Defining Go And No-Go Disease Areas As An R&D Business
Exploring How Unmet Need Effects Decision-Making And How The Term Has Evolved
Some believe unmet need refers only to rare diseases and tiny patient populations. But it is more than this. In 2020, the term sits at the heart of decision-making for drug makers – along with cost, access and value, of course.
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With new antibiotics a rare commodity, persistently inadequate reimbursement for innovations and worthy but often piecemeal pilots, antimicrobial resistance has quietly risen to become a factor in well over a million deaths annually. Now that COVID-19 is not the all-encompassing threat to health it was until fairly recently, AMR is once again moving towards the center of attention. But properly funded actions and mindset changes are needed.
Increasing scrutiny is being placed on trial sponsors and regulators to improve trial data reporting. Researchers complain that, without access to specific data, results cannot be easily duplicated, which inhibits greater understanding of how medicines might work, adversely affecting treatment decisions and health care costs. Are penalties and public reprimands enough to change behavior?
Exploring the continued controversy around the 340B US federal drug discount program. As the story moves into 2022, key questions remain unanswered.