logisticssupply chain management
In March 2016 Dalvir Gill, CEO of TransCelerate, was getting ready to type a congratulatory e-mail to the Comparator Network Team. Dalvir had a deep sense of satisfaction at how the Comparator Network, one of the five initial projects, had evolved since TransCelerate’s inception in 2012 and surpassed the $100 million milestone in comparator spend across member organizations.
In September 2012, 10 leading biopharmaceutical companies announced that they had formed a nonprofit organization to accelerate the development of new medicines. Abbott, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly, GlaxoSmithKline, Johnson & Johnson, Pfizer, Roche, and Sanofi launched TransCelerate BioPharma Inc. (TransCelerate), the largest-ever initiative of its kind, to identify and solve common drug development challenges with the end goals of improving the quality of clinical studies and bringing new medicines to patients faster.
TransCelerate evolved from relationships fostered via the Hever Group, a forum for executive R&D leadership to discuss relevant issues facing the industry and solutions for addressing common challenges. In the words of the acting CEO of TransCelerate Garry Neil, MD, “There is widespread alignment among the heads of R&D at major pharmaceutical companies that there is a critical need to substantially increase the number of innovative new medicines, while eliminating inefficiencies that drive up R&D costs.”
The mission at TransCelerate is to work together across the global biopharmaceutical research and development community and share research and solutions that simplify and accelerate the delivery of exciting new medicines for patients. TransCelerate membership is available to biopharmaceutical research and development organizations that engage in innovative discovery, development, and manufacturing of new medicines. TransCelerate has three membership tiers, based on an organization’s global research and development spend, which allows companies of all sizes to consider membership.
In the words of Janet Woodcock, MD, director of the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation & Research, “We applaud the companies in TransCelerate BioPharma for joining forces to address a series of longstanding challenges in new drug development. This collaborative approach in the pre-competitive arena, utilizing the collective experience and resources of 10 leading biopharmaceutical companies and others to follow, has the promise to lead to new paradigms and cost savings in drug development, all of which would strengthen the industry and its ability to develop innovative and much-needed therapies for patients.”
Members of TransCelerate identified clinical study execution as the organization’s area of focus. Five initial projects were selected by the group for funding and development, including
· Development of a shared user interface for investigator site portals.
· Mutual recognition of study site qualification and training.
· Development of a risk-based site-monitoring approach and standards.
· Development of clinical data standards.
· Establishment of a comparator drug supply model.
In December 2012, TransCelerate appointed Dr. Dalvir Gill, PhD, as their chief executive officer to lead the newly created entity.
The Comparator Network
One of the five initial projects selected by TransCelerate member companies under clinical study execution was the establishment of a comparator drug supply model.
What Are Comparator Medicines?
Comparator medicines are marketed commercial drug products used in clinical trials to provide a direct comparison against an investigational medicinal product (IMP) or another commercial drug product. They may also be used in conjunction with the IMP or as a standard of care.
The purpose of conducting a clinical trial is to demonstrate the safety and efficacy (effectiveness) of an IMP in treating the target medical condition by comparing it to the existing standard of care (comparator medicine) or a placebo (substance with no active therapeutic effect). Depending on the study design, a clinical trial consists of one or more arms (treatment groups), i.e., an IMP arm, a comparator arm, a placebo arm (refer to Attachment A for details regarding the “Phases of a Clinical Trial”).
Clinical trials usually involve randomly assigning patients to treatment groups and giving one group the IMP, another group the comparator, another group the placebo, as dictated by the study design. The goal is to ensure that the patients and often the doctors do not know which group is receiving the IMP, the comparator, or the placebo. This approach is followed to prevent any bias as regards the patient’s response to the treatment.
When a comparator medicine is used in a clinical study, the IMP is being benchmarked against a commercial drug product that is already being used to treat patients. The rationale is that if an approved medicine is already available on the market, the regulatory bodies (FDA (U.S.), MHRA (UK), etc.) require an innovator (biopharma company) to prove that their IMP is equal to or better than the available treatment options. Depending on the goal of the study, the innovator’s focus is to prove that its candidate (IMP) is just as good or better than the comparator medicine by way of superior efficacy or reduced risk (e.g., lesser side effects) or an alternate mechanism of action.
Given the importance of comparator medicines in the development of new therapies, historically, some biopharmaceutical companies have seen a competitive advantage in trying to prevent other companies from buying their products, the rationale being that if another company could not obtain their commercial drug product for use as a comparator, then that other company would be unable to develop a competing drug. This philosophy is flawed on two counts: First, if a company could prevent the development of new therapies, that strategy only hurts patients. There are many patients for whom the current therapies do not work, and those patients are desperately waiting in the hope that the next new therapy will be the one that works for them. Second, everyone in the industry has found a way of
getting the medicine, if not directly from the manufacturer, then by using alternate channels. Biopharmaceutical innovator companies began to seek out ways of buying comparator medicines from “under the radar” of the manufacturing companies. In response, a new class of specialty-sourcing wholesalers arose in the market to provide their services in securing drug confidentiality on behalf of their clients. These intermediaries in the comparator supply chain seek out the supply of drugs globally and slowly accumulate quantities so as not to capture the attention of the manufacturing companies that closely monitor their global inventory. These specialty wholesalers became very adept and successful at this practice.
The selection and use of comparator medicines in clinical trials is thus challenging for biopharma companies in terms of both cost as well as availability of the comparator medicine.
The Traditional Supply Chain for Comparator Medicines
Under the traditional supply chain for comparator medicines, biopharma innovators approach the specialty comparator wholesalers with their demand for a specific comparator medicine, providing information like drug product name, presentation (bottles, blisters, vials, prefilled syringes, etc.), market, duration of the study, quantity needed, and desired expiry date.
A typical request for a comparator drug to a specialty wholesaler may read as follows:
Product Name: Warfarin Tablets
Strength: 5 MG
Presentation: 30 Count Bottle
Market: European Medicines Agency (EMA) Country
Quantity: 2,000 bottles per quarter from Q1 2016 to Q2 2017
Desired Expiry: 18 months from the time of purchase
Once a request is received, the wholesaler gleans its supply network and determines the feasibility of fulfilling the demand. If the wholesaler is in a position to fulfil the demand, the innovator (buyer) initiates a formal purchase and the wholesaler sells the comparator medicine by typically adding a markup to its acquisition cost.
The wholesaler’s supply network consists of biopharmaceutical manufacturers. Depending on the comparator medicine that the wholesaler is seeking, on a case-by-case basis, the manufacturer may either not require the wholesaler to share the clinical study data (for the study that the comparator medicine will be used for) or may ask for detailed study data.
The value proposition offered by these specialty wholesalers is that they provide a buffer between the innovator organization and the manufacturing organization. Additionally, they have the infrastructure to facilitate the sale of comparator drugs.
Challenges Encountered under the Traditional Operating Model
Though the traditional operating model is an established norm within the biopharmaceutical industry, it has its limitations.
By buying drug product through a comparator wholesaler, the innovator is not securing it directly from the manufacturer and thus assuming supply chain integrity risk, particularly the introduction of counterfeit product, which is a significant risk within the biopharma industry. The introduction of counterfeit product not only compromises patient safety but also jeopardizes the results of the clinical study.
Another risk that the innovator assumes under this operating model is the risk of supply chain continuity. What this means is that the availability of the desired drug product during a time period does not guarantee availability in future periods; i.e., because the wholesaler was able to secure the desired product during the current time period does not guarantee assured supplies in the future. As a result, innovators may buy larger-than-needed quantities of comparator drug product when it is readily available and run the risk of expiry, if the medicines are not used in a timely manner, or obsolescence, in case a clinical study is discontinued ahead of schedule. The innovator is thus balancing supply chain continuity risk versus the risk of expiry or obsolescence.
Besides securing drug product, another important aspect of comparator sourcing is getting access to key documentation at the product level—e.g., Material Safety Data Sheet (MSDS), Equivalency Data, and Allowable Temperature Excursion Data—or at the batch level—e.g., Certificate of Analysis (COA). These documents are either not readily available or not possible to secure under the traditional model.
The TransCelerate Comparator Network
As described earlier, one of the five initial areas of opportunity (projects) identified by TransCelerate member companies was the establishment of a comparator drug supply model. The Comparator Network was initiated with an aim to leverage the opportunities for collaboration between member companies in the area of comparator drug supply.
The Comparator Network is open to all TransCelerate Member Companies, although not all member companies participate in the network. A Clinical Trial Supply Network Agreement was drafted and had to be signed by a member company as a prerequisite to joining the network. An operating model was developed within the confines of this agreement.
The process flow for the TransCelerate Comparator Network is as follows (refer to Attachment B for an overview of the operating model):
All participating member companies enroll with each other as a “Customer” or “Vendor” to “Buy” or “Sell” drug product in each desired market.
A buying member reaches out to a selling member and provides its forecast for a particular drug product in a particular market using the TransCelerate online portal.
The selling member reviews the forecast with its supply chain planning team and confirms its ability to supply product during the requested time period.
On a case-by-case basis, the selling company is mostly able to fulfill the buying company’s request for a desired shelf life, i.e., expiry date.
Once a confirmation is received, the buying company issues a purchase order to the selling company.
The selling company delivers the requested drug product to the buying company at a designated location within the requested market.
Additionally, the buying company can request related documentation for the drug product being purchased, like batch–specific Certificate of Analysis, Allowable Temperature Excursion Data, and so on.
An online portal has been developed to register and facilitate these transactions.
All transactions remain confidential between the buying and selling companies, with a neutral TransCelerate representative available to facilitate the transaction.
This operating model marks a paradigm shift in the manner in which comparator medicines have been traditionally secured by the participating companies. It infinitely simplifies the process of securing comparator medicines by creating a direct relationship between the buying and selling companies and fosters a shared commitment to a more efficient supply chain. As of the end of 2016 there were 10 participating member companies in the Comparator Network.
Benefits Arising from this Transformative Approach
The TransCelerate Comparator Network marks a transformative shift in the manner in which biopharmaceutical companies have historically secured comparator medicines to conduct clinical studies. It has led to the creation of a collaborative environment that provides member companies access to clinical medicines, documentation, and data that facilitate their ability to conduct clinical studies more efficiently and with enhanced integrity. The key benefits arising from participating on the Comparator Network are described below.
Supply integrity leading to enhanced patient safety: The Comparator Network enables participating member companies to buy drug product directly from the manufacturer, which significantly reduces the risk of introducing counterfeit product into the supply chain. This ability to purchase medicines directly from a “known source,” i.e., the manufacturer, enhances Patient Safety and reduces the risk of potentially jeopardizing the clinical study.
Transparency in sharing forecasts leading to assured supply: The sharing of forecasts between the buying and selling companies is mutually beneficial to both parties as the buyer now has access to assured supply and the seller has a reduced risk of potential outages in smaller markets (e.g., in some cases, clinical demand in the UK could equate to approximately 6 months of commercial demand) where the buyer would otherwise buy product “under the radar.”
Flexibility to schedule periodic purchases and a corresponding reduction in obsolescence risk: Because under the comparator network operating model buying companies share their forecasts with selling companies and have access to assured supply, it enables them to schedule periodic purchases of smaller quantities of comparator medicines with desirable expiry dates. Unlike the traditional model, by adopting this approach the buying companies avoid stockpiling of large quantities of expensive comparator medicines. As a result they are able to significantly reduce the risk of medicines expiring or inventory becoming obsolete in case a clinical study is discontinued ahead of schedule.
Market access: The Comparator Network provides access to drug product in the United States and the European Union, as well as other markets, if the buying and selling companies are able to arrive at a collaborative agreement.
Access to documentation: In the biopharmaceutical research environment, access to documentation is probably as valuable as access to assured supplies of comparator medicines. The data provided by this documentation is a key enabler in planning and conducting clinical studies. Additionally some of these documents facilitate the movement of comparator medicines across borders, from a customs standpoint. The Comparator Network enables the buying company to access documentation like Material Safety Data Sheets, the Certificate of Analysis, and in select cases certain equivalency data, which facilitates their ability to conduct the clinical study.
Access to Stability Data: Stability Data is developed by biopharmaceutical companies to support manufacturing and logistics, as well as determine shelf life. This data demonstrates that the medicine is retaining its quality attributes over time. Allowable Temperature Excursion Data is derived from Stability Data. From a logistics standpoint, Allowable Temperature Excursion Data is key to evaluating “whether a medicine can be used or discarded,” in cases where a product has undergone a temperature excursion either in-transit or during handling at the clinic. Access to Allowable Temperature Excursion Data is a key benefit to buying companies as it enables them to make usage decisions regarding the comparator medicine, in cases where the product has encountered temperature excursions that are outside the prescribed ship and store temperature conditions printed on the product label.
Savings: By buying directly from the manufacturer generally at wholesale pricing or equivalent, the innovator can source comparator medicines less expensively than it would when sourcing through alternate channels. This is, however, just one of the multiple dimensions across which the innovator can incur savings by participating on this network. The ability to schedule purchases in smaller quantities with desirable expiry dates reduces both the inventory carrying costs and the associated risks. Additionally, by having access to allowable temperature excursion data, the innovator can rescue product that encountered temperature excursions, which would have otherwise been discarded for lack of stability data.
The above listed are the explicit benefits of participating in the Comparator Network. There is also the added benefit of being part of the comparator network community that provides representatives from participating member companies an environment to foster relationships with industry colleagues from other organizations. These relationships not only provide new avenues for those member companies to seek input on issues relating to the business environment, but on an ongoing basis have been instrumental in facilitating the collaborative resolution of issues relating to ongoing clinical studies, which was not imaginable in the past.
TransCelerate Comparator Network: Moving Forward
Member companies participating within the TransCelerate Comparator Network have been successfully buying and selling product from each other since 2014 (refer to Attachment C for details regarding transactions, spend, and documents exchanged). In the initial years a Comparator Network lead role was created to provide leadership and orchestrate the activities during the “project phase” of this initiative. The network is administered by a core committee, where each participating member company nominates a representative. The core committee meets on a periodic basis to review ongoing challenges and future opportunities. One of the areas of opportunity that is steadily gathering traction within the network is the sale of placebo by biopharmaceutical manufacturers to innovators, an area in which innovators have to invest significant resources to develop placebo under the current scenario.
In 2016, the TransCelerate Comparator Network was transitioned from a “project phase” to a “realization phase.” Based on the network’s strong performance, TransCelerate leadership had the confidence that this initiative could function in a self-sustaining manner on an ongoing basis.
With a strong track record in place, other TransCelerate member companies continue to show keen interest in this initiative; as a result the membership is expected to grow in the future. The progress made by the TransCelerate Comparator Network has surely contributed toward the founding goal of TransCelerate, i.e., collaborating across the biopharmaceutical industry to address longstanding challenges in new drug development to ultimately bring innovative and much-needed therapies to patients.
Council of Supply Chain Management Professionals
Read the Case Study The TransCelerate Comparator Network: Transforming the Supply Chain for Clinical Comparator Medicines on page 505 of your textbook. Also, be sure to watch the videos listed below:
Leadership Lens: Dalvir Gill, CEO, TranCelerate (Links to an external site.)
The Transcelerate Hack: Transforming and Automating the Future of Clinical Research (Links to an external site.)
In your case study paper, you will address the following questions.
1. Identify the major benefits from TransCelerate utilizing the transformative approach to secure comparator medicines to conduct clinical trials. Please be explicit in your response
2. With respect to managing relationships with customers and suppliers, in the textbook, chapter 10 (pp.295-301) identifies two types of Investment – Base Business Models: shared services and equity partnerships. With respect to TransCelerate’s success, identify which type of model you think they utilized and identify two major benefits that arose from utilizing that model. Please be explicit in your response
3. Put on your thinking cap and identify different organization(s) that can utilize the same approach you identified in the previous question with the types of Investment – Base Business Models: shared services and equity partnerships. Explain why you think this would be a good fit for the organization of your choice.
You will submit a paper of at least 500 words, not including title or reference page.
You will need use at least one source, the course textbook, to support the conclusions provided. All references are to be from academic journals, professional or academic textbooks, authored websites, or standard business publications, such as The Wall Street Journal. No more than 15% of the content can be taken directly from all sources. This means if TurnItIn is used, then the similarity index must be 15% or lower. The final score of the case study will be reduced by one point for each percentage point over 15%.
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