Shanghai Medicilon Inc.

Regulatory reviewers spend more time managing incoming data than on the drug evaluation process, says Instem which has inked a deal with WIL Research for its nonclinical IT systems. Preclinical contract research organisation (CRO) WIL has placed an order with IT technology firm Instem for study-related software systems at all its sites worldwide, expanding on an exclusive nonclinical partnership deal struck back in May. Among the systems WIL has purchased is Instem’s Submit software, used to support the Standard for Exchange of Nonclinical Data (SEND) which is being adopted by the US Food and Drug Administration (FDA) to speed up the development process by providing a vehicle for easier transportation of results of regulatory toxicology studies to regulators. “FDA reviewers continue to receive mostly paper or electronic paper (PDF) submissions as they evaluate new applications for drugs,” Julie Jones a spokesperson from Instem told Outsourcing-Pharma.com . “They are then manua...

Over the last three years US turnover in clinical monitoring has dropped from 29.4% to 16.4% and globally overall company turnover has dropped from 27.2% to 14.2% on average, according to the 16th annual CRO Industry Global Compensation and Turnover Survey. The survey from HR+Survey Solutions found that turnover globally was the highest in Switzerland, New Zealand and Hong Kong. Study author Judy Canavan told Outsourcing-Pharma.com, “ The CRO industry is a niche industry so it is easy for a couple of companies to drive high turnover numbers in a specific country. The industry is expanding rapidly... This growth creates a demand for talent which drives turnover .” She noted that the falling turnover rates in the past couple of years may be a sign that the industry is maturing. The relatively high turnover rate that remains, she added, seems to be the product of a number of factors, including: Home-based positions that create two issues (1) changing jobs is as simple as getting ...

Cardiac hypertrophy occurs in up to 95% of patients with CKD and increases their risk for cardiovascular death. In the kidney, full-length membranous Klotho forms the coreceptor for fibroblast growth factor 23 (FGF23) to regulate phosphate metabolism. The prevailing view is that the decreased level of Klotho in CKD causes cardiomyopathy through increases in serum FGF23 and/or phosphate levels. However, we reported recently that soluble Klotho protects against cardiac hypertrophy by inhibiting abnormal calcium signaling in the heart. Here, we tested whether this protective effect requires changes in FGF23 and/or phosphate levels. Heterozygous Klotho-deficient CKD mice exhibited aggravated cardiac hypertrophy compared with wild-type CKD mice. Cardiac magnetic resonance imaging studies revealed that Klotho-deficient CKD hearts had worse functional impairment than wild-type CKD hearts. Normalization of serum phosphate and FGF23 levels by dietary phosphate restriction did not abrogate th...

Biologics are the next challenge for multinationals looking to enter the lucrative Chinese market, but such drugs must offer value and genuine innovation, say the CEOs of Merck KGaA and Chi-Med. “Referring to China as an emerging market is a bit like referring to Google as a new economy,” said Stefan Oschmann, CEO Pharma at Merck KGaA, during a panel discussion discussing new market opportunities at last month’s FT Global Healthcare and Biotech Conference in London, UK. Approximately 40% of the Germany-headquartered firm’s revenues come from markets which are generally described as ‘emerging,’ with China being a major focus of investment for the Merck Serono division. Last year China's healthcare spend was around $132bn, up from $5bn in 2000, the panel said but for multinationals looking at entering this lucrative market the challenge is to offer high quality branded products at affordable prices, according to Oschmann. “Traditionally business [in China] has...

For the first time in history, scientists are beginning to understand the inner workings of human disease at the molecular level. Recent advances in genomics, proteomics and computational power present new ways to understand illness. The task of discovering and developing safe and effective drugs is even more promising as our knowledge of disease increases. As scientists work to harness this knowledge, it is becoming an increasingly challenging undertaking. It takes about 10-15 years to develop one new medicine from the time it is discovered to when it is available for treating patients. The average cost to research and develop each successful drug is estimated to be $800 million to $1 billion. This number includes the cost of the thousands of failures: For every 5,000-10,000 ompounds that enter the research and development (R&D) pipeline, ultimately only one receives approval. These numbers defy imagination, but a deeper understanding of the R&D process can explain why...

Research and Markets  ( http://www.researchandmarkets.com/research/jnxd8w/china_contract ) has announced the addition of the  "China Contract Research Organization (CRO) Industry Report, 2013-2016"  report to their offering. China CRO industry has developed rapidly in recent years, registering a CAGR of 27.2% during 2007-2013, of which the market size reached RMB 36 billion in 2013, occupying 10% of global market share. As China is full of talents, has advantage of relatively low costs and is rich in disease spectrum, the world's renowned CRO companies, including Quintiles, Covance, Parexel and Charles River, have entered the Chinese market through sole proprietorship, corporation or acquisition, driving the industry towards standardization to some extent. At present, there are about 500 companies involved in CRO market in China, but only a few of them are operating at scale and in good shape. WuXi AppTec, ShangPharma Corp, Asymchem and Hangzhou Tigermed Consul...

This report says considering huge potentials of Chinese pharmaceutical market, intensive talent resource, relatively low cost and rich spectrum of diseases, foreign enterprises are accelerating to expand CRO market there. Compared to Europe and America, China developed pharmaceutical CRO industry 40 years later, with domestic industrial players amounting to over 500, most of which are SMEs. In general, Chinese CRO market scale occupies only 7%-10% of the world’s total, and in 2011-2012 the CRO market size of China approximated RMB22-28 billion. Considering huge potentials of Chinese pharmaceutical market, intensive talent resource, relatively low cost and rich spectrum of diseases, foreign enterprises are accelerating to expand CRO market there. Presently, world-renowned CRO companies including Quintiles, Covance, PPD, CRL and ICON have set foot in China by building new establishments and M&As. In China, homegrown leaders cover WuXi AppTec Co., Ltd., Shanghai-headquartered Sha...

Veeva Systems has reported a robust Q3 strengthened by increasing interest in its cloud-based clinical trial management software and a deal with inVentiv Health. Two years after launching the cloud-based regulated content management system Veeva Vault, the California-based company has announced it has surpassed 100 customers attributing to a 52% jump in sales for the first quarter fiscal year 2015 year-on-year. Vault hosts a number of tools to assist pharma and biotech, in organising and processing R&D documentation - including cloud-based electronic trial master file (eTMF) and regional submission system for clinical trials, and Vault QualityDocs for managing quality and manufacturing SOPs – but CEO Peter Gassner said having contract research organisations (CROs) on the books is testament of the efficiency of such technology. “The CROs are important, whether they're growing incrementally or shrinking incrementally, they're doing almost half of the clinical trials...

The pace of recruitment is the biggest challenge in carrying out trials in Eastern Europe, says Mabion which has extended an agreement with local CRO Altiora for its biosimilar study. Polish biopharma firm Mabion’s lead candidate is a biosimilar of Roche’s MabThera (rituximab) - a monoclonal antibody intended to treat lymphoma, leukemia and rheumatoid arthritis – known as MabionCD20. Last week the firm obtained the consent of regulators in Croatia, Bosnia and Herzegovina, Serbia and Poland to perform clinical trials of the drug in patients with diffuse large B-cell lymphoma, and announced it would extend a service agreement with Zagreb, Croatia-based contract research organisation ( CRO ) Altiora to carry out the work. “Altiora presented the most advantageous offer including comprehensive management of project,” Mabion’s CEO Maciej Wieczorek told Outsourcing-Pharma.com. “Based on previous cooperation, we have developed a clear trail of communication and procedures, and therefo...

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...