Meghan Swardstrom

Oragenics, Inc Partners with Avance Clinical for Phase II Concussion Trial in Australia SARASOTA, Fla., May 07, 2024 (GLOBE NEWSWIRE) -- Oragenics, Inc. (NYSE American: OGEN), a pioneer in developing innovative intranasal pharmaceuticals for neurological disorders, today announced a partnership with Avance Clinical, a leading Contract Research Organization (CRO), to conduct a Phase II clinical trial in Australia. This trial aims to evaluate Oragenics' lead drug candidate, ONP-002, for mild Traumatic Brain Injury (TBI), commonly known as concussion. ONP-002, a novel chemical entity (NCE), is delivered through a unique intranasal device and designed to maximize drug delivery directly to the brain. Avance Clinical, renowned for its clinical trial management capabilities and quality of service in Australia, New Zealand, and North America, brings over two decades of expertise in navigating the Therapeutic Goods Administration, Food and Drug Administration, and European Medicines Agency regulatory landscapes. An Oragenics Phase I clinical trial, recently completed in Australia under the management of Avance Clinical, demonstrated that ONP-002 is safe and well-tolerated. "Concussion remains a significant unmet medical need," said Dr. Jorgen Mould, Senior Director of Scientific and Regulatory Services at Avance Clinical. "Oragenics is poised to address this challenge, and we are delighted to be part of the team, especially given Australia's high incidence of sports-related concussions." Read the full Press Release 👇 https://lnkd.in/geAB5kMV #AvanceClinical #CRO #Concussion #Biotech #DrugDevelopment #Oragenics #TraumaticBrainInjury #TBI #SportsInjuries #Australia #AustralianAdvantage #ClinicalTrials #ClinicalResearch

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Exciting times in the world of immuno-oncology! 🎉 Kumquat Biosciences and Takeda join forces in a groundbreaking pact with over $1.2 billion at stake. 🤝🔬 This alliance brings together a pioneering biotech and a pharmaceutical giant, spotlighting a promising small molecule inhibitor. As Kumquat completes phase 1 trials, Takeda stands ready to propel development and commercialization to new heights. 💡 The potential here is immense - not just in financial terms with up to $130 million in near-term payments for Kumquat, but in the true value that such medical advancements can bring to cancer treatment. 🌟 A testament to strategic collaborations, this partnership reiterates our collective commitment to innovation in the battle against cancer. 🔍💊 #ImmunoOncology #PharmaPartnerships #Innovation #Takeda #KumquatBiosciences

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Looking forward to attending #ASH2024 this year. Let's connect and I can share with you how TD2 can support your next trial. 🔗https://hubs.li/Q02YXgqv0 #HematologyOncology #ClinicalTrials #OncologyCRO #BloodCancerResearch #DrugDevelopment #PrecisionOncology #ClinicalTrialSolutions

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Didn't catch our webinar? Watch the recording! Beatriz Rocha & Teresa Oblak from Fortrea explain the newest FDA guidance on diversity in clinical trials. https://gag.gl/HBHm7o #FDA #Diversity #ClinicalTrials #webinar

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Topic 24 - How to Select the Perfect Clinical Trial Sites When planning a clinical trial, choosing the right site is as much an art as it is a science. Your site selection impacts recruitment speed, trial credibility, and long-term strategic partnerships. Here's how to get it right: 1)    Start at the Top: Premier institutions are a must. They lend credibility, attract top-tier talent, and make forming a clinical advisory board around the site’s principal investigator (PI) much easier. Many KOLs (key opinion leaders) at these institutions also advise major pharma players—valuable for future strategic partnerships. 2)    Find the Best Fit: Identify which premier centers have leading KOLs in your therapeutic area (TA). Engage these experts early. Ask for their insights on the best PIs—they’ll often point you in the right direction. 3)    Do the Math: Estimate the patient enrollment numbers you’ll need and share your inclusion criteria with the KOLs. Ask if their site can realistically meet these targets. Patient recruitment and retention are critical, and it’s better to address potential bottlenecks now. 4)    Avoid the Common Pitfall: During a conversation with a CEO from a top CRO, I learned a staggering statistic—86% of Phase III sites in large trials fail to enroll a single patient! In my experience, all trial sites consistently enrolled at least 4–5 patients. The secret? Paying close attention to the site’s patient population and its recruitment capability upfront. What Makes an Ideal Trial Site? Top KOLs with expertise in your TA. Confidence in recruiting and retaining the required number of patients. Experience conducting trials to ensure protocol execution excellence. While premier institutions often guarantee trial quality, PI selection can significantly influence enrollment speed—a topic I’ll dive into next time. Interested in streamlining your clinical trial process and ensuring patient enrollment success? Visit my website at sikoraconsulting.bio to learn more about how I can help your team succeed. Let’s build trials that deliver results. 🚀

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What an interesting read on the shift from traditional patient recruitment methods in rare disease! Learn more about how to optimize patient-driven site engagement in my team member’s blog: https://bit.ly/4eHoBn4

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Phase 1 clinical trials are crucial in the drug development process, yet many potential treatments fail at this stage due to several key factors. Here at iNGENū CRO CRO, we find that the five most common reasons for Phase 1 trial failures include: Unexpected Safety Issues: Safety is paramount, and unexpected adverse effects can halt trials. Lack of Efficacy: Early indications that a drug does not work as intended can prevent further development. Poor Pharmacokinetics: Issues with how the drug is absorbed, distributed, metabolized, or excreted can cause failures. Inadequate Study Design: Poorly designed trials can lead to inconclusive or misleading results. Patient Recruitment Challenges: Difficulty in enrolling a sufficient number of eligible participants can undermine the trial’s validity. Understanding and addressing these factors is essential for improving the success rates of Phase 1 trials. Early and thorough preclinical research, meticulous planning, and adaptable study designs are vital strategies to mitigate these risks. By recognizing these common pitfalls, researchers can better navigate the complexities of early-stage clinical trials, ultimately enhancing the likelihood of bringing effective new treatments to market. For a more detailed exploration, the full whitepaper is available here. https://lnkd.in/eim4-3CN #clinicaltrials #clinicalresearch #phase1

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🚨 New Clinical Trial Recruitment: "FOG-001 in Locally Advanced or Metastatic Solid Tumors. The goal of this clinical trial is to determine if FOG-001 is safe and effective in participants with locally advanced or metastatic solid tumors." This trial is currently recruiting patients in Arizona, Connecticut, Massachusetts, Missouri, New York, Oregon, Tennessee and Texas. Check back to see if additional locations are added soon. If you have questions, please contact the study contact listed in the link below. 🔗 Explore the trial details and participation criteria: https://lnkd.in/eYVWHraJ. #Desmoid #clinicaltrial #DesmoidTumors #DesmoidTumor #aggressivefibromatosis #DTRF #DesmoidTumorResearchFoundation #Desmoidian #desmoidresearch

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#PRIMR’s 78 IRB-approved pieces empower patients with simplified trial info. The RadiCaL Study for kidney cancer patients with bone metastases examines Ra-223 with cabozantinib to see if it improves outcomes. PI: Rana McKay UC San Diego School of Medicine Alliance for Clinical Trials in Oncology See IRB-approved video below 👇 https://lnkd.in/d97fj9dj #kidneycancer #kidneycancerawareness #cabozantinib #radium223 #radiopharmaceuticals #clinicaltrials #cancer #clinicalresearch #DEI #digital #health #immunotherapy #kidneycancer #men #menshealth #metastatickidneycancer #oncology #patienteducation #video #women #womenshealth #digital

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🚀 Biotech Q3 Scorecard: 19 Stock-Moving Events to Watch! 📊 Exciting times ahead in the biotech world! Here are key developments to keep on your radar: Alnylam Pharmaceuticals vutrisiran vs BridgeBio acoramidis for ATTR-CM: ESC presentation in August Novo Nordisk's monlunabant for obesity: Phase 2 results (watch Skye Bioscience Inc. and Corbus, LLC too!) Viridian Therapeutics, Inc.'s VRDN-001 for thyroid eye disease: Phase 3 readout in September Sage Therapeutics' Sage-324 for essential tremor: Mid-stage study results Apellis Pharmaceuticals' Empaveli for kidney diseases: Phase 3 VALIANT study results early Q3 Eli Lilly and Company's bimagrumab for obesity: Phase 2 results mid-year UCB and Biogen's dapirolizumab for lupus: Phase 3 results Neurocrine Biosciences's NBI-1117568 for schizophrenia: Phase 2 results Elevation Oncology's EO-3021 for gastric/pancreatic cancers: Data update Plus: • AstraZeneca's Imfinzi FDA panel (July 25) • Potential approvals for Alzheimer's drugs: Eisai US/Biogen's Leqembi (EU) • Multiple FDA decisions including Gilead Sciences, Regeneron, Syndax Pharmaceuticals, Roche, and Bristol Myers Squibb 🔬 The biotech sector is buzzing with potential breakthroughs. Which company or development are you most excited about? Share your thoughts below! 👇 #Biotech #PharmaTrends #ClinicalTrials #DrugDevelopment

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The duration for approval of new Multiple myeloma treatments to be dramatically shortened, after FDA's recognition of MRD as an accepted endpoint for accelerated approval. That's why investing on labwork and diagnostics may save money, time and most importantly, lives. Until now, for a phase III study to reach the acceptable median PFS to get the FDA's approval could take even more than a decade from study onset, while the size of the study populations to allow proper statistical comparisons were enormous. Subsequently, the cost for drug discovery in multiple myeloma was already almost unaffordable. This was the result of some great breakthroughs on the treatment of MM that prolonged the PFS time for the majority of patients. These breakthroughs occurred in the latest 10-15 years and included the approval of Bortezomib, Daratumumab and the use of the ASCT procedure for newly diagnosed patients. However, MRD -as an early onset efficacy endpoint- is expected to reduce the required follow up time to months post recruitment completion. Also, being a binary endpoint, smaller populations will be needed to allow for proper statistical comparisons, further shortening the time for study completion and reducing dramatically the cost of investment. Next big news will be to find a way to perform MRD assesments using blood samples, rather than bone marrow. I'd expect many more pharmaceuticals to start investing in hematoncology after these highly anticipated news.

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💥 Top 5 MSL Frustrations and How to Overcome Them💥 The MSL Talk podcast is back after a 2 week long holiday break!! This weeks guests are Patrina Pellett, PhD, Medical Excellence Lead at MSL Mastery and Sarah Snyder, Medical Affairs Recruiter at The Carolan Group who discuss common frustrations faced by Medical Science Liaisons, exploring the top challenges and offering practical solutions. In this episode, we discuss… 👉 The top 5 most common MSL frustrations 👉 Practical ways to overcome field and personal challenges 👉 The importance of addressing self doubt and imposter syndrome This episode is sponsored by MSL Mastery, helping Medical Science Liaisons and aspiring MSLs to excel in their careers and lives through courses, coaching, and community. For more details, please visit MSLmastery (dot) com. The MSL Talk Podcast is available on all podcast platforms and the MSL Talk YouTube Channel.   MSL Talk is a podcast that features helpful information for current Medical Science Liaisons, Medical Affairs leaders, job seekers looking to break into the pharmaceutical industry in their first MSL role as well as anyone interested in hearing good industry conversations and medical affairs discussions. #msl #medicalaffairs #medicalscienceliaison #realworldevidence #careers

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🚨🧠 Neuroscience News – 7 day recap: 13/12 🥼 Clinical News AC Immune announced interim safety and tolerability data from their Phase 1b/2 ABATE trial evaluating ACI-24.060 in those with Down Syndrome. They now plan to move to a high-dose cohort uniQure reached an agreement with the FDA on key elements of an Accelerated Approval pathway for AMT-130 which is targeting Huntington’s AbbVie announced positive topline results from their Phase 3 TEMPO-2 trial evaluating Tavapadon targeting Parkinson’s. Tavapadon met the primary and key secondary endpoints. This is another positive result across all 3 Phase 3 TEMPO trials and AbbVie are on track to submit an NDA in 2025 Alpha Cognition, Inc. announced positive preclinical data further supporting the development of ALPHA-1062 aimed at the treatment of mild traumatic brain injury caused from repetitive blast trauma, very relevant in military injury Bionomics Ltd published positive results from their Phase 2 ATTUNE study evaluating BNC210 targeting PTSD. Phase 3 study expected H2 2025 Kariya Pharmaceuticals have successfully completed a Phase 1 SAD of lead program KP405 targeting Parkinson’s Actinogen Medical treated their first participant in a randomised Phase 2b/3 trial targeting mild-moderate Alzheimer’s evaluating Xanamem® Corcept Therapeutics missed the primary endpoint in their Phase 2 DAZALS study targeting ALS Relmada Therapeutics, Inc have discontinued their Phase 3 studies Reliance II and Relight which was evaluating REL-1017 off the back of the news the other week CervoMed missed key statistical significance thresholds for their primary endpoint and all key secondary endpoints in their Phase 2b trial RewinD-LB targeting dementia with Lewy bodies 💰 Financial News AbbVie have agreed to purchase Aliada Therapeutics to the tune of $1.4B. The acquisition will see AbbVie take control of notable lead asset ALIA-1758 targeting Alzheimer’s Noema Pharma have closed their series B financing raising a total of $147M. The financing will assist Noema with four already active Ph2 trials where key data readouts are due in 2025 ProQR Therapeutics and Rett Syndrome Research Trust have further strengthened their alliance. RSRT have granted an extra $8.1M to ProQR in addition to the $1M they gave at the start of the year (January)                                                                   🤝 Collaborations Novo Nordisk have made an undisclosed equity investment into Eikonizo Therapeutics through their Science2Science iNNvest initiative. This will support Eikonizo to develop their lead candidate EKZ-102 which is a CNS penetrant HDAC6 inhibitor with indications such as ALS and others

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