Solution of ordinary differential equations by means of Lie series

Solution of ordinary differential equations by Lie series - Laplace transformation, Weber parabolic-cylinder functions, Helmholtz equations, and applications in physic

Bringing function to the forefront of cell therapy: how do we demonstrate potency?

Unlike conventional pharmaceuticals, biologics and Advanced Therapy Medicinal Products (ATMPs) are required to meet a standard of “potency” as part of the final release criteria at completion of manufacture. During early phase clinical trials, most regulatory agencies have been willing to accept very immature potency assays with an expectation that these will be improved, qualified and validated during the clinical development of the drug to Marketing Authorisation Application (MAA) or Biologics License Application (BLA) submission.This model of continuous development of potency assay in parallel with drug development has already led to at least two notable problem cases; namely Iovance and Mesoblast. Both companies completed successful phase III clinical trials but, in both cases, the initial BLA was rejected on the basis that their potency assay for drug product release was inadequate. Fortunately these issues appear to have been overcome in March of this year, with Mesoblast receiving acceptance of their BLA for Remestemcel and Iovance obtaining a rolling BLA approval for Lifileucel

SL(2,C) Chern-Simons theory and the asymptotic behavior of the colored Jones polynomial

We clarify and refine the relation between the asymptotic behavior of the colored Jones polynomial and Chern-Simons gauge theory with complex gauge group SL(2,C). The precise comparison requires a careful understanding of some delicate issues, such as normalization of the colored Jones polynomial and the choice of polarization in Chern-Simons theory. Addressing these issues allows us to go beyond the volume conjecture and to verify some predictions for the behavior of the subleading terms in the asymptotic expansion of the colored Jones polynomial.Comment: 15 pages, 7 figure

Development, fabrication, testing, and delivery of advanced filamentary composite nondestructive test standards Final report

Development and fabrication of filament composite nondestructive test standard

Bringing function to the forefront of cell therapy: how do we demonstrate potency?

Unlike conventional pharmaceuticals, biologics and Advanced Therapy Medicinal Products (ATMPs) are required to meet a standard of “potency” as part of the final release criteria at completion of manufacture. During early phase clinical trials, most regulatory agencies have been willing to accept very immature potency assays with an expectation that these will be improved, qualified and validated during the clinical development of the drug to Marketing Authorisation Application (MAA) or Biologics License Application (BLA) submission.This model of continuous development of potency assay in parallel with drug development has already led to at least two notable problem cases; namely Iovance and Mesoblast. Both companies completed successful phase III clinical trials but, in both cases, the initial BLA was rejected on the basis that their potency assay for drug product release was inadequate. Fortunately these issues appear to have been overcome in March of this year, with Mesoblast receiving acceptance of their BLA for Remestemcel and Iovance obtaining a rolling BLA approval for Lifileucel

Transplantation in children

Kidney transplantation in very young children, less than 2 years of age, has usually failed, mainly because of difficulties maintaining these patients on hemodialysis long enough to permit retransplantation after loss of the original graft. Liver replacement in the very young child has been associated with a higher frequency of vascular and biliary obstruction than in the older child, due to the small size of these structures. Such accidents have contributed to unsatisfactory results with biliary atresia. Transplantation of kidney or liver into older children has been more successful than transplantation of these organs into adults. Related or cadaveric kidney transplantation in the child has been followed by at least a 60 per cent patient survival for 6 to 13 years and a very acceptable quality of life. Liver replacement for diseases other than biliary atresia has been followed by a 56 per cent 1 year survival rate, and two children have survived for more than 5 years