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Tracks and Themes

The overarching theme for next 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 1 – COVID Learnings

Track 2 – New and Unusual Modalities

Track 3 – Well-Characterized Biologicals and Biosimilars: Post-Licensure Issues

 

Crisis-Driven Efficiency and Innovation. When Crisis Spurs Efficiency and Speed to Patient – What We Learned and Must Retain

Innovation as a necessity during crisis – when there is no mold, but progress must be made.

When The Mold Does Not Fit - New Biologics and Modalities

Using innovation to make the scientific case(s) for regulatory and development paradigm shifts to avoid molds that don’t fit anymore.

When Innovation Breaks the Mold – Letting Science Drive Compliance and Quality for “Old” Products

Assuring that retrospective innovation reaches late-lifecycle and legacy products: breaking existing molds that do not fit or make sense anymore

Theme 1

Speed to patient – what was pivotal for the development of the Covid vaccines and how can this apply to other patient-urgent licensure processes?

Gene therapies, gene editing, CAR-T

Vaccines – innovation in the land of legacy products and what to do about post approval changes in the era of ICH Q12

Theme 2

Managing collateral damage – supply chain disruptions, manufacturing, limited capacities everywhere: evolving our manufacturing processes.

Cell therapies, Complex and combination products

Biosimilars, interchangeable biologics, and well-characterized products: comparability and when ‘good enough’ means ‘scientifically appropriate’

Theme 3

Clinical trial design, execution, and associated disciplines at crisis pace: how can we create ‘urgency momentum’ to benefit all drug development?  

Drug/device, patient-individualized approaches. Digital components? Managing the sample and testing chain

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

 

Scientific Programming Committee

Lauren Stevenson, Immunologix Laboratories, Ph.D. (Chair)
Heather Myler, PPD Laboratories, Ph.D. (Vice-Chair)
Tapan Das, BMS (Board Liaison)

Well-Characterized Biologicals and Biosimilars: Post-Licensure Issues

Robert Nelson, Labcorp Drug Development, Ph.D. (Chair)
Leo Tseng, 89bio, Ph.D., MBA (Sub-Track Chair)
Maaike Everts, Evonik Corporation, Ph.D. (Sub-Track Chair)

New and Unusual Modalities

Beata Swerdya-Krawiec, Tarveda Therapeutics, Ph.D. (Chair)
Ashwin Parenky, Regeneron Pharmaceuticals, Ph.D. (Sub-Track Chair)
Devangi Mehta, Immunologix Laboratories, Ph.D. (Sub-Track Chair)

COVID Learnings

Michael Patridge, Regeneron Pharmaceuticals, Ph.D. (Chair)
Yongchao Su, Merck & Co Inc, Ph.D. (Sub-Track Chair)
Shoshana Oberstein, PPDA Laboratories (Sub-Track Chair)