Tufts, CSDD

	Competition between drugs within a given class has intensified, according to a new study recently published by the Tufts Center for the Study of Drug Development (Tufts CSDD). Newly approved first-in-class prescription drugs face substantially shorter periods of exclusivity within which to recoup the high and rising cost of drug development.

	Tufts CSDD reviewed 40 multiple-entrant pharmacologic classes that produced 108 new drug approvals in which the first-in-class agent received approval between 1998 and 2011. Comparing market exclusivity periods for drugs approved between 1998-2004 and those approved between 2005-2011, the results show a 51% reduction in the median time-from 4.7 years down to 2.3 years-from when the first-in-class drug was approved to when the first competitor entered the market. Three-out-of-four second entrants in a given drug class were approved within 3.7 years and 25% were approved in less than six months. Tufts CSDD also found that nearly half (49%) of the 40 classes examined eventually had three or more competitors. 

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Study shows sharp reduction in market exclusivity periods for first-in-class treatment entrants.

Competitive Pressure for First-in-Class Drugs is Intensifying

		The opportunity to more precisely target and to personalize medical treatments based on biomarker data has attracted growing interest from biopharmaceutical companies. A recent study by the Tufts Center for the Study of Drug

 Development (Tufts CSDD) finds that oncology dominates personalized medicine product development in part because cancer-related illnesses are extremely complex and they receive the highest level of R&D activity. Companies involved in developing personalized medicines report that across all phases, 73% of oncology drugs now rely on biomarker data. This compares with 42% of compounds in all indications.

Study finds that almost 75% of cancer drug candidates rely on biomarker data. 

Oncology Leads Personalized Medicine

The 10-year increase in the number of unique and total procedures per protocol corresponds to an increase in the number of endpoints supported by these procedures. Research conducted by the Tufts Center for the Study of Drug Development (Tufts CSDD) finds that between 2004 and 2012, the number of endpoints per protocol has nearly doubled from an average of eight per protocol in the earlier period to 14 endpoints in the later period. Half of all procedures support supplemental secondary, tertiary, and exploratory endpoints—a proportion that has remained constant during this eight-year period. Sponsor companies have added more procedures for a variety of reasons: clinical scientists seek more contextual data to interpret and validate findings and guide development decisions; statisticians wish to collect more data to explain observations and potential new interactions; and sponsor companies also note that procedures supporting tertiary and exploratory endpoints are added in anticipation of perceived or real regulatory agency and payor inquiry, commercialization, and competitive pressures. 

—Tufts Center for the Study of Drug Development, 

Between 2004 and 2012, the Number of Endpoints per Protocol has Nearly Doubled

A 2012 study conducted by the Tufts Center for the Study of Drug Development shows that academic centers and hospitals take significantly longer to initiate industry-funded clinical trials. Overall, it takes an AMC or hospital more than one year (12.9 months) on average from the pre-study visit to first patient in (FPI) the clinical trial. This compares with 7.9 months for community-based physician practices to complete the same cycle—nearly a 40% time reduction. The Tufts CSDD study evaluated start-up cycle times for 5,296 investigative sites participating in 105 Phase II and III clinical trials. The largest bottleneck is the time from when the contract is received by the center to the time that the contract is executed. AMCs and hospitals take nearly 73% longer than their for-profit counterparts—4.1 months on average versus 1.1 months. Cycle times from contract execution to site initiation, and from site initiation to FPI for non- and for-profit investigative sites are much closer, suggesting that AMCs and hospitals perform more competitively once they get through their less efficient administrative tasks. 

Tufts, CSDD

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Competitive Pressure for First-in-Class Drugs is Intensifying

Oncology Leads Personalized Medicine

Between 2004 and 2012, the Number of Endpoints per Protocol has Nearly Doubled

Survey Results of Start-Up Cycle Times