Discussion 2

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University of Massachusetts, Boston *

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6463

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Medicine

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Oct 30, 2023

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Uploaded by MasterMule3708

Discussion 2 The term "unmet clinical needs" refers to flaws or gaps in the current healthcare system where available therapies or strategies are insufficient to meet particular patient populations or health conditions. Research, patient feedback, clinical observations, data analysis, and regulatory guidelines are frequently combined to determine these needs. They serve as an example of the difficulties patients, healthcare professionals, and the medical community encounter in providing quality care and obtaining the best possible health results. Unmet clinical needs that have been recognised act as a catalyst for healthcare innovation. They serve as a catalyst for the creation of novel treatments, technologies, medications, medical devices, and healthcare practices that can close these gaps and offer patients greater options. In order to improve patient well-being, advance medical science, and push the boundaries of innovation, it is crucial to address unmet clinical demands. (Zhang,2021) These unmet demands are closely related to the development of a Target Product Profile (TPP) once they have been acknowledged. The TPP functions as a strategic pathway chart, laying out the particular qualities and traits a new medical product should have to successfully close those identified clinical gaps. Efficacy, safety, patient demographics, dose, administration, and other details are included. The TPP also takes market trends and rivalry into account to make sure the product can successfully satisfy customer expectations. The TPP directs research, clinical trials, regulatory strategy, and commercialization efforts throughout the product development process, ensuring that the finished product is in line with the identified unmet clinical needs and is well-positioned to have a significant impact on patient care and healthcare results. (Cocco et al., 2020) (Identifying and Filling the Unmet Need - ORA Clinical, 2017) Unmet clinical needs must be dealt with, and an in-depth Target Product Profile (TPP) needs to be developed. These steps are crucial to a product development plan because they support both commercial and regulatory objectives. These components prioritise the needs of patients and link product development to actual healthcare issues. Achieving regulatory approvals is more likely when clinical needs and TPP specifications are followed, ensuring that goods meet strict safety and efficacy requirements. (Lambert,2010) In addition, from a business point of view, this strategy can result in market excellence, quicker adoption, and long-term profitability by providing solutions that are actually appealing to healthcare providers, payers, and patients. Additionally, it reduces the risks connected to purchasing products that might not be accepted by the market or approved by regulatory bodies. In the end, these components fill the gap between moral healthcare innovation and prosperous commercialization. (Anderson, 2022) References:- Zhang, K., Kumar, G., & Skedgel, C. (2021). Towards a New Understanding of Unmet Medical Need. Applied health economics and health policy, 19(6), 785–788. https://doi.org/10.1007/s40258-021-00655-3 Identifying and filling the unmet need - ORA Clinical. (2017, December 12). Ora Clinical. https://www.oraclinical.com/resource/identifying-and-filling-the-unmet-need/

Cocco, P., Ayaz-Shah, A., Messenger, M., West, R., & Shinkins, B. (2020). Target Product Profiles for medical tests: a systematic review of current methods. BMC Medicine, 18(1). https://doi.org/10.1186/s12916-020-01582-1 Lambert W. J. (2010). Considerations in developing a target product profile for parenteral pharmaceutical products. AAPS PharmSciTech, 11(3), 1476–1481. https://doi.org/10.1208/s12249-010-9521-x Anderson, T. (2022, February 16). The Road To Commercial Success - The Target Product Profile | Premier Consulting. Premier Consulting. https://premierconsulting.com/resources/blog/the-road-to-commercial-success-the- target-product-profile/

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