Fred Orensky’s Post

We are excited to announce that our Co-founder and Chief Science Officer, Prof. Xiaoling Li, has authored a groundbreaking book. “Oral Bioavailability and Drug Delivery: From Basics to Advanced Concepts and Applications”. The book provides a comprehensive coverage of this subject as well as its drug development applications. Beginning with basic terminology and fundamental concepts, it provides a thorough understanding of the challenges and barriers to oral bioavailability as well as the possibilities for improving this parameter. The resulting book is an indispensable tool for drug development research.

Interesting post about the use of Knowledge Graphs in the pharma industry by Neo4j.

#pointofcare and distributed #pharmaceutical #manufacturing is a great area where advanced inline process analytical technologies can play an important role in #qualitycontrol and reliability.

"Quality is everyone’s responsibility. A culture of quality is more than simply a catchphrase used by businesses; it's the tune reverberating through the offices, labs, and hallways, protecting patients at all costs." Here are the essential elements and values of leadership in quality as presented by Martin Van Trieste: ✅ Setting the tone for quality ✅ Leading by example ✅ Communicating effectively ✅ Demonstrating commitment ✅ Creating a culture of recognition I am proud to have been part of this CEO's orchestra, playing the tune from 2006 to 2013 in the Quality organization at Amgen in Puerto Rico. These values transcend time and continue to resonate within me, regardless of where I go. #valuesmatter #qualitybeyondgmp #dotherightthing #besciencebased #teamwork #qualityculture #biotechnology

Thanks for sharing (Joe). I whole heartedly agree! If you get down to the granular level, a primary stopgap to getting the 'right' data is the frustrating fact that instrument providers(Agilents, PerkinElmers, Waters, CharlesRs, etc) are in it for themselves. They want you to use their own proprietary softwares to manage their proprietary raw data formats. This inevitably leads to siloes & messy scientific data pipelines that aren't positioned well to support AI/ML initiatives.

“The European Clinical Trial Act of 2014 does not require the pharmaceutical industry to demonstrate that their new medicine represents a therapeutic breakthrough, thus squandering a chance to stimulate comparative assessments of new drugs with existing ones.32 Critics argue that the FDA has lowered its evidence criteria by approving drugs with debatable efficacy, and its decisions in areas of urgent unmet medical need have received particular attention.33, 34 Frequently, manufacturers are granted marketing authorization with insufficient data on clinical benefit. Comparative trials are often absent, or may suffer from various methodological issues, making it difficult or impossible to establish clinical effectiveness.35-38 These are a few reasons why we have many “me too” drugs on the market. These products, whereas not offering additional clinical benefit, may offer important alternative treatment options to patients; however, overproduction of so-called “me too” options diverts important resources from pursuing developments which can make clinically important differences to patients”.

📢 𝗜𝗻 𝗰𝗮𝘀𝗲 𝘆𝗼𝘂 𝗺𝗶𝘀𝘀𝗲𝗱 𝗶𝘁 📢 🚀 Hoodin 𝗥𝗔𝗤𝗔 𝗗𝗲𝗲𝗽 𝗗𝗶𝘃𝗲𝘀 🤿 with Veronika Valdova 👀𝗧𝗵𝗲 𝗳𝘂𝗹𝗹 𝗩𝗶𝗱𝗲𝗼 ⏯ ⏹⏮ ⏪ ⏩❗ 𝗧𝗵𝗮𝗻𝗸 𝘆𝗼𝘂 🙏 Veronika Valdova and Marcus Emne for an deep introduction to the complex world of classification dilemmas in the medical field. 💊💉 This presentation really sheds light on the challenges that sponsors of regulatory submissions often face, particularly when dealing with substance-based devices. These devices, notorious for their complexity, can be classified as a drug in one region and as a medical device in another. This dichotomy presents unique challenges and requires a deep understanding of the regulatory landscape across different regions. 🌍 Veronika and Marcus, you really helped bring invaluable clarity and guidance in navigating these challenges and probably saved some of the audience time and money moving forward. 𝙂𝙧𝙚𝙖𝙩𝙡𝙮 𝙖𝙥𝙥𝙧𝙚𝙘𝙞𝙖𝙩𝙚𝙙 👏 𝗧𝗵𝗮𝗻𝗸 𝘆𝗼𝘂 🙏 Hoodin 𝗧𝗵𝗮𝗻𝗸 𝘆𝗼𝘂 🙏 for your time and please 𝗦𝗵𝗮𝗿𝗲, 𝗟𝗶𝗸𝗲 👍 and/or 𝗖𝗼𝗺𝗺𝗲𝗻𝘁 #medicaldevices #invitrodiagnostics #combinationproducts #mlv #qualityassurance #regulatoryaffairs 

𝗥𝗲𝘃𝗼𝗹𝘂𝘁𝗶𝗼𝗻𝗶𝘇𝗲 𝗣𝗵𝗮𝗿𝗺𝗮 & 𝗕𝗶𝗼𝘁𝗲𝗰𝗵 𝘄𝗶𝘁𝗵 𝗖𝗼𝗻𝗻𝗲𝗰𝘁 𝗖𝗠𝗖™! Hey there, movers and shakers of the pharmaceutical realm! Brace yourselves for a paradigm shift in data management and analysis. Dive into the future of pharmaceutical and biotech manufacturing with Mareana's latest innovation, Connect CMC™! This game-changing AI-powered solution is not just about data management – it's about unleashing the full potential of your operations. Picture this: Streamlined processes, faster investigations, and pinpoint accuracy in analysis – all at your fingertips. Whether you're still stuck with paper batch records or collaborating with CDMOs, Connect CMC™ has got you covered. Plus, with its user-friendly SaaS model hosted on Mareana's cutting-edge cloud platform, it's never been easier to stay ahead in the pharma world. As biotech, pharmaceutical, and cell therapy manufacturers embark on the journey of modernization, Connect CMC™ emerges as a pivotal solution, perfectly aligning with the industry's need for compliance and optimization. Engineered with GxP standards at its core, this innovative tool not only upholds data integrity but also elevates operational efficiency and decision-making processes. Trusted by leading pharmaceutical companies across the United States, Connect CMC™ stands as a beacon of transformation, enhancing investigation speed, ensuring analysis accuracy, and simplifying regulatory submissions. Ready to transform the way you work? Connect CMC™ is your ticket to operational excellence and faster time to market.

Next steps https://lnkd.in/gqN--KaE

batch manufacturing record is a very essential document & it provides us with the full history of batch manufacturing. We can trace out the personnel involved in the manufacturing of a specific batch. We can trace out which equipment was used during the manufacturing of a specific batch. We can trace out the qualified personnel involved in the manufacturing of a specific batch. We can verify which excipients' lot numbers were used in a specific batch along with their quantities. We can verify which APIs' lot was used for manufacturing. BMR gives us information about real-time or actual data at which the batch was granulated, compressed, coated, filled, or filtered. BMR also contains quality control reports & we can trace out the batch results.