Applying Systems Thinking to Regenerative Medicine Proceedings of a Workshop (2021) / Chapter Skim
Currently Skimming:
1 Introduction
1 Introduction
Pages 1-8
The Chapter Skim interface presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter.
Select key terms on the right to highlight them within pages of the chapter.
From page 1... ...
It is important to understand which measurements accurately and reliably characterize products in a way that is predictive of their clinical efficacy and safety for patients. The quality attributes of regenerative medicine products was a topic of discussion at a previous public workshop of the Forum on Regenerative 1The planning committee's role was limited to planning the workshop, and the Proceedings of a Workshop was prepared by the workshop rapporteurs as a factual summary of what occurred at the workshop.
|
From page 2... ...
It is a multidisciplinary effort and can incorporate tools and knowledge from the fields of data science, biology, engineering, manufacturing, regulatory science, and clinical research and therefore requires the use of disparate data sources. Systems thinking for regenerative medicine might involve consideration of the characteristics of starting materials, ancillary materials, manufacturing processes, and patient characteristics in models that consider the physical factors that control the regulatory pathways associated with a given therapeutic outcome.
|
From page 3... ...
To explore how cross-disciplinary systems thinking approaches can support the identification of relevant quality attributes and streamline manufacturing and regulatory processes of regenerative medicine products, a planning committee of the National Academies of Sciences, Engineering, and Medicine will hold a public workshop. Speakers at the workshop may be asked to discuss new advances in data acquisition, data analysis and theoretical frameworks, and how systems ap proaches can be applied to the development of regenerative medicine products that can address the unmet needs of patients.
|
From page 4... ...
In addition to a focus on data, data structures, data modeling, and how data modeling and theory can help cultivate the understanding and development of regenerative medicine products, Roy encouraged workshop participants to consider several additional issues. In particular, he mentioned challenges related to data-intensive analytical methods and theoretical models, strategies to influence the regulatory process using data and theoretical approaches, and the use of systems modeling and artificial intelligence to optimize and manage the complex supply chain for regenerative medicine products.
|
From page 5... ...
FIGURE 1-1 Cell therapy: interaction of multi-scale dynamic complex systems. SOURCE: Krishnendu Roy workshop presentation, October 22, 2020.
|
From page 6... ...
SOURCE: Anne Plant workshop presentation, October 22, 2020.
|
From page 7... ...
. Speakers discussed the use of artificial intelligence in cell and gene therapies, modeling the manufacturing process in regenerative medicine, and supply chain and cost modeling.
|
Key Terms
This material may be derived from roughly machine-read images, and so is provided only to facilitate research.
More
information on Chapter Skim is available.