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Category: Pharmaceuticals

Investment State-of-Play in Big Pharma: Bayer’s Eugene Borukhovich Weighs In

By JESSICA DaMASSA, WTF HEALTH

Bayer’s G4A team launched their 2019 program today, so here’s a little help for anyone curious about the state of pharma startup investment and what it takes to land a deal there these days.

I had the chance to pick the brain of Bayer’s Global Head of Digital Health, Eugene Borukhovich, during JP Morgan Healthcare Week and pulled out these three gloriously thought-provoking soundbites from our conversation to give you some insight as to the mindset over at big Bayer.

  • “Digital therapeutics are shining light on the convoluted, complex mess of digital health”

If you’ve wondered what lies ‘beyond the pill’ for Big Pharma, wonder no more. It seems the answer is digital therapeutics. Eugene predicts that “within the next couple of years, ‘digital health’ as a term will disappear,” and calls out organizations like the Digital Therapeutics Alliance for their efforts to set standards around evidence-base and behavior modification so regulators and strategic investors alike can properly evaluate claims made by health tech startups. As time goes on, it looks like efforts to ‘pharma-lize’ the ways startups take their solutions to market will increase, pushing them into more traditional go-to-market pathways that have familiar and comforting guidelines in place. As Eugene says, “Ultimately, what we say in my team, is that it’s about health in a digital world today.” Sounds like that’s true for both the products he’s seeking AND the way pharma is looking to bring them to market… 

  • “These multi-hundred million [dollar] press releases are great to a certain extent, but what happened to the start-up style mentality?”

When asked about Big Tech getting into Big Health, in the end, it seems, Eugene shakes out to be in favor of the ‘Little Guy’ – or, at least, in their approach. Don’t miss his comments about “cockiness in our healthcare industry” and how Big Tech is working around that by partnering up, but the salient point for startups is that big companies still seem very much interested in buddying with smaller businesses. It’s for all the same reasons as before: agility, the ability to iterate quickly, and the opportunity to do so within reasonable budgets. Eugene offered this telling rhetorical musing: “Just because it’s a combination of two big giants…do you need to do $500 million? Or, do you give some…traction, milestone, [etc.]…to prove it, just like a start-up would?”

  • “In large organizations, transformation equals time, and…we don’t have time.”

“To me,” says Eugene, “the biggest challenge is actually landing these inside the organization.” He’s talking about novel health solutions – digital therapeutics or otherwise – after learning from previous G4A cycles. Culture, precedent, and years of market success loom large in big healthcare companies across the ecosystem, which is one reason why innovation inside them is so challenging. Eugene says he’s “a big believer in a small team – even in large organizations – to take something by the cojones, and get shit done, and move it forward, and push the envelope from the bureaucracy and the process.” There’s a sense of urgency to ‘innovate or die’ in the face of the growing competition in the healthcare industry. “Back to this earlier conversation around whether it’s tech giants or other companies,” he adds, “it is a race to the speed of the organization. How quickly we learn and how quickly we make the decisions. Bottom line, that’s it.”

There’s plenty more great insights and trend predictions where these came from, plus the juicy details behind how G4A itself has pivoted this year. Check out the full interview now.

THCB Spotlights: eyeforPharma

By ZOYA KHAN

Jessica DaMassa interviews Paul Simms, the Chairman of eyeforpharma. Eyeforpharma are the “media moguls” when it comes to the Pharma industry. In order to innovate the industry, they are holding two different conferences this year to bring pharma leaders and health technology startups together to foster relationships and strategic partnerships with one another. Their first conference will be held in Barcelona in March, and the second one will be in Philadelphia in April.

Paul speaks to Jess about how health tech startups are maturing in their ways and realizing that health care is an institutionalized game, causing them to pivot their companies’ directions to fit that model. He also comments on how the pharmaceutical industry is trying to build strong relationships with particular startups to innovate their business practices, whether it be in R&D, drug discovery, or clinical research. Paul argues that the future of Pharma is more akin to a platform model, where pharma companies are not just limited to their internal capacity but are much more reliant on a larger ecosystem of moving parts that will help develop and grow the space. He also mentions that Pharma companies could really benefit from taking a page out of Google’s or Facebook’s business model which allows people to innovate and create their own content on these platforms. He further states that large B2C companies, like Amazon, will change the entire game of how people receive and curate their health insurance plans. 

eyeforphrama’s conference theme is “medicine is just the beginning”. Paul and his team believe if they bring together specific groups of people, it will benefit the pharmaceutical industry in the short term as well as the long term. Paul believes that “Pharma companies need to have a wider portfolio of innovation that goes far beyond medicine, whether that is drug+plus a solution or without the pill at all.”  Currently, Paul states, that the merging of pharma companies with other pharma companies is like having “s*x with your cousins” and believes that Pharma companies need to bridge out of their own space to keep up with the times. If you are a startup in this space, be sure to check out eyeforpharma’s upcoming conferences.

Zoya Khan is the Editor-in-Chief of The Health Care Blog and an Associate at SMACK.health

Increased Payer and Provider Support May Drive Billions of Dollars in Savings from Biosimilars

By SHEILA FRAME Sheila Frame, biosimilars

FDA Commissioner Scott Gottlieb has said biosimilars are “key to promoting access and reducing health care costs. And it’s a key to advancing public health.” While the Administration works to reduce barriers to bringing biosimilars to market, payers and providers can help increase adoption of biosimilars in clinical practice and ensure cost savings.

Organizations such as the American College of Rheumatology and the American Society of Clinical Oncology have issued educational documents to help guide providers in incorporating biosimilars into treatment plans, where appropriate. Yet, many doctors remain hesitant to prescribe them due to concerns about safety, efficacy, immunogenicity, effects of switching to a new biosimilar and the economic value to patients.

Biosimilars are developed in a similar way as existing biologics and have the same safety, efficacy, and quality profiles, but are more competitively priced to ensure more patients have access to these important medicines and that the system can afford them. A ten-year growing body of real-world use in the EU shows biosimilar medicines increase usage of biologic medicines, while matching their reference biologics in terms of safety, efficacy and quality.

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Last Month in Oncology with Dr. Bishal Gyawali: November 2018

Keynote speech

There was a very sobering piece in NEJM by the FDA last month in which the authors try to explore what went wrong with the Keynote-183, Keynote-185 and checkmate 602 trials testing PD-1 inhibitors combinations with pomalidomide or lenalidomide and dexamethasone in multiple myeloma. Interim analysis of Keynote 183 and 185 revealed detrimental effects on overall survival (OS) with hazard ratios of 1.61 and 2.06, not explained by differences in toxicities alone. The checkmate 602 trial was also halted in light of these findings and also showed higher mortality in the nivolumab combination arm.

In the thoughtful NEJM piece, the authors make at least three important points. First, they question why these PD-1 inhibitors were tested in combination despite their having limited single-agent activity. In fact, a couple of years ago, Vinay Prasad and I asked the same question: why are novel cancer drugs being tested in combination despite having limited activity as a single agent? We found that these drugs, even when ultimately approved, provide relatively low value and recommended that drugs with poor single agent activity not be tested in combinations unless there are specific reasons to expect synergy.

The second important point in the article is that many cancer drug approvals are lately based on durable response rates in single arm trials without a control group, a situation in which it is difficult to evaluate the safety and efficacy of drug combinations. Indeed, without an RCT, the oncology community would never have known these signals of detrimental effect. If the FDA had approved these PD-1 inhibitors in multiple myeloma on the basis of non-randomized trials, which it often does in other oncology contexts, who knows how long it would have taken to recognize the increased mortality in patients—and at what cost. This is another reason why we need RCTs more now than ever. Finally, the authors point out that these PD-1 inhibitors in multiple myeloma were directly advanced to phase 3 trials after phase 1 trials were completed, without phase 2 information. Indeed, in a recent paper, Alfredo Addeo and I showed that a substantial percentage of drugs that fail in phase 3 trials do not have supporting phase 2 data.
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Saying No to the Drug Crisis

By BRIAN KLEPPER

In a recent essay, VIVIO Health’s CEO Pramod John guides us through four sensible drug policy changes and supporting rationales that could make drug pricing much fairer. Reading through it, one is struck by the magnitude of the drug manufacturing industry’s influence over policy, profoundly benefiting that sector at the deep expense of American purchasers. As Mr. John points out, the U.S. has the world’s only unregulated market for drug pricing. We have created a safe harbor provision that allows and protects unnecessary intermediaries like pharmacy benefit managers. We have created mechanisms that use taxpayer dollars to fund drug discovery, but then funnel the financial benefit exclusively to commercial interests. And we have tolerated distorted definitions of value – defined in terms that most benefit the drug manufacturers – that now dominate our pricing discussions.

The power of this maneuvering is clear in statistics on health industry revenues and earnings. An Axios analysis of financial documents from 112 publicly traded health care companies during the 3rd quarter of 2018 showed global profits of $50 billion on revenues of $636 billion. Half of that profit was controlled by 10 companies, 9 of which were pharmaceutical firms. Drug companies collected 23% of the total revenues during that quarter, but retained an astounding 63% of the profits, meaning that the drug sector accounts for nearly two-thirds of the entire health care industry’s profitability. Said another way, the drug industry reaps twice the profits of the rest of the industry combined.

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AI Doesn’t Ask Why — But Physicians And Drug Developers Want To Know

By DAVID SHAYWITZ MD

At long last, we seem to be on the threshold of departing the earliest phases of AI, defined by the always tedious “will AI replace doctors/drug developers/occupation X?” discussion, and are poised to enter the more considered conversation of “Where will AI be useful?” and “What are the key barriers to implementation?”

As I’ve watched this evolution in both drug discovery and medicine, I’ve come to appreciate that in addition to the many technical barriers often considered, there’s a critical conceptual barrier as well – the threat some AI-based approaches can pose to our “explanatory models” (a construct developed by physician-anthropologist Arthur Kleinman, and nicely explained by Dr. Namratha Kandula here): our need to ground so much of our thinking in models that mechanistically connect tangible observation and outcome. In contrast, AI relates often imperceptible observations to outcome in a fashion that’s unapologetically oblivious to mechanism, which challenges physicians and drug developers by explicitly severing utility from foundational scientific understanding.

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Last Month in Oncology with Dr. Bishal Gyawali

By BISHAL GYAWALI MD

Me-too deja vu

I read the report of a phase 3 RCT of a “new” breast cancer drug but I had the feeling that I had already read this before. Later I realized that this was indeed a new trial of a new drug, but that I had read a very similar report of a very similar drug with very similar results and conclusions. This new drug is a PARP inhibitor called talazoparib and the deja vu was related to another PARP inhibitor drug called olaparib tested in the same patient population of advanced breast cancer patients with a BRCA mutation. The control arms were the same: physician choice of drug, except that physicians couldn’t choose the one drug that is probably most effective in this patient population (carboplatin). The results were nearly the same: these drugs improved progression-free survival, but didn’t improve overall survival. In another commentary, I had raised some questions on the choice of control arm, endpoint and quality of data about the olaparib trial when it was published last year. This current talazoparib trial is so similar to the olaparib trial that you can literally replace the word “olaparib” with “talazoparib” in that commentary and all statements will stay valid.

The oncology version of half-full, half-empty glass

The PARP inhibitors olaparib and niraparib are also approved in ovarian cancer based on improvement in progression-free survival (PFS), without improving overall survival (OS). If a drug doesn’t improve OS but improves only PFS, it should also improve quality of life to justify its use. According to two new reports, these drugs do not appear to improve quality of life. The niraparibtrial reported that the patients were able to “maintain” their quality of life during treatment while the olaparib trial reported that olaparib did not have a “significant detrimental effect” on quality of life. I find it remarkable that a drug that isn’t proven to improve survival is lauded for not significantly worsening quality of life … at $10,000 a month!

It is also important to recognize that these drugs were tested as maintenance therapy against placebos. For “maintenance therapies,” as explained in this paper, improving PFS alone is not an important endpoint. That’s why I am also not excited about this new trial of sorafenib maintenance in ovarian cancer. A drug has to be very ineffective to fail to improve even PFS as a maintenance therapy against placebo.
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Part 2: Bypassing Prior Authorizations

By NIRAN AL-AGBA, MD

A few weeks ago, I saw a young patient who was suffering from an ear infection. It was his fourth visit in eight weeks, as the infection had proven resistant to an escalating series of antibiotics prescribed so far. It was time to bring out a heavier hitter. I prescribed Ciprofloxacin, an antibiotic rarely used in pediatrics, yet effective for some drug-resistant pediatric infections.

The patient was on the state Medicaid insurance and required a so-called prior authorization, or PA, for Ciprofloxacin. Consisting of additional paperwork that physicians are required to fill out before pharmacists can fill prescriptions for certain drugs, PAs boil down to yet another cost-cutting measure implemented by insurers to stand between patients and certain costly drugs.

The PA process usually takes from 48-72 hours, and it’s not infrequent for requests to be denied, even when the physician has demonstrated an undeniable medical need for the drug in question.

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“Remember that Oath?”: EPCS and the Fight Against Opioid Abuse

By SEAN KELLY, MD

 

As doctors, we all took an oath when we graduated from medical school to “do no harm” to patients. It is, therefore, our duty to speak up and take action when there is an opportunity to prevent harm and improve patient care, safety and well-being. On average, the opioid crisis is killing more Americans on a monthly basis than traumatic injuries. It is time for the medical community to raise its voice even more loudly in support of proven technology that helps curb this crisis.

This month, California Governor Jerry Brown became the latest state lawmaker to embrace electronic prescribing for controlled substances (EPCS) — joining nearly a dozen other states that have passed legislation mandating that health care providers and pharmacies use the technology. The Golden State law was signed at the same time the U.S. Senate passed a bill requiring e-prescriptions for any reimbursement under Medicare Part D.

Clearly, EPCS is emerging as a key tool in the fight against opioid abuse. And legislators aren’t alone in driving the trend — corporations are playing a key role as well. Walmart, one of the nation’s largest pharmacy chains, is requiring EPCS by January 1, 2020. In their press release, it was noted that “E-prescriptions are proven to be less prone to errors, they cannot be altered or copied and are electronically trackable.”

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A Rosa Parks Moment is Coming in Phase 1 Cancer Trials

By DAVID C. NORRIS, MD

David Norris, MD

 

I want to tell you about the most exciting discovery I’ve made in 2+ years of research on dose individualization methods for phase 1 cancer trials. This discovery has nothing to do with any of the technical problems I’ve confronted and solved along the way. It involves no gigantic equation, no table of simulations results, and no colorful plot. Rather, it’s a discovery about sources of power to innovate in drug development.

In general, how would you describe the balance of power between Big Pharma and the individual patient? The question seems ludicrous—maybe even offensive—in light of ongoing scandals with price-hikes and shortages for critical drugs. But in the special area of trial methodology, I’ve got a real surprise for you…

One result from my DTAT research has been a clear demonstration that 1-size-fits-all dose finding in phase 1 cancer trials can cut the value of a drug in half, or even drop it to zero by setting the drug up for failure in phase 2 or 3. Although this economic argument has never been made quite so explicit and rigorous, I am certain the underlying principle comes as no surprise to anyone. (I note hardly anyone bats an eye when I detail the math.) Continue reading…

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