The need to optimize drug development and facilitate faster access for patients has ignited
discussions around the importance of improving interactions between health technology …

Earlier patient access to beneficial therapeutics that addresses unmet need is one of the
main requirements of innovation in global healthcare systems already burdened by …

Implicit in the drug-approval process is a host of decisions—target patient population, control
group, primary endpoint, sample size, follow-up period, etc.—all of which determine the …

Rare diseases are associated with difficulties in addressing unmet medical needs, lack of
access to treatment, high prices, evidentiary mismatch, equity, etc. While challenges facing …

Adaptive, seamless, multisponsor, multitherapy clinical trial designs executed as large scale
platforms, could create superior evidence more efficiently than single‐sponsor, single‐drug …

Background: Adaptive approaches to the introduction of drugs and medical devices involve
the use of an evolving evidence base rather than conventional single-point-in-time …

After nearly a decade of discussion, analysis, and development, the Medicines Adaptive
Pathways to Patients (MAPPs) initiative is beginning to see acceptance from regulators …

The current system of biomedical innovation is unable to keep pace with scientific
advancements. We propose to address this gap by reengineering innovation processes to …

Investment in R for drugs launched in the late 1970s to early 1990s generated good returns
for investors. R was inexpensive. Clinical trial success rates were high. Consumption was …

We explore differences between biosimilars and conventional small molecule
pharmaceutical generic drugs with respect to development, regulatory requirements, legal …