ramarketing news round-up
Sharp announces a strategic partnership with China-based ClinsChain to expand its reach and capabilities in the Chinese market, juggling the regulatory complexities of clinical trials with automations, BioAgilytix achieves ISO accreditation, and more!
Sharp partners with ClinsChain
Sharp will collaborate with ClinsChain – which specializes in providing clinical supply services for local and global clinical trials – to facilitate access to the Chinese market for Sharp’s pharma and biopharma clients, while also helping Chinese innovators to globalize their reach.
Sharp has also expanded its clinical service offering in Europe through the addition of labeling and secondary packaging services at its Heerenveen facility supporting open and randomized clinical trials, to complement existing clinical storage and distribution capabilities. This portfolio expansion follows the recent construction of new purpose-built production suites at the facility to facilitate the packaging, storage, and distribution of gene therapies.
Advancing process chromatography in DSP
According to Biopharm International due to technological advances, process chromatography challenges are surmountable, but increasingly complex therapies in the pipeline will demand more efficient processes in the future.
According to market research, the chromatography systems segment within downstream processing (DSP) is dominant. This dominance is reflected in various business strategies being employed by companies, such as expanding chromatography portfolios, improving efficiencies with single-use technologies, seeking out new products for more continuous processes, and developing technologies to deal with newer therapeutic modalities more effectively.
However, process chromatography in DSP remains challenging and is an area that can benefit from the adoption of more technologically advanced approaches, given the fact that therapeutic modalities are seemingly becoming more complex as time goes on.
BioAgilytix achieves cybersecurity accreditation
The leading global contract research organization, which focuses on supporting pharmaceutical and biotech partners in all phases of drug development, has received the ISO 27001:2013 certification for its Information Security Management System (ISMS).
ISO 27001:2013 is an internationally recognized security standard published by the International Organization for Standardization (ISO). This certification demonstrates BioAgilytix’s alignment with international information security best practices.
The initiative validated BioAgilytix’s commitment to ensuring the confidentiality, integrity, and availability of proprietary client data managed by the company.
Pharma industry performance snapshot
According to BiopharmaDive biotechnology companies are struggling in 2022, with the stock values of many declining – however large pharmaceutical companies have fared comparatively better. Shares in Eli Lilly, Merck & Co., and Bristol Myers Squibb are at or near 5-year highs, while companies like Pfizer continue to benefit from their COVID-19 work.
Interest rates, federal drug pricing legislation, and an active Federal Trade Commission could all play a major role in the performance of the pharma industry’s top ranks through the rest of this year.
Juggling the regulatory complexities of global clinical trials
According to PharmaManufacturing deploying an automated process can help simplify safety and compliance information.
Regulatory compliance continues to be a complex and cumbersome requirement for sponsors of clinical trials. These regulations require interpretation by experienced and qualified individuals who can ensure a thorough understanding of the requirements and how they can best be applied to drug development.
Ultimately, it is always the responsibility of the clinical trial’s sponsor to meet regulatory compliance and defend the data that is reported.
Covid origin studies say evidence points to Wuhan market
According to the BBC, scientists say there is “compelling evidence” that Wuhan’s Huanan seafood and wildlife market was at the centre of the Covid-19 outbreak.
Two peer-reviewed studies published on Tuesday re-examine information from the initial outbreak in the Chinese city. One of the studies shows that the earliest known cases were clustered around that market. The other uses genetic information to track the timing of the outbreak. It suggests there were two variants introduced into humans in November or early December 2019.
Together, the researchers say this evidence paints a picture that Sars-Cov-2 was present in live mammals that were sold at Huanan market in late 2019. They say it was transmitted to people who were working or shopping there in two separate “spillover events”, where a human contracted the virus from an animal.