Adapting Clinical Supply Strategies Through The Phases

By Ana-Zeralda Canals Hamann, Debiopharm

In the rapidly evolving pharmaceutical landscape, the ability to adapt your supply chain strategies through various developmental and commercial phases is critical for success. As products transition from early development to clinical trials and eventually to market, the logistics and supply chain requirements undergo significant transformations. Understanding and implementing phase-appropriate logistics are essential for pharmaceutical companies aiming to efficiently manage resources, maintain regulatory compliance, and ensure timely delivery of lifesaving drugs.

Preclinical And Early Clinical Development: Flexibility And Speed

In early development stages, including preclinical testing and Phase 1 trials, the focus is on speed and adaptability. Logistics strategies should be designed to handle:

• Rapid prototyping and small batches — Manufacturing processes in these phases are often not scaled up and require the ability to produce small quantities of the drug efficiently for testing.
• High flexibility and adaptability in supply chain — As new information and formulations emerge rapidly, quick adjustments to manufacturing processes are necessary.
• Strict temperature and handling controls — Many drugs in development are sensitive to environmental conditions, necessitating advanced logistics solutions to ensure stability.

Supply chain management at this stage often relies on specialized vendors who can provide high flexibility and meet the stringent standards required for handling experimental drugs.

Scaling Up For Late-Stage Clinical Trials

As the drug progresses to Phase 2 and 3 clinical trials, the logistics strategy shifts from flexibility to scalability and efficiency:

• Increased production volumes — The number of participants in late-stage trials requires significantly more product, necessitating a scale-up in production.
• Global distribution — Clinical trials often take place in multiple countries, requiring a global distribution strategy that can handle complex regulatory environments.
• Cost efficiency — Managing costs becomes more crucial as the scale of operations grows. Logistics strategies need to be cost-effective while maintaining compliance with global standards.

During these phases, partnerships with third-party logistics providers (3PLs) who have global capabilities and expertise in pharmaceutical logistics can be invaluable.

Regulatory Review And Transition To Commercial Production

Once a drug has demonstrated efficacy and safety in clinical trials, it must undergo a regulatory review. During this period, preparing for commercial production is paramount:

• Scalability preparations — Transitioning from limited clinical production to large-scale manufacturing requires detailed planning and adjustment of supply chains.
• Compliance and documentation — Ensuring all logistics operations are compliant with regulatory standards and well-documented is crucial for a smooth regulatory review.
• Engagement with marketing and sales teams — Logistics must align with marketing strategies to ensure that the product can be launched promptly once approved.

Effective supply chain management during this phase ensures that once the drug is approved, it can immediately transition into commercial production without delay.

Commercial Launch And Beyond: Efficiency And Reliability

The commercial phase places different demands on the logistics strategy:

• Mass production — Manufacturing processes must be optimized for large-scale production.
• Robust distribution networks — Efficient distribution networks that can handle the wide scale distribution of the product are established.
• Market expansion — As the drug gains market acceptance, expanding the supply network to new regions and markets becomes necessary.
• Post-market surveillance — Logistics systems should support the collection of data on the drug's performance in the market, which is crucial for ongoing safety monitoring.

In this phase, the focus is on creating a logistics backbone that not only supports efficient distribution but also adapts to market changes and expansions.

Continuous Improvement And Adaptation

Across all phases, continuous improvement and adaptation are key. Leveraging technologies such as artificial intelligence and blockchain can enhance visibility, tracking, and compliance across the supply chain. Furthermore, a proactive approach to anticipate regulatory changes and market demands ensures that the logistics strategy remains robust and responsive.

Phase 1

• Just-in-time manufacturing — In Phase 1 trials, where the patient population is limited and the dosing regimen is still being established, manufacturing large quantities of a drug can be impractical and costly. Just-in-time manufacturing addresses this by producing drugs in alignment with the trial schedule, ensuring that fresh batches are available exactly when needed. This approach minimizes the risk of drug wastage due to expiration or changes in trial protocols, which are common in early phases.

Phase 2

• Customized packaging — This can include features such as child-resistant closures, single-dose packaging, or placebo-controlled study designs that require matching packages to ensure blinding. This customization helps prevent administration errors at the site and supports the integrity of the clinical trial data.
• Risk management plans — This phase involves more participants, so implementing comprehensive risk management plans becomes crucial. These plans assess potential supply chain disruptions and establish protocols for mitigating risks such as natural disasters, political instability, or pandemics. Contingency plans might include identifying alternative suppliers or additional storage facilities to ensure that the trial can continue without significant delays.
• Regulatory compliance integration — With the geographic expansion often seen in Phase 2, integrating regulatory compliance into the supply chain process is vital. This involves understanding and adhering to the varying regulatory requirements of each country involved in the trial. Systems need to be in place to ensure that documentation, labelling, and import/export procedures meet local regulations to avoid legal issues and delays.

Phase 3

• Global logistics partners — For global Phase 3 trials, partnering with logistics firms that specialize in pharmaceutical shipping is vital. These partners must navigate diverse regulatory landscapes, manage customs clearances, and ensure compliance with international shipping regulations. Utilizing partners with an established global network can reduce transit times and ensure that medications are delivered within the required temperature specifications to maintain efficacy.
• Temperature control innovations — Innovations in temperature control are essential for the successful global distribution of sensitive medications. Technologies such as real-time temperature monitoring systems and GPS tracking are integrated into the shipment containers. These systems alert staff of any deviations from the set temperature range, allowing for immediate corrective action, thus safeguarding the medication's effectiveness until it reaches its destination.

Phase 4

• Supply chain analytics — Advanced analytics play a crucial role in Phase 4 to optimize the supply chain for commercially available drugs. Predictive analytics tools analyze historical sales data, patient demographics, and market trends to forecast future demand accurately. This information helps pharmaceutical companies adjust production schedules, manage inventory levels more effectively, and reduce the risk of drug shortages or excessive overstock.
• Feedback loop integration — In Phase 4, where the drug is already on the market, integrating feedback loops into the supply chain is crucial. This includes monitoring patient outcomes and adverse events through data collected from healthcare providers and patients. This real-time data can be used to adjust manufacturing and distribution strategies quickly to address any emerging safety concerns or changes in demand.
• Sustainability practices — With increasing awareness of environmental impact, implementing sustainability practices in the supply chain becomes a priority in Phase 4. This can involve optimizing delivery routes to reduce carbon emissions, using recyclable materials for packaging, or investing in green technologies at manufacturing facilities.

About The Author:

Ana-Zeralda Canals Hamann is an associate director of clinical trial supplies at Debiopharm. She has more than a decade in sponsor-side pharmaceutical clinical operations, CMC, supply chain management, regulatory, IP, project management, and preclinical services. She earned her M.Sc. in clinical research administration and a Ph.D. in molecular medicine from the University of Oxford.