Prnewswire | September 10, 2020
ConcertAI has hired Claudio D'Ambrosio, PhD, as head of biopharma partnerships and real-world evidence Solutions. Claudio brings over 15 years of experience as a cancer researcher, commercial leader, and strategic scientific partner to the life sciences industry to help advance the goals of ConcertAI of bringing rapid innovation and precision real-world evidence oncology to the world's top global pharmaceutical companies. ConcertAI is a fast-growing company with the leading technology for integrated Real-World Data (RWD), AI cloud solutions, and advanced outcomes, and data science services for oncology RWE). The mission of ConcertAI is to advance the regulatory and market access applications of precision RWE through a unique set of validated RWD solutions and complementary eurekaHealth technologies.
Thermo Fisher Scientific | September 03, 2021
Thermo Fisher Scientific's clinical sequencing business and AstraZeneca today announced they will co-develop next-generation sequencing (NGS)-based companion diagnostics (CDx) to support AstraZeneca's expanding portfolio of targeted therapies. The companies will collaborate under a multiyear, global agreement.
"As the pipeline of targeted therapies expands, the availability of diagnostic tools that can interrogate multiple biomarkers simultaneously will ensure patients can be matched with the right therapies more rapidly – this is the promise of precision medicine," said Garret Hampton, president of clinical next-generation sequencing and oncology at Thermo Fisher Scientific. "Introduction of diagnostic tools early in the process of drug development can further facilitate the success of companion diagnostic development – and that's what we're doing with AstraZeneca."
NGS-based companion diagnostics are increasingly used to match patients with new therapies for cancer and other diseases. More than 90 percent of AstraZeneca's clinical pipeline, across all main areas from oncology, cardiovascular and renal to metabolic and respiratory disease, are targeted precision medicine therapies.
"Using the latest diagnostic science allows us to match the best treatment to the patient," said Ruth March, senior vice president, precision medicine and biosamples, AstraZeneca. "This collaboration with Thermo Fisher offers the technology, expertise and ability to decentralize CDx tests to local healthcare providers across our global markets, which will help us identify more patients around the world who may benefit from treatments and effective patient care."
Thermo Fisher currently offers the only globally distributable NGS CDx solution approved and reimbursed by government and commercial insurers in more than 15 countries, including the U.S., multiple European nations, Japan, South Korea and the Middle East, and covering more than 550 million lives globally.
To expand global access to a growing list of precision medicine therapies, in 2019 Thermo Fisher introduced the Ion Torrent Genexus System*, the first fully-integrated NGS platform featuring an automated specimen-to-report workflow that economically delivers results in a single day. The company's complete NGS workflow, powered by Ion AmpliSeq technology, includes multiple solutions for solid tumor biomarkers and liquid biopsy testing.
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $30 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 80,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon.
CureVac, EMA | February 18, 2021
The European Medicines Agency (EMA's) Committee for Human Medicinal Products (CHMP) has begun a moving audit of CureVac AG's COVID-19 antibodies, CVnCoV.
The survey was started on the grounds that starter research facility contemplates and early clinical preliminary outcomes recommend the immunization triggers the creation of antibodies and insusceptible cells that target SARS-CoV-2, the infection that causes COVID‑19.
The survey will successively audit information as it opens up, beginning with the preclinical and beginning stage proof presently submitted. As opposed to a customary advertising authorisation application, in which all information on a medication's or immunization's viability, security and quality and all necessary archives should be prepared toward the beginning of the assessment.
Continuous preliminaries are proceeding to assess the immunization's wellbeing, immunogenicity and viability against COVID-19. EMA will assess information from these and other clinical preliminaries as they become accessible.
The moving audit will proceed until the CHMP concludes that adequate information is accessible for a conventional showcasing authorisation application. Because of the work attempted in the moving audit, it should take less time than typical to assess such an application.
EMA will survey the immunization's consistence with the typical norms for adequacy, wellbeing and drug quality inside the moving audit measure.
CVnCoV is an mRNA vaccine which encodes the SARS-CoV-2 Spike (S) protein. The mRNA sequence is formulated in minute lipid particles to prevent it from being broken down too quickly.
When a person receives the vaccine, some of their cells will use the mRNA molecules to temporarily produce the S protein. This activates the person’s immune system, priming it to respond more quickly to a subsequent SARS-CoV-2 infection.