Julia D.

Next year's theme focuses on fast-tracking solutions to drastically cut emissions through the use of bio-based fuels and chemicals to produce a wide array of products and materials that are currently derived from hydrocarbons. It's a call to action for a sustainable, net-zero future. #ScalingUp

13

Marc-Henry PITTY, MD, CEO of Oregon Therapeutics, "To date, our first-in-class #metabolicinhibitor, XCE853, has exhibited robust preclinical efficacy in both in vitro and in vivo models across multiple #cancer types. Lantern’s (NASDAQ: LTRN) #RADR®AI platform will leverage the in vitro and in vivo data to potentially advance XCE853 development in a highly targeted manner and will help inform disease indications and #biomarker signatures that can aid in the design of future #clinicaltrials and in the pursuit of combination therapies with other approved cancer drugs. Our team is looking forward to efficiently selecting among the landscape of ideal development options and efficiently de-risking future clinical development decisions." https://lnkd.in/g8XPQSsa #biotech #france #texas #oncology #artificialIntelligence

6

Are you grappling with the complexities of regulatory requirements and standards for cell therapies? How are recent FDA Guidance documents impacting your development strategy. Join us at CHI's 9th Annual Cell Therapy CMC and Analytics conference (part of the #chiBioprocessingSummit) on August 19-20 at the Sheraton in Boston to discover advanced strategies from top industry leaders. Reasons to Attend:  - Discover regulatory insights with Steve Bauer of @Wake Forest Institute for Regenerative Medicine.  - Dissect recent FDA Guidance documents with Scott Burger from Advanced Cell and Gene Therapy LLC - Learn about cell therapy advancements at Dana Farber with Felicia Ciuculescu.  - Explore the latest analytical standards with Laura Pierce of NIST.  - Engage in pivotal discussions on raw material quality with Ben Clarke of USP.  - Understand the critical aspects of biological raw materials with Christopher Bravery of Advanced Biologicals Ltd.   Click here to review the final speakers and abstracts, learn more about how you can get involved. https://lnkd.in/dvzQtz5   We also invite you to make the most of your time by attending the Cell Therapy Manufacturing track, taking place August 21-22 as part of the Cell Therapy stream.  The Bioprocessing Summit in Numbers: - 14 𝐂𝐨𝐧𝐟𝐞𝐫𝐞𝐧𝐜𝐞 𝐓𝐫𝐚𝐜𝐤𝐬 including a new stream on "AI and Digitalization" - 300+ 𝐏𝐫𝐞𝐬𝐞𝐧𝐭𝐚𝐭𝐢𝐨𝐧𝐬 across the spectrum of biologics, gene, cell, and mRNA therapies - 90 𝐄𝐱𝐡𝐢𝐛𝐢𝐭𝐨𝐫𝐬 showcasing innovative bioprocessing technologies and services - 100+ 𝐑𝐞𝐬𝐞𝐚𝐫𝐜𝐡 𝐏𝐨𝐬𝐭𝐞𝐫𝐬 revealing the latest in biomanufacturing and analytics - 𝐓𝐰𝐨 𝐏𝐥𝐞𝐧𝐚𝐫𝐲 𝐒𝐞𝐬𝐬𝐢𝐨𝐧𝐬 tackling the current and future challenges in bioprocessing

15

https://lnkd.in/gnzREG8x New article in Nature by Michael Eisenstein puts a spotlight on using AI to drive cancer therapy selection. TL;DR AI algorithms are already analyzing a complex array of data – from imaging to genomics – to predict patient response to specific therapies, esp. immunotherapy. Early results are impressive, with some models beating traditional methods in identifying ideal candidates for these powerful drugs. A few thoughts: The current fiasco around Google Search's "AI Overview" recommendations (e.g. eat a rock a day, put glue on your pizza) reminds us of the potential pitfalls of using AI in healthcare--nebulous "black box" models and biased algorithms can have dire consequences for patients. The key hurdles? 👉 Limited, fragmented data 👉 A lack of explainability in AI predictions We can help mitigate some of these problems through democratizing AI innovation in oncology by empowering more local institutions (and their datasets) to identify patterns and insights within local populations, define and test their hypotheses, and eventually investigate and publish their research. Ensuring "algorithmic equity" vis-à-vis more diverse datasets is essential: AI models trained on historical data risk perpetuating existing healthcare disparities. Oncologists need to understand the "why" behind an AI recommendation--not just the "what." So AI models need to be developed in collaboration with oncologists with a "clinician-in-the-loop" (CIL) approach--not just by data scientists and researchers. More patient-centric insights can be integrated into the model design, ensuring recommendations are clinically relevant and interpretable. So is AI in oncology experiencing growing pains or a golden age? The Google Search snafu suggests caution, but the promise of AI-powered cancer therapies is undeniable. IMO the path forward requires transparency, collaboration between clinicians and data scientists, and a relentless focus on inclusivity. What are your thoughts? #Oncology #AI

27

2 Comments

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

28

1 Comment

Great to see diagnostics companies being recognized as “cool” Diagnostics tools aren’t just about “diagnosing disease” - these tools have tremendous power to transform health by helping people before disease states start. They epitomize the intersection of medicine and public health through enabling proactive / preventive medicine. And what’s even cooler - they are built on amazing engineering foundations from biochemical to mechanical to software and AI.

19

2 Comments

Bob Nelsen, co-founder of ARCH Venture Partners, emphasizes the firm's pursuit of home runs in drug development.... ...ARCH's recent $3 billion fund, slightly larger than the previous $2.97 billion fund, reflects the firm's focus on groundbreaking ventures like AI bio Xaira Therapeutics. This spring, Xaira Therapeutics raised $1 billion, marking one of biotech's largest company launches... ...Nelsen highlighted the thorough diligence process by LPs, despite the challenging investment landscape. Noteworthy developments coincide with ARCH's fund announcement, including a potential FDA approval for a schizophrenia treatment from one of its neuroscience bets. The firm's strategic approach continues to draw attention in the venture capital landscape, alongside recent fund announcements by other industry players. ARCH Venture Partners #advancedtherapies #funding #financing #biotech #biotechnology #regenerativemedicine #lifesciences #lifescience #celltherapy #genetherapy #geneticmedicine Bain Capital Flagship Pioneering #venturecapital #duediligence

20

2 Comments

Join A Growing Community of World-Class Entrepreneurs. Biotech Labs. Tech Workspaces. Medical Offices. At Colorado Health & Tech Centers (CHTC), we are a premier hub for a diverse array of companies specializing in health and technology, allowing you to expand your network and spur your innovation. Join the world-class CHTC network and discover the power of collaboration in the life science and biotechnology sector. https://coloradohtc.com/ #Denverrealestate, #biotechnology, #Pharmaceutical, #biotech, #pharma, #innovation, #tech, #Technology, #CBSA, #CoBioscience, #cro , #cdmo , #laboratory,  #relocationspecialist, #Medicaldevice, #entrepreneurship, #startups, #culture, #HR, #partnerships, #LetsWork, #Whatinspiresme, #Productivity, #socialentrepreneurship, Babak Kia, Thomas Malcolm, Danny D. Martinez

21

3 Comments

At the frontier of biotech innovation, synthetic biology promises revolutionary advancements in agriculture, health and medicine, energy, and more. Check out the video Scope & Sequence produced for Stanford Emerging Technology Review (SETR) . For more information about emerging technologies and SETR click here: https://setr.stanford.edu/ #biotech #explanationvideo

4

It is hard to see what activist investor Starboard’s objectives are vis a vis Pfizer. After years of indifferent leadership that focused on cost-cutting rather than innovation, Pfizer finally brought in Albert Bourla who seems to have re-invigorated the company, its science and its business development deal-making. He also literally saved the world through its effective vaccine, delivered within mind-bogglingly record time. After the vaccine was successful in doing what it was supposed to, Pfizer unsurprisingly saw a return to some of the revenue challenges caused by the pre-Bourla years of lack of innovation. Now comes Starboard with seemingly no understanding or plan, trying to rope in the pre-Bourla leadership. To no one’s surprise, Starboard was met with scepticism and ridicule - and Ian Read and Frank Amelio clearly and rapidly saw their return was unwelcome. Now it is time for Starboard to also head home and redirect their energies to things they actually understand. Please let Bourla get back to remaking Pfizer and to restoring its iconic position in the biopharma world. #pfizer #activistinvestors #biotech #innovation

5

25 Comments

check out today's top news Investorideas.com- News that inspires big investing ideas Transformative #Biopharma #Stocks - Citius Pharmaceuticals, Inc. (Nasdaq: CTXR), Vertex Pharmaceuticals (Nasdaq: VRTX), CRISPR Therapeutics (Nasdaq: CRSP), Recursion (NASDAQ: RXRX) #biotech #pharma #stockstowatch #ai #crispr   July 11, 2024 (Investorideas.com Newswire) Investorideas.com, a go-to investing platform releases the first of a two-part series looking at transformative innovation in biopharma, featuring Citius Pharmaceuticals, Inc. (Nasdaq:CTXR), a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products. The Company's diversified pipeline includes two late-stage product candidates. The global biopharmaceutical market size was USD 411.4 Billion in 2022, 436.7 Billion in 2023 and analysts say it will grow at 15, 4% from 2024 to 2033. Looking at key trends in the sector, including AI and CRISPR, Labiotech reports, "2024 stands as a pivotal year that could potentially mark a turning point in the biotech industry. With the right blend of innovation, collaboration, and regulatory oversight, the industry is well-positioned to harness these emerging trends and transform the landscape of healthcare and therapeutic interventions. The future of biotech is not just about technological advancements, but also about how these technologies are integrated responsibly and ethically into our healthcare systems to create a healthier, more sustainable world." Citius Pharmaceuticals, Inc. (Nasdaq:CTXR) just announced expected milestones in the second half of calendar 2024 and recapped key achievements year-to-date. Leonard Mazur, Chairman and CEO of Citius stated, "Our solid execution since the beginning of the year sets us up for potentially transformative catalysts in the coming months. Mino-Lok's strong Phase 3 topline results support its potential to become part of the standard of care for treating catheter-related bloodstream infections. Mino-Lok would also have a first and only advantage in a market with no approved or investigational products for salvaging infected central venous catheters. For LYMPHIR™, the FDA is currently reviewing our Biologics License Application, with an expected decision on August 13th. We are preparing for near-term commercialization of LYMPHIR if approved. These near-term catalysts should enable the company to optimize its current cash runway, future cash needs, as well as create potential non-dilutive cash opportunities." Paid news dissemination for Citius Pharmaceuticals.

4

Unveiling the Percent Epitope Accessibility (PEA) Calculator Proud to announce the development of an innovative web tool designed to revolutionize peptide vaccine research — the PEA Calculator! The PEA Calculator is a specialized platform for evaluating the Percent Epitope Accessibility (PEA) of vaccine candidates, focusing on how accessible the epitopes are to the immune system. Built using the powerful capabilities of NACCESS for solvent-accessibility predictions, this tool bridges the gap between computational predictions and practical vaccine design. Why is PEA important? In peptide vaccine development, identifying epitopes that are highly accessible to immune cells is crucial for triggering robust immune responses. PEA provides a quantitative measure to assess these regions, offering insights into their potential immunogenicity and suitability for vaccine development. 💡 How does it help researchers? The PEA Calculator is designed to: 1️⃣ Streamline epitope accessibility analysis. 2️⃣ Provide accurate and reliable results to guide vaccine design. 3️⃣ Simplify complex processes for researchers, making vaccine optimization more efficient and user-friendly. 👩‍🔬💻 Whether you're an immunologist, computational biologist, or a researcher in vaccine development, the PEA Calculator is here to simplify and enhance your workflows. Stay tuned for more updates on how this tool, and others in the pipeline, will contribute to the field of immunoinformatics and beyond! Find PEA Calculator here: https://lnkd.in/gvF2si8N #VaccineResearch #EpitopeAccessibility #Bioinformatics #PeptideVaccine #Innovation #Immunology #ComputationalBiology

20

Hierarchical Encoding for mRNA Language Modeling (HELM): A Novel Pre-Training Strategy that Incorporates Codon-Level Hierarchical Structure into Language Model Training Messenger RNA (mRNA) plays a crucial role in protein synthesis, translating genetic information into proteins via a process that involves sequences of nucleotides called codons. However, current language models used for biological sequences, especially mRNA, fail to capture the hierarchical structure of mRNA codons. This limitation leads to suboptimal performance when predicting properties or generating diverse mRNA sequences. mRNA modeling is uniquely challenging because of its many-to-one relationship between codons and the amino acids they encode, as multiple codons can code for the same amino acid but vary in their biological properties. This hierarchical structure of synonymous codons is crucial for mRNA’s functional roles, particularly in therapeutics like vaccines and gene therapies. Researchers from Johnson & Johnson and the University of Central Florida propose a new approach to improve mRNA language modeling called Hierarchical Encoding for mRNA Language Modeling (HELM). HELM incorporates the hierarchical relationships of codons into the language model training process. This is achieved by modulating the loss function based on codon synonymity, which effectively aligns the training with the biological reality of mRNA sequences. Specifically, HELM modulates the error magnitude in its loss function depending on whether errors involve synonymous codons (considered less significant) or codons leading to different amino acids (considered more significant). The researchers evaluate HELM against existing mRNA models on various tasks, including mRNA property prediction and antibody region annotation, and find that it significantly improves performance—demonstrating around 8% better average accuracy compared to existing models. The core of HELM lies in its hierarchical encoding approach, which integrates the codon structure directly into the language model’s training. This involves using a Hierarchical Cross-Entropy (HXE) loss, where mRNA codons are treated based on their positions in a tree-like hierarchy that represents their biological relationships. The hierarchy starts with a root node representing all codons, branching into coding and non-coding codons, with further categorization based on biological functions like “start” and “stop” signals or specific amino acids. During pre-training, HELM uses both Masked Language Modeling (MLM) and Causal Language Modeling (CLM) techniques, enhancing the training by weighting errors in proportion to the position of codons within this hierarchical structure. This ensures that synonymous codon substitutions are less penalized, encouraging a nuanced understanding of the codon-level relationships. Moreover, HELM retains compatibility with common language model architectures and can be seamlessly applied without major...

1

Advances in molecular format complexity and the need for higher protein concentrations in biotherapeutics present significant formulation challenges. Predicting protein behavior at high concentrations and the risks like high viscosity or aggregation remain challenging. Computational approaches are gaining popularity for biologics screening, while automation offers opportunities to accelerate formulation development. Join our 11th Annual Protein Stability & Formulation conference (https://lnkd.in/dtUXhBmG) at #PEGSEurope to learn from industry experts like Benjamin Weiche, Giuseppe Licari, Kannan Sankar, and Maurizio Baldassarre. #formulationdevelopment #insilico #computational https://lnkd.in/dtUXhBmG

10

🚨 Tempus to Acquire Ambry Genetics: A Strategic Bet on Genomics Expansion 📈Tempus AI’s Q3 results signal solid growth, with a 33% YOY revenue boost, but the $600M acquisition of Ambry Genetics—partially debt-financed—presents both opportunity and risk. 🧬Ambry Genetics‘ expertise in hereditary cancer testing and inherited disease coverage could strategically bolster Tempus’ offerings across pediatrics, cardiology, and rare diseases. 💵Yet, with a $75.8M quarterly net loss, this acquisition is a high-stakes move to accelerate growth in an increasingly competitive precision medicine landscape. 🔗https://lnkd.in/dEs3YxMn #Genomics #PrecisionMedicine #AI #StrategicGrowth

29

What a pleasure to see Alexandra Snyder, MD and share insights on how #AI is revolutionizing the #drugdevelopment industry, with its ability to surpass human intelligence and generate new ideas. Thank you HCW for hosting the AI panel discussion, with partners at Nasdaq. ❓️how can we take advantage of this technology? Defining your requirements to the target, to a novel molecule, and setting expectations to clinical development are crucial to successfully deploying AI in #clinicalresearch. ❓️Can we cure #cancer with #AI? The heterogeneity of disease in a single cancer sub-set of population is mind-blowing, let alone in multiple cancers. The power of AI is evident in its ability to capture the extent of this heterogeneity and help with strategic development path of a program. ❓️What do we need to be able to use AI? To fully appreciate its potential, we need the infrastructure and tools to deploy information and analytics. #ArtificialIntelligence #healthcare and ##drugdevelopment #innovation #endpoints and #analytics

43