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Jason Kaimana

Jason Kaimana 0
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cancer, technology, chemotherapydisease, researchPharmaceutical Development
December 6, 2024

Drug Development Trends of 2024

Recent advancements in technology have significantly impacted the drug development process. Increasingly advanced and powerful tools have shifted the focus of primary drug activation as well as which diseases are gaining attention. Rare Diseases Rare diseases have become a greater interest to manufacturers due to scientific advancements and regulatory incentives. The Orphan Drug Act has included incentives such as extended exclusivity periods, tax credits, and waiving of FDA fees, leading to a large number of drug approvals focused on rare diseases. These and other incentives have made rare diseases faster and more accessible to pursue, resulting in an explosion of interest from pharma. Advancements in genomics and bioinformatics have improved our understanding of the mechanisms of previously neglected diseases such as malaria and TB. While these diseases have not received as much attention in the past due to complexities in drug discovery, advanced technology has provided the opportunity for targeted therapies with longer market exclusivity and higher prices. Companies such…
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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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Data ManagementPharmaceutical IndustryResearch
August 13, 2024

AI in Pharmaceuticals: Embracing a Competitive Advantage 

The integration of generative AI in the pharmaceutical industry is revolutionizing drug development and manufacturing processes. This transformation is driven by the rapid advancements in AI technology, offering a competitive advantage to companies that adopt these innovations.  LLMs & AI Agents  Large Language Models (LLMs) such as GPT-4, are a type of AI that excels at understanding and generating natural language text. In pharmaceuticals, LLMs are useful for summarizing large amounts of scientific literature, generating hypotheses based on existing research, and facilitating communication between researchers and clinicians. They can also be used to create patient education materials and interpret complex medical data.  LLMs differ from AI agents in that agents have more autonomy. Agents are designed to automate tasks they are trained for, and don’t require as much human direction and input. Agents are designed for analyzing data, predicting outcomes, and optimizing processes. Some of their complex roles include drug discovery tasks, drug development and manufacturing optimization, and optimizing clinical…
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