Timothy Schofield

Biography

 Timothy Schofield has recently joined Arlenda, a statistical consulting and software company providing support to the pharmaceutical, devices, and pharmaceutical testing industries. Prior to joining Arlenda Tim was Director in the U.S. Regulatory Affairs department of GlaxoSmithKline where he provided regulatory support to vaccines, as well as head of the Nonclinical Statistics department in Merck Research Labs, supporting development and manufacture of Merck pharmaceuticals, biologics, and vaccines. In addition to his service to GSK and Merck, Tim has held several positions on industry and regulatory committees. He was elected to the PhRMA Biostatistics and Data Management Technical Group in 2002 where he represented nonclinical statistics for 3-years, and is an active member of the AAPS CMC Statistics Expert Team since 2004.Tim also served as liaison to the PhRMA Biologicals and Biotechnology Subcommittee, where he was co-chair of the Specifications and Formulation Working Group. In that role he led efforts to publish a PhRMA white paper on A Rational Approach for Setting and Maintaining Specifications for Biological and Biotechnology–Derived Products. He is also a coauthor on a PhRMA white paper on Quality by Design for Biotech Products. Tim is co-chair of the USP Statistics Expert Committee and a member of the USP Bioassay Validation ad hoc Panel where he led efforts to write Chapter <1033> Bioassay Validation. He co-edited a special edition of Biologicals on Stability Evaluation of Vaccines, a compilation of papers stemming from WHO implementation meetings in Korea and Geneva. 

Research Interest

 phRNA of biological submission.biological therapy &biomedice pregmentation of biological therapy.