www.biopharminternational.com October 2021 eBook BioPharm International 25
to comply. In the meantime, compa-
nies are encouraged to be proactive in
establishing a data-handling frame-
work and setting up policies that will
help them align with the forthcoming
regulations. A robust framework and
processes put into practice by compa-
nies in regulated environments could
serve as the basis for new regulations
for AI, making it easier for these com-
panies to comply.
I m p l e m e n t i n g s o l u t i o n s a n d
processes for ensu r ing data qua l-
it y is necessar y for sca labilit y and
ongoing relevance in the industr y.
Organizations that embrace digitiza-
tion for the creation and curation of
data to pursue trends in AI will effec-
tively circumvent the challenges and
risks inherent with the technolog y.
Modernizing data handling enables
companies to identif y and mitigate
issues that could other wise lead to
inaccurate AI outcomes.
REFERENCES
1. Sumitomo Dainippon, "Sumitomo
Dannippon Pharma and Exscientia
Joint Development New Drug
Candidate Created Using Artificial
Intelligence (AI) Begins Clinical
Study," ds-pharma.com/ir/news/pdf/
ene20200130.pdf, Jan. 30, 2020.
2. G. Press, "A Very Short History of
Artificial Intelligence (AI)," forbes.
com, Dec. 30, 2016.
3. A. Kudumala, D. Ressler, & W.
Miranda. "Scaling Up AI Across the
Life Sciences Value Chain," deloitte.
com, Nov. 4, 2020.
4. A. Powell, "AI Revolution in
Medicine," news.harvard.edu, Nov.
11, 2020.
5. FDA, "Resiliency Roadmap for FDA
Oversight," fda.gov/media/148197/
download, May 2021.
6. FDA, "Data Modernization Action
Plan," fda.gov/about-fda/reports/data-
modernization-action-plan, Mar. 3,
2021.
7. FDA, "Advancing Regulatory
Science at FDA: Focus Areas of
Regulatory Science (FARS)," fda.gov/
media/145001/download, 2021.
8. FDA, "Real World Evidence," fda.
gov/science-research/science-and-
research-special-topics/real-world-
evidence, July 16, 2021.
9. K. Zo et al., J Multidiscip Healthc,
2020; 13: 671–679. July 22, 2020.
10. UN News, "WHO Guidance
on Artificial Intelligence to
Improve Healthcare, Mitigate
Risks Worldwide," news.un.org/en/
story/2021/06/1094902, June 28,
2021.
11. M. McCarthy, "Artificial Intelligence
in Health: Ethical Considerations
for Research and Practice," himss.org/
resources/artificial-intelligence-health-
ethical-considerations-research-and-
practice, June 17, 2019.BP
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