GEN Podcasts

→ WHAT IT COVERS A panel of biotech and pharma experts from Latin America, The Gulf, and Europe examines how pandemic-era collaboration models — spanning academia, government, and industry — can reshape emerging markets' biomanufacturing capabilities post-COVID. → KEY INSIGHTS - **Collaboration velocity:** During COVID-19, the industry recorded over 90 partnerships in a single year — a volume that previously took roughly two decades to accumulate.

→ WHAT IT COVERS Dr. Christa Rantanen, cancer biology PhD and director of scientific applications at Baker Company, explains how ambient oxygen levels in standard cell culture incubators invalidate experimental results by disrupting HIF-1 signaling and cellular physiology. → KEY INSIGHTS - **Oxygen mismatch in cell culture:** Standard incubators expose cells to ~19.8% oxygen, yet even the best-oxygenated human cells — lung epithelial cells — experience only ~14%.

→ WHAT IT COVERS Dr. Gerard Brophy, EVP of biopharma production at Avantor, outlines how single-use systems in bioprocessing have grown post-COVID, and details the supply chain risks, regulatory compliance frameworks, and operational excellence strategies manufacturers need to manage these systems at commercial scale globally. → KEY INSIGHTS - **Supply Chain Diversification:** Shift from just-in-time to just-in-case inventory management by holding regional safety stocks near production sites.

→ WHAT IT COVERS Avantor's Dr. Jared Brophy examines downstream biopharmaceutical purification bottlenecks, focusing on chromatography resins, mixed-mode technologies, buffer optimization, and digital analytics tools. Downstream processing accounts for roughly 60% of total biologics production effort, with up to 30% of harvested material lost across multiple purification steps.

→ WHAT IT COVERS Avantor EVP Jared Brophy outlines the material sourcing challenges and supply chain precautions facing cell and gene therapy manufacturers, covering autologous versus allogeneic production differences, single-use system considerations, CDMO reliance, and how supplier partnerships must evolve as the sector approaches a projected 40% compound annual growth rate.

→ WHAT IT COVERS John Burke, president and CEO of Applied BioMath, explains how mechanistic modeling integrates with NOAEL and MABEL frameworks to improve first-in-human dose predictions, manage patient variability in clinical trials, and accelerate therapeutic development for gene and cell therapies through quantitative systems pharmacology approaches.

→ WHAT IT COVERS John Burke, president and CEO of Applied Biomath, explains how mechanistic PKPD modeling advances drug development by incorporating mechanism-of-action biology into mathematical simulations. The episode covers model iteration across preclinical stages, competitive benchmarking, CAR-T cell therapy design, and FDA Project Optimus dose optimization for oncology IND submissions.

→ WHAT IT COVERS John Burke, cofounder and CEO of Applied BioMath, explains how mechanistic modeling replaces traditional allometric scaling in drug development. Using differential equations to simulate biological systems from in vitro through human dose prediction, the approach reduces late-stage attrition, accelerates IND submissions, and helps companies prioritize which drug candidates to advance.

→ WHAT IT COVERS GEN Biotechnology editor-in-chief Hana El-Samad, UCSF professor and Chan Zuckerberg Biohub senior investigator, outlines the vision for a new peer-reviewed journal launching in early 2022, covering the full biotechnology ecosystem from foundational research to applied therapeutics, sustainability, and diversity in STEM. → KEY INSIGHTS - **Interdisciplinary entry into biotech:** Researchers from non-biology backgrounds can contribute meaningfully by mapping existing expertise...

→ WHAT IT COVERS Joe Dougherty, associate professor at Washington University in St. Louis, explains how massively parallel reporter assays (MPRAs) help researchers identify which noncoding genetic variants among thousands of candidates actually affect gene expression, with applications to psychiatric disorders including autism, depression, and schizophrenia.