Advancing Complex Biologics into Real Treatments: Technologies, Experts and Part

Developing next-generation and breakthrough biologics can be a painstakingly slow process. However, harnessing new and emerging technology, like AI, can help speed this process and provide first-to-market capability. In a competitive industry like biologics, being first is everything.

Join us on this fascinating panel as we learn from some of the leading innovators and tech-focused experts from the biologics and pharma space as they discuss introducing improved technology and address some of the more vexing problems in the winding road of discovery to launch. This panel will highlight how just having solutions isn’t enough. Being able to implement change and streamline workflows are just part of the conversation.

In this session you’ll learn:

• Ways to build infrastructure for introducing new technology
• Develop metrics and analysis to uncover ROI
• Address the risks and ethics associated with AI

Bionova’s Darren Head (Chairman & President) and Jesse McCool, PhD (Chief Scientific Officer) will discuss new innovations that are accelerating the pathway from late discovery to first-in-human trials. They will address the critical role CDMOs can play in getting early-stage innovators to Phase 1 faster and with lower risk and expense, bridging the proverbial “valley of death.”

Drug discovery and development are complex and require significant resources, expertise, and time. With the industry becoming more and more competitive, pharmaceutical companies need to utilize new approaches to launch products more efficiently. However, companies are still met with obstacles from regulatory guidelines to recruitment of clinical trials to other market competition

Join us as for this insightful conversation with pharma executive(s) to explore key barriers in advancing new treatments and how to navigate the uncertainty through the late phase clinical trials to launch. This session will explore how the pros and cons of leveraging cutting-edge technology to overcome challenges in the late phase and launch treatments and bring life-saving treatments to patients faster.

The latest generation of biologics are becoming increasingly difficult and costly to produce using conventional mammalian systems. These rely on constitutive “always on” expression of the target gene, which can overwhelm cellular machinery, limiting protein yield and driving up production costs —especially for complex or toxic proteins.

These obstacles can be overcome using molecular optogenetics, a technology that employs genetically encoded, light-sensitive proteins to precisely control gene expression. By decoupling growth from production, cells can first reach high density before switching to efficient protein expression. Coupling this with closed-loop control enables the ability to dynamically tune protein expression to maximize titer, improving manufacturability.

Deniz Kent, PhD, Co-Founder and CEO of Prolific Machines will discuss how the development of optogenetically-enabled cell lines and bioprocessing can be used to accelerate the production of next-generation biologics.

Bionova CSO Jesse McCool, PhD, will discuss the strategies and technologies Bionova is leveraging to assist early-stage biologics innovators in bridging the chasm between discovery and Phase 1. Dr. McCool will discuss specific advances, such as Bionova’s upgraded cell line development platform, which is drastically reducing CLD timelines. He will also describe how Bionova intentionally co-located and integrated all pre-GMP activities under one roof. This approach is yielding meaningful technical and efficiency gains as process development teams facilitate seamless technology transfer by scaling and training simultaneously.