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The Future of Clinical Trials at Pfizer

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BY JESSICA DaMASSA

From de-centralized clinical trials to real world data (RWD), real world evidence (RWE), and even social media, the future for clinical research at Pfizer sounds increasingly tech-enabled and focused on meeting and engaging patients where they are.

Pfizer’s Head of Clinical Trial Experience, Judy Sewards, and Head of Clinical Operations & Development, Rob Goodwin, drop in to chat about what Pfizer’s approach to clinical research looks like now, after the rapid evolution it underwent to “lightspeed” the development of the Covid-19 vaccine.

The big change? Rob says they are “obsessed” with de-centralized trials, with nearly 50% of clinical trial visits still happening virtually. And, beyond the convenience factor, both point to de-centralization as a critical factor in being able to recruit more patients into trials as well as improve the diversity of their participant groups. In the end, the decentralized approach, says Judy, is “not just a matter of equity, but good science as well.”

And what about improvements to the cost of drug development? Is it too soon to tell if de-centralization will make an impact on the bottom line? Innovation may be expensive to implement at first, but, explains Rob, “If you can recruit your trial faster, overall, the cost of development goes down and speed to the patient goes up.”

We chat through the full suite of benefits that de-centralized clinical trials are bringing Pfizer and its patient populations, and get into the utility of real-world data, which also saw new notoriety when the Covid-19 vaccine was being developed. How is RWD impacting clinical research even when it’s not being used as evidence in a regulatory approval process? Watch and find out more about how data innovation is shaping the future of pharma!

Ribbon Health & Provider Data’s Holy Grail: The Accurate Provider Directory

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BY JESSICA DaMASSA

It’s one of the greatest mysteries of the era of health data digitization: Why is provider directory still so hard to get right?? Ribbon Health’s co-founder & CEO Nate Maslak explains how Ribbon (which started out in the symptom-checker biz) pivoted to take on, once-and-for-all, the miserable state of provider data management to not only fix provider directories (which are still wrong 50% of the time!), but also referral management systems, health plan enrollment data, and now, thanks to those new price transparency rules, price lists.

“All of the different use cases we focus on around enrollment, referral management, provider data management for directory…” explains Nate, “These are actually the same problem that use different words to describe it because of the different parts of the ecosystem that we’re in.” So, as Ribbon gets the process right for provider directory by building an underlying tech platform that uses predictive analytics and network effect methodologies to work its magic to validate-and-verify that kind of healthcare data, then it can apply that framework to ANY healthcare data to the same end. And, maybe one day, layer member-facing services – like instant-booking with a doc – on top of them.

Backed by nearly $54 million from Andreesen Horowitz and General Catalyst, and we get into what makes this startup’s take on one of the oldest healthcare infrastructure issues so appealing. From platform to business model (which serves a mix of health plans, provider orgs and patient-facing solutions) to grand plans for the future (which include figuring out how “API as a platform” can further productize provider data management and power care decisions) we chat with Nate on all things Ribbon Health.

When Medical Error Becomes Personal, Activism Becomes Painful

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BY MICHAEL MILLENSON

In the mid-1990s, researching a book about the quality of medical care, I discovered how the profession had for years been ignoring evidence about the appalling death toll from preventable medical error. Though I’d never myself experienced an error, I became an activist.

Recently, however, a relative was a victim, and the frustrating persistence of error became personally painful.

Thanks to my relative being acutely aware of the need to be alert (and a bit of luck), no harm was caused by what could have been a serious medication mistake. That was the good news. The bad news is that even Famous Name Hospitals, like the one where my relative was treated, are rarely doing everything possible to forestall the impact of inevitable human fallibility.

September 17 was World Patient Safety Day, and the theme for the next 12 months is “Medication Without Harm.” That makes this an opportune time to examine more closely what the profession euphemistically calls a “medication misadventure.”

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Goliath, Meet David

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BY KIM BELLARD

I’m a sucker for underdog stories.  I love unconventional wisdom overthrowing conventional wisdom. I’m deeply suspicious of Big Tech, Big Oil, and big health.  I know unfettered competition is not always to my benefit but get nervous when I don’t really have many options.  

So when I read that Google is starting to worry about a threat to its search dominance and that TikTok and other social media giants are scared of a rival start-up, well, count me in. I just wish it was health care goliaths that were worried.

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#HealthTechDeals Episode 46 | Redesign Health, Theranica, Soda Health, and Kyruus

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It’s that time of the year! Summer is over and it’s conference season! The Rock Health Summit was a fun session, the highlight of which was diversity, equity, inclusion, and representation. Tune in for Jess’s and my thoughts on the summits, the end of the world, and new deals: Redesign Health raises $65 million, Theranica raises $45 million, Soda Health raises $25 million, and Kyruus buys Epion Health.

-Matthew Holt

Constructed of star dust, will Guardian Angels continue to exist?

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BY MIKE MAGEE

“EXCLUSIVE: Royal beekeeper has informed the Queen’s bees that the Queen has died and King Charles is their new boss in bizarre tradition dating back centuries. … He placed black ribbons tied into bows on the hives, home to tens of thousands of bees, before informing them that their mistress had died.”

So read John Dingwall’s exclusive in the Daily Mail posted at 03:48 EDT, 10 September 2022. In defense of what might first appear a bizarre practice, others were careful to provide evidence that the practice, of informing fellow natural creatures of important human losses, is well documented in art and literature, such as in “Der Bienenfreund” (“The Bee Friend”), an 1863 painting by the German artist Hans Thoma.

That painting arrived on the scene nine years after the death of German philosopher Friedrich Wilhelm Joseph von Schelling, a stalwart of “German Idealism.” His focus (in part) was on “humankind’s relationship to nature,” a subject that has received a spotlight as our planet’s “climate emergency” status  has become undeniable.

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THCB Gang Episode 104, Thursday September 15 at 1pm PT, 4pm ET

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Joining Matthew Holt (@boltyboy) on #THCBGang on Thursday September 15 patient safety expert and all around wit Michael Millenson (@mlmillenson); Suntra Modern Recovery CEO JL Neptune (@JeanLucNeptune); fierce patient activist Casey Quinlan (@MightyCasey); delivery & platforms expert Vince Kuraitis (@VinceKuraitis); &  policy expert consultant/author Rosemarie Day (@Rosemarie_Day1);

You can see the video below & if you’d rather listen than watch, the audio is preserved as a weekly podcast available on our iTunes & Spotify channels.

Why mandating boosters for college kids is a no good, very bad, dumb idea

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By ANISH KOKA and VIRAL MYALGIA

A number of colleges have mandated boosters for students returning to campus this fall. There are some points parents, teenagers, and whoever is coming up with policies at colleges may want to consider. Since no one has thought fit to actually generate any clinical data on boosters in college kids because of the continuous state of COVID emergency we have been in since early 2020, we are left to try to extrapolate from a vast amount of ecological data and surrogate endpoints.

While it would be impossible to include every single study ever done on the matter, there is clearly enough data to argue against their being the overwhelming scientific consensus that would be needed to underpin a policy that essentially forces individuals to receive a medical therapeutic.

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Start the Revolution without Us

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BY KIM BELLARD

Well, as usual, there’s a lot going on in healthcare.  There’s the (potential) Amazon – One Medical acquisition, the CVS – Signify Health deal, and the Walmart – United Healthcare Medicare Advantage collaboration.  Alphabet’s just raised $1b.  Digital health funding may be in somewhat of a slump, but that’s only compared to 2021’s crazy numbers. Yep, if you’re a believer that a revolution in healthcare is right around the corner, there’s a lot of encouraging signs.  

But I was in a Walmart the other day, and my thought was, these people don’t look like they care much about a revolution in healthcare. In fact, they don’t look like they much care about health generally.  That’s not a knock on Walmart or Walmart shoppers, that’s an assessment about Americans’ appetite for changes in our health care.  

That’s not to say we like our healthcare system.  A new AP-NORC survey found that 56% felt that the US did not handle healthcare well (curiously, 12% thought we handled it extremely/very well – huh?).  Prescription drugs, nursing homes, and mental health rated especially low.  We’d like the government to do more, but not, it would seem, if it means we pay higher taxes.

Much of what is wrong is our own fault. We know that we eat too many processed foods, that the food industry scientifically preys on us to target our weaknesses for fat, sugar, and salt, that we’d rather sit than drive and drive than walk, and that we are poisoning our environment, and, in turn, ourselves.  Given a choice between short term benefits versus long term consequences, though, we’ll eat that Oreo every time, literally and metaphorically.

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Meet Voice Tech Start-Up Cardiokol

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BY JESSICA DaMASSA

Early-stage health tech start-up Caridokol is developing technology that listens to the sound of a patient’s voice over a mobile phone, landline phone or smart speaker to detect and analyze vocal biomarkers that indicate that the patient may be suffering from disease. The voice tech co is proving its case first in detecting arrhythmias, which are often asymptomatic and usually go undetected until they’ve led to a more serious issue like a stroke.

Cardiokol’s CEO James Amihood explains the tech behind this first use case – which already has one US patent granted and is pending approval on three more – and his plans to expand the company’s base of vocal biomarkers to enter into new disease states and new markets. The company is currently raising a Series A funding round and is planning to expand from Israel and Europe to the US. How could the technology change the game for disease prevention, starting with strokes? James connects the dots to the big vision for the company’s future as he explains how Cardiokol’s tech is already providing those most at-risk of arrythmia a very cost-effective, simple-to-use way to screen and monitor their long-term heart health.

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