The aspect of increasing regulatory requirements, the growing complexity of small molecules for progressively 'personal' (focused patient groups) and, thus, smaller volume active ingredients is driving costs up — whereas society needs lower price solutions. A true dilemma of epic proportions.
The pharmaceutical innovators being served by contract development and manufacturing organisations (CDMOs) such as Sai Life Sciences are facing significant cost pressures — combined with a need to accelerate supply — and are undergoing dramatic changes in their operating environment. Contributing factors include geopolitical upheavals, more alliances and partnerships, full transparency expectations, an increased emphasis on innovative technologies, convergence between the medical technology and pharmaceutical industries and a proliferation of regulatory changes.
This has added to the complexity of the life sciences supply chain, escalating the importance of ensuring that all products are manufactured, distributed and delivered in a safe, cost-effective and timely manner.
Compliance is therefore as much about the spirit — and not just the letter — of the law. Indeed, regulators and life sciences supply and development companies have the same interests at heart — patient safety and products that effectively treat the therapeutic need. The life sciences industry is also experiencing dynamic shifts in consumer attitudes, such as expecting earlier access to new products. There is also a move towards greater patient engagement, both in determining the effectiveness of a particular therapeutic pathway and its impact on patient adherence, and in obtaining information on patient reported outcomes.
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