Modern-day pharmaceutical businesses are no longer solely defined by innovation through discovery, as success will depend on execution, or the speed, efficiency, ethics, and intelligence of moving from initial concept through to patient treatment. While innovation continues to push the boundaries of science, the operations that underpin clinical development have become just as critical to the success of pharmaceutical companies.
The area of comparator drug sourcing is one discipline in the operational backbone of clinical development, which has been largely ignored but is a critical component for determining feasibility, cost, and ultimately the success of clinical trials worldwide.
The emergence of pharma contract manufacturing companies over the last decade has also dramatically changed how drugs are manufactured, distributed, and controlled throughout the supply chain. These two key disciplines have intersected to create new and exciting opportunities for sponsors in their approach to sourcing comparator products and/or comparators.
This blog will describe how modern pharma contract manufacturing companies can create resilient, adaptive, and intelligent clinical supply chains by using the expertise of sourcing and the excellence of manufacturing without wasting resources on traditional inefficiencies.
The Strategic Importance of Comparator Drug Sourcing
Comparator drugs aren’t simply reference products for trials; they’re also key elements to establish the safety & effectiveness of investigational treatments. The role of comparator drugs is absolutely fundamental when used for bioequivalence studies, head-to-head studies, and for regulatory submissions.
However, obtaining comparator drugs is not an easy task.
Companies no longer exist in isolation from each other. Rather, they exist within an interconnected ecosystem where:
- Manufacturing is often outsourced across continents
- Clinical trials are conducted in multiple locations
- Licensing agreements govern how quickly a company can access the market
- Supply chains will need to remain resilient against geopolitical and economic disruption
Why Strategic Guidance is more Important than Ever
A contract manufacturing consultant has become much more than a simple support function for a company; they have become a strategic partner who is integrated into companies’ decision-making processes.
Complexities of Sourcing Comparator Drugs
- Variability: There are many different approved versions of a product around the world with different packaging and labelling requirements.
- Limited Availability: There may be a limited supply due to patent limitations or a shortage of drugs in the geographic region where the study is to be conducted.
- Regulatory Compliance: The need for stringent documentation and traceability.
- Cold Chain & Logistics: Many comparator drugs must be shipped and stored under controlled environments.
The complexity increases significantly if the study is taking place across multiple geographic regions. The challenge of keeping batches consistent amongst different regions and different timelines becomes a significant logistical challenge.
Moving Beyond Procurement: A Strategic Lens
In the past, the process of procuring comparator pharmaceuticals was purely a procurement function focused on sourcing products on a cost and availability basis; however, these practices are now outdated.
Comparator drug sourcing today requires:
- Risk Mitigation Planning
- Supplier Qualification & Auditing
- Forecasting & Demand Planning
- Regulatory Intelligence Integration
As a result, sourcing has become a strategic function rather than being considered just an operational function.
The Importance of this Change
Delays in sourcing can cause trials to be delayed. Compliance problems can cause the rejection of study results. Mismatches in product specifications can trigger the rejection of the submission by regulatory authorities.
Therefore, sourcing is now considered not just an afterthought; it is the primary driver behind strategic sourcing.
The Role of Pharma Contract Manufacturing Companies
With the evolution of sourcing, the contract manufacturing industry for pharmaceuticals is changing the way companies manufacture products.
Instead of developing internal capabilities, which require large capital investments, pharmaceutical companies are outsourcing production to specialised contract manufacturers.
Advantages of Contract Manufacturing
- Scale rapidly to meet the production requirements of different studies.
- Access to specialised technologies and regulatory expertise.
- Lower capital infrastructure and operational costs.
- Flexibility to accommodate fluctuations in requirements.
True transformation happens when companies include contract manufacturers in the clinical supply chain, as opposed to viewing them as separate entities.
The Convergence: Sourcing Meets Manufacturing
Historically, there has been a clear distinction between how comparators are sourced and manufactured. The idea of having these two areas work together has created opportunities for efficiency gains.
Benefits of An Integrated Supply Chain
Greater Predictability in Forecasting
Manufacturing capabilities help identify the volume and timing of sourcing.
Shorter Lead Times
Coordinated efforts can remove duplication of effort.
Greater Regulatory Compliance
A single set of documentation helps ensure compliance with regulatory requirements.
Cost Savings
Purchasing larger quantities and producing delivered items at the same time helps to lower the cost overhead.
This integration is especially important for more complicated comparator sourcing for clinical trials that require multiple comparators, dosage forms, and regions.
Impact of Digital Transformation in Clinical Supply Chains
Technology continues to play a major role in both sourcing and manufacturing.
Some of the New Digital Capabilities
- AI-based Demand Forecasting
- Using Blockchain to Track Products
- Accessing Real-time Inventory Information
- Using Predictive Risk Analytics
These capabilities allow for more proactive decision-making and minimise risk in an area that has been historically very difficult to execute properly.
Regulatory Intelligence: The Hidden Advantage
The rules and regulations regarding comparators differ across countries. An approved comparator drug may meet approval in one country and not in another.
Points of Regulatory Intelligence
- Labeling
- Import/Export
- Batch Traceability
- Documentation
Adding regulatory intelligence to sourcing will allow compliance at the beginning of the sourcing process rather than retrofitting compliance later.
The Need for Sustainability in the Clinical Supply Chain
Many pharma contract manufacturing companies are under constant pressure to reduce their environmental impact, as a sustainability initiative is needed.
Sustainable Sourcing & Manufacturing
- Ethical sourcing of suppliers
- Reduced packaging
- Optimized logistics
- Energy-efficient manufacturing
A leading pharma contract manufacturing organisation should be a leader in sustainability and provide long-term value by including sustainability in its operations.
Risk Management in Comparator Drug Supply
There is inherently risk involved in performing comparator sourcing for clinical trials; however, these risks can be successfully managed with the right comparator drug supply.
Some Common Risks
- Supply Shortages
- Regulatory Delays
- Transportation Interruptions
- Quality Inconsistencies
Risk Mitigation Strategies
- Multi-sourcing
- Stockpiling strategically
- Auditing suppliers
- Planning for contingencies
An effective comparator drug supply and comparator sourcing for clinical trials will provide a high degree of continuity, even in times of volatility.
Customisation: One Size Does Not Fit All
Each Clinical Trial is unique in its design based upon its therapeutic area, geography of trials, the populations being involved in the trial, the requirements of appropriate regulatory authorities, etc. Therefore, there are many variables that will affect comparator drug sourcing/manufacturing strategies.
Examples of Customisation
- Blinded Packaging of Comparator Products
- Encapsulation
- Labelling of Products to Suit Trial and Compliance Issues
- Sourcing Strategies Specifically for Regions in which the trial will be conducted
Customisation also ensures compliance with all trial-specific requirements of the comparator drugs.
Get Tailored Solutions for Your Trial!
Geographic inequities are one of the most difficult challenges faced by sponsors of today’s clinical trials. Many sponsor companies are increasingly looking to emerging markets for potential clinical trial locations; however, emerging markets often create regulatory and sourcing issues for sponsors.
Challenges posed by emerging market countries:
- No comparators available for sourcing.
- Complicated import regulations.
- Limits on proper research site infrastructure.
Strategic solutions for sponsors in emerging markets can include:
- Building local partnerships.
- Developing regional sourcing hubs.
- Creating flexible manufacturing options.
A truly global partnership approach allows trial managers to ensure that their multicenter trials are consistently run throughout the world.
Get Tailored Solutions for Your Trial!
If you look only at cost, you may be missing out on value. Historically, cost reductions have always been the priority for clinical trial sponsors. Focusing on cost vs. value can create risks; therefore, sponsor companies should develop a strategic plan emphasising value.
Value-based strategies include:
- Investing in long-term supplier relationships.
- Using reliability as the value of the working supplier relationship vs. the lowest price.
- Investing in quality assurance before starting a clinical trial.
The supplier that you partner with for the comparator drug sourcing and supply for clinical trials should create long-term value, rather than generating short-term savings.
Final Thoughts
As a result of changes in the pharmaceutical sector, both clinical supply chains and comparative drugs will be affected. It is now essential that both sourcing and manufacturing of comparative drugs be considered part of a clinically aligned function, as each is critical to the success of clinical trial programs.
Through integration, technology application and strategic partnerships, organisations will be positioned to create resilient, adaptable and capable systems that can help them overcome uncertainty. Ultimately, success in this new landscape will not come from companies that independently innovate, but rather from companies that execute through collaboration, intelligence, and precise execution.