Dara Grantham Wright, MBA

Revolo Biotherapeutics President & CEO Woody Bryan, Ph.D. made a bold decision to pivot the route of administration for his company's lead #peptide candidate in allergic diseases. On this week's episode of the #businessofbiotech, Woody and I discuss what happens at the intersection of patient centricity, enabling science, and #biotech business strategy. Tune in and subscribe wherever you listen to podcasts, or check out the videocast at utm_source=linkedin&utm_medium=social&utm_campaign=MSPutm_source=linkedin&utm_medium=social&utm_campaign=MSP Bioprocess Online Life Science Connect

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CureVac and MD Anderson find new ways in oncology The partnership between CureVac and MD Anderson Cancer Center has been in place since March of this year - very recently. An important step in our mission to develop mRNA-based therapies was on the horizon: the development of novel cancer vaccines that we hope will one day change the lives of many people. And that's where MD Anderson comes in - as one of the most respected cancer research centers in the world. Dr. Jeffrey Molldrem, the head of the ECLIPSE platform there, sees this partnership as “combining complementary strengths” - and we couldn't agree more. By combining our respective expertise, we can make faster progress. This partnership allows us to validate new immune targets and develop vaccines that provide much-needed treatment options. This is what the collaboration looks like in detail: 1/ CureVac's contributions Antigen discovery, mRNA design and production, supported by comprehensive genome and RNA sequencing. 2/ MD Anderson's contributions Translational research and clinical validation, guided by state-of-the-art bioinformatics and the specialized ECLIPSE program. Together, we are developing vaccines for various tumor types where the medical need for new treatment options is high. Our vision is clear: mRNA vaccines will one day have the potential to significantly improve outcomes for cancer patients. This partnership demonstrates the value of international collaboration in science - especially in a field as complex and promising as mRNA oncology.

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Another day another RNA deal... Boehringer Ingelheim is teaming up with Ochre Bio to work on multiple targets for liver disease, including MASH. Rather than silencing certain factors and pathways, Ochre is taking a different approach to enhance the liver's ability to regenerate, and therefore, potentially treat liver disease. The liver has always been a favorite target due to the capacity for LNPs to achieve hepatic delivery. As such, there are no shortage of companies working on similar approaches for MASH and other liver diseases such as Alnylam, GSK, Arrowhead, Ionis, and Novo Nordisk (Dicerna). This includes several candidates in clinical trials. But Ochre is the only one taking a non-silencing approach. Boehringer Ingelheim, no stranger to partnerships in the RNA space, must have seen something they really liked! #genetherapy #RNA #drugdiscovery https://lnkd.in/ghavaK9c

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Life Sciences-This Week: November 22, 2024 · Revvity Expands Partnership with Genomics England to Enhance UK Genomic Research ·  10x Genomics and Beckman Coulter Life Sciences Introduce Automated Single Cell Assay Solution ·  Leader Life Sciences to Distribute Bio-Techne Products in GCC Region ·  Halozyme, Inc. Proposes €2 Billion All-Cash Acquisition of Evotec   SUBSCRIBE to be notified of new episodes and watch prior episodes. https://lnkd.in/gkgVPgUs #LifeSciences #News #SAMPS

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Life Sciences-This Week: November 22, 2024 ·  Revvity Expands Partnership with Genomics England to Enhance UK Genomic Research ·  10x Genomics and Beckman Coulter Life Sciences Introduce Automated Single Cell Assay Solution ·  Leader Life Sciences to Distribute Bio-Techne Products in GCC Region ·  Halozyme, Inc. Proposes €2 Billion All-Cash Acquisition of Evotec   SUBSCRIBE to be notified of new episodes and watch prior episodes. https://lnkd.in/gkgVPgUs #LifeSciences #News

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A must read for those interested in understanding the landscape of companies seeking to deliver innovative ways of treating type 1 diabetes - and in Sernova's case, providing a 'functional cure' to T1D patients. Chris Sandburg from Insider Financial describes Sernova as: 'The best of breed in T1D....with the only proven vascularized device in clinical trials and the ability to scale their payload size with larger pouches. They currently have a $70 million market cap. The exit for SEOVF is a buyout over the $2.9 billion that SNY paid for an inferior asset. If there is no buyout, they will be able to license to a number of pharmas looking for an approved delivery vehicle for their stem cell lines as well as use of EVO’s stem cell derived islets. We see the big pharmas such as AZN, SNY, NVO are circling SEOVF as the company progresses. T1D is a huge market and buying best of breed in biotech can be a rewarding strategy. #T1D #CellTherapy #iPSC #Biotech

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Exploring Velocity's integrated model for clinical research in Latin America offers a fascinating glimpse into the future of Medtech trials. Here's a step-by-step look at how this model unfolds: 1. Strategic Expansion: Velocity's move into Latin America, led by Renata Berardocco, signifies a major step in their growth strategy, targeting Brazil, Argentina, and Mexico. 2. Local Expertise: With Renata's extensive experience, the focus is on building a strong network that leverages local talents and knowledge. 3. Technological Advancements: Velocity's commitment to technology enhances trial efficiency, facilitating access to large patient populations. 4. Impact on US Medtech: This expansion provides US Medtech companies with unprecedented opportunities to conduct early feasibility trials, supported by organizations like bioaccess®. 5. Future Prospects: With a proven track record, Velocity's integrated model promises substantial benefits for Medtech innovations globally. #ClinicalResearch #Medtech https://lnkd.in/eCx8zS9b

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LESS THAN 2 WEEKS AWAY, REGISTER NOW! (There is no cost to register) Register here 👇🏾👇🏾👇🏾 https://lnkd.in/epBSVG7G So far almost 100 people have signed up to hear how Aanika Biosciences, Inc. Biosciences, Inc. can bundle insurance coverage with novel technology. Working with us can: 1) Mitigate the adoption of new biologics or other technologies if you are a farmer / food company 2) Allow farmers and food companies to obtain simpler and less restrictive insurance coverage 3) And if you're developing new technologies in the food/ag space, can shorten your sales cyles differentiate your product! ***We will also be discussing a new application of insurance coverage bundled with our biotags which is just awesome, for lack of a better word*** This is a "can't miss" event if you're in the food / ag space. Jamie Richards, PhD Amol Deshpande Daniel J. Luciano, PhD Gurleen Sahansra Sam Pilkington #agriculture #foodsafety #cropprotection #biotechnology #insurance

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Are you attending the Sept. 25th San Francisco #AdvancedTherapiesXchange? Drawing on his 30+ years of experience leading immune cell operations, Kevin King, Senior Director of #CellandGeneTherapy Strategy and Growth at BioIVT, will be leading the 11:25am session “From Donor to Development: Minimizing Risks in the Cell Starting Materials Supply Chain” discussing strategies to de-risk the utilization of cellular starting and raw materials in the manufacture of #AdvancedTherapies: https://hubs.ly/Q02Qbz6B0 In the absence of industry-wide standardization of human cells, tissues, and cellular and tissue-based products (HCT/Ps), production and manufacturing processes are not equivalent among suppliers. This can create significant efficiency, quality and regulatory obstacles as therapeutic platforms transition from preclinical to clinical application. Kevin will also be joined by Lisa Kretzschmar, Senior Scientific Advisor for CGT at BioIVT, and Adam Ross, Technical Sales Specialist for CGT at BioIVT, for 1:1 meeting requests to discuss: - Why you need a partner that can take you from RUO to GMP - The value of having a geographically expansive, secure supply chain - The importance of donor diversity and its impact on your success - How BioIVT can support your CGT development, from discovery to clinical development Make sure to connect with our expert team if you’d like to schedule a meeting! Learn more about our CGT solutions: https://hubs.ly/Q02QbVwK0 #CellTherapy #GeneTherapy #ATMPs #hubXchange

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The top regional #healthcare and #biotech news for December 13th via the Big4Bio newsletters: San Diego: Exec Changes at Boundless Bio; Palisade Bio Prices $5M Offering; Upcoming Events https://lnkd.in/gszFjGvF SF Bay: BeiGene Inks $150M Deal; Gilead Sciences Names CMO; Alessa Therapeutics, Inc. Closes $15M https://lnkd.in/geqByjkM Seattle: Aptevo Therapeutics Inc Receives Funding Boost; Bill & Melinda Gates Foundation $5.9M Funds for Diagnostics Development; Upcoming Events https://lnkd.in/gqbQTZ8c Los Angeles: University of Southern California Secures $2.7M NIH Grant; MaxScientific's Innovation in Anti-Aging; Upcoming Events https://lnkd.in/gJtFqk_u Boston: iSpecimen Hires CEO; Layoffs at Editas Medicine; iTeos Therapeutics Drops Cancer Candidate; Keros Therapeutics Shares Collapse https://lnkd.in/gnf-gihH Philadelphia: INOVIO Pharmaceuticals, Inc. Prices $30M Offering; Transcenta's TNBC Data; Zelira Therapeutics' Path to Approval https://lnkd.in/gM8W4kPf Capital Region: Revolo Biotherapeutics Reveals Preclinical Data; Bringing Infectious Disease Tests to Market; Hot Investor Mandates https://lnkd.in/gHpgp3nH NYC: Pfizer's Blockbuster Scores; Intercept Pharmaceuticals Drug Faces Scrutiny; Padlock Therapeutics, Inc., Bristol Myers Squibb Dispute; HUTCHMED Hits Milestone https://lnkd.in/gJFm8CkV

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Antimicrobial resistance is making our battle against bacteria tougher than ever. To stay ahead in this arms race, we need advanced diagnostics to slow down evolving resistant strains

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Really enjoyed being on the Nephron Research LLC AI panel alongside ConcertAI CEO Jeff Elton on Wednesday in Napa. (Enjoyed wine tasting with Jeff even more, but the panel was fine, fine 🤪). Real World Data (RWD) companies like Concert are fascinating to me as they are at the top of what I think of as the omics stack: (4) RWD: collecting, curating, and selling omics data (e.g. ConcertAI) (3) LABS: onco DX (e.g. Natera) (2) BIOINFORMATICS: Upleveling raw omics data (e.g. DNAnexus) (1) EQUIPMENT: instruments and reagents (e.g. Illumina) IMO the RWD level is the best place to be: omics data sources are exploding: phenotypes from opened up EHRs and prescription data, genomes from lower cost sequencing, liquid biopsy, and increasing acceptance by the medical community of the need for onco DX in cancer treatment. RWD players like Concert are being rewarded for leveraging AI to bring order to these massive flows of disparate information. RWD customers - biopharma - are of course where the big money is and are increasingly hungry for data to drive their commercial and clinical decisions. And then of course there's my favorite new nascent RWD data market - massive training data sets for drug design AIs 👏 The power of the RWD data layer can be seen in Tempus AI with its $8B valuation that is both a lab providing NGS onco testing and a RWD provider. But their RWD revenue is higher margin and growing faster than their lab revenue. ConcertAI is a pure-play in that it doesn't do testing: data+AI only seems like a great model with the highest potential scalability. Margins will be good if they can buy data from 3rd parties at a decent price which can be challenge: the data owners like the big pharmacy chains have learned that the data they own has a lot of value so are driving harder bargains. Watching this space 🧐 🍿

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🚀 $MIRA MIRA Pharmaceuticals Announces Key Milestone in Ketamir-2 Clinical Development! We're thrilled to share an exciting update as MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA) accelerates its journey toward becoming a clinical-stage company! 🔬 Clinical Trial Site Selected: We've chosen The Centre for Human Drug Research (CHDR) in Leiden, The Netherlands, as the site for our Phase I/IIa trial for Ketamir-2, our novel oral ketamine analog. Recruitment begins in Q1 2025, and initial safety and efficacy data is expected in the second half of 2025. 💡 Why CHDR? Their cutting-edge PainCart® technology will allow us to assess early signs of Ketamir-2’s efficacy in healthy subjects during Phase I—a groundbreaking approach to pain management. 📋 Innovative Study Design: Our trial will include: Phase I: Focused on safety, tolerability, and early efficacy in healthy subjects. Phase IIa: Targeting diabetic neuropathy patients, with initial efficacy data anticipated in the first half of 2026. 🏆 Advancing Breakthroughs: Ketamir-2 has shown superior efficacy compared to existing drugs like pregabalin and gabapentin, offering a potential non-addictive, safe, and effective solution for pain and depression. 💪 Strong Financial Position: With a healthy balance sheet, MIRA is well-equipped to achieve these milestones without unfavorable financing deals. 📈 Looking Ahead: As we transition into a clinical-stage company, we remain dedicated to building strategic partnerships, advancing Ketamir-2, and exploring its potential across additional indications. 🔗 Visit our website to learn more: https://lnkd.in/eZNZzHR7 Together, we're redefining possibilities in pain and depression treatment. 🚀 #Pharmaceuticals #ClinicalTrials #Innovation #PainManagement #DepressionTreatment #Biotech #FDA

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Exciting developments in coronary disease treatment! Advanced NanoTherapies has unveiled the promising SirPlux™ Duo Drug-Coated Balloon (DCB). This innovative treatment, combining sirolimus and paclitaxel, aims to improve coronary health by preventing restenosis and keeping vessels open. The initial human trials at Cecanot Hospital in Santo Domingo have shown encouraging results. As ANT plans to conduct the DYNAMIC DUO I study in the US, the focus is on evaluating the safety and effectiveness of this cutting-edge technology. Medtech startups exploring early feasibility clinical trials in Latin America can benefit from bioaccess®'s expertise. Their services enable companies to navigate the complexities of clinical research in the region efficiently. Stay informed about these advancements and the potential they hold for global healthcare. 🌍💡 #Medtech #ClinicalTrials

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🌟 Breaking new ground in urology treatment! Resurge Therapeutics has launched its first-in-human study for a minimally invasive Benign Prostatic Hyperplasia (BPH) treatment in the Dominican Republic. The Problem: BPH affects around 40 million men in the US, causing uncomfortable urinary symptoms and potentially serious complications if untreated. Our Solution: Introducing an innovative local drug delivery system, designed to provide fast relief while minimizing side effects compared to traditional oral medications. This approach leverages years of expertise in drug delivery and urology to focus treatment directly where it's needed. The Result: If successful, this study could redefine BPH care, offering improved quality of life for millions. Our collaboration with bioaccess®, the sole Medtech-only CRO in Latin America, ensures top-tier execution of clinical trials, propelling medical device innovations forward. Stay informed about this groundbreaking journey! 🌍 #MedtechInnovation #BPHCare https://lnkd.in/eBRBebSg

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As a provider of specialized care for women for over 30 years, I'm excited to see a novel mechanism that has the potential to impact millions struggling with depression. Did you know that depression affects roughly two-thirds of females worldwide? With Arrivo BioVentures LLC championing SP-642, we may soon have an answer for better depression care. As a clinician, nothing is scarier than the 6 inches between someone's ears. There are no obvious hemorrhages or lab tests to assist in depression diagnosis. Solas BioVentures has placed a marker on this one as we collectively believe it is going to be game-on for depression and possibly other targets in CNS. Platform plays such as this program help patients tremendously, as depression seldom exists in a vacuum. Well done team Arrivo and big congrats on the first patient enrollment. Today we celebrate the first patient dosed in the Phase 2B clinical trial for SP-642! Read more about the trial and our progress here: https://lnkd.in/eFktp3QD #Depression #WomensHealth #SP624 #SIRT6 #MentalHealth

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In an era where medicine is as complex as the diseases it aims to treat, involving patients isn't just beneficial—it's imperative. Patient insights drive the development process, from initial design to regulatory approval. This approach isn't just about compliance; it's about crafting therapies that genuinely help those who need it. When patients are the cornerstone of our development strategy, it leads to faster trial enrollments, particularly in rare diseases. It helps us navigate the regulatory landscape more effectively by aligning early with patient needs and expectations.

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