The Growing Diversity Between SME Biotech Business Models
As with most sectors, the biotechnology industry is driven by the innovative vigor of small or medium-sized enterprises (SMEs). Most biotechnology SMEs grow slowly and depend on limited financial opportunities from external sources. However, the lack of resources in larger companies and fundamental problems in the models of business prevent most SMEs from succeeding. Competition from larger companies and the lack of marketing capabilities have also battered many opportunities for SMEs. There are three major factors that contribute to the restriction of growth of biotech SMEs: Complicated patenting and costly regulatory systems. Insufficient risk capital for early-stage development. The incongruous marriage between science and business. It is crucial for all new and existing biotech companies to take these three factors into their business model. The key implications of SME research and development depend on the dynamic business models, i.e. a fluid construct model instead of concrete
Genzyme China: 3 Top Tips for Effective Clinical Operations
With more clinical trials being held in China than ever before, clinical trial supply systems need to become increasingly sophisticated in order to cope with local regulations, importation and exportation guidelines, application of licenses, transit, packaging and labeling requirements, temperature-controlled storage and transportation and local distribution. In this quickfire Q&A we speak with Wang Tao, Head of Clinical Operations at Genzyme, about the the clinical trial supply issues faced by the pharmaceutical industry in China.
Top 10 Statistics From Pharma IQ's Clinical Trial Supply Survey
The latest results from Pharma IQ’s survey of industry professionals highlights that running clinical trials in emerging market (e.g. BRIC) nations remains a firm priority for companies actively perusing research. The survey carried out the research team here at Pharma IQ in April has revealed many of the most important trends within Clinical Trial Supply and it suggests many reasons to be optimistic.
The Clinical Trials Process
What are the 7 Deadly Sins of Quality Assurance and Quality Control? Download our free QA QC eBook now to find out! Clinical trials play an extremely important role in helping pharmaceutical companies get their products to market. They are designed to ensure the safety and efficacy of new products before they are marketed to the public and they are needed for companies to be granted a licence for their drugs. Approval has to be sought by the regulatory authorities in the individual countries where the pharmaceutical clinical trials are being conducted before they can begin. In the United States, this is the Food and Drugs Administration, while in the UK, the Clinical Trials unit of the Medicines and Healthcare Products Regulatory Authority is tasked with the responsibility. Pharmaceutical clinical trials can be carried out either in-house or by clinical research organisations (CRO), which are also sometimes known as contract research organisations. The Association of
Talking Heads: 7 Growing Trends in Clinical Trial Supply
Pharma IQ had a quick ring around with some of our trusted experts who are working in clinical trials to get an overview on current and emerging trends in clinical trial supply. This panel of experts included, Robert Bronstein, Director - Clinical Supply Operations, MacroGenics; Robert Smith, Clinical Trials Expert and Steven A. Jacobs, MBA, R.Ph.President, Global BioPharm Solutions, LLC.
Site Perspectives on Clinical Trial Supply- Samantha Carmichael
Samantha Carmichael Lead Pharmacist Clinical Trials NHS Greater Glasgow & Clyde Samantha Carmichael has 18 years experience as a pharmacist, having spent time in many different areas of pharmacy, including hospital pharmacy and within the private sector working for a large international pharmaceutical company. She is currently the Lead Pharmacist for Clinical Trials and one of the Lead Sponsor Representatives within NHS Greater Glasgow & Clyde Healthboard. NHS GGC is the largest healthboard in the UK, providing healthcare services to a population of 1.2 million in the West of Scotland. She manages a team of pharmacists and pharmacy technicians who deliver on studies sponsored by NHS GGC or co-sponsored with the University of Glasgow, as well as hosting around 400 CTIMPs across 4 research portfolios, covering all phases and therapeutic areas. She has practised as a clinical pharmacist in the areas of oncology, critical care and anaesthetics.