Good morning from Pharma and Biotech daily: the podcast that gives you only what's important to hear in Pharma e Biotech world. Viral vector manufacturers are facing challenges such as high production expenses, low titers, empty capsids, and limited scalability when producing cell and gene therapies. To overcome these challenges, they are turning to next generation production processes to create a cost-effective and robust AAV manufacturing process. This new approach aims to produce higher titers and full capsids, increase efficiencies resulting from high yields, and drive down the cost per dose. By implementing these strategies, manufacturers can improve the productivity of AAV production and bring promising treatments to the market more effectively.Embecta received FDA approval for its insulin patch pump, featuring a larger insulin reservoir based on feedback from people with type 2 diabetes. Meanwhile, Illumina avoided a fine for its acquisition of Grail in a European court victory. The ARPA-H program will focus on AI degradation in medical tools, while a pathology group is suing to block an FDA lab test rule. Additionally, Medtronic's chief medical officer of acute care and monitoring has departed for a new role.The text discusses various updates in the biopharma industry as of September 3, 2024. It covers topics such as the next challenger to Prevner, advancements in AI drug discovery, concerns over suicide risk of obesity drugs, Recursion's lead drug safety, Vaxcyte's positive data for a pneumococcal vaccine, Sanofi's mixed results in MS drug trials, and the value of digital insights in pharma success.A new study predicts a healthcare labor shortage by 2028, with certain states and specialties facing acute shortages. The study also reveals disparities in fighting medical bills, as uninsured and less educated patients are less likely to question their bills. The ARPA-H program will focus on addressing AI degradation in medical tools. Other updates include tracking healthcare worker strikes and data breaches. The use of technology is transforming healthcare to combat challenges such as workforce shortages and shifting care utilization patterns.FDA Commissioner Dr. Robert Califf is considering reforms to advisory committees, including potentially scrapping expert voting in some circumstances. Califf believes that the discussions within these committees may be more valuable to the FDA than the final vote outcomes. Eliminating voting could help clarify the role of advisory committees. Other potential reforms being discussed include addressing conflicts of interest.The text discusses the importance of getting the Institutional Review Board (IRB) review right the first time and introduces a checklist of critical questions to ask potential IRB partners to ensure a smoother review process. By asking the right questions and choosing the right IRB, the review process can be more efficient and effective.Novo Nordisk's drug Ozempic will continue to face shortages into the fourth quarter due to supply issues, even as the company tries to expand its indication. Astellas Gene Therapies is closing its biomanufacturing facility in San Francisco, affecting about 100 employees and shifting manufacturing to North Carolina.In a landscape where consumers are willing to switch brands to save money, it is crucial for brands to establish and maintain loyalty among shoppers. By leading with value, moving consumers from awareness to loyalty to advocacy, and creating connection and community, brands can build brand love even in the face of economic pressures.The text discusses how emerging oncology innovations have led to more effective therapies for cancer patients. The increased investment in cancer research has introduced new treatments such as cell and gene therapies, antibody drug conjugates, and checkpoint inhibitors. Despite these advancements, the industry still faces challenges in expanding access and improving outcomes.