EP-064 - Industry Insights - BIOSECURE ACT 2.0 скачать в хорошем качестве

EP-064 - Industry Insights - BIOSECURE ACT 2.0

BIOSECURE Act 2.0 | Pharmaceutical Supply Chain | National Security | CDMO Manufacturing | Cloud MES | Tech Transfer Discover how the revised BIOSECURE Act is reshaping global pharmaceutical manufacturing by replacing named company targets with a dynamic watchlist system managed by the Office of Management and Budget. This episode examines the strategic shift from Congressional legislation to executive branch oversight and explores how cloud-based Manufacturing Execution Systems enable rapid adaptation to new supply chain realities. KEY TOPICS COVERED: BIOSECURE Act 2.0 Framework Changes Criteria-based designation system replacing named-company approach Office of Management and Budget authority for biotechnology companies of concern list Pentagon Section 1260H Chinese military companies integration 90-day and 60-day implementation timelines with five-year grandfathering provisions WuXi AppTec potential inclusion despite not being explicitly named National Security and Strategic Rationale Human multiomic data protection from foreign adversaries 80% of active pharmaceutical ingredients sourced overseas China's 90% market dominance in critical antibiotic manufacturing 450% increase in Chinese biotechnology patent filings since 2020 Intelligence assessments on bioweapon development and supply chain vulnerabilities Global Manufacturing Transformation WuXi AppTec's $4.7 billion US revenue exposure India emerging as primary beneficiary with double-digit CDMO growth Ireland, Singapore, Mexico, Puerto Rico, and Eastern Europe expansion opportunities 20-40% projected increase in drug development costs Major facility construction timeline 2026-2032 Cloud MES Technology Solutions Connected Manufacturing Networks enabling rapid CDMO transitions Accelerated tech transfer reducing 18-24 month timelines to months Agentic AI for real-time process optimization and comparability studies Multi-site visibility across distributed global operations Digital batch records and complete manufacturing genealogy Instant FDA audit readiness and regulatory compliance automation Apprentice.io Tempo Manufacturing Cloud for supply chain resilience Perfect for: Pharmaceutical manufacturing executives and supply chain professionals CDMO leaders and biotechnology operations teams Quality assurance and GMP compliance specialists Healthcare policy analysts and national security professionals Featured Companies: WuXi AppTec | WuXi Biologics | BGI | Sai Life Sciences | Jubilant Pharmova | Laurus Labs | Neuland Labs | Divi's Labs | Apprentice.io Tempo Platform Host: Frank Maggiore Series: Apprentice.io Industry Insights Podcast #BIOSECUREAct #PharmaceuticalManufacturing #SupplyChainSecurity #CDMO #CloudMES #Biotechnology #NationalSecurity #DrugManufacturing #TechTransfer #GMPCompliance #PharmaceuticalIndustry #ManufacturingTechnology #RegulatoryCompliance #QualityControl #ProcessOptimization #DigitalTransformation #BiomanufacturingCapacity #DrugSupplyChain #PharmaceuticalPolicy #IndustryInsights ENGAGE WITH US: Like this video if you found it valuable. Comment with your thoughts on BIOSECURE Act implications. Subscribe for weekly science-based pharmaceutical insights. Share with colleagues in pharma, biotech, and manufacturing operations. Learn more about cloud-based manufacturing solutions: apprentice.io Disclaimer: The content in this video podcast is for informational purposes only. The views and opinions expressed are those of the speakers and do not necessarily reflect the official policy or position of Apprentice.io or any other agency, organization, employer or company. This podcast does not constitute medical, financial, regulatory, or legal advice. Viewers should consult with appropriate professionals for specific advice. Apprentice.io makes no representations or warranties of any kind, express or implied, about the completeness, accuracy, reliability, suitability or availability of the information contained in this video. Any reliance you place on such information is strictly at your own risk. Related Topics: contract manufacturing organizations, pharmaceutical supply chain disruption, China pharmaceutical manufacturing, India CDMO sector growth, biotechnology companies of concern, Office of Management and Budget designation authority, Pentagon 1260H list, multiomic data security, genomic data protection, active pharmaceutical ingredients sourcing, drug shortage risks, manufacturing execution systems, digital batch records, FDA regulatory compliance, tech transfer acceleration, process validation, batch genealogy, manufacturing cloud platforms, agentic AI manufacturing, pharmaceutical geopolitics, biomanufacturing capacity expansion, strategic competition era, nearshoring pharmaceutical production, friend-shoring strategies, continuous manufacturing technology