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Achieving End-to-end Success in the Clinic: Pfizer's Learnings on R&D Productivity

Overview
Specialty Pharmacology
Date 2021 Dec 18
PMID 34922020
Citations 16
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Abstract

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.

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References
1.
Simon R . Optimal two-stage designs for phase II clinical trials. Control Clin Trials. 1989; 10(1):1-10. DOI: 10.1016/0197-2456(89)90015-9. View

2.
DiMasi J, Florez M, Stergiopoulos S, Pena Y, Smith Z, Wilkinson M . Development Times and Approval Success Rates for Drugs to Treat Infectious Diseases. Clin Pharmacol Ther. 2019; 107(2):324-332. DOI: 10.1002/cpt.1627. View

3.
Prigodich A, Wang S, Verhoest P, Warne N, Allerton C, Burkhardt J . Innovation in breakthrough drugs and vaccines: Development risk, patient impact, and value. Drug Discov Today. 2021; 26(10):2232-2237. DOI: 10.1016/j.drudis.2021.05.002. View

4.
Bhattacharya I, Manukyan Z, Chan P, Heatherington A, Harnisch L . Application of Quantitative Pharmacology Approaches in Bridging Pharmacokinetics and Pharmacodynamics of Domagrozumab From Adult Healthy Subjects to Pediatric Patients With Duchenne Muscular Disease. J Clin Pharmacol. 2017; 58(3):314-326. DOI: 10.1002/jcph.1015. View

5.
Aroda V . A review of GLP-1 receptor agonists: Evolution and advancement, through the lens of randomised controlled trials. Diabetes Obes Metab. 2018; 20 Suppl 1:22-33. DOI: 10.1111/dom.13162. View