Podcasts about generics

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.

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.

Brenden Matthews, a seasoned software engineer, entrepreneur, and author of the Idiomatic Rust and Code Like a Pro in Rust books (both from Manning), speaks with SE Radio host Gavin Henry about Idiomatic Rust. They start with a look at what "idiomatic" means, and then discuss Generics, Traits, common design patterns you'll see in well written Rust code, and anti-patterns to avoid. Matthews suggests some tools that can help you immediately write idiomatic Rust, as well as what building blocks can also help. This episode examines what Generics are and how they compare to other languages, as well as what Traits are, how macros help, what a Fluent Interface is, and why unwrap() is bad. They also discuss what code smells to look out for, Clone, Copy, and a really nice place to go read real-world Idiomatic Rust code. Brought to you by IEEE Computer Society and IEEE Software magazine.

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.

Generics Bulletin editors Dave Wallace and Dean Rudge discuss the latest updates on Stelara (ustekinumab) biosimilars in the US, including recent launches, pricing strategies, and parallels with the biosimilar Humira (adalimumab) experience.

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.

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.

A Super Bowl commercial for weight loss drugs causes an uproar; Adding a familiar amino acid to tuna reduces mercury content; Rethinking epidural shots for back pain; CV Sciences debuts innovative new CBD gummies, drinks. 

Ben Locwin discusses the science, quality, and future of GLP-1 receptor agonists, revolutionary drugs used in diabetes and obesity treatment. The episode explores the history and development of GLP-1s, their commercial viability, manufacturing challenges, and regulatory landscapes. Ben dives into the mechanisms of GLP-1s, including their influence on appetite, blood sugar, and gastrointestinal effects. They also touch on the capacity issues in production, the impact of compounding, and the sustainability concerns associated with injector pens. The conversation provides an in-depth look at the pharmaceutical industry's response to the surge in GLP-1 demand, highlighting the broader implications for patient care and market trends. 00:00 Introduction to GLP Receptor Agonists 00:46 Guest Introduction: Ben Locwin 01:48 Historical Context of GLP-1 Development 05:54 Mechanisms and Effects of GLP-1 09:51 Market Impact and Manufacturing Challenges 11:16 Regulatory and Advertising Considerations 17:44 Sustainability and Injector Pen Issues 19:40 Risk Management and Future Directions 23:31 Conclusion Ben Locwin is a Healthcare Executive, MMA fighter, Jiu Jtisu pro and Quality and Regulatory SME working in medical devices, pharma and other regulated industries. 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.

Join our Patreon to get early access content on our Patreon Discord, our 6 pack twice monthly give away, A PCG Voucher that can be spent once a quater that is the sum of your Patreon subscription and 10% of cards at Thistle Tavern. We also like to do random give aways! https://www.patreon.com/PushThePoint Grade your cards at PCG: https://premiercardgrading.com/ For all your Flesh and Blood singles, head over to Thistle Tavern: Push the Point Patreons receive a 10% discount. https://thistletavern.com/ You can now order Metal Fab Tokens in the UK with Royal Mail postage prices! Just head over to the UK tab on the Metal Fab Tokens website and follow the instuctions! Patreons get early orders before the public! Check out Metal Fab Tokens here: https://metalfabtokens.com

Command Stack discusses massive changes to generic upgrades.

In this episode of Let's Combinate, host Subhi Saadeh interviews Shelly Amster, a trailblazer in reproductive health with over 45 years of experience. Shelly shares her journey from being one of the first IVF lab directors in the U.S. to her role as an advisor at 3 Daughters. They discuss the early days of IVF, overcoming career-related insecurities, and the challenges and advancements in fertility treatments. Shelly also talks about her experience in managing technical conferences and offers advice for early-career professionals. The conversation covers innovative technologies in women's health, particularly in IUD development and surgical advancements. 00:00 Welcome to Let's Combinate 00:13 Pioneering in Reproductive Health 00:42 Early Challenges and Opportunities 02:10 Breaking Barriers in IVF 04:52 Career Reflections and Lessons 06:40 Conference Planning Insights 13:37 Overcoming Shyness and Networking 19:11 Retirement and Career Advice 26:21 Innovations in Women's Health 30:26 Future Technologies and Closing Thoughts Shelley Amster is a trailblazer in reproductive medicine with over 45 years of experience, including being one of the first IVF lab directors in the United States. Currently an advisor at Three Daughters, she has dedicated her career to advancing fertility treatments, IUD development, and surgical innovations in women's health. Shelley is also a seasoned conference organizer and mentor, sharing invaluable insights with early-career professionals in the field. 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.

In this episode of Let's Combinate, host Subhi Sadeh welcomes regulatory expert Doug Mead. Doug, who brings extensive experience in regulatory affairs for medical devices and combination products, discusses the significant role of the 'Drugs at FDA' database in navigating submission strategies. They explore how AI is being used to search through this database efficiently and reveal both the benefits and limitations of AI in regulatory processes. Doug also shares insights into the evolution of FDA's review processes, the importance of validation, and the practical application of AI in regulatory work. 00:00 Welcome and Introduction 00:07 Meet Doug Mead: Regulatory Expert 00:58 Understanding the Drugs at FDA Database 01:25 Navigating Review Memos and Regulatory Strategies 04:18 Challenges and Limitations of the FDA Database 07:23 Advanced Search Techniques and AI Integration 10:58 Developing a Specialized AI Search Tool 14:57 Practical Applications and Client Benefits 33:22 Conclusion and Contact Information Douglass(Doug) Mead is Founder of CP Pathways. He's a highly experienced combination products regulatory expert with more than 40 years of experience in large and small pharma and medical device companies. He has a diverse background in regulatory affairs for drugs and devices, including their design and testing, risk analysis, human factors testing, stability testing, and clinical trial real use patient handling assessments. www.cppathways.com 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. Artificial intelligence in Pharma, AI Pharma, AI Medical Devices, Medical Device AI

Good morning from Pharma and Biotech Daily: the podcast that gives you only what's important to hear in Pharma and Biotech world. Wegovy, a drug by Novo Nordisk, has shown increased weight loss in a phase III trial when given at a high dose, nearly matching the efficacy of Zepbound. Drugmakers like Novo Nordisk and Boehringer Ingelheim are facing pressure in drug price negotiations, with Novo's Ozempic and Wegovy being targeted. Predictions for 2025 deals and fundraising were discussed at JPM, with executives making predictions for the industry. AGC Biologics offers validation before GMP for gene of interest candidates to accelerate timelines. In other news, AstraZeneca gets full FDA approval for a lymphoma treatment, Novartis is trying to prevent copycats as generics gain ground, and Amgen wins colorectal cancer expansion for Lumakras. At JPM25, biopharma deals are starting to flow, with one deal dwarfing last year's activity. Biogen executives are deflecting urgency to make deals at JPM25.

Teva Pharmaceuticals CEO Richard Francis reflects on company performance in 2024, drug pricing, getting more drugs to market and supply shortages of the drug Adderall. He speaks to Bloomberg's Katie Griefeld from the JPMorgan Healthcare Conference.See omnystudio.com/listener for privacy information.

In this episode of 'Let's Combinate,' host Subhi Saadeh delves into the challenges and complexities of working with prefilled syringes in regulatory, quality, and product development settings. Subhi, who has worked on vaccines, biologics, and small molecules in prefilled syringe systems He explores what makes a prefilled syringe a combination product and explains the varying regulatory requirements across different regions, including the US, EU, China, and Japan. The episode emphasizes the importance of understanding these differences to ensure success in product development and market approval. Saadeh also invites viewers to engage and provide feedback in the comments section.00:00 Introduction to Prefilled Syringes01:54 Understanding Combination Products02:32 Regulatory Frameworks for Prefilled Syringes04:59 Global Regulatory Perspectives06:10 Key Takeaways and ConclusionSubhi 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.Pre-filled Syringes: Are They Really Combination Products?Are They Really Combination Products?,are they really combination products?,Is a PFS a Combination Product,https://youtu.be/eq_IEsBflQE,https://youtu.be/eq_iesbflqe,They Really Combination Products,they really combination products,Are They Really Combination,are they really combination,They Really Combination,they really combination,steph curry,Pre-filled Syringes Are They Really Combination,filled Syringes Are They Really Combination,Pre-filled Syringes Are They Really

By viewing ISO 13485 through the lens of interconnected Plan-Do-Check-Act (PDCA) cycles, Subhi offers a fresh perspective that simplifies the implementation of this quality management standard. He explains the structure of ISO 13485, highlighting how each clause aligns with PDCA, and provides practical examples of applying this cycle to different processes within the standard. Subhi emphasizes that ISO 13485 is more than a rule book; it's a guide for continuous improvement and real-world application in the medical device field. 00:00 Introduction to Game-Changing ISO 13485 Insight 01:24 Understanding ISO 13485 as a Guide 02:11 ISO 13485 Structure and Clauses 03:56 Plan, Do, Check, Act (PDCA) Cycle Explained 05:44 Applying PDCA to ISO 13485 Clauses 07:33 Real-World Application and Continuous Improvement 09:10 Conclusion and Call to Action 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.

In this episode, Subhi Saadeh, a seasoned professional in the pharma and medical device industry, shares his insights on whether choosing bioengineering is the right career path. Drawing from his 10+ years of experience, Subhi discusses the differences between bioengineering and biomedical engineering, the pros and cons of studying bioengineering, and how to approach this field in 2025. He emphasizes the importance of technical skills, networking, and adapting to a competitive, fast-paced, and evolving industry. Additionally, Subhi provides practical advice for high school and early college students considering this major, highlighting key skills to develop and strategies to stand out in the field. 00:00 Is Bioengineering the Right Path for You? 00:58 Understanding Bioengineering vs. Biomedical Engineering 03:06 My Personal Journey into Bioengineering 06:00 The Future of Bioengineering Careers 07:48 Pros and Cons of Studying Bioengineering 12:32 How to Succeed in Bioengineering in 2025 15:32 Final Thoughts and Advice 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.

In this episode of Let's Combinate, host Subhi Saadeh discusses the significance of audits as a key appraisal activity and draws parallels with personal self-assessment inspired by Peter Drucker's book, 'Managing Oneself.' He emphasizes the value of understanding one's learning style and values in personal development. Subhi delves into the different types of audits, including internal, second-party, and third-party audits, and explains their unique purposes and importance. The episode highlights the relevance of audits in maintaining quality and compliance in the pharma and medical device industries, while also offering best practices for effective audit management. Subhi invites listeners to use audits as a tool for growth, safety, and success. 00:00 Introduction 00:12 'Managing Oneself' by Peter Drucker 00:55 Key Quotes from the Book 03:33 Connecting Audits to Self-Improvement 04:37 Understanding Audits 06:55 Types of Audits 10:27 Best Practices in Auditing 12:03 Conclusion and Final Thoughts 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.

In this episode of Let's Combinate, host Subhi Saadeh dives into the world of digital transformation in healthcare with Dr. Timothy Aungst, a visionary pharmacist and digital health expert. Dr. Aungst breaks down digital therapeutics, smart drug delivery systems, and wearable technology. He elaborates on the nuances of digitalization, digital transformation, and how these concepts are reshaping the pharmaceutical and healthcare industries. The discussion also touches on the evolving role of pharmacists in a tech-driven healthcare landscape, the impact of AI, and the regulatory challenges in adopting new technologies. 00:00 Introduction to Digital Apothecary with Dr. Timothy Ongst 01:00 Understanding Digital Transformation in Healthcare 03:11 The Evolution of Digital Health and Its Impact 08:23 Future of Healthcare: Expectations and Innovations 13:03 Challenges and Strategies in Pharma's Digital Transformation 20:46 The Role of Digital Tools in Drug Delivery and Adherence 21:19 Challenges of Digital Integration in Healthcare 22:14 Pharmacist's Perspective on Drug Line Therapy 24:04 Clinical and Payer Considerations 25:33 Digital Transformation in Medication Efficacy 30:36 Regulatory Challenges and Bias in Healthcare 36:38 The Role of AI in Digital Health 39:48 Closing Thoughts and Future Outlook Dr. Timothy Aungst is a leading expert in digital health and pharmacy, widely recognized for his work in advancing digital therapeutics, medication adherence technologies, and the integration of health apps into clinical practice. As the voice behind The Digital Apothecary, Dr. Aungst bridges the gap between emerging digital health innovations and the pharmaceutical landscape. His insights provide valuable guidance for healthcare professionals navigating the rapidly evolving intersection of technology and medicine. 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.

Generics Bulletin's editorial team discusses key topics from the year, including the latest rankings of the GB Top 50, Amgen's surprise launch of a US Eylea biosimilar, the EU's Urban Waste Water Treatment Directive and supply-chain issues for the off-patent sector.

In this episode, Charles sits down with TypeScript expert Matt Pocock to dive deep into the world of TypeScript migration, learning curves, and developer challenges. They explore why having a TypeScript "wizard" is crucial for teams transitioning from JavaScript and how TypeScript's integration with development environments like Visual Studio Code has been a game changer.Charles and Matt discuss the importance of real-time typechecking, the community's role in TypeScript's success, and practical strategies for migrating large codebases to TypeScript. You'll hear about Matt's journey from drama school to becoming a DevRel expert, his contributions to the XState library, and his philosophy of type-driven development. Together, they highlight TypeScript's advantages, such as enhanced code reliability and the nuanced benefits of explicit vs. inferred types.Whether you're a seasoned developer or just starting with TypeScript, this episode offers valuable insights and actionable advice to help you harness the full power of static typing in your projects. Tune in for a fascinating discussion that underscores the value of "boring" code, the need for continual learning, and the ongoing evolution of software development practices. Stay with us as we unravel the intricacies of TypeScript and share practical tips to elevate your coding journey.SocialsLinkedIn: Matt PocockBecome a supporter of this podcast: https://www.spreaker.com/podcast/javascript-jabber--6102064/support.

In this episode, Subhi Saadeh delves into the specifics of USP chapters 788 and 790, which focus on the testing and acceptance criteria for sub-visible and visible particles in injectable drug products. He explains the importance of these standards in preventing health risks such as embolisms and allergic reactions. The episode outlines the methods used for testing, including light obscuration and microscopic particle count tests, as well as the required visual inspections for visible particles. Subhi also discusses the differences in scope between USP and ISO standards and emphasizes the critical role of operator training and clean handling practices in ensuring product safety. 00:00 Introduction to Today's Topic: Particles 00:48 Understanding USP and Its Role 02:52 Diving into USP 788: Sub-Visible Particles 05:40 Testing Methods for Sub-Visible Particles 07:00 Acceptance Criteria for Sub-Visible Particles 08:53 Exploring USP 790: Visible Particles 11:12 Inspection Techniques and Practical Considerations 12:50 Conclusion and Wrap-Up 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.

Reducing the cost of prescription drugs has been a bipartisan priority for years. One recent effort is the Preserve Access to Affordadble Generics and Biosimilars Act (S. 142), sponsored by Sen. Klobuchar with the support of Sen. Grassley and others. This bill would give the FTC new authority to investigate settlements between branded and generic drug companies that delay generic/biosimilar market entry and are deemed anticompetitive. The bill proposes allowing the FTC to make factual findings and liability determinations that the district court applies when computing damages. Our expert panel will discuss whether this bifurcated administrative/judicial arrangement can be squared with SEC v. Jarkesy and more broadly discuss issues around patent settlements in the bio/pharma space. Featuring:Matthew S. Hellman, Partner, Jenner & BlockWilliam M. Jay, Partner, Appellate & Supreme Court Litigation, Goodwin Procter LLPProf. Emily Michiko Morris, David L. Brennan Endowed Chair, Associate Professor, and Associate Director of the Center for Intellectual Property Law & Technology, The University of Akron School of LawMatthew D. Rowen, Partner, Clement & Murphy PLLCModerator: Brian Pandya, Partner, Duane Morris LLP--To register, click the link above.

In this episode, Subhi delves into 'Quality is Free' by Philip Crosby, a seminal book in quality management. Highlighting its personal significance, the host discusses the core concept that quality, when properly managed, incurs no extra cost, aligning with prevention rather than fixing issues. The episode dissects five erroneous beliefs about quality, including the idea that quality equates to luxury, that it is intangible and immeasurable, and that quality issues stem from workers or are confined to the quality department. Emphasizing a holistic and preventative approach, the discussion reflects on different quality philosophies and the importance of leadership alignment. The episode concludes by encouraging listeners to read the book themselves for a deeper understanding of quality management principles. 00:00 Introduction to 'Quality is Free' 00:24 The Impact of 'Quality is Free' 01:30 Key Concepts: What We Think We Know is All Wrong 02:23 5 Erroneous Beliefs About Quality 06:26 Measuring Quality: Cost and Prevention 09:09 Quality "Responsibility" in Different Departments 15:02 Aligning Leadership and Quality Management 17:05 Conclusion 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.

In this episode of Let's Combinate, host Subhi Saadeh explores the essential frameworks of risk management in medical devices and pharmaceuticals: ISO 14971 and ICH Q9. He discusses the origins, key elements, similarities, and differences of these standards and guidelines, explaining their application in the development and manufacturing of combination products. Saadeh also highlights the definitions of risk, historical developments, and updates in these frameworks, particularly ICH Q9's recent refinements on managing subjectivity and the formality of risk assessments. The episode compares the structured approach of ISO 14971, focused on patient safety through the entire lifecycle of medical devices, with the broader risk management scope of ICH Q9, which encompasses various elements within the pharmaceutical process. Saadeh provides insights into specialized tools, the concept of state-of-the-art, and the importance of verification of implementation and effectiveness in risk management plans. Listeners from regulatory, quality, product development, and risk management fields will gain a comprehensive understanding of balancing these crucial frameworks for combination products. 00:00 Introduction to Risk Management 00:21 Understanding ISO 14971 and ICH Q9 01:02 Key Elements and Differences 01:35 Deep Dive into ISO 14971 05:08 Deep Dive into ICH Q9 08:53 Comparing Risk Management Tools 14:21 Combination Products and Risk Management 18:34 State-of-the-Art and Residual Risks 21:35 Verification and Effectiveness 22:50 Conclusion and Final Thoughts 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.

In this episode of *Let's Combinate*, Subhi delves into the critical distinctions between drug tech transfer and device design transfer, especially pertinent to combination products. Sue comprehensively outlines the regulatory frameworks governing each process—ICH Q10 for drug transfer and ISO 13485 for device design transfer. The episode discusses key elements like analytical method transfer and process validation for drugs, and the DHF and risk management in device design. Subhi looks into the differing complexities, regulatory submissions, and validation requirements for both processes. The episode concludes with commercializing combination products, emphasizing project management, regulatory submissions, and post-market surveillance. 00:00 Introduction to Combination Products 00:55 Understanding Drug Tech Transfer 04:04 Exploring Device Design Transfer 08:49 Key Differences Between Drug and Device Transfers 14:30 Commercialization of Combination Products 17:54 Conclusion and Final Thoughts 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.

A generic drug is a medication created to be the same as an already marketed brand-name drug in dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use. In other words, you can take a generic medicine as an equal substitute for its brand-name counterpart. Clicks customers are increasingly opting for generic medicine driven by lower prices as the group plans an aggressive rollout of pharmacies next year, including specialised 24-hour pharmacies. Generics include not only Clicks branded products but also those from other pharmaceutical companies. In the year to August, sales from generics grew 10% and made up 59% of pharmacy sales by value and 69% of volume. Pharmacy sales for the year to August rose  8.9% to R9.7bn...See omnystudio.com/listener for privacy information.

Million Bazillion listener Kade wants to know why brand-name products cost more than store-brand and generic products. Bridget and Ryan head to a grocery store where they meet a talking can of soup in need of a brand makeover. In this episode, they learn the differences between brand-name products and generics, why we care about brands, and why they’re more expensive. If your family is interested in learning more about the difference between brand names and generics, check out the page for this episode at our website. We’ve got discussion questions and tips! This episode is sponsored by Greenlight. Sign up for Greenlight today at greenlight.com/million.

Million Bazillion listener Kade wants to know why brand-name products cost more than store-brand and generic products. Bridget and Ryan head to a grocery store where they meet a talking can of soup in need of a brand makeover. In this episode, they learn the differences between brand-name products and generics, why we care about brands, and why they’re more expensive. If your family is interested in learning more about the difference between brand names and generics, check out the page for this episode at our website. We’ve got discussion questions and tips! This episode is sponsored by Greenlight. Sign up for Greenlight today at greenlight.com/million.

Million Bazillion listener Kade wants to know why brand-name products cost more than store-brand and generic products. Bridget and Ryan head to a grocery store where they meet a talking can of soup in need of a brand makeover. In this episode, they learn the differences between brand-name products and generics, why we care about brands, and why they’re more expensive. If your family is interested in learning more about the difference between brand names and generics, check out the page for this episode at our website. We’ve got discussion questions and tips! This episode is sponsored by Greenlight. Sign up for Greenlight today at greenlight.com/million.

In this episode, host Subhi reflects on three years of podcasting, drawing analogies to strength training and discussing the incremental progress achieved. The episode highlights the importance of consistency in podcast production, inspired by Robert Greene's 'Mastery,' and outlines plans for the show's future evolution. 00:00 Welcome and Podcast Journey 00:39 Strength Training Analogy 02:10 Reflecting on Three Years 04:11 Significant Life Update 05:46 Lessons Learned and Trusting Others 07:37 Podcasting Process and Scheduling 10:34 The Challenges of Editing 11:21 Finding the Right Tools 12:11 Promotion and Growth 12:56 Consistency and Sustainability 13:07 Starting a Podcast: Advice and Reflections 15:52 The Future of the Show 20:12 Engaging with Listeners 21:12 Final Thoughts and Farewell 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.

Join us each week as we do a quick review of three compelling stories from the pharma world — one good, one bad and one ugly. Up this week:   The good — Gilead inks deal with generics manufacturers to expand HIV drug access  The bad — J&J announces layoffs at New Brunswick headquarters  The ugly — Amgen sued for hiding $10.7B tax bill 

Generics Bulletin's editorial team discusses recent conferences held by Medicines for Europe and the AAM, while looking ahead to the key off-patent industry events on the calendar over the next few months and beyond.

This episode is a cross-post of an interview I did with Etienne Nichols over at the Global Medical Device Podcast at GreenLight Guru(Episode #380). In this episode, Etienne and I discuss: 02:50 The Start of the Combinate Podcast 06:00 Efficiency and Tools in Podcast Production 08:40 Understanding Combination Products 09:43 Regulatory Frameworks and Definitions 13:46 Challenges and Misconceptions in the Industry 20:47 Evolution of Regulations: QMSR and Part 4 22:05 Exploring Unique Podcast Episodes 25:56 The Pyramid of Regulations 30:40 The Role of Coaching and Mentorship 32:59 Trends in Combination Products 35:23 Recommended Books and Final Thoughts 37:04 Encouragement for Lifelong Learning Subhi Saadeh is a Quality Professional and host of the Combinate Podcast. 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. Etienne Nichols is a Medical Device Guru and Mechanical Engineer who loves learning and teaching how systems work together. He has both manufacturing and product development experience, even aiding in the development of combination drug-delivery devices, from startup to Fortune 500 companies and holds a Project Management Professional (PMP) certification. Having managed cross-functional teams to update designs of legacy products, Etienne understands the pain of following the Design Controls process in paper-based QMS environment. His expansive knowledge, experience, and passion with medical devices is evenly matched with how much he enjoys helping customers work efficiently through the design and development process to bring safe, high quality products to market

Links from the show:State of Generics and Collections — The PHP Foundation — Supporting, Advancing, and Developing the PHP LanguageGenerics in PHP??? - YouTubeCherry pick a commit to a different branch in any JetBrains IDE - YouTubeTo double quote or not, that's the question! - DEV CommunityI just crossed $1 million on GitHub Sponsors.

Walmart offers up to a 30-day supply of over 300 different generic medications for $4 per prescription. They also offer a 90-day supply of many generic medications for $10. These prices do not apply to prescriptions filled by mail order. Prescriptions refills may be ordered online or by telephone, but Read More Shared by United Resource Connection August 9, 2024

Welcome to episode 049 of Life Sciences 360.In this episode of Life Sciences 360, host Harsh Thakkar welcomes Jesse Mendelsohn, Senior Vice President at Model N. Jesse delves into the intricacies of revenue optimization and compliance within the pharmaceutical industry. He shares insights on how Model N's platform aids pharmaceutical companies in navigating complex pricing, regulatory challenges, and government negotiations.Chapters :0:00 - Introduction1:30 - Welcoming Jesse Mendelsohn2:00 - Jesse's Journey with Model N6:00 - Evolution of Pharma Pricing and Compliance8:30 - Challenges in Commercial Contracting12:00 - Regulatory Side of Pharma Pricing14:30 - Impact of Government as a Major Drug Purchaser16:00 - Inflation Reduction Act Overview19:00 - Medicare's Right to Negotiate Drug Prices21:00 - Aftershocks of the Inflation Reduction Act23:30 - Key Takeaways for Pharma Executives26:00 - Impact on Drug Development Strategy28:00 - Generics and Biosimilars Market Impact30:30 - Positive Outcomes of the Inflation Reduction Act32:00 - What's Next for Model N36:00 - Importance of Accurate Data in Pricing38:30 - Closing Remarks and Connect with Jesse----- Links:* Jesse Mendelsohn LinkedIn (https://www.linkedin.com/in/jessedm/)* Model N LinkedIn (https://www.linkedin.com/company/modeln/)* Model N website (https://www.modeln.com/)*Harsh Thakkar LinkedIn ( https://www.linkedin.com/in/harshvthakkar/  )*Listen to this episode on the go!

Generics Bulletin's editorial team discusses the latest strategic developments for major industry players Teva, Sandoz and Sawai, as well as explaining the recent debate over US patent listings in the FDA's Orange Book.

First generics of heart failure drug gain approval; mRNA vaccine approved for RSV; CDC make drug recommendation for STI prevention; Advisory Committee vote on MDMA for PTSD; Rinvoq approval expanded

This is a solo episode. On this episode, Subhi goes through: 01:51 Draft FDA Guidance - Platform Technology Designation Program for Drug Development Guidance for Industry 13:03 EMA Guidance - Questions & Answers for applicants, marketing authorisation holders of medicinal products and notified bodies with respect to the implementation of the Regulations on medical devices and in vitro diagnostic medical devices (Regulations (EU) 2017/745 and (EU) 2017/746) 18:25 USP - USP-Listed Device Monographs and Recommendations for Product Quality and Performance Testing of the Drug Component of Combination Products 20:10 Race Recap: Sugar Badger 50K 26:51 Conclusion Subhi Saadeh is a Quality Professional and host of the Combinate Podcast. 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. Subhi is an Ironman Triathlete and a Marathoner/Ultramarathoner.

2024 Global Generics & Biosimilars Awards by Citeline

Are generics for fingolimod as effective as the non-generic formulation? Find out about this and more in today's PV Roundup podcast.

The global ag sector has recently passed a turning point, with prices and future outlooks for key commodities taking a decidedly pessimistic turn. Though market volatility is nothing new for producers, it does change the profitability equation. One of the first targets for pencil-sharpening and scrutiny tends to be farm inputs– from crop protection chemistry and fertilizers, to equipment purchases and agtech investments. To get us up to speed on the state of global farm input markets, and how growers are likely thinking about planning and practice adjustments in the months and years ahead, we sat down with Sam Taylor, Farm Inputs Analyst and Executive Director for Research at Rabobank. For more information and resources, visit our website. The information in this post is not investment advice or a recommendation to invest. It is general information only and does not take into account your investment objectives, financial situation or needs. Before making an investment decision you should read the information memorandum and seek financial advice from a professional financial adviser. Whilst we believe Information is correct, no warranty of accuracy, reliability or completeness.

Pediatricians, families, and pharmacists are faced with increasing drug costs and a vast array of complex biologic therapies. Up-to-date knowledge on prescribing practice is constantly a need, specifically regarding generics and the availability of biosimilar and interchangeable biosimilar agents. According to a report from the Association for Accessible Medicines, the U.S. healthcare system saved $408 billion from using generic and biosimilar drugs in 2022, a huge jump from the $195 billion in savings accumulated in 2013. In today's episode, we have a rare opportunity to learn critical knowledge about this topic from renowned experts in the field.  We are joined by John Routt Reigart, MD, and Dr. Siu. Dr. Reigart is professor emeritus at the Medical University of South Carolina as well as the chairperson for the American Academy of Pediatrics' (AAP) Committee on Drugs. “I have been recognized in my state, and to some extent nationally, as being an advocate for improved health for children. I feel that it's very important that pediatricians be advocates for effective regulations for their patients,” Dr. Reigart says.  Dr. Siu is a clinical professor, the vice chair for teaching and learning, and the director of faculty mentoring at the Ernest Mario School of Pharmacy at Rutgers University. She is a pediatric pharmacy clinical coordinator and practices at the K. Hovnanian Children's Hospital and Jersey Shore University Medical Center. She has also been appointed to the board of directors of the Board of Pharmacy Specialties and the pediatric pharmacy association liaison for the AAP Section on Clinical Pharmacology and Therapeutics executive committee. “We want to make sure that medications are easily accessible to families and we also want to make sure that they are also cost effective,” Anita Sui, PharmD, says.  This episode was recorded at the 2023 American Academy of Pediatrics National Conference and Exhibition. Some highlights from this episode include:  The difference between biologics and generics  What the orange and purple books are and their roles in the industry  What an interchangeable product is  Patents and exclusivity  What savings could look like with an uptick of biologics and generics    For more information on Children's Colorado, visit: childrenscolorado.org    

Living well with MS means learning to plan ahead. And, while planning ahead may not solve every issue that crosses your path, taking time to understand some of the details and making the right choices when it comes to your health insurance can make a huge difference in your MS care and treatment. MS Navigator and insurance resources specialist Carla Turechek joins me to share strategies for successfully navigating the health insurance maze with a minimum number of "surprises." We're also sharing study results that can help you get the most benefit from your everyday physical activity. We'll introduce you to an early-stage biotech company that just secured funding to develop three novel therapies that will address myelin repair and neuroinflammation. We'll share study results that show that a high level of a protein in the blood is a reliable predictor of future disability progression among people living with progressive MS. We're sharing some eye-opening discount prices from the Mark Cuban Cost Plus Drug Company for generics for three different disease-modifying therapies. And, speaking of generics, we'll explain why you can buy the generic for Tecfidera in the United States today, but it won't be available in Europe until next year, at the earliest. We have a lot to talk about! Are you ready for RealTalk MS??! This Week: Successfully navigating the health insurance maze  :22 STUDY: The benefit of physical activity lies in step rate and not step count  1:42 Myrobalan Therapeutics secures financing to develop 3 therapies that address myelin repair and neuroinflammation  3:47 STUDY: High levels of a protein in the blood may predict disability progression in people with primary progressive MS  5:41 You'll want to check out the prices of generics for 3 disease-modifying therapies at Mark Cuban's Cost Plus Drug Company  8:50 Generics for Tecfidera have been delayed at least one year in Europe  10:47 MS Navigator and insurance resources specialist Carla Turechek shares strategies for maximizing your health insurance benefits and minimizing your costs   12:03 Share this episode  26:46 Have you downloaded the free RealTalk MS app?  27:07 SHARE THIS EPISODE OF REALTALK MS Just copy this link & paste it into your text or email: https://realtalkms.com/334 ADD YOUR VOICE TO THE CONVERSATION I've always thought about the RealTalk MS podcast as a conversation. And this is your opportunity to join the conversation by sharing your feedback, questions, and suggestions for topics that we can discuss in future podcast episodes. Please shoot me an email or call the RealTalk MS Listener Hotline and share your thoughts! Email: jon@realtalkms.com Phone: (310) 526-2283 And don't forget to join us in the RealTalk MS Facebook group! LINKS If your podcast app doesn't allow you to click on these links, you'll find them in the show notes in the RealTalk MS app or at www.RealTalkMS.com STUDY: Free-Living Ambulatory Physical Activity and Cognitive Function in Multiple Sclerosis: The Significance of Step Rate vs Step Volume https://pubmed.ncbi.nlm.nih.gov/38214757 Myrobalan Therapeutics  https://myrotx.com STUDY: Serum Glial Fibrillary Acidic Protein and Disability Progression in Progressive Multiple Sclerosis  https://onlinelibrary.wiley.com/doi/10.1002/acn3.51969 The Mark Cuban Cost Plus Drug Company https://costplusdrugs.com Join the RealTalk MS Facebook Group https://facebook.com/groups/realtalkms Download the RealTalk MS App for iOS Devices https://itunes.apple.com/us/app/realtalk-ms/id1436917200 Download the RealTalk MS App for Android Deviceshttps://play.google.com/store/apps/details?id=tv.wizzard.android.realtalk Give RealTalk MS a rating and review http://www.realtalkms.com/review Follow RealTalk MS on Twitter, @RealTalkMS_jon, and subscribe to our newsletter at our website, RealTalkMS.com. RealTalk MS Episode 334 Guest: Carla Turechek Privacy Policy