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Sourcing Comparators

Today’s marketplace demands that clinical trials are designed with a component to compare and contrast drugs in development with existing compounds. Comparative trials are designed to assist pharmaceutical and biotechnology companies in attaining this best-in-class claim.

With healthcare costs nearing three trillion dollars, our industry is strongly motivated to support a commitment to excellence. This is not only a domestic concern, but also one that we share on an international level. This global obligation has encouraged the industry to design clinical trials on a worldwide scale to further ensure that the most efficacious drug is identified, approved, and made available for every individual that needs it. The industry has responded accordingly and, as a result, comparative clinical trials are increasing in numbers, not only in the US and Europe but also within emerging regions such as South America and south east Asia.

This growth will inevitably have a positive financial impact on the market and perhaps re-energise the vitality of medical research. It has been reported that by 2015 there will be 50 per cent growth seen in the global clinical trials market, and that by 2020 the number of clinical trials being conducted in emerging markets will be equal that of the US and Europe combined. Offshoring clinical trials to emerging markets – specifically India, China, Brazil, Russia, and central and eastern Europe – is also expected to demonstrate revenue growth. For example, China is anticipated to be the world’s second largest market for clinical trial services by 2021 due to an expected compound annual growth rate exceeding 20 per cent. Emerging regions have large patient populations, increased speed of recruitment, concentrated in-country technical expertise, and are less costly – estimated at 60 per cent of large scale clinical trials. The global investment in clinical trials is therefore too attractive and lucrative a venture to ignore, which is why the global execution of clinical trials has shown upward growth.

This significant growth of multiregional comparative clinical trials has added to the complexity of clinical trial execution, specifically as it pertains to securing the comparator product itself. In general, the two major obstacles are insufficient knowledge of the geographical area and ground logistics. In sourcing this unique commodity, these obstacles are just a few of the many challenges that can arise when it comes to securing authentic material. The standard requirements of the comparator are that it is readily available and can be delivered via a secure and reliable supply chain. New pedigree requirements and more stringent regulations around the materials’ inspection for tampering and adulteration are but two enforcements that regulators have begun to impose upon the industry.

Good planning and coordination for a clinical trial will ensure fewer delays and efficient trial execution. Pre-planning and collaborative partnerships are essential. Thorough planning includes detailing product requirements in the trial’s design phase; confirming further manufacturing/re-packaging requirements; and understanding product availability, logistics and any import regulations. This planning minimises the risk of trial delays and ability for teams to make decisions at critical steps in the process. It also allows for alternate option considerations to lower expenses. One key measurement of the success of multiregional comparative clinical trial is the flawless delivery of comparator drugs to all clinical trial sites without any interruptions to the overall clinical trial timeline.

Comparator Sourcing

Comparators are a unique commodity with limited availability, uncertain lead times, varied regional specification requirements, such as complex logistics and distribution requirements, and volatile prices. The process of procuring the comparator should not be underestimated or unplanned.One aspect of comparator sourcing is that there are many avenues to explore in order to attain authentic material that meets the clinical trial’s requirements, which can vary from needing multiple lots, short and long dated inventory, small and large quantities, and so on. Access to information is one of the most critical strategy components for an organisation to possess in order to successfully accomplish this task. Often, gaining access to proprietary information without disclosing trial details can be difficult if this negotiation is not organised by a mediator. Partnering with industry colleagues and leveraging their global reach and existing relationships strengthens the positional stance to secure the information required to move forward with executing the sourcing strategy. This component, along with strategising and implementing a successful multi-regional sourcing plan with viable alternative options, allows an organisation to source the comparator as required.

When sponsor companies are conducting trials in emerging markets without the infrastructure or staff on the ground in the regions in which the trials are being executed, they have to rely on their own intelligence or industry partners as information resources, since a greater access to intelligence is required to ensure the success of multiregional trials. The tasks associated with information gathering and procurement of the comparator for global trials are very time-consuming and quite labourintensive. Therefore, utilising available resources that have a global reach comparable to the sponsor’s needs streamlines the process of not only providing key support to the comparative agent, but also executing all of its subsequent packaging and distribution requirements as well.

There are key steps to take and options to consider with regards to sourcing the comparator, including the need to: identify the overall need as well as any regional specifications; ensure the authenticity of material; and secure a direct, safe and efficient supply chain.

The ultimate goal is to ensure that the comparators supply chain is supported and secure from receipt to reconciliation. Evaluating the overall need for the comparator to be sourced includes:
  • Identifying what products are available in each region that the trial will be conducted in
  • Assessing the availability of the comparator and the forecasted quantities needed in each region
  • Recognising the source of how to attain the comparator
  • Confirming product lead times and expiry dates
  • Understanding the access to supporting documentation needed
  • Realising the requirements of any further manufacturing needed for the comparator
  • Strategically identifying practical alternatives for any supply restriction situations while confirming that the key piece to this puzzle matches the customer’s requirements
The aforementioned key steps assist in determining the sourcing complexity of the comparator and, once that has been vetted, a recommendation is made to compile a sourcing strategy, which has an assessment component included to ensure compliance and authenticity of materials.

Direct Sourcing

Direct sourcing, or sourcing through an authorised wholesaler or distributor as defined by the manufacturer, is the most reliable way of ensuring the authenticity of the comparator product.These procurement avenues allow access to the necessary pedigree information required to validate the material. Direct sourcing also permits the best access to single batches of material with long expiration dates. Additionally, several organisations can be used to secure supply such as national providers, local wholesalers, and multinational specialist providers.

Indirect sourcing increases the risk of receiving damaged or adulterated inventory with incorrect paperwork or uncertain pedigree. Any problems with the comparator could cause delays in the trial execution, harm to the patient or an end to the trial. Direct sourcing often requires disclosure of trial information resulting in a potential breach in anonymity, and many organisations lack resources to determine how to ultimately source the comparator in the most efficient manner. If a partnership is desired, due diligence is a must.Good starting questions are:
  • Do they have access to gather needed information and present flexible options?
  • Can they provide transparency?
  • Can they mitigate and control costs?
  • Do they offer services in terms of project, logistics and distribution management?
  • Are they able to give unbiased clinical trial supply advice? 
Despite the investment in proper planning and preparation, if the comparator cannot seamlessly get from point A to point B, then all of the strategising and planning will be in vain. Thus, in order to secure a direct, safe and efficient supply chain, an audit of the logistics and distribution measures that need to be executed for the comparator are warranted. In addition one should ask if:
  • Clinical trial supply management is a core competency and business function
  • Appropriate procedures are in place that can be executed effectively
  • Communication, emergency response and disaster recovery plans have been developed

It is important that the clinical trial sponsor has a firm understanding of the following:
  1. Acknowledge that comparators are a unique commodity
  2. Pre-planning and coordination are essential
  3. The requirements of the comparator must be identified
  4. Determine the sourcing complexity of the comparator
  5. Develop an executable but flexible strategy
  6. Assess the quality of the source product
  7. Evaluate internal capabilities
  8. Audit the industry partners and providers
  9. Don’t compromise on the delivery of the 5Rs: Get the Right material; In the Right amount; To the Right place; At the Right time; In the Right manner
  10. Have a practical back-up plan

Sourcing comparators for clinical trials domestically has its own challenges, and organisations that are conducting these trials globally have even more hurdles to overcome. However, if a flexible sourcing strategy can be designed and executed, along with a secure supply chain in place, then sound delivery of the comparator product and its associated requirements will positively contribute to the overall clinical trial outcome.

In order to confidently contribute to the general welfare of the human population, the industry must focus on comparing and contrasting drugs in development with existing compounds. Consequently it is also the industry’s responsibility to ensure that access to the comparative compounds is uninhibited and that particular comparator sourcing specifications are fulfilled without strain and limitation. The key ingredient to success in global sourcing is having access to reliable resources with global reach and information intelligence repositories.This will ensure that multiregional clinical trials are effectively executed, and that the outcomes can further assist in achieving the universal goal of supplying the best-in-class pharmaceutical to the patient community worldwide.

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Lekishia White is Vice President for the Multipharma Group and Managing Director for Multipharma, Inc where she is responsible for the US, Canadian and South/Latin American operations. Lekishia obtained her BS in Biology from Spelman College in Atlanta, Georgia, and her MBA from Pepperdine University in Malibu, California. For over 10 years, she worked and held several key roles in various departments for Amgen, Inc and became a subject matter expert in the following areas: good manufacturing practices and operations, cell culture manufacturing, good distribution practices, warehouse logistics, quality and regulatory compliance, clinical and commercial supply chain management, procurement and strategic sourcing, and personnel and project management.
Lekishia White
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