5.2 yrs

Fig. 1.21. R&D Productivity: Development Times (Outlook 2005. Boston: Tufts Center for the Study of Drug Development, 2005,

Source: Kaitin KI. Tufts Center for the Study of Drug Development, 2003 & 2004

review time. PDUFA I (1992), II (1997), and III (2002) are laws providing income to the FDA for more reviewers by requiring application fees from the pharmaceutical industry; about $150,000 would be a typical fee. The FDA is obligated to provide a 1-year turnaround time for the review time and an official response regarding approval status. The figure demonstrates for both biologicals and drugs the FDA success in reducing review times in half. Also, in response to the high mortality in the AIDS crisis and with cancer along with their acute need for novel drugs, a fast-track status was created and can be given to a product for life-threatening diseases. This status creates a 6-month or less review period for a product and has worked well for patients, the FDA, and companies. Clinical development times for fast-track drugs were about 4 years vs. 5-6 years for standard drugs, and review times were 6 months vs. over 1 year, respectively, in a Tufts CSDD report. In return for the fast-track status, companies have been required to perform more postmarketing clinical trials to further study safety especially and establish efficacy further with more data, which also adds to cost (about $90 million). The total number of postapproval trials committed to be done in FDA statistics has increased from about 130 in the 1992-1994 time period to 170 in 1995-1997 to 230 in 1998-2000.

Further FDA regulations were promulgated to allow for more official meetings between the FDA and companies at major milestones (e.g., pre-IND and end of phase 2), to clarify research and regulatory requirements. Therefore, NDAs would contain the best possible trials and information to facilitate the review and approval process. However, although review times with the FDA were reduced significantly and the new review time commitments were generally met, the overall time for clinical development rose for biological products to equal the times for drugs (now about 7 years), mostly because much more clinical work needed to be done especially for biological products (Fig. 1.21). The added clinical work for both drugs and biologicals includes more trials, with larger trials (higher number of patients), over a longer time period, being done with greater workup of patients (more procedures), and with more complex and expensive monitoring. For example, procedures per patient numbered 100 in 1992 and in 2002 were 153. The number of studies for an NDA is substantial (37 in total: 21 in phase I, 6 in phase II, and 10 in phase III/IIIB). The number of patients and study sites per trial is also substantial (phase I, 33 patients/trial at 2.4 sites; phase II, 133 patients at 14.1 sites; and phase III, 1,367 patients at 110 sites). From the 1960s to 2000, the time for clinical work increased to 6 years (50% increase for drugs and over 100% for biologicals); however, for drugs, the 2000s showed a decrease of more than 1 year for clinical work; perhaps, it is some evidence of efficiencies effected by the industry and the better working relationship with the FDA. Clinical costs are $250 to 500 million out of the $800-$900 million for drug development. Growth in this clinical work has greatly increased costs of product development (e.g., estimated clinical cost increases from $106 million in 1991 to $467 in 2000) [10-14, 22, 25, 27, 32, 33].

Speed to market is a key measure of operational and regulatory efficiency of pharmaceutical companies, and the regulatory authorities as well (Fig. 1.22). Every day extra needed for research and regulatory review time is a day lost on the patent life of a product, a day lost for improved patient care opportunity, and a day lost of sales for a company (an average of $1.3 million per day for all products, and up to $11 million per day for blockbusters). The time for exclusivity of product r Best practices:

O Global PPM c Realistic protocols c Collaboration with regulatory authorities ^ Technology for project planning

& communication c Project team operations

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