Events

A limited proportion of drug candidates ultimately achieve regulatory approval, often due to challenges such as insufficient efficacy, safety concerns, complex or poorly understood targets, limitations in predictive preclinical models, or commercial viability issues. Given the significant cost and time associated with development, early identification of promising candidates and the implementation of a robust development...

Join Stephen Ferrell, Chief Product Officer at Valkit.ai as he provides a critical analysis of one of the most significant regulatory updates to impact pharmaceutical computerized systems in over a decade. The proposed EU GMP Annex 11 revision transforms European compliance requirements from risk-based guidance to prescriptive technical specifications, introducing mandatory audit trails for all...

The oligonucleotide market is moving fast. Now is an exciting time with 20 therapeutics on the market and so many oligos being developed for future treatments. While the market traditionally centred around the outstanding and essential work with rare diseases, some blockbusters are emerging for much larger patient indications. We know that you’re the expert...

As the demand for plasmid DNA (pDNA) continues to surge across gene therapies, mRNA vaccines, and cell therapies, manufacturers are facing growing pressure to expand capacity with speed and precision. But scaling pDNA production is far from straightforward. Unforeseen complexities in areas like facility design or process innovation often leads to costly delays and missed...

We are very excited to announce our indoor Biotech Innovation & Vendor Expo at the Cambridge Marriott. Mark your calendars for a great opportunity to connect with industry leaders, explore innovative products, and mingle with fellow professionals in the biotech community. This biotech community event will bring together researchers from local biotech/pharma accounts in Cambridge/Boston...

Selecting the right CRO is one of the most critical decisions in clinical development, yet rarely a straightforward one. Sponsors often find that comparing CRO proposals isn’t an apples-to-apples exercise — with variations in assumptions, timelines, and resource structures making true comparisons difficult. This session draws on insights from more than $2B in CRO selections...