Podcasts about biologics

About a week ago, we published an episode on this program detailing how two Chinese nationals (a researcher at the University of Michigan and her boyfriend) were caught by the FBI trying to smuggle in a dangerous pathogen into the United States—a type of deadly fungus that can target crops.And we ended that episode by considering out loud: How many other Chinese researchers here in the United States are possibly doing the same thing?And wouldn't you believe it, within a week, another Chinese researcher, also from the University of Michigan, also at the Detroit Metropolitan Airport, was also caught by the feds for trying to smuggle in biological material. Although this time, it wasn't a fungus—it was instead a type of roundworm.And perhaps the best part of it all—which was probably more coincidence than anything—was that this Chinese scholar came here from everyone's favorite city: Wuhan, China.Let's go through the details together.

What if your body had built-in tools to regenerate itself but you've been looking in the wrong places? Dr. Khoshal Latifzai reveals overlooked therapies like peptides, shockwave, stem cells, & ketamine that go beyond symptom masking. He explains how athletes & longevity seekers use diagnostics, fasting, & advanced biologics to stay ahead of aging & feel better, faster. Meet our guest Dr. Khoshal Latifzai is a Yale-trained, board-certified emergency physician who founded Rocky Mountain Regenerative Medicine to focus on prevention, longevity & performance. Inspired by his humanitarian work & experience in critical care, he blends advanced biologics, hormone optimization & regenerative therapies to treat pain, enhance vitality & extend healthspan. His personalized approach serves athletes, executives & anyone seeking to thrive at every stage of life. Thank you to our partners Outliyr Biohacker's Peak Performance Shop: get exclusive discounts on cutting-edge health, wellness, & performance gear Ultimate Health Optimization Deals: a database of of all the current best biohacking deals on technology, supplements, systems and more Latest Summits, Conferences, Masterclasses, and Health Optimization Events: join me at the top events around the world FREE Outliyr Nootropics Mini-Course: gain mental clarity, energy, motivation, and focus Key takeaways Track biomarkers regularly through frequent, detailed bloodwork to personalize health strategies & catch negative effects early Cycle medications & supplements like peptides & metformin to prevent tolerance & maintain effectiveness Personalize metformin use since benefits, dosing & side effects vary Use low-dose rapamycin for potential longevity benefits, monitoring closely with regular biomarker testing Go beyond standard panels by checking ApoB, Lp(a) & homocysteine for better insight into cardiovascular risk Question outlier biomarkers like A1C by considering factors such as red blood cell lifespan before making assumptions Use ketamine therapy under supervision to address depression & anxiety when conventional treatments fall short Trigger targeted repair in joints or tissues using shockwave therapy to activate local stem cell healing Bank stem cells early while they're younger & more effective to improve outcomes for future injuries or illnesses Support stem cell health with regular fasting, exercise & optimized metabolic function to maintain potency with age Episode Highlights 09:39 Metformin & Rapamycin for Longevity 16:53 Underrated Biomarkers & Diagnostics 24:23 Ketamine Therapy for Brain Remodelling 45:30 Shockwave & Stem Cell Therapy Deep Dive   Links Watch it on YouTube: https://youtu.be/UbA4DzzNqN0  Full episode show notes: outliyr.com/214 Connect with Nick on social media Instagram Twitter (X) YouTube LinkedIn Easy ways to support Subscribe Leave an Apple Podcast review Suggest a guest Do you have questions, thoughts, or feedback for us? Let me know in the show notes above and one of us will get back to you! Be an Outliyr, Nick

Having Generalized Pustular Psoriasis (GPP) can steam roll your life. Hear how dermatologist Dr. Oanh Lauring and patient advocate Jordan Hicks overcame the challenge of recognition to treating this rare form of psoriasis. GPP is far more than just psoriasis. Recognition of this form of psoriasis with a unique cytokine presents challenges when symptoms are not so apparent and confusing. Join host Alan Simmons as he dives into the diagnosis journey, and treatment from acute to chronic flares with dermatologist Dr. Oanh Lauring, and what it means to live and stand up for yourself with GPP with Jordan Hicks. This episode offers a heartfelt look at life with generalized pustular psoriasis (GPP) and the value of standing up for your health. Join GPP Awareness Day in August. Timestamps: ·       (0:00)          Intro to Psound Bytes & guest welcome dermatologist                          Dr. Oanh Lauring and patient advocate Jordan Hicks. ·       (1:08)          Jordan's diagnosis journey with generalized pustular                             psoriasis (GPP). ·       (2:37)          What is generalized pustular psoriasis and Dr. Lauring's                         first encounter with GPP. ·       (8:00)          How GPP is different from plaque psoriasis but they can                      coexist together. ·       (9:53)          Treatment of acute GPP flares vs ongoing flare                                         management. ·       (12:29)       The impact of GPP on Jordan's life. ·       (13:22)        How to support those who live with GPP in the clinic                             setting and their mental health. ·       (15:24)        Tips for working with other specialists in management                         of  GPP. ·       (17:30)        Feelings associated with being diagnosed with GPP. ·       (20:43)        Being a self-advocate is important to your healthcare                             journey. ·       (22:18)        If you have GPP, you are not alone. Initiation of GPP                              Awareness Day. 4 Key Takeaways: ·       Diagnosis of generalized pustular psoriasis can take time given its confusing presentation in the early stages but can shift rapidly to urgent care when in the acute phase of the disease. ·       Generalized pustular psoriasis and plaque psoriasis are distinct forms but can coexist together. 50% of patients with GPP also have plaque psoriasis. ·       The impact of living with GPP is significant and finding support from those who understand, including health care providers, is critical to treating and coping with the disease. ·       If you have GPP be a strong advocate for your health and your self-worth. Your symptoms are valid and you deserve to be heard. Guest Bios: Dr. Oanh Lauring is a board-certified dermatologist in private practice at Lauring Dermatology where she provides the utmost care and expertise for patients with serious skin diseases such as psoriasis that impact the skin, scalp, hair, and nails. She offers a variety of the latest medical treatments including generalized pustular psoriasis to help her patients achieve a natural and refreshed appearance. Jordan Hicks took her health into her own hands. She moved from a small Texas town to Las Vegas in order to obtain care for her generalized pustular psoriasis or GPP. Once there she found her community and learned to speak up for herself and others. Jordan and her dog have been active advocates for GPP and Psoriasis ever since. Resources: Ø  Find Support through GPP Circles and others who understand what it means to live with GPP https://www.psoriasis.org/gpp-circles/   Ø  Join us to create awareness for the first GPP Awareness Day August 13, 2025. Request your tool kit.     https://www.psoriasis.org/gpp-toolkit/

Who/When to Treat Clinically Suspect Arthralgia Thoughtful, Effective RA Care Should be Guided by Need —Not Age The Impact of Biologics on Methotrexate Adherence Jokes Aside: The Impact of Laughter in RA JAK Safety Update Why is RA Difficult to Treat? DMARD Combinations in RA Treatment Increased Risk of VTE in RA: Lessons Learned from 40 Years of Data ALTO: Long-term Outcomes of APIPPRA

Seronegative Arthritis Breakthroughs Jokes Aside: The Impact of Laughter in RA The Impact of Biologics on Methotrexate Adherence Thoughtful, Effective RA Care Should be Guided by Need —Not Age Sonelokimab in PsA Using Combination csDMARDs in PsA

Host Liz Edwards and Dr. Michael Norvell provide an overview of biologics in this episode of "Let's Clear the Air!"  The Allergy, Asthma & Sinus Center began using biologics for asthma in 2010. Since then, biologics have been on a fast path of development. These molecularly engineered products operate on a very small scale and are different from typically prescribed or over-the-counter medicines, which use chemicals to initiate a physical response.  Listen to learn more about the superior safety profiles of biologics, their multiple uses within the allergy and asthma specialty, and their proven effectiveness. 

If you've ever wondered what a combination product is—or how to explain it—this video breaks it down clearly and simply. This is a non-technical, high-level explanation of what a combination product is. It's meant for anyone who works in or around pharma, medtech, or biotech and wants a clear, shareable reference—without getting into detailed regulatory definitions or region-specific nuances.I'm Subhi Saadeh, and I've spent my career in drug-device combination products. In this short reference video, I walk through:- What defines a combination product- Two key factors: primary mode of action and how components are combined- The difference between drug-led and device-led products- Examples of single-entity, co-packaged, and cross-labeled products00:00 Introduction to Drug Device Combination Products00:31 Defining Combination Products00:54 Philosophical Factors of Combination Products01:10 Drug-Led Combination Products01:51 Device-Led Combination Products02:32 Combination Configurations03:50 Summary and ConclusionAdditional Resources: - 21 CFR Part 4 FDA regulation on Current Good Manufacturing Practice (CGMP) requirements for combination products https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-4- FDA Guidance: Current Good Manufacturing Practice Requirements for Combination Productshttps://www.fda.gov/media/90652/download- FDA Combination Products Overview Page https://www.fda.gov/combination-products- 21 CFR Part 3 Regulations on combination product classification and primary mode of action (PMOA) https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-3- EU MDR Article 117 Requirements for drug-device combinations under the European Medical Device Regulation (Regulation (EU) 2017/745) https://health.ec.europa.eu/system/files/2021-10/md_mdr_2017-745_en_0.pdfSubhi 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.

Why is autoimmune disease in menopause becoming more prevalent? And why are college-age patients a growing autoimmune demographic?  In your 60s, when the world is thinking of retirement, would you ever consider being a founder of a new business instead of spending days on the golf course or traveling?  Answers to the increase in autoimmune disease in menopause and more in this special episode I think you may find both alarming and fascinating; both a shot of reality and hope.    My Guest: Dr. Bonnie Feldman, 69, Co-founder and Chief Patient Officer of Rheumission, is an entrepreneur, health practitioner, researcher, financial analyst, digital health advisor and autoimmune patient and advocate.  Since 2010, Dr. Feldman integrates digital tech, virtual-first care, and lifestyle interventions with conventional care to improve outcomes for autoimmune patients. She spent the past decade raising awareness of the underserved and growing autoimmune market opportunity for private investment. Her experience as an autoimmune patient have fueled Bonnie's passion for prevention, earlier diagnosis and improved care for all autoimmune patients.   Questions We Answer in This Episode: [00:04:50] Tell me about your own journey - why become a startup founder at an age (now 69) that most people are already in retirement? [00:09:16] What are autoimmune diseases? [00:13:18] What do people not understand about autoimmune disease? [00:18:21] Why do you say that autoimmune disease is a women's health crisis? [00:22:39] What is fundamentally wrong and needs to change in the way autoimmune patients are treated and diagnosed? What are doing to change this? [00:24:42] What is biologics? What are the negative side effects of biologics?  [00:33:04] What is the legacy you hope to leave (for your 10 grandchildren)?   Know if You May Have Autoimmune Disease in Menopause   What is Autoimmune Disease? Old Definition When the immune system attacks itself. 100 different kinds e.g. multiple sclerosis, rheumatoid arthritis, psoriatic arthritis, all sort of colitis and Crohn's New Definition Now includes the inflammatory spectrum and autism spectrum   Autoimmune Disease Is a Women's Health Crisis 80% of autoimmune patients are women, around 40 million people Hormones influence during puberty, pregnancy, menopause Late-onset autoimmune diagnoses are on the rise. The biggest growth is in young adult women who are college age.   Treatment for an Autoimmune Disease Patient Conventional Medicine The patient sees different kinds of specialized doctors that do not necessarily talk to each other (e.g. dermatologists, rheumatologists, etc.) Rheumission A Care Team is provided under one virtual roof with access to the patient digitally 24/7 if needed. This includes lifestyle medicine physician, an autoimmune psychologist, an autoimmune dietitian, an exercise program, and a care coordinator. Uses lifestyle medicine as the first lever of defense like diet, sleep, psychological, etc. Medicines are used in the lowest dose when needed.   Connect with Dr. Bonnie: Dr. Sharon's Website - Rheumission Facebook - rheumission Instagram - @rheumissionhlth YouTube - @rheumission   Other Episodes You Might Like: Previous Episode - Supplements I Take in Menopause Next Episode - What's Best Total Body or Split Routine in Menopause More Like This - How to Have and Still Thrive with Autoimmunity in Menopause   Resources: GYROTONIC® Feldenkrais Gait Therapy Pelvic Floor Therapy Short & Easy Exercise videos in this 5 Day Flip Challenge. Don't know where to start? Book your Discovery Call with Debra.  

Clip taken from Raised By Giants episode titled "Roswell 1947, Extraterrestrial or Interdimensional? & Cryptozoology with Tom Carey” link to full episode here: https://youtu.be/AIuLF2GXgOkRaised By Giants LInkTree: https://linktr.ee/raisedbygiantspod

You've heard it before: If it's not documented, it didn't happen. But in life sciences, documentation isn't just a formality—it's the foundation of trust, compliance, and product quality. In this episode, Subhi Saadeh breaks down what documentation actually means by exploring the principles of ALCOA and ALCOA+.Learn where these principles come from, how they're applied, and why they still matter—even in today's digital systems. From FDA guidances to $500M data scandals, this episode covers what goes wrong when data integrity isn't taken seriously.⏱️ Timestamps:00:00 – Introduction: Why Documentation Still Matters01:24 – Defining Data Integrity in Regulated Industries03:06 – ALCOA Explained: Attributable, Legible, Contemporaneous, Original, Accurate07:18 – ALCOA Plus: Complete, Consistent, Enduring, Available08:54 – Real-World Examples: From Whiteout to Warning Letters11:00 – Why Old SOPs Can Ruin New Inspections12:21 – Final Thoughts: Documentation Is About Trust, Not Just Compliance

Chronic sinusitis might be doing more than just clogging your nose–it could be clouding your brain. In this episode of Backtable ENT, Dr. Aria Jafari, an assistant professor at the University of Washington and co-director of the Neuroendocrinology Advanced Sinus and Skull-base Surgery Fellowship, discusses the connection between sinusitis and cognitive dysfunction with hosts Dr. Gopi Shah and Dr. Ashley Agan. --- SYNPOSIS Dr. Jafari shares how his interest in this field developed and details his research on the relationship between chronic rhinosinusitis (CRS) and brain function. The conversation highlights the comprehensive impact of sinus inflammation on overall health, emphasizing the importance of viewing CRS as a whole-body condition. They also discuss patient experiences, the methodologies used to assess cognitive dysfunction, potential treatments, and what's next in the research frontier.---TIMESTAMPS00:00 - Introduction 06:18 - The Impact of CRS on Quality of Life14:02 - Understanding Brain Fog and Cognitive Dysfunction24:29 - Pathophysiology and Theories of Cognitive Dysfunction27:44 - Chronic Inflammation and Cognitive Effects28:59 - Impact of Biologics on Cognitive Function31:28 - Risk Factors for Cognitive Dysfunction35:02 - Olfactory Symptoms 37:13 - Future Research and Treatment Approaches45:31 - Conclusion and Final Thoughts --- RESOURCES Dr. Aria Jafari https://www.uwmedicine.org/bios/aria-jafari

Have a red, painful eye that's sensitive to light? Could be uveitis. Hear ophthalmologist Dr. Timothy Janetos discuss uveitis and how it relates to psoriasis and psoriatic arthritis. Join host Takieyah Mathis for an eye opening discussion about uveitis, cataracts, and eye health with ophthalmologist Dr. Timonthy Janetos from Northwestern Medicine, Department of Ophthalmology. Listen as they discuss what is uveitis and cataracts from key symptoms, the significance of the HLA-B27 marker, diagnosis, to treatment options that help reduce inflammation and preserve long term vision. This episode offers information to help you advocate for your eye health by recognizing when you need help from an ophthalmologist and what actions you can take to reduce your risks associated with uveitis. Timestamps: ·       (0:00)          Intro to Psound Bytes & guest welcome ophthalmologist                      Dr. Timothy Milton Janetos. ·       (1:21)          Definition of uveitis and the relationship to psoriatic                            disease. ·       (5:35)          Symptoms of uveitis. ·       (7:45)          How uveitis is diagnosed. ·       (9:24)          Treatment options for uveitis. ·       (13:11)       What happens if eye injections are needed as treatment. ·       (14:47)        Association between inflammation, psoriatic disease,                           and cataracts. ·       (15:48)        Symptoms of a cataract. ·       (16:33)        Treatment for cataracts. ·       (21:11)        New advancements in treating uveitis and cataracts. ·       (25:50)        General eye health actions to help reduce risks                                       associated with inflammation. Early detection is key. 4 Key Takeaways: ·       Uveitis is a huge spectrum of different diseases with about half of the associations due to chronic, immune related diseases like psoriasis or psoriatic arthritis.   ·       If you wake up with a red, painful eye that's sensitive to light, seek help from an ophthalmologist right away to minimize risk of scar tissue formation. ·       Work with a health care team to treat all aspects of psoriatic disease to reduce inflammation whether it's in the skin, joints, and/or the eye. ·       Lifestyle changes such as stop smoking and yearly eye exams are actions that can help reduce inflammatory factors and maintain overall eye health. Guest Bio: Dr. Timothy Milton Janetos is a board-certified and nationally recognized ophthalmologist with Northwestern Medicine, Department of Ophthalmology who specializes in uveitis and cataract surgery.  He is also an Assistant Professor at the Feinberg School of Medicine, Department of Ophthalmology. Dr. Janetos offers comprehensive care using a personalized treatment plan for both children and adults with intraocular inflammation and infections. He is a professional member of the American Uveitis Society (AUS) and the Association for Research in Vision and Ophthalmology (ARVO), as well as the Editor for Frontiers in Ophthalmology and an Editorial Board Member for Annals of Eye Science. Resources: Ø  Psoriatic Arthritis and Uveitis: What's it All About? Podcast with rheumatologist and ophthalmologist Dr. James Rosenbaum. (Released in 2019.)   https://www.psoriasis.org/watch-and-listen/psoriatic-arthritis-and-uveitis-whats-it-all-about-psa/   Ø  Eye Inflammation and Psoriatic Arthritis         https://www.psoriasis.org/advance/eye-inflammation-and- psoriatic-arthritis/  

In this episode of The Top Line, Fierce Biotech’s Chris Hayden sat down with Dr. Juergen Eckhardt of Bayer and Dr. Seth Ettenberg of BlueRock Therapeutics to discuss an innovative partnership that’s reshaping how big pharma teams up with biotech startups. BlueRock, a wholly owned subsidiary of Bayer, operates with the independence of a small biotech while benefiting from Bayer’s global reach and infrastructure. The “arm’s-length” model gives BlueRock the agility to innovate while leveraging Bayer’s resources in manufacturing, clinical trials and commercialization. The collaboration has already led to major milestones, including the development of a promising cell therapy for Parkinson’s disease, which is expected to enter Phase 3 trials later this year. “This isn’t just a partnership—it’s a relationship,” Eckhardt said. “We’re combining the best of both worlds: biotech speed and pharma scale.” The episode also explores how Bayer’s experience in biologics manufacturing has helped BlueRock overcome one of regenerative medicine’s biggest challenges—scaling complex cell therapies. The model has proven so effective that Bayer has since replicated it with other companies, signaling a broader shift in how the company approaches innovation. To learn more about this unique partnership and what it means for the future of neurological disease treatment, listen to the full episode of The Top Line.See omnystudio.com/listener for privacy information.

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.

Support the show and get 50% off MCT oil with free shipping – leave us a review on iTunes and let us know!https://podcasts.apple.com/us/podcast/live-beyond-the-norms/id1714886566You go to the dermatologist with a full-body rash or a child who can't sleep because they scratch till they bleed—and the first option you're handed is a lifelong biologic drug?Something's not right.In this episode, I sit down with Kerry Jenkins, a certified physician assistant with 23+ years in medical and aesthetic dermatology, who's blowing the whistle on the standard system and helping patients heal chronic skin conditions by treating the root cause.Kerry doesn't just talk about acne, eczema, and psoriasis. She gets into the deeper problem: what our skin is trying to say about our gut, our toxic load, and the way we eat, live, and sleep.We dive into everything from Accutane and vitamin deficiencies to the real deal with sunscreen. We also talk about the insane rise in chronic rashes in babies, and why so many parents are being pushed toward risky immune-suppressing drugs way too fast.If you've ever wondered why skin issues aren't being solved, this one will wake you up."Just because somebody's popular and has a lot of followers and they're promoting a product does not mean that it's legit or that it works. You need to do your due diligence.” ~ Kerry JenkinsAbout Kerry Jenkins, PA-CKerry Jenkins is a certified physician assistant who has been practicing medical and aesthetic dermatology for over 23 years. After discovering the power of functional and integrative medicine, she obtained additional certifications from the School of Applied Functional Medicine, the Institute for Functional Medicine, and certifications in root cause dermatology. Today, she is the founder of Whisper Health, where she provides patients with a holistic approach to chronic skin issues. Kerry believes that true healing occurs when the underlying drivers of disease are identified and addressed. Her mission is to empower people with the knowledge that they can choose how they treat their skin conditions.Resources:➡️ Learn more about the molecule behind the longest life extension in history at https://MyVitalC.com Connect with Kerry Jenkins:- Website: https://www.whisper-health.com- Instagram: https://www.instagram.com/whisperhealth - Facebook: https://www.facebook.com/WhisperHealthFunctionalMedicine  Connect with Chris Burres:- Website: https://www.myvitalc.com/ - Website: http://www.livebeyondthenorms.com/ - Instagram: https://www.instagram.com/chrisburres/ - TikTok: https://www.tiktok.com/@myvitalc - LinkedIn: https://www.linkedin.com/in/chrisburres/ 

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

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. 

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

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.