RESUMO
As has been true with many emerging technologies, successful clinical development and recruitment of capital sufficient to reach market approval is measured as an industry platform. Risk, failure and achievement by individual companies are shared by all in the context of access to enthusiastic capital markets and codevelopment partnerships.
Assuntos
Consenso , Indústria Farmacêutica/legislação & jurisprudência , Controle Social Formal , Indústria Farmacêutica/economia , Transplante de Células-Tronco Hematopoéticas/economia , Transplante de Células-Tronco Hematopoéticas/legislação & jurisprudência , Humanos , Células-Tronco Mesenquimais/citologia , Medicina Regenerativa/legislação & jurisprudência , Medicina Regenerativa/organização & administraçãoAssuntos
Terapia Baseada em Transplante de Células e Tecidos , Indústria Farmacêutica/economia , Doença Arterial Periférica/terapia , Ensaios Clínicos como Assunto , Comércio , Análise Custo-Benefício , Tomada de Decisões , Indústria Farmacêutica/educação , Acessibilidade aos Serviços de Saúde , Humanos , Doença Arterial Periférica/economia , Transplante de Células-Tronco de Sangue Periférico/economia , Transplante de Células-Tronco de Sangue Periférico/métodos , Medicina Regenerativa/educação , Medicina Regenerativa/tendências , Sociedades CientíficasRESUMO
The last decade has seen a dramatic rise in the development of new cellular therapeutics in a wide range of indications. There have been acceptable safety profiles reported in early studies using blood-derived and adherent stem cell products, but also an inconsistent efficacy record. Further expansion has been hindered in part by a lack of capital (both private and public) and delayed entry into the cell therapy space by large healthcare and pharmaceutical companies, those members of the industry most reliably able to initiate and maintain advanced-phase clinical trials. With recognition that the International Society for Cellular Therapy (ISCT) is uniquely positioned to serve the global translational regenerative medicine research community as a network hub for scientific standards and policy, the ISCT commissioned the establishment of an Industry Task Force (ITF) to address current and future roles for industry. The objectives of the ITF were to gather information and prioritize efforts for a new Commercialization Committee (CC) and to construct innovative platforms that would foster constructive and synergistic collaborations between industry and ISCT. Recommendations and conclusions of the ITF included that the new CC: (1) foster new relationships with therapeutic and stem cell societies, (2) foster educational workshops and forums to cross-educate and standardize practices, (3) create industry subcommittees to address priority initiatives, with clear benchmarks and global implementation, and (4) establish a framework for a greater industry community within ISCT, opening doors for industry to share the new vision for commercialization of cell therapy, emphasizing the regenerative medicine space.
Assuntos
Terapia Baseada em Transplante de Células e Tecidos , Ensaios Clínicos como Assunto , Indústria Farmacêutica , Comércio , Humanos , Guias de Prática Clínica como Assunto , Medicina Regenerativa , Sociedades Científicas , Pesquisa Translacional BiomédicaRESUMO
The medical and dental aspects of management for patients diagnosed with snoring and obstructive sleep apnoea are well documented. However, guidance for treatment by the general dental practitioner is lacking. This article reviews aspects of appliance provision and presents the use of a silicone material in an attempt to improve the longevity of a recognized prosthesis.