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  • Today's challenges to drug development
    Over the last 20 years, bringing a drug to market has become increasingly time-consuming, risky, complex and expensive. Many stakeholders have changed their attitude towards new drugs and line extensions of existing drugs.
  • Regulatory change
    Following several high-profile market withdrawals as well as emerging safety issues with “well-established” marketed drugs, regulators have become increasingly risk-averse. As a result,
    Any preclinical safety signal is now being “greeted” with increased scrutiny
    The size of clinical safety databases has increased substantially
    Efficacious new drugs have been refused approval because of “questionable” effect size
    Reliance on surrogate markers has decreased and hard endpoints are increasingly necessary to secure approval
    Extensive post-approval commitments are now the norm, rather than the exception
    Lastly, failures of other products of the same class or in the same indication lead to increased scrutiny of the new candidate
  • Market access hurdles
    In turn, payers have also become reluctant to grant premium prices to new drugs. After witnessing the tsunami of popular “me-too” drugs from classes such as the statins, ACE-inhibitors, PPI’s, biphosphonates (to mention a few), they saw the emergence of high-cost treatments for low-prevalence or orphan indications. In an effort to curb expenditure increases in drug budgets, virtually all payers now demand:
    Rigorous demonstration that incremental treatment costs result in added value as compared to “standard of care”
    Long-term, “real-life”, and often: local usage data that show appropriate use of the new product
    Periodic review of reimbursement status in light of the changing state of the art
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