ISPE-CaSA’s Post

Yesterday, Wheeler Bio, Inc.'s Chief Manufacturing Officer Yuk Chun Chiu delivered two great presentations at KENX's Validation University Conference. Here, Yuk gave his insight into utilizing risk-based approaches in the commissioning, qualification, and validation (CQV) of single use systems (SUSs) followed by practical considerations for the implementation of a data infrastructure for advanced analytics. We are very proud to have such a great mind representing Wheeler and sharing his knowledge and experiences with the industry. If you did not get the chance to attend Yuk's ISPE or KENX talks, keep an eye out for more great presentations coming later this year! #Bioprocessing #Biopharma #Pharma #Biotech #Innovation

In this week's The Patent Lawyer newsletter 📢 A top 100 global innovators deep dive into the medical and biotechnology sector. Clarivate shares its latest report, A Top 100 Global Innovators Deep Dive into the Medical and Biotechnology Sector. The report provides a deep dive into the Medtech sector within the data behind the Clarivate Top 100 Global Innovators™ 2024 report and uncovers the key organizations and trends shaping the future of global healthcare. Read the full news article here 👉 https://lnkd.in/guDP77Wa Subscribe to our newsletter to stay up-to-date with all the most pertinent patent stories and news here https://lnkd.in/eNFGimuS Want to write for The Patent Lawyer newsletter? Email ellen@ctclegalmedia.com #patent #lawyer #news #clarivate #top100 #globalinnovators #medical #biotechnology #medtech #healthcare #IPlaw

📣 Big Savings Alert! 📣 If you've considered enrolling in our next #marketaccess training course, now is the time! We have a limited number of seats remaining, and we want the class to be full. Enroll today using the discount code "FINALSEATS" to save 50% (That's $2,250 in savings). Learn more about the curriculum and enroll here: https://lnkd.in/gnhHMGBN October 22 & 23, 20204 in Philadelphia, PA #pharma #biotech #elevateandaccelerate #traininganddevelopment

Developing biotech and biological medicines involves a complex process that goes far beyond scientific discovery. The addition of a robust business strategy enables the pathway for development and a well-defined Target Product Profile (TPP) can help to steer the product through each stage of development while boosting the chances of success and avoiding costly mistakes along the way. But what is a TPP? We’ve put together a helpful blog covering exactly what a TPP is and a guide to 10 essential considerations when developing a successful Target Product Profile. You can learn more by clicking on the link below. 👇 https://lnkd.in/eVQDq_bv The TPP is a critical document, but it doesn't need to be overwhelming or overly complex. If you want to enhance your TPP, 3Biotech offers expert support to help streamline the process and ensure your product is poised for success. 👉 Get in touch today to find out more. #TPP #Drugdevelopment #Biotech #CMC

Bruce Booth & Atlas Venture are out with their annual year-in-review for #biotech & #pharma. As usual, it's full of interesting stuff, but I was really struck by this slide that shows the hill biopharma companies are climbing. Over the past decade, the average cost to develop a therapy is up by $1 billion. At the same time, success rates have fallen, as has the average value of an approved drug. The science right now is incredibly exciting. Crossed fingers that the other variables required for success -- regulatory frameworks, IP protection, interest rates, etc. -- incentivize break through treatments in 2025 and beyond. The whole presentation is worth your time. https://lnkd.in/eEzQEwDK Recommended, Biorasi!

EXCERPTS: Five Chinese-linked biotechnology firms won a reprieve Saturday when negotiators on a key defense bill decided not to include legislation blacklisting the companies from new federally funded research and contracts. The legislation would have affected five companies to start — BGI Group, BGI spinoffs MGI Tech Co. and MGI’s US subsidiary Complete Genomics Inc., WuXi AppTec Co. and WuXi Biologics. The bill’s backers have argued the measure is necessary to prevent China from dominating another field the US pioneered.

#PrivateEquity deals in pharma services hit 110 in Q3, which is very close to the Q1 2022 record of 114, according to PitchBook data. This surge was driven by interest rate cuts, trade policy shifts such as the proposed Biosecure Act, and a growing demand for #lifesciences solutions. PE firms are consolidating drug developers, manufacturers, and clinical trial providers across the U.S., Europe, and Asia, capitalizing on supply chain restructuring. High barriers to entry and strong demand position pharma services as a PE hotspot. How will this momentum shape life sciences investments? Check out this article for more - https://lnkd.in/gShRdCzz #innovation #artificialintelligence #mergersandacquisitions #techlaw #biotechnology #pharmaservices #foleyforward #garage2global Foley & Lardner LLP

The BIOSECURE Act, bipartisan legislation pending before the U.S. House and Senate, is poised to impact the U.S. life sciences industry by limiting contractual relationships with certain biotechnology companies associated with foreign adversaries. OGC life sciences attorney Elizabeth Dana Smith takes a closer look at this legislation with an eye toward mitigating its potential impact. https://lnkd.in/eSAuVSP7 #OGC #lifesciences #BIOSECUREAct

Did you know that the U.S. Congress is currently considering legislation to prevent the governments of certain foreign adversaries from siphoning data and information from U.S. companies in order to advance their own capabilities in the biotechnology field? Read on for more interesting details from my OGC life sciences partner Elizabeth Dana Smith.

The Pistoia Alliance recently conducted a survey as a pulse check on which laboratory technologies the #pharma / #biotech industry is investing in and companies' progress integrating new tech into their labs. Check out the key findings in this new article by Becky Upton: https://lnkd.in/euazW9XV #drugdevelopment #advancedtechnologies