IPI Autumn 2020

Page 96

Logistics & Supply Chain Management

Creating a Fit-for-purpose Supply Chain for the COVID-19 Vaccine The race is on amongst the international scientific research community to develop a vaccine that will prevent infection by SARS-CoV-2, the virus that causes COVID-19. While many nations who were the early epicentres have successfully flattened the curve, both in terms of new confirmed cases and the number of people who are losing their lives to this novel Coronavirus, the virus is continuing to spread at an accelerated rate elsewhere, particularly in the Americas and Southeast Asia. There is also the very real risk of a second wave of Coronavirus infection in countries that have already been badly hit earlier in 2020, as autumn looms. By the end of 2021, the World Health Organisation (WHO) plans to deliver over 2 billion doses of a Coronavirus vaccine internationally to accelerate herd immunity and wipe out the highly infectious virus. But this ambitious timeline presents a huge challenge for pharmaceutical supply chains and healthcare systems. Decades of underinvestment and growing pressure from numerous stress factors like new medicine types, increasing demand from emerging economies, the rise in counterfeiting and falsification, and stricter regulation has left the pharmaceutical supply chain in substandard condition. For too long, the pharmaceutical industry has relied on supply chain networks that are neither flexible nor cost-effective. Faced with the task of delivering a safe and effective COVID-19 vaccine to billions of people worldwide, the time for the pharma industry and its partners to act is now. The benefits of a modern pharma supply chain that’s fit for today’s challenges and tomorrow’s will long outlive the COVID-19 pandemic. It will provide cost-saving and efficiency gains for years to come, while simultaneously helping the industry to fulfil its social responsibilities, including 94 INTERNATIONAL PHARMACEUTICAL INDUSTRY

the need to both pioneer more sustainable manufacturing processes and produce more effective and safer medicines the entire world can afford. Where are we with COVID-19 vaccine development? Developing a new vaccine is a long and complex process, often taking between 10 and 15 years to complete. It also requires huge sums of public and private investment. The record for the fastest new vaccine developed is currently held for the Zika virus (seven months) but the epidemic naturally came to a halt before the vaccine became available. There’s also the uncomfortable fact that up to 94 per cent of new vaccines fail to pass the clinical trial stage because generally, vaccines are even more thoroughly tested than non-vaccine drugs due to the number of human subjects in vaccine clinical trials usually being greater. In vaccine development, there are usually three different phases of clinical trials (Phase I involving a small batch of people, Phase II with a few hundred, then finally Phase III with thousands) and researchers usually leave months in between each

phase to review the findings and secure approval for subsequent phases. According to WHO, as of 6th July, there are 21 candidate vaccines in clinical evaluation with the developers from the University of Oxford and Astra Zeneca, and Sinovac leading the way with their vaccines currently in Phase III clinical trials. Many are expecting (and very much hoping) a vaccine is available within the next 12–18 months, and that it’s good enough to accelerate a population’s progression towards herd immunity before it’s reached naturally. And the international pharma supply chain needs to be ready to go in anticipation of this date. What’s needed to deliver a safe and effective vaccine? Delivering a new vaccine for COVID-19 to billions of people worldwide will be one of the greatest challenges faced by modern pharma and its supply chains. The difficulties are intensified by the shortcomings of the current pharma supply chain model, which has been short of investment and innovation for decades. Linking the laboratory to the marketplace, the supply chain deserves the same 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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