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Interviews
Challenges in Technology Transfer for Oligonucleotide Therapeutics: Analytical Complexity, Process Robustness, and CMC Readiness with Rowshon Alam, Ph.D. — Vice President, Prime Medicine, Inc.
A strategic deep dive with Rowshon Alam, Ph.D. of Prime Medicine on analytical complexity, process robustness, and technology transfer readiness in next-generation oligonucleotide therapeutics.
Interviews
The Future of RNA CMC: Early Strategy, Smart Outsourcing, and Fully Integrated Development Architectures with Hagen Cramer, Ph.D., QurAlis CTO
Breaking CMC bottlenecks in RNA therapeutics is no longer a technical challenge, it is a strategic imperative under Hagen Cramer’s biotech leadership at QurAlis.
Interviews
De-Risking Biotech Investment Through CMC: Aligning Process Development, Manufacturing, and Market Viability with Seshu Tummala, PhD
From scaling gene-editing pipelines at CRISPR Therapeutics to leading end-to-end drug substance manufacturing at Uniquity Bio, Dr. Seshu Tummala defines how CMC strategy transforms breakthrough science into scalable, real-world therapeutics.
Regulatory Affairs
Architecting Risk-Based Quality Systems for Agile Clinical Supply: Elie Arslan at the Intersection of Compliance and Execution
Elie Arslan’s systems-driven approach to quality governance and clinical supply redefines clinical packaging as a dynamic, data-integrated control layer enabling agile, compliant, and predictive trial execution.
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Interviews
Challenges in Technology Transfer for Oligonucleotide Therapeutics: Analytical Complexity, Process Robustness, and CMC Readiness with Rowshon Alam, Ph.D. — Vice President, Prime Medicine, Inc.
A strategic deep dive with Rowshon Alam, Ph.D. of Prime Medicine on analytical complexity, process robustness, and technology transfer readiness in next-generation oligonucleotide therapeutics.
Interviews
The Future of RNA CMC: Early Strategy, Smart Outsourcing, and Fully Integrated Development Architectures with Hagen Cramer, Ph.D., QurAlis CTO
Breaking CMC bottlenecks in RNA therapeutics is no longer a technical challenge, it is a strategic imperative under Hagen Cramer’s biotech leadership at QurAlis.
Interviews
De-Risking Biotech Investment Through CMC: Aligning Process Development, Manufacturing, and Market Viability with Seshu Tummala, PhD
From scaling gene-editing pipelines at CRISPR Therapeutics to leading end-to-end drug substance manufacturing at Uniquity Bio, Dr. Seshu Tummala defines how CMC strategy transforms breakthrough science into scalable, real-world therapeutics.
Regulatory Affairs
Architecting Risk-Based Quality Systems for Agile Clinical Supply: Elie Arslan at the Intersection of Compliance and Execution
Elie Arslan’s systems-driven approach to quality governance and clinical supply redefines clinical packaging as a dynamic, data-integrated control layer enabling agile, compliant, and predictive trial execution.
Medicinal Chemistry & Pharmacology
Igor Nasonkin and Phythera Therapeutics: Moving Oncology Beyond Single Targets into Engineered Polypharmacologic Systems
Igor Nasonkin’s systems-driven approach at Phythera Therapeutics reframes oncology drug development from single-target inhibition to AI-enabled polypharmacologic network modulation using nature-derived molecular architectures.
Drug Discovery Biology
Governing Multi-Component Therapeutics: Andrea Small-Howard’s Systems Framework at GB Sciences, Inc.
A systems-driven analysis of Dr. Andrea Small-Howard’s leadership at GB Sciences, Inc., detailing how multi-component cannabinoid therapeutics, governance architecture, and AI-enabled discovery are converging to redefine translational drug development.
Artificial Intelligence and Data Analytics
Inside Johnson & Johnson’s External Innovation Engine: Devin Swanson on Translating Integrated Discovery into Strategic Value
Devin Swanson’s leadership at Johnson & Johnson Innovative Medicines redefines external innovation as a tightly governed, AI-enabled translational system integrating multi-modal drug discovery, biomarker strategy, and capital-efficient execution.
Immunology & Oncology
From DMPK to Distributed Execution: Mehran F. Moghaddam’s Systems Strategy at OROX BioSciences, Inc.
A systems-level examination of how Mehran F. Moghaddam operationalizes DMPK, externalized R&D, and lipid-mediated therapeutics into a predictive, high-velocity biotech development architecture.