Participating companies indicate that one of the top challenges and a major cause of delays in sourcing comparators and co-therapies
is associated with obtaining required documentation (e.g., equivalency documentation, certificates of conformity, certificates
of analysis, and BSE/TSE statements) from the manufacturer and temperature excursion data (e.g., stability data).
Comparator and co-therapy product availability is another top mentioned difficulty, especially for products that represent
a sizable portion of a manufacturer's revenue and supply. Oncology products, rare disease products, and anti-inflammatory
MABs, for instance, are closely monitored and protected by the manufacturer as they contribute a large portion of that company's
Comparator sourcing managers note a particular difficulty in obtaining comparators when supply is limited or when expiry dates
are of short duration. Other notable problems include increasing complexity of trial design, variation in approved indications
globally, and increased regulation. These factors can lead to longer lead time in defining comparator requirements prior to
purchasing the comparator drug. Multiple requests for proposals to third-party buyers may signal secondary markets to inflate
drug pricing or limit availability. Sourcing managers also find that establishing reliable pricing forecasts can become an
issue, as there is not always sufficient information on availability of a product within particular regions or countries.
Counterfeiting, particularly in remote emerging regions with limited regulatory oversight and law enforcement, is another
challenge of note. Another factor at play is rapid expansion of the market and the number of players involved in the pharmaceutical
supply chains. The regulatory and law enforcement agencies are also responding in an effort to keep pace with this expansion.
The results of this Tufts CSDD study indicate that a surprisingly high proportion of clinical studies now involve comparator
drugs and co-therapies and that these drugs are typically branded products. Based on average spending levels per company,
we estimate that the industry overall is spending $1.5 to $2 billion annually to include comparators and co-therapies in their
Participating companies anticipate that the operating challenges and costs associated with sourcing comparators and co-therapies
will continue to worsen and they are eager to identify improvement opportunities.
This Tufts CSDD study is an important first step in compiling and presenting metrics that begin to characterize the prevalence
and cost of sourcing comparator drugs and co-therapies. The conclusions drawn in this study are based on a limited sample
of clinical studies. More data, from a larger number of companies, should be gathered to establish more robust measures.
Through metrics and the identification of shared challenges, pharmaceutical and biotechnology companies would be advised to
begin a discussion about potential solutions to be implemented across the drug development enterprise. To date, organizations
have had limited opportunities to establish long-term sourcing arrangements with a single peer company. Some companies have
indicated that they are entering into discussions between company R&D functions—particularly those where there is therapeutic
area alignment—to establish a more direct exchange of drug supply. In most companies, however, the commercial division is
responsible for handling and fulfilling requests for approved drug products.
Among participating companies, senior sourcing executives have indicated high receptivity to establishing a pre-competitive
comparator consortium that would create a transparent, centralized forum for companies to be paired efficiently when one is
seeking the other's comparator or co-therapy drug. Such a consortium might have its members agree to adhere to standard documentation
and supply practices in addition to preferred pricing levels. A consortium model—although often suggested at industry meetings
and conferences—has yet to be formally embraced and championed by a pharmaceutical or biotechnology company.
Concerns about competitive pricing, antitrust, and collusion have prevented the precompetitive consortium concept from gaining
momentum. Overall patent expiries and challenges in R&D productivity make some companies reluctant to partner, as there is
a perception that it may erode sales of marketed drugs faster. TransCelerate BioPharma has established a working subcommittee
to consider how to build and launch a reliable, rapid source of commercial products for use in clinical trials. A pilot is
planned for this year. Tufts CSDD is committed to working with TransCelerate and others to measure the impact of new solutions
to address this costly challenge.
Mary Jo Lamberti is Senior Project Manager at the Tufts Center for the Study of Drug Development (TCSSD). She can be reached at firstname.lastname@example.org
. Ken Getz is Director of Sponsored Research Programs and Associate Professor, TCSSD. He can be reached at email@example.com
. Terry Walsh is Head of Comparators, Investigational Material Supply, GlaxoSmithKline. He can be reached at firstname.lastname@example.org