Optimizing clinical drug product performance: applying Biopharmaceutics Risk Assessment Roadmap (BioRAM) and the BioRAM Scoring Grid

Paul A. Dickinson; Filippos Kesisoglou; Talia Flanagan; Marilyn N. Martinez; Hitesh B. Mistry; John R. Crison; James E. Polli; Maria T. Cruañes; Abu T. M. Serajuddin; Anette Müllertz; Jack A. Cook; Arzu Selen

doi:10.1016/j.xphs.2016.07.024

Optimizing clinical drug product performance: applying Biopharmaceutics Risk Assessment Roadmap (BioRAM) and the BioRAM Scoring Grid

Paul A. Dickinson, Filippos Kesisoglou, Talia Flanagan, Marilyn N. Martinez, Hitesh B. Mistry, John R. Crison, James E. Polli, Maria T. Cruañes, Abu T. M. Serajuddin, Anette Müllertz, Jack A. Cook, Arzu Selen

11 Citations (Scopus)

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.

Original language	English
Journal	Journal of Pharmaceutical Sciences
Volume	105
Issue number	11
Pages (from-to)	3243-3255
Number of pages	13
ISSN	0022-3549
DOIs	https://doi.org/10.1016/j.xphs.2016.07.024
Publication status	Published - 1 Nov 2016

Access to Document

10.1016/j.xphs.2016.07.024

Cite this

Dickinson, P. A., Kesisoglou, F., Flanagan, T., Martinez, M. N., Mistry, H. B., Crison, J. R., Polli, J. E., Cruañes, M. T., Serajuddin, A. T. M., Müllertz, A., Cook, J. A., & Selen, A. (2016). Optimizing clinical drug product performance: applying Biopharmaceutics Risk Assessment Roadmap (BioRAM) and the BioRAM Scoring Grid. Journal of Pharmaceutical Sciences, 105(11), 3243-3255. https://doi.org/10.1016/j.xphs.2016.07.024

Optimizing clinical drug product performance: applying Biopharmaceutics Risk Assessment Roadmap (BioRAM) and the BioRAM Scoring Grid. / Dickinson, Paul A.; Kesisoglou, Filippos; Flanagan, Talia et al.
In: Journal of Pharmaceutical Sciences, Vol. 105, No. 11, 01.11.2016, p. 3243-3255.

Research output: Contribution to journal › Journal article › Research › peer-review

Dickinson, PA, Kesisoglou, F, Flanagan, T, Martinez, MN, Mistry, HB, Crison, JR, Polli, JE, Cruañes, MT, Serajuddin, ATM, Müllertz, A, Cook, JA & Selen, A 2016, 'Optimizing clinical drug product performance: applying Biopharmaceutics Risk Assessment Roadmap (BioRAM) and the BioRAM Scoring Grid', Journal of Pharmaceutical Sciences, vol. 105, no. 11, pp. 3243-3255. https://doi.org/10.1016/j.xphs.2016.07.024

@article{0c0039d08b0344f483693b0ff7ccf0f3,

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.",

author = "Dickinson, {Paul A.} and Filippos Kesisoglou and Talia Flanagan and Martinez, {Marilyn N.} and Mistry, {Hitesh B.} and Crison, {John R.} and Polli, {James E.} and Crua{\~n}es, {Maria T.} and Serajuddin, {Abu T. M.} and Anette M{\"u}llertz and Cook, {Jack A.} and Arzu Selen",

note = "Published by Elsevier Inc.",

year = "2016",

month = nov,

day = "1",

doi = "10.1016/j.xphs.2016.07.024",

language = "English",

volume = "105",

pages = "3243--3255",

journal = "Journal of Pharmaceutical Sciences",

issn = "0022-3549",

publisher = "Elsevier",

number = "11",

}

TY - JOUR

T1 - Optimizing clinical drug product performance

T2 - applying Biopharmaceutics Risk Assessment Roadmap (BioRAM) and the BioRAM Scoring Grid

AU - Dickinson, Paul A.

AU - Kesisoglou, Filippos

AU - Flanagan, Talia

AU - Martinez, Marilyn N.

AU - Mistry, Hitesh B.

AU - Crison, John R.

AU - Polli, James E.

AU - Cruañes, Maria T.

AU - Serajuddin, Abu T. M.

AU - Müllertz, Anette

AU - Cook, Jack A.

AU - Selen, Arzu

N1 - Published by Elsevier Inc.

PY - 2016/11/1

Y1 - 2016/11/1

N2 - 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.

AB - 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.

U2 - 10.1016/j.xphs.2016.07.024

DO - 10.1016/j.xphs.2016.07.024

M3 - Journal article

C2 - 27659159

SN - 0022-3549

VL - 105

SP - 3243

EP - 3255

JO - Journal of Pharmaceutical Sciences

JF - Journal of Pharmaceutical Sciences

IS - 11

ER -

Optimizing clinical drug product performance: applying Biopharmaceutics Risk Assessment Roadmap (BioRAM) and the BioRAM Scoring Grid

Abstract

Access to Document

Fingerprint

Cite this