Sheila Ann Mikhail

“One of the key things that has delayed a fair number of (cell and gene therapy) approvals over the course of time has been issues related to potency”. This is a quote from a highly respected FDA Director made during an all-day working session organized by the Alliance for Regenerative Medicine (ARM) and the American Society of Gene & Cell Therapy (#ASGCT) in October 2022. An industry representative further added “At the end of the day, we’re all here because we think potency assays could be improved both by us and by the regulators. We understand that they are a hurdle to getting these drugs rapidly to patients, and we ultimately serve the patient”. Almost 2 years have passed since then. Has anyone in the meantime identified solution that go beyond mere individual analytical measures, and instead give a more holistic view on the potency of a cell therapy (in a form factor that can be used during R&D as well as during routine manufacturing QC release)? Looking forward to hearing your thoughts on this, Benjamin McLeod, Shivali Joshi, Qiang Qin, Van Hoang, Zhu Pirot, Shibani Mitra-Kaushik, Yves Peeraer, Tim Desmet. Want to read more: https://lnkd.in/eDbjuRpj imec.xpand #ATMP #potency #GeneTherapy #HealthTech #celltherapy #CARTcell #biotechnology #innovation #science

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Investment, therapeutic viability, and next-gen. technologies... That's what the cell therapy field needs. I had the pleasure of sitting down with Jason C. Foster of Ori Biotech recently on their podcast to talk all things cell therapy, the enabling technologies that support this modality, and the need for more investment. What did we touch on (and link to full podcast below)? Investors needing to see a return when investing in cell therapies. Need to bring manufacturing costs down to expand access. Next-gen. tools to create better, more robust therapies. Purpose-built therapies require purpose-built tools! Our consulting practice, how we help our clients, and how we view the field of advanced therapies. We take a differentiated approach to tracking, following, and mapping key trends across advanced therapies to bring novel, business-impacting insights to our clients. Want to discuss any of the above? Where the field of cell therapies are going? What it means for your own development pipeline? Reach out and let me know what you think in the comments! #celltherapy #venturecapital #consulting https://lnkd.in/g7SH9FAU

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Ursheet P. from Mayfield Fund message to early founders: Don’t try to do it all on your own. You can get to scale faster, cheaper, and more efficiently through partnerships, collaborations, and outsourcing. Focus on your core capabilities and look externally to execute on scalability. #synbiobeta2024

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🔬 Dive into cutting-edge biotech advancements for autoimmune diseases with this detailed mind map. 🌟 Stay on top of the latest developments and lead the way in the field! Check it out nowo

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Also in This Issue: The single-drop pan-diagnostic is back (for real this time) Early Cancer Detection tests - ready for prime time? Adding liquid bx to standard tumor staging acronym Bird flu update #sensitiveandspecific #diagnostics #genetics #genomics #personalizedmedicine #infraredspectroscopy #proteomics #biomarkers #diseasedetection #birdflu #H5N1 #MCED #MCEDtest #earlydetection #liquidbiopsy #olympics #wastewatersurveillance

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Clinical decision support systems (CDSS) are transforming healthcare by making prescribing safer and more effective. Here are some key benefits: 📉 Reduced Errors: CDSS reduces medication errors by 55% and improves prescription appropriateness by 60% . 🔬 Pharmacogenomics Integration: By incorporating pharmacogenomics, CDSS can consider genetic factors alongside clinical data, ensuring personalized and effective treatment plans. This integration promotes adoption across healthcare providers, highlighting the importance of tailored therapy. 🤝 Interdisciplinary Support: They provide evidence-based recommendations and patient-specific information, benefiting interdisciplinary healthcare teams and improving patient outcomes. 📋 Optimizing Prior Authorization: CDSS plays a crucial role in streamlining the prior authorization process for specialty medications. By automating and optimizing approval workflows, CDSS reduces delays and administrative burdens, ensuring timely access to essential therapies for patients . 🤖 Advanced Analytics: With the integration of machine learning, CDSS promises even more accurate and personalized decision-making, though it requires transparency and rigorous evaluation . #HealthcareInnovation #ClinicalDecisionSupport #PatientSafety #MachineLearning #HealthTech #PrescribingExcellence #priorauthorization #precisionmedicine STRIPE GenXys

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In 2022 when Illumina and GRAIL leadership where touting how many lives would be saved if only the antitrust authorities got out of the way, here's what was really happening. Please read carefully, shows how this "life saving" test doesn't work: "[With the] San Francisco firefighters, the test did not identify the statistically expected number of cancers, provided false positives for half the cancers it did identify, and missed at least three cases of confirmed cancer. In other words, the exercise showed Galleri to be a disaster." "In this example prominently featured on GRAIL’s website and in marketing materials as an example of how “multi-cancer early detection screening can be critical for those at elevated cancer risk”—GRAIL provided 1,786 screenings to a group of San Francisco firefighters and their family members, a “high risk” group for certain kinds of cancer. During that testing round, which was conducted on December 6, 2022—Galleri generated six false positives and identified only five instances of cancer." "...such a result is alarming in light of the fact that, based on statistical experience, cancer should have been detected in about 29 (not five) of the 1,786 tests. Moreover, of the five instances of where cancer signals were identified, two individuals already knew they had cancer to begin with. Further, all of the instances of detected cancer were at a “late stage,” and where the cancer was too advanced to make a difference for the patients. One firefighter was diagnosed with stage 3 pancreatic cancer and is now in hospice, while another firefighter was diagnosed with lung cancer, which has now metastasized to the brain." "Galleri also missed at least six instances in which the San Francisco firefighters actually had cancer—failing to identify instances of melanoma, prostate cancer, and lymphoma that were identified by private doctors just months after the Galleri test indicated “no cancer signal.” "Further, in one instance in the San Francisco firefighters screening where Galleri generated a false positive, the patient underwent a painful bone marrow biopsy procedure to determine whether the patient did have cancer. In that case, the patient’s bone marrow biopsy procedure, clinically shown to involve “unbearable pain” to the “worst possible pain” a patient can experience, revealed that there was, in fact, no cancer." "The screenings provided to the San Francisco firefighters were an expensive “disappointment.” According to Tony Stefani, the organization’s founder, the screenings demonstrated that the probability of catching an early-stage cancer through the Galleri test was “negligible,” and the screenings only caught “some serious cancers at a later stage,” which likely would have been detected within one or two months without the test. Given the test’s high costs and useless real-world performance, Stefani stated that Galleri was a total “disappointment” and that the foundation had been sold a “bill of goods.” 🤯🤯🤯

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What a thrill for us to be recognized as a finalist in the Transformational Therapy Category at the Biotech Week Boston Awards gala last night!   Our team at Indaptus Therapeutics, Inc. is passionate about re-thinking cancer treatment by developing innovative therapies that challenge conventional precision and targeted approaches. We're pushing boundaries, and it’s exciting to see our efforts acknowledged alongside some of the industry’s top innovators. Chaunte Lowe, OLY, a 4-time Olympian and cancer survivor, set an inspiring tone as host. Her resilience and story of overcoming adversity resonated with everyone in the room, and served as a powerful reminder of the perseverance it takes to innovate and save lives. It was also great to reconnect with a legend in the field of immunotherapy, Arthur Krieg from Zola Therapeutics, and talk about his latest work.  It’s fascinating to listen to someone who has been at the forefront of innovation for so many years, and I always learn something new every time we speak. And a special shoutout to Adam Thomas (he/him) from MOMA Therapeutics. Besides being a fantastic presenter, he surely should have won a "best dressed" award for his sharp kilt! Though we didn’t bring home the award this time, it was a privilege to be a finalist and celebrate the accomplishments of everyone attending.  Congratulations to all the winners, and here’s to continuing our shared mission to drive forward life-saving innovation.   #BWBAWARDS #IndaptusTherapeutics #Biotech #LifeSciences #CancerResearch #NeverGiveUp

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Proud to have fellow Biotechnology Innovation Organization board member and Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) CEO Frank Watanabe testify at the House Ways and Means Committee hearing on July 12th in Salt Lake City. Frank highlighted the contributions the biotech industry has made to human health and the economy: "In the last quarter century, American life expectancy has continued its steady increase upwards, with roughly one-third of that improvement directly attributable to biopharmaceutical innovations.” The big picture: The industry’s direct and indirect contribution to the U.S. GDP is anywhere from 2-7%, with an economic impact of $2.9 trillion in 2021. Biotech capabilities enhance national security by ensuring we can care for ourselves. Legislative proposals that would support innovation include: - The Ensuring Pathways to Innovative Cures (EPIC) Act, which would give small molecule drugs the same 13-year protection from price controls as biologics, and the ORPHAN Cures Act, which would exempt orphan drugs from price controls even if approved for more than one indication. - The Tax Relief for American Families and Workers Act (H.R. 7024), which was passed by the House earlier this year, to restore the R&D tax deduction. Allow for monetization of net operating losses (NOLs) and reform Section 382 on NOLs. - Improve the capital gains exemption under Section 1202 to encourage investment in small biotechs. - Ensure strong strong patent protections and reasonable regulation of M&A activity. Proud of the work BIO does to support the industry, and proud to be a part of community that works tirelessly to drive innovation and improve human and planetary health. #patientsfirst #biotechnology #innovation #humanhealth #sustainability

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Prof. Ehrlich, we found the targets for your magic bullets! We updated our video from three years ago and posted it on our new website, https://www.fbbbio.com. #venturecapital #angelinvestor #cancer #hivaids #bioOS #biotechnology #diagnostics #innovation #technology #management #startups #liquidbiopsy #neurodegenerativediseases #multiplesclerosis #parkinsonsdisease #alzheimersdisease #longhaulers #longcovid #humangenome #onetestonelife #longevity #artificialintelligence #rna #rnaseq #personalizedprevention OK

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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

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Interested in the latest developments at the FDA's Office of Therapeutic Products (#OTP)? Join a free, public webinar on June 14th featuring Dr. Nicole Verdun, OTP's Super Office Director, and Rachael Anatol, Ph.D., Deputy Super Office Director. What you'll learn: The new "Super Office" structure of the OTP Progress on hiring new staff An overview of the OTP's organization Brought to you by Alliance for Regenerative Medicine. Please use the link in the post below. #celltherapy #genetherapy #cellandgenetherapy #advancedtherapies #lifescience #lifesciences #regulatory #structure #biotech #biotechnology #webinar #productupdate #regulatorystructure

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Epoch 38: BIOTECH HEALTH - IS UP REALLY UP? 👉 Macro - rates and elections 👉 Deal valuation comps 👉 Pharma exit activity metrics https://lnkd.in/dEkBy2bY

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