Interesting statistics in this (short) article which confirm our vision that more nimble, tech savvy biotechs are the future of drug R&D and late stage compounds. They are beating BP (relic, antiquated thinking, too big to make the turns, entrenched) all to Hell.
Bodes well for the “next wave” of BP’s being incubated now, in the form of small, smart, faster biotechs!
Go AVXL, and all other small start-ups...the future of medicine!!
(Had to cut and paste - paywall)
Help with a better version is welcomed...it had graphics...which aren’t appearing here. Still...the info/text is relevant.
Biostock
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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In a new report out looking over the landscape of drug R&D, IQVIA has been tracking the swelling role that startups play in the development game. And some of the conclusions may surprise you.
First and foremost, the number of active R&D compounds surged 37% in the 5 years from 2013 to 2018. And with biotechs able to operate increasingly independently of Big Pharma partners, the researchers determined that emerging companies now control 72% of the 2,853 late-stage drugs they tracked.
That’s up from 65% of a much smaller set of 2,083 therapies in 2013 and 52% of the 1,383 drugs in late-stage development in 2003. And close to half of the new drugs approved last year were launched by emerging biotechs, in stark contrast to the domination large companies once enjoyed in the marketing arena.
Big Pharma’s share of the late-stage pipeline, meanwhile, has plunged from 31% to 20% over the past decade.
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.
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.
• 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.
• 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.
• 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.
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