Clinical Research Advancement’s Post

Excited to be attending the #STATBreakthrough Summit East today! With sessions moderated by STAT’s award-winning journalists ✍🏼, it's sure to be a stimulating 💡 day of learning from patients, providers, and biopharma leaders. Looking forward to gaining insights on patient advocacy 📣, health tech 👩🏻💻, biotechnology 🧑🔬, and drug development 💊. Follow along for updates! #patientadvocacy #healthtech #biotechnology #drugdevelopment

This must-read from Nature Review Drug Discovery breaks down the industrywide R&D spending in 2021, a landmark year in life sciences, with an estimated over $276B—six times the NIH budget and far surpassing the usual $100B figure from PhRMA surveys. Public commercial-stage firms led with 74% of total R&D spending, while private and development-stage companies also played significant roles. R&D intensity was 27% globally and 34% in the US—staggering numbers compared to other industries. This insightful paper highlights the immense investment and innovation driving the industry. #DrugDiscovery #RnDSpending #Pharma https://lnkd.in/gk6xWmFV

Are you interested in networking with your peers and learning about #DrugDevelopment? There is STILL TIME to register for the BENELUX Drug Development Symposium 2.0 in Utrecht on 28 Nov. 2024. Where? Accelerator, Uppsalalaan 17, Utrecht Science Park, Netherlands Register here: https://gag.gl/4YjTnB You will gain new perspectives on pitching to investors and get insights from biotech leaders on drug development, AI in clinical trials, and the role of innovation and technology in sustainability and global health equity. #biotech #innovation #clinicaltrials #healthequity #sustainability

Watch as our CEO shares how CTB connects clinical trial sponsors with the perfect service providers by matching needs with expertise. 👉 Follow us to see how CTB can speed up your clinical trial journey! #CTB #clinicaltrials #vendormatching #clinicaltrials #biotech #healthcare #innovation #research #medicaltrials

Interested in networking with your peers and learning about #DrugDevelopment? There's STILL TIME to register for the BENELUX Drug Development Symposium 2.0 in Utrecht on 28 Nov. 2024. Where? Accelerator, Uppsalalaan 17, Utrecht Science Park, Netherlands Register here: https://gag.gl/4YjTnB Gain fresh perspectives on pitching to investors, hear insights from biotech leaders on drug development, AI in clinical trials, and explore the role of innovation and technology in sustainability and global health equity. #biotech #innovation #clinicaltrials #healthequity #sustainability

Are you interested in networking with peers and learning about #DrugDevelopment? There is STILL TIME to register for the BENELUX Drug Development Symposium 2.0 in Utrecht on 28 Nov. 2024. Where? Accelerator, Uppsalalaan 17, Utrecht Science Park, Netherlands Register here: https://gag.gl/4YjTnB You will gain new perspectives on pitching to investors, receive insights from biotech leaders on drug development, AI in clinical trials, and the role of innovation and technology in sustainability and global health equity. #biotech #innovation #clinicaltrials #healthequity #sustainability

Are you interested in networking with peers and learning about #DrugDevelopment? There's STILL TIME to sign up for the BENELUX Drug Development Symposium 2.0 happening in Utrecht on 28 Nov. 2024. Where? Accelerator, Uppsalalaan 17, Utrecht Science Park, Netherlands Register here: https://gag.gl/4YjTnB Gain fresh perspectives on pitching to investors, hear insights from biotech leaders on drug development, AI in clinical trials, and explore the role of innovation and technology in sustainability and global health equity. #biotech #innovation #clinicaltrials #healthequity #sustainability

Are you interested in networking with peers and learning about #DrugDevelopment? There is STILL TIME to register for the BENELUX Drug Development Symposium 2.0 in Utrecht on 28 Nov. 2024. Where? Accelerator, Uppsalalaan 17, Utrecht Science Park, Netherlands Register here: https://gag.gl/4YjTnB You will gain new perspectives on pitching to investors and receive insights from biotech leaders on drug development, AI in clinical trials, and the role of innovation and technology in sustainability and global health equity. #biotech #innovation #clinicaltrials #healthequity #sustainability

We see it in the life science industry, but also in our daily lives – unmet medical needs are growing, making innovation in drug development more crucial than ever. The privilege of working in the life science industry is that we’re right in the mix, developing solutions in real-time that drive speed and efficiency for biopharma and biotech companies aiming to meet those medical needs.  I was pleased to join my Thermo Fisher Scientific colleague Mike Kleppinger, PhD, MBA in providing insights on the latest advancements we’re seeing in this space. Next-gen technologies and collaborative approaches are transforming the partnerships that drive drug development progress. The name of the game is to enable a connected, comprehensive journey – from discovery directly to patient delivery. You can read our full blog, here: https://lnkd.in/erXwD5Uu

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.