The Need for Increased Maturity in the Risk Assessment Ecosystem

Descriptive words blog

by Dr. Jean Orelien

Last year, the US EPA declared they would phase away from animal testing by 2035. Reaching this milestone will require the maturity of the risk assessment ecosystem. By maturity, I mean new roles need to be assumed along with improved interactions and (stronger) bonds within and between group as well as new entities. In this post, I share a few ideas as to what this might look like. 

While there are certainly exceptions, much of the regulated community does not have the expertise and capacity to develop and implement new approach methods (NAMs), otherwise referred to as non-animal data, that would be suitable for risk assessment. As such, there needs to be contract research organizations (CROs) that can assist in generating and interpreting the data from these studies. One would expect the larger companies in our industry Covance (owned by Labcorp), Charles River Lab (CRL) or Eurofins to pivot to meet these needs, but the problem with giants is that it is difficult for them to turn on a dime. Also, for these behemoths, the chemical industry is not their largest or most profitable client segment; it is pharma. As a result, given the increased demand for studies using NAMs for regulatory submissions, smaller and emerging CROs must step up to help meet the 2035 EPA target. ScitoVation intends to become one of the chemical industry trusted CROs to help conduct NAMs studies for both regulatory submissions and supporting internal decisions. 

What we outlined above is the role that must be fulfilled by both existing CROs and inevitably, new entrants. For these CROs to serve their clients and the public, there needs to be greater collaboration in the risk assessment community. This is particularly key between industry (manufacturers and service providers) and government agencies. For example, the acceptance of a novel method will require interactions to first build confidence and then develop standards for submissions. While there are established frameworks for the validation of new tests (*), the reality is that building confidence in a new approach is a process that demands consultations with the different parties. In our experience, we have found that some US regulators are more open to providing feedback on new methods and what it would take for them to accept evidence from these methods for submission.  To build industry-wide confidence in the data we are generating as service providers,  we must put robust quality assurance procedures in place to ensure that a study submitted by a CRO can be replicated by any other provider. There is this perception that in vitro studies are more likely to show spurious relationships or have greater variability (between studies or between labs). This will necessitate that we have in place beyond scientific rigor, what I would term “logistical rigor” from the consistency in the quality of the cells we use to the templates for submission of the results. 

Finally, part of the maturation of our ecosystem will require new entrants in the form of funders such as venture capital (VC).  This is akin to plant-based foods where VC capital has led to the creation of unicorns (companies with more than $1B in valuation) such as Impossible Foods, NotCo, or Oatly. It is estimated that the in vitro and in silico market is forecasted to double in size from $25B to $51B over the next seven years(+). Note that an injection of capital in our industry is likely to introduce new innovations that impact preclinical services for pharma given the skills for assessing chemical safety of chemicals is interchangeable with the skills for determining both safety and efficacy in the drug discovery phase.  

At ScitoVation, we are preparing for the new era of regulatory submissions using NAMs by working with the various members of the risk assessment community. One of the roles we believe we can best play is as a bridge between industry and regulators in the type of studies to be conducted and the presentation of the results. This was our role with the first submission of data from a type of mathematical model (PBPK) to determine the impact of a chemical on sensitive and vulnerable populations (within human variability). We are also working with both government agencies and industry partners on a solution to predict whether chemicals impact thyroid. Because we have been fortunate to develop scientific methods and software that are widely used for assessing chemical safety, we believe that we owe it to our community to help implement these methods. As such, we recently increased our education and outreach efforts. We offer more frequent webinars (monthly) and  classes where we ensure participation from different segments. 

We welcome your input on how ScitoVation can be a better partner in an era where we decide on safety of compounds using NAMs.  

References: 

(*) http://www.oecd.org/officialdocuments/publicdisplaydocumentpdf/?doclanguage=en&cote=env/jm/mono(2005)14).  Accessed August 16th, 2021 

(+) Grandview Research: https://www.grandviewresearch.com/industry-analysis/in-vitro-toxicology-testing-market#:~:text=b.-,The%20global%20in%2Dvitro%20toxicology%20testing%20market%20size%20was%20estimated,USD%2025.2%20billion%20in%202021.&text=The%20global%20in%2Dvitro%20toxicology%20testing%20market%20is%20expected%20to,USD%2051.1%20billion%20by%202028. Accessed August 16th, 2021 

(^) US EPA (2019) https://www.epa.gov/ingredients-used-pesticide-products/evaluation-fqpa-safety-factor-pyrethrins-and-pyrethroids . Accessed August 2021.