Panelists:
Erin Dieveney
Vice President, Quality Assurance
Aldevron
Khaled Yamout
Founder & CEO
Y-Chem Consulting
Kok-Seong Lim, PhD
Founder and Principal
Eight Crest Strategies
Michael Lehmicke
Senior Vice President, Scientific Affairs
Alliance for Regenerative Medicine
- Time:
As biologics become more diverse, complex, and faster-moving, how can the biotech and biopharma industry ensure that quality standards keep pace with innovation? We will address this fundamental question in the latest GEN Spotlight on Biologics Standards for Innovation, Quality and Access, presented in partnership with USP. This virtual event will explore how evolving standards can provide a stronger foundation for developing and manufacturing next-generation therapeutics.
This Spotlight on Biologics Standards for Innovation, Quality and Access brings together experts from across biopharma, standards development, and analytical science to examine the challenges of testing increasingly complex modalities, including monoclonal antibodies, cell and gene therapies, and RNA therapeutics. Sessions will explore when and how to standardize emerging therapies, a practical layered framework for quality—from raw materials and analytical methods to identity, purity, and potency—and the growing importance of community input in developing standards for new modalities.
Session highlights include:
- A roundtable explores layered frameworks to ensure quality in multi-modal therapeutic development featuring Erin Dieveney (Aldevron) and Kok-Seong Lim, PhD (Eight Crest Strategies).
- A panel discussion on building standards for a multi-therapeutic modality future, featuring Khaled Yamout (Y-Chem Consulting) and Michael Lehmicke(Alliance for Regenerative Medicine)
- And a discussion featuring senior executives from USP on the importance of community input in developing standards for new modalities.
Join us on Wednesday, October 14, to discover how standardization can reduce development risk, support innovation, and help establish a shared foundation for the future of biologics.
Registration for this 2.5-hour event is free.
Produced with support from:


