title: Examining Manufacturing Readiness for Breakthrough Drug Development.
authors.affiliation: Technical Regulatory Policy, Genentech, a Member of the Roche Group, 1399 New York Ave, NW, Suite 450, Washington, DC, Washington, 20005, USA. dye.earl@gene.com.
authors.forename: Earl
authors.initials: E
authors.lastname: Dye
authors.affiliation: Regulatory-CMC, Bristol-Myers Squibb Company, New York, New York, USA.
authors.forename: Annie
authors.initials: A
authors.lastname: Sturgess
authors.affiliation: Biologics Process Development & Commercialization, Merck & Co., Inc., Kenilworth, New Jersey, USA.
authors.forename: Gargi
authors.initials: G
authors.lastname: Maheshwari
authors.affiliation: Biologics CMC Regulatory Affairs, Merck & Co., Inc., Kenilworth, New Jersey, USA.
authors.forename: Kimberly
authors.initials: K
authors.lastname: May
authors.affiliation: Technical Research and Development, Novartis Pharmaceuticals Corporation, Hannover, New Jersey, USA.
authors.forename: Colleen
authors.initials: C
authors.lastname: Ruegger
authors.affiliation: Regulatory Affairs, CMC, Pharmacyclics Inc., Sunnyvale, California, USA.
authors.forename: Usha
authors.initials: U
authors.lastname: Ramesh
authors.affiliation: Quality and Technical Operations, Pharmacyclics Inc., Sunnyvale, California, USA.
authors.forename: Heow
authors.initials: H
authors.lastname: Tan
authors.affiliation: Regulatory Affairs, Amgen, Thousand Oaks, California, USA.
authors.forename: Keith
authors.initials: K
authors.lastname: Cockerill
authors.affiliation: Global Chemistry Manufacturing & Controls, Pfizer Inc., New York, New York, USA.
authors.forename: John
authors.initials: J
authors.lastname: Groskoph
authors.affiliation: Biosimilars and Biologics Policy, Office of Biotechnology Products, CDER, U.S. FDA, 10903 New Hampshire Ave, Silver Spring, 20993, Maryland, USA.
authors.forename: Emanuela
authors.initials: E
authors.lastname: Lacana
authors.affiliation: Office of Pharmaceutical Quality, CDER, U.S. FDA, 10903 New Hampshire Ave, Silver Spring, 20993, Maryland, USA.
authors.forename: Sau
authors.initials: S
authors.lastname: Lee
authors.affiliation: CDER, U.S. FDA, 10903 New Hampshire Ave, Silver Spring, 20993, Maryland, USA.
authors.forename: Sarah Pope
authors.initials: SP
authors.lastname: Miksinski
mesh_terms: D017277:Drug Approval / Q000331:legislation & jurisprudence / Q000379:methods; D055808:Drug Discovery / Q000331:legislation & jurisprudence / Q000379:methods / Q000639:trends*; D004345:Drug Industry / Q000331:legislation & jurisprudence / Q000379:methods / Q000639:trends*; D006801:Humans; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence / Q000639:trends*
keywords: CMC; FDA; breakthrough therapy