With constantly shifting regulations, new technologies and sustainability concerns, the life sciences sector continues to develop at a rapid pace. Biocair’s position as a leading global life sciences logistics expert at the forefront of industry excellence and customer service means the company has a unique insight into the future of this sector.
Here, Jeff Stone, US General Manager, shares his predictions for 2025 and discusses how Biocair is staying ahead of trends that will shape the industry.
Sustainability in the life sciences supply chain
Sustainability is now a crucial consideration within supply chain dynamics. This is part of a broader industry trend of companies collectively committing to sustainability targets. Ensuring that companies utilize reusable, certified packaging in their supply chains without compromising on patient safety and product integrity necessitates a thorough approach supported by technical knowledge, advanced technology and uncompromising commitment.
In an industry where cargo must be rigorously temperature-controlled, limiting which packaging materials can feasibly be used, creating a sustainable supply chain is often not as simple as just implementing reusable materials.
When seeking materials with the best thermal performance, companies must take into account shipment method, route, seasonal and cross-hemisphere temperature variations, and duration of transit, often eliminating the possibility of reusable options. However, by thinking outside the box, steps towards sustainability can be made elsewhere. By ensuring cargo safety and fleet efficiency, errors in transit can be reduced, helping to eliminate repeat deliveries, thereby decreasing emissions.
“Reaching ambitious sustainability targets will only be possible for the life sciences industry with the support of all stages of the supply chain. While maintaining the quality of the products must remain a priority, the use of new technologies can help to facilitate a high quality, sustainable supply chain.”
- Stephen Cawley, Global Head of ESG and Risk and Chief Compliance Officer (CCO)
Collaboration remains vital
With a decrease in funding being observed throughout 2024, collaboration is now more than ever a top priority. Cultivating the right partnerships will enable companies to unlock new resources, international markets and specialized expertise without relying on unreliable funding cycles.
Recognizing what you can offer others is instrumental in knowing what needs to be sought out through collaboration. For example, Biocair’s specialized knowledge of regional variations in transportation, climatic conditions, regulations and standards is a valuable asset to fostering supply chain partnerships with Contract Manufacturing Organizations (CMOs) and Contract Development and Manufacturing Organizations (CDMOs).
Early in 2024, Biocair announced a seven-step process to mitigate the risk posed to goods in transit, which concluded that whether you are a CMO/CDMO, or a supply chain partner like Biocair, it is essential to foster third-party partnerships to manage and mitigate risks across complex supply chains.
This was put into practice when Biocair partnered with Aramex, a global logistics leader, earlier this year. Their collaboration illustrates the synergy that can be achieved when organizations combine their areas of expertise, which helped both companies to deliver tailor-made solutions to problems faced in Ireland’s life sciences sector, and to competently navigate post-Brexit complexities and export challenges.
Peter Canning, Air Freight Manager for Aramex Ireland, said: “By combining Biocair's expertise with our own, we’re able to create tailored solutions for customers... The partnership offers an end-to-end solution for Biocair's customers, integrating services seamlessly between the two companies. This comprehensive approach ensures that customers receive exceptional service and tailored solutions.”
Regulatory compliance and commitment to transparency
As advances in treatments drive a shift towards personalized medicines, adherence to regulatory standards becomes paramount to ensure that sensitive and critical life science materials can be delivered to patients with the highest of care. A proactive approach is needed to keep in line with the key regulatory bodies in the industry such as the FDA and MHRA. Noncompliance with regulation can lead to delays to a consignment, which is particularly significant for temperature-sensitive items, and more serious consequences such as destruction of samples, large fines, and prosecution.
As a Good Distribution Practice (GDP) compliant logistics specialist, Biocair’s worldwide experts make sure that every stage of each shipment is managed with the required knowledge and precision.
Dedicating time, personnel and resources to understanding global shipping regulations is essential to delivering the highest standards of distribution. Getting to know specific laws in certain countries can help to avoid costly mistakes. For example, ongoing developments around the US Biosecure Act are likely to limit the Chinese providers that federally funded US pharmaceutical companies can work with1. Some organizations are already looking for alternative partners that are not considered a “biotechnology company of concern”2. However, this is still a developing piece of legislation, and as such difficult to predict how it will be implemented in the future3. The same is true of other global political changes, and the impact these will have. Being aware of the most up to date local and international regulation is vital and collaborating with experts can help to streamline efforts.
Biocair’s in-house Quality and Compliance team helps to ensure this, with an extensive knowledge of customs tariff codes, classification of dangerous goods, labelling and other requirements.
“Working closely with our customers everyday gives us a unique perspective on the challenges they are facing as well as enabling us to make them aware of potential future requirements they should consider. As an extension of your team, we help you avoid hurdles and ensure you are suitably prepared.”
- Jeff Stone, US General Manager
Coordinating with major regulators can help streamline compliance processes. Biocair is an Authorized Economic Operator, (AEO) working closely with the International Air Transport Association (IATA), Medicines Healthcare Products Regulatory Agency (MHRA) and the Food and Drug Administration (FDA), to meet all regulatory requirements.
“Biocair's BSI certifications have established a control function that makes it easy to implement automated processes. The smooth and simple running of work processes confirms that they are acting in accordance with the standards,” British Standards Institution (BSI)4.
Keep up with cutting edge pharmaceuticals
In 2024, we saw the explosion of new drugs across the biopharma industry. For logistics experts, rapid surges in demand for specific drug types can cause challenges in implementing the necessary supply chains with reliable partners. It will be necessary for pharma companies to work with their global partners to enable these treatments to progress through clinical trials and onto the market.
Neuroscience, rare diseases and immunology remain important areas of focus in the coming years. New modalities in these growing areas demand different processes and logistics experts must stay ahead of how this will impact their handling requirements to ensure the drug product is protected.
Flexibility and Agility
The impact of recent global events can still be felt throughout the world of supply chain logistics. What is clear now more than ever is the need to be agile and flexible within the rapidly moving industry, where next-generation treatments are necessitating new approaches to logistics.
By pioneering cutting-edge innovations and emerging technologies, while at the same time securing valuable collaborations across the industry, companies can keep ahead of the curve.
Deloitte’s 2024 Global Life Sciences Sector Outlook5 especially highlighted the potential of generative AI to automate tasks, streamline workflows, and optimize processes, allowing for reduced costs, increased efficiency and a personalized patient experience. Harnessing new technologies and combining them with existing processes can help to unlock the potential of the data and information you already possess.
A proactive approach and keeping up with how these tools are being used by other key players in the industry is key to maximizing their potential and finding innovative solutions.
Every year, the challenges faced by life science companies evolve, but it remains one of the most innovative and exciting industries. Playing our part in moving science forward is what drives the team at Biocair, and we look forward to working with our clients to solve their logistics challenges through 2025 and beyond.
References:
1. https://cen.acs.org/business/outsourcing/2024-Biosecure-Acts-impact-became/102/i38
2. https://www.congress.gov/bill/118th-congress/house-bill/8333
3. https://firstwordpharma.com/story/5919579
4. https://www.biocair.com/en-gb/expertise/regulatory-compliance
5. https://www.deloitte.com/global/en/Industries/life-sciences-health-care/analysis/global-life-sciences-sector-outlook.html
Jeff Stone
US General Manager
Jeff Stone has over a decade of experience in various leadership positions across research and development, manufacturing and logistics within the pharmaceutical sector. He began his pharmaceutical career in 2011 working with a leading CDMO, where he gained a diverse range of experience in logistics and clinical trial management across various clinical indications. He went on to work in the specialty logistics market, where he played a pivotal role in building a global Project Management Organization and infrastructure to support critical cell and gene therapies. This included the creation of a state-of-the-art control center in North Carolina’s Research Triangle Park. At Biocair, Jeff oversees all aspects of operations and commercial sales in the US. He drives efficiency and effects positive change to enhance the overall client experience.
