Prevail InfoWorks

This inspiring article from Pfizer follows a patient named Eric through his clinical trial journey. For those looking to learn more about the clinical trial process, this is a great resource. “From the thousands of patients who volunteer each year to the scientists, clinicians, and principal investigators (PIs), each individual who contributes to a trial helps to bring about life-changing treatments and advances our knowledge of diseases.” #ClinicalTrials #Patients #Safety #Discovery https://lnkd.in/eUQEb2bn

Announcing the Global Health & Pharma “Most Advanced Tech-Enabled CRO 2024 - USA” award has been given to Prevail InfoWorks. Here are criterion making the case for the Prevail InfoWorks Inc. award of distinction: -Cost-Effective Solutions – Our advanced technology and data-driven platform allows us to streamline processes, making clinical trials more affordable while improving quality. We believe innovation should benefit your bottom line.?? -Cutting Study Start-Up Time in Half – Our unified systems ensure faster study start-ups, getting your trials moving in record time and cutting down on unnecessary delays. This means quicker paths to market for life-saving therapies.?? -Guaranteed Database Lock in Hours – With our real-time data management tools, we offer unparalleled efficiency in database lock. No more waiting around for days – we guarantee database lock within hours, so you can focus on what matters: results.?? -Empowering Our Teams, Benefiting Our Clients – Our experienced internal clinical teams are equipped with the best tools, freeing them from administrative burdens like paper chasing, and supporting their proactive management. This keeps turnover at an industry low, ensuring consistency and expertise throughout your project. “At the end of the day, we put people first. The innovative technology we have developed is aimed at making clinical trials as efficient and effortless as possible. Our tech serves to enhance the work of our talented teams and deliver exceptional results for you, our valued partners.” Jack Houriet – CEO of Prevail InfoWorks. Ready to experience the future of clinical trials? Visit us at https://lnkd.in/eUmTFHrn

Shaping the Future of Drug Regulation: FDA’s 2024 Guidance on Real-World Data and AI The FDA has released its final guidance on Real-World Data (RWD), focusing on using electronic health records (EHRs) such as those provided by Cerner Corporation and Epic, and medical claims data from providers such as Veradigm? (Allscripts) and athenahealth to support regulatory decision-making for drug and biological products. Here are some key insights: -Guidance Released:?July 25, 2024 -Clarifications On: Data sources, study variables, and the use of AI technologies -Impacted Stakeholders: Sponsors, EHR vendors, payors, AI tool developers, and data aggregators -Focus Areas: Data quality, selection of study variables, and data linking -Does Not Endorse: Specific study designs or methodologies The guidance marks the latest advancement in the FDA’s ongoing efforts to define the appropriate role of real-world data (RWD) and real-world evidence (RWE) in the regulatory process. If you are employed in any of the referenced organizations or somewhere similar, what caution might you give to your colleagues regarding these finalized guidelines? Feel free to check out more about these guidelines in the article linked in the comments below. #FDA #RealWorldData #RealWorldEvidence #DrugRegulation #EHR #MedicalClaims #AIinHealthcare #ClinicalTrials #DataDriven #RegulatoryGuidance #HealthcareInnovation #Pharmaceuticals #HealthTech #DataQuality #ClinicalResearch

Congratulations?to Kairos Pharma Ltd. (NYSE: KAPA) on their recent New York Stock Exchange (NYSE) Initial Public Offering. This is a significant milestone for any company.?With IPO behind them, the?Kairos?team is now focused on advancing in clinical trials its innovative?therapeutic program that aims to reverse cancer resistance against standard of care therapeutics.? ? Kairos?has chosen Prevail InfoWorks as its?Clincial Research Organization (CRO)?to manage?its?phase II randomized multi-institutional?center?trial of ENV 105 for patients with castrate-resistant prostate cancer and a phase I trial of ENV 105 in patients with EGFR-driven lung cancer who have developed partial or complete resistance to Osimertinib.?Prevail was recently awarded the title of "Most Advanced Tech-Enabled CRO 2024" and these studies will benefit from Prevail’s integrations and advanced?analytics?data-driven approach?for accelerated analysis in clinical?trials. "We're honored to partner with?Kairos?Pharma in advancing these critical trials, leveraging our clinical services and technologies to support their mission of delivering life-saving therapies to patients in need." - Jack Houriet, CEO of Prevail InfoWorks What advancements in oncology are you most excited about, and how do you see them shaping the future of cancer treatment? Learn more via the press release:?https://lnkd.in/eKsAWZvF #KairosPharma #ClinicalTrials #CRO #OncologyResearch #PharmaInnovation #CancerTreatment #ProstateCancer #LungCancer #ClinicalPartnership #IntegratedAnalytics #DataDrivenHealthcare #PatientCare #Pharmacovigilance #HealthcareTechnology #TrialManagement #EGFRLungCancer #Osimertinib #CancerResearch #BiotechCollaboration #PrevailInfoWorks

Breaking Barriers: Empowering Women to Lead the Future of Healthcare Innovation Women continue to play a critical role in advancing healthcare innovation and business. According to a BCG article, while approximately 77% of the healthcare workforce is female (US Bureau of Labor Statistics), women remain underfunded in leadership and entrepreneurial roles.? Healthcare Businesswomen’s Association (HBA) is launching its first-ever Pitch Competition for Women Innovators at the 2024 HBA Annual Conference in Toronto. This dynamic event shines a spotlight on female founders in healthcare and life sciences, addressing the significant funding gap where only 3% of venture capital goes to women-led startups. 8 female-led startups have been selected, including: Bfree Cup, Cura Therapeutics Inc., endogene.bio, FemTherapeutics, HDAX Therapeutics, ImaginAble Solutions, Scotiaderm Inc. and Vessl Prosthetics. Leaders from Merck, Novartis, Johnson & Johnson, and others will evaluate the pitches.? This competition is not just about recognition—it’s about empowering women with the tools and support needed to thrive in the healthcare business. How do you see this initiative influencing the future of women-led innovation? "We are thrilled to have such high-caliber startups showcase their groundbreaking ideas and solutions during HBA's inaugural Pitch Competition for Women Innovators. By shining a spotlight on these amazing women-led startups, we hope to build awareness for the urgent need to close the funding gap and drive the future of healthcare forward," said Mary Stutts, MHA, CEO of the HBA. Interested in learning more? Read the full article in the comment section. #HealthcareInnovation #FemaleFounders #WomenEmpowerment #VentureCapital #LifeSciences #HealthcareBusiness #FundingEquity #PitchCompetition #WomenInHealthcare

Advancing Genetic Medicine: Novo Nordisk’s Strategic Shift with NanoVation Partnership Novo Nordisk is advancing its commitment to genetic medicines by partnering with NanoVation Therapeutics? in a deal worth up to $600 million. The collaboration focuses on using NanoVation’s technology to target cells outside the liver, initially for rare genetic diseases and potentially expanding to cardiometabolic conditions. Here are some key insights: -Novo Nordisk is shifting from peptides and proteins to advanced modalities like RNAi and gene editing, especially in rare diseases. -The partnership with NanoVation leverages lipid nanoparticle (LNP) technology to deliver therapies to tissues beyond the liver, including bone marrow, tumors, and skin. -The deal starts with two rare disease therapies and could expand to five additional targets. Do you think these “nano” particles are worthy of such a “mega” investment? Novo's decision to start with two rare diseases and potentially add cardiometabolic targets fits its strategy for exploring new modalities. At the March capital markets day, Martin Holst Lange, M.D., Ph.D., EVP of development, said the company will "test and learn in the rare disease space" before expanding technologies like gene editing to broader areas. Feel free to check out the article linked in the comments below. #GeneticMedicine #RareDiseases #RNAi #GeneEditing #LipidNanoparticles #PharmaInnovation #Biotechnology #CardiometabolicHealth #PrecisionMedicine #BiotechPartnerships #MedicalAdvancements #NovoNordisk #NanoVation #HealthcareInnovation #DrugDevelopment

Novo Nordisk’s Latest Move in RNA Therapy: $530M Collaboration with Korro Bio Novo Nordisk has just signed a $530M biobucks deal with Korro Bio, Inc. Bio to advance two cardiometabolic-related RNA editing targets using Korro's innovative OPERA platform. Here are some key highlights on this new deal: -Partnership with Korro Bio:?Targeting cardiometabolic diseases through RNA editing with Korro’s OPERA platform, which modifies mRNA without altering DNA. -Novo’s RNA Expansion:?Builds on previous RNA related acquisitions of --Dicerna Pharmaceuticals & Cardior, alongside collaborations with Eleven Therapeutics. -Strategic Focus:?Addressing unmet needs in obesity, diabetes, and cardiovascular disease by modulating previously undruggable protein targets. -Financials:?A total deal value of $530M, with Korro leading preclinical development before handing it over to Novo for human trials. As a big pharma company shakes up the RNA landscape with this new exciting deal, do you think others will follow suit? Uli Stilz, Head of Novo Nordisk’s Bio Innovation Hub, said in a press release that they are “excited to partner with Korro on its differentiated RNA editing platform as we explore novel technologies to address the unmet need for people living with cardiometabolic diseases.” Feel free to check out the article linked in the comments below. #RNATherapy #BiotechInnovation #CardiometabolicHealth #GeneticMedicine #PharmaPartnerships #NovoNordisk #KorroBio #HealthcareInnovation #Biopharma #RNAEditing #CardiovascularResearch #ObesityTreatment #DiabetesCare #FutureOfMedicine #PharmaDeals

Gilead Sciences partners with Genesis Therapeutics in a $35M collaboration to accelerate AI-driven drug discovery? ? Genesis’ innovative GEMS AI platform continues to capture attention, now attracting Gilead Sciences to its growing list of partners. With this new collaboration, Gilead is investing $35M upfront for AI-based drug discovery on three undisclosed targets. This marks Genesis’ third major pharma partnership, following previous deals with Genentech and Eli Lilly. Together, Gilead and Genesis aim to revolutionize the discovery of treatments for difficult protein targets by harnessing the power of generative AI.? Did you know there is also AI for the clinical development process? By automatically harnessing, consolidating and reconciling study data, while a study is ongoing, Prevail InfoWorks delivers predictive analytics, confirmatory clinical observations early, and the fastest trend analyses and reporting. To learn more about this and other technologies in clinical development, access Prevail InfoWorks’ proven track record here: https://lnkd.in/e2wWMMej "Needs are diverse and ever-changing, and that’s why we are committed to staying ahead of the curve, anticipating trends, and delivering solutions that exceed expectations." stated Jack Houriet, CEO of Prevail InfoWorks. How do you think AI is transforming the future of our life sciences industry and will it overcome the inefficiencies and burdensome processes? Read more in the comment section. #DrugDiscovery #Biotechnology #GileadSciences #GenesisTherapeutics #PharmaInnovation #HealthcareAI #ClinicalResearch #ArtificialIntelligence #RDCollaboration

Breaking New Ground: Eli Lilly and Haya Therapeutics Team Up in $1B Obesity Treatment Deal Exciting news from Eli Lilly and Company as they expand their focus on obesity treatment through a $1 billion partnership with HAYA Therapeutics. This collaboration leverages Haya's cutting-edge technology to target long noncoding RNAs (lncRNAs), which play a key role in regulating gene expression and could open doors to next-generation obesity therapies. Lilly is working to maintain its early lead by securing multiple deals aimed at developing next-generation obesity treatments. With this move, Lilly continues to position itself at the forefront of innovative weight management solutions. As things shake up further in weight management therapies, what might this deal mean for the future of obesity R&D? Will we see even bigger partnerships in the future? “By identifying disease-driving cell states and novel lncRNA therapeutic targets, Haya’s proprietary regulatory genome discovery platform may pave the way for the development of genetic medicine therapies that modify disease cell states, augmenting the efficacy of current obesity targeting therapies,” says Haya’s CEO Samir Ounzain. Feel free to check out the article linked in the comments below. #Obesity #ObesityTreatment #PharmaInnovation #GeneticMedicine #RNA #lncRNA #BiotechPartnership #HealthcareR&D #NextGenTherapies #WeightManagement #EliLilly #HayaTherapeutics #Biopharma #ObesityResearch #PrecisionMedicine #RNAtherapeutics #LifeSciences

From Rare to Routine: Gene Therapy’s Visionary Approach to Fighting Blindness in the Elderly Can you imagine what it would feel like to regain the gift of sight after years of darkness with just a single treatment? Gene therapy is on the verge of transforming treatment for wet age-related macular degeneration (AMD), the leading cause of blindness in older adults. According to American Foundation for the Blind (AFB), 2.2% of Americans 65 to 74 years of age reported having vision loss, and 15.2% of Americans 75 years of age and over reported having vision loss.?Vision loss can be linked to cognitive impairment and dementia. REGENXBIO Inc. and AbbVie’s candidate ABBV-RGX-314, uses an AAV8 vector to deliver a gene that encodes an anti-VEGF antibody fragment. Adverum Biotechnologies uses intravitreal injections, and it has shown a 90% reduction in the need for annual injections. The most familiar method, used by Adverum and 4D Molecular Therapeutics, mimics current treatment methods but aims for long-term efficacy. With advancements from companies like REGENXBIO, AbbVie, 4D Molecular Therapeutics (4DMT) and Adverum, these innovative approaches could offer a long-term solution, significantly reducing the burden of ongoing treatments. It could lead to widespread adoption, providing a new standard of care for wet AMD. Read more in the comment section #GeneTherapy #WetAMD #VisionCare #Biotechnology #Healthcare #Innovation #ElderlyCare #RegenerativeMedicine #ClinicalTrials #Ophthalmology #MedicalBreakthrough