The pharmaceutical industry is getting more holistic, and we have the CDMOs to thank for it. The CDMOs cannot take all the glory, however; after all, most of these trends emerged due to the pandemic.
While the pandemic continues to disrupt and transform industry business strategies and practices, it also provides new solutions to long-standing issues such as pricing, reimbursement, and customer engagement caused by tensions between innovation, market access, and financially-strained health systems.
Furthermore, the industry's attempts to battle the epidemic have opened up new avenues for innovation and growth. Hence, it is no surprise to see newly developed rules and policies crop up and become the norm. Here are some of these new policies:
1. Agile Workflows
Both the Covid-19 outbreak and the ensuing digital transition among liquid manufacturing CDMOs have spurred and facilitated more flexible methods of working and thinking. One example of the advantage of agile workflow is the speedy development and approval of Covid vaccines, as well as the optimization of joint efforts and techniques.
More broadly, agile project management underscores the industry's aim to take full advantage of its ingenuity, productivity, and effectiveness, reflecting the growing concern for drug cost control. Embracing the agile method also allows for the flexibility and responsiveness required to improve the actual value of products and services. Today's pharmaceutical sector is in continual change, servicing a larger, more diverse, technologically empowered, and demanding consumer base.
By limiting face-to-face interaction and hastening the use of digital technologies and media, the pandemic has prompted many CDMO pharmaceutical companies to entirely rethink their business strategies. This is evident in clinical development, where limited access to trial venues due to Covid limitations has accelerated the use of remote or hybrid clinical studies. Companies may now better discover and categorize potential clinical trial participants using digital tools, and then tailor studies to particular patients' preferences or abilities.
Interactive data flow, remote monitoring, home care, and mobile devices for recording real-time patient outcomes in virtual/hybrid trials all open the door to novel digital endpoints in clinical trials. They may provide more accurate, fast, and complete measures of a larger variety of outcomes, better reflecting the entire patient experience.
2. HTA adoption
The use of health technology assessment (HTA) to restrict medicine access and pricing is gaining traction across the world. However, HTA criteria and techniques can vary greatly from market to market. Although harmonizing the regulatory framework for evaluating and approving medicines in the European Union (EU) has aided in the facilitation and expedition of access to the European market, reimbursement decisions for medicines, as well as any pharmacoeconomic assessments that underpin those decisions, have always been left to individual EU member states. This can lead to severe discrepancies between markets, which are further amplified by regional and local evaluations, resulting in major delays in launches and acceptance, or, in the worst-case scenario, wholesale withdrawal from the market.
Efforts have been made to reconcile these disparities, but in recent years, the emphasis has switched toward the development of a mandated, centralized joint clinical assessment (JCA) system.
Companies are increasingly looking for a more comprehensive knowledge of drug innovation that goes beyond the rather narrow value criteria currently used by HTA authorities. This would ideally acknowledge the whole spectrum of long-term cost offsets and social benefits possible from inventions that genuinely push the limits of medicine.
Conclusion
The approaching year will provide more substantial difficulties and possibilities for pharmaceutical businesses, reflecting both organic market trends and the disruptive effects of the pandemic. However, certain companies are adjusting well, and one is Sovereign Pharmaceuticals.
Sovereign Pharmaceuticals is a major liquid manufacturing CDMO and solid dose CDMO. Contact us to get our services.
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