IPI Spring 2021

Page 102

Logistics & Supply Chain Management

Cold Chain in 2021: COVID-19’s Continued Influence As we eagerly enter 2021 and prepare this year’s cold chain industry predictions, we reflect on the events of 2020. Nowhere leading into the year did we predict a global pandemic. Yet its impact crosses all facets of business, causing companies to pivot and adapt. Some were able to harness new opportunities to serve our everchanging way of life and others struggle to stay the course. The pharmaceutical and cold chain industries were pushed this previous year to innovate through vaccine development, temperature-controlled packaging that met the needs of new deep frozen vaccine storage and increased demand for existing products. They rose to the challenge, working in unprecedented ways to make 2021 a brighter year. Though there is hope for a return to a more normal environment in 2021, COVID-19 will continue to drive business operations. This is certainly true for pharmaceutical and cold chain companies. Our three predictions below all show how COVID-19’s influence persists, and in some instances, may have a long-term ripple effect. Return to Refrigerated Temperatures for COVID-19 Vaccines As of December 8, 2020, 78 different COVID-19 vaccines are in clinical trials, under regulatory review for approval or approved for limited use. Though two vaccine candidates show strong promise, with one approved for emergency use in the United Kingdom, we expect the number of viable, approved COVID-19 vaccines will continue to grow in 2021. All else equal, it is likely the market will favour vaccines that require refrigerated temperatures of 2–8 degrees Celsius. Existing infrastructure exists to more easily transport and store these vaccines around the world. Additionally, refrigerated temperatures eliminate concerns around shortages of dry ice and concerns about how it reduces the amount of available cargo space on aircraft. 100 INTERNATIONAL PHARMACEUTICAL INDUSTRY

This preference for refrigerated vaccines could push pharmaceutical companies with deep frozen vaccines to determine how to maintain efficacy of the vaccine at a refrigerated temperature. If this happens, we will gain knowledge that will move pharmaceuticals’ current storage and distribution temperature from -80°C to easier to distribute ranges of -50°C, -20°C or even refrigerated.

COVID-19 also increases the chances home-based offerings will grow outside of clinical trials. Over the past year, healthcare companies and consumers learned that it is possible to receive healthcare at home. We expect that a subset of the population will continue to prefer home-based healthcare for its convenience, driving more companies to offer this service.

Outsourcing the Cold Chain Pharmaceutical supply chains continue to reach new levels of complexity that challenge even the most seasoned logistics and supply chain professionals. Contract manufacturing organisations (CMOs) and contract development and manufacturing organisations (CDMOs) offer expertise in manufacturing and development of therapies, allowing pharmaceutical companies to focus on their areas of expertise.

Services like phlebotomy, drug administration and sample collection that require refrigeration will require cold chain solutions. We anticipate a drive toward solutions that require little training and are easy for home healthcare professionals and patients to operate. We should also see more assessment and evaluation of the cold chain for home-based care in 2021.

This year we expect to see even more pharmaceutical companies outsource these capabilities to CMOs and CDMOs, which will help them reduce overall costs. We also believe CMOs and CDMOs will expand to include more services. This will include cold chain, working with partners like us. Offering end-to-end expertise will help reduce complexity by standardising as many pieces of the supply chain as possible. Growth in Direct-to-patient and Direct-frompatient Brings Cold Chain to the Last Mile Over the past several years, clinical trials have become increasingly complex. They require extensive data collection, utilise complicated drug regimens and enrol global patient populations. Frequent travel to a clinical site for routine drug administration, sample collection and simple tests can deter patients from participating. This is especially true when patients do not live close to a medical facility. Currently, 24 per cent of clinical trials offer home-based solutions that allow patients to receive medical care in their homes or ship study samples from their homes to a medical facility. We expect to see this number increase out of necessity, but also out of a desire for continued convenience.

Dave Williams Dave Williams is the President of Peli BioThermal, a division of Pelican Products, Inc. In this role, he is responsible for the strategic growth of product and service offerings to serve Peli BioThermal’s worldwide clients and partners. Throughout his 30 year career, Williams has held many management and engineering positions. Prior to being appointed President of Peli BioThermal, he held the position of Vice President of Strategic Initiatives at Pelican Products, where he was responsible for the oversight and coordination of evaluating and enhancing the company's systemic strengths and minimising weaknesses for maximum efficiency and profitability, as well as executing approved growth strategies. Previously he served as Vice President of Capital and Engineering at Technicolor and as Project Director for compact disc pioneer, Nimbus. Williams attended Harvard University in Boston, Massachusetts. He was a 2007 graduate of the Harvard Business School's Executive Strategy Leadership Program and the Thomson Executive Leadership Program. Spring 2021 Volume 13 Issue 1


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Articles inside

Cold Chain in 2021: COVID-19’s Continued Influence

4min
pages 102-103

Deploying AI in the War on Counterfeit Drugs

11min
pages 98-101

Granulation in Pharmaceutical Technology

11min
pages 94-97

Are Plant-based Softgels the New Gold Standard for Pharma?

9min
pages 90-93

The Effects of Heat from Electro-mechanical Components in Critical Instrumentation

8min
pages 86-89

Whitepaper: Together Beyond COVID-19 A Look at the Future

15min
pages 72-75

Next-generation Aseptic Tech Needed to Cut Contamination Risk

10min
pages 78-81

Adopting Connected Drug Delivery Devices Top Tips for Pharmaceutical Companies

8min
pages 82-85

Redefining Healthcare: Digital Trends in 2021

6min
pages 76-77

Beta Glucans and Endotoxin Testing

7min
pages 70-71

How Approaches to Clinical Research Are Set to Change in the ‘New Normal’

10min
pages 66-69

Pharmacokinetic and Statistical Considerations in First-in-human Clinical Trials

12min
pages 62-65

Digital Medication Adherence in Clinical Trials

7min
pages 60-61

A Greener Future for the Inhalation Industry A Critical Year for Our Climate

9min
pages 52-55

The Danish Approaches for Personalised Medicine

10min
pages 44-47

Key Considerations when Repositioning a Known Drug for Inhalation Therapy

10min
pages 48-51

Connectivity, Cybersecurity and Medical Devices What are the Threats?

12min
pages 56-59

Innovate UK-funded Project Results in Next-generation AI Drug Discovery Technology

16min
pages 38-43

The COVID-19 Catalyst – Accelerating the Move to Patient powered Medicine

11min
pages 34-37

Comparison of Regulatory Process of COVID-19 Vaccines Between Emerging Markets, EU

11min
pages 30-33

Respiratory Drug Development – Perspective from Spray and Aerosol Characterisation Expert

9min
pages 14-17

Managing Competition, Price and Access The changing paradigm for the pharmaceutical sector

9min
pages 26-29

EU MDR Changes are Only the Beginning – Ensure IFU Compliance Now and be Prepared for More to Come

7min
pages 20-21

Nemera: The Holistic Partner for Your Combination Product Development

14min
pages 10-13

Editor’s Letter

5min
pages 8-9

Marketing Medical Cannabis in Europe

5min
pages 18-19

Can the UK Solve its ‘Money Laundering’ Problem with the Proceeds of Medicinal Cannabis?

11min
pages 22-25
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