BusinessPharmaceutical IndustryRegulatory
November 5, 2024

Outsourcing Trends in 2024

Outsourcing Trends & Strategies in the Pharmaceutical Industry Outsourcing is essential in the pharmaceutical industry, driven by the needs for cost reduction, operational efficiency, and access to specialized expertise. Understanding the latest trends and implementing effective outsourcing strategies is crucial for maintaining competitive advantage and ensuring sustainable growth. Current Trends in Pharmaceutical Outsourcing Focus on Quality and Compliance Maintaining high standards of quality and regulatory compliance is a top priority for pharmaceutical companies. Outsourcing partners must adhere to stringent regulatory requirements to ensure product safety and efficacy. This has led to increased scrutiny and more rigorous selection processes for choosing outsourcing partners, particularly regarding their regulatory experience, inspection histories, and perceived ability to handle the complexities of the approval process. This latter point is amplified by regulatory differences among nations, given the necessity of global clinical trials. Increased Reliance on Contract Development and Manufacturing Organizations Pharmaceutical companies are increasingly partnering with CDMOs to handle various aspects of drug development and…
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Pharmaceutical IndustryRegulatory
September 19, 2024

Regulatory Landscape 2024

Recent trends in the regulatory landscape and healthcare could significantly impact the pharmaceutical industry. Expansion of Therapeutic Modalities: The modality landscape is broadening beyond traditional small molecules and proteins to include peptides, antibody-drug conjugates, nucleotide-based therapies (especially antisense oligonucleotides, siRNAs, and mRNAs), radionuclides (theranostics) and cell and gene therapies. This diversification brings new preclinical and drug development requirements and additional regulatory complexities.  For example, the complexities of bringing a radionuclide to market are amplified when regulatory agencies must cope with the fact that most radioactive therapeutics need to be used within one week – and often the same day – that they are manufactured.  These requirements necessitate regulation at the level of the radionuclide generator itself (68Ga and 99mTc) or as radionuclide precursor formulations (177Lu, 111In, 64Cu, 90Y) due to the sophisticated infrastructure involved. Increased Focus on Digital Technology: Regulatory changes in 2024 aim to clarify technology and data collection rules. This includes updates to the International Council for Harmonisation's…
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