• posted by: Lee Smith
• posted on: March 28, 2017

Several vaccines for Zika virus including a traditional inactivated virus vaccine, as well as newer DNA vaccines have passed animal tests and are now ready for human trials.

• posted by: Lee Smith
• posted on: January 30, 2017

Last October (2016) I posted an article on whether there should be a global vaccine development fund. Therefore, I was very excited to see an announcement made at the World Economic Forum in Davos, Switzerland on January 18th (2017) that a new global coalition had been formed; the Coalition of Epidemic Preparedness Innovations, or CEPI.

• posted by: Lee Smith
• posted on: December 31, 2016

Happy 2017!

• posted by: Lee Smith
• posted on: December 21, 2016

Just a quick note from all of here at GreyRigge Associates, we’d like to wish you a Merry Christmas and a very Happy New Year

• posted by: Lee Smith
• posted on: November 15, 2016

I’ve been working closely with contract manufacturing organisations (CMOs) for many years now.  Some of these have been in the USA, some in Europe and some in Asia.  What they have in common is that all have been a vital component in the development and manufacturing strategy of the organisations that I’ve been working for.   Unsurprisingly, I was generally working with a small and mid-size biopharmaceutical entity (SME) rather than multinational pharma that often have the resources to perform their own manufacturing or testing whereas the smaller companies do not.   If you look at the numbers relating to CMO use in the United States, almost 80% of products approved by the FDA will have been manufactured by a CMO on behalf of a SMEs. This drops to approximately 50% for mid-sized companies.

• posted by: Lee Smith
• posted on: October 25, 2016

I recently attended the World Vaccine Congress in Barcelona. I joined a round table discussion hosted by Dr. Greg Poland from the Mayo clinic where the question asked was ‘should there be a vaccine development fund?’ The thrust of the discussion was based upon a publication that was made in the New England Journal of Medicine last year about Establishing a Global Vaccine-Development Fund. Vaccine funding is a complex question. Vaccines are probably one of the better value, if not the best, medicinal investments in that they focus on disease prevention rather than treating the consequential symptoms of the disease. Therefore, we might say from a public health economics perspective that vaccines make a lot of sense. But is that true?

• posted by: Lee Smith
• posted on: October 11, 2016

Frequently when a process development team are putting together the upstream and downstream components of their processes, the last thing on the their minds is the performance of the tests or assays that they'll be measuring it by.  Even if they do think about, they may make an unhealthy assumption that they can simply rely on the data.  Sometimes they'll be right, often they'll be wrong.  When measuring the performance of their process they need to be thinking about the process variability.....

• posted by: Lee Smith
• posted on: October 5, 2016

Dr. Lee Smith from GRA will be attending the World Vaccine Congress 2016 in Barcelona from the 10-12 October. The conference will be held at the Fairmont Rey Juan Carlos hotel. Hope to see you there!

• posted by: Lee Smith
• posted on: October 4, 2016

GreyRigge Associates (GRA) has re-developed its website with the new site containing features including blogs, articles, videos, presentations and templates all relating to the biotech industry.  All of these features will be regularly updated over the coming months.  The site also connects to social media including sites like Linked In, Twitter and Google so please do take a moment to connect with or follow GRA so you can find be amongst the first to find out new content has been added to the site.  Furthermore, at the bottom of the website you’ll see a signup feature.  If you want to receive our quarterly newsletter then please add in your name and email and we’ll do the rest.