How do we improve prediction rates for safety and efficacy measurements of chemical compounds? Why should consumers, patients, advocates, and scientists care about the efficiency and safety aspects of how chemical compounds are manufactured and tested? The short answer is “time and cost”: 1) time needed to develop novel effective compounds and drugs for consumers and patients, respectively; and 2) cost estimates used by large corporations to prioritize their product pipelines and internal R&D. Ultimately, the end-users (patients, in all medical cases) are affected by how quickly a new-and-better better drug is delivered to their bedside. That’s why we should care.

To give you some estimates on the need:

1) Pharmaceuticals: >90% of drug candidates fail in clinical studies, with an average drug development cost of ~$4Billion – $11Billion (US Dollars). How can we improve these numbers?

2) Industrial Chemicals: there is a growing concern over the lack of safety data (>10K chemicals worldwide) on humans. Most recently, the US Department of Defense and the EPA issued a comprehensive report on in vitro and computational methods, assays, and platforms that are needed for categorizing chemicals and evaluating their safety.

3) Pesticides: >10,000 compounds need registrations on their effects on the environment and on humans. The current process still requires animal-testing (a time consuming and costly process).

4) Cosmetics ingredients: european cosmetics directives have banned animal testing in recent years. There is rising concern over safety and animal testing worldwide (~1.7billion consumers). In June of 2015, a new bill — the Humane Cosmetics Act — entered the US House of Representatives (see Ref4 below). What’s next?

Which types of technologies will assist in the evaluation of chemical compounds? A few chemistry, toxicology, and biophysics experts have come forward (see Refs 1-3 below). They organized “chemical responses” into the following flowchart:

Chemical properties –> Macro-Molecular Interactions –>Cellular Responses –> Organ Responses –> Organism Responses –>Population responses.

Moving forward, scientists and government administrators need to agree on:

1) key molecular genetic phenomenon for which non-animal tests can be developed for assessment.

2) toxicity assessments with low uncertainty and high human relevance.

3) validated human cellular models that will eventually replace animal-testing.

Food for thought? Your comments are encouraged!

~Lilly of Tempo’s Support Team support@tempobioscience.com

References:

1) Catherine Willett, PhD, Human Toxicology Project Consortium, The Humane Society of the United States.

2) Kristie Sullivan, Physicians Committee for Responsible Medicine, SOT annual meeting, March 2014.

3) Ankley et al., 2010, Environ Tox Chem 29(3): 730-741.

4) Passage of the Humane Cosmetics Act, H.R.2858, will bring the U.S. in line with more than 30 other countries – home to more than 1.7 billion consumers – that have already implemented similar bans on animal-testing. The bipartisan bill was introduced by U.S. Reps. Martha McSally (R-AZ), Don Beyer (D-VA), Joe Heck (R-NV) and Tony Cárdenas (D-CA).