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...
This congress is designed to help educate and share innovative program design, latest customer strategies and practical solutions to overcome complex barriers, enhance program performance and deliver best-in-class patient programs amidst evolving regulations. Compliance and Operations teams unite at Patient Support Services Congress for next-level benchmarking to drive program success. Benefit from collaborative sessions as...
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...
Never has so much been at stake when it comes to investments in health care. All kinds of uncertainty — political, social, and scientific — stand between new preventatives, treatments, and cures and the patients who need them. But never has investment been more important either. Join us for a look at what is at...
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...
Greater Philadelphia sits at the forefront of a dynamic life sciences evolution, where strategic decision-making today will shape the trajectory of the region’s biotech and innovation economy for years to come. As funding landscapes shift, groundbreaking research emerges, and tenant demands evolve, stakeholders across commercial real estate, including developers, investors, and brokers, need critical insights...
What You'll Learn: How will lower interest rates influence biotech funding, investment flows, and real estate capital allocation in 2025? With a record volume of new lab and GMP supply delivering this year, how can owners make their assets stand out in a crowded market? Is renewed activity in biotech IPOs and venture funding a...
AAV vectors offer clear benefits for gene therapy, and continued advances in technology have increased target specificity, improved potency, and intensified production efficiency. Even with significant attention early in development, analytical activities for gene therapy often land on the critical path. This webinar provides considerations for phase-appropriate AAV characterization and release activities from pre-clinical to...
Alzheimer’s disease is the most common cause of dementia. It is associated with the build-up of small protein aggregates in the brain, termed β-amyloid plaques, ultimately leading to brain damage and memory loss. Overall, more women are affected by Alzheimer’s disease than men, but the reasons for these differences are not fully understood. Elucidating these...
Spotlight Panels: A New Way to Maximize Visibility for Innovative Biotech Companies In a rapidly changing world, scientific discovery has the power to transform the health and wellbeing of everyday people — yet the pace of innovation often outstrips public understanding, policy adaptation, and ethical reflection. This session of The Briefing Room explores how to...
