Vaccines“Knowledge of science is one of the most beautiful things humans have to offer each other.” Alan Alda, Actor and Science Communicator, who has a namesake Alan Alda Center for Communicating Science, Stony Brook University.
Infectious disease vaccines were a top story in 2015. During the summer of 2015, an Ebola vaccine was shown to be ‘highly effective against Ebola’. In addition, a vaccine against malaria currently under development is showing promising results, nearly cutting in half the cases of malaria in children between seven months and five years old.
And yet with this undoubtedly good news against devastating diseases, is an epidemic of vaccine denial in California, and its subsequent effects upon the spread of preventable disease. (For background on the anti-vaccine movement, here is a useful graphic reviewing the last 17 years from the original study - since discredited - until now.) In case you were wondering what kind of effect vaccines have had in annual deaths for fourteen diseases (from Rubella to Hepatitus A to Polio) here’s some data for you.
It is not only for infectious diseases such as malaria or the measles, but early work on neoantigen-based ‘personalized vaccines’ are showing promise against melanoma. In addition development work on a malaria vaccine may point the way to a potential method for a cancer therapeutic.
Personalized medicine
The year 2015 began with a President of the United States giving the annual State of the Union address and announced the Personalized Medicine Initiative, a multi-year effort ‘to lead a new era of medicine - one that delivers the right treatment at the right time’. An NIH Workshop on Building a Precision Medicine Research Cohort was convened shortly after, and the two-day workshop video and summary information are available online. Several sizable funding opportunities are still available. Several additional workshops, presentations and hearings have been held, with their transcripts and other resources available.
Against this backdrop, concerns between the use of genetic information and privacy are raised again, where personal genetics companies seek to aid pharmaceutical development. There is the potential for personalized medicine to become a 'Faustian bargain', where those whose DNA samples helped develop specific therapies may never be able to afford the resulting therapeutic.
Yet the ‘one-size-fits-all’ model of medicine is changing, and new models for clinical trials are needed in this age of precision medicine. Basket trials such as the NCI-MATCH (Molecular Analysis for Therapy Choice) have started in 2015, that will study more than twenty targeted cancer therapies, with 2,400 participating sites.
And by the way, in case there was any question whether Precision Medicine has had an impact on cancer survival rate, here’s one figure for you.
FDA Regulation
In October 2014 the FDA published draft guidance for regulatory oversight of laboratory developed tests, published in the Federal Register here. In February of 2015, the FDA held a public workshop entitled “Optimizing FDA’s Regulatory Oversight of Next Generation Sequencing Diagnostic Tests” to gather additional feedback from relevant stakeholders. And in November another workshop was held called “Standards Based Approach to Analytical Performance Evaluation of Next Generation Sequencing In Vitro Diagnostic Tests”. We wrote up one perspective here at Genomic Precision recently. The next workshop (on the topic of oncology) is expected to be held in early 2016.
2016 will be sure to have continuation of these themes that we'll be covering here at Genomic Precision. Be sure to register in order to receive new post notifications.
