CVS splashes into clinical trial services, leaning on local roots to change the game in terms of patient engagement

May 21, 2021 11:14 AM EDTUpdated 05:40 PM

CVS splashes into clinical trial services, leaning on local roots to change the game in terms of patient engagement

Nicole DeFeudis

Editor

Imagine picking up a gallon of milk and participating in a clinical trial while you’re at it.

That’s the future that CVS Health has dreamed up, and it could soon be a possibility as the company rolls out its new clinical trial services. While not technically a CRO, CVS Health plans to partner with them and drugmakers to recruit patients, run trials, and collect real-world data.

“Our focus is to give the patient or potential research participant choice,” Owen Garrick, VP of conduct and clinical trial services, told Endpoints News. “If we look at the assets and capabilities and history of CVS Health, we have the ability to essentially meet the patient where they are.”

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ZS Perspective: 3 Predictions on the Future of Cell & Gene Therapies

Ben Hohn

The field of cell and gene therapies (C&GTs) has seen a renaissance, with first generation commercial therapies such as Kymriah, Yescarta, and Luxturna laying the groundwork for an incoming wave of potentially transformative C&GTs that aim to address diverse disease areas. With this renaissance comes several potential opportunities, of which we discuss three predictions below.

Allogenic Natural Killer (NK) Cells have the potential to displace current Cell Therapies in oncology if proven durable.

Despite being early in development, Allogenic NKs are proving to be an attractive new treatment paradigm in oncology. The question of durability of response with allogenic therapies is still an unknown. Fate Therapeutics’ recent phase 1 data for FT516 showed relatively quicker relapses vs already approved autologous CAR-Ts. However, other manufacturers, like Allogene for their allogenic CAR-T therapy ALLO-501A, are exploring novel lymphodepletion approaches to improve persistence of allogenic cells. Nevertheless, allogenic NKs demonstrate a strong value proposition relative to their T cell counterparts due to comparable response rates (so far) combined with the added advantage of a significantly safer AE profile. Specifically, little to no risk of graft versus host disease (GvHD), cytotoxic release syndrome (CRS), and neurotoxicity (NT) have been seen so far with allogenic NK cells (Fig. 1). In addition, being able to harness an allogenic cell source gives way to operational advantages as “off-the-shelf” products provide improved turnaround time (TAT), scalability, and potentially reduced cost. NKs are currently in development for a variety of overlapping hematological indications with chimeric antigen receptor T cells (CAR-Ts) today, and the question remains to what extent they will disrupt the current cell therapy landscape. Click for more details.

January 22, 2022 06:00 AM EST

Weekly

What lured Hal Barron away?; Top FDA minds on accelerated approval reforms; ‘Dead wrong’ Aduhelm ad blitz; and more

Amber Tong

Senior Editor

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

Nothing can really compete with Hal Barron’s departure from GlaxoSmithKline as the news of the week, but we do have plenty of original reporting and analysis from the Endpoints team in this edition. Enjoy and have a nice weekend.

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January 21, 2022 07:30 AM EST

Pharma

Merck wins legal battle over insurance coverage after ransomware attack

Nicole DeFeudis

Editor

Merck has emerged victorious from a years-long legal battle with insurers over the coverage of more than a billion dollars in losses from the malware NotPetya, with a New Jersey Superior Court judge concluding that the responsibility is on insurers to clarify their policies around cyber attacks.

The pharma giant was one of several victims of a global cyber attack back in 2017 that also hit Danish shipping company Maersk, American food company Mondelēz, French construction giant Saint-Gobain and even the systems monitoring the Chernobyl nuclear power stations, Bloomberg reported back in 2019.

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ENDPOINTS CAREERS

Associate Director, Program Management - Cell & Gene Therapy Manufacturing

Lonza

Portsmouth, NH, USA

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January 21, 2022 07:20 AM EST

Outsourcing

FDA+

Florida man convicted of falsifying clinical trial results sentenced to over 2 years in prison

Josh Sullivan

Associate Editor

A Florida man who falsified medical records in connection to clinical trials was sentenced to 30 months in prison in federal court Thursday.

Daniel Tejeda, 35, of Clewiston, was also ordered to pay $2.1 million in restitution. Tejeda was a project manager and study manager for the CRO Tellus Clinical Research, and made it appear that subjects were participating in trials when they weren’t. Two other research workers from Florida were sentenced in the same case in August for 46 and 30 months, respectively.

January 21, 2022 11:06 AM ESTUpdated 02:02 PM

Pharma

Marketing

Critics push back on Alzheimer’s Association ad blitz to get Medicare to change its Aduhelm ruling: 'Dead wrong'

Beth Snyder Bulik

Senior Editor

The latest Alzheimer’s Association advertising campaign encourages people to fight.

Not against the disease or for more research or treatments, but against the Centers for Medicare and Medicaid Services. More specifically, CMS’ recent reimbursement decision to only pay for Biogen and Eisai’s controversial Alzheimer’s drug Aduhelm for patients in clinical trials.

With CMS’ preliminary decision now in a 30-day comment period, patient advocates’ goal is to convince CMS to reverse its decision with a marketing blitz and public pressure.

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Dan O'Day, Gilead CEO (Jim Watson/AFP via Getty Images)

January 21, 2022 11:05 AM EST

Pharma

FDA+

Failing to confirm clinical benefit, Gilead pulls 2 accelerated approval indications for cancer drug

Zachary Brennan

Senior Editor

Gilead recently decided to pull two indications for its cancer drug Zydelig — in relapsed follicular B-cell non-Hodgkin lymphoma (FL) and relapsed small lymphocytic leukemia (SLL) — after failing to complete the confirmatory trials required as part of the accelerated approvals from 2014.

“As the treatment landscape for FL and SLL has evolved, enrollment into the confirmatory study has been an ongoing challenge,” Gilead said in a statement, noting it formally notified the FDA of its decision to voluntarily withdraw these indications.

Richard Pazdur (via AACR)

January 21, 2022 09:55 AM ESTUpdated 11:08 AM

FDA+

Time limits on accelerated approvals? FDA's oncology chief Rick Pazdur eyes potential reforms via international approaches

Zachary Brennan

Senior Editor

The spotlight on the accelerated approval pathway continues to shine bright, with the FDA’s top oncology official writing in an opinion that the pathway may be strengthened with bits and pieces of what other regulators in Europe and elsewhere have done with their expedited approval pathways, such as adding expiration dates for these faster approvals to ensure they confirm clinical benefit in a timely manner.

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ENDPOINTS CAREERS

Director, Business Development, Cell & Gene Therapies

Lonza

Remote

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Hal Barron, Endpoints UKBIO20 (Jeff Rumans)

January 20, 2022 08:31 AM ESTUpdated 10:30 AM

Bioregnum

Cell/Gene Tx

'Altos was really a once-in-a-lifetime opportunity': Hal Barron reflects on his big move

By all accounts, Hal Barron had one of the best jobs in Big Pharma R&D. He made more than $11 million in 2020, once again reaping more than his boss, Emma Walmsley, who always championed him at every opportunity. And he oversaw a global R&D effort that struck a variety of big-dollar deals for oncology, neurodegeneration and more.

Sure, the critics never let up about what they saw as a rather uninspiring late-stage pipeline, where the rubber hits the road in the Big Pharma world’s hunt for the next big near-term blockbuster, but the in-house reviews were stellar. And Barron was firmly focused on bringing up the success rate in clinical trials, holding out for the big rewards of moving the dial from an average 10% success rate to 20%.

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Executive Director of the EMA Emer Cooke (AP Photo/Geert Vanden Wijngaert)

January 20, 2022 07:21 AM EST

Pharma

FDA+

European Parliament signs off on strengthening drug regulator's ability to tackle shortages

Zachary Brennan

Senior Editor

The European Parliament on Thursday endorsed a plan to increase the powers of the European Medicines Agency, which will be better equipped to monitor and mitigate shortages of drugs and medical devices.

By a vote of 655 to 31, parliament signed off on a provisional agreement reached with the European Council from last October, in which the EMA will create two shortage steering groups (one for drugs, the other for devices), a new European Shortages Monitoring Platform to facilitate data collection and increase transparency, and on funding for the work of the steering groups, task force, working parties and expert panels that are to be established.

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