Maren von Fritschen, PhD’s Post

Register now! On March 4th, 2024 we will start with the next edition of the online course Market Approval. In this 5-week interactive learning-by-doing online course, you’ll learn how to identify the relevant regulatory guidelines that will steer you through the development process using our free Market Approval Navigator tool. This course uses real-world case studies such as the development of a gene therapy product, an antibiotic and also a fictitious mRNA-based vaccine to familiarize you with common issues that can arise during product development, and you’ll learn how to assess an IMPD (Investigational Medicinal Product Dossier) using the relevant guidelines and how to set up a Target Product Profile (TPP). The course includes our educational documentary The Rise, Fall and Return of Thalidomide, with several important take home messages for current drug developers. Contributions are from spiros vamvakas (Head Scientific Advice, European Medicines Agency), Murray Lumpkin (former Director CDER, FDA), Onno van de Stolpe (former CEO Galapagos), Jerry Zeldis (former CMO Celgene), Eline Bunnik (Erasmus MC), Henk Schuring (former Vice President Head Rare Neurological Disease, Genzyme ), Bert Leufkens (former Chairman College ter Beoordeling van Geneesmiddelen), Sjaak Bot (former Vice President Regulatory Affairs, The Janssen Pharmaceutical Companies of Johnson & Johnson), mentor Ineke Jonker-Hoogerkamp and more. For more information, free demo and brochure go to https://lnkd.in/eMhGYn8h #professionaldevelopment #onlineeducation #onlinelearning #lifelonglearning #marketapproval #fda #EMA #regulatoryaffairs #pharma #biotech #medtech

Caroline Peachey at European Pharmaceutical Review interviewed Roberto Formisano, Senior Process Transfer Manager at the Advanced Therapies London 2024 conference. They discussed challenges in technology transfer within gene therapy and viral vectors, emphasizing tight timelines for clinical trials. Roberto advised on seamless transitions and predicted a shift towards larger-scale viral vector production, stressing the need for scalable, cost-effective processes. He also featured insights into how AGC's tailored LVV and AAV platforms can help developers seeking to create a scalable process for cGMP stages. Watch the full interview, here: https://lnkd.in/gbXD7Z3c #biotech #pharma #Biopharma #pharmaceuticals #LifeScience #Biotechnology #advancedtherapies #genetherapy #Biopharmaceuticals #AGCBio #CDMO

𝐒𝐨, 𝐈 𝐠𝐨𝐭 𝐭𝐡𝐞 𝐫𝐞𝐩𝐥𝐲 𝐟𝐫𝐨𝐦 𝐍𝐏𝐑𝐀 In my previous post, I mentioned the insufficient attention of tissue engineering and stem cell therapy in authorities such as the National Pharmaceutical Regulatory Agency (NPRA), and coincidentally, I was having site visit to NPRA after that. I raised the concern mentioned to them and was enlightened that NPRA had established the guidance note for the Cell and Gene Therapy Products (CGTPs) manufacturing facility in Malaysia in 2021. It is a guideline for any organization or establishment manufacturing CGTP facilities regulated by NPRA. I was also told by NPRA that both industries and authorities are still learning about the technologies of CGTPs products and they are keen to understand and control the products through different phases with respective objectives such as the registrations and applications, GLP and GMP inspection of CGTPs products. It is an ongoing process that requires synergistic efforts to amplify the impact of stem cell technology in Malaysia; therefore, NPRA strongly encourages industries to share their knowledge with the authorities and NPRA. I definitely learnt a lot from the visit to CTERM and NPRA over the past weeks, and it was eye-opening for me to understand how different parties collaborate to advance Malaysia's healthcare technology and, ultimately, to provide a better living environment for Malaysians. #NPRA #CGTPs #CTERM

🌟 New Biological Entity have the potential to offer innovative therapies, such as targeted biologics, gene therapies, and personalized medicines. However, a big challenge is addressing their development and manufacturing processes. 📓 The journey of bringing one NBE from the research lab to the market is a long one. It takes almost 7 years and requires extensive research, scientific expertise, and rigorous testing to ensure safety, efficacy, and regulatory compliance. 💡 Despite these challenges, a total of 50 new chemical and biological entities were approved by the FDA in 2021, out of which 14 were classified as new biological entities. #workbytes #biopharmaceuticals #downstreamprocessing #biologicdrug #chromatography

#NewsArticle // Read our recent article "Microbiology is Vital to Compliance to Annex 1 and Risk-Based Regulation" published by Applied Clinical Trials Magazine. The new revision of the #Annex1 describing the importance of qualification, training, behavior, and experience as key areas in minimizing contamination risk to sterile product manufacture. In this article, Noelle Clifford - Manager Consultant at PharmaLex, dives into the hot topic within the industry - Annex 1 compliance & the key takeaways related to specific topics arising from the guidelines: ➡️ Knowledge and Training ➡️ CCRA ➡️ Sterility Assurance ➡️ Challenges in Cell and Gene Therapy Manufacturing The article is a must-read for anyone involved in the pharmaceutical industry, and provides valuable insights into the complex world of microbiology and its relevance to Annex 1 compliance. Read the full article here: 🔗 https://bit.ly/48UAP97 #PharmaLex #SterilityAssurance #Microbiology #Compliance #PharmaceuticalIndustry #CellandGeneTherapyManufacturing #KnowledgeandTraining #CCRA

Thoughts on this? >> Keeping Track: Two Breakthrough Oncologics, Another Antibiotic Clear US FDA Along With Pfizer's Hemophilia B Gene ... - Pink Sheet >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #pharmaceutical #healthcare #biotech #pharma #competitivemarketing