IPI Autumn 2020

Page 20

Regulatory & Marketplace

Ensuring the Pharmaceutical Industry is Prepared for a Future Pandemic The COVID-19 pandemic has stretched healthcare suppliers, organisations, governments and healthcare professionals to their very limits, locking down the world like never before. Healthcare industries, which were already under huge strain across the world, have been placed under unprecedented pressure. But, as the saying goes, there’s always light at the end of the tunnel and we’re beginning to see positive signs. While there is still a threat of a second wave on the horizon, deaths and infection rates are declining and the recent discovery of dexamethasone as a viable treatment for the sickest patients has been greeted with enthusiasm by the scientific community. Similarly, Oxford University appears to be making some progress on the vaccine front, with a drug developed that’s safe and triggers an immune response. With such a focus on drug development and also on searching for existing drugs that can help the fight against COVID-19, the pharmaceutical industry has been central and will continue to play a leading role in the months to come. However, it’s not been without difficulty. COVID-19 has had a significant impact on all sectors of the economy, including pharmaceuticals. On the one hand, new opportunities have opened up; first of all, the involvement of companies in the development of new drugs for the treatment of COVID-19, as well as in the clinical trials of these drugs and in the future in production and distribution.

Like many other industries, pharmaceuticals are often not a vertically integrated business. In order to create, properly register, produce and subsequently market a medicine, the efforts and involvement of many companies, sometimes located in different countries and on different continents, are needed.

breakneck pace to reach a solution, it is fair to say times have been tough.

For example, we produce a generic drug at a factory in India, buy raw materials for this drug in Japan and after production, the drug goes to a distribution warehouse located in Europe. After that, the drug is delivered to different countries, including via air delivery, all whilst bearing in mind that the drug has a rather short shelf-life and in some countries it is impossible to deliver the drug with a residual period of less than, for example, one year. This example on one specific drug shows how vulnerable the pharmaceutical business is.

2. Speed and Collaboration are Key The scientific community has come together to discover ways to protect against the virus at a speed never seen in our lifetimes. The virus having originated in China, much of the essential groundwork was also completed by the Chinese, ensuring the rest of the world at least had some degree of preparedness before the virus reached their shores.

Preparing Ourselves Undoubtedly, the way we have approached this pandemic will become a case study which will inspire our response to future global disease outbreaks. So, with this in mind, what are the lessons that can be learnt to ensure that the pharmaceutical industry can respond quickly and definitively to the next pandemic? The answers are many, but finding them will be key to saving lives.

Secondly, the state budgets allocated to healthcare in many countries were significantly increased and a fairly large part of this funding was directed to the procurement of medicines.

1. Applying Unique Approaches to a Unique Virus Scientists and pharmaceutical experts have faced myriad challenges, as is to be expected from COVID-19’s status as a novel coronavirus. While similar in ways to the viruses that caused the SARS outbreak of 2002–2004 and the MERS outbreak that began in 2012, COVID-19 has proven to be much more transmissible, with its presence in the vast majority of countries now confirmed.

But on the other hand, despite the stereotypes that pharmaceuticals are one of the few industries for which the pandemic and subsequent quarantine have brought certain benefits, the pharmaceutical industry has suffered from quarantine no less than other industries.

Essentially, those charged with coming up with effective treatments or a vaccine have had to start from scratch, while contending with the various restrictions brought about by global lockdowns. Combined with a growing sense of panic amongst the general public and the subsequent need to move at

18 INTERNATIONAL PHARMACEUTICAL INDUSTRY

However, there have been a number of success stories that underline the vital work that the pharmaceutical industry does, and it is these that should serve as examples of how to approach the future.

The pace of developments since then has been relentless. Teams around the world are working furiously to develop an effective vaccine, with promising results seen already. As far as viable treatments are concerned, the evidence of remdesivir reducing patient recovery times shows significant promise, and the discovery of dexamethasone – an affordable, widely available steroid in use since the 1960s – in improving survival rates has led to the UK government approving it for immediate use. The bottom line here is that speed and collaboration have been hugely beneficial in turning the tide against COVID-19, and will continue to be so in the ongoing battle. It is necessary that state regulators, together with relevant organisations and with the involvement of other players in the pharmaceutical industry, develop principles for the work of the healthcare industry in general and pharmaceuticals in particular in a pandemic and other possible scenarios. In this case, everyone will understand how they act in certain conditions and procedures should be simplified, including clinical trials and drug registration. Any future pandemic will only be successfully beaten if pharmaceutical companies, experts, scientists and governments are willing to spring into action and work together for the common good. 3. Analysing Big Data Data gathering and analysis have grown Autumn 2020 Volume 12 Issue 3


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Articles inside

End-to-end Visibility – The Foundation of Addressing Today’s Challenges in Pharmaceutical Distribution

15min
pages 100-288

Automated Quality Control of Pharmaceutical Packaging Materials

7min
pages 92-95

Advanced Capsule Development for Today’s Needs: HPMC

24min
pages 82-91

Using Phase-appropriate Delivery to Accelerate Inhaled Product Development

10min
pages 78-81

Creating a Fit-for-purpose Supply Chain for the COVID-19 Vaccine

10min
pages 96-99

Calcium Bioavailability is Key

5min
pages 74-77

Trapped Ion Mobility Mass Spectrometry (TIMS) Drives High-throughput Phosphoproteomics Research

9min
pages 70-73

Pharma’s Quantum Leap: Launching New Medicine in the Age of AI

11min
pages 66-69

Respiratory Drug Delivery – What has Happened and What Might the Future Hold?

11min
pages 48-53

Returning to Basics of siRNA Design to Fulfil Therapeutic Potential

11min
pages 58-61

The Role of Connected Inhalers in Improving Usability and Adherence in Respiratory Disease

18min
pages 42-47

Optimising HPAPI Value Chain to Achieve Maximised Product Value

14min
pages 36-41

Regeneron v Kymab: Transgenic Mice Claims Found Insufficient

14min
pages 54-57

Pre-filled Safety Syringes and the Self-administration Trend A Mutually Reinforcing Relationship

7min
pages 32-35

Barriers in Medical Device Innovation

12min
pages 14-19

Agile and Flexible – A Fitness Check for the Pandemic Era

5min
pages 26-27

Editor’s Letter

4min
pages 8-9

The Patent Landscape Behind COVID-19 Vaccines

9min
pages 22-25

Successful Marketing of Medicinal Cannabis and Cannabis-derived Products – Part II

10min
pages 28-31

Pharmacovigilance: Why are so Many Companies Failing their Regulated Audits?

6min
pages 10-11

Building Solid Foundations for Regulatory Data Automation

6min
pages 12-13

Ensuring the Pharmaceutical Industry is Prepared for a Future Pandemic

9min
pages 20-21
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