitoring technologies, and drug delivery devices, with a focus on balancing technical innovation with market viability. In addition to leading Archimedic, he teaches courses on product development, regulatory strategy, and entrepreneurship at institutions like MIT, the University of Pennsylvania, and West Chester University, helping to bridge the gap between engineering education and industry application. Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

Bryan Mazlish is CEO of Surf Bio, a company focused on novel subcutaneous formulations of biologics to enable patients to self-administer these treatments at home. The limitations of subcutaneous administration have historically made time-consuming IV infusions necessary for many biologics. The growing number of biologics and biosimilars in development will further strain the capacity of infusion centers, making subcutaneous administration a way to increase access, reduce healthcare costs, and improve patient adherence. Bryan explains, "Surf Bio is focused on enhancing the ability for patients to take a lot of the innovative and novel biologics that are currently on the market and in development. The vast majority of these historically have required a trip to the infusion center at the hospital, which is quite burdensome and takes a lot of time and resources from the patients and the healthcare system. We focus on creating novel formulations of those same drugs. These biologics can be self-administered at home in seconds instead of requiring a patient to spend the better part of the day commuting to and from an infusion center and sitting in a chair." "When you formulate biologics, they typically are formulated in water and concentrated to very high levels. They become extremely viscous and, consequently, not injectable. So, the ability to inject very high-concentration biologics subcutaneously is limited by the volume that can be administered and the concentration of the biologic that can be squeezed into that volume. As a consequence of this, historically, a large quantity of drug has been diluted at great levels and then dripped into your bloodstream through the intravenous route, which can typically take an hour or, in some cases, multiple hours." #SurfBio #BiologicsDelivery #SubcutaneousInnovation #HealthcareEfficiency surf.bio Download the transcript here

Bryan Mazlish is CEO of Surf Bio, a company focused on novel subcutaneous formulations of biologics to enable patients to self-administer these treatments at home. The limitations of subcutaneous administration have historically made time-consuming IV infusions necessary for many biologics. The growing number of biologics and biosimilars in development will further strain the capacity of infusion centers, making subcutaneous administration a way to increase access, reduce healthcare costs, and improve patient adherence. Bryan explains, "Surf Bio is focused on enhancing the ability for patients to take a lot of the innovative and novel biologics that are currently on the market and in development. The vast majority of these historically have required a trip to the infusion center at the hospital, which is quite burdensome and takes a lot of time and resources from the patients and the healthcare system. We focus on creating novel formulations of those same drugs. These biologics can be self-administered at home in seconds instead of requiring a patient to spend the better part of the day commuting to and from an infusion center and sitting in a chair." "When you formulate biologics, they typically are formulated in water and concentrated to very high levels. They become extremely viscous and, consequently, not injectable. So, the ability to inject very high-concentration biologics subcutaneously is limited by the volume that can be administered and the concentration of the biologic that can be squeezed into that volume. As a consequence of this, historically, a large quantity of drug has been diluted at great levels and then dripped into your bloodstream through the intravenous route, which can typically take an hour or, in some cases, multiple hours." #SurfBio #BiologicsDelivery #SubcutaneousInnovation #HealthcareEfficiency surf.bio Listen to the podcast here

Jeremy Agresti is the Founder and CTO of Triplebar Bio.

Send us a textSickle cell disease, a genetic disorder affecting thousands, presents a daily struggle akin to having shards of glass tearing through one's veins. Despite breakthrough gene therapies approved by the FDA, the prohibitive cost of $2.2 million per treatment limits their accessibility.In the latest episode of the Smart Biotech Scientist Podcast, host David Brühlmann discusses five critical challenges the bioprocessing industry must overcome to make these life-saving therapies accessible to a broader population.Moving Away from Platform TechnologiesTraditional bioprocessing has relied heavily on platform technologies, particularly in the production of antibodies. This conventional method involves cultivating cells in bioreactors, predominantly CHO cells, followed by a series of purification steps. This well-established process is now being disrupted by new modalities that cannot adhere to this template. As the industry progresses, creating flexible and scalable systems compatible with novel therapies becomes essential.Increased Personalization and Smaller Batch SizesThe rise of personalized medicine is another formidable challenge. Treatments like autologous cell therapy, which involves extracting and cultivating the patient's cells before reintroducing them, require highly customized approaches. Each patient essentially represents a batch size of one, making automation difficult and leading to manual, paper-driven processes. This shift from large-scale manufacturing to smaller, lab-like settings demands innovation in bioprocessing equipment and methodologies to maintain efficiency and quality.Cultivating Sensitive CellsAs bioprocessing diversifies, the cultivation of increasingly sensitive cells has become a significant hurdle. Unlike the robust CHO cells, newer cell types require gentler handling and innovative bioreactor designs. Startups like Kolibri, Biothrust, and Green Elephant Biotech are pioneering novel bioreactor technologies to address these needs. From acoustic wave bioreactors to stress-free cultivation conditions and minimal-space cell screws, these innovations aim to provide the optimal environment for sensitive cells to thrive.The Cell as the ProductThe complexity of the products has exponentially grown. While an antibody weighs roughly 150 kDa, a single cell weighs a staggering 10 to the power of 14th Da, making it a billion times more massive. This increase in complexity translates to heightened production challenges, monitoring, and quality control to ensure each cell-based product meets therapeutic standards. The industry must develop refined processes and technologies to manage and scale the production of these intricate cellular products effectively.Accessibility and Cost ChallengesPerhaps the most pressing issue is the prohibitive cost of advanced therapies. Despite the existence of revolutionary treatments for conditions like severe asthma and sickle cell disease, the high price tags render them inaccessible to most patients globally. For instance, in the CAR T cell therapy space, only 21,000 out of an estimated 900,000 eligible patients have received treatment due to financial constraints. Addressing these cost barriers is crucial to expanding the reach of these life-saving therapies.Innovative Approaches and Collaborative EffortsAs discussed in the podcast, industry leaders from academia, small companies, and big pharma are actively seeking solutions to these challenges. Collaborative efforts are essential to drive innovation and reduce manufacturing costs. By focusing on scalable, cost-effective, and high-quality production methods, the industry can move towards wider accessibility of advanced therapies. Ensuring that breakthroughs in bioprocessing translat

In this episode of Let's Combinate, host Subhi Saadeh, a seasoned quality professional, delves into the concept of 'everyone owns quality' and explains why this notion is flawed. Subhi recalls his eye-opening experience with Joanna Gallant's article on quality ownership and discusses the importance of clear accountability within organizations. The episode emphasizes that while all employees play a role in quality, true ownership lies with top management. Subhi also highlights regulatory frameworks like ISO 13485 and 21 CFR 820, noting how they mandate management's responsibility for quality systems. The discussion extends to real-world examples, including the Ranbaxy scandal, to illustrate the dire consequences of poor quality management. The episode concludes with a call to shift the mindset from 'everyone owns quality' to 'leadership owns quality.' 00:00 Introduction to Quality Ownership04:10 Regulatory Frameworks and Quality Management05:14 The Flaws in 'Everyone Owns Quality'06:45 Case Study: Ranbaxy Laboratories08:49 The Importance of a Strong Quality CulturePrevious Episodes:Joanna Gallant: https://www.letscombinate.com/076-gmp-training-competence-human-error-and-mentorship-with-joanna-gallant/Katherine Eban: https://www.letscombinate.com/115-bottle-of-lies-generic-drugs-quality-ranbaxy-audits-and-inspiring-quality-pros-with-nyt-be/Links: ICH Q10: https://database.ich.org/sites/default/files/Q10%20Guideline.pdfISO13485: https://www.iso.org/standard/59752.html21CFR820: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820/subpart-B/section-820.20BBC Article: https://www.bbc.com/news/world-asia-india-22520953Bottle of Lies: https://www.amazon.com/Bottle-Lies-Inside-Story-Generic/dp/0062338781Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.

In the latest episode of The Top Line, Chris Hayden of Fierce Pharma sits down with Mary Lou Glotzbach, senior manager of drug delivery partnerships at Grand River Aseptic Manufacturing (GRAM). They explore the evolving landscape of biologics, the increasing importance of cold chain management, and how contract development and manufacturing organizations (CDMOs) are adapting to industry shifts. Glotzbach highlights a growing trend in biotech: transitioning patient treatments from infusion centers to home delivery. This shift demands innovative drug delivery solutions, including wearable devices and auto-injectors, capable of handling high-viscosity biologics. She also emphasizes the industry's push for smaller batch sizes due to the high cost and complexity of producing biologics, which challenges traditional manufacturing processes. Another key discussion point is the rising demand for transparency and early collaboration between pharmaceutical companies, CDMOs, and device manufacturers. Glotzbach notes that CDMOs are now being brought into the development process earlier than ever, allowing for better alignment on formulation, container design, and regulatory compliance. The conversation also touches on Annex 1 compliance and the need for standardization in primary containers like syringes and cartridges. Glotzbach envisions a future where standardized components streamline production, making drug development more efficient. For anyone interested in the intersection of biologics, manufacturing, and drug delivery innovation, this episode offers valuable insights into how GRAM is helping shape the future of the industry. Tune in to learn more about the latest advancements and challenges in aseptic manufacturing.See omnystudio.com/listener for privacy information.

In this episode of Let's Combinate, host Subhi Saadeh is joined by quality systems expert Aaron Snyder to explore the critical quality system element known as CAPA (Corrective and Preventive Action). They dive into the differences between CAPA approaches in the pharmaceutical and MedTech industries, examining their historical and regulatory contexts. Aaron explains how U.S. regulations describe deviations on the pharma side and non-conforming products on the MedTech side, and how these are handled differently under respective quality systems. The conversation also touches on topics like root cause analysis, verification of effectiveness, and the importance of management support in making CAPA systems effective. Aaron highlights the value of continuous improvement and debunks common misconceptions about CAPA in both industries.00:00 Introduction and Guest Introduction00:33 Understanding CAPA in Pharma and MedTech01:08 Regulatory Differences and Their Implications03:12 Event Handling and Investigation Processes08:13 CAPA System Effectiveness13:57 Quality System Approaches in Pharma and MedTech26:22 Root Cause Analysis and Continuous Improvement30:43 Conclusion and Contact InformationAaron Snyder is a quality management systems expert and the founder of Quality Systems Explained. He previously served as VP of QA at Allotex and has held roles at Fresenius Kabi, Molnlycke, Waters Corporation, Covidien, Cardinal Health, and General Electric. With extensive experience across pharmaceuticals, medical devices, and combination products, Aaron is also a member of the AAMI Faculty, teaching several courses on various QMS topics. An avid content creator, he dissects, presents, and teaches QMS and cGMP topics on his YouTube channel, Quality Systems Explained.Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

Are you confident in managing patients on bisphosphonates or biologics? Which medications increase the risk of medication-related osteonecrosis of the jaw (MRONJ)? How do you decide when to extract a tooth and when to refer to a specialist? In this episode, Jaz is joined by oral surgery consultant Dr. Pippa Cullingham to explore the complexities of MRONJ. They break down the key risk factors, share expert advice on when to proceed with extractions, and discuss the latest guidelines for managing patients at risk. They also discuss the importance of early assessment - by identifying at-risk teeth early, you can help prevent serious complications and ensure the best outcome for your patients. https://youtu.be/KnQoI8Z-FhM Watch PDP215 on Youtube Protrusive Dental Pearl: it is so important to assess patients before they start taking high-risk medications like bisphosphonates or biologics, using radiographs to identify potential issues. Extractions should ideally be done before medication starts to avoid complications, as MRONJ risk increases once treatment begins. Key Takeaways: Medication-related osteonecrosis of the jaw concerns medications other than bisphosphonates. Risk assessment is crucial when considering dental extractions for patients on certain medications. Guidelines from the Scottish Dental Clinical Effectiveness Partnership are valuable resources for dentists. Higher-risk patients require careful management and communication with their medical teams. Denosumab has a different risk profile compared to bisphosphonates. Patients on long-term bisphosphonates may still have risks even after stopping the medication. Dentists should feel empowered to manage certain extractions in primary care with proper guidance. The decision to extract a tooth should weigh the risks and benefits for the patient. Always assess the patient's risk before extraction. Eight weeks is a critical time for assessing healing. Antibiotics are not recommended for preventing MRONJ in the UK. Radiotherapy history significantly impacts extraction risk. Referral to specialists may be necessary for high-risk patients. Highlights of this episode: 02:15 Protrusive Dental Pearl 03:52  Interview with Dr. Pippa Cullingham: Insights and Experiences 06:40 Medications and Their Risks 10:02 MRONJ: Incidence and Prevalence 13:13 Biologics and other medications 14:19 Guidelines and Best Practices 17:22 Managing High-Risk Patients 25:03 Prophylactic Antibiotics  26:55 Risk Assessment 28:47 Radiotherapy & ORN Risk 31:49 Tips and Key Takeaways 33:32 New Medications & Prevention Strategies For the best approach to managing MRONJ, check the SDCEP Guidelines and the American White Paper. This episode is eligible for 0.5 CE credits via the quiz on Protrusive Guidance.  This episode meets GDC Outcomes B and C. AGD Subject Code: 730 ORAL MEDICINE, ORAL DIAGNOSIS, ORAL PATHOLOGY (Diagnosis, management and treatment of oral pathologies) Dentists will be able to - 1. Be aware of the medications that increase the risk of MRONJ. 2. Learn how to assess the risk of MRONJ in patients, particularly before starting high-risk medications. 3. Understand when to proceed with extractions and when to refer patients to specialists for management. If you liked this episode, check out PDP206 - White Patches

With biosimilars entering the market for the treatment of osteoporosis, there is a lot healthcare providers need to know. On this episode, Dr. Alan Low, a Clinical Professor in the Faculty of Pharmaceutical Sciences at the University of British Columbia, Care Director at MedInfuse Health, Primary Care Pharmacist / Pharmacy Lead at BioPro Biologics Pharmacy Clinical and a member of Osteoporosis Canada's Scientific Advisory Council, discusses how biologics and biosimilars work, the benefits of biosimilars and how to speak to patients about these new treatment options.

With a range of treatments available to treat moderate to severe psoriasis, it can be tough to navigate the landscape. Kara Gooding, MMS, PA-C and Joe Gorelick, MSN, FNP-C provide updates on pathogenesis and the latest treatments. Plus, Jayme Heim, MSN, FNP-BC addresses the diagnosis of CSU and Ted Rosen, MD talks about the challenges of diagnosing STIs. Like what you're hearing? Want to learn more about the Dermatology Education Foundation? Explore assets and resources on our website.

Episode Summary: In this episode of NRAP's PainExam Podcast, host David Rosenblum, MD, interviews Dr. Thomas Strouse about his extensive experience with Scrambler Therapy and the evidence supporting its use in treating chronic pain.   They delve into the intricacies of this innovative therapy, discussing treatment protocols, patient responses, and the overall effectiveness of Scrambler Therapy for various pain conditions.    Key Topics Discussed: - Overview of Scrambler Therapy and its analgesic response. - The importance of adjusting treatment intensity based on patient feedback. - Sensations experienced by patients during therapy (from burning to tapping). - Safety considerations for patients with pacemakers during treatment. - Insights into the effectiveness of Scrambler Therapy for conditions such as discogenic back pain and peripheral neuropathy. - Discussion on treatment costs for patients and providers. - Experiences with patients who have experienced pain recurrence after treatment. - The role of booster sessions in maintaining pain relief. -   Challenges faced by failed back surgery patients and the potential benefits of Scrambler Therapy. Resources Mentioned: -   Contact information for Stefan Erickson at  stefan@mail.scramblertherapy.com to integrate Scrambler therapy into your practice.   Links to additional resources and research on Scrambler Therapy. Info] Additional Information: - For more information about upcoming webinars, including the next session on cervical ultrasound, visit  www.NRAPpain.org   Thank you for tuning in to NRAP's PainExam Podcast! We hope you find the insights shared in this episode valuable in your journey toward understanding and managing chronic pain.   NY based anesthesiologist, David Rosenblum, MD, is one of the first interventional pain physicians in the country to integrate ultrasound guidance into his pain practice. Since 2007, he has been an international leader in the treatment of chronic pain. He has helped countless of patients suffering from back, neck, knee, shoulder, hip joint pain and has been at the forefront of regenerative pain medicine, minimally invasive pain therapies and medical education. Patients can schedule a consultation by going to www.AABPpain.com or calling: Brooklyn Office 718 436 7246   Creators Biography: David Rosenblum, MD, currently treats patients in Garden City and Brooklyn. He serves as the Director of Pain Management at Maimonides Medical Center and AABP Integrative Pain Care. As a member of the Department of Anesthesiology, he is involved in teaching, research, CME activities, and was key faculty in developing the anesthesiology residency's regional anesthesia block rotation, as well as institutional wide acute and chronic pain management protocols to ensure safe and effective pain management. He currently is a managing partner in a multi-physician private pain practice, AABP Integrative Pain Care, located in Brooklyn , NY. He is one of the earliest interventional pain physicians to integrate ultrasound guidance to improve the safety and accuracy of interventional pain procedures.    Dr. Rosenblum has been named several times in NY Magazine's Best Pain Management Doctor List, Nassau County's Best Pain Physician, has appeared on NY1 News, and has made several appearances on XM Radio's Doctor Talk. He currently is working closely with the American Society of Interventional Pain Physicians (ASIPP), Eastern Pain Association (EPA), the North American Neuromodulation Society (NANS), World Academy of Pain Medicine United, and various state societies, to support educational events and develop new courses. Since 2008, he has helped over 3000 physicians pass the Pain Management Boards, and has been at the forefront of utilizing ultrasound guidance to perform pain procedures. He now hosts the PainExam podcast, AnesthesiaExam Podcast, PMRExam Podcasts and uses this platform to promote the safe and effective use of ultrasound in the performance of various procedures such as Peripheral Nerve Stimulation, Caudal Epidurals, Selective Nerve Root Blocks, Cluneal Nerve Blocks, Ganglion impar Blocks, Stellate Ganglion Blocks, Brachial Plexus Blocks, Joint Injections and much more!   Doctor Rosenblum is a co-founder of the International Pain Academy and created the NRAP (Neuromodulation Regional Anesthesia and Pain) Academy and travels to teach various courses focused on Pain Medicine, Regenerative Medicine, Ultrasound Guided Pain Procedures and Regional Anesthesia Techniques. Office based Pain Physicians, Physiatrists, Emergency Room Physicians, Anesthesiologists, Neurologists and Orthopedics who treat pain, utilize Neuromodulation and use PRP, Bone Marrow Aspirate or any other Biologics will benefit from this course. #longislandpaindoctor #interventionalpain #paindoctor #scrambler #scramblertherapy

In this episode of Let's Combinate Drugs and Devices, host Subhi Siddhey welcomes Eric Sugalski, founder and CTO of Archimedic. Eric shares insights into the complexities of working as a CDMO, emphasizing the importance of recognizing whether a sponsor company needs overflow capacity or specialized expertise. They discuss common pitfalls, such as companies getting in their own way by misaligning their needs with their outsourcing strategy and the detrimental effects of premature concept lock. Eric highlights the value of giving design firms creative space, the importance of early user research, and the impact of timing and market readiness on project success. He also elaborates on the benefits of open-source quality management systems and hands-on market research to bridge the gap between engineers and users. Together, they explore how to set up projects for success through balanced, well-researched approaches.00:00 Introduction and Guest Welcome00:13 Challenges in Outsourcing for Pharma and Med Device Companies01:04 Importance of Expertise in Outsourcing03:27 Effective Collaboration with CDMOs04:41 Concept Development and Design Requirements05:38 Balancing Innovation and Practicality07:48 Commercialization and Product Development09:57 Understanding User Needs in Design20:47 Advice for Aspiring Engineers25:15 Conclusion and Contact InformationEric Sugalski is the Founder and CTO of Archimedic, a contract design and development organization (CDMO) specializing in drug delivery devices and combination products. With over 25 years of experience in medical device development, he has worked extensively on early-stage concept development, human factors engineering, and commercialization strategies. His work spans life-support systems, remote monitoring technologies, and drug delivery devices, with a focus on balancing technical innovation with market viability. In addition to leading Archimedic, he teaches courses on product development, regulatory strategy, and entrepreneurship at institutions like MIT, the University of Pennsylvania, and West Chester University, helping to bridge the gap between engineering education and industry application.Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

Amy Attaway, MD, hosts the latest ATS Breathe Easy episode with former ATS President Monica Kraft, MD, and Asthma and Allergy Network's Chief Research Officer, De De Gardner, DrPH, discuss the benefits and challenges of biologics for asthma. What factors guide selection of a specific biologic for asthma? When should a patient transition from one biologic to another? 08:15 What does shared decision making mean?09:12 How often does a patient need to take a biologic? 12:58 What if you need to renew your biologic but you've stopped taking your inhaler?21:53 What's a strategy for combining biologics for asthma?

In the second part of this two-part series, we continue our discussion with Drs. Eric Suhler and George Mount regarding the use of biologics for the management of non-infectious uveitis.Disclosures:Dr. Suhler has consulted for Abbvie

Listen to this unique episode that is so good it had to be split into two episodes! Hear our moderators Jeff Brown, LB Herbert, and Kaitlin Walden comment honestly on what it means to live with psoriasis and psoriatic arthritis from the challenge of not knowing what each day brings, feeling confident, coping with fears, medication changes, to advocating for your own health care. It's possible you may feel the same way and learn a few tips too.