Vice President, Business Development for Global Manufacturing and EMEA Clinical Services, PCI Pharma Services
In general, what are some critical issues facing the pharmaceutical industry in regards to the global supply chain?
The global pharma supply chain faces many challenges, below are what I would consider the top three:
Globalization - The pharmaceutical supply chain is becoming global: products are sourced and manufactured from around the world, clinical trial sites and patients span the globe and then marketed products are supplied to an equally large proportion of the global population. The complexity of such global supply chains leads to logistical challenges, from disruptions in distribution and long lead times, shortages in supply of both actives and components to the increasing volatile and unpredictable weather patterns and its impact on the transportation of temperature sensitive drug products.
The complexity of drug products – Increasingly, as therapies become more targeted, drug products are becoming more complex with the growth in the development of biologics taking center stage. Many factors associated with biologics as a therapy class result in a more complex supply chain versus their chemical counterparts, for example, thermal stability requirements mean that cold and ultra-cold storage and distribution conditions are a necessity, specialist packaging and active shipping solutions will likely be needed.
Supply chain security - Providing patients with safe and effective medicines requires assurance that the pharmaceutical supply chain has robust security, maintaining the highest standards for safety and regulatory compliance with domestic and international regulations implemented to address the global integrity of the supply chain. This supply chain security becomes even more acute when dealing with life-changing and life-saving critical medicines where the breakdown of the supply chain is not an option.
How has the COVID-19 pandemic exacerbated supply chain issues for the pharmaceutical industry?
The COVID-19 pandemic and its impact on the integrated global supply network underscores the interdependencies of the global supply chain, how it has evolved and the necessity to understand and mitigate the risks associated with the supply of medicines.
With the unprecedented surge in the development and production of COVID-19 vaccines and therapeutics, there has been significant impact on material availability across the pharmaceutical supply chain. All CDMOs operating in the sterile fill-finish space typically use the same processing components: tubing, connectors, vials, stoppers, vessels, and filters and we are all facing similar challenges around lead times and supply.
As global suppliers experience workforce shortages and interruptions in their ability to source APIs and consumables, the downstream ramifications for pharmaceutical companies developing new and innovative therapies inevitably means delays. To overcome some supply chain challenges, pharmaceutical companies and CDMOs alike are now looking to ensure their ability to source materials from domestic suppliers as well as their global network, which not only helps reduce the company’s carbon footprint and have a positive impact on ESG but can also assist in reducing lead times.
Pharmaceutical companies have become acutely aware of their dependency on increasingly complex supply chains that span several global locations. As a result, the pandemic has forced stakeholders to review and take note of weaknesses and build more resilience into their supply chains to secure a reliable supply of vital medicines to patients around the world.
What are some recent advances in supply chain management that have helped pharmaceutical companies to mitigate some of the risk involved in running global operations?
Recent events have put a spotlight on the need for nimble and agile supply chains. Inputs to the manufacture and packaging of medicines, as well as warehousing, distribution, shipping and downstream logistical channels were all challenged, creating unforeseen obstacles that threatened the supply of life-saving therapies to patients. Just-in-time principles, and other Lean agility planning tools, have demonstrated to be significantly impactful in ensuring continuity of supply as well as supply optimization.
Application of technologies such as Late Stage Customization (LSC) and Just-in-Time (JIT) supply models afford clients a much more streamlined approach, minimizing waste and loss, optimizing inventory, and furthermore enabling a more nimble supply capable of adapting to shifting market demands. Along the same lines, having this operational flexibility allows companies to manage effectively through unforeseen supply dynamics such as raw material shortages or natural disasters that can plague global supply conditions. Given the ever-increasing high value of medicines, particularly for indications such as oncology, this is important in getting vital medicines to patients around the world.
Specifically, what is “dual sourcing” and how can this approach work towards eliminating risk in the pharmaceutical supply chain?
Although there is a broad movement towards the simplification of supply chains with biopharmaceutical companies looking towards single source supply partners, in truth, this needs to be balanced with the need to reduce risk when it comes to ensuring an uninterrupted supply of critical life-saving therapies.
Proactive supply chain analysis and scenario planning is needed to address questions such as; what would happen if an unplanned event was to occur at an existing supplier? What impact would a natural disaster have on supply chains? If there was a surge in demand, could the existing supply chain model absorb it? What risk control and mitigation plans are in place to prevent drug supply disruptions and shortages of critical medicines?
Recent FDA draft guidelines ‘Risk Management Plans to Mitigate the Potential for Drug Shortages’ provides guidance to help drug manufacturers develop, implement, and maintain risk management plans. This new development is part of the FDA’s effort to address disruptions in manufacturing which cause drug shortages.
A risk control measure noted in the FDA guidelines is the identification of alternative/back-up suppliers. Dual sourcing is a strategy biopharmaceutical companies are utilizing by appointing a second supplier to ensure they have a continuity of supply for their life-saving drug products and to help mitigate risk should something untoward happen to their primary supply source. Dual sourcing can also be utilized to provide supply chain agility and flexibility to deliver any increase in demand, with a second source of supply manufacturing additional supplies outside of the original forecast.
Can you tell us about other strategies PCI Pharma Services offers to pharmaceutical companies to help them alleviate supply chain risk and bring both existing and new products to market?
PCI as a leading global CDMO and by providing integrated solutions across the entire drug product lifecycle from development to commercialization, helps clients to reduce supply chain complexity and risk as a single partner for the lifecycle of their drug products.
At PCI, we recognize the importance of supply chain risk mitigation and work with a number of global clients on a dual supply basis to ensure life-saving therapies reach patients when needed. With client needs varying from large pharmaceutical company internal policies insisting on a dual supply model for critical medicines in their portfolio, to smaller biotech companies who are considering selling an asset and needing to demonstrate supply chain assurance during the due diligence process, we offer flexible supply models to meet the needs of all our clients. From dual market supply, scale-up to address increase in demand, capacity reservation models to back-up supply when needed; we collaborate with our clients to help safeguard their supply chain.
At PCI, we foster a culture of proactive communication and risk mitigation strategies, but also leverage industry-leading technology such as PCI Bridge, our integrated and predictive supply chain management platform. Working with our clients, adjusting forecasts, ordering additional supplies and leveraging existing relationships and partnerships to source materials as needed, we ensure project milestones are delivered throughout the product lifecycle, supporting clinical and commercial supply chains alike.
Looking forward how do you see the pharmaceutical industry strengthening its global supply chains and how will PCI Pharma Services continue to innovate to provide services to current and future clients?
Pharmaceutical companies can build supply chain resilience through greater visibility, rigorous risk management and employing advanced technologies.
Successful supply chain risk assessment management starts with understanding what’s happening at each stage of the supply chain from sourcing materials to manufacture, packaging and final distribution. Collating, analyzing and leveraging this data makes decision-making faster and more accurate and helps to identify and solve inefficiencies, putting in place the necessary risk control strategies such as building redundancy into manufacturing operations, improving relationships with suppliers or even identifying alternative or back-up suppliers.
PCI is regarded as a true pharmaceutical and biopharmaceutical supply chain solutions provider to our global customer base, leveraging 50 years of experience we have the experience to deliver a flexible approach and excellence in what we do. To continue being our customers’ bridge between life-changing therapies and patients, we will continue to invest in our digital transformation strategy to build even more collaboration and efficiency across our global organization and bring online the latest in advanced technologies to deliver new levels of customer experience.
Alan started his career at Ciba-Geigy as a sales representative and progressed through a variety of business development leadership roles at Medeva PLC, Quintiles, Aptuit, Patheon and Thermo Fisher Scientific (Fisher Clinical Services).
Alan joined PCI Pharma Services in July 2021 where he is VP Business Development for global Manufacturing and EMEA Clinical Services. Alan brings over thirty years sales team leadership experience within the CRO/CDMO sectors in North America, EMEA and APAC regions. His responsibility for services has ranged across small molecule API, large molecule biological drug substance development and manufacture through to formulation development, clinical and commercial manufacture of drug product (oral solid dose, soft gel capsules and sterile products).
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