Introduction. VP, Sales in a Global Courier Company

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1 ARTICLE AUGUST 2014 Abstract: Impact analysis of Just in Time packaging and labeling on clinical supply chain Clinical supply chain is in intense pressure for better management due to factors like globalization of clinical trials and increase of triple blinded clinical studies. Traditional supply chain practices don t allow room for flexibility in shipments for medication kits as they are packaged and labeled in central depot. This has led to an increase in clinical wastages to the tune of 40-60%. However, if options for flexibility are provided to an investigator then these high wastages can be reduced to comfort levels and R&D investments from Pharma Companies can be streamlined to some extent. This can be done if organizations can bring packaging and kitting of medication drugs nearer to clinical trial sites. This will also assist clinical supply chain vendors to plug supply-demand mismatch for majority of trial sites. Just-in-time (JIT) Packaging and Labeling is considered to be one of the solutions for achieving greater control over clinical trial supplies. Rahul Sodhi Senior Research Analyst Pharma R&D Copyright Beroe Inc., All Rights Reserved

2 Introduction Majority of clinical supply chain vendors still follow traditional supply chain practices where all the packaging, labeling, kitting and collation activities are done at central depot level. Clinical trials these days have become more diverse, challenging and reaching out to more geographies which needs better supply chain management. According to an analysis the clinical supplies are experiencing wastage to the tune of 40-60% which is pretty high. Industry needs to bring more innovations in the supply chain processes so that they can assist pharma sponsors in saving precious investment some part of which gets wasted. Bringing packaging and kitting processes near to clinical trial sites can be very useful (in) streamlining clinical supplies. And Just in Time (JiT) clinical packaging and labeling can be very helpful in evolving clinical supply chain in this way. JIT Packaging and Labeling is a process taken care at depots. Vendors if authorized and certified by FDA and/or other regulatory authorities can only provide this service. All protocol related to information like protocol number, expiry dates, quantities to be used, etc. are labeled just before dispensing to a particular clinical trial site. This needs a robust electronic and web based systems to be in place. Once data and results for clinical trial site are triggered by IVRS/ IWRS systems the process can effectively precede. JIT Packaging and Labeling can assist clinical trial managers with more flexibility during clinical trials. There may be many incidents like patient return, frequency/ volume increase/ decreased on a trial site, etc. those need to be take care of to avoid unnecessary wastes. This concept is not new to the market, still industry expert feels that the concept is on growth trajectory as pharma and supply chain companies are in dire need for efficiency. Implementing JIT labeling and packaging process effectively can potentially reduce clinical trials wastes in a range of 30-50% depending upon some factors. VP, Sales in a Global Courier Company Key Issues faced by clinical supply chain for global multi-center clinical trials There are various issues which are affecting the clinical supply chain. Clinical trials can t be stopped and pharma companies are forced to provide overage supplies of up to 150% depending upon the risk factors. These issues are pushing for bringing innovative methods like JiT packaging and labeling in the clinical supply chain. Some of the biggest pain points of this segment are discussed as follows: Supply demand mismatch: Most of the clinical trial sites complain about supply-demand mismatch for clinical trial materials. Forecasting actual number of patient enrollment is a very challenging task. Vendors generally follow the initial decided timelines for shipments but it often confronts with unexpected issues like customs, patient enrollment issues, lead time, quality issues, etc. Less Flexibility: If there is a change in study or if forecasted supply varies with actual need of supply then one leads to high overage and wastes creating high wastage in investment for R&D. And CTSOs (Clinical Trial Supply Organization) generally follow a fixed protocol for supply chains leaving less room for on-time changes required in supply of clinical materials due to protocol amendments. Geographical Issues: Regulatory requirements in emerging markets are very dynamic. There are other linguistic requirements as well according to regulatory point of view. Most of the IMPs and Non-IMPs are manufactured in Western Europe and other processes like packaging and labeling are also done here only. Many times the shipments are send back or get trapped in customs due to improper paper work, regulatory issues, quality issues, etc. leading to huge time and investment wastage.

3 All these factors lead to huge wastage in clinical materials for clinical trials. According to a recent study, 30-50% of comparator drugs gets wasted or remains unused due to such supply chain issues. Even IMPs are facing wastages no less than these figures. This leads to capital wastage for running clinical trials by pharma sponsors. If JiT packaging and distribution is effectively implemented then these issues can be reduced to a significant degree leading to more fruitful investment in clinical trials. There are many benefits of implementing JiT concept for clinical supply chain. These are as follows: Platform for Drug Pooling Better management for Complex Clinical Trials Region specific approach Multiple studies or protocols can be covered under one bulk batch of IMPs with primary packaging. Bulks of drugs when put on one regional depot can be labeled according to the need in different studies and thus can be used. Currently it can be assigned to different studies for same sponsor but in future it can be extended to broader term of drug pooling. This also enables the vendor to initiate resupply of medications after proper labeling and packaging. In case the volume of drug is over exhausted at one depot and designated trial site needs more drugs then one can get it from some other nearby depot because in this case the drugs were only primary packaged. Biopharma R&D and Comparator trials are more complex than traditional clinical trials. Many times large molecules get damaged while in transit due to temperature fluctuations where as high patient randomization makes managing comparator trials an uphill task. Biologics: Using a regional or local depot can be very helpful for storage of these temperature sensitive drugs. Labeling and Packaging just before request from investigator can save them from getting damaged in long journey periods in supply chain. For effective and robust process the medication order should get dispatched within hours after the order was placed. Independent randomization and dose titration: Some complex clinical trials like clinical trials on oncology, comparator clinical trials, etc. need higher level of patient randomization and dose titrations. This is programmed according to expected patient enrollment. But in real time situation planning and execution mismatch may occur due to low patient participation or other secondary reasons. In this scenario one can adopt very flexible approach and can modify the randomization process accordingly. It will assist in turning the clinical supply chain more robust for emerging markets. Regional depots play a role of a window for understanding the geography and streamlining the supply chain process. There are some significant parameters which demand better understanding to achieve effectiveness in supply chain: Dynamic Regulations: In emerging markets, the regulations change at a rapid pace as these countries are in a process of reforms for clinical trials in the respective countries. Multilingual Environment: Regulations in many countries make it necessary to provide labeling on the drugs kits, protocols, etc. needs to be in local language. This makes it difficult to manage labels from one place and need a regional hub model. In this scenario label contents can be selected individually country specific and can be put accordingly. The approach becomes very strategic due to the extent of integrity with each trial sites. One of the clinical trial sites in US was handling around 37 protocols. While interacting with the investigator and observing the trial site we found that more than 70-80% of the clinical supplies were mismatching in timeline with clinical trials. And it became really difficult for her to search right product for particular clinical trial in that inventory warehouse. If similar scenario occurs during biologics trials as well then it can be really disastrous for the sponsor. Industry needs to start thinking and planning accordingly. Clinical Supply Chain Organization

4 Country specific shipment initiation Higher degree of synchronization with trial sites Ease of labels contents modifications Reduction in overall inventory level Clinical supply activation for any country can be initiated independently from other countries. Most of the time the patient recruitment in one country mismatch with the same in other country, therefore, one need not to wait for other country to complete patient recruitment or need not to send the trial supplies much before initiation of trials. JIT strategy complements the on demand shipment of clinical supplies. It can assist in more synchronization of clinical supplies in terms of demand and supply. One can initiate the supplies strictly according to the demand from the trial sites or investigators. And JIT strategy can assist in adopting this level of flexibility. In this case study medication which is ordered from trial site will be prepared leaving rest in stock for demand in future. Label content modification is feasible according to the trial requirements. Drug already labeled for one trial site can be directed to other one by modifying the labels according to required procedures. They can also be modified according to the intake prescriptions like use-by-date. Overall inventory level will reduce with introduction of more flexible approach. JiT delays product differentiation until the actual order is not placed. Once the order is placed this semi-finished form is quickly customized and send to clinical trial sites for patients. Key Challenges: Why JiT concept is not implemented fully in clinical supply chain? Investment: Clinical supply chain companies don t have required infrastructure for this concept especially in emerging markets. They need to make investments in terms of resources, infrastructure, etc. if they want to implement the concept. Infrastructure: CTSOs and 3PLs/Courier companies have limited infrastructure in place for implementing JiT in clinical supply chain. Lack of resources makes it very difficult to change the traditional practices in supply chain. Implementation Implementing JIT concept is not an easy task but need proper consideration and planning before actual implementation. Otherwise it can lead to huge cost escalations which are basically due to logistics involved in it. Some of the requirements for effective implementation of JIT concept are as follows: Understanding geographies: Geography based strategies must be chalked out. One can t implement one strategy in all the countries. Clinical trial volume, logistics, infrastructure, market maturity, etc. are some of the parameters which must be considered for the implementation of the process. Integration of planning and process: It includes all vendors those are involved in the clinical trial execution like Contract Research Organizations (CROs), Clinical Supply Chain, 3rd Party Logistics (3PLs), and Courier Service Providers. Process planning these days is very fragmented and there is very less collaboration in service providers horizontally for proper planning and execution.

5 Emerging Collaborations for JiT process The most significant part of the system is depot vendors. Currently 3PLs or Courier Companies maintain global/regional depot and distribution network of clinical trial supplies. And CTSOs have started playing a significant role in emerging markets with more investments in depot infrastructures in LATAM, China and Singapore regions. Effective implementation of JiT concept requires extensive resources at depots which is limited with these organizations maintaining depots. In this space industry is expecting extensive CTSOs and courier companies collaborations with clinical packaging and labeling companies those have expertise in implementing JiT Packaging and Labeling in the clinical supply chain. For an instance, if labeling process goes more nearer to clinical trial sites i.e. if it shifts to in-country depots then implementation of the process for global courier companies become extremely difficult. In this scenario they need to collaborate with two kinds of organizations: Local Depots: Local Depots provide them leverage to not to invest in each country for depot requirements e.g. many CTSOs, 3PLs, Pharma companies engage with Depot Meridian in Turkey for local as well as regional requirements. Some global CTSOs are opening regional/local depots to make the supply chain process more agile and flexible. For an instance Parexel opened Singapore distribution facility; Marken opened a warehouse near the Beijing Capital International Airport in China last year as part of big expansion throughout the world; French drug maker Sanofi last year decided to put its largest logistics center on the African continent in Morocco. Depots nearer to clinical trial sites can be best place for managing supply chain for that region. But currently clinical supply chain companies just don t have required facilities for JiT concept in their depots. They can either build inhouse capabilities or can get assistance from clinical packaging companies in this space. Expert, Clinical Packaging Company Clinical Packaging CTSO collaboration: Currently such collaborations at regional or local level are very less. But if CTSOs want to implement JiT concept effectively then they need to have more vertical collaborations with clinical packaging companies. This will also give them better visibility over regulatory and linguistic aspects at regional level. Conclusion: Clinical supply chain is becoming more complex which needs more innovations to address emerging challenges. Bringing packaging and labeling for medication kits nearer to clinical sites can be helpful in streamlining the overall process. And JiT packaging and labeling can be one of the solutions. Sources and References: 1. ^Palmer, Eric. (2014). Parexel opens Singapore distribution facility. FiercePharmaManufacturing , p ^Wattie, May. (2013). Facing Fears of Just in Time Labeling. PharmaceuticalOutsourcing , p ^Seymour, P. (2012). Utilizing Just-in-Time Labeling to Increase Flexibility in Clinical Supplies [Internet].BPTC, Munich (Germany). Available from: [Accessed 1 March 2014] 4. ^Yim, S. (2011). CASE STUDY: Overcoming Challenges Involved with Removal of the Expiry Date from Investigational Drug Product [Internet]. Medimmune. Available from: [Accessed 1 March 2014] Disclaimer: Strictly no photocopying or redistribution is allowed without prior written consent from Beroe Inc. The information contained in this publication was derived from carefully selected sources. Any opinions expressed reflect the current judgment of the author and are subject to change without notice. Beroe Inc. accepts no responsibility for any liability arising from use of this document or its contents. For more information, please contact: info@beroe-inc.com