1027 Safety, Tolerability, and Efficacy of Anti-Tl1a Antibody Pf-06480605 in Treatment of Ulcerative Colitis: The Open-Label, Multicenter, Phase 2a Tuscany Study

Danese, Silvio; Kłopocka, Maria; Scherl, Ellen; Romatowski, J; Allegretti, Jessica R.; Peeva, Elena; Vincent, Michael S.; Schoenbeck, Uwe; Xi, Li; Ye, Zhan; Hassan‐Zahraee, Mina; Rath, Natalie; Li, Gang; Neelakantan, Srividya; Banfield, Christopher; Lepsy, Christopher; Chandra, Deepa; Hung, Kenneth E.

doi:10.1016/s0016-5085(20)31203-8

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2022

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“…4 a), demonstrated significant efficacy in participants with moderate to severe UC. 15 Fig. 4 a shows the estimate of the endoscopic improvements at week 14 for a single-arm Phase IIa study.…”

Section: Dissecting Our Successes and Failuresmentioning

confidence: 99%

Achieving end-to-end success in the clinic: Pfizer’s learnings on R&D productivity

Fernando

Menon

Jansen

et al. 2022

Drug Discovery Today

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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.

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Section: Dissecting Our Successes and Failuresmentioning

confidence: 99%