Literature DB >> 24754565

Translating cell-based regenerative medicines from research to successful products: challenges and solutions.

Yves Bayon1, Alain A Vertès, Vincent Ronfard, Matthieu Egloff, Sarah Snykers, Gabriella Franco Salinas, Robert Thomas, Alan Girling, Richard Lilford, Gaelle Clermont, Paul Kemp.   

Abstract

The Tissue Engineering & Regenerative Medicine International Society-Europe (TERMIS-EU) Industry Committee as well as its TERMIS-Americas (AM) counterpart intend to address the specific challenges and needs facing the industry in translating academic research into commercial products. Over the last 3 years, the TERMIS-EU Industry Committee has worked with commercial bodies to deliver programs that encourage academics to liaise with industry in proactive collaborations. The TERMIS-EU 2013 Industry Symposium aimed to build on this commercial agenda by focusing on two topics: Operations Management (How to move a process into the good manufacturing practice [GMP] environment) and Clinical Translation (Moving a GMP process into robust trials). These topics were introduced by providing the synergistic business perspective of partnering between the multiple regenerative medicine stakeholders, throughout the life cycle of product development. Seven industry leaders were invited to share their experience, expertise, and strategies. Due to the complex nature of regenerative medicine products, partnering for their successful commercial development seems inevitable to overcome all obstacles by sharing experiences and expertise of all stakeholders. When ideally implemented, the "innovation quotient" of a virtual team resulting from the combination of internal and external project teams can be maximized through maximizing the three main dimensions: core competences, technology portfolio, and alliance management.

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Year:  2014        PMID: 24754565     DOI: 10.1089/ten.TEB.2013.0727

Source DB:  PubMed          Journal:  Tissue Eng Part B Rev        ISSN: 1937-3368            Impact factor:   6.389


  5 in total

Review 1.  Translational Challenges in Cardiovascular Tissue Engineering.

Authors:  Maximilian Y Emmert; Emanuela S Fioretta; Simon P Hoerstrup
Journal:  J Cardiovasc Transl Res       Date:  2017-03-09       Impact factor: 4.132

Review 2.  Tissue engineered constructs: perspectives on clinical translation.

Authors:  Lichun Lu; Harvey M Arbit; James L Herrick; Suzanne Glass Segovis; Avudaiappan Maran; Michael J Yaszemski
Journal:  Ann Biomed Eng       Date:  2015-02-25       Impact factor: 3.934

Review 3.  Global position paper on cardiovascular regenerative medicine.

Authors:  Francisco Fernández-Avilés; Ricardo Sanz-Ruiz; Andreu M Climent; Lina Badimon; Roberto Bolli; Dominique Charron; Valentin Fuster; Stefan Janssens; Jens Kastrup; Hyo-Soo Kim; Thomas F Lüscher; John F Martin; Philippe Menasché; Robert D Simari; Gregg W Stone; Andre Terzic; James T Willerson; Joseph C Wu
Journal:  Eur Heart J       Date:  2017-09-01       Impact factor: 29.983

Review 4.  Orthopaedic regenerative tissue engineering en route to the holy grail: disequilibrium between the demand and the supply in the operating room.

Authors:  Ibrahim Fatih Cengiz; Hélder Pereira; Laura de Girolamo; Magali Cucchiarini; João Espregueira-Mendes; Rui L Reis; Joaquim Miguel Oliveira
Journal:  J Exp Orthop       Date:  2018-05-22

5.  An Industry-Driven Roadmap for Manufacturing in Regenerative Medicine.

Authors:  Joshua G Hunsberger; Thomas Shupe; Anthony Atala
Journal:  Stem Cells Transl Med       Date:  2018-07-15       Impact factor: 6.940

  5 in total

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