This week’s headlines include, FDA’s guidance on IRB responsibilities, cerebral organoids from stem cells, CIRM grants $40.6 Million, California Assembly approves biosimilar bill, Sanofi Fluzone trial, heart cells repair damage after heart attack, and Pharma’s top companies for revenue.
Cell Culture Events:
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Don’t miss the talk “A Case Study in Creation of a Strategic Technical Lifecycle Plan (TLCP) for Continuous Improvement of a Legacy Biological Process,” Naveen Pathak, Associate Director, Technical Strategy, Manufacturing Science & Technology, Genzyme, a Sanofi Company
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“The US Food and Drug Administration (FDA) has published a new document consolidating its guidance for institutional review boards (IRBs) as they review the adequacy of biomedical research sites and clinical investigators. While this oversight is generally the responsibility of the trial sponsor, the agency wants IRBs and investigators to have greater involvement “in order to protect the rights and welfare of study subjects”.
If you like this story, please see our blog titled “Navigating in the Single-Use Space – How to Find the Right Cell Culture Bioreactor
“Scientists have grown the first mini human brains in a laboratory and say their success could lead to new levels of understanding about the way brains develop and what goes wrong in disorders like schizophrenia and autism. Researchers based in Austria started with human stem cells and created a culture in the lab that allowed them to grow into so-called “cerebral organoids” – or mini brains – that consisted of several distinct brain regions.”
If you like this story, please see our blog titled “From Product Candidate to Product: The Road to Commercialization in Regenerative Medicine”
“California’s $3 billion stem cell agency on Wednesday approved $12.7 million in grants to San Diego scientists to speed the translation of research into therapies. The grants, approved at the agency’s meeting in La Jolla, were among $40.6 million given to researchers statewide. The largest amount, $6.4 million, went to John Cashman of the Human BioMolecular Research Institute, in the University City area east of La Jolla. Cashman is developing drugs for a serious heart rhythm irregularity, using induced pluripotent stem cells. These cells act much like embryonic stem cells, which can grow into nearly any tissue in the body.”
If you like this story, please see our blog titled “Moving Cell Therapy from Concept to Product – A discussion about navigating funding and grant writing, partnering with organizations and the regulatory process”
“California pharmacists would be allowed to dispense substitute medications that are biologically similar to brand-name treatments under a bill that cleared the state Assembly on Monday. Biological medicines, which are created from living cells rather than by mixing chemicals, have been used to treat cancer and immune-system disorders. Those treatments are becoming a fast-growing segment of the pharmaceutical market, with manufacturers also creating medications that are similar to some biological medicines. Unlike traditional generic medications, the so-called biosimilars resemble but are not identical to the biological medication they are replicating.”
If you like this story, please see our blog titled “Companion Diagnostics – The Future of Personalized Medicine”
“Sanofi said on Monday that a large clinical trial showed its Fluzone High-Dose vaccine to be more effective at preventing influenza in adults aged 65 and older than a standard dose of Fluzone. Sanofi said it plans to submit the full clinical study report to the U.S. Food and Drug Administration for review by early 2014 and will seek to modify to the label for Fluzone High-Dose vaccine to reflect the superior efficacy data in this age group.”
If you like this story, please see our blog titled “Interesting Late Stage Viral Vaccine Candidates”
“Scientists report that they’ve transformed one kind of human heart cell into another in laboratory experiments, a promising development in the bid to find ways to repair damage from heart attacks. The research is far from ready for prime time, however, and it’s not clear if the strategy will work in live people. Still, the treatment is a promising approach to regenerating organs “that would harness cells already within a damaged organ and convert them to the type of cells that are needed for that organ to function,” said study co-author Dr. Deepak Srivastava, director and senior investigator at the Gladstone Institute of Cardiovascular Disease in San Francisco.”
If you like this story, please see our blog titled “Advances in Adherent Cell Culture Approaches Abound – Promoting Progress in Production Performance for Attachment Dependant Processes”
“Pfizer has remained the world’s largest public manufacturer of pharmaceuticals, according to an industry report, though dropped revenue in 2012 has left Novartis hot on its heels.”
If you like this story, please see our blog titled “Cell Culture, More Science than Art – A Call for Care in Cell Culture Practices”