Achieving End-to-end Success in the Clinic: Pfizer's Learnings on R&D Productivity
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Over the past decade, Pfizer has focused efforts to improve its research and development (R&D) productivity. By the end of 2020, Pfizer had achieved an industry-leading clinical success rate of 21%, a tenfold increase from 2% in 2010 and well above the industry benchmark of ∼11%. The company had also maintained the quality of innovation, because 75% of its approvals between 2016 and 2020 had at least one expedited regulatory designation (e.g., Breakthrough Therapy). Pfizer's Signs of Clinical Activity (SOCA) paradigm enabled better decision-making and, along with other drivers (biology and modality), contributed to this productivity improvement. These laid a strong foundation for the rapid and effective development of the Coronavirus 2019 (COVID-19) vaccine with BioNTech, as well as the antiviral candidate Paxlovid™, under the company's 'lightspeed' paradigm.
Raman K, Kumar R, Musante C, Madhavan S Clin Transl Sci. 2025; 18(1):e70124.
PMID: 39797502 PMC: 11724156. DOI: 10.1111/cts.70124.
DeDiego M, Portilla Y, Daviu N, Lopez-Garcia D, Villamayor L, Vazquez-Utrilla P Int J Nanomedicine. 2024; 19:13763-13788.
PMID: 39723174 PMC: 11669338. DOI: 10.2147/IJN.S475323.
Venhorst J, Hanemaaijer R, Dulos R, Caspers M, Toet K, Attema J Front Pharmacol. 2024; 15:1442752.
PMID: 39399467 PMC: 11466758. DOI: 10.3389/fphar.2024.1442752.
Genetic factors associated with reasons for clinical trial stoppage.
Razuvayevskaya O, Lopez I, Dunham I, Ochoa D Nat Genet. 2024; 56(9):1862-1867.
PMID: 39075208 PMC: 11387188. DOI: 10.1038/s41588-024-01854-z.
Pearce S, Cross N, Smith D, Clench M, Flint L, Hamm G Metabolites. 2024; 14(6).
PMID: 38921450 PMC: 11205347. DOI: 10.3390/metabo14060315.