Literature DB >> 26565607

Bringing regenerative medicines to the clinic: the future for regulation and reimbursement.

Tania Bubela1, Christopher McCabe2, Peter Archibald3, Harold Atkins4, Steven E Bradshaw5, Panos Kefalas6, Michelle Mujoomdar7, Claire Packer8, James Piret9, Mike Raxworthy10, Marta Soares11, Sowmya Viswanathan12.   

Abstract

Significant investments in regenerative medicine necessitate discussion to align evidentiary requirements and decision-making considerations from regulatory, health system payer and developer perspectives. Only with coordinated efforts will the potential of regenerative medicine be realized. We report on discussions from two workshops sponsored by NICE, University of Alberta, Cell Therapy Catapult and Centre for Commercialization of Regenerative Medicine. We discuss methods to support the assessment of value for regenerative medicine products and services and the synergies that exist between market authorization and reimbursement regulations and practices. We discuss the convergence in novel adaptive licensing practices that may promote the development and adoption of novel therapeutics that meet the needs of healthcare payers.

Keywords:  access with evidence development; adaptive licensing; advanced-therapy medicinal products; cost–effectiveness modeling; horizon scanning; patent landscaping; regenerative medicine; regulation; reimbursement; value of information

Mesh：

Year:  2015        PMID： 26565607     DOI： 10.2217/rme.15.51

Source DB:  PubMed          Journal:  Regen Med        ISSN： 1746-0751            Impact factor:   3.806


  13 in total

1.  Bioartificial Kidneys.

Authors:  Peter R Corridon; In Kap Ko; James J Yoo; Anthony Atala
Journal:  Curr Stem Cell Rep       Date:  2017-04-12

Review 2.  Liver tissue engineering: From implantable tissue to whole organ engineering.

Authors:  Giuseppe Mazza; Walid Al-Akkad; Krista Rombouts; Massimo Pinzani
Journal:  Hepatol Commun       Date:  2017-12-21

Review 3.  Adaptive Pathways: Possible Next Steps for Payers in Preparation for Their Potential Implementation.

Authors:  Patricia Vella Bonanno; Michael Ermisch; Brian Godman; Antony P Martin; Jesper Van Den Bergh; Liudmila Bezmelnitsyna; Anna Bucsics; Francis Arickx; Alexander Bybau; Tomasz Bochenek; Marc van de Casteele; Eduardo Diogene; Irene Eriksson; Jurij Fürst; Mohamed Gad; Ieva Greičiūtė-Kuprijanov; Martin van der Graaff; Jolanta Gulbinovic; Jan Jones; Roberta Joppi; Marija Kalaba; Ott Laius; Irene Langner; Ileana Mardare; Vanda Markovic-Pekovic; Einar Magnusson; Oyvind Melien; Dmitry O Meshkov; Guenka I Petrova; Gisbert Selke; Catherine Sermet; Steven Simoens; Ad Schuurman; Ricardo Ramos; Jorge Rodrigues; Corinne Zara; Eva Zebedin-Brandl; Alan Haycox
Journal:  Front Pharmacol       Date:  2017-08-23       Impact factor: 5.810

4.  A quantitative, multi-national and multi-stakeholder assessment of barriers to the adoption of cell therapies.

Authors:  Benjamin M Davies; James Smith; Sarah Rikabi; Karolina Wartolowska; Mark Morrey; Anna French; Robert MacLaren; David Williams; Kim Bure; Rafael Pinedo-Villanueva; Anthony Mathur; Martin Birchall; Evan Snyder; Anthony Atala; Brock Reeve; David Brindley
Journal:  J Tissue Eng       Date:  2017-08-11       Impact factor: 7.813

5.  A novel, flexible and automated manufacturing facility for cell-based health care products: Tissue Factory.

Authors:  Tetsutaro Kikuchi; Masahiro Kino-Oka; Masanori Wada; Toyoshige Kobayashi; Midori Kato; Shizu Takeda; Hirotsugu Kubo; Tetsuya Ogawa; Hironobu Sunayama; Kazuhito Tanimoto; Manabu Mizutani; Tatsuya Shimizu; Teruo Okano
Journal:  Regen Ther       Date:  2018-09-19       Impact factor: 3.419

6.  Preparing for cell culture scale-out: establishing parity of bioreactor- and flask-expanded mesenchymal stromal cell cultures.

Authors:  Ruud Das; Rens Roosloot; Melissa van Pel; Koen Schepers; Marijn Driessen; Willem E Fibbe; Joost Dick de Bruijn; Helene Roelofs
Journal:  J Transl Med       Date:  2019-07-24       Impact factor: 5.531

7.  Hurdles to uptake of mesenchymal stem cells and their progenitors in therapeutic products.

Authors:  Peter G Childs; Stuart Reid; Manuel Salmeron-Sanchez; Matthew J Dalby
Journal:  Biochem J       Date:  2020-09-18       Impact factor: 3.857

8.  Addressing Pressing Needs in the Development of Advanced Therapies.

Authors:  David Morrow; Anton Ussi; Giovanni Migliaccio
Journal:  Front Bioeng Biotechnol       Date:  2017-09-25

9.  Treatment With Tumor-infiltrating Lymphocytes in Advanced Melanoma: Evaluation of Early Clinical Implementation of an Advanced Therapy Medicinal Product.

Authors:  Melanie A Lindenberg; Valesca P Retèl; Joost H van den Berg; Marnix H Geukes Foppen; John B Haanen; Wim H van Harten
Journal:  J Immunother       Date:  2018 Nov/Dec       Impact factor: 4.456

10.  Identifying and understanding factors that affect the translation of therapies from the laboratory to patients: a study protocol.

Authors:  Manoj M Lalu; Joshua Montroy; C Glenn Begley; Tania Bubela; Victoria Hunniford; David Ripsman; Neil Wesch; Jonathan Kimmelman; Malcolm Macleod; David Moher; Alvin Tieu; Lindsey Sikora; Dean A Fergusson
Journal:  F1000Res       Date:  2020-06-01
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