In the first part of a two-part interview, Paz Vellanki of Precision for Medicine explains what sponsors should bring to early FDA meetings and how manufacturing and assay readiness can delay rare disease trials.
|Articles|June 29, 2017
Pfizer Breaks Ground on New R&D Facility
Author(s)BioPharm International Editors
The company has broken ground on a R&D and process development facility in Missouri.
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On June 27, 2017, Pfizer
The facility will provide approximately 295,000 ft2 of R&D space to house Pfizer’s BioTherapeutics Pharmaceutical Sciences group and enabling partners. This team is responsible for advancing Pfizer’s biologics, vaccines, and gene therapy portfolio by developing manufacturing processes and dosage forms applying analytical technologies, conducting non-GMP manufacturing, and scale-up studies. According to Pfizer, this work enables the development of potential new medicines to treat ailments in oncology, rare disease, internal medicine, inflammation and immunology, and vaccines, including biosimilars.
The campus will include a floorplan that provides flexible laboratory layouts, scientific casework and utility hookups, open office and collaboration spaces, and increased conferencing technologies where researchers can collaborate. As part of the strategic incentives package from St. Louis County and the State of Missouri, Pfizer is donating $20,000 to the local Parkway School District to support STEM education.
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FDA clears the IND for Biolojic Design’s BD200, an AI-designed Trop2/Nectin-4 multibody ADC; Blackstone Life Sciences agrees to provide Pfizer up to $1.5 billion to develop its monthly GLP-1 receptor agonist berobenatide; and enGene Therapeutics plans a year-end BLA for detalimogene voraplasmid in BCG-unresponsive non-muscle invasive bladder cancer.
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