Integrated DNA Technologies’ Post

New eBook “CRISPR Therapeutics: From Bench to Bedside” is available! Learn fundamentals, therapeutic landscape, the development process and regulatory requirements.

Everyone loves a #goodpodcast! If you are in the Life Sciences industry and looking for timely, relevant content then you should #starthere with "Research in Action" with Oracle. Insightful conversations with scientists, clinicians, and leaders from pharma, biotech, and health. #lifesciences #drugdiscovery, #clinicaltrials, #therapeuticdevelopment

Get a glimpse into the future of drug development with this episode of #AViewOn Drug Bioavailability Enhancement, exploring how PBPK modeling enhances drug bioavailability and paves the way for personalized medicine. Join experts Deanna Mudie and John DiBella in this discussion on making medications safer and more effective. Find the full episode here: https://lnkd.in/d34iFzHF

💊 Clinical Trial planning In the search for patient-centric outcomes, research conducts rigorous, randomized, and placebo-controlled trials. All to determine the sought after straight-line effect between treatment and outcome. But is there enough discussion and testing to ensure a meaningful relationship between treatment and control groups? Perhaps, the Intention-to-Treat analysis can give us some perspective if patients are randomly assigned or even test if protocols are violated. Can this possibly minimize the risk of bias and ultimately failures? Clinical Trial authenticity, suitability, and integrity are tantamount, today, and tomorrow. With more and more challenged trials today, the need for a highly protocoled clinical trial is evident. It is time!      #mentalhealth #biotech #medicine #brainhealth #bigpharma #clinicaltrials BioSpace BiotechTV Fierce Biotech BioPharmaTrend.com World Health Organization

Launching your iPS cell-based therapy? Lindville Bio (www.lindvillebio.com) is here to help. From lab to clinic, the journey of developing cell-based therapies is challenging, but with Lindville Bio by your side, we make it possible. We provide expert advice for: 1️⃣ iPS cell sourcing and quality control 2️⃣ iPS cell expansion and scale-up 3️⃣ Preclinical efficacy and safety testing 4️⃣ Navigating complex regulatory pathways 5️⃣ Manufacturing and process development 6️⃣ Designing and executing clinical trials 7️⃣ Intellectual property and competitive analysis 8️⃣ Ensuring reproducibility and consistency 9️⃣ Long-term safety monitoring 🔟 Securing funding and investment 1️⃣1️⃣ Tackling regulatory and legal hurdles 1️⃣2️⃣ Market access and commercialization Let's bring your therapy to life together. Arrange an initial discussion today at www.lindvillebio.com #iPSC #CellTherapy #Biotech #LindvilleBio #BiopharmaSolutions #HealthcareInnovation

The most advanced regulatory processes for complex biological products have been put in place in many countries to provide appropriate regulatory oversight of biotherapeutic products in general, and similar biotherapeutics in particular. This process is still ongoing and requires regular updates to national regulatory requirements in line with scientific developments and up-to-date standards. For this purpose, strong knowledge of and expertise in evaluating biotherapeutics in general and similar biotherapeutic products, also called biosimilars, in particular is essential. Here, we discuss the World Health Organization’s international standard-setting role in the regulatory evaluation of recombinant DNA–derived biotherapeutic products, including biosimilars, and provide examples that may serve as models for moving forward with nonbiological complex medicinal products. A number of scientific challenges and regulatory considerations imposed by the advent of biosimilars are described, together with the lessons learned, to stimulate future discussions on this topic. In addition, the experiences of facilitating the implementation of guiding principles for evaluation of similar biotherapeutic products into regulatory and manufacturers’ practices in various countriesoverthepast10yearsarebrieflyexplained,withtheaimofpromotingfurtherdevelopmentsandregulatory convergence of complex biological and nonbiological products.

🌟 Exciting Update Alert! 🌟 🔬 Get ready to explore the cutting-edge world of biotherapeutics and biosimilars with our latest review article titled "WHO Standards for Biotherapeutics: Evaluating Complex Biological Products," authored by the esteemed experts Ivana Knezevic and Elwyn Griffiths. 📚 This illuminating article delves into the intricate regulatory processes governing biotherapeutic products, offering insights into the evolving landscape of biosimilars evaluation. From the essential role of the World Health Organization to the scientific challenges posed by biosimilars, this article promises to be a thought-provoking read for professionals and enthusiasts alike. 🌍 Let's come together to celebrate the collaboration and expertise behind this groundbreaking article, and stay tuned for its release as we prepare to unravel the complexities of biotherapeutics regulation! #Biotherapeutics #Biosimilars #RegulatoryStandards #WHO #Science #Innovation #StayTuned 🚀

Clinical trials are essential to bring life-saving medicines and new medical devices to market. But how comfortable are patients sharing their health data with researchers to accelerate research and development and how can pharma and medtech companies tap into data to deliver faster, cost-effective clinical research? To see the answers and learn how clinical trial transformation can reach its full potential, download our latest research findings. ______________________________ Would you share your health data to advance clinical research? PA Consulting we were surprised when the research showed that 64% of US consumers would. ______________________________ #ClinicalTrials #innovation #research #healthdata

There’s no time to waste in charting new horizons toward #patient success. The first step? Staying informed about the latest #lifesciences developments and discovery. Preview some featured articles in our latest issue of #DIAGlobalForum: ➡️ A Platform Approach to #mRNA Product Development and #Regulation: Necessary and Feasible Now ➡️ Issues, Ideas, and Initiatives: Proposals from the DIA/Harvard-MIT CRS Cell and #GeneTherapy #Executive Roundtable ➡️ See our full May ‘24 publication and previous issues at https://ow.ly/hyWm50RBXx5 #DIA2024 #DIApublications #biotech #biopharma #clinical #trialresearch

"We should no longer force yesterday’s one-size-fits-all approach onto #biotech’s third wave of advanced drug development. As #precisionmedicine effectively makes every trial today a #raredisease trial, the operations of these trials must keep pace or else we squander today’s most promising clinical advancements. By embracing #AI-optimized approaches, we can improve operations and ensure that decades of scientific #innovation achieve the ultimate goal: improving the human condition." - Rohit Nambisan, Lokavant Article: 'The future is now: Clinical trials must keep up in the age of precision medicine' https://lnkd.in/g5VTskDP via ACRP - Association of Clinical Research Professionals #biohealth #clinicalresearch #technology