Herb Anthony

Very excited to be presenting this webinar on FDA’s Final Rule for Laboratory Developed Tests for RQM+. When: June 20, 2024 @ 11:00AM EST Register here: https://lnkd.in/ebfw66B2 There have been a LOT of LDT webinars in the last few weeks, but I promise this one is different. We will not just be regurgitating the rule. Instead, Bethany Knorr Chung, PhD, RAC and I will be giving you strategies and tips for execution. Do you have questions? Drop them in comments or my messages before the the webinar, or bring them along the day of.

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BDRA Consulting LLC has been a member of AMDM since 2013. Come join AMDM for the entire story. Twice a year, members get to meet with the FDA to discuss upcoming regulatory and quality policies. The FDA provides industry updates. This year's meeting was held at Building 66, White Oak campus on May 21, 2024. Key Takeaways from the May 2024 AMDM Industry FDA Roundtable: 1. Cybersecurity for medical devices is a key issue. OHT7 and CDRH have increased focus on cybersecurity for medical devices. 2. The Oncology Diagnostic Pilot Program is nearly a year old, and no company has been accepted. This is primarily because drug manufacturers have not been able to provide validation data. 3. Reclassification plans for companion diagnostics are ongoing and will be completed by November 2027. - FDA is considering down-classifying three types of CDxʼs: i. Nucleic acid-based CDX ii. In situ hybridization-based CDX iii. Immuno-histochemistry-based CDX - Technologies will be grouped based on the intended use. 4. PCCP guidance for medical devices will be published before the end of the fiscal year 2024. A PCCP may be used to make changes to sample type changes, which may be acceptable in certain cases. 5. QSIT is being replaced by an entirely novel risk-based approach, which is currently being worked out. Manufacturers should be working through transition plans. #AMDM

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Checkout this video for out initial thoughts on the final rule for LDTs.

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Exciting news to share for #biotech, #biopharma, and #cdmo organizations looking to elevate the safety and efficacy profile in related #biologics, #genetherapy, #celltherapy, and #tissueengineering sectors.

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A unique opportunity for #raredisease advocates and those who serve our community including #diagnosticlaboratories that design and offer #labdeveloped tests #LDTs and that with the newly finalized FDA #LDT rule will have to comply with #device #regulations for #invitrodiagnostics #IVDs. (Almost) everything you ever wanted to know about #regulatoryaffairs for #prescriptiondrugs, #biologics, and #medicaldevices, wrapped up in one neat two-day conference, and participation is FREE! Join FDA *May 29 and 30th* either in-person or remotely, and learn about #clinicaltrial #innovation, the use of #AI #artificialintelligence in #drugdevelopment, #combinationproducts, the #510(k) process, quality management systems #QMS, the development of #genetherapies for rare diseases, best practices for #patientengagement, and so much more. Go here to learn more and register: https://lnkd.in/eEc9XWbD

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The 2026 deadline for compliance with FDA's new QMSR is closer than you think! At this year’s AAMI-FDA neXus, we heard from CDRH Director Jeff Shuren and other FDA experts about the rule, and what’s next for medical device manufacturers. #Medicaldevices #FDA #RegulatoryCompliance https://lnkd.in/ecuSzq4Y

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Topic suggestions? – ASGCT-FDA workshop on AAV class considerations Following on discussions at the 2024 ASGCT-FDA Liaison Meeting, ASGCT and FDA are planning to co-host a two-day, fully virtual workshop in early 2025 with approximately 8 total hours of presentations + discussion to provide an in-depth examination of AAV class considerations. The workshop format will likely model the FDA-ASGCT workshop Immune Responses to AAV Vectors. Currently, the list of topics being considered include: Biodistribution, Immunosuppression regimens, Contraception, Immunogenicity, Alcohol abstinence, Integration and theoretical oncogenicity risk, Shedding studies. Thoughts on prioritization of these topics? Suggestion on other topics? 

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LDT final rule is in. 528 paces with over 100 pages of references. https://lnkd.in/eigxjnM9

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Attended an early session of today’s FDA conference where they discussed the new key elements sections for informed consent. This update is crucial for our ongoing projects and compliance efforts. For more information, check out the details. https://lnkd.in/gpBrM5Z6 #FDA #InformedConsent #Compliance #ClinicalResearch #ClinOptimaSolutions

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#FeaturedBlog Today's feature discusses The FDA phase out of the LDT Enforcement Discretion. The FDA has outlined a phased approach to implementing a new regulatory framework for LDTs. This approach is designed to provide laboratories with sufficient time to adjust to the new requirements while minimizing disruption to patient care. Laboratories will be expected to gradually transition their LDTs to comply with FDA regulations, with priority given to tests that pose the greatest risk to patients. Read more here: https://lnkd.in/enhtD7XM

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Burning questions about LDTs? Make sure to catch Eliquent expert Maura Norden as she discusses this timely topic. Register at the link below. Get in touch if you or your organization need guidance on navigating the LDT final rule.

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Please stop by the booth if you are there and hear about what we can do to assist you in: 1) accelerating your regulatory filings, 2) relieving SMEs of the burden of technical writing (we write INDs, BLAs and NDAs from source documents) and 3) global regulatory strategy. Because we see so many INDs/BLAs/NDAs over the course of a year, we have a unique insight into what the regulatory authorities are focusing on and asking about today. We also do RTF and CRL remediation too but hopefully you will use us first so that remediation isn't needed!

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🔥 Coming out of one of the Fireside Chat sessions at the 2024 ASGCT Annual Meeting is more on the need for guidelines, a framework of 'global regulatory convergence' in Cell and Gene Therapy, particularly in the development, manufacturing, and access. Leading the discussion is US #FDA's Marks, CBER Director. 🌎 Marks explained to the audience that varied countries' criteria for CGTs, from preclinical testing to manufacturing, make it difficult for patients in certain parts of the world to obtain treatments, particularly those in the rare disease space. Forward-looking: "Five to 10 years from now, Marks’ vision is that there will be enough global regulatory convergence “such that we can get to where we are currently with vaccines” internationally. “It would reduce regulatory burden.”" #ASGCT #CellAndGeneTherapy #CellTherapy #GeneTherapy #RegulatoryAffairs #Oversight #Innovation #Biotech #Healthcare

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Innovative designs of #clinicaltrials can make the difference between a successful #clinicaltrial and one that is not - in particular for #rarediseases. But, successfully integrating innovative designs into global #drugdevelopment programs can be a challenge, in particular when it comes to enrolling #children or #pregnant individuals earlier in #clinicalresearch. That is why FDA's efforts in this space are so vital. Read this new FDA Voices article by Dr. Hilary Marston and Dr. Kevin Bugin to learn more - hot off the press!!! https://lnkd.in/eYvH5AaS

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In the fourth edition of our neurosciences blog series, Parexel expert and former regulator, Simona Stankeviciute, M.D., shares valuable insights on several best practices and creative approaches to assist biotech companies in developing effective trial design strategies and planning for successful regulatory submissions. Read the full article here: https://lnkd.in/gBnixZw2 #Alzheimers #Regulatory #ParexelBiotech

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Get ready for Episode 7 of the GxPodcast! 🎙️ This week, we're joined by Chris Lewis, the Vice President of GMP Quality for Umoja Biopharma. Tune in to hear us discuss quality culture and excellence in life sciences. We look at cell and gene manufacturing, the connection between innovation and purpose, and the importance of data management in our industry. Tune in to the full episode here: 🔗 https://lnkd.in/exW4jkBB #GXPodcast #iPharmGxP

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The latest U.S. Biotechnology Instruments Market report unveils remarkable growth and new opportunities. Here are 10 essential takeaways for every biotech professional: 1️⃣ Market Growth Projections: The market is set to surge from USD 36.16 billion in 2024 to an impressive USD 49.11 billion by 2033, with a CAGR of 3.46%. 2️⃣ Dominance of Analytical Instruments: Analytical instruments, holding a 65.9% market share in 2023, play a vital role in biotechnological applications, from research to quality control. 3️⃣ Rapid Growth in Cell Culture Instruments: The cell culture instruments segment is poised for the fastest growth through 2033, driven by advancements in biopharmaceuticals, regenerative medicine, and personalized healthcare. 4️⃣ Pharmaceutical & Biotech Companies Lead in End-Use: Dominating the end-use segment with a 40.11% market share in 2023, these companies showcase the industry's dedication to drug discovery and genetic engineering. 5️⃣ Rising Investment in Precision Medicine: With expanding applications, precision medicine presents substantial opportunities, boosting demand for biotechnology instruments crucial for genomic sequencing and biomarker analysis. 6️⃣ Regional Innovation Hubs: California and Massachusetts remain strongholds of biotech innovation, with emerging clusters in Texas and North Carolina contributing significantly to industry growth. 7️⃣ Addressing Regulatory Challenges: Navigating regulatory complexities, especially around gene editing and stem cell research, is crucial for sustaining innovation and market growth. 8️⃣ Global Market Size Estimates: The global biotech instruments market is projected to grow from USD 89.85 billion in 2023 to USD 132.36 billion by 2033, at a CAGR of 3.95%. 9️⃣ Recent Product Innovations: 2024 saw notable advancements, including LICORbio's Odyssey® F biomolecular imaging systems and Waters Corporation’s Alliance iS Bio HPLC System, enhancing productivity and research capabilities. 🔟 Impact of Biopharmaceutical R&D: The expansion of biopharmaceutical R&D, focusing on biologic drugs like monoclonal antibodies and cell therapies, is driving increased demand for sophisticated biotechnology instruments. For those looking to stay ahead, these insights provide a roadmap to understanding market dynamics and seizing growth opportunities. Dive into the full report for an in-depth analysis. Procure Complete Report (220+ Pages PDF with Insights, Charts, Tables, and Figures) @ https://lnkd.in/dGry4wGJ #Biotech #MarketInsights #Innovation #PrecisionMedicine #Genomics #Biopharmaceuticals #BiotechInvestments #RegulatoryAffairs #BiotechResearch #MarketGrowth Let's continue to elevate the biotech industry together! 🚀

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