More than half of new drug approvals last year were for rare diseases – which face long cycle times and other operational challenges that are necessitating the rapid adoption of new solutions, per a recent Tufts report.
Scientific advances and regulatory incentives are driving the use of genetics in drug development, though the industry’s ability to perform wide-scale testing has outpaced its understanding of the results, the misinterpretation of which can have “disastrous”...
Improving the prognostic value of early phase data is among one of several ways to increase the probability of successes in drug development, a process which has become more expensive as failure rates have risen, says an industry expert.
As regulators work to advance the modern clinical trial, the risk-averse clinical research industry is falling behind in the race to bring new therapies to patients, says an industry expert, echoing the former FDA commissioner’s calls for innovation.
Natural history studies provide researchers with a better understanding of a disease’s progression, supporting clinical trial design, among other benefits, say industry experts commenting on the FDA’s new draft guidance.
Researchers describe a technique to quantify a person’s “immune age,” information which could help design and analyze clinical trials – improving the drug development process, among other “impressive” possibilities, says industry expert.