The Regulatory Imperative: International Perspective

Bertram, Tim; Hellman, Kiki B.; Bayon, Yves; Ellison, Simon; Wilburn, Special Recognition: Sarah

doi:10.1089/ten.teb.2012.0654

Cited by 17 publications

(9 citation statements)

References 10 publications

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“…Examples include the European Medicines Agency (EMA) in Europe, the State Food and Drug Administration (SFDA) in China, the Ministry of Health, Labour and Welfare (MHLW) in Japan, and the Therapeutic Goods Administration (TGA) in Australia. Globalization and regulatory harmonization are still significant challenges for these regulatory authorities 11 .…”

Section: Clinical Researchmentioning

confidence: 99%

Tissue Engineered Constructs: Perspectives on Clinical Translation

Arbit²,

Herrick

et al. 2015

Ann Biomed Eng

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In this article, a “bedside to bench and back” approach for developing tissue engineered medical products (TEMPs) for clinical applications is reviewed. The driving force behind this approach is unmet clinical needs. Preclinical research, both in vitro and in vivo using small and large animal models, will help find solutions to key research questions. In clinical research, ethical issues regarding the use of cells and tissues, their sources, donor consent, as well as clinical trials are important considerations. Regulatory issues, at both institutional and government levels, must be addressed prior to the translation of TEMPs to clinical practice. TEMPs are regulated as drugs, biologics, devices, or combination products by the US Food and Drug Administration (FDA). Depending on the mode of regulation, applications for TEMP introduction must be filed with the FDA to demonstrate safety and effectiveness in premarket clinical studies, followed by 510(k) premarket clearance or premarket approval (for medical devices), biologics license application approval (for biologics), or New Drug Application approval (for drugs). A case study on nerve cuffs is presented to illustrate the regulatory process. Finally, perspectives on commercialization such as finding a company partner and funding issues, as well as physician culture change, are presented.

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Section: Clinical Researchmentioning

confidence: 99%

Tissue Engineered Constructs: Perspectives on Clinical Translation

Arbit²,

Herrick

et al. 2015

Ann Biomed Eng

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“…Communication and co‐ordination between all parts of the product development process from basic scientists to regulators to end user clinicians, is crucial to prevent knowledge sequestration within specific sectors (Bayon et al, ). Inter‐disciplinary conferences, government initiatives and academic‐private industry partnerships are being formed to facilitate this and promote harmonization between international agencies (Bertram et al, ; Rietschel et al, ).…”

Section: Barriers To Biomaterials Translationmentioning

confidence: 99%

Translating Regenerative Biomaterials Into Clinical Practice

Stace

Dakin

Mouthuy

et al. 2015

Journal Cellular Physiology

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Globally health care spending is increasing unsustainably. This is especially true of the treatment of musculoskeletal (MSK) disease where in the United States the MSK disease burden has doubled over the last 15 years. With an aging and increasingly obese population, the surge in MSK related spending is only set to worsen. Despite increased funding, research and attention to this pressing health need, little progress has been made toward novel therapies. Tissue engineering and regenerative medicine (TERM) strategies could provide the solutions required to mitigate this mounting burden. Biomaterial-based treatments in particular present a promising field of potentially cost-effective therapies. However, the translation of a scientific development to a successful treatment is fraught with difficulties. These barriers have so far limited translation of TERM science into clinical treatments. It is crucial for primary researchers to be aware of the barriers currently restricting the progression of science to treatments. Researchers need to act prospectively to ensure the clinical, financial, and regulatory hurdles which seem so far removed from laboratory science do not stall or prevent the subsequent translation of their idea into a treatment. The aim of this review is to explore the development and translation of new treatments. Increasing the understanding of these complexities and barriers among primary researchers could enhance the efficiency of biomaterial translation.

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“…The review of any regulated product is therefore undertaken on a case-by-case basis but generally considers four aspects: product manufacture, preclinical testing (laboratory and animal models), clinical performance, and product labeling according to claim of intended use. These processes are time, labor, and money intensive and have often been criticized for lack of clarity and inconsistencies between different regulatory agencies ( 46 , 47 ), which have in turn hindered the availability of products in some areas. The tissue-engineering field is still in early development and hence regulatory requirements are also continuing to evolve with it.…”

Section: The Challengesmentioning

confidence: 99%

“…The tissue-engineering field is still in early development and hence regulatory requirements are also continuing to evolve with it. There is now increasing dialog between the international TERMIS committees and regulatory bodies in order to work toward a consensus on regulatory requirements in order to foster innovation while continuing to ensure the safety and efficacy of tissue-engineered solutions ( 46 ).…”

Section: The Challengesmentioning

confidence: 99%