From adaptive licensing to adaptive pathways: delivering a flexible life-span approach to bring new drugs to patients

H-G Eichler; L G Baird; R Barker; B Bloechl-Daum; F Børlum-Kristensen; J Brown; R Chua; S Del Signore; U Dugan; J Ferguson; S Garner; W Goettsch; J Haigh; P Honig; A Hoos; P Huckle; T Kondo; Y Le Cam; H Leufkens; R Lim; C Longson; M Lumpkin; J Maraganore; B O'Rourke; K Oye; E Pezalla; F Pignatti; J Raine; G Rasi; T Salmonson; D Samaha; S Schneeweiss; P D Siviero; M Skinner; J R Teagarden; T Tominaga; M R Trusheim; S Tunis; T F Unger; S Vamvakas; G Hirsch

doi:10.1002/cpt.59

From adaptive licensing to adaptive pathways: delivering a flexible life-span approach to bring new drugs to patients

H-G Eichler, L G Baird, R Barker, B Bloechl-Daum, F Børlum-Kristensen, J Brown, R Chua, S Del Signore, U Dugan, J Ferguson, S Garner, W Goettsch, J Haigh, P Honig, A Hoos, P Huckle, T Kondo, Y Le Cam, H Leufkens, R LimC Longson, M Lumpkin, J Maraganore, B O'Rourke, K Oye, E Pezalla, F Pignatti, J Raine, G Rasi, T Salmonson, D Samaha, S Schneeweiss, P D Siviero, M Skinner, J R Teagarden, T Tominaga, M R Trusheim, S Tunis, T F Unger, S Vamvakas, G Hirsch

Pharmacoepidemiology and Clinical Pharmacology

European Medicines Agency (EMA), London, UK.

Research output: Contribution to journal › Article › Academic › peer-review

Abstract

The concept of adaptive licensing (AL) has met with considerable interest. Yet some remain skeptical about its feasibility. Others argue that the focus and name of AL should be broadened. Against this background of ongoing debate, we examine the environmental changes that will likely make adaptive pathways the preferred approach in the future. The key drivers include: growing patient demand for timely access to promising therapies, emerging science leading to fragmentation of treatment populations, rising payer influence on product accessibility, and pressure on pharma/investors to ensure sustainability of drug development. We also discuss a number of environmental changes that will enable an adaptive paradigm. A life-span approach to bringing innovation to patients is expected to help address the perceived access vs. evidence trade-off, help de-risk drug development, and lead to better outcomes for patients.

Original language	English
Pages (from-to)	234-46
Number of pages	13
Journal	Clinical Pharmacology and Therapeutics
Volume	97
Issue number	3
DOIs	https://doi.org/10.1002/cpt.59
Publication status	Published - 2015

Keywords

Drug Approval/legislation & jurisprudence
Drug Discovery/legislation & jurisprudence
Humans
Licensure

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Clin Pharma and Therapeutics - 2014 - Eichler - From adaptive licensing to adaptive pathways Delivering a flexibleFinal published version, 1.57 MBLicence: CC BY

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Eichler, H.-G., Baird, L. G., Barker, R., Bloechl-Daum, B., Børlum-Kristensen, F., Brown, J., Chua, R., Del Signore, S., Dugan, U., Ferguson, J., Garner, S., Goettsch, W., Haigh, J., Honig, P., Hoos, A., Huckle, P., Kondo, T., Le Cam, Y., Leufkens, H., ... Hirsch, G. (2015). From adaptive licensing to adaptive pathways: delivering a flexible life-span approach to bring new drugs to patients. Clinical Pharmacology and Therapeutics, 97(3), 234-46. https://doi.org/10.1002/cpt.59

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abstract = "The concept of adaptive licensing (AL) has met with considerable interest. Yet some remain skeptical about its feasibility. Others argue that the focus and name of AL should be broadened. Against this background of ongoing debate, we examine the environmental changes that will likely make adaptive pathways the preferred approach in the future. The key drivers include: growing patient demand for timely access to promising therapies, emerging science leading to fragmentation of treatment populations, rising payer influence on product accessibility, and pressure on pharma/investors to ensure sustainability of drug development. We also discuss a number of environmental changes that will enable an adaptive paradigm. A life-span approach to bringing innovation to patients is expected to help address the perceived access vs. evidence trade-off, help de-risk drug development, and lead to better outcomes for patients. ",

keywords = "Drug Approval/legislation & jurisprudence, Drug Discovery/legislation & jurisprudence, Humans, Licensure",

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doi = "10.1002/cpt.59",

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Eichler, H-G, Baird, LG, Barker, R, Bloechl-Daum, B, Børlum-Kristensen, F, Brown, J, Chua, R, Del Signore, S, Dugan, U, Ferguson, J, Garner, S, Goettsch, W, Haigh, J, Honig, P, Hoos, A, Huckle, P, Kondo, T, Le Cam, Y, Leufkens, H, Lim, R, Longson, C, Lumpkin, M, Maraganore, J, O'Rourke, B, Oye, K, Pezalla, E, Pignatti, F, Raine, J, Rasi, G, Salmonson, T, Samaha, D, Schneeweiss, S, Siviero, PD, Skinner, M, Teagarden, JR, Tominaga, T, Trusheim, MR, Tunis, S, Unger, TF, Vamvakas, S & Hirsch, G 2015, 'From adaptive licensing to adaptive pathways: delivering a flexible life-span approach to bring new drugs to patients', Clinical Pharmacology and Therapeutics, vol. 97, no. 3, pp. 234-46. https://doi.org/10.1002/cpt.59

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T2 - delivering a flexible life-span approach to bring new drugs to patients

AU - Eichler, H-G

AU - Baird, L G

AU - Barker, R

AU - Bloechl-Daum, B

AU - Børlum-Kristensen, F

AU - Brown, J

AU - Chua, R

AU - Del Signore, S

AU - Dugan, U

AU - Ferguson, J

AU - Garner, S

AU - Goettsch, W

AU - Haigh, J

AU - Honig, P

AU - Hoos, A

AU - Huckle, P

AU - Kondo, T

AU - Le Cam, Y

AU - Leufkens, H

AU - Lim, R

AU - Longson, C

AU - Lumpkin, M

AU - Maraganore, J

AU - O'Rourke, B

AU - Oye, K

AU - Pezalla, E

AU - Pignatti, F

AU - Raine, J

AU - Rasi, G

AU - Salmonson, T

AU - Samaha, D

AU - Schneeweiss, S

AU - Siviero, P D

AU - Skinner, M

AU - Teagarden, J R

AU - Tominaga, T

AU - Trusheim, M R

AU - Tunis, S

AU - Unger, T F

AU - Vamvakas, S

AU - Hirsch, G

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N2 - The concept of adaptive licensing (AL) has met with considerable interest. Yet some remain skeptical about its feasibility. Others argue that the focus and name of AL should be broadened. Against this background of ongoing debate, we examine the environmental changes that will likely make adaptive pathways the preferred approach in the future. The key drivers include: growing patient demand for timely access to promising therapies, emerging science leading to fragmentation of treatment populations, rising payer influence on product accessibility, and pressure on pharma/investors to ensure sustainability of drug development. We also discuss a number of environmental changes that will enable an adaptive paradigm. A life-span approach to bringing innovation to patients is expected to help address the perceived access vs. evidence trade-off, help de-risk drug development, and lead to better outcomes for patients.

AB - The concept of adaptive licensing (AL) has met with considerable interest. Yet some remain skeptical about its feasibility. Others argue that the focus and name of AL should be broadened. Against this background of ongoing debate, we examine the environmental changes that will likely make adaptive pathways the preferred approach in the future. The key drivers include: growing patient demand for timely access to promising therapies, emerging science leading to fragmentation of treatment populations, rising payer influence on product accessibility, and pressure on pharma/investors to ensure sustainability of drug development. We also discuss a number of environmental changes that will enable an adaptive paradigm. A life-span approach to bringing innovation to patients is expected to help address the perceived access vs. evidence trade-off, help de-risk drug development, and lead to better outcomes for patients.

KW - Drug Approval/legislation & jurisprudence

KW - Drug Discovery/legislation & jurisprudence

KW - Humans

KW - Licensure

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DO - 10.1002/cpt.59

M3 - Article

C2 - 25669457

SN - 0009-9236

VL - 97

SP - 234

EP - 246

JO - Clinical Pharmacology and Therapeutics

JF - Clinical Pharmacology and Therapeutics

IS - 3

ER -

From adaptive licensing to adaptive pathways: delivering a flexible life-span approach to bring new drugs to patients

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