Investigational Drug Product Returns with Lonie Scott

Lonie Scott, Director of Clinical Business Development discusses Investigational Drug Product Returns in an Article Courtesy of Contract Pharma, October 2014

Preparing for the End: Keep sight of Drug Product Returns logistics as you prepare for clinical trials

Over the past decade, the pharmaceutical industry has been under tremendous pressure to bring new drug products through their pipeline. This pressure is driven by several factors. The industry experienced unprecedented revenue loss due to the “patent cliff”. In the years 2012 – 2018, it is estimated that the industry will have lost $290b in revenue from branded prescription medications going off patent. Some estimate that 2012 was the peak, with some $33b in revenue lost in that year alone. As the industry was faced with the prospect of “the cliff”, experts estimate over $11 trillion was spent trying to shore up pipelines over the period 2002-20121. Meanwhile, costs associated with executing clinical studies have increased and the attrition rate of drugs advancing through clinical trials has suffered. In a recent Forbes article, the top 12 leading pharmaceutical companies spent $82b over the period 1997-2011, resulting in 139 approved molecules, which equates to $5.8b per drug2. This increased spending is coupled with increasing lead times to get products from preclinical development to regulatory approval, rising from 11.4 years for the time period 1999 – 2001 to 13.7 years at last measure. This increase is directly attributed to the duration of the latter clinical phases rising from 7.1 years to 9 years3. While drugs take longer to get through development, they are also failing to progress through the phases at an increasing rate. at last measure 1 in 12 drug candidates entering human clinical trials results in FDA approval2.

Clearly, with mounting pressures, the industry’s focus is on developing quality drug candidates and getting them through clinical development as efficiently and cost-effectively as possible. Much attention is paid to upfront study planning and ensuring the onset of clinical studies are executed in a timely fashion.

As investigational clinical studies have evolved and become more complex in recent years, current-day trials can involve a substantial amount of logistical challenges in achieving successful execution. Sourcing developmental drug product, the development and interpretation of study protocol, coordinating language translations, labeling and executing packaging, sourcing comparator drug product, and executing monitored logistics in getting IMP drug to investigational sites around the globe is an activity best left to the experts, and even then there can be unforeseen and unanticipated challenges such as the current conflict in Ukraine. Studies are increasingly executed multinationally, and around the globe that is increasingly in emerging markets, countries such as Russia and Eastern Bloc countries, Asia Pacific countries, China, or South America creating other unique cultural and regulatory challenges. In the fervor of getting studies initiated and supplied, what is often neglected is planning for reverse logistics for these global studies, returning unused drug product at the completion of the study.

Current IMP regulations require that unused study medication must be returned and accounted for at the completion of each study. This process of reverse logistics back to the sponsor or designated Returns vendor may involve hundreds or thousands of packages to be returned and accounted for. For the scope of some studies, this may involve accountability down to the individual dose level. Controlled substances, for example, require meticulous reconciliation to the tablet level. Detailed records must be maintained and returned drug must be efficiently processed.

Sponsor companies can significantly ease the drug product returns process by providing clear instructions to investigator sites at the onset of the study, outlining the process by which samples should be returned. Likewise, clear expectations should be set for the parties providing Returns management services to ensure prompt processing of returned product. Sponsor companies should be prepared that Returns may begin to be received ahead of the conclusion of a study, as investigator sites often have very limited space for storing study materials. Prompt and efficient processing of returned study material is typically best accomplished by dedicated Returns management staff, versed in the training and skills required for this type of precise and exacting service. Communication between all parties at the onset is critical, namely how frequently should communications be expected and by what mechanism. Increasingly this requires data entry and returns accountability confirmation via common cloud based electronic third party IVR/IRT systems. Choosing the most appropriate system at the onset of a study can have a tremendous impact positively or negatively on the Returns process during and at the conclusion of a study. Having effective and user friendly Returns modules in the IVR/IRT system can help expedite data processing and timeliness of information reporting. Systems with a poor user experience can encumber the Returns process and inhibit timely resolution of discrepancies. Timing of processing and timeliness of communications is vitally important to ensure efficient resolution of any discrepancies between what was perceived to be sent from the investigator site and what was actually received by the Returns processor. Both investigator sites and Returns processors must understand the implications and ramifications of discrepancies that may arise. Discrepancies can tie up valuable time and resources and potentially inhibit the sponsor’s ability to formally close the study. Product unblinding can also be a potential issue in the Returns process, and both the sites and the Returns processors need to understand the potential impact to integrity of the study if product unblinking were to occur.

Sponsor companies can also benefit by giving forethought as to what will be the disposition once drug product returns are received and processed. Determination should be made regarding whether product be designated to be immediately destroyed, stored and cataloged until the completion of that study/phase, or potentially years past that. These discussions can allow a sponsor to establish cost estimates and budgets at the onset, where alternatively the lack of these conversations can lead to scope creep and unexpected costs at the end of a study. Providers of Returns management services can help mitigate costs by working with clients to create dialogue on potential options and industry best practices. At PCI we help guide customers early in study development to help avoid the frustrations common to sponsors in the latter Returns management process. This helps clients focus their energies on the next phase of their development and ultimately successful commercialization of their lifesaving therapy.

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