San Diego, US is host to the Society of Toxicology (SOT) annual conference this week, welcoming nearly 7,000 preclinical sector professionals to discuss the latest trends and developments.
US contract research organisation (CRO) Charles River Laboratories (CRL) has sent 90 staff to SOT this year according to company musculoskeletal research scientist Rana Samadfam, who told Outsourcing pharma that microbiome science is a big focus this year.
“A trend we are seeing at SOT this year are discussions surrounding the new and red-hot area of microbiome science represented in a number of talks and papers. It’s new and it’s interesting and it’s no longer just the focus of microbiologists.”
For our non-microbiologist readers, a microbiome is the collection of microorganisms that all animals carry – humans are colonised by 200 and 1400grams of bugs according to various estimates – which impact health.
In preclinical research it is increasingly being recognised that the microbiomes of animals used to test drugs need to be taken into consideration when interpreting results.
e-Cigarettes and new diseases
For Battelle Life Sciences Research emerging diseases are a hot topic at SOT this year.
Spokesman Chris Corsbie told us “there are many emerging infectious diseases that require development of new drugs and vaccines and these studies require specialized biocontainment facilities" adding that "many of these diseases require regulatory approval under the FDA “Animal Rule” where pivotal efficacy must be demonstrated in animals. To accomplish this there are often requirements to establish specific biomarkers in the animal model that will represent efficacy in humans.”
Crosbie cited Ebola as an example, explaining that: “This year’s special session will highlight our knowledge of the development of drugs and vaccines for Ebola.”
He also highlighted inhalation research as a growth area for the preclinical sector, explaining that the market is being driven by “new regulatory initiatives for tobacco products and specifically new harm-reduction products like electronic cigarettes.”
Minimizing animal research
Growing regulatory demand for more effective drug safety testing is coupled with pressure to minimize the use of animals in research and this is another hot topic for SOT attendees according to Corsbie, who explained the firm monitors alternatives to keep pace with the changing environment.
He said the Battelle had focused on “becoming proficient in robust in vitro models for drug safety and then predicting when these new techniques will become acceptable and embraced by the FDA” adding that the firm a goal of minimizing the use of animals in research.