Don Weber

CBG reduces anxiety in first double-blind, placebo-controlled study? Brand new study of 34 participants from Carrie Cuttler and Amanda Stueber from my alma matter Washington State University, Ziva Cooper of UCLA and Ethan Russo, MD of CReDO Science LLC First - love seeing a well designed, blinded and placebo controlled study for cannabinoids! I'll add all of these authors are top notch. Essentially, 20mg CBG in a broad-spectrum alcohol extract tincture from a CBG strain, and survey data up to 60 min post-dose. Conclusion: "Most notably, there was a significant main effect of CBG on subjective state ratings of anxiety. Specifically, there was a mean decrease in anxiety ratings of 0.95 on a 10-point scale which represents a 26.5% reduction in the already low levels of baseline anxiety (M = 3.59 on a 0–10 VAS) in the CBG condition. In contrast there was a 0.66-point reduction in anxiety ratings in the placebo condition (which represents a 22.5% reduction in anxiety in the placebo condition)." There was a consistently bigger effect from CBG over placebo, however looking at the data (posted figure) makes it a little less clear cut for two reasons: 1) There was a large effect at 20 minutes, reduced at 45, then large again at 60. This does not smack as a drug effect to me, especially at 20 minutes. 2) The difference between baseline and placebo was much larger than the difference between placebo and CBG. The placebo effect is real, especially in cannabis consumers (which they recruited their 34 subjects). Regardless, very suggestive there is something to CBG and anxiety/stress and great to see these kinds of studies coming out. "Additional research is needed to corroborate these novel findings as well as to extend them to a clinical population of patients with anxiety disorders." Of note from competing interests: "This research was funded by CReDO Science (https://credo-science.com) who are working with CBG. The funder had no role in the analyses or interpretation of the findings." "ER is founder and CEO of CReDO science which formulates and works with CBG." "Outside of this work, ZDC reports receiving study drug from Canopy Growth Corp and True Terpenes, and study-related materials from Storz & Bickel. She served a scientific consultant for Canopy Growth Corporation in 2021 and on the scientific advisory board for FSD Pharma in 2020. ZDC’s research is funded by grants from the National Institute on Drug Abuse, National Center for Complementary and Integrative Health, California Department of Cannabis Control, Center for Medicinal Cannabis Research, and the California Highway Patrol. ZDC and ER had no role in the analyses or interpretation of the findings. Dr. Cuttler reports receiving study-related materials from Storz & Bickel as well as research funds from Huxley Health and Healer. Amanda Stueber declares no conflicts of interest." #BetterCannabisThroughScience Full article link in comments

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In this episode of #LongevityByDesign, Ashley Reaver, MS, RD, CSSD, and I welcome renowned professor Dr. Keith Baar. As the head of the Functional Molecular Biology Lab at University of California, Davis, Dr. Baar has made groundbreaking discoveries about how #exercise and #nutrition influence the adaptation of #muscles, #tendons, and #ligaments. During this episode, he shares his expertise on the critical role of exercise and nutrition for #musculoskeletal #health, #longevity, and improving quality of life. InsideTracker https://lnkd.in/gpzFvn-p

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By implementing these strategies, you can can enhance your competitiveness in the market while contributing to increased access to affordable medications for patients. https://lnkd.in/dAdEmn2b

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So the "Chevron deference" ruling by this Supreme Court has created a strange sort of panic attack within the life sciences ecosphere. I suspect this is a huge over reaction and that in reality very little will change. Agencies, including the FDA, will continue to make rules and regulations, and in the FDA's case based on science. And ALL of these are still enforceable. What is slightly altered is the path of litigation to challenge these rulings. SCOTUS has suggested that Congress needs to tighten up their legislation and provide more guidance to agencies. That is NOT going to happen. It is not how legislation is written, nor how it passes. The ambiguities in the law are often what allows for the compromise that allows for passage. Sometimes in the appropriations process an "earmark" may provide some specificity for an agency on how to spend certain money, but that is not what SCOTUS had in mind here. What they did rule, was that the Courts could no longer simply say "we defer" to the expertise of the particular agency as a matter of law (for instance the FDA). It did NOT say that the Courts couldn't, and in fact shouldn't, defer to the expertise in the agency. Judges are not going to all of a sudden become molecular biologists, or experts in genetic engineering. Nor are they going to clog up their (already over crowded) dockets with evidentiary hearings where volumes of counter balancing "data" are presented by (say the FDA) and a company challenging a ruling. That's simply not how it actually works. In general Judges are simply going to substitute the words "accept" the FDA's conclusion on the evidence, for "defer to as a matter of law". Yes there are going to be occasions where an agency, even the FDA, makes such a glaring error that even this low level of review will enable a successful challenge, but we should welcome that as further strengthening the system, not destroying it. The FDA is, in fact, acknowledged as the gold standard around the world. We should trust that processes and decisions can stand up to some minimal added level of scrutiny.

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Couldn't make it to my recent Master Class on FDA pre-submissions? I've got you covered, regulatory peeps. 😁 Here's the video of the full presentation: https://lnkd.in/gUz5pVEB Video TL;DW? I've also published a summary blog to my website (link in the comments below). And as always, the leanRAQA team is ready to assist with any questions, problems, concerns or frustrations you may have. Just give us a call. #medicaldevices #regulatoryaffairs #compliance #qualitymanagement #medtech #biotech #startups #FDA #510k

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What do the #redbloodcells look like in an adult with #pkdeficiency who has had her spleen removed? A recent case-study highlights the special features of #RBCs as they undergo #hemolysis and adapt to #loweroxygen, #lowerenergy environments of anemia. 🩸 https://ow.ly/vBu950SREPN #pyruvatekinasedeficiency #echinocytes #spikeycells #hematology #rareanemias #blooddisease #blooddisorder #PKD #anemia

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Interesting - from the article: “In a retrograde move, the U.S. Department of Energy (DOE) has just issued a final rule that, effective June 25, 2028, will firmly cement the dominance of unhealthy blue-pump LED light bulbs. We must reverse this decision before it is too late.” “There are so many misstatements and flawed analyses in the 110-page notice of April 19, 2024, in the Federal Register that it is hard to know where to begin. But here are some key extracts:” “DOE believes at this time that circadian-friendly integrated LED lamps do not possess unique attributes compared to other (GSLs).” (i.e. light bulbs, which they refer to as general service lamps). (p. 28877) This is nonsense. Circadian-friendly light bulbs have distinct spectral power distributions—i.e., the relative amounts of light at each color wavelength. Circadian-friendly lights are rich in 480 nm blue during the day and emit minimal 480 nm blue in the evenings and at night. This can easily be measured with a handheld spectrophotometer #health #news #sleep https://lnkd.in/gzWC6JpK

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👉 Biotech startup founders: check out this new webinar series from PBSS International!

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You should read Steve Usdin’s insightful essay on #FDA's approval of Elevidys’ DMD label expansion: https://lnkd.in/g2jK2A5i Beginning with Janet Woodcock’s reversal on Sarepta’s Exondys 51, Steve believes a series of “center director’s decision[s] to override agency staff” means “FDA has adopted a new Peter principle: when reviewing a proposed therapy for a terrible disease, a center director can cite any glimmer of positive data to justify approval.” But instead of caprice, this can be viewed in a benign light as embodying a patient-centric regulatory philosophy: As Congress intends and patients desire, the Agency is leaning in –hard in this case– for patients with life-threatening diseases and few therapeutic options to enable access, clinical practice, and evidence generation (more below vv), absent overriding safety concerns, judging that this more than balances the risks that efficacy may ultimately be equivocal in the broader patient population. Like Duchenne patients, FDA is taking risks. This is precisely why Pat Furlong calls this “a monumental leap forward in our collective efforts to end Duchenne muscular dystrophy” and Muscular Dystrophy Association deems it “a major source of hope for countless families affected by this relentless disease.” Dr Peter Marks and his staff reached profoundly different conclusions– what Steve calls an “idiosyncratic” decision that “disregard[s] the competence of long-serving staff.” Even though Marks has nothing but respect for his staff, Steve asks how reversals like this will impact their morale. Steve rightly notes “the problem is that Marks didn’t describe his disagreement with CBER staff as a matter of policy” and here in fact is Dr Mark’s policy-driven conclusion: “[t]he benefit to risk considerations are favorable, taking into account the existing uncertainties, such as the ultimate duration of response, which is not yet known, as well as the significant unmet need.” Finally, though, I don’t see any connection between the decision and a new ‘ultra-rare’ disease review pathway. That is apples to oranges. With a US prevalence in the tens of thousands, DMD is rare but not ‘ultra-rare’. And, if anything, Dr Mark’s decision proves a new pathway is not only inapplicable, but unnecessary. Setting aside the risks of legislating, FDA is fulfilling –here and in cancer– decades of congressional intent to bring novel treatments to market faster. What is crucial –which Steve points out– is timely completion of confirmatory trials; FDA must use their new accelerated approval authorities to their fullest to ensure this. We should read Dr Mark’s decision memo as an invitation for public discourse like Steve’s on FDA use of its regulatory authority– not for flawed legislation, whether ultra-rare, right-to-try, or promising pathways. FDA is not perfect. But clearly, they are trying hard to drive #innovation into the lives of patients with #rarediseases. #kendallsquarepolicy

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This work is one of my favorites! Can postbiotics have nootropic properties similar to the world’s widely used stimulant, caffeine? Do they help with wakefulness or alertness by modulating the gut-brain axis? How do the biotics compare with known cognition boosters: caffeine, botanicals, vitamins? Check out M. Adnan Qureshi's presentation at #ProbiotaAmericas. Here is what it took us in our search for nootropics. ** It required biologists, microfluidic engineers and AI developers at NemaLife to come together to pull this feat of measuring an alertness-like phenotype in worms at scale, and across worm-life. ** C. elegans responds to touch. Mechanosensory neurons and the underlying neural circuitry are activated upon touch which leads to a striking fight or flight response. This reflexive response declines with age similar to loss of tactile function in older people. ** Traditionally the touch assay required gentle stroking of the worm with an eyelash or eyebrow hair to record the reflexive response. Worm-by-worm, graduate students and postdocs would do this to painstakingly (and yes pulling their own eyelashes) to dissect the genetics and neural circuitry underlying the biological meaning of touch. ** How can we speed the touch assay? At NemaLife, we use microfluidic chips to culture worms with daily fluid injection of media/food to feed and washout-progeny. It is well known in biomechanics that fluid stresses induce cellular mechanotransduction. Can the fluid stress mimic touch-like behavior and elicit an organismal response? The answer was yes. This solved the eyelash problem! ** Best-in-class AI: The next major challenge was getting the reflexive response data from the videos. When the fluid flow is introduced into the chip, tracking the response of dozens of worms in the chip requires eliminating noise from debris, progeny, bubbles etc..We worked through several refinements of our AI model, to finally get the multi-worm detection and tracking right. Each stimulus and worm tracking generated 70,000 data points of reflexive response. How to scale this compute for several hundreds of chips per day - that is a story for another day! ** How do we know the touch-based reflexive response captures aspects of alertness. We tested mutants defective in touch-sensation as well as bioactives that are neurostimulants. This effort required analyzing more than a million images to extract phenotypic data on this reflexive response, and a data team to collate, synthesize and interpret the essence to define postbiotics that could be cognition boosters.

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Wrapping up three dynamic days at Biotechnology Innovation Organization annual convention in San Diego, where we released Cure.’s inaugural biotech benchmark report, Ready, Set, Growth! Cure, an affiliate of Deerfield Management, conducted this highly anticipated assessment of the #biotech industry in partnership with the Deerfield Institute, a division of Deerfield Management. The survey included company #founders and #CEOs, #managing directors, #investors, #scientists, and more. Exciting insights from experts in the field revealed an overwhelming sense of #hope and #optimism across the biotech sector, with 79 percent of individuals betting on growth. Advances in #science and investment opportunities in areas like #neurology, #metabolicdisease, and #oncology, driven by cutting-edge technologies such as #cell and #genetherapies and #AI and #machinelearning are fueling this positivity. Despite progress in various key areas, the survey highlighted a significant lack of innovation and investment in #womenshealth. Nearly 65 percent of respondents expressed #support for more #investment in women’s health. This trend is encouraging, as increased attention and #government funds are now being directed towards women's health, paving the way for potential industry #growth and resurgence. The much-needed investment in #womenfounders and women's health could be the cornerstone for the biotech #comeback and expansion. While it’s hard to know if the trend lasts, nurturing the growth of women's health initiatives could be the #catalyst for the industry #turnaround we aspire to see. Thanks to Caroline D. Marion E. Glick Daniel Glass William Cheung Anna Howell Leah Rosenbaum Cedric Beckles Ben Green Leah Rosenbaum Paul Oestreicher Elizabeth Rose Hansen Rosie Zaloum Foster Dan Hoffman Lauren Ruotolo David Duncan for a terrific report and the ground team who brought everything to life including Caroline D. Susanna Ling Vilia Baumilas Alana Elliott and our new COO Charles Kim. Plus thanks to David Greenwald, Ph.D. Mary Stutts, MHA Jamie Metzl David Fajgenbaum, MD, MBA, MSc Grant W Mitchell, MD, MBA Brittany Connors, PMP Stephanie Fertig Matthew Portnoy Raheleh H. To read the report go to www.wewillcure.com Finishing up the morning with a panel on De-risking drug development with Wyatt Gotbetter Gotbetter Ned Wydysh Susan Billings, Ph.D. Dan Gold Abhiram Rao, PhD Parexel #BIO2024 #wewillcure

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We are excited to delve into the future of heart failure treatment without biopsies on Excellence Talks! Thank you, Murat Aydin, for your leadership and support of precision cardiac medicine efforts at InvivoSciences. Join me in exploring InvivoScience's and Ayla's journey, which is dedicated to healthcare innovation and improving patients' lives globally. Here are some key questions we discussed: 🔹 Why did Ayla co-found InvivoSciences, and what fuels the company's mission? 🔹 What milestones has she achieved in precision medicines for genetically defined heart failures, and what significant challenges did InvivoSciences overcome in this journey? 🔹 What's essential for reaching InvivoSciences' pending milestones in drug programs, and how does Ayla plan to address these needs? 🔹 How does InvivoSciences innovate precision cardiology for HFpEF cardiac disease, bridging the gap from current methods? #PrecisionMedicine #HealthcareInnovation #Cardiology #InvivoSciences #excellencetalks

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We are excited to delve into the future of heart failure treatment without biopsies on Excellence Talks! Thank you, Murat Aydin, for your leadership and support of precision cardiac medicine efforts at InvivoSciences. Join me in exploring InvivoScience's and Ayla's journey, which is dedicated to healthcare innovation and improving patients' lives globally. 🔹 What milestones has she achieved in precision medicines for genetically defined heart failures, and what significant challenges did InvivoSciences overcome in this journey? 🔹 What's essential for reaching InvivoSciences' pending milestones in drug programs, and how does Ayla plan to address these needs? 🔹 How does InvivoSciences innovate precision cardiology for HFpEF cardiac disease, bridging the gap from current methods? #PrecisionMedicine #HealthcareInnovation #Cardiology#InvivoSciences #excellencetalks

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Join Us at BIO 2024 in San Diego! 🚀 Are you attending the BIO conference in San Diego from June 3-6? If so, let’s connect! Our dynamic startup is on the cutting edge of real-time diagnostics, specifically in critical care settings. We’re poised to provide physicians with real-time cytokine measurements at the patient beside, transforming the way we understand and manage complex conditions like Sepsis and adverse events of immunotherapies. Sepsis, in particular, is a challenging heterogeneous condition that could be much better treated with immediate insights into patients’ state of immune system. We’re passionate about making a difference in this space and eager to collaborate with like-minded professionals. If you’re interested in advancing real-time diagnostics and improving acute healthcare, let’s meet at BIO 2024. Comment below or send me a message to arrange a time to chat. Together, we can drive innovation and improve patient outcomes. Looking forward to connecting! #BIO2024 #RealTimeDiagnostics #Sepsis #CriticalCare #Immunotherapy #CytokineMeasurements #HealthcareInnovation

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💪 Invest In Your Future Quality Of Life Opportunity ends TONIGHT at MIDNIGHT! 🔗 invest.cytonics.com Here are several compelling reasons to consider investing in Cytonics Corporation's and the future of regenerative medicine. 🔬 Succeeding Where Big Pharma Has Failed CYT-108 is a next-generation biologic, developed to treat osteoarthritis by targeting and inhibiting catabolic enzymes responsible for cartilage degradation, potentially the first and only disease-modifying treatment for osteoarthritis​​. Preclinical studies have demonstrated CYT-108's ability to reduce cartilage damage by up to 87%, and synovial inflammation by up to 78%, which significantly outperforms the natural A2M protein​​. 🧠 If Anyone Can Do It, It’s Us Led by Gaetano Scuderi, MD, a board-certified orthopedic surgeon and prolific researcher, and Joey Bose, a former healthcare investment banker with expertise in protein engineering​​ developed at Johns Hopkins University School of Medicine. The genius behind CYT-108 is Lewis Hanna, PhD, Chief Scientific Officer, with over 30 years of experience in protein engineering and pharmaceutical R&D. Dr. Hanna single handedly developed the process to synthesize CYT-108, a scientific feat that is a massive barrier to entry in orthobiologics. He has extensive knowledge in large-scale production, quality, and regulatory requirements for FDA approval​​. The leadership team combines clinical, academic, and financial expertise critical for navigating the complex biotech landscape. 🏦 Overflowing Coffers We have raised over $25M to date, including over $15M from equity crowdfunding. Cytonics has no debt on the balance sheet, is fully funded through the next inflection point (Phase 1 clinical trial), and allocates 70% of all investor dollars directly to R&D for CYT-108. 🌟 Massive Untapped Market Osteoarthritis affects over 600 million people worldwide, with related healthcare costs exceeding $240 billion annually. The market for a disease-modifying osteoarthritis therapy is vast and growing​​, with over 25% of the US adult population predicted to suffer by 2030. The biotech sector has seen significant IPO and M&A activity in the last 6 months, providing a favorable environment for biotech startups and innovations. Read more about the biotech bonanza: https://lnkd.in/e2hiQqR9 🛡️ A Defensible Moat Cytonics holds over 24 U.S. and international patents, securing a competitive edge and protection for its innovations​​. The novel mechanism of CYT-108 and massive unmet clinical need for an OA therapy may qualify for FDA fast-track status and priority review, potentially accelerating its path to market. #Biotechnology #RegenerativeMedicine #CytonicsInnovations #Osteoarthritis #InvestInHealth #HealthTech

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From the (Hill) headline below, do you agree or disagree with her assessment? And what evidence or theory would you have to support your answer? Until an agreeable solution has been formulated by the responding governmental agencies, might we recommend our bio-technology solution currently available now to combat this growing concern. The Hill Birx says US making ‘same mistakes’ with bird flu as COVID-19 Story by Lauren Sforza • 17h https://lnkd.in/gvGXkEEV From the article: “This is why I’m really concerned because we’re making the same mistakes today that we made with COVID. And what do I mean by that? We’re not testing to really see how many people have been exposed and got asymptomatically infected,” Birx told CNN’s Kasie Hunt on Tuesday. 4.2M Chickens to Be Killed After Bird Flu Detected Story by Rob Quinn https://lnkd.in/gWCSEXth From the article: The US Department of Agriculture says more than 92 million chickens have been culled since the country's bird flu outbreak began in 2022. The virus is also spreading among dairy cows and at least two dairy workers have been infected. Bird flu detected in San Francisco wastewater and chickens Story by Susanne Rust • 16h  https://lnkd.in/gVx-uCDR From the article: Authorities say the source of H5N1 in San Francisco's wastewater is unclear and that the city's sewer system incorporates both wastewater and stormwater — meaning it could be coming from animal waste, milk or people, or from a combination of sources. #222nm #h5n1 #nextpandemic

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🕛 The Final Countdown: Cytonics Corporation Crowdfunding Campaign Ends Tonight: invest.cytonics.com 🔥 Are you ready to join over 6,000 other shareholders in pursuit of The Holy Grail of Regenerative Medicine? 🕛 Less Than 12 Hours Left to Invest Since 2006, Cytonics has been leading the charge in developing groundbreaking therapies for osteoarthritis. With the steadfast support of our investors, we have successfully raised over $25 million, pushing our innovative CYT-108 therapy into Phase 1 human clinical trials. As we enter into the final day of the round, your participation is more crucial than ever. With less than 12 hours remaining, seize the opportunity to join over 6,000 dedicated shareholders committed to eradicating osteoarthritis once and for all. This is more than an investment in a promising biotech upstart; it's an investment in a future free from the pain of osteoarthritis. 💡 Investment Considerations 🏦 Institutional support: raised over $25M to date including institutional support from J&J (a 14% shareholder) and a biotech family office. ✅ Hitting our milestones: on schedule to begin the Phase 1 human clinical trial in 2Q24. The single most significant milestone in our company’s history! 📝 Strong IP portfolio: issued 24 US and international patents (and 5 pending) covering all three of our technologies: the APIC therapy, FACT diagnostic, and CYT-108 biopharmaceutical. 👥 Experienced leadership: management has over 100 years’ combined experience in biotech research and development. 🌟 Track record of success: Our FDA-cleared “APIC” therapy was successfully commercialized in 2015, providing clinical and commercial proof that our core A2M technology works! 💲 Responsible spending: 69% of investor funds were spent on Research and Development in 2023. Every marginal dollar is put to work maximizing shareholder value. #biotech #biotechnology #arthritis #osteoarthritis #investing #crowdfunding #venturecapital #healthcare #drugdevelopment #clinicaltrials #regenerativemedicine #orthopedics #orthopaedics #surgery #investor #FDA #medicine #lifesciences #researchanddevelopment #capitalmarkets

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I learned early on that the image coming out of the back of the objective is the best it will ever be and the microscope's job is to not screw it up. Here's a concise reference explaining the desirable characteristics of an objective and why you pay for higher NA. "Objective Specifications Drive Performance in Biomedical and Life Sciences Research" https://lnkd.in/g9Uy7d76

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With all respect, I disagree with this article. It all comes down to lack of education. I have been around the study and use of these types of products for the past 5 years and have witnessed nothing but great success stories from patients without alternative treatment options. I have also been involved with working with the FDA to get approval for a clinical trial using these therapies. From my interactions with the FDA, they are aware of the GRAS nature of these products and agree to skip many of the approved INDs straight to phase II because of the long history of recorded safety these products have shown. What concerns me most are patients not being given the right to choose these therapies freely and/or having to pay tens of thousands of dollars for a treatment only because it is offered without competition by a limited number of providers. My focus is to help educate about these products, but it is hard to do when articles like this don’t reflect the entire picture and focus on spreading fear. Instead please read the article below to better understand the potential of these products. Although there are tons of published articles similar to this one, the truth is that there would be so many more if physicians were able to share these stories freely without fear of being accused of flouting. https://lnkd.in/gmGf-scZ

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