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European Pharmaceutical Contractor

Setting the Standard

With more than 3,000 active global development programmes conducted annually at approximately 40,000 investigative sites dispersed worldwide (1), clinical operations and global supply chain executives face strong and growing demands in sourcing drugs and supplies for trials. Complex study designs, variations in approved indications globally and increased regulatory requirements present significant challenges (2) – changes in drug therapies necessitate cold chain and temperaturesensitive shipping needs, while combination therapies and companion diagnostics add sourcing and logistical issues. The rising cost of comparators and other therapies used in trials, as well as the expenses for shipping and labour, require the adoption of more efficient and cost-effective operating approaches.

Regulations that impact both investigational medicinal products (IMPs) and noninvestigational medicinal products (nIMPs), labelling and all aspects of the clinical supply chain and distribution are currently being updated and revised. New legislations for clinical trials carried out in the EU will take effect by mid-2016 (3), creating new requirements for nIMPs and labelling that will influence both sponsors and sites.

In addition to regulatory and operational hurdles, global clinical supply professionals face further ongoing risks to supply chain security, traceability and authentication of product – especially in developing regions, where a secure supply chain has not yet been established. Counterfeiting is also a constant threat, which can impact patient safety and could potentially add to the cost of ensuring product quality (4). nIMPs that are sourced locally are particularly affected by these risks.

In light of the discrepancies among countries, the lack of a standard approach to sourcing nIMPs and the absence of published data on industry practices and strategies, Tufts CSDD conducted a study to better understand the factors and key drivers that impact nIMP sourcing decisions. In-depth interviews were undertaken with 24 senior level executives, who occupy diverse roles across clinical supply chain management and operations within 21 large and mid-sized pharmaceutical and biotechnology companies.

Study Focus
 
Given the variation globally in how nIMPs are classified, Tufts CSDD carried out interviews defining them as standard of care and concomitant therapies, rescue medications and ancillary materials. Data were also gathered on respondents’ roles and affiliations, types of strategies or approaches used for sourcing nIMPs, and how those strategies are managed and implemented. Furthermore, other areas investigated were the primary factors driving decision-making, outsourcing tactics, standard of care and insurance, and the function of investigative sites in sourcing nIMPs.

One of the key findings was that across the 21 organisations, no consistent approach or clear strategies were utilised. The following was also gathered:
  • Ten companies primarily employ a tactical method, while four rely on a more strategic system
  • Eleven businesses do not use a specific strategy based on therapeutic area; two use one strategy across a portfolio; and five focus on selected therapeutic areas or study requirements
  • The average lead time received to source medications varies widely – from less than one month to more than six months – based on the size of the trial, type of drug and study design. The median lead time is four months
  • The point at which sourcing decisions are made also differs, with 11 companies reporting that they are made before protocols are finalised; one indicating that they occur after protocols are completed; and nine stating a mix of both
Sourcing and Distribution Strategies

The results of the study suggest that, although executives perceive that local sourcing is less expensive, there are no consistent strategies used across organisations – with both central and local sourcing being utilised.

Interviewees reported using both local and central sourcing based on study-specific criteria assessed by decision-makers within particular functions, including clinical supply as well as clinical and regulatory affairs. One respondent stated: “We do not have a clear strategy. We have a decision tree. The first choice is to source locally if possible. Questions need to be answered, and the first priority is related to demand in clinical trials.”

Some interviewees suggested that there was a preference for local sourcing, because it is perceived to be less expensive. One company representative noted that: “There is a general principle: standard of care and rescue medications are sourced locally at a study centre because it saves costs.” Another implied that there are cost savings related to labelling, distribution and storage when sourcing at the study centre. A further respondent reported that there is too much variation for control to source centrally. “Our general strategy is to source locally because there is too much variation for control worldwide. When locally sourced, they can supply the drugs. Some studies are single-sourced and can be a much more difficult task, because of the diligence involved in securing a single source.”

Distribution strategies utilised within organisations were mixed, with nearly half (49%) of respondents indicating that they outsource to CROs, third-party vendors, packagers or suppliers; 40% of respondents source nIMPs at sites or study centres; and 11% partner with other pharma companies. The majority of respondents revealed that using CROs and third parties can vary from study to study, and CRO employment can differ globally. The preference is for local expertise, and many businesses partner with a few different third-party providers.

Critical Challenges


Study results indicate that the approaches used are inconsistent and non-specific. Variation occurs with use of central sourcing, site sourcing, working directly with pharma companies and outsourcing to third parties. In addition, country difference in standard of care and views of what is classified as an nIMP complicates sourcing tactics.

Interviews also revealed a number of other challenges, but few successful approaches to nIMP sourcing. Several top hurdles cited were availability of material and instability of the supply chain in given events, such as shortages or recalls. One interviewee observed that: “Central sourcing has its benefits, such as controlling supply, but the risk is if we have a shortage, we have to switch our strategy and need to replenish before it expires.”

A common obstacle that was revealed across respondents was country variation in standard of care. This is further complicated by not only the differences in standard of care across countries, but also uncertainty over definitions of IMPs and nIMPs. The majority of interviewees believed that it is easier to source nIMPs in the US – compared to Europe and Rest of World (ROW) markets – because the definition of an IMP and nIMP are clearer, there are fewer drug shortages and it is more amenable to site sourcing. Overall, though, sourcing nIMPs in the US and EU was viewed as comparable when considering other regions. For example, Latin America and ROW countries were cited as particularly challenging due to regulation and importation issues.

To provide further clarity, one respondent discussed the differences by region: “The US is more flexible. Their pharmacy system is quite robust and FDA confidence is high. In the EU and Pan Asia, it is somewhat conservative. In the EU, not all drugs are approved and they are centrally sourced. There are parallel imports and complicated geopolitical factors. In Latin and South America, we centrally source as there are quality issues and counterfeiting.”

No specific or consistent approaches were viewed as successful by respondents. Methods that do work well are similar to sourcing strategies identified, and tend to be variable and inconsistent. These approaches included the use of central and site sourcing, working directly with pharma companies and outsourcing to third parties. One method reported to be unsuccessful is the sourcing of all nIMPs by one company globally. Interviewees identified a few key drivers of change, including the regulatory environment, transition from branded drug to generic equivalent, the constant search for cost reduction and operating efficiencies, as well as the pressure to support more strategic sourcing practices.

A respondent stated that drivers are: “The need to reduce costs and be more effective. For certain therapeutic areas, cost as a driver takes on more importance. Getting the product as quickly as possible and to save money are drivers.” Another interviewee observed that drivers are: “Costs and changes in the regulatory environment. There have not been a lot of changes in the nIMP area in the last 10 years.”

Use of Sites

There was a wide variation reported in the use of investigative sites among companies. Some only trust experienced sites to source nIMPs, while others were not using sites due to concerns about capabilities, lack of experience, and uncertainty around product quality, storage and traceability.

One interviewee remarked that “using sites tends to be very efficient. The only concern is if the nIMP is in short supply.” Another stated that: “We prefer not to leverage sites. It becomes a budget consideration. If there is a recall, it puts a strain on the relationship with the site. If we have a site that we have a great relationship with, we have more confidence. But there is the issue of traceability. It is a slippery slope and gets into Good Clinical Practice procedures.”

Some of the inefficiencies noted were the wide variability of site infrastructure, capabilities and levels of skill. If a site lacks experience in procuring medication and agrees, but fails to execute properly, it can result in substantial delays for the study. Sites possessing a great deal of expertise and that have been vetted by the sponsor are the most reliable and efficient at sourcing nIMPs. An additional issue raised was the protracted contract negotiation timelines associated with site reimbursement when sponsors source nIMPs.

Key Findings


The findings of the study suggest that uninsured patients participating in a sponsor’s clinical trial were typically covered by the sponsor. The results were split, however, regarding the use of pharmacy cards that provide reimbursement for medication.

An overwhelming majority of respondents (14 out of 17 companies) indicated that uninsured participants are covered by the company organising the study, although a few noted that this may vary based on healthcare coverage and the region in which the trial is being conducted. Additionally, nine businesses take part in programmes such as Rx Cards or ClinCard, which provide reimbursement for medication for patients participating in trials. These cards are similar to insurance cards and are used at the pharmacy to facilitate payment of medication.

The study results further imply that approaches and strategies to sourcing nIMPs across organisations are varied and inconsistent, and that regulatory and operational issues are continual challenges. These assumptions can lead to inefficient practices within a company’s supply chain, difficulty when partnering with CROs and third-party providers, as well as additional costs. What is more, product quality and availability can potentially be compromised.

Business approaches also differ based on the type of study, therapeutic area, size and scope of study, and global regions in which a trial is conducted. Country to country differences in definitions of IMP and nIMP and in standard of care also have an impact, leading to the use of mixed sourcing models across organisations. Site sourcing of nIMPs is most successful with experienced sites, an established infrastructure and those that have been vetted by a sponsor. The perceived key drivers of change in sourcing strategies are regulatory changes, cost constraints and the need for operating efficiencies.

References

1. Getz KA and Lamberti MJ, Global site landscape remains highly fragmented with variable performance, Tufts Center for the Study of Drug Development Impact Report 15(1-3), March/ April 2013
2. Lamberti MJ, Walsh T and Getz KA, Tracking trial cost drivers: The impact of comparator drugs and co-therapies, Pharmaceutical Executive 33(5): pp34-37, 2013. Visit: http://images2. advanstar.com/pixelmags/pharma-executive/ digitaledition/05-2013.html#38
3. Visit: www.ec.europa.eu/health/files/eudralex/ vol-1/reg_2014_536/reg_2014_536_en.pdf
4. Brown D, Trends in contract pharma serialization and supply chain security, Contract Pharma 17(7): pp62-63, 2015


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Mary Jo Lamberti is Senior Research Fellow and manages multi-sponsored and grantfunded research projects at Tufts CSDD. She has extensive experience conducting research on biopharma industry practices and trends affecting CROs and investigative sites. Mary holds a BA from Wellesley College, US, and a PhD in Psychology from Boston University, US.

Josephine Awatin is involved with the Tufts CSDD Research Faculty as a Research Analyst to build a detailed understanding of clinical pharmacology, drug development and regulation by analysing data to compile and create reports for various projects. She received a BS from Syracuse University, US in Biotechnology, with a minor in Economics.

Ken Getz is the Director of sponsored research programmes at Tufts CSDD. He has more than 20 years of experience in original research benchmarking R&D management practices, global outsourcing and the investigative site landscape, which has contributed to industry-wide understanding of these critical markets and to improvements in management strategy and execution.

Michael Cohen has been with Myoderm since 2001 and is their Managing Director. Prior to working for the company, Michael held positions in the publishing, advertising, financial and utility industries. He holds a BS in Statistics from the University of Pittsburgh, US, and an MBA from the University’s Katz Graduate School of Business.

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Mary Jo Lamberti
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Josephine Awatin
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Ken Getz
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Michael Cohen
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