Kevin Nam1, Kay Larholt2, Gigi Hirsch2, Paul Beninger3, David Fritsche2, Diane Shoda4, John Ferguson5, Florence T Bourgeois6,7, Donna Palmer2, Karen Katz8, Matt W Courtney8. 1. MIT Lincoln Laboratory, Massachusetts Institute of Technology, 244 Wood St., Lexington, MA, 02421, USA. kevin.nam@ll.mit.edu. 2. MIT Center for Biomedical Innovation, Massachusetts Institute of Technology, 77 Massachusetts Avenue, Building E19-604, Cambridge, MA, 02139, USA. 3. Public Health & Community Medicine, Tufts University School of Medicine, Boston, USA. 4. Greyscaling LLC, 3722 Las Vegas Blvd S, Unit 2111, Las Vegas, NV, 89158, USA. 5. Pharmacovigilance Specialty Care, Sanofi-Genzyme Business Unit, 50 Binney St., Cambridge, MA, 02142, USA. 6. MIT Lincoln Laboratory, Massachusetts Institute of Technology, 244 Wood St., Lexington, MA, 02421, USA. 7. Harvard Medical School, 300 Longwood Avenue Boston, Boston, MA, 02115, USA. 8. FoCUS Project, NEWDIGS, MIT Center for Biomedical Innovation, Massachusetts Institute of Technology, 77 Massachusetts Avenue, Building E19, Cambridge, MA, 02139, USA.
Abstract
BACKGROUND: Data sharing among stakeholders in the development, access, and use of drug therapies is critical but the current system and process are inefficient. METHODS: We take a Systems Engineering approach with a realistic use case to propose a scalable design for multi-stakeholder data sharing. RESULTS: We make three major contributions to the drug development and healthcare communities: first, a methodology for developing a multi-stakeholder data sharing system, with its focus on high-level requirements that influence the design of the system architecture and technology choice; second, the development of a realistic use case for long-term patient and therapy data tracking and sharing in the use of potentially curative and durable gene and cell therapies. Further, a bridge for the 'awareness gap' was found between the payer (Payer is organization which takes care of financial and operational aspects (which include insurance plans, provider network) of providing health care to US citizens. Or refer to health care insurers.) and the regulator communities by illustrating the common data tracking needs, which highlights the need for coordinated data activities; and third, a proposed system architecture for scalable, multi-stakeholder data sharing. Next steps are briefly discussed. CONCLUSION: We present a system design for multiple stakeholders such as the payer, the regulator, the developer (drug manufacturer), and the healthcare provider to share data for their decision-making. The stakeholder community would benefit from collaboratively moving the system development proposal forward for efficient and cost-effective data sharing.
BACKGROUND: Data sharing among stakeholders in the development, access, and use of drug therapies is critical but the current system and process are inefficient. METHODS: We take a Systems Engineering approach with a realistic use case to propose a scalable design for multi-stakeholder data sharing. RESULTS: We make three major contributions to the drug development and healthcare communities: first, a methodology for developing a multi-stakeholder data sharing system, with its focus on high-level requirements that influence the design of the system architecture and technology choice; second, the development of a realistic use case for long-term patient and therapy data tracking and sharing in the use of potentially curative and durable gene and cell therapies. Further, a bridge for the 'awareness gap' was found between the payer (Payer is organization which takes care of financial and operational aspects (which include insurance plans, provider network) of providing health care to US citizens. Or refer to health care insurers.) and the regulator communities by illustrating the common data tracking needs, which highlights the need for coordinated data activities; and third, a proposed system architecture for scalable, multi-stakeholder data sharing. Next steps are briefly discussed. CONCLUSION: We present a system design for multiple stakeholders such as the payer, the regulator, the developer (drug manufacturer), and the healthcare provider to share data for their decision-making. The stakeholder community would benefit from collaboratively moving the system development proposal forward for efficient and cost-effective data sharing.
Entities:
Keywords:
Gene and cell therapies; Multi-stakeholder sharing; Payers; Regulatory agencies; Scalable data architecture; Systems engineering
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