Katherine A. Pikal-Cleland
Ph.D.
CMC Technical Writing
Katherine serves our clients in the area of technical writing for Chemistry, Manufacturing, and Controls (CMC) sections of regulatory submissions and other related technical documents, such as comparability protocols for drug product manufacturing and formulation change, as well as qualification reports and QC stability and formulation development reports.
Katherine has over 10 years of experience in formulation and delivery of small molecules, peptides, and proteins moving products such as Exubera (inhaled insulin), anthrax (rPA102) vaccine, and Hematide (peptide-based ESA) from research into and through development. In addition, Katherine has developed formulations of new drugs with complex devices for pulmonary and transdermal delivery. Throughout this period she wrote sections and technical reports for several IND amendments as well as technical reports to support the Exubera NDA, the anthrax vaccine clinical program, and the Hematide clinical program. As a consultant, Katherine has been a writer and reviewer for 4 pre-INDs, 5 INDs (including eCTD format), 2 IND amendments, 3 IND annual reports, and an IMPD, as well as method characterization/qualification reports for small molecules and biologics. The CMC submissions included data review and interpretation of results for CMC strategy.
Katherine holds a Ph.D. in Pharmaceutical Sciences from the University of Colorado Health Sciences Center, a M.S. in Pharmaceutics from the University of Michigan, and a B.S. in Chemical Engineering from Purdue University.
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