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Biologics Standards for Innovation, Quality and Access

Credit: Ruslanas Baranauskas / Science Photo Library / Getty Images

Panelists:

Image of Erin Dieveney

Erin Dieveney

Vice President, Quality Assurance
Aldevron

Panelist

Image of Erin Dieveney

Erin Dieveney

Erin Dieveney leads quality assurance at Aldevron where she helps ensure the quality, compliance, and reliability of products that enable next-generation genomic medicines. Throughout her career, Erin has assumed increasing leadership responsibilities across quality, regulatory affairs, product development, and customer support, developing deep expertise in bringing innovative life sciences technologies to market.

Image of Khaled Yamout

Khaled Yamout

Founder & CEO
Y-Chem Consulting

Panelist

Image of Khaled Yamout

Khaled Yamout

Khaled Yamout is a thought leader in analytical sciences, quality and manufacturing. He was previously senior director of analytical services and quality control at TriLink Biotechnologies, where he oversaw the Analytical Sciences Center of Excellence and all analytical aspects of method development and validation to product release and stability, in support of regulatory filings for both small and large molecules. Prior to TriLink, Khaled held various positions in quality control, R&D, and manufacturing where he supported several drug products (small molecules and biologics) from clinical phase to commercial. His experience spans Fortune 500 firms as well as small entrepreneurial businesses in the areas of synthetic, analytical, colloidal, surface modification, protein, and antibody modification and purification.

Khaled holds a BS degree in chemistry from the University of Texas at Arlington.

Image of Kok-Seong Lim, PhD

Kok-Seong Lim, PhD

Founder and Principal
Eight Crest Strategies

Panelist

Image of Kok-Seong Lim, PhD

Kok-Seong Lim, PhD

Kok-Seong Lim, PhD, is a pharmaceutical leader with more than 20 years of experience in biological research and development, specializing in analytical sciences, quality control, and CMC strategy for advanced therapy platforms. He has held multiple management roles at Metagenomi, Aura Biosciences, Editas Medicine, and Thermo Fisher Scientific (formerly Brammer Bio), where he contributed to the advancement of more than ten gene therapies and CRISPR-based medicines for rare diseases and oncology indications.

Throughout his career, Kok-Seong has led the buildout of GMP-compliant facilities and analytical infrastructures to support early- and late-stage development. He has managed complex, multimillion-dollar budgets and contributed to regulatory submissions in both the U.S. and EU. Kok-Seong has served on committees such as the USP Biologics Expert Committee for Cell and Gene Therapy and the Standards Coordinating Body, helping to shape best practices and standards for the cell and gene therapy community.

Kok-Seong earned his PhD in biochemistry from the National University of Singapore and holds a BSc in pharmacy from the University of Strathclyde, Scotland.

Image of Michael Lehmicke

Michael Lehmicke

Senior Vice President, Scientific Affairs
Alliance for Regenerative Medicine

Panelist

Image of Michael Lehmicke

Michael Lehmicke

Michael Lehmicke joined the Alliance for Regenerative Medicine in 2019 as its first director of science and industry affairs. Michael has over 20 years of R&D experience in biomaterials, medical devices, and regenerative medicine. He has led product development teams for class II devices, human cell and tissue-based products, and drug/device combination products. He is a creator and an inventor with multiple U.S. patents to his name.

Michael has an MSc in biomedical engineering, with a focus on tissue engineering, from Drexel University. Michael’s areas of expertise include cell-based tissue engineering, bioceramics, biodegradable polymers, project management, strategic pipeline development, and business development.

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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:

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