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  • Brindley DA, Arshad Z, Luo D, Dopson S, Hollander G, Frost S, Bountra C, Smith JA. 21(st) Century Cures Act: An Act of Cure or Diagnosis? Rejuvenation Res. 2015 Aug;18(4):295-8. PubMed: 26291241. Categories: Beyond the Bench

    21(st) Century Cures Act: An Act of Cure or Diagnosis?

    Rejuvenation Res. 2015 Aug;18(4):295-8.

    21(st) Century Cures Act: An Act of Cure or Diagnosis?

    Brindley DA, Arshad Z, Luo D, Dopson S, Hollander G, Frost S, Bountra C, Smith JA.

    Abstract

    Abstract:

    No abstract available.

  • Hughes BB, Kuhn R, Margolese-Malina ES, Rothman DS, Solórzano JR. Opportunities and challenges of a world with negligible senescence. Technol. Forecast. Soc. Change 99:77-91 (2015). Read on external site. Categories: Beyond the Bench

    Opportunities and challenges of a world with negligible senescence.

    Technol. Forecast. Soc. Change 99:77-91 (2015).

    Opportunities and challenges of a world with negligible senescence.

    Hughes BB, Kuhn R, Margolese-Malina ES, Rothman DS, Solórzano JR.

    Abstract

    Abstract:

    The development of anti-aging technologies could have dramatic implications for a world already challenged by population aging. We explore how the world might evolve given the development and deployment of technologies capable of nearly eliminating mortality and morbidity from most causes. We consider both the great benefits and some of the complex sociopolitical rebalancing resulting from such advances. We use the International Futures (IFs) long-term, multi-issue, global forecasting system in our analysis of the interactions among demographic changes, the related changes in health costs and government finances, shifts in labor force participation, resultant economic transformations, and the environmental sustainability of the dramatically-altered human demands that emerge. We find that the widespread deployment of anti-senescence technologies would cause populations to surge—making fertility rates an issue of tremendous social import—while a much larger, healthier, labor force would spur economic growth. But this is not a given; the cost of treating entire adult populations could prove unbearable to non-high-income economies without significant transfers within and across societies. In the absence of new transformative production technologies, life-pattern financing would require the virtual elimination of retirement and a major restructuring of government finances. Pressures on the environment would also greatly intensify.

    Click here to read this paper for free on ScienceDirect.

  • Meadows NA, Morrison A, Brindley DA, Schuh A, Barker RW. An evaluation of regulatory and commercial barriers to stratified medicine development and adoption. Pharmacogenomics J. 2015 Feb;15(1):6-12. doi: 10.1038/tpj.2014.51. Epub 2014 Oct 7. PubMed: 25287070. Categories: Beyond the Bench

    An evaluation of regulatory and commercial barriers to stratified medicine development and adoption.

    Pharmacogenomics J. 2015 Feb;15(1):6-12. doi: 10.1038/tpj.2014.51. Epub 2014 Oct 7.

    An evaluation of regulatory and commercial barriers to stratified medicine development and adoption.

    Meadows NA, Morrison A, Brindley DA, Schuh A, Barker RW.

    Abstract

    Abstract:

    Today, a range of products based on genomics, proteomics and metabolomics have facilitated the development of 'stratified' medicines and companion diagnostics. This investigation profiles a series of targeted medicines and corresponding diagnostics, and their role(s) in supporting evidence-based medicine. Despite their potential benefits we found that scientific, financial and regulatory barriers impede the development and adoption of companion diagnostics. Therefore, in order to realise improvements to the risk/benefit profiles of health-care interventions-notably reducing clinical uncertainty-conferred by the use of companion diagnostics, industry representatives, health-care providers and regulators will need a coordinated response to overcome these barriers.

  • Davies BM, Rikabi SR, French A, Pinedo-Villanueva R, Morrey ME, Wartolowska K, Brindley DA. Quantitative assessment of barriers to the clinical development and adoption of cellular therapies: A pilot study. J Tissue Eng. 2014 Sep 19;5:2041731414551764. doi: 10.1177/2041731414551764. eCollection 2014. PubMed: 25383173. Categories: Beyond the Bench

    Quantitative assessment of barriers to the clinical development and adoption of cellular therapies: A pilot study.

    J Tissue Eng. 2014 Sep 19;5:2041731414551764. doi: 10.1177/2041731414551764. eCollection 2014.

    Quantitative assessment of barriers to the clinical development and adoption of cellular therapies: A pilot study.

    Davies BM, Rikabi SR, French A, Pinedo-Villanueva R, Morrey ME, Wartolowska K, Brindley DA.

    Abstract

    Abstract:

    There has been a large increase in basic science activity in cell therapy and a growing portfolio of cell therapy trials. However, the number of industry products available for widespread clinical use does not match this magnitude of activity. We hypothesize that the paucity of engagement with the clinical community is a key contributor to the lack of commercially successful cell therapy products. To investigate this, we launched a pilot study to survey clinicians from five specialities and to determine what they believe to be the most significant barriers to cellular therapy clinical development and adoption. Our study shows that the main concerns among this group are cost-effectiveness, efficacy, reimbursement, and regulation. Addressing these concerns can best be achieved by ensuring that future clinical trials are conducted to adequately answer the questions of both regulators and the broader clinical community.

  • French A, Suh JY, Suh CY, Rubin L, Barker R, Bure K, Reeve B, Brindley DA. Global strategic partnerships in regenerative medicine. Trends Biotechnol. 2014 Sep;32(9):436-40. doi: 10.1016/j.tibtech.2014.05.007. PubMed: 25150363. Categories: Beyond the Bench

    Global strategic partnerships in regenerative medicine.

    Trends Biotechnol. 2014 Sep;32(9):436-40. doi: 10.1016/j.tibtech.2014.05.007.

    Global strategic partnerships in regenerative medicine.

    French A, Suh JY, Suh CY, Rubin L, Barker R, Bure K, Reeve B, Brindley DA.

    Abstract

    Abstract:

    The approach to research and development in biomedical science is changing. Increasingly, academia and industry seek to collaborate, and share resources and expertise, by establishing partnerships. Here, we explore the co-development partnership landscape in the field of regenerative medicine, focusing on agreements involving one or more private entities. A majority of the largest biopharmaceutical companies have announced strategic partnerships with a specific regenerative medicine focus, signifying the growth and widening appeal of this emerging sector.

  • Roberts M, Wall IB, Bingham I, Icely D, Reeve B, Bure K, French A, Brindley DA. The global intellectual property landscape of induced pluripotent stem cell technologies. Nat Biotechnol. 2014 Aug;32(8):742-8. doi: 10.1038/nbt.2975. PubMed: 25093884. Categories: Beyond the Bench

    The global intellectual property landscape of induced pluripotent stem cell technologies.

    Nat Biotechnol. 2014 Aug;32(8):742-8. doi: 10.1038/nbt.2975.

    The global intellectual property landscape of induced pluripotent stem cell technologies.

    Roberts M, Wall IB, Bingham I, Icely D, Reeve B, Bure K, French A, Brindley DA.

    Abstract

    Abstract:

    Will freedom to research and innovate be restricted as the induced pluripotent stem cell field advances toward the clinic, or are concerns premature within a rapidly changing ecosystem?

  • Brindley DA, French AL, Baptista R, Timmins N, Adams T, Wall I, Bure K. Cell Therapy Bioprocessing Technologies and Indicators of Technological Convergence. BioProcess International 12(3)s (March 2014). Read on external site. Categories: Beyond the Bench, Delivery Mechanisms

    Cell Therapy Bioprocessing Technologies and Indicators of Technological Convergence.

    BioProcess International 12(3)s (March 2014).

    Cell Therapy Bioprocessing Technologies and Indicators of Technological Convergence.

    Brindley DA, French AL, Baptista R, Timmins N, Adams T, Wall I, Bure K.

    Abstract

    Abstract:

    The cell therapy industry is undergoing a natural evolution from scientific curiosity into a commercially and clinically attractive opportunity (1). This evolution is by no means complete, and growing evidence suggests that its progression is driving significant developments in cell therapy bioprocessing — notably, convergence.

  • French AL, Bure K, Brindley DA. CASMI TSCC Launch Event, Paris, France, July 2013: An Assessment of the Key Barriers to the Commercialization and Clinical Adoption of Pluripotent Stem Cell Therapies. Rejuvenation Res. February 2014, 17(1): 84-88. doi:10.1089/rej.2014.1545. PubMed: 24392658. Categories: Beyond the Bench

    CASMI TSCC Launch Event, Paris, France, July 2013: An Assessment of the Key Barriers to the Commercialization and Clinical Adoption of Pluripotent Stem Cell Therapies.

    Rejuvenation Res. February 2014, 17(1): 84-88. doi:10.1089/rej.2014.1545.

    CASMI TSCC Launch Event, Paris, France, July 2013: An Assessment of the Key Barriers to the Commercialization and Clinical Adoption of Pluripotent Stem Cell Therapies.

    French AL, Bure K, Brindley DA.

    Abstract

    Abstract:

    The high incidence of unmet medical needs in combination with the rising burden of chronic diseases, linked to an increasingly aging population, necessitates new approaches to therapeutic intervention. One potential class of health care innovation that may offer an alternative approach to addressing current shortfalls is stem cell therapies. The CASMI Translational Stem Cell Consortium (CTSCC) was formed to elucidate the key hurdles to the commercialization and clinical adoption of stem cell technologies, with a particular focus on pluripotent stem cell (PSC) technologies. As a global pre-competitive academic–industry consortium, the CTSCC unites thought leaders from a range of sectors and technical specialties in defining and discovering solutions to roadblocks that will impede the field. Targeted toward stakeholder requirements at the delivery end of the translational spectrum, the CTSCC aims to provide mechanisms for multidirectional dialogue and to produce academically rigorous and commercially practicable research outputs to accelerate industry progress. On the 30th and 31st of July, 2013, the CASMI Translational Stem Cell Consortium (CTSCC) held a launch event at the Saint James Club, Paris, France.

  • Rehki R, Wall I, French A, Bure K, Carr AJ, Brindley DA. Cell Therapy Biomanufacturing Risk Management. In: Cell Therapy Translation (D. Williams and D. Scadden, eds.), StemBook, 2014. Categories: Beyond the Bench

    Cell Therapy Biomanufacturing Risk Management.

    In: Cell Therapy Translation (D. Williams and D. Scadden, eds.), StemBook, 2014.

    Cell Therapy Biomanufacturing Risk Management.

    Rehki R, Wall I, French A, Bure K, Carr AJ, Brindley DA.

    Abstract

    Abstract:

    (No abstract available.)

  • Brindley DA, French A, Suh J, Roberts M, Davies B, Pinedo-Villanueva R, Wartolowska K, Rooke K, Kramm A, Judge A, Morrey M, Chandra A, Hurley H, Grover L, Bingham I, Siegel B, Rattley MS, Buckler RL, McKeon D, Krumholz K, Hook L, May M, Rikabi S, Pigott R, Morys M, Sabokbar A, Titus E, Laabi Y, Lemaitre G, Zahkia R, Sipp D, Horne R, Bravery C, Williams D, Wall I, Snyder EY, Karp JM, Barker RW, Bure K, Carr AJ, Reeve B. The implementation of novel collaborative structures for the identification and resolution of barriers to pluripotent stem cell translation. Stem Cells Dev 2013;22 Suppl 1:63-72. PubMed: 24304079. Categories: Beyond the Bench

    The implementation of novel collaborative structures for the identification and resolution of barriers to pluripotent stem cell translation.

    Stem Cells Dev 2013;22 Suppl 1:63-72.

    The implementation of novel collaborative structures for the identification and resolution of barriers to pluripotent stem cell translation.

    Brindley DA, French A, Suh J, Roberts M, Davies B, Pinedo-Villanueva R, Wartolowska K, Rooke K, Kramm A, Judge A, Morrey M, Chandra A, Hurley H, Grover L, Bingham I, Siegel B, Rattley MS, Buckler RL, McKeon D, Krumholz K, Hook L, May M, Rikabi S, Pigott R, Morys M, Sabokbar A, Titus E, Laabi Y, Lemaitre G, Zahkia R, Sipp D, Horne R, Bravery C, Williams D, Wall I, Snyder EY, Karp JM, Barker RW, Bure K, Carr AJ, Reeve B.

    Abstract

    Abstract:

    Increased global connectivity has catalyzed technological development in almost all industries, in part through the facilitation of novel collaborative structures. Notably, open innovation and crowd-sourcing-of expertise and/or funding-has tremendous potential to increase the efficiency with which biomedical ecosystems interact to deliver safe, efficacious and affordable therapies to patients. Consequently, such practices offer tremendous potential in advancing development of cellular therapies. In this vein, the CASMI Translational Stem Cell Consortium (CTSCC) was formed to unite global thought-leaders, producing academically rigorous and commercially practicable solutions to a range of challenges in pluripotent stem cell translation. Critically, the CTSCC research agenda is defined through continuous consultation with its international funding and research partners. Herein, initial findings for all research focus areas are presented to inform global product development strategies, and to stimulate continued industry interaction around biomanufacturing, strategic partnerships, standards, regulation and intellectual property and clinical adoption.

  • Brindley DA, Barker RW, Lachmann PJ. Health care: Better drug access for terminal patients. Nature. 2013 Oct 3;502(7469):38. doi: 10.1038/502038c. PubMed: 24091972. Categories: Beyond the Bench

    Health care: Better drug access for terminal patients.

    Nature. 2013 Oct 3;502(7469):38. doi: 10.1038/502038c.

    Health care: Better drug access for terminal patients.

    Brindley DA, Barker RW, Lachmann PJ.

    Abstract

    Abstract:

    The late statistician Les Halpin was the founder of the Empower: Access to Medicine campaign to improve the availability of experimental therapies and to accelerate drug approval and licensing for people with life-threatening illnesses.  His campaign has enabled drugs to get to market faster and more cheaply.

  • Brindley DA, Wall IB. Commercial Manufacture of Cell Therapies. In: Standardization in Cell and Tissue Engineering: Methods and Protocols (V. Salih, ed.) Woodhead Publishing, 2012, pp. 212-240. Read on external site. Categories: Beyond the Bench

    Commercial Manufacture of Cell Therapies.

    In: Standardization in Cell and Tissue Engineering: Methods and Protocols (V. Salih, ed.) Woodhead Publishing, 2012, pp. 212-240.

    Commercial Manufacture of Cell Therapies.

    Brindley DA, Wall IB.

    Abstract

    Abstract:

    (No abstract available.)

  • French A, Buckler RL, Brindley DA. Commercialization of regenerative medicine: learning from spin-outs. Rejuvenation Res 2013;16(2):164-70. PubMed: 23470045. Categories: Beyond the Bench

    Commercialization of regenerative medicine: learning from spin-outs.

    Rejuvenation Res 2013;16(2):164-70.

    Commercialization of regenerative medicine: learning from spin-outs.

    French A, Buckler RL, Brindley DA.

    Abstract

    Abstract:

    The meeting "Commercialization of Your Regenerative Medicine Research: Lessons from Spin Out Successes" was hosted by the Oxbridge Biotech Roundtable (OBR) (Oxford, UK) at the University of Oxford in February, 2013, and attracted a multi-stakeholder audience spanning academia and industry. The event featured case studies from Gregg Sando, CEO, Cell Medica (London, UK), John Sinden, CSO, Reneuron (Guilford, UK), and Paul Kemp, CEO and CSO, Intercytex (Manchester, UK). OBR is a student-led initiative with over 7000 members across eight different UK and US locations with a mission to foster a conversation about the healthcare and life sciences industry. Here we review the main themes of the meeting and the major questions facing the regenerative medicine industry and its rapidly emerging subsets of cellular and gene therapies. Notably, we discuss the compatibility of regenerative therapies to the existing healthcare infrastructure, biomanufacturing challenges (including scalability and comparability), and the amenability of regenerative therapies to existing reimbursement and investment models. Furthermore, we reiterate key words of advice from seasoned industry leaders intended to accelerate the translation path from lab bench to the marketplace.

  • Brindley DA, Wall IB, Bure K. Automation of Cell Therapy Biomanufacturing: Minimizing Regulatory Risks and Maximising Return on Investment. Bioprocess International, Supplement; vol. 11, No. S3, March 2013, pp. 18–25.
 Read on external site. Categories: Beyond the Bench

    Automation of Cell Therapy Biomanufacturing: Minimizing Regulatory Risks and Maximising Return on Investment.

    Bioprocess International, Supplement; vol. 11, No. S3, March 2013, pp. 18–25.


    Automation of Cell Therapy Biomanufacturing: Minimizing Regulatory Risks and Maximising Return on Investment.

    Brindley DA, Wall IB, Bure K.

    Abstract

    Abstract:

    (No abstract available.)

  • Rae MJ. SENS Foundation: Accelerating Progress Toward Biomedical Rejuvenation. In: Fahy GM, West M, Coles LS, Harris SB (eds). The Future of Aging: Pathways to Human Life Extension, Chapter: SENS Foundation: Accelerating Progress Toward Biomedical Rejuvenation. 2010; Springer Verlag, New York, pp. 806–826. Read on external site. Categories: Beyond the Bench

    SENS Foundation: Accelerating Progress Toward Biomedical Rejuvenation.

    In: Fahy GM, West M, Coles LS, Harris SB (eds). The Future of Aging: Pathways to Human Life Extension, Chapter: SENS Foundation: Accelerating Progress Toward Biomedical Rejuvenation. 2010; Springer Verlag, New York, pp. 806–826.

    SENS Foundation: Accelerating Progress Toward Biomedical Rejuvenation.

    Rae MJ.

    Abstract

    Abstract:

    An overview of the "damage-repair" heuristic of rejuvenation biotechnology, and the role of SENS Research Foundation in catalyzing the emergence of a comprehensive panel of such therapies.

  • Rae MJ, Butler RN, Campisi J, de Grey ADNJ, Finch CE, Gough M, Martin GM, Vijg J, Perrott KM, Logan BJ. The Demographic and Biomedical Case for Late-Life Interventions in Aging. Sci Transl Med. 2010 Jul 14;2(40):40cm21. PubMed: 20630854. Categories: Beyond the Bench

    The Demographic and Biomedical Case for Late-Life Interventions in Aging.

    Sci Transl Med. 2010 Jul 14;2(40):40cm21.

    The Demographic and Biomedical Case for Late-Life Interventions in Aging.

    Rae MJ, Butler RN, Campisi J, de Grey ADNJ, Finch CE, Gough M, Martin GM, Vijg J, Perrott KM, Logan BJ.

    Abstract

    Abstract:

    The social and medical costs of the biological aging process are high and will rise rapidly in coming decades, creating an enormous challenge to societies worldwide. In recent decades, researchers have expanded their understanding of the underlying deleterious structural and physiological changes (aging damage) that underlie the progressive functional impairments, declining health, and rising mortality of aging humans and other organisms and have been able to intervene in the process in model organisms, even late in life. To preempt a global aging crisis, we advocate an ambitious global initiative to translate these findings into interventions for aging humans, using three complementary approaches to retard, arrest, and even reverse aging damage, extending and even restoring the period of youthful health and functionality of older people.

  • Bussel II, Stupple A, Moody KJ, Lefkowitz DM. Call to action: medical students for regenerative medicine. Rejuvenation Res. 2010 Feb;13(1):1-2. PubMed: 20230272. Categories: Beyond the Bench

    Call to action: medical students for regenerative medicine.

    Rejuvenation Res. 2010 Feb;13(1):1-2.

    Call to action: medical students for regenerative medicine.

    Bussel II, Stupple A, Moody KJ, Lefkowitz DM.

    Abstract

    Abstract:

    No abstract available.

  • Brindley DA, Davie N. Regenerative Medicine Through a Crisis: Social Perception and the Financial Reality. Rejuvenation Research 2009, 12(6): 455-461. PubMed: 20041739. Categories: Beyond the Bench

    Regenerative Medicine Through a Crisis: Social Perception and the Financial Reality.

    Rejuvenation Research 2009, 12(6): 455-461.

    Regenerative Medicine Through a Crisis: Social Perception and the Financial Reality.

    Brindley DA, Davie N.

    Abstract

    Abstract:

    The aim of this perspective piece is to highlight how the “social perception” and “financial reality” of regenerative medicine may act to hinder its evolution into the principal health-care option for the future. We also consider the role of the consumer and the need for increased public awareness. Furthermore, we consider the effects of the changing social attitudes toward the field, as well as taking into account the influence of current and future political thinking. From a financial viewpoint, we analyze the compatibility of the current venture capital model with regenerative medicine start-ups and explore approaches to ensure sufficient funding and support throughout all stages of product development, for example, the modularization of funding.