Plenary Session 7 - Knowledge Management and Sharing – You Don’t Know What You Know

Jan 25, 2023 4:45pm ‐ Jan 25, 2023 6:15pm

Identification: 47899

Knowledge Management and Sharing is about Continuous Improvement through learning before, during, and after a project, and it’s about “working out loud” by paying it forward through collaborating, learning, and adapting. We want to know what we know as a company, as an industry, or a regulatory agency, in order to make better decisions so that we can deliver the best medicines to patients. In order to maintain and leverage knowledge we need advanced data science techniques to both find what we are looking for and to gain insights from that information: data to information to knowledge to wisdom. Knowledge Sharing helps lead to “wisdom”. This session will include concepts on how regulators may share knowledge, how knowledge is shared across industry, and examples of the types of knowledge being collected.
• Accumulus Synergy Project Update
• Knowledge Collection and Sharing Across Industry
• Update from the FDA KASA/PQ-CMC initiatives – how can we all learn?

Plenary Session 8 - The Wonders and Woes of Biological Platforms

Jan 26, 2023 9:00am ‐ Jan 26, 2023 10:30am

Identification: 47904

The need for efficiency and standardization has driven industry and regulators alike to establish the concept of platforms. Based on prior knowledge and clinical needs, a platform approach is tailored to molecular classes, manufacturing and analytical processes, drug delivery and regulatory practices. Common technology, like expression systems, single-use processes, and analytical method instrumentation, can drive adoption of platforms within a company and across industry with significant benefits of speed to development, capital equipment usage, and expedited documentation.

The use of platforms may, however, result in some drawbacks. The strict adherence to a platform can blind both industry and regulators to innovation. Company platforms may remain unaltered despite the efforts of venders, new developments, and startup companies to introduce improvements and advanced technologies. Regulatory authorities become comfortable with established standards putting added pressure on the introduction of new technologies.

This session will dive into regulatory science, the process of discovery and implementation of risk-based science to drive regulation towards enhanced product and analytical development, and lifecycle management. Talks will derive from institutions engaged in the development of novel technology platforms and regulatory paradigms as well as industry and regulatory efforts in this field. Discussion will follow, probing opportunities and hurdles, with the hope of seeing value in and a pathway towards modern biologicals development, regulation, and commercial practices.




Additional Panelist:

Philip Krause, Independent Consultant

Technical Seminar Sponsored by ProtaGene

Jan 26, 2023 12:30pm ‐ Jan 26, 2023 1:30pm

Identification: 47912


Technical Seminar Sponsored by Waters Corporation

Jan 26, 2023 12:30pm ‐ Jan 26, 2023 1:30pm

Identification: 47911


Unearth the real value of your complex biopharma analytical data through a powerful enterprise software platform

Jan 26, 2023 12:30pm ‐ Jan 26, 2023 1:30pm

Identification: 459388

As biopharmaceuticals are becoming increasingly complex, the data generated with different analytical techniques is increasing in volume and variety. Obtaining the prescient insights scientists need and can subsequently be fed into further stages of development has been hindered by the fact that data come from all over the place and is disconnected. Worse, results are often locked into desktop software and sharing reports is manual and cumbersome. Instead, with Deep Query tools from Protein Metrics, and Dashboards for visualising data mining, you get instant access, with shareable insight.

Mass spectrometry data produces extremely valuable data for biotherapeutic research, development and production. Advanced enterprise data systems allow organizations to curate, interrogate and faithfully share that information for timely decision-making. As many companies are embracing digital transformation, researchers are not only looking for solutions that allow easier data sharing by leveraging cloud capabilities, but are looking for platforms that offer data processing in a native web environment, which are accessible from anywhere, so that scientists are no longer bound to their desktop software or manual information sharing.  

In this short presentation, you can learn about advancements in ByosphereA, Protein Metrics' vendor neutral enterprise software platform: Enable your organization's scientists to process data easily in front of any computers with web access from anywhere and share the results just as easily with colleagues with access to the same data. Make your data work for you in an effortless and automated fashion by turning it into actionable insights only within minutes after an acquisition is completed. Analytical scientists will never want to go back to old ways if they discover how data mining with deep query and visualization of the processed and extracted information with dynamic dashboards can enable them to do their work faster with insights at a glance. 

Get the value out of your complex data by processing it faster, sharing it easily, and summarizing it for non-experts in a GxP environment.


Plenary Session 9 - Next Generation Therapeutics and Vaccines

Jan 26, 2023 3:45pm ‐ Jan 26, 2023 5:15pm

Identification: 47919

The unprecedented speed and global impact of COVID vaccine development has put next-generation therapeutics at the forefront. In recent years, the landscape has evolved significantly: mRNA is part of the general lexicon, and the requirement for robust and nimble response to emerging pandemics is now a driving force in development. Speed of scientific innovations has allowed the development of novel modalities ranging from cell and gene therapies to microbiomes, or live biotherapeutics.
This session will focus on three areas, the design of next-generation therapeutics and vaccines using computational approaches, novel delivery approaches such as nasal delivery, microneedles, and regulatory perspective on various novel modalities and vaccines.