Top 4 Challenges for Vaccine Manufacturers

Recently we undertook the research for the 15th annual World Vaccine Congress, and so asked what the biggest challenges are for each segment of the market. When we spoke to vaccine manufacturers, these came up as the 4 biggest issues:   1)      Adjuvants Adjuvants are often lauded as the way forward to make vaccines more effective, but given how new …

Vaccine Asia

Vaccine Asia Live: Overcoming the Challenges of Vaccine Trials to Address the Growing Demand in Asia

Seeing the great importance of vaccine development in Asia due to its great demand, it is pertinent that any challenges in vaccine development be addressed, especially in vaccine clinical trials. To help address these challenges, Dr Teoh Yee Leong, CEO of Singapore Clinical Research Institute(SCRI) , spoke about what these challenges were and advice on how to overcome them. Singapore …

Jeff Ryel

Requirements for flu virus stock for human administration in clinical trials

Jeff Ryel, RN – SGS Life Science Services joined us last year at the World Vaccine Congress Europe to present on ‘Requirements for flu virus stock for human administration in clinical trials’ Download this presentation now to find out more about: GMP production regulatory requirements Lab quality and safety testing requirements Clinical validation requirements Clinical Case Study …And much more! …

Benchmark Research Wins as “Best Clinical Site & Trial Network” in the 2014 Vaccine Industry Excellence (ViE) Awards

  Benchmark Research’s New Orleans location has won the “Best Clinical Trial Site & Trial Network” category for the 2014 Vaccine Industry Excellence (ViE) Awards.  April 9, 2014 Benchmark Research’s New Orleans location has won the “Best Clinical Trial Site & Trial Network” category for the 2014 Vaccine Industry Excellence (ViE) Awards. Winners were presented at the 14th Annual World …

Collaborative strategies for enhanced regulatory approval outcomes

Protection of human subjects enrolled in clinical trials is the focus of regulation during vaccine development. The guiding principles behind agency interactions during development are as follows: · To understand the regulatory requirements at each stage of development · Guidance documents outline general considerations, but program-specific input is essential · Agency engagement may provide insights · New data or information …

Download: the Meningitis Vaccine Project experience of ethical issues in vaccine clinical trials

The Meningitis Vaccine Project experience of ethical issues in vaccine clinical trials- tell us what you think in the space provided below! As an industry, it is important that we understand our ethical responsibilities. The Meningitis Vaccine Project works told us there experience at the World Vaccine Congress Washington 2013. Why not download the full presentation and find out more …

Ethical concerns in the globalization of clinical trials

With significant increases in the number of clinical trials abroad; between 1995 and 2005, the number of countries serving as trial sites outside of the United States more than doubled; increasing numbers of clinical investigators, patient visits, study sites outside of US are required. These increases have fuelled the continuing debate surrounding global standards of care and benefit sharing. Concerns …

Innovative strategies and methods for the implementation of Phase IIIb efficacy trials

Tina Washington, Senior Clinical Trial Manager, sanofi pasteur joined us the World Vaccine Congress Washington 2012 to review the innovative strategies and methods being employed in the implementation of 2 large Fluzone HD trials. The background of the Fluzone HD Program can be summed up as follows: · High dose trivalent inactivated influenza vaccine · Phase IIIb efficacy trial for …

Climate change in vaccine trials: Moving from a one-size-fits-all to a custom fit in operational delivery

Dr Vigdorth has 30 years of drug development research experience in the clinical setting and pharmaceutical and CRO industries. She has led clinical development programs across a range of therapeutic indications with extensive experience in antibiotic, antiviral, vaccine, and antifungal agents.   Dr Vigdorth's experience has developed from multiple perspectives including working in the clinical investigative site setting, multi- national …