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Systemic inefficiencies in the pharmaceutical industry undermine problem-solving efforts.
As infant formula shortages force parents to be creative in finding new types of supply, the post-pandemic world forces us all to be more aware of what products we need, and what systems we rely on to get them. Pharmaceutical companies, already focused heavily on implementing serialization tools for the US Drug Supply Chain Security Act (DSCSA) requirements, could “... link serialization data with temperature data collected along the supply chain (such as storage, transportation, last mile, and more) to gain better end-to-end visibility and leverage stability budgets across the supply chain,” conjectures an Elpro representative in an article in this issue on cold chain advances by Suzanne Shelley (1). Vaccine access and efficacy conversation has had a spillover effect placing food and drug supply more into mainstream conversation.
Inside that conversation, one of the largest (missed?) opportunities and unmet needs, continues to be neurological health. The second installment of BioPharm’s sister publication, Pharmaceutical Technology’s new series “Weighing Up Big Pharma” looks with a Sophoclean steady gaze at industry performance. One major conclusion is that, “Pharma should expand on successful cell therapies in oncology by applying these development and manufacturing methods to neuronal cell therapies,” asserts author Marina Necdina (2). She also contends that products have resorted to dealing with effects (such as beta amyloid plaques) rather than their root causes. Memory enhancing drugs—both in business performance and private pursuits—would be on most people’s wish list as welcome additions. But ending or mitigating neurodegenerative diseases are a holy grail, worth any effort.
And as a parting thought, more than 25% of drugs on the market worldwide and candidates in the pharmaceutical pipeline are considered to be formulated with highly potent APIs (HPAPIs) in 2020. More than 115 contract manufacturing organizations had the capability to produce highly potent drugs, and many had recently invested or were in the process of implementing capacity expansions to meet growing demand for HPAPIs and products formulated with them. “But in addition to specialized facilities, equipment and highly trained personnel,” writes Cynthia Challener. “Organizations developing and manufacturing highly potent drugs must have the requisite expertise to overcome numerous formulating challenges ranging from lack of sufficient toxicity data to managing poor solubility and bioavailability to ensuring uniform dosing of low concentrations of HPAPIs” (3). How to manage manufacture and deployment of these strong drugs, remains a challenge.
1. S. Shelley, BioPharm Int. 35 (7) (2022).
2. M. Necdina, PharmTech 46 (7) (2022).
3. C. Challener, PharmTech 46 (7) (2022).
Mike Hennessy Jr. is the President and CEO of MJH Life Sciences.
Volume 35, Number 7
When referring to this article, please cite it as M. Hennessy, “How Can We Come Up Short So Often?,” BioPharm International 35 (7) 3 (2022).