Collaboration among competitors is hardly new, but it usually involves working together in non-core areas, such as warehousing or transportation of product. Helping another company to actually go head to head with yours is a very different thing. But that’s essentially what the creators of the TransCelerate Comparator Network have done – help others in the pharmaceutical world to develop medicines to vie with theirs in the marketplace.
Research and development in the pharmaceutical space can be enormous, and companies looking to develop medicines for a market already being served face formidable R&D challenges. The TransCelerate Comparator Network, a biopharmaceutical industry forum, is designed to facilitate and reduce costs in the procurement of so-called “comparator” medicines and the exchange of information among participating member companies. The goal of the network, the largest ever initiative of its kind, is to identify and solve common drug development challenges, improve the quality of clinical studies and bring new medicines to patients faster.
In September 2012, ten biopharmaceutical companies -- Abbott, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly, GlaxoSmithKline, Johnson & Johnson, Pfizer, Roche and Sanofi -- announced that they had formed a non-profit organization, TransCelerate BioPharma Inc., to accelerate the development of new medicines. There are almost 20 members today.
Establishment of a comparator drug supply model was a key goal. Comparator medicines are marketed commercial drug products used in clinical trials to provide a direct comparison against an “investigational medicinal product” (a drug in development) or another commercial drug product.
The purpose of conducting a clinical trial is to demonstrate the safety and efficacy of the investigational medicinal product, or IMP, in treating the target medical condition by comparing it to the existing standard of care (the comparator medicine) or a placebo (a substance with no active therapeutic effect).
Clinical trials usually involve randomly assigning patients to treatment groups and giving one group the IMP, another group the comparator, and another group the placebo. Patients and often the doctors do not know which group is receiving the IMP, the comparator or the placebo in order to prevent any bias in 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 already being used to treat patients. The rationale is that if an approved medicine is already available on the market, the regulatory bodies (such as the FDA in the U.S. or the MHRA in the UK) 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 their 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 is 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.
Network proponents acknowledge there was serious resistance within their own companies to establishing the forum and its operating model.
However, advocates say the thinking 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 current therapies do not work, and they are desperately hoping 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 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 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.
Under the traditional supply chain for comparator medicines, biopharma innovators approach the specialty comparator wholesalers with their demand for a specific medicine.
Though the traditional model is an established norm within the biopharmaceutical industry now, it has its limitations. By buying drug product through a comparator wholesaler, the innovator is not securing it directly from the manufacturer and thus assumes 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 jeopardizes the results of the clinical study.
Another risk that the innovator assumes under this operating model is the risk of supply chain continuity. The availability of the desired drug product during a certain time period does not guarantee availability in 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, Equivalency Data and Allowable Temperature Excursion Data; or at the batch level: e.g., Certificate of Analysis. These documents are either not readily available or not possible to secure under the traditional model.
The Comparator Network is open to all TransCelerate member companies, although not all participate in the network. The 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 facilitates their ability to conduct clinical studies more efficiently and with enhanced integrity.
Benefits include supply integrity leading to enhanced patient safety; transparency in sharing forecasts leading to assured supply; the flexibility to schedule periodic purchases and a corresponding reduction in obsolescence risk; access to drug product in the United States and the European Union; access to documentation; access to stability data; and savings, which can be enormous.
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TransCelerate BioPharma Inc.
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