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

A New Era for Schizophrenia Treatment?  Bristol Myers Squibb’s newly approved drug Cobenfy brings a much-needed update to schizophrenia care. According to the World Health Organization (WHO), approximately 24 million people are affected by schizophrenia worldwide. Here are the key takeaways:  -First new antipsychotic in 20+ years: Cobenfy offers a novel approach by activating muscarinic receptors, unlike traditional drugs that target dopamine or serotonin.   -Fewer disruptive side effects: Clinical trials showed reduced risk of weight gain, restlessness, and movement issues, improving patient adherence.   -Insurance hurdles remain: At $22,500 per year, access may be challenging due to insurer barriers, though Bristol Myers is working to address this.   -Future potential: Beyond schizophrenia, trials are underway for bipolar disorder and Alzheimer’s-related psychosis.  Cobenfy offers potentially more effective treatment options with fewer side effects compared to existing antipsychotics. What impact do you think Cobenfy will have on mental health care?  Read more in the comment section below.  #HealthcareInnovation #SchizophreniaTreatment #Biotechnology #PharmaNews #MentalHealthMatters #BristolMyersSquibb #DrugDevelopment #Biopharma #KarunaTherapeutics #FDAApproval #Cobenfy

We’re back at the Annual Outsourcing in Clinical Trials New England 2024  Come on back to Outsourcing in Clinical Trials (OCT) New England next week because we are bringing something new to share with you! Hopefully this tempts you to Booth 61 for what’s made Prevail InfoWorks famous and our clients heroes in their organizations. From study setup in half the time, to data lock in hours and everything in between, you will see what can make your work life easier. A one-stop-shop for all trial needs from the tech-enabled full service CRO/FSP at OCT. Join us at Booth 61 with old friends and new acquaintances because you deserve less work and more results. Outsourcing in Clinical Trials Event Series #OCTNewEngland #ClinicalTrials #BiotechBiopharmaPharma #LifeSciences #ClinicalResearch #Outsourcing #ClinicalOperations #Boston #Networking

Epilepsy Innovation Takes Center Stage: Lundbeck Acquires Longboard for $2.5B Lundbeck's recent $2.5B investment in Longboard Pharmaceuticals paves the way for a next-gen epilepsy drug. After seeing promise in Longboard’s bexicaserin epilepsy drug, Lundbeck plans to acquire the company to expand their neuroscience pipeline. Here are the exciting details of this transaction: -Deal: Lundbeck is acquiring Longboard for $2.5B, driven by bexicaserin data Potential: Bexicaserin halved seizures in early trials, showing promise and boosting Longboard's stock -Focus: The deal fits Lundbeck's strategy to grow its neuro-rare portfolio and diversify revenue -Plans: Lundbeck targets a 2028 launch with potential peak sales of $1.5B–$2B What impact might this huge deal have on the future of epilepsy research and development? Will we see other investors follow suit in epilepsy related investments? “This transformative transaction will become a cornerstone in Lundbeck’s neuro-rare franchise, with a potential to drive growth into the next decade,” says Charl van Zyl, Lundbeck CEO. Feel free to check out the article linked in the comments below #PharmaAcquisition #NeuroscienceInnovation #BiotechNews #NeuroRareDiseases #Lundbeck #LongboardPharmaceuticals #Bexicaserin #EpilepsyTreatment #HealthcareInvestments #PharmaDeals #SeizureDisorders #DrugDevelopment #HealthcareInnovation #EpilepsyAwareness

Fueling the Future: Frazier Life Sciences Adds $630M to Biotech Fund Exciting news coming from Frazier Life Sciences, announcing that they just raised additional capital in their public fund focused on small and mid-cap biotechs. With fresh capital from both new and returning investors, the Californian firm's public fund has now reached roughly $1.7 billion since its inception three years ago. Here are some key insights: -Total Raised: An additional $630M, bringing its biotech fund to $1.7B -Focus: Small/mid-cap biotechs with flexibility for private investments -Investment Portfolio: Including Sierra Oncology, Chinook Therapeutics, and Alpine Immune Sciences, Inc. so far -Track Record: Frazier Life Sciences-backed companies have over 50 FDA-approved therapeutics since 2010 As excitement sparks with more money entering the industry, what could this mean for smaller sized biotechs? Which promising companies should investors keep their eye on? “We look forward to continuing to invest in management teams that we believe drive innovation and deliver transformational treatments to patients in need,” says Jamie B., general partner and portfolio manager at Frazier Life Sciences. Feel free to check out the article linked in the comments below. #BiotechInvestment #LifeSciences #BiotechInnovation #HealthcareInvesting #SmallCapBiotech #MidCapBiotech #FrazierLifeSciences #BiotechFunding #HealthcareInnovation #Therapeutics #BiotechGrowth

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