Shanghai Medicilon Inc.

Making clinical trials more open has pros and cons for CROs and drugmakers according to experts from Amgen, Celgene, AstraZeneca, Icon and Lab Corp who spoke at an industry conference in Spain last week. The term trial transparency usually refers to a sponsor’s publication of data from all clinical studies – now a legal requirement thatnks to pressure from oragnisation's like the Alltrials group. The argument is that publication allows independent researchers to scrutinise safety and efficacy profiles of drugs in a way that improves the development of effective medicines. The drug industry has instead called for more limited data publication or “responsible transparency ,” arguing that issues like patient privacy and concerns about giving information to potential competitors as reasons for limiting disclosure. Such concerns were not in evidence at Partnerships in Clinical Trials (PCT) in Barcelona where industry speakers said that - in general - making the entire...

The age-old question persists: which came first, the chicken or the egg? Approximately 24 hr after fertilization occurs in a chicken, the egg is laid. The newly formed single cell begins to divide; tissue begins to form on the yolk by the end of day 1. By the end of day 2, the heart begins to beat. On day 14, claws begin to form and the embryo is moving into position to hatch. On the 21st day, the chick finishes its escape from the shell. Image: This image depicts a 13-day-old chicken embryo. The networks of chorioallantoic membrane blood vessels used for gas exchange and the yolk sack blood vessels used for nutrient uptake can easily be seen. By day 8, the beak and feathers are also visible. The allantois (sac involved in gas exchange and excretion) shrinks to become the chorioallantoic membrane (vascular membrane). And so begins the appearance of claws and leg scales. Inset: Photo of two fully developed chicks with their mother.  This image shows the development of a chic...

1. Introduction of EU Regulatory landscape The European medicines regulatory system is based on a network of regulatory authorities (national competent authorities (NCA)) from the 28 European Union member states, Iceland, Norway and Liechtenstein, the European Commission and the European Medicines Agency (EMA). This network is what makes the EU regulatory system unique, in comparison with the United States, where the Food and Drug Administration is the regulating agency. The role of EMA is to prepare the scientific guidelines that govern the development of drugs within the EU, they reflect the latest thinking on scientific developments. EMA guides sponsors in their development programs and ensure that medicines development is conducted consistently and to the highest quality across the EU. The EMA also gives scientific advice, decides on the classification of Orphan Designations, and authorizes the market access of drugs through the centralized procedure. The role of the natio...

Comparing the human genome with the mouse genome reveals both shared general principles and important differences in how each species’ genes are regulated. For years, scientists have considered the laboratory mouse one of the best models for researching disease in humans because of the genetic similarity between the two mammals. Now, researchers at the Stanford University School of Medicine have found that the basic principles of how genes are controlled are similar in the two species, validating the mouse’s utility in clinical research. However, there are important differences in the details of gene regulation that distinguish us as a species. “At the end of the day, a lot of the genes are identical between a mouse and a human, but we would argue how they’re regulated is quite different,” said Michael Snyder, PhD, professor and chair of genetics at Stanford. “We are interested in what makes a mouse a mouse and a human a human.” The research effort, Mouse ENCODE, is meant to...

The year 2014 has become a notable one for activities in the biosimilars arena. Although the summer months have traditionally been viewed as “quiet”, being vacation season, this year, particularly in the U.S., this has certainly not been the case. This article will examine a few of these more recent developments. The first generation of biotechnology-produced pharmaceuticals has already reached, or is close to, patent expiry. This includes many monoclonal antibody products that are successful blockbuster drugs, and command premium prices for courses of treatment. Within the past decade, a pharma sector driven by the need for more affordable medicines, has emerged. In many countries, biosimilars are marketed as legally approved versions of existing patent-expired, branded biologics. They are granted marketing approval on the basis of analytical, preclinical and clinical data that show they are highly similar to the original drug. The European Union (EU) established the first lega...

A genetically diverse mouse model is able to predict the range of response to chemical exposures that might be observed in human populations, researchers from the National Institutes of Health have found. Like humans, each Diversity Outbred mouse is genetically unique, and the extent of genetic variability among these mice is similar to the genetic variation seen among humans. Using these mice, researchers from the National Toxicology Program (NTP), an interagency program headquartered at the National Institute of Environmental Health Sciences (NIEHS), were able to identify specific genes or chromosomal regions that make some mice more susceptible, and others more resistant, to the toxic effects of benzene. Benzene is a common air pollutant and human carcinogen found in crude oil, gasoline, and cigarette smoke, and naturally produced by wildfires and volcanoes. The scientists found that, like humans, each Diversity Outbred mouse developed at The Jackson Laboratory, Bar Harbor, Mai...