Lonza’s Post

It's not long until Altasciences hosts a free symposium on Campus covering 'How to Safely and Effectively Accelerate Your Drug Development'. A panel of industry experts will discuss strategies to plan for successful drug development, including selecting the right regulatory pathway for safely securing market access faster. Secure your space here - https://ow.ly/KKZV50PzR9b #lifescience #drugdevelopment #regulatoryaffairs

Relying on existing data, the 505(b)(2) pathway can streamline the drug approval process, bringing modified versions of existing drugs to market faster and at a lower cost. Is it right for you? Find out: https://bit.ly/3z2jSdB #FDAApprovals #DrugDevelopment #ClinicalTrials

Revisit resources from the FDA workshop with National Center for Advancing Translational Sciences (NCATS). The workshop emphasized the critical role of academic investigators, #patient groups, and small or emerging #pharmaceutical and #biotechnology companies in #raredisease drug development. It provided guidance for those who may lack #regulatory experience, focusing on bridging the gap between academic research and the regulatory aspects of #drugdevelopment. 👇

Revisit resources from our workshop with @NCATS_NIH_GOV to enhance your knowledge and explore how academic investigators look to bridge the gap between their work and the regulatory aspects of drug development: https://lnkd.in/eGwdS7ZH #RareDiseaseWednesday

In Part 3 of our webinar series on 505(b)(2) NDA drug development, we focus on pre-IND meetings. Watch our on-demand recording for some examples of inadequate pre-IND meetings and to learn how to craft recovery plans for unsatisfactory ones: bit.ly/3K1jz7O #505b2 #pind #preind

Successfully launching a drug is extremely hard! 💊 About 1 in every 10,000 drug compounds will make it through all phases of clinical trials and achieve approval. That's 0.01% 🤯 On average, it takes a product ~10 years ⏳ and ~$2.6B💲from development to market, with clinical trials alone taking 6-7 years. #nesfircroft #lifesciences #drugdevelopment #clinicalresearch

With approximately 90% of candidates entering clinical trials failing to achieve regulatory approval, understanding the reasons behind these failures is crucial for companies aiming to future-proof their product candidates. Read our latest whitepaper, “Learning the Lessons of Failure: How to improve the economics of Life Sciences R&D” and dive deep into eight real-world case studies that reveal the challenges and invaluable lessons learned from drug development programs. View here: https://ow.ly/alUj30sBRwA #clinicaltrial #drugdevelopment #regulatory

Discover the world of clinical labeling in drug development. From understanding its significance to exploring target labeling and safety information, gain insights into streamlined processes. Explore Freyr's expertise in clinical labeling. https://lnkd.in/gjtPYEAB   #ClinicalLabeling #DrugDevelopment #TargetLabeling #LabelingCompliance #FreyrSolutions  

Data from registries can be used to complement your information during regulatory, reimbursement and clinical decision making, and from preclinical to post Market. No matter where you are in your drug development process, OM1 Aspen is; ▶ Cost Effective ▶ Hypothesis Generating ▶ Generalizable, Individualized ▶ Flexible ▶ Reusable Click here to book a meeting with me to learn more: https://lnkd.in/eaDhgxXM #clinicaltrial, #retrospective #patientoutcomes #patientrecruitment #regulatorysubmissions #rwe