J. Dean Zikria

Do not miss this webinar about how to make your scientific data #FAIRdata #sciencedata and #AIready - ZONTAL and the rest of the SciY companies can certainly help!

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#digitalisation and #automation of #biopharma #manufacturing workflows, leading to #smartmanufacturing - don't miss this Bruker #webinar in a few weeks, with Anna Codina Matteo Pennestri and Sergey Shilov

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🚀 Navigating the PMA Submission Process for Class III Medical Devices 🚀 Bringing a Class III medical device to market is a complex journey, and understanding the Pre-Market Approval (PMA) process is essential for success. Here’s a breakdown of the key steps: 1️⃣ Pre-submission Preparation Start by establishing clear communication and expectations with the relevant regulatory authority. Early interactions with the FDA or other health authorities (HA) can set the foundation for a smoother process. 2️⃣ Choosing a Submission Type Select the most suitable PMA submission pathway for your device. The choice depends on factors such as the device's risk profile and the amount of existing data. 3️⃣ Preparing the PMA Submission Assemble a comprehensive package that demonstrates your device’s safety and effectiveness. This documentation is crucial for the FDA’s review. 4️⃣ FDA Review and Approval The final step is navigating the FDA’s review process and securing approval to bring your life-saving device to market! 💡 The PMA process might seem daunting, but it ensures that only the safest and most effective medical technologies reach patients. #MedicalDevices #PMA #ClassIIIDevices #FDAApproval #RegulatoryAffairs #HealthcareInnovation #Compliance

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This edition of Orrick’s life sciences series reviews key venture investment trends in Q2 2024 and features a roundtable on ARPA-H, which funds high-impact biomedical research. https://lnkd.in/gEEXNwpf

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Insights from "Reality Check: DTx Investment Landscape, still hot or cooling down?" panel at LSX - partnering for Life Science eXecutives Things are improving. Some rounds are unannounced. The Click Therapeutics, Inc. deal with Otsuka Pharmaceutical Co., Ltd. is giving people some hope. So do DiGA companies in Germany. Now that there are no more public DTx companies, we need to reassess how to value DTx companies. When talking about DTx not having delivered, we should take into account the very unusual context in which past investments have taken place - low interest rates, Covid etc. This was bound to create disappointments. The crisis is actually helpful. It will weed out the weak companies. If we look at the Dotcom bubble bursting and the Financial Crisis, we saw that the recovery started 6-8 quarters after the crash. We are now in Q 8 after the start of the current crisis. So thinks will start to pick up again. We made 3 investments in the US in the last year and 2 in Europe. When we look at market access and regulation things are better now and are looking more promising than they ever have. So there are also bright sides! Competitive advantage is a combination of clinical outcomes and sophisticated go to market motion that does not try to boil the ocean. You have to think about targeting and segmentation. We ask: how many touch points are required until you can charge for your solution? How many people do you need to convince? How many clicks to potential users need to make to actually use your solutions? Pharma companies spend hundreds of millions of dollars to bring products to market. Why would believe that we can be successful with a tiny fraction of that? It does not have to be the same, but we need substantial investments to make significant progress. Pharma partnerships have generally been difficult. Pharma should invest in these DTx companies to have a real stake in their success. If you want to work with a pharma companies you can expect a year of scoping, a year of planning and year of implementation. When the pharma company is a big tanker, that yacht next to it is the 8bn acquisition target. DTx companies are a rubber ducky. They often don't know what to do with them. The NHS is sometimes likened to the Lannisters in Game of Thrones. They will pay you... eventually. As a bank we have a hard time getting comfortable with these super long sales cycles. Having something harmonised for DTx companies across Europe would make it easier to invest in DTx companies. This is even more difficult in Asia. In Europe we at least have the CE mark. Some people say: why would anyone launch in the US right now? That would be insane. As a DTx company Europe is where you should launch right now. Whether you focus on reimbursement or D2C focus on one market first. Do that exceptionally well and then move elsewhere. Andy Molnar, Josep Ll. Sanfeliu, Ingrid Teigland Akay, MD MBA, Dominick Kennerson, Erki Mölder, Shamik J Parekh

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The challenge of determining appropriate payment models for AI is not unique to payers and providers – it also affects pharma companies. Example: in clinical trials, pharma companies often hire expert human reviewers known as "central readers" to assess clinical trial endpoints. An expert gastroenterologist might review colonoscopy videos for a Crohn's Disease trial – a manual process that can take months. These reviewers are commonly paid per-read, hourly, or on a fixed fee basis. Interestingly, when a computer vision algorithm is used instead to perform these reviews (or as one of many reviewers), the payment model differs. Many pharma companies choose to pay based on the number of successful patient randomizations in the trial, rather than per read. This approach ties AI compensation to a downstream event that is actually influenced by multiple human factors, rather than the AI's direct performance. This phenomenon is interesting because (assuming performance equivalence) the AI delivers the same value as a human reader in less time. the output (i.e., determining whether a patient met the trial endpoint) is the same. However, the AI is compensated based on a broader metric of trial success, which may not solely reflect its efficiency or accuracy on the determined task, or factors that the AI can meaningfully influence. This example poses the question: should AI be paid for via the same structures as humans for performing similar tasks? My short answer is no. In many cases, traditional healthcare payment models (e.g., time-based billing) don't make sense for AI; partially because we are using AI to redesign task constructs altogether, but also because the payment models must be aligned with the actual value the AI is generating. Non-sensical (and at times, misaligned) business models seem to emerge when we hold AI to a higher, magical bar (above status quo human performance), or allow for AI scope creep (i.e., the assumption that AI will impact/fix everything in a workflow). In healthcare, what we seek to demonstrate first is human performance equivalence, robustness, value creation, and importantly, safety. The business models that support these demonstrations should reflect this.

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Model Medicines, is excited to propose a new standard for assessing the capabilities and potential of AI drug discovery companies: The AI Pharma Code. This set of criteria aims to differentiate the most promising players in the field and provide a comprehensive measure of their ability to revolutionize the drug discovery process. The AI Pharma Code consists of the following criteria: 1. New Biology/Target Discovery 2. New Chemical Entities 3. Zero-Shot Hit Rates >30% at <20μM 4. Tanimoto Scores <0.5 5. Pipeline Across Biology & Disease 6. Preclinical POC in Gold Standard Animal Model At Model Medicines, we are proud to adhere to The AI Pharma Code. Our proprietary GALILEO™ platform has enabled us to identify novel targets, such as the RdRp Thumb-1 site, and generate NCEs with an unprecedented 66.7% hit rate for pan-antiviral activity at a concentration well below 20μM in zero-shot learning experiments. Our AI-generated compounds have an average Tanimoto score of 0.32, showcasing their structural novelty and diversity. We have a broad pipeline spanning multiple therapeutic areas of oncology, virology, weight disorders, and rare diseases. Our lead asset, MDL-001, has demonstrated preclinical proof of concept in a gold-standard animal model. We believe that The AI Pharma Code sets a new bar for excellence in AI drug discovery, and we encourage our peers, partners, and investors to embrace this standard. By holding ourselves accountable to these rigorous criteria, we can accelerate the development of transformative therapies and realize the full potential of AI in revolutionizing the pharmaceutical industry. Join us in this exciting journey as we redefine the future of drug discovery and development! 🚀 #TheAIPharmaCode #AIDrugDiscovery Sean Russell Tyler Umansky Virgil Woods Navya Tippananapalya Ramesh Patrick ONeill Lani O. Bret Awbrey Thalia Gietzen Davey Smith, MD, MAS, FACP, FIDSA Tushar Menon, PhD David Garvey Launa Aspeslet 8VC Alex Moore Nex Cubed Kip Quackenbush Marlon Evans ParticleX Jeffrey Friedman Thermopolis Partners LLC Philip Treick Clayton E. Hartman Kevin Whalen Irving Investors Jeremy Abelson Andrew Kalmar Christopher Chism Delilah Panio Kristina M. Herbert, Ph.D. Greg Goldner Stephanie Walek Nick Phillips Paul Ostrowski Tim Lugo Greg White Fan Zhang, PhD Oivin Guicherit Stacie Calad-Thomson Ken Denman

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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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An ounce of #prevention is worth a pound of cure. #GLP-1s rule the healthcare market now, and is predicted by some to be a $100B market by 2030, and is likely here to stay for the long haul given the multitude of health benefits associated with weight lost. But if we truly want to tackle #obesity, we need to start thinking about what we should do for patients after they’ve lost weight. How can they keep the weight off, especially since weight rebound seems to be a common phenomenon post GLP-1 discontinuation? More fundamentally, how do we prevent weight gain in the first place? There are many people in situations in which weight gain isn’t a simple case of "letting yourself go". How can we keep these people from gaining weight and developing comorbidities that can dramatically increase their mortality rate? Read on to see how we at The Healthcare Syndicate think about life after GLP-1s and the innovations needed to advance weight gain prevention strategies: https://lnkd.in/g2sscVDd #healthcareinnovation #angelinvesting

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Ortho startups, The FDA is not your friend. You must understand that the FDA is a bureaucratic organization whose incentives are shaped by this history... A critical insight that companies often miss is that the FDA is primarily incentivized to avoid negative publicity and political fallout. The agency is deeply influenced by its historical experience, particularly the thalidomide tragedy, which has instilled a culture of extreme caution. This means that the FDA’s top priority is to avoid approving a device that could later be found harmful, which would lead to public scandal and congressional scrutiny. The result is a conservative approach that prioritizes minimizing risks over maximizing benefits.

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Regeneron is facing a critical strategic decision: Should they persist with the failed #strategy of cannibalizing Eylea 2mg sales with Eylea HD, or should they focus on protecting their $4.5B market share in Eylea 2mg from the onslaught of biosimilars by deploying aggressive incentive programs? In their recent conference call, Regeneron highlighted “stickiness” as a defense for retaining the Eylea 2mg market share—referring to the combination of brand loyalty and switching costs. However, as Ben Franklin wisely said, “To persuade, appeal to incentives, not reason.” For Regeneron, “stickiness” alone is unlikely to outweigh the power of incentives. So, will Regeneron choose to defend Eylea 2mg with incentives, or will they continue with their current strategy, risking significant market share loss? I’m not optimistic. As Charlie Munger aptly put it, “The inconsistency avoidance bias is a strong driver of human decision-making.” #retina #pharmaceuticals #ophthalmology

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Large pharma companies involved in the first U.S. negotiations over prices for the Medicare program said they do not expect a significant impact on their businesses after seeing confidential suggested prices from the government for their drugs that will take effect in 2026. Biden's Inflation Reduction Act, signed into law in 2022, the Medicare agency was required to identify the 100 most expensive drugs in the program, and industry perceived this as the government was "price setting" under the program and that the practice would harm innovation. If you have spent time on the commercial side of the drug industry one would know it is common for drugmakers to provide discounts off the list price based on sales volume, but those discounts are not made public. PhRMA and the U.S. Chamber of Commerce filed lawsuits to stop the prices from going into effect, which have largely failed, as expected, because price setting has been a flawed and political process," said Longo, spokeswoman for PhRMA. Recently, PBM and insurers have been under scrutiny for profits from prescription drug programs. The games continue into another political season. Thoughts?

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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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According to the latest Pitchbook data, venture creation in biotech hit its slowest quarterly pace in eight years during 1Q 2024. With just over 60 new biotechs raising their first round of financing, the sector’s company formation activity has slowed 50-60% from its historic peak in 2021. Thank you Bruce Booth for penning your views on why this is a good thing. -Contraction in venture creation IS a healthy dynamic for the sector. -We need to ensure that the best ideas are getting advanced by the sector. -Greater discipline should translate into better returns in the long term for LPs and GPs/ VC #Venturecapital #Startups

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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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Insights from the 'Mergers and Acquisitions in the Digital Therapeutics Industry" panel at Digital Therapeutics Alliance Summit RealizedCare: The strategic rationale can be completely different: - very similar companies, extending an existing portfolio building a larger platform - extend into a new market or business model ResMed: We have done over ten acquisitions in recent years. Sometimes it's about growing the core sleep apnea business. In other cases it was about extending into new complementary areas. DarioHealth : We wanted to expand from D2C to B2B2C. One was about expanding product and capability, the other was a pure tech acquisition. We always have to weigh: What do we want to do organically and what can be better done through acquisitions? This is a precious moment. We are always talking about how these are hard times. But now is the time to buy and build. It was in these moments of crisis that companies like Amazon and Google were built! We have had a steady flow of making acquisitions. I actually expect the momentum of this to pick up. We want to acquire more additional capabilities that allow us to serve new groups of customers, building out our platform. What's the lead time for your deals? - We did two deals. Both took about two years. - When we first make a strategic investment we see the company grow over time (so it can take many years to close a deal) and sometimes companies are offered to us by bankers (this can sometimes be done in a few months) - We have done four acquisitions and I would say you cannot generalise this. Culture is the number one success factor for post-merger integration. You need alignment on purpose, values and behaviours. When you build models and come up with synergies in Excel, culture does not show up anywhere! People say the culture does not change without hard work. I disagree with that. It can get much worse without you doing anything, when you suddenly have people on board that do not perform up to your standard. Target companies often open up their documents without going through them with an outside perspective. You should identify red flags ahead of time to avoid delays that could lead to the cancellation of a deal. If you have multiple business models and revenue streams, be very clear which of them will still matter post acquisition. Communicate clearly what it is that you are selling. Explain your commercial model like you are explaining it to a five year old. Buying a small startup company as a large acquirer you have to be able limit your exposure to risks and liabilities of the target (an acquirer will not want to take over contracts with uncapped liability). Prepare your team for the transition. Everything will change over night. People sometimes say: don't worry, nothing is going to change. That's nonsense. Post-acquisition things will be different. Insight from: Aaron Gani Wayne Janke Omar Manejwala, M.D. Susa Monacelli Gabriele Tundo

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Physicians can become investors in owning devices. KIC Ventures is a private equity healthtech investment firm with the world's largest portfolio of majority-owned differentiated spine technology companies. We remain committed to our founding strategy: identifying a Problem, Predicting the need for a better solution, and developing an innovative Product that drives global adoption and lasting value. To learn more www.KICventures.com Join the change. NANISX KIC Ventures FacetFuse Sacrix NanoFUSE Biologics Inspan Sagitechnology LESS Spine MISquito AxioMed #LESS #Spine #Surgery #exposure #lessexposurespinesurgery #technology #disc #discreplacement #tdr #adr #spinesurgery #physicians #orthopedic #spine #medical #medicaltechnology #nass #lasvegas #business #invest #equity #device #cervicalspine This post is for informational purposes only and does not constitute an offer to sell or a solicitation of an offer to buy securities.

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