Making Every Effort

Editor’s Note: This article was published in Pharmaceutical Technology Europe’s April 2020 print issue.

While the majority of the world is in isolation to try to slow the spread of the virus responsible for COVID-19, companies and regulatory bodies in the bio/pharma industry are facing numerous challenges and committing significant efforts to support the development of novel therapeutics and monitor supply chains. 

Drug and vaccine development

According to the European Federation of Pharmaceutical Industries and Associations (EFPIA), its members are actively engaged in the development of collaborative research programmes that will assist in accelerating the advancement of therapeutics for COVID-19 (1). Some examples of work being performed by EFPIA member companies in tackling the COVID-19 outbreak include: companies, such as Bayer and GlaxoSmithKline, joining the COVID-19 Therapeutics Accelerator Initiative and opening up compound libraries; the donation of supplies, such as Merck’s donation of interferon beta-1a, to be used in clinical trials; provision of expertise and advice to relevant stakeholders; and leveraging previous vaccine development work to potentially enable a more rapid development of a COVID-19 vaccine, such as work being done by Sanofi (1).

Some notable drugs and vaccines for COVID-19 in development are:

• Messenger RNA vaccines, from CureVac and BioNTech, are in preclinical stages.

• Remdesivir, from Gilead Sciences, originally developed to treat Ebola, is in Phase III clinical trials.

• SNG001, from Synairgen Research, is an inhaled formulation of interferon-beta-1a that is entering Phase II clinical trials.

• Chloroquine and hydroxychloroquine are currently being investigated in clinical trials and are being donated by various companies for evaluation.

Regulatory response

The global pandemic of COVID-19 has been pushing the boundaries of regulatory possibilities both within Europe and around the rest of the world. Guidance on how to best manage clinical trials in the current situation, deferral of non-essential inspections, prioritization of COVID-19 treatment applications, expediting applications, and funding are some of the measures being taken by European authorities to support the industry.

These practical measures being implemented by European regulatory enforcers have undoubtedly been more easily formulated as a result of lessons learned from previous outbreaks. In this issue’s European Regulatory Watch (pages 6–8), Sean Milmo delves into this topic in more detail, looking at specific examples from past outbreaks and how closer relationships built up by agencies in Europe with companies and researchers is advantageous for the current situation.

Supply chain concerns

Another important aspect being looked at by regulatory bodies and industry associations, which has the potential to be detrimentally impacted by the COVID-19 pandemic, is that of supply chain. For example, industry concerns were raised when the Indian government revealed it would be restricting the export of 26 APIs and formulations, including paracetamol, progesterone, and vitamin B12, as a result of COVID-19 early in March 2020 (2).

And, it isn’t just trepidations around the availability of ingredients, there is also the added issue of hoarding drugs that are not yet proven to be effective in the treatment of COVID-19. As reported by The Guardian people suffering from lupus are now facing empty pharmacy shelves that would normally contain a vital medicine used for their treatment, hydroxychloroquine (3). The emptying of the shelves can be attributed to the, as of yet unproven, link with the drug having efficacy in the treatment of COVID-19. 

Therefore, in this current climate, it is imperative that pertinent scientific information that can be of reassurance and informative be disseminated with due diligence and care. So, in addition to thanking all those working tirelessly to develop potential vaccines and treatments, the Pharmaceutical Technology Europe team invites you to keep up-to-date with industry efforts via our website, www.PharmTech.com where there will be regular COVID-19 coverage spanning drug development, research, supplier news, and regulatory updates.

Stay safe and healthy.

References

1. EFPIA, “European Pharmaceutical Industry Response to COVID-19,” efpia.eu, Press Release, 25 Feb. 2020. 
2. Pharmaceutical Technology Editors, “Indian Government Restricts Export of APIs and Formulations Due to COVID-19,” PharmTech.com, 6 March 2020.
3. The Guardian, “Vital Drug for People with Lupus Running Out After Unproven COVID-19 Link,” theguardian.com, 27 March 2020. 

Article Details

Pharmaceutical Technology Europe
Vol. 32, No. 4
April 2020
Page: 5

Citation 

When referring to this article, please cite it as F. Thomas, “Making Every Effort,” Pharmaceutical Technology Europe 32 (4) 2020.