Some leading practices are to use a regional hub that is diverse and has regional experience. For this reason, localized CROs fare best. When leveraging smaller firms and, at the same time, implementing leading practices, there is an opportunity for a hub-and-spoke model or an apprenticeship model, where all people involved are trained on processes and procedures, rather than simply allowing smaller local CROs to take all ownership i.
It will also be critical to have a model to allow for ongoing training and learning. The growth happening in Asia, China in particular, is undeniable. Not only does the industry need to prepare for widely dispersed growth, but there is also a dire need to systemize the industry with a complete, integrated suite of processes and frameworks. Before further dissemination, now is the time to hone in on leading practices to maximize successes. One example was noted of bringing together three CROs and performing an end-to-end process flow integration and sharing of best practices across each.
They both put on a spectacular show, hosted by RPS. This entry was posted on Wednesday, April 6th, at pm and is filed under clinical , clinical trials , conferences. You can follow any responses to this entry through the RSS 2. You can leave a response , or trackback from your own site. You are commenting using your WordPress. You are commenting using your Google account.
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Immuno-toxicology Conferences. Kevin M. Flanigan: A small number of boys with Duchenne muscular dystrophy have a disease caused by a duplication of exon 2 of the DMD gene which encodes dystrophin. This exon duplication can be removed through the use of an adeno-associated virus 9—based vector, which carries copies of the non-coding small nuclear RNA U7 with a sequence directed toward splice donor and acceptor sites within the duplicated exon.
This exon-skipping approach is a first in-human trial and results in exclusion of a copy of DMD exon 2, and expression of the full-length, wild-type dystrophin. Preliminary data have been presented showing successful expression, for the first time, of full-length dystrophin in response to this viral gene therapy.
There are four more gene therapies for Duchenne muscular dystrophy being tested, but each of these requires delivery of a gene encoding an engineered microdystrophin, which is not present in nature and which is expected to result in substantial functional improvement. David Nutt: Psilocybin, a psychedelic derived from fungi, is showing great promise in the treatment of mental-health conditions. First, it tackles the huge problem of depression that is resistant to existing treatments. Finally, it will also give some readouts on the dose—effect relationship, as they are testing three greatly differing doses of psilocybin, at 1 mg, 10 mg and 25 mg.
David Nutt is the Edmond J. Yoshikazu Yonemitsu: This is a phase 1 open-label study of ASP administered by intratumoral injection in patients with advanced or metastatic solid tumors. ASP is a genetically engineered oncolytic vaccinia virus that expresses two cytokines, IL-7 and IL, that help stimulate antitumor immune responses. ASP was effective in multiple immunocompetent mouse models and showed promising results in both directly treated tumors and distant tumors.
This study will for the first time assess the safety, tolerability and antitumor activity of this oncolytic vaccinia virus in patients with cancer. Ruth A. Karron: Respiratory syncytial virus RSV is a leading cause of severe respiratory infections in infants and children, but there is currently no vaccine against this.
It carries a YTE mutation, which extends its half-life; this means that a single dose of the antibody could protect an infant throughout their first RSV season. This is a big improvement over the current monoclonal antibody to RSV, palivizumab, which lasts about a month and therefore is used only for high-risk infants.
The final results will be interesting, because they will determine if vaccine-policymaking bodies are willing to approve a monoclonal antibody, rather than a vaccine, as a prophylactic product. Jennifer Litton: People with triple-negative breast cancer have fewer treatment options than others with this type of cancer. Although pembrolizumab marketed as Keytruda was originally developed to treat advanced melanoma, it has since been approved to treat a variety of cancers.
This trial will answer important questions about the use of adjuvant pembrolizumab for patients with high-risk triple-negative breast cancer. Nearby hotels and apartments centre convencions internacional barcelona address, barcelona, , spain. Discover more events in barcelona. Save event Saved Remove. Check out other events in barcelona. Evensi is now part of the Events.
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