Is AAALAC Accreditation Mandatory for Biopharmaceutical Research?

It’s now well known that biopharmaceutical companies are increasingly turning to third-party suppliers to support their research and development. As this trend continues, more regulated, high-risk services are being outsourced, requiring an increase in the level of due diligence that research organizations must conduct before they can even begin a project. One of the fastest growing sectors in the contract research space for outsourcing is in vivo services, with the global in vivo CRO market projected to grow to over 6 Billion USD in the next 6 years.¹

Today, AAALAC is considered by many to be one of the higher standards of animal welfare accreditation. However, it is limited due to its basis on The Guide (published by the National Institutes of Health [NIH]) and a decided US regulation focused assessment. Additionally, it was originally designed to assist institutions with voluntary assessment; it was not meant to satisfy the specific needs of commercial entities. Currently, only 46% of AAALAC accredited facilities are in the commercial segment, with the remainder working in academia, non-profit, government and other public sectors.²

Due to the heavily regulated nature of novel drug development, appropriate due diligence is critical to ensure that the most reputable and highest quality suppliers are identified and accessed. In the current environment, this can often result in increased R&D costs and delayed timelines, but the alternative, using a subpar supplier, can not only cost potentially millions of dollars in lost development but can also jeopardize an organization’s reputation in the public eye. Not to mention, COVID-19 has made travel and onsite assessments even more difficult to complete.

Through Scientist.com’s work with the world’s top pharmaceutical companies, as well as many of the largest in vivo service providers, we found that one of the major pain points experienced on both sides is the difficulty of on-site assessments and due diligence. Different research organizations have varying animal welfare standards they must follow depending on the nature of the work being performed, location of the customer, stage of drug development, location of the study and many other variables. For this reason, many pharma companies cannot rely solely on US-based accreditations or other existing standards and still require their own site assessments before placing work with a supplier in the in vivo space.

VERIF.i, Scientist.com’s supplier pre-assessment program, pinpoints the standards to which each supplier site conforms, no matter where they are located geographically. As many organizations strive to improve their animal welfare programs, they may want to work with CROs that apply EU standards, even if they are in the US or Asia. VERIF.i provides the transparency needed to delve into details about caging, handling, euthanasia and more.* Additionally, VERIF.i assessments can be conducted anywhere and are on-demand. While borders may be closed, in-country experts are available to help meet the needs of our fast-paced industry.

Plus, the AAALAC accreditation process must fit within specific trimester deadlines, whereas VERIF.i assessments can be performed at any time agreed upon between supplier and auditor. Long term, AAALAC will likely cost more with upfront costs of $4k-$16k+ and annual fees of $3k-$11k+.³

As opposed to existing standards, VERIF.i was created by biopharma for biopharma. Here are a few defining elements of the program:

• Independent auditors – Assessments are conducted by trained external auditing firms, allowing for impartial, unbiased assessments

• Assessments performed prior to work being awarded – Suppliers and information is immediately available to customers upon completion

• Standardization - Every evaluation is performed in the same manner using the same criteria to ensure consistency

• Independent decision making - Instead of assigning a grade, Scientist.com allows each research organization to review the findings according to their own internal quality standards.

• No Pass or Fail - VERIF.I provides visibility to a supplier’s procedures, processes and auditor observations

• No annual fee – VERIF.i assessments are on-demand and valid for a period of 3 years. With no annual fee in between assessments, there are no additional surprise bills.

• VERIF.i is also available for providers of Human Biological Samples (HBS)

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Visit the VERIF.i info page to learn more about Scientist.com’s VERIF.i program.

Want to connect with the Scientist.com team to learn more? Email our Compliance team to get questions answered and schedule a demo.

References

1. https://www.reportsanddata.com/report-detail/in-vivo-cro-market
2. AAALAC International’s Trends Data Review 2013-2018 PPT
3. https://www.aaalac.org/accreditation-program/fees-and-deadlines/
4. https://www.globenewswire.com/en/news-release/2019/07/29/1892954/0/en/In-vivo-CRO-Market-To-Reach-USD-5786-4-Million-By-2026-Reports-And-Data.html
5. https://grants.nih.gov/grants/olaw/guide-for-the-care-and-use-of-laboratory-animals.pdf