Replies to post #190236 on Anavex Life Sciences Corp (AVXL)

[nidan7500]

Thanks Biostockclub:

The biotech era in late-stage drug R&D and marketing has arrived. And it looks like it’s here to stay

by john carroll — on April 23, 2019 09:15 AM EDT

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IQVIA also tracked a distinct slip in success rates, with the overall composite rate sliding from 14.4% to 11.4% last year. The report concludes:

Trial productivity has been highest for respiratory, infectious disease and endocrinology and lowest for oncology and declined 27% from 2013 to 2018 across all trial phases, heavily influenced by a decrease in productivity in Phase I.

CNS Diseases not mentioned and yet it is the area of great need?



As always, that problem with productivity has focused attention on a new set of technologies that have been grabbing the attention of R&D execs. And here’s the tool kit that IQVIA sees as the most likely to spur real change — though they’re likely to get some kickback on several of these.

IQVIA’s spotlight fell on:

• Digital health technologies to enable the capture of drug efficacy and safety data remotely, which can improve patient safety, enable virtual trial formats and ease site work burden. (read ERP)

• Patient-reported outcomes that will shed new light on patient experience and drug efficacy and safety outside the clinical setting and lead to accelerated trial times as endpoints shift. Read QOL/RWD/RWE

• Real-world data to optimize trial design, speed investigator and site selection, and enable new trial designs by acting as virtual control arms and supporting pragmatic, adaptive and RWE registry trials.

• Predictive analytics and artificial intelligence to identify new clinical hypotheses, reduce trial design risks and speed enrollment by identifying protocol-ready patients. (SEE)

• Shifts in types of drugs tested, for instance, to targeted therapies and next-generation biotherapeutics that improve efficacy and success rates and have accelerated development timelines but require longer-term patient follow-up.

• Biomarker testing availability to help narrow patient populations to those more likely to see effect, resulting in improvements in efficacy, safety and success.

• Regulatory landscape changes that will encourage the adoption of precision medicine approaches, novel trial designs and endpoints while providing means for accelerated drug approvals and regulatory success.

• Pools of pre-screened patients and direct-to-patient recruitment, which will facilitate enhanced trial enrollment, shortened trial duration and faster market availability.

Maybe we are on the right track w/changes in locations and methods, timing accelerated RWE.