title: Optimizing Clinical Drug Product Performance: Applying Biopharmaceutics Risk Assessment Roadmap (BioRAM) and the BioRAM Scoring Grid.
abstract: The aim of Biopharmaceutics Risk Assessment Roadmap (BioRAM) and the BioRAM Scoring Grid is to facilitate optimization of clinical performance of drug products. BioRAM strategy relies on therapy-driven drug delivery and follows an integrated systems approach for formulating and addressing critical questions and decision-making (J Pharm Sci. 2014,103(11): 3777-97). In BioRAM, risk is defined as not achieving the intended in vivo drug product performance, and success is assessed by time to decision-making and action. Emphasis on time to decision-making and time to action highlights the value of well-formulated critical questions and well-designed and conducted integrated studies. This commentary describes and illustrates application of the BioRAM Scoring Grid, a companion to the BioRAM strategy, which guides implementation of such an integrated strategy encompassing 12 critical areas and 6 assessment stages. Application of the BioRAM Scoring Grid is illustrated using published literature. Organizational considerations for implementing BioRAM strategy, including the interactions, function, and skillsets of the BioRAM group members, are also reviewed. As a creative and innovative systems approach, we believe that BioRAM is going to have a broad-reaching impact, influencing drug development and leading to unique collaborations influencing how we learn, and leverage and share knowledge.
authors.affiliation: Seda Pharmaceutical Development Services, The Biohub at Alderley Park, Alderley Edge, Cheshire, UK SK10 4TG.
authors.forename: Paul A
authors.initials: PA
authors.lastname: Dickinson
authors.affiliation: Biopharmaceutics, Pharmaceutical Sciences and Clinical Supply, Merck & Co, Inc., West Point, Pennsylvania 19486.
authors.forename: Filippos
authors.initials: F
authors.lastname: Kesisoglou
authors.affiliation: Pharmaceutical Technology and Development, AstraZeneca R&D, Macclesfield, UK SK10 2NA.
authors.forename: Talia
authors.initials: T
authors.lastname: Flanagan
authors.affiliation: US Food and Drug Administration/Center for Veterinary Medicine/Office of New Animal Drug Evaluation, Rockville, Maryland 20855.
authors.forename: Marilyn N
authors.initials: MN
authors.lastname: Martinez
authors.affiliation: Manchester Pharmacy School, University of Manchester, Manchester, UK M13 9PT.
authors.forename: Hitesh B
authors.initials: HB
authors.lastname: Mistry
authors.affiliation: Pharmaceutical Consulting, LLC, Martindale, New Jersey 08836.
authors.forename: John R
authors.initials: JR
authors.lastname: Crison
authors.affiliation: Industrial Pharmacy and Pharmaceutics, University of Maryland School of Pharmacy, Baltimore, Maryland 21201.
authors.forename: James E
authors.initials: JE
authors.lastname: Polli
authors.affiliation: Merck & Co., Las Piedras Operations, Las Piedras, Puerto Rico 00771.
authors.forename: Maria T
authors.initials: MT
authors.lastname: Cruañes
authors.affiliation: College of Pharmacy and Health Sciences, St. John's University, Queens, New York 11439.
authors.forename: Abu T M
authors.initials: ATM
authors.lastname: Serajuddin
authors.affiliation: Bioneer: FARMA, Department of Pharmacy, University of Copenhagen, Copenhagen, Denmark 1165.
authors.forename: Anette
authors.initials: A
authors.lastname: Müllertz
authors.affiliation: Clinical Pharmacology Department, Global Product Development, Pfizer, Inc., Groton, Connecticut 06340.
authors.forename: Jack A
authors.initials: JA
authors.lastname: Cook
authors.affiliation: US Food and Drug Administration/Center for Drug Evaluation and Research/Office of Pharmaceutical Quality/Office of Testing and Research, Silver Spring, Maryland 20993. Electronic address: arzu.selen@fda.hhs.gov.
authors.forename: Arzu
authors.initials: A
authors.lastname: Selen
mesh_terms: D006801:Humans; D001702:Biopharmaceutics / Q000379:methods / Q000592:standards; D002626:Chemistry, Pharmaceutical / Q000379:methods / Q000592:standards; D003657:Decision Making; D055808:Drug Discovery / Q000379:methods / Q000592:standards; D004364:Pharmaceutical Preparations / Q000737:chemistry / Q000592:standards; D018570:Risk Assessment / Q000379:methods / Q000592:standards; D057170:Translational Research, Biomedical / Q000379:methods / Q000592:standards
chemical_list: D004364:Pharmaceutical Preparations
keywords: Biopharmaceutics Classification System (BCS); Biopharmaceutics Risk Assessment Roadmap (BioRAM); bioavailability; clinical trial simulations; drug delivery; in silico modeling; in vitro and in vivo correlations/relationships (IVIVC/R); in vitro models; pharmokinetic/pharmacodynamic models; quality by design (QbD)