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 …

Vaccine Asia Live: Current Situation of Cervical Cancer Vaccines

Levent Shih-Jen Liu, the Associate Investigator of National Health Research Institute in Taiwan, moderated the Round Table Discussion, covering the topic of cervical cancer vaccines. Human Papilloma Virus (HPV) Vaccine, a vaccine developed to prevent cervical cancer among women, has been introduced in many countries around the world, including those in Asia. Through valuable inputs from each delegate, a clear …

20% of Americans Believe in a Vaccine Conspiracy

A report published in JAMA Internal Medicine suggests that 20% of the American public believe that doctors and the government know that vaccines cause harm, and yet they continue to inoculate children.  The survey found that, of the 1351 participants, 69% had heard of this conspiracy theory, making it the most widely known medical conspiracy theory mentioned in the survey. Of the …

Download: How to advance regulatory convergence in Asia

At this years World Vaccine Congress Asia Wang Der-Yuan, Division of Research and Analysis, (TFDA) Department of Health, Republic of China delivered the presentation: Advancing Regulatory Convergence in Asia with International Standards. Some of the points explored in this presentation include: Prophylactic Vaccines Vaccine needs in Asia Current regulatory process for vaccines Regulatory process of NRA How to ensure safety …

Does the industry need to rethink its approach to regulatory approval in light of low approval rates?

Download the eBook here >> We asked several industry experts at the World Vaccine Congress USA 2013 the following three questions: What role do you see the developing world taking in relation to vaccine development? Does the industry need to rethink its approach to regulatory approval in light of low approval rates? What technological advances could revolutionise the vaccine industry …

Post marketing safety monitoring during a pandemic- Dr Hector Izurieta

  Flu: Post marketing safety monitoring during a pandemic- Dr Hector Izurieta Subscribe: http://www.youtube.com/user/vaccinenation  In light of the 2009 influenza pandemic, discussion into control and prevention of influenza pandemics is a key topic of discussion and of research within the industry. Dr Hector Izurieta from the US FDA joined us at the World Vaccine Congress to discuss post marketing safety …

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 …

Presentation download: the Quality by Design concept

  Trevor Deeks, Senior Director, Manufacturing Management Services from Emergent BioSolutions joined us at the World Vaccine Congress Washington to give us his take on regulatory expectations for a biological process:   What are the Regulatory Expectations for a Validated Process? · A qualified facility that has been demonstrated to be capable of supporting the process · An assessment of …

What are the new regulatory considerations for vaccine manufacturing?

Vaccine manufacturing is at the heart of the vaccine industry. Jane Halpern, Vice President, Regulatory Affairs, Novavax joined us at the World Vaccine Congress 2012 in Washington to detail the new regulatory considerations for vaccine manufacturing. Novavax is developing a series of recombinant vaccines for infectious diseases using its recombinant nanoparticle platform, a Virus-like particle (VLP) vaccine (influenza) with Nanoparticle …