republishing scientific study to prospective customers isn't protected opinion Advance Dx, Inc. v. YourBio Health, Inc., --- F.Supp.3d ----, 2024 WL 4393314, No. 24-10595-WGY (D. Mass. Oct. 3, 2024) Advance sued YourBio, which competes in the market for at-home medical device testing patients’ level of anti-Mullerian hormone, for false advertising, tortious interference, defamation/disparagement, unjust enrichment, and unfair trade practices under Massachusetts statutory law. Advance makes a card used to collect a blood sample obtained from a patient’s lanced fingertip, while YourBio manufactures a device that is used to collect a blood sample by attaching to the back of a patient’s arm and piercing capillaries close to the skin’s surface with microneedles. In 2022, BioMed studied the parties’ products and conventional venipuncture. “After processing the data, BioMed imposed an internal control, calculated based on the Study’s data, to normalize Advance’s results to the venipuncture instead of using the recommended internal control provided in Advance’s guidelines.” It then published the study, concluding that YourBio’s testing device was more accurate, superior, and has stronger consumer preference than Advance’s. YourBio used PR Newswire to tout its superiority and also repeatedly promoted the study “to consumers, industry professionals, and third parties at trade shows and in YourBio’s marketing materials.” However, after it learned about the use of the simulated control, the testing lab “stated that any discordance noted in the Study may be due to BioMed’s failure to follow Advance’s instructions for the Card, and not due to any fault of the Card.” YourBio argued that the study was a non-actionable scientific conclusion and statement of opinion and therefore could not be falsified. The court disagreed. Even under the rule of ONY, Inc. v. Cornerstone Therapeutics, Inc., 720 F.3d 490 (2d Cir. 2013), “we must take into account the statement’s context, including the medium in which the statement was published and the audience to which it was presented.” The medium here was republication by YourBio specifically to promote its devices. “Unlike a typical scientific journal, the medium in this case is not meant to communicate insights into matters of scientific debate, despite the fact that the Study may have been first published by BioMed for exclusively scientific reasons.” The audience was also not “purely scientific,” but rather targeted at customers/potential customers. The court also found that Advance was not a public figure, so defamation required only negligence, although it did plead that YourBio was aware of the falsity. And damage could be presumed without evidence of economic loss because the statements were of the kind that would harm Advance’s business. The same basic logic allowed the Lanham Act false advertising claims to proceed. (Advance didn’t say a lot about “interstate commerce,” but alleging that the false...
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The title of this article caught our eye "All I want for Christmas is a UK Industrial Strategy.' Forbes contributor Kath Mackay, Chief Scientific Officer for Bruntwood SciTech discusses the impact of CRISPR technology on the life sciences sector and the recent approval of a CRISPR therapy by the Medicines and Healthcare products Regulatory Agency (MHRA) to treat sickle cell disease and beta thalassemia. It emphasises the significance of this approval for British life sciences and the confidence it inspires among international researchers, pharmaceutical manufacturers, and investors. However, it also highlights the challenges in the investment landscape for life sciences businesses in the UK, including difficulties in securing funding and talent acquisition struggles. The article calls for an overarching, joined-up approach to address the investment shortfall in life sciences and emphasises the need for a new UK Industrial Strategy to bolster confidence in UK life sciences. What are your thoughts on a more cohesive approach to support the growth and innovation of the UK's life sciences industry? #LifeSciences #LifeScienceNews #MHRA #crispr
All I Want For Christmas Is A UK Industrial Strategy
forbes.com
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Market entry consultant | Start-up specialist and business growth leader | Experienced General Manager | Healthcare | Pharmaceuticals | Biotech | Managing Director at MoorPharm Consulting Ltd.
The title of this article caught our eye "All I want for Christmas is a UK Industrial Strategy.' Forbes contributor Kath Mackay, Chief Scientific Officer for Bruntwood SciTech discusses the impact of CRISPR technology on the life sciences sector and the recent approval of a CRISPR therapy by the Medicines and Healthcare products Regulatory Agency (MHRA) to treat sickle cell disease and beta thalassemia. It emphasises the significance of this approval for British life sciences and the confidence it inspires among international researchers, pharmaceutical manufacturers, and investors. However, it also highlights the challenges in the investment landscape for life sciences businesses in the UK, including difficulties in securing funding and talent acquisition struggles. The article calls for an overarching, joined-up approach to address the investment shortfall in life sciences and emphasises the need for a new UK Industrial Strategy to bolster confidence in UK life sciences. What are your thoughts on a more cohesive approach to support the growth and innovation of the UK's life sciences industry? #LifeSciences #LifeScienceNews #MHRA #crispr
All I Want For Christmas Is A UK Industrial Strategy
forbes.com
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🔥 Exciting News! I am delighted to announce the publication of our poster "Utilizing OMICS, RWE, and AI: on the way to personalized medicine", representing a piece of my MSc thesis! ✨ I am truly grateful for the support and guidance provided by my university mentors Andreas Bechthold, Stefan Guenther, Dr. Anja Langeneckert, and my industry mentor Dr. Marion Mueller throughout this project, which illustrates the potential of these approaches in transforming medical practice. 🔎 Our findings highlight the power of OMICS, Real-World Evidence, and Artificial Intelligence in advancing disease prevention, diagnosis, and therapies. 💊 I would like to express my sincere gratitude to be part of the Regulatory Affairs and Drug Development - M.Sc. Study Program at The University of Freiburg for shaping my understanding in pharmaceutical sciences, combining academic and industry insights. Please follow the link below ⬇ if you want to know more about our research! #PersonalizedMedicine #OMICS #RWE #AI #ResearchPublication #MScStudent
Utilizing OMICS, RWE, and AI: on the way to personalized medicine - Peeref
peeref.com
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📢Excited to share the publication of my first ‘first-author’ paper titled 'Exploring the impact of co-exposure timing on drug-drug interactions in signal detection through spontaneous reporting system databases: a scoping review’ on Expert Review of Clinical Pharmacology!📔 📌 This work, conducted during my internship at the Københavns Universitet - University of Copenhagen, delves into the critical realm of drug-drug interactions (DDis) within Spontaneous Reporting System (SRS) databases. By incorporating key pharmacological principles, particularly focusing on temporal plausibility, we aim to enhance the accuracy of signal detection while minimizing false positives. 🔍Our scoping review, conducted using MEDLINE, offers a detailed analysis of various methods employed for DDI signal detection in SRS databases. We investigate the evaluation of co-exposure timing between interacting drugs, an area significantly underexplored in existing literature, emphasizing the need for further exploration and method development. #DrugSafety #Pharmacovigilance #Research #Clinical #Pharmacology #Drug #Review 🔗 Read the full article here:
Exploring the impact of co-exposure timing on drug-drug interactions in signal detection through spontaneous reporting system databases: a scoping review
tandfonline.com
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Here is my long awaited....summary of the 2024 PDA - Parenteral Drug Association Microbiology conference in Washington, DC broken down by the stats, the science and the scoop. The STATS: - A record setting ~500 attendees, most attended in the history of the event! - Various colleagues presented about 63 different scientific posters, & the science was GREAT. - Approximately 40 exhibitors, some with brand new product launches! The SCIENCE: - Regulators want every method validated- including surface monitoring and will now start to enforce? - USP Microbiology Expert Committee has a lot of updates happening which will greatly impact our industry in the coming year. - PDA TR33 for Rapid Micro Methods has undergone a MAJOR technical overhaul and anticipated release is beginning of 2025. - NASA won't have an official space station anymore, it'll be owned by corporations & anyone can rent it out, including big pharma. - Future of using microbiota for therapeutics is here, and goes beyond FMTs for C. difficile into new, innovative therapeutics. - Biofilms suck, and they suck even more on textured medical devices, including dermal fillers, implants, etc., a better solution is needed - Contamination control strategy remains a hot topic, as it should be The SCOOP: - I literally saw people change their mind on the use of AI in the QC Microbiology lab, on certain rapid methods, and more! Super cool to witness. - After conference parties/events are becoming so posh, with almost 3-4 events a night! They include major swag too. - Food quality on Mars may actually be better than this year’s lunch :) - We even got our very own PDA Micro t-shirt this year, line was long whew - Do the survey so next year's 20th anniversary meeting is even more spectacular (if that's possible) Thanks too all the old, the new, and in everything in between. Our community is very special, and thats credit to all the amazing people in it. Enjoy the collage!
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AIM Collaborations is a UK-led educational conference that will bring leading artificial intelligence companies and major pharmaceutical industries together all under one roof. The two-day event will be the first of its kind and hopes to build on the rapid and groundbreaking advancements of artificial intelligence and aims to- · Give a detailed insight into artificial intelligence developments in the medical field through first-class speakers. · Create and develop innovative partnerships between AI and pharmaceutical companies. · Bring together national leading medical HCP’s with new-world AI pioneers. · Make medical AI the number one news topic of today. We at the AIM Collborations have recognised that AI is going to be the number one subject in the world. This congress will show just how much the landscape of the medical industry is going to change: from the way patients are diagnosed to the way they are treated to when they walk out of the door – AI will soon be at every step of the way. This meeting allows everyone to learn and – most importantly – collaborate in a way we can use AI together to bring the UK to the very top of healthcare. Coming Dec ’24…
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📢 Pathcore is excited to announce a partnership with Fortelinea Software Systems to accelerate the adoption of digital pathology and streamline digital review of slides. 🔗https://zurl.co/omcd This partnership aims to integrate Fortelinea’s Prima for Pathology specimen tracking and management software with PathcoreFlow, the image management system (IMS) developed by Pathcore, enabling automatic exchange of detailed specimen processing information. This advanced solution empowers pathologists with comprehensive data for accurate diagnoses, optimized workflows, and faster reporting, particularly in high-volume scenarios such as routine clinical sign-outs and preclinical toxicological pathology studies. #Immunooncology #Multiplex #PrecisionMedicine #SpatialBiology #AI #Pathology #DigitalPathology #DrugDiscovery #DrugDevelopment #DataManagement #Biopharmaceuticals #CancerResearch #PharmaIndustry #Biopharma #Biotechnology #Biotech #MedTech #RegulatoryCompliance #Fortelinea #LabManagement #PathologySolutions #LIMS
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Partner at Axon Lawyers: life sciences | medical devices | IVDs | medicines | biotech | AI | REACH | Batteries | EU law | Dutch law | M&A | commercial contracts | due diligence | healthcare | (regulatory) litigation
The European Medicines Agency Reflection paper on the use of Artificial Intelligence (AI) in the #medicinalproduct lifecycle contains interesting statements about the use of AI as a medical device or in vitro diagnostic medical device in #medicine #clinicaltrials in just a very little short paragraph (2.3.3.2 on Use of #medicaldevices and #invitrodiagnostics in clinical trials). This states that an #AIsystem used in a clinical trial may well qualify as a medical device or in vitro diagnostic medical device when used for #clinicalmanagement of an individual patient. The EMA refers to MDCG 2019-11 for qualification of software as a medical device or IVD, but that's not the whole story. For more context about what constitutes "clinical management of an individual patient" in practice take a look at MDCG 2022-10, which describes this in a lot of detail in the context of IVDs specifically (which detail is lacking in MDCG 2019-11). For example, an AI system that provides information as input for the decision to include a patient in the trial or not would likely constitute a medical device or IVD as this is patient management (see Q6 of MDCG 2022-10). If the AI system is also a medical device or IVD, it must be CE marked beforehand or be included as an investigational device in the trial design and protocol. If you get this wrong, the clinical trial data may not be usable and that would be a very costly mistake. Would you like to know more? Let me know. I've been working on these questions for years already and have seen clients get this right and wrong (and regret it in the latter scenario). #artificialintelligence #AIAct #medtech #invitrodiagnostics #moleculardiagnostics #clinicaltrial https://lnkd.in/dvtsnUqp
Reflection paper on the use of Artificial Intelligence (AI) in the medicinal product lifecycle_240903
ema.europa.eu
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🌐 Exclusive Livestream NOW AVAILABLE 🌐 Can AI become a game-changer in diagnosing patient outcomes? Where does artificial intelligence fit in the future of medicine? To unravel these burning questions, we invited leaders from the world’s largest pharmaceutical companies for a groundbreaking discussion. The Accreditation Council for Medical Affairs (ACMA) Think Tank Series on AI in Pharma isn’t just another event; it’s a pivotal moment for industry leaders striving to make strategic AI implementation decisions that could redefine their business and the healthcare landscape. Dive deep into the controversy, the insights, and the expert opinions that emerged from this exclusive think tank. Get streaming access: https://lnkd.in/dAmNvbMP Get the report: https://lnkd.in/drSTdz2s Tania Small, MD, Bristol Myers Squibb Imad Haddad, Novartis Oncology Allison Trucillo, MD, Avalyn Pharma Inc. Matthew Goodwin, scPharmaceuticals Jennifer Ghith, Pfizer Mimi Huizinga, MD MPH, Gilead Sciences Luca Quagliata, PhD, BCMAS, COA, Thermo Fisher Scientific Eva Gallagher, Ph.D, Agios Pharmaceuticals Matt Smollin, PharmD, Karius #ACMA #ACMAThinkTank #BCMAS #medicalaffairs #MSL #medicalscienceliaison #AI #ArtificialIntelligence #leadership #credibility #pharma #biotech #pharmaceutical #healthcare #MD #PhD #PharmD
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While this article is titled "𝗗𝗿𝘂𝗴 𝗱𝗶𝘀𝗰𝗼𝘃𝗲𝗿𝘆 𝗮𝗻𝗱 𝗱𝗲𝘃𝗲𝗹𝗼𝗽𝗺𝗲𝗻𝘁: 𝗶𝗻𝘁𝗿𝗼𝗱𝘂𝗰𝘁𝗶𝗼𝗻 𝘁𝗼 𝘁𝗵𝗲 𝗴𝗲𝗻𝗲𝗿𝗮𝗹 𝗽𝘂𝗯𝗹𝗶𝗰 𝗮𝗻𝗱 𝗽𝗮𝘁𝗶𝗲𝗻𝘁 𝗴𝗿𝗼𝘂𝗽𝘀" I think it is equally useful to clinicians, basic scientists and researchers. All relevant stakeholders need to be aware of the complex process behind drug development. 𝗞𝗲𝘆 𝗽𝗼𝗶𝗻𝘁𝘀 𝗳𝗿𝗼𝗺 𝘁𝗵𝗲 𝗮𝗿𝘁𝗶𝗰𝗹𝗲 𝗶𝗻𝗰𝗹𝘂𝗱𝗲: 👉The process of drug development from discovery to regulatory approval takes 12-15 years on average with a total cost of around $2.8 billion. 👉Artificial intelligence and machine learning are being applied to try to make the process faster and more efficient, but still have limitations. 👉 Drug repurposing (finding new uses for existing drugs) is being explored as a potentially faster and cheaper approach. 👉New regulatory approaches are emerging, such as allowing non-animal testing methods. 👉Open science collaborations between academia (universities) and industry (pharma) are being explored to improve efficiency. 👉Current challenges in drug development include high costs, long timelines, high failure rates, difficulty predicting toxicity and efficacy in humans and limited understanding of disease mechanisms. 👉The authors advocate of wider involvement of patients and the public in the drug development process. 🌟Despite these challenges, advances in technology and innovative approaches offer hope for developing more effective, targeted therapies in the future. Free full text link in comments. #clinicaltrials #drug #development #pharma #academia #patientgroups #regulation #medicine #clincial #therapeutic #diseases #optometry #ophthalmology #patientinvolvement
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