AAPS National Biotechnology Conference 2022

NBC is back with a live in-person event for 2022!

The overarching theme for this year’s NBC is the concept of understanding how we can let science and innovation lead us in accelerating and improving our biotechnology drug development processes. The three tracks each explore different settings that create paradigm challenging circumstances to the “business as usual” of biotechnology drug development because they do not fit into established processes. How can we get better and more effective in evolving existing paradigms and increase speed to patient?

Track and Themes

• Track 1 – COVID Learnings – Themes: Speed to patient – what was pivotal for the development of the Covid vaccines and how can this apply to other patient-urgent licensure processes?, managing collateral damage – supply chain disruptions, manufacturing, limited capacities everywhere: evolving our manufacturing processes, clinical trial design, execution, and associated disciplines at crisis pace: how can we create ‘urgency momentum’ to benefit all drug development?
• Track 2 – New and Unusual Modalities – Themes: Gene therapies, gene editing, CAR-T, cell therapies, complex and combination products, Drug/device, patient-individualized approaches. Digital components? Managing the sample and testing chain
• Track 3 – Well-Characterized Biologicals and Biosimilars: Post-Licensure Issues – Themes: Vaccines – innovation in the land of legacy products and what to do about post approval changes in the era of ICH Q12, Biosimilars, interchangeable biologics, and well-characterized products: comparability and when ‘good enough’ means ‘scientifically appropriate’, new assays raise questions about the products we thought we knew: Immunogenicity and other concerns, Validation Challenges, analytical comparability – recognizing when assays that cannot or should not be compared