Roundtable Report

Access key takeaways from a roundtable on the evolving landscape for rAAV-based gene therapies. Experts discussed approaches to clinical development, regulatory barriers, and the future outlook for AAV developers and lab services organizations.

Expert panelists discuss regulatory challenges, flexible approaches to assay selection, and applying scientific reasoning with guidelines to address immunogenicity and safety assessment challenges in oncology biologics and biosimilars.

Stay current with trends in infectious disease clinical trials, with fresh insights from a recent roundtable event. Discover how the landscape is evolving and what to expect in the future, with key takeaways from industry experts.

Cell and gene therapies (CGTs) are a fast-advancing, emerging area of drug development that faces unique challenges when it comes to manufacturing and compliance. To ensure that CGT developers adhere to existing guidelines or can modify their processes without infringing regulations, it is essential that they have in place reliable, effective quality management systems. Designing and implementing such systems comes with special considerations that take into account the resource related, supply chain, scalability, and other limitations CGT companies typically encounter.

Drug development is undergoing a process of deep digital transformation, with technologies such as artificial intelligence (AI), machine learning (ML), and robotic process automation (RPA) becoming rapidly embedded in operations.

To industry players, the COVID-19 pandemic served as a wake-up call that exposed weaknesses in pharmaceutical supply chains and led to alarming shortages of essential medicines.

Recruitment, retention, and diversity are critical elements of clinical trials that, if insufficient, can jeopardize successful trial completion.

The past few years have been steadfast enthusiasm by venture capitalists and unwavering optimism by biotech company founders keen on bringing innovative therapies to market.

Research into messenger RNA (mRNA) vaccine technology started decades before COVID-19, but it was still considered an emerging technology when COVID-19 arrived.

In recent years, real-world evidence (RWE) has gained increased visibility and many life sciences companies have declared it a priority.