Journal Articles
Journal Article
Pharmaceutical companies increasingly rely on Contract Development and Manufacturing Organizations (CDMOs) to bring efficiency, flexibility, and innovation to their operations. As partnerships with CDMOs become critical to achieving business objectives, it is imperative for pharma companies to choose the right partners and manage these relationships effectively. To shed light on how pharma companies can optimize CDMO collaborations, we spoke with Annette Boland, a seasoned Quality & Compliance Executive at PharmaLex, a Cencora Company.
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Local affiliates face significant time demands, often with very limited resources. These demands are perhaps most keenly felt in pharmacovigilance (PV). In many markets, requirements can include assurance of 24/7 cover, local presence, and local language.
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Strategies for ensuring revenue from mature drugs are much more complex than with newer products, and an uncertain regulatory future means that they may become more complicated in the coming years. Pharmaceutical Executive spoke with Kirsten Jacobs, PhD, chief strategy officer at PharmaLex, about strategies pharma companies can consider.
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The use of contract development manufacturing organisations (CDMOs) is now the established norm in the pharma/medtech supply chain. The CDMO model provides cost-effective, reliable and compliant solutions with speed to market for critical healthcare products. It takes advantage of core competencies/experience from the contract giver (eg, brand development, marketing, etc) and contract acceptor (eg, manufacturing excellence, quality operations, etc) to allow for targeted focus on key operational pillars to ensure overall programme success and synergies.
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The EU legislation for substances of human origin (SoHOs) has been revised, bringing blood products, tissues and cells under one regulation.
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Combination-product growth has surged globally as both physicians and patients request fewer invasive procedures in favor of user-friendly treatment delivery options.
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Advances in the cancer treatment space have renewed hope for breakthroughs with personalized cancer vaccines (often also called personalized immunotherapies). More recently, there have been promising results in a number of areas, including pancreatic cancer, melanoma, and non-small cell lung cancer (NSCLC).{1} According to analysts, significant growth is expected for cancer vaccines, with one report noting that the global market for cancer vaccines should grow from $10.21 billion in 2023 to $30.16 billion by the end of 2033.{2}
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The steps to commercialization readiness are complex, multi-faceted and often left too late in the launch strategy of a pharmaceutical product. This can be particularly problematic in Europe where the diversity of national legislation can make supply chain logistics very challenging. Among the issues faced, particularly for non-EU countries, are defining the product’s logistics, identifying stakeholders who will be involved in the supply chain in Europe, and ensuring that all these individuals are ready to assume their roles soon after the product’s approval (Marketing Authorization) with the relevant Licences and Quality Technical agreements in place.
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One of the biggest challenges when launching a product in the EU is understanding the complex regulatory landscape. Besides the overarching European legislation, each country has its own national requirements for the supply of medicinal products.
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The advancement of bioinformatics has allowed for an explosion in the field of precision medicine over the last decade. There are more and more drugs that address a specific subset of patients, not least within oncology. In parallel, the centralisation process of determining clinical benefit is approaching fast, and Joint Clinical Assessment (JCA) as part of EU HTA regulation will be implemented for new oncologics and ATMPs (advanced therapy medicinal products) in January 2025. As several emerging therapies could be treatment game-changers, quick patient access without delay is of outermost importance.
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Targeted medicines have already had a dramatic effect on treatment for many patients, with advances in technology instrumental in helping to ensure they reach individuals that will benefit from them.
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While regulatory authorities are increasingly adopting reliance programs to asses applications, few offer the opportunity to take advantage of simultaneous assessment and approval timelines across borders and jurisdictions.