This significantly increases the risk of Adverse Drug Events (ADEs) and hospitalization. Up to one third of emergency admissions in elderly people is drug-related.
There remains a lack of clinical data to support prescription decisions as relatively few medicines have been clinically evaluated in age-appropriate patients. In addition, many drugs are not available in formulations that are suitable for the elderly, leading to non-compliance and lack of therapeutic efficacy. In 2011, the EMA introduced its Geriatric Medicines Strategy to ensure that the medical requirements of older people are identified earlier in the drug development process. In 2012, the ICH E7 guidelines were revised to include a greater focus on involving more geriatric patients in drug trials.
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Scope
– Reviews the current regulatory landscape and helps sponsors to understand the potential impact of recent guidelines.
– Assesses the barriers to entry in geriatric medicines and identifies potential ways to overcome them and improve clinical decision making.
– Evaluates the importance of establishing Target Quality Product Profiles (TQPP) to help sponsors determine the target patient population earlier on in drug development.
– Identifies treatment gaps and commercial opportunities based on primary care real-time data and KOL insights.
– Analyses different strategies to develop age-appropriate medicines in niche therapeutic fields and discusses methods to encourage the smarter prescription of medicines.
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Key Reasons to Purchase
– Utilize the insights from this study to analyze the barriers facing the geriatrics market
– Understand the impact of drug development in this market now and in the future
– Find out why regulators are paying more attention to unnecessary “exclusion criteria” and encouraging the inclusion of older people to ensure trials are age-appropriate and more representative of the real world setting.
– Assess the opportunities available for companies to develop age-appropriate dosages and formulations for existing drug classes that are currently widely associated with ADEs in the elderly as well as new therapeutic prospects.
Table of Contents:
Executive Summary
Methodology
Geriatric medicines: an overview
Emerging issues Unmet clinical needs Current landscape
Regulatory environment
Political will for change
Strategic considerations for developing geriatric medicines
Barriers to developing geriatric drugs
Clinical trial considerations
“Big data’s” role in identifying treatment gaps and commercial opportunities
Raising physician and patient awareness
Commercial opportunities to address the treatment gap
Improving existing therapies
New therapeutic opportunities Appendix
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