Jim Barlow

BIG NEWS FOR HORMONE HEALTH! Almost 2 years in the making, so proud of the Elix team for the completion of our second independent clinical trial focused on #PCOS (Polycystic Ovary Syndrome). Big shoutout to our medical advisors, our passionate team and most of all - our community members for your strength, resilience and belief in more sustainable approaches to our health and longevity. The clinical study assessed two of Elix's flagship products—Cycle Balance and Daily Harmony. These herbal supplements, rooted in 5,000 years of TCM research, target inflammation and hormone imbalances associated with PCOS. Results revealed that in a group of non-birth control users: * 89.3% of participants agreed that Elix Cycle Balance and Daily Harmony have helped to regulate their cycle.
 * 85.7% of participants agreed that they had fewer premenstrual and menstrual cramps after taking Elix Cycle Balance and Daily Harmony.
 * 71.4% of participants agreed that taking Elix Cycle Balance and Daily Harmony had improved their hormonal acne/breakouts and that they experienced fewer mood swings.
 The trial, conducted over six months, involved 70 participants with Polycystic Ovary Syndrome aged 18-36, divided into two groups: those using hormonal birth control (BC) and those not using it (No BC). Each participant was also diagnosed with PCOS and experienced symptoms such as irregular menstrual periods or the absence of menstrual periods and/ or excessive facial or body hair, thinning hair, hair loss on the scalp, oily skin, and or acne. Additionally, the majority of participants in the Clinical Study experienced improvements in the following symptoms: * Cycle regulation
 * Bloating
 * Fatigue
 * Mood swings
 * Anxiety
 * Sleep quality
 * Premenstrual and menstrual cramps
 * Hormonal acne/breakouts
 * Brain fog
 * Mental clarity
 * Focus
 * Weight gain
 * Unwanted facial / body hair
 * Fluid retention
 * Overall PMS symptoms
 * Overall PCOS symptoms
 * Overall health and wellbeing https://lnkd.in/eUjV7DkZ

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Looking forward to presenting alongside Mary Christian from C4 Therapeutics, Inc. next week as part of the Innovation Presentation at the CNS Summit! Join us to learn about real metrics and value when applying GenAI to regulatory writing. If you're attending the summit next week, please come by and say hi -- I'd love to hear how your organization is thinking through AI implementation. #CNSSummit2024 #PeerAI #RegulatoryWriting #Innovation #CNSSummit

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Takeda's CEO's annual letter hits on some key themes that many biopharma CEO's are converging on: value-based care, price transparency, breaking up the middlemen, and driving healthcare access and equity. "For several years I have been outlining Takeda’s thinking on health equity—including advocating for a transition to value-based health care that pays for outcomes and care quality, emphasizing the need to prepare for the next pandemic by ensuring global vaccine equity and explaining how the protection of intellectual property rights is essential to incentivize investment in R&D. One area where we would like to see greater progress this year is pharmacy benefit managers reform. We support efforts in Congress to delink rebates from list prices or wholesale acquisition cost. It is a complex system, but the bottom line is that the current system creates misaligned incentives that ultimately result in higher costs for the system and higher out-of-pocket costs for patients. One potential way to address these challenges is through greater transparency. Transparency at the point of purchase for patients would empower them to make decisions knowing exactly what their costs will be. This could lower costs for the entire system by building in greater pricing accountability along the chain so that no stakeholder can benefit from the inefficiencies that result in the prices that patients pay today." At COEUS, we are working with the world's leading biopharma companies to help transition them from a broken FFS model towards value-based care. We have built the world's leading platform that hosts the biggest CGT commercial launches, and rapidly moving into Oncology, Obesity/ Diabetes, and beyond. 1. Enabling Value-Based Healthcare: Our solution facilitates the transition to value-based healthcare by providing a powerful tool for creating and managing contracts that pay for outcomes and care quality. 2. Enhancing Transparency: By aggregating disparate healthcare data from various sources, our platform provides unprecedented transparency into the entire healthcare ecosystem. This empowers payers, providers, and patients to make informed decisions and helps stakeholders across the value-chain to tie price and value to therapeutic outcomes. 3. Driving Innovation: Our platform's ability to evaluate complex rules for value-based contracts, real-world evidence studies, and health equity measurements fosters innovation in the pharmaceutical industry. By providing a tool to measure the impact of new solutions, we help companies drive medical advancements while ensuring equitable access. 4. Improving Access and Affordability: Our solution helps identify areas where access and affordability can be improved without compromising innovation. By providing data-driven insights into the effectiveness of various interventions, we enable stakeholders to make informed decisions that benefit patients and the healthcare system as a whole. Visit https://coebra.ai/.

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Given biotech’s market downturn since the Covid-19 pandemic, many biotech startups have struggled to get by. In this BioPharma Dive article, industry VCs and CEOs give 5 tips for surviving biotech’s’ new normal. Learn more here: https://lnkd.in/en6BTQ2Y

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Novartis released Q2 earnings yesterday, and also raised its 2024 profit guidance. Here's a recap of key developments, broken out by therapeutic area: Oncology: Kisqali showed continued strength in metastatic breast cancer, both in its ongoing clinical data and market performance, with revenue up 50% to $717M last quarter and a leading NBRx share in mBC at 47% in the US, with over 7,000 prescribing physicians. Novartis is waiting on an FDA decision for use in post-surgical settings as an adjuvant treatment for early stage breast cancer. Pluvicto, one of Novartis's two approved radioligand therapies (RLTs), also saw substantial sales growth of 44% to $345M. Pluvicto has overcome supply issues from last year, and in January Novartis opened its newest and largest RLT manufacturing facility in Indianapolis. However, Pluvicto sales were still lower than some analyst expectations, and CEO Vas Narasimhan noted the medicine is in a transitional phase where it must expand beyond early adopters and into a wider range of treatment centers. To that effect, Novartis has increased the size of its field sales force, and is beginning a DTC ad campaign in Q3 of this year. It is also creating a new dose form that will reduce the infusion time from 1 hr to 10 minute. Mgmt. also highlighted pricing challenges in European markets, some of which have pushed back on Pluvicto's high cost. Mgmt noted that because of the complexity of manufacturing RLTs, there wasn't as much room to cut price, which will have an impact on the speed of adoption. Cardiometabolic: Entresto continued its impressive run of sales growth, with quarterly sales reaching $1.9B, up 28% from the prior year. Entresto is facing an LOE soon - Novartis's own forecast has it in the middle of 2025 - but an ongoing series of lawsuits may push it out a bit more. That said, it will face pressure in 2026 regardless due to its inclusion for IRA price negotiations. Meanwhile, Leqvio, the company's RNA interference medicine for cholesterol, more than doubled revenue to $182M, while also showing strong recent real world evidence of 80% persistence rates over a 12 month period. Immunology & Neuroscience: Cosentyx saw strong sales growth of 22%, with better growth in the US offset by slower growth ex-US due to one-time pricing challenges. Cosentyx is facing an LOE on the horizon - composition of matter patents begin to expire in 2026, but a patent term extension runs until 2029. Unlike Entresto, which is a small molecule, Cosentyx is a biologic, and is thus harder for generics manufacturers to replicate, giving it more protection post LOE. Kesimpta delivered even stronger growth of 65%, and has the benefit of several additional years of patent protection through 2031.

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Eli Lilly and Company's shares were up 7% this morning on guidance that they are seriously ramping up their production capacity for their obesity and diabetes drugs, Mounjaro and Trulicity. They also increase their revenue forecast by $2B this year! We already know that diabetes drugs like Ozempic have become very mainstream and the drug companies are all making huge profits, but the question is, can the average consumer or aspiring founder benefit from this craze? The answer is yes. I've shared my POV time and time again that I think that drugs like Ozempic are going to have a massive impact on the global economy for the foreseeable future. I break down how I would approach capitalizing on the whitespace Ozempic is generating because this is truly a once in a life time opportunity. #startup #entrepreneur #ozempic #diabetes #weightloss

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We started out Q1 with cautious optimism and the numbers continue to show the confidence was warranted. Biopharma M&A activity more than doubled nationally during the year’s first three months, coinciding with a rebound in venture capital deals as well as a flurry of IPOs. These are all good signs that the drug development cycle is normalizing and should translate into additional funding being available at the seed and Series A stages. Certain to be on the minds of funders and startups attending #AlignSummit24 on Thursday! https://lnkd.in/erEiJm6S  

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#FoundersX@TECH WEEK by a16z The Healthcare panel hosted by our partner Leo (Naiwen) Cui, Ph.D., with Vijay Vaswani, co-founder & CEO of Omniscope, sharing his insights on decoding and indexing our immune system with high throughput single-cell TCR sequencing technology, is highly informative. What Vijay and Omniscope team is building with their ImmuneGPT will help transform our healthcare from current sickcare model to true healthcare with preventive power. US healthcare cost is 18% GDP and the current model is not sustainable. Omniscope brings us hope by turning our immune cells into most powerful medicines to safeguard our health. Go Omniscope! Please save our healthcare system! 😎 FoundersX Ventures Omniscope Tom Kosnik Leo (Naiwen) Cui, Ph.D. Sizi Chen Yvonne Jiang Andi White, PhD Holger Heyn Lynnette Ang Matthew S. Stanford University Graduate School of Business Stanford Directors'​ College Harvard Business School University of California, Berkeley, Haas School of Business #AI #GenAI #AIagents #startup #techbio #venturecapital #healthcare #ImmuneGPT

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After several days in Denver at American Society for Reproductive Medicine - ASRM, I am more energized than ever about the future of the IVF industry. Our tight Conceivable Life Sciences team delivered 18 presentations to audiences ranging from five to nearly 500, sparking meaningful discussions on the role of automation in advancing IVF (for an example, see the photo our Head of Mechatronics, César Millán Castillo, dazzling a capacity crowd with our automated, robotic C:SPERM workstation in the Mile High Ballroom). Lab directors, in particular, were engaged, informed, and open to exploring how robotic automation can drive better outcomes. A standout moment was watching Mina Alikani, our Director of Scientific Affairs, captivate a discerning audience of High Complexity Lab Directors with her in-depth presentation on AURA's comprehensive testing and validation. Following her talk, Mina, along with Nuno Costa Borges, Adolfo Flores Saiffe Farías, Ph.D., and Jacques Cohen, handled insightful questions on the future of IVF and the need to scale innovation while preparing the next generation of embryologists. Additionally, we had productive meetings with C-suite leaders from some of the largest fertility clinics. These execs were not only open to imagining how robotic automation can enhance their IVF lab operations, but are also keen to explore how it can optimize both CapEx and OpEx while scaling to meet the significant demand that is coming. Finally, the tailwinds from recent IVF mandates out of Washington and California generated palpable buzz in the Mile High halls of the Colorado Convention Center. Now, it's back to work, gearing up for our 100-plus person IRB in January to further validate the impressive results of our initial study, which resulted in 20 pregnancies and outcomes on par with the best clinics in the world. More updates on that to come. #IVF #IVFautomation #automation #innovation #CapEX #OpEx #biotechnology

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Women spend about 25% more of their lives in poor health compared to men, according to McKinsey’s 2024 report on the women’s health gap (Lucy Perez). Until the early 90s, women were not required to be included in clinical trials, leading to a lack of biological knowledge especially in disease areas that affect women either disproportionately or differently.  The first wave of women’s health companies have become unicorns—like Flo Health Inc., Kindbody, Progyny, Inc., and Maven Clinic. They’ve paved the way by eliminating the taboo surrounding women’s health and emphasizing the tremendous unmet need and built great businesses. It is time that biotech startups prioritize a biology-first approach to women’s health and provide better treatments as better services can only go so far. Unless we have new diagnostics and treatments that bring women’s health to parity with other areas of medicine when it comes to biomedical innovation, women will continue to suffer. Initiatives from Melinda French Gates, Advanced Research Projects Agency for Health (ARPA-H)’s Sprint for Women’s Health, and Women's Health Access Matters (WHAM)’s Investment Collaborative, led by Carolee Lee and Jessica J. Federer with participation from our investors Insight Partners and RA Capital Management and others, are creating this much-needed momentum. I am honored to have worked on this piece with a fellow women’s health biotech CEO, Maneesh Jain. Maneesh is a world-leading diagnostics expert who could be working in any other field of medicine, including those much more profitable than women’s health, but he is breaking barriers with the Mirvie team to improve the health and safety of expecting mothers. As someone who is working on technology to help women achieve their family-building goals, who also experienced firsthand a dangerous post-pregnancy complication, I am fully committed to advancing biology-first solutions to improve these issues. Women’s health biotech team members are heroes! https://lnkd.in/ggf8cP2i

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How do we minimize the number of protocol amendments and increase the operational feasibility of our clinical trials? This article below points out the benefits of using data, conversations and real world data to enhance the feasibility of the protocol design and inclusion/exclusion criteria: 1) Are we being too strict on our criteria in order to "control" for data variability? 2) Do are criteria allow for the intended patient population in the real world (if not, they need to) 3) How realistic is your design in how the study sites actually work? How they see and treat patients? How is your company ensuring the design meets these requirements? https://lnkd.in/gzJzFd-3

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July 27 2024 – 5 Notable Articles To Read Article: Artiva Biotherapeutics Announces Pricing of Upsized $167.0M Initial Public Offering Takeaway: A biotechnology company at the clinical stage, dedicated to developing effective, safe, and accessible cell therapies for patients suffering from severe autoimmune diseases and cancers. Source: GlobeNewswire Link: https://lnkd.in/driqTcHj Article: Funding surge for blank cheque companies points to Spac bounceback Takeaway: An investment class once written off due to early excesses and poor performance is now showing signs of revival. Source: Financial Times Link: https://lnkd.in/dZa_XGx7 Article: Informa agrees to buy Cannes Lions owner Ascential for almost £1.2B Takeaway: The acquisition of Ascential marks the completion of Informa's three-year investment program, which has strengthened its position as the world's largest events business. Source: Financial Times Link: https://lnkd.in/dsHnARte Article: VCs are still pouring billions into generative AI startups Takeaway: According to Crunchbase data, if the current trend continues, generative AI companies are set to match or surpass the approximately $21.8B raised in 2023. The breakdown of the H1 2024 total by stage is as follows: 198 angel/seed deals amounting to $500Mn, 39 early-stage deals totaling $8.7B, and 18 late-stage deals reaching $3.1B. Source: TechCrunch Link: https://lnkd.in/dPADfDt7 Article: National Basketball Association (NBA) Announces $77B TV and Streaming Deals with Amazon, The Walt Disney Company and NBCUniversal Takeaway: The new 11-year agreements, set to last through the 2035-2036 season, will have Disney paying the NBA an average of $2.6B per year, a significant increase from the $1.5B per year under the current deal. Source: The Information Link: https://lnkd.in/dRPU8cSq #news #research #ai #business

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Epoch 16: Gaining an Edge in Post-Pandemic Biotech 👉 $XBI down nearly 10% this week why not to worry 👉 Pandemic vs Post Pandemic investing 👉 Series A the new sweet spot for private deals? 👉 Round sizes trending up? 👉 More mega-rounds than ever... 👉 Where it is easiest to find lead investors 👉 Bcell depeltion musings 👉New Venture funds 👉Convertible note trends https://lnkd.in/dEkBy2bY

An insightful (and inevitable) panel at HLTH USA, 'Straight to the Source: A Middleman Saga,' tackled the pressing issue of price transparency in the pharmaceutical supply chain. Josh Flum from LRVHealth kicked off the conversation with a question about the complex pricing dynamics between PBMs and pharmaceutical manufacturers. He highlighted the growing tension between list prices, post-rebate pricing, and how patients ultimately bear the brunt of the costs, with increasing finger-pointing between stakeholders. He raised the crucial question: How do we find a balance between price, payment for innovation, and patient access? Lori Reilly, COO of PhRMA, emphasized the vital role that competition plays in reducing drug prices. She referenced the case of hepatitis C treatments, where competition between branded products successfully drove prices down. However, Lori pointed out a significant challenge: while insurers and PBMs benefit from these price negotiations, patients often don’t see the savings. Instead, many patients with high deductibles are left paying the full list price at the pharmacy counter, despite the deep discounts negotiated behind the scenes. Lori shared a startling example from a study of Medicare Part D, where 79 of the top 100 most rebated drugs resulted in patients paying four times more than insurers. To address this, she proposed three key changes: 1. Breaking the link between PBM payments and list prices, which incentivize higher costs. 2. Passing discounts directly to patients at the pharmacy counter to reflect the real savings negotiated. 3. Increasing transparency in the system to ensure that patients aren't left paying unfairly inflated prices. Rick Gates, SVP of Walgreens, focused on improving patient engagement and pharmacy infrastructure. He stressed the importance of digital enhancements like check-in tools and scheduling systems to simplify the pharmacy experience for consumers. Laura Jensen from Amazon Pharmacy echoed the call for greater transparency and simplicity in healthcare access. She emphasized that healthcare remains far too complicated and that Amazon is focused on making healthcare as seamless, accessible, and transparent as any other service they provide. With increasing pressure from policymakers on drug pricing and innovation, this discussion was inevitable. The healthcare industry is reaching a critical point where we need to find a balance between affordability and fostering continued innovation. #HLTH2024 #HealthcareInnovation #PriceTransparency #PatientAccess #DigitalHealth #PharmaPricing #FutureOfHealthcare

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Acurx Pharmaceuticals Announces Presentation of Ibezapolstat Phase 2 Clinical Trial Results for CDI at Scientific Conference   • Additional analyses of clinical and microbiological data from the Phase 2b segment show favorable gut microbiome changes including increased relative proportion of Actinobacteria in ibezapolstat-treated patients with C. difficile Infection (CDI) • Results consistent with those shown in earlier human volunteer studies and Phase 2a studies • Preservation and increased concentrations of beneficial Firmicute (Bacilotta) phylum known to be involved in bile acid homeostasis and short chain fatty acid metabolism was demonstrated  • Actinobacteria and Bacteroides preservation also confirmed using quantitative analysis   https://lnkd.in/eseFt8GZ   #nasdaq #acxp #antibiotics #acurx Acurx Pharmaceuticals, Inc. (Nasdaq: ACXP) David Luci

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Editas Medicine Medicine Announces $50+ Million Monetization Financing with DRI Healthcare Trust Strengthens balance sheet with non-dilutive capital to enable further pipeline development and related strategic priorities CAMBRIDGE, Mass., Oct. 03, 2024 (GLOBE NEWSWIRE) -- Editas Medicine, Inc. (Nasdaq: EDIT), a clinical-stage gene editing company, today announced the sale of certain future license fees and other payments owed to Editas Medicine under its Cas9 license agreement with Vertex Pharmaceuticals to a wholly-owned subsidiary of DRI Healthcare Trust (DRI) for an upfront cash payment of $57 million. The upfront cash payment brings non-dilutive capital to Editas Medicine, helping enable further pipeline development and related strategic priorities. “We are pleased to partner with DRI to monetize a portion of the licensing payments from the Vertex Cas9 license deal we announced last December, providing us with considerable non-dilutive capital that we can put to work immediately as we develop our pipeline of future medicines,” said Gilmore O’Neill, M.B., M.M.Sc., President and Chief Executive Officer, Editas Medicine. “We look forward to an ongoing relationship with DRI as we continue to execute our strategy.” Under the terms of the agreement, Editas Medicine will receive an upfront cash payment of $57 million in exchange for up to 100% of certain future annual license fees payable to Editas Medicine, ranging from $5 million to $40 million per year (inclusive of certain sales-based annual license fees that may become due) and a mid-double-digit percentage of Editas Medicine’s portion of a $50 million contingent upfront payment for which Editas Medicine is eligible under the Vertex license agreement. In addition to a portion of any such contingent upfront payment, Editas Medicine retains rights to fixed annual license fees for 2024 and a mid-single-digit million-dollar payment due to Editas Medicine in the event of Vertex’s achievement of certain annual sales milestones. https://lnkd.in/ecQYjKEH

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Despite a slight improvement, securing equity funding remains a hurdle for many #Biotech & #LifeSciences Companies Do you or any companies you know have: The following assets in development? A strong team with a clear vision? Complete our investment assessment form : https://lnkd.in/ewd47Tbt #biotech #lifesciences #investment #clinicalresearch #innovation

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A good post from Derek Lowe regarding Pfizer's missed opportunity with GLP-1 in the early 1990s. It came down to using needles. Many people who don't work in large companies can't appreciate how decisions, good or bad, come down to a few executives (if not one executive) that have deep ramifications to the economics of the company and treatment of needy patients. In this post Derek Lowe comments on Jeff Flyer's article that the reason for the Pfizer executive teams termination for Flyer's GLP-1 was due to unacceptable drug delivery system - inconvenience of another injectable for the treatment of diabetes. Market can tolerate only insulin as an injectable. Come back when you have developed intranasal or transdermal peptide delivery - a death sentence for a start up initiative, with techincal difficulty not appreciated by those uneducated / ignorant in the science of drug delivery formulation. Fascinating read.

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Proud to partner with Brian Weiss and his team at Carebox, who are enabling pharma sponsors, sites and advocacy groups to advance trial research and provide access to the latest treatment options for patients and caregivers in times of critical need. H.I.G. Capital’s investment represents Carebox’s first growth capital raise, and we are excited to provide the team with additional resources to continue their category-defining innovation path. Carebox addresses a significant market pain-point and provides a unique solution offering: ✅ Large and growing market opportunity - The pharma industry spent $230B on R&D in 2023 (growing to $270B by 2027), with $2B specifically on patient recruitment. Drug sponsors are increasingly disintermediating CROs and clinical sites to guarantee higher rates of enrollment, retention, and clinical efficacy. Additionally, clinical trials pipelines have shifted toward rare diseases, oncology therapies, and more complex therapeutic areas which require sick patients (vs. healthy participants). Participants for these trials are difficult to source and retain due to their low absolute occurrence rates and poor health. Many sponsors today leverage outsourced services businesses and in-house teams to manage the patient recruitment process, providing ample greenfield opportunity for Carebox’s self-service software offering and capture eligible patients at a cheaper cost-per-lead. ✅ Significant ROI - Patient recruitment and time to market are critical pain points in clinical trials for drug therapies, with failure rates of 48% to meet enrollment targets, 80% to meet enrollment timelines and 11% to enroll a single patient. These failure rates have led to increased trial costs and timelines, with US registered trial costs at $108B in 2023 (5-year CAGR of 5% and average cost per trial $14M) and the average duration to trial primary completion date increasing from 1.7 years in 2014 to 2.3 years in 2021. Not only do lengthier timelines increase costs, but it is estimated that there is ~$800k per day lost in revenue due to delayed trials. Carebox’s software offering provides more efficient, direct-to-patient intake and AI-driven matching to trials to get revenue producing therapies quicker to market. ✅ Differentiated product, with growing data moats - Carebox’s algorithm identifies patients for clinical trials, powers patient advocacy group referrals, and drives organic, high-intent traffic to patient-facing trial portals. This collection of products generates a data flywheel that reinforces the matching engine to drive better leads and higher rates of patient conversion into trials. CC: Albert Koh, Justin Marpole-Bird, Angela Chon, Emily Yu PR: https://lnkd.in/gfaTSz_f

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