Challenges of the biopharmaceutical industry
Product development and manufacturing is most of the times a rough ride that requires a continuous adaptation of focus between keeping the holistic overview and insight into detail matter.
The journey from a promising idea for a novel drug lead to a clinically validated drug is long and takes several years of focused and consistent collaboration of various professional specialties and competencies.
Over the product development cycle, quality requirements imposed by regulatory authorities are continuously increasing depending on the development phase. GXP elements need to be iteratively implemented and complied with. Experience in the industry has proven these requirements to be challenging for many organizations developing novel drug leads and even established drug manufacturers need to invest significant effort to maintain the required level of compliance.
Besides technical challenges, regulatory requirements and risks associated with product development, economic and social constraints and expectations need to be taken into consideration and integrated into the decision-making processes with regard to novel drug lead development and establishing a manufacturing and distribution framework.
Key drivers impacting decision-making are the disease area, the targeted market, the population dynamics and disease burden forecast, and the capabilities of the population in the target market to access the drug.
Identifying the optimal development strategy for a novel lead and setting up a commercially viable drug manufacturing and distribution framework which is as close as possible to the sweet spot of all impacting factors is a very complex task.
Important decision-making is required at early stages when risk of attrition in new drug lead development is still very high while already increasingly binding significant resources.
Good decision-making requires sensible balancing of various risks with swift but robust progressing of new drug lead development or establishment of the correct manufacturing and distribution framework.
Approaching the challenges of the biopharmaceutical industry necessitates therefore thorough understanding of the driving factors and the capability to build knowledge and capacities towards the final objective of a successfully launched or manufacture drug in an environment operating at varying levels of maturity.
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