While platform approaches can effectively expedite standard programs, innovators often confront molecules with unique challenges and unanticipated technical hurdles. These programs require a team that has not only the technical depth but also the experience to anticipate the distinct risks and opportunities embedded in each molecule’s story. Success depends on seeing beyond the immediate scope...
The Demy-Colton Executive Clinics, part of the Global Biotech CEO Summit family of conferences, are designed to advance the capabilities of current and future life science executives. These intensive, one-day sessions deliver actionable insights into critical leadership, operational, and governance challenges facing the sector. THE LEADERSHIP MEETING: Optimize leadership strategies to govern with agility, navigate...
Bioprocess Online's Bio-Expo Live is back with its series of live virtual events designed to empower biopharma professionals. Through these sessions, attendees will have the chance to explore the newest equipment and solutions offered by our presenters, aimed at addressing the current challenges within the drug development process. This interactive online platform ensures convenience and...
The current oligo manufacturing paradigm relies on solid-phase synthesis, a process heavily reliant on organic solvents/raw materials. However, siRNA manufacturers—both biotechs and CDMOs—are in the process of starting a slow but important manufacturing transition away from solid phase synthesis toward enzymatic production, starting with enzymatic ligation for siRNA products. This will be a closer look...
This premier conference brings together newly public and select private biotech companies with the investment banking community for two days of business and regulatory sessions, Company Presentations, BIO Partnering™, and networking. Join us in Miami Beach for two impactful days as we address the most pressing issues facing our industry, from navigating the financial landscape...
Transform your CGT manufacturing from a regulatory bottleneck into a competitive powerhouse. Learn how digital integration slashes release times and harmonizes FDA/EMA compliance. You’ll walk away with a clear roadmap for scaling "batch-of-one" production using real-time analytics, ensuring your operations are both future-proof and ready for global commercialization.
The draft ICH Q1 guidance marks a major shift in biologics stability, turning it from a back-end regulatory task into a front-line, risk-based development discipline. This session explores why traditional approaches fall short, where hidden risks emerge late, and how ICH Q1 can be applied to strengthen programs across the product lifecycle. You’ll learn how...
Cell and gene therapy manufacturing is evolving fast—and scaling successfully now requires more than just meeting regulatory expectations. It requires turning them into an advantage. Our Panel will explore how leading CGT manufacturers are navigating cGMP complexity, harmonizing FDA and EMA requirements, and using digital tools to embed quality at the source—while scaling from batch-of-one...
Join us for a 2-hour virtual expo designed to help clinical trial professionals discover and compare the best Electronic Data Capture (EDC), electronic Clinical Outcome Assessment (eCOA), & Data Management technologies on the market, without the time, cost, or travel of traditional conferences. Whether you are mid-trial or preparing for your next protocol, this showcase...
Stem cells are a powerful frontier in cell and gene therapy, offering pluripotency, self-renewal, and the ability to produce engineered, standardized therapeutic cell populations. iPSC platforms reduce donor variability and support scalable, consistent manufacturing for regenerative medicine, gene correction, and next-generation cell therapies. However, stem cell products are inherently process-defined: cell identity, function, potency, and...
