Join Cell & Gene’s Chief Editor, Erin Harris, for this timely Cell & Gene Live offering an in-depth regulatory outlook with two of the field’s most trusted experts, Wilson Bryan, M.D., former director of FDA’s Office of Tissues and Advanced Therapies (OTAT), and Daniela Drago, Ph.D., RAC, Partner at NDA Partners. Drawing on his tenure...
Hear directly from leading CDMOs about their current fill/finish capabilities, facility locations, and timelines. Through short, interactive presentations, you’ll gain insight into available capacity across sterile filling, lyophilization, and advanced packaging—all with the opportunity to ask live questions.
Developing robust cell harvest and media exchange processes is often complex, particularly when moving from development to GMP manufacturing. Differences in equipment, scale, and automation can introduce variability and delay clinical timelines. Common methods such as TFF face challenges in maintaining consistent parameters during scale-up, while disc-stack centrifugation lacks scale-down models and can expose cells...
Study design is increasingly empowered by a rich and diverse array of data. New sources continue to emerge, fueled by advances in AI that enable the integration of information from literature, ClinicalTrials.gov, digitized protocols, and beyond. Harnessing these complementary data streams allows researchers to design studies that are not only operationally efficient but also more...
This virtual event demonstrates how to bridge the gap between shopfloor operations (OT) and enterprise IT systems to achieve seamless machine integration, real-time data flow, and regulatory compliance.
The Conference for Women Who Are Leading the Way in Life Science Join us for two-days of networking with resourceful exhibitors, presenters and speakers, who are shaping what's next in life science, biotech, medtech, femtech, pharma, women's health and medicine. With a focus on Funding & Entrepreneurship, HR, Career Development, New Products, and Career Connections,...
Join Drug Delivery Leader's Chief Editor Tom von Gunden as he engages drug delivery experts Beate Bittner, Shannon Hoste, Jonathan Amaya-Hodges, and Fran DeGrazio in a discussion of innovations and advances in injectable, infusible, and implantable devices, systems, platforms, and combinations. Focusing on unmet patient needs and expanded therapeutic targets, the panel will discuss approaches...
Join KBI Biopharma and Argonaut Manufacturing Services for a candid fireside chat on breaking down silos between drug substance and drug product. Explore how an integrated, quality-aligned approach can simplify execution and reduce timelines by 2–3 months from cell line development to drug product manufacturing. What you’ll learn: * How to overcome common CDMO and...
Watch industry experts share practical guidance on how to evaluate CDMOs beyond the basics—focusing on experience, talent, and technologies that align with your development goals. Speakers: Jana Spes, CEO & Co-founder, JT Biopharma Partners Peter Bigelow, CEO & Co-founder, SCmple Solutions Christine Sheaffer, Manufacturing & Supply Consultant, Executive Leader Biotech Industry Jeff Buguliskis, PhD, Chief...
Join West Pharmaceutical Services for a discussion on how to simplify the complex process of selecting a prefillable syringe system. With combination product requirements and ambiguous regulations, traditional evaluation and testing can slow development and delay clinical timelines. This presentation introduces the West Synchrony™ S1 Prefillable Syringe System—a fully integrated, verified solution combining the barrel,...
The road to first-in-human is one of the most pivotal—and complex—stages in drug development. It’s a journey that requires foresight, coordination, and a clear map connecting scientific innovation to operational execution. In this live webinar, experts from inSeption Group will outline proven strategies for navigating each phase of early clinical readiness and IND preparation. Learn...
The rapid growth of complex antibody modalities—including bispecifics, multispecifics, Fc-fusions, and emerging formats—has widened the gap between discovery-stage expression systems and manufacturability. Transient expression, still widely used for screening and optimization, often fails to reveal architecture-driven liabilities such as chain imbalance, mispairing, instability, aggregation, or poor effective yield. As a result, promising molecular formats may...
