Opinion: STAT+: What does the presidential election mean for ICHRA and the health insurance market?
Over the past two presidential administrations, the health care market has changed dramatically with the…
Category: Opinions+
Opinion: STAT+: How to keep the BIOSECURE Act from hobbling U.S. biotech and pharma
In a rare display of bipartisan agreement, Congress is getting serious about addressing China’s influence…
Opinion: STAT+: What the newly released Medicare prices for 10 drugs do and don’t tell us
For many of us, Thursday was Health-Policy-Wonk Festivus. The Centers for Medicare & Medicaid Services…
Opinion: STAT+: Cell donors are essential for new therapies. They need to be taken care of
Cutting-edge FDA-approved therapies made from human cells are now being used to treat cancer, diabetes,…
Opinion: STAT+: Private equity and neuroscience: a novel approach to developing new treatments for neurological disorders
Neurological diseases are now the leading cause of poor health and disability worldwide. An estimated…
Opinion: Could billions of dollars in AI funding lead to the same number of new drugs?
Drug discovery has quickly become the most enticing place to apply artificial intelligence. Billions of…
Opinion: STAT+: Unmasking the ‘centricity’ illusion in clinical trials
During my 25 years working in clinical trial operations, I’ve seen the biopharmaceutical world talk…
Opinion: STAT+: Use evidence to support early coverage of gene therapy after accelerated approval
Gene editing and therapy to replace missing or defective genes is one of the most…
Opinion: STAT+: How AI can help satisfy FDA’s drug, device diversity requirements
The Food and Drug Omnibus Reform Act of 2022 (FDORA), which was passed as part…
Opinion: STAT+: Medical devices makers are trying to take a page from Uber’s playbook
In a recent survey of U.S. companies, medical device makers reported spending $31 million on…
Opinion: STAT+: It’s time to rethink everything about our approach to psychiatric drug development
In many ways, psychiatry is still flying blind. People experiencing mental health conditions are prescribed…
Opinion: STAT+: A year in, the U.S. is still not taking advantage of lower-cost biosimilars for Humira
It’s been one year since the launch of the first adalimumab biosimilar for Humira in…
Opinion: STAT+: A California court is setting a dangerous precedent over drug development (or lack thereof) liability
The assault on the development of new lifesaving therapies continues apace. Recently, the First Appellate…
Opinion: STAT+: Some countries are moving to digital prescription drug information for patients. The U.S. shouldn’t follow suit
Getting a new prescription can be overwhelming: medication schedules, foods to eat or avoid, interactions…
Opinion: STAT+: The necessary roughness of 2023 has set up a very promising 2024 for biotech jobs
What a week — this year’s might have been the busiest JPM I’ve ever had….
Opinion: STAT+: Dana-Farber CEO Laurie Glimcher has always been a trailblazer and a risk taker
Dr. Laurie Glimcher learned early on from her father, a prominent physician-researcher, that success in…
Opinion: STAT+: Health care AI requires a new Hippocratic oath
It was no surprise when the Biden administration recently outlined in a broad executive order…
Opinion: STAT+: A bold approach to pay for weight loss drugs for everyone who needs them
The news about anti-obesity drugs keeps getting better. In November, data presented at the American…
Opinion: STAT+: The PATCH Act’s approach to securing medical devices actually gives malicious actors a blueprint
In August 2013, the FDA made news when it issued cybersecurity guidance for medical devices….
Opinion: STAT+: How to make the EU’s new Joint Clinical Assessment process work for industry — and for patients
Today, the criteria used to assess the clinical value of new pharmaceuticals and medical devices…
Opinion: STAT+: Preventive drugs may be the best solution to the antibiotic resistance crisis
The antibiotics crisis is a silent pandemic that threatens to knock modern society back into…
Opinion: STAT+: How payer-participating trials could help transform clinical research on FDA-approved drugs
Earlier this year, Food and Drug Administration Commissioner Robert M. Califf proposed something radical: that…
Opinion: STAT+: The problem with potential changes to the biosimilar regulatory framework
Biosimilars are no longer a new and untested class of medicines. Today, they provide critical…
Opinion: STAT+: The IRA needs changes to better support patients with rare diseases
This time last year, members of Congress were working around the clock to draft and…
Opinion: STAT+: Sanofi CEO Paul Hudson: The right way to bring AI into pharma
While it’s widely accepted that the pharma industry is innovative in R&D, it is also…
Opinion: STAT+: What Mark Cuban gets wrong about prescription drugs
Mark Cuban, the Dallas Mavericks owner and “Shark Tank” star, has been making headlines recently…
Opinion: STAT+: One way to create resilient drug supply chains: incentivize predictive models
My first exposure to pharmaceutical shortages happened in 2017 as a new-to-practice nurse working on…
Opinion: STAT+: How I’m helping companies think through whether they should cover GLP-1s like Ozempic for employees
We have a knack in the U.S. for blurring behavior and medicine. Look at weight….
Opinion: STAT+: An overlooked way to make participants in clinical trials look more like America
A recent report from the National Academies of Sciences, Engineering and Medicine (of which one…
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Opinion: STAT+: At-home clinical trials are the future
In the early days of the Covid-19 pandemic, much of the clinical trials industry came…
Opinion: Where are the guidelines for the production of animals with intentional genomic alterations?
Genetic engineering has the potential to transform how we raise animals for meat and other products, making…
Opinion: STAT+: 3 keys to successful biopharma-academia drug development collaborations
Academia can be an excellent source of novel drug targets and new technologies that can…
Opinion: STAT+: 4 concrete steps to realize the AI Bill of Rights for clinical decision support software
The Blueprint for an AI Bill of Rights the White House recently published didn’t come…
Opinion: STAT+: Continuous manufacturing can help pharma companies save time, money, and more
The pharmaceutical industry has been slow to adopt a business practice that is faster, safer,…
Opinion: STAT+: Removing barriers to biosimilar adoption in the United States
Biosimilars, a much-lauded approach to reducing drug costs in the United States, are still underused…
Opinion: STAT+: HHS’s proposed rule prohibiting discrimination via algorithm needs strengthening
The Department of Health and Human Services has proposed a rule to prohibit clinical algorithms…
Opinion: STAT+: The need for regulatory grade evidence: Are you in the stadium or the sandbox?
As real-world data (RWD) and real-world evidence (RWE) continue to share the limelight in pharmacoepidemiologic…
Opinion: STAT+: How machine learning and automation can solve biomanufacturing scale-up challenges
Biomanufacturing has produced important materials, ingredients, therapeutics, and more for decades, yet it is still…
Opinion: STAT+: Clinical validation will save digital health’s reputation
The meteoric rise of telehealth and other types of virtual care during the Covid-19 pandemic…
Opinion: STAT+: How to close biopharma’s data science and engineering skills gap
In biopharma research and development, laboratory data now exist in petabytes. Today’s fastest liquid-handling robots…
Opinion: STAT+: How the U.S. can mitigate and prevent medical device shortages
Just weeks after the U.S. declared Covid-19 to be a public health emergency in early…
Opinion: STAT+: QR codes can help pharmaceutical companies in two big ways
QR codes, which had begun a fall into obscurity, have come roaring back. Many restaurants…
Opinion: STAT+: A market failure is preventing efficient diffusion of health care AI software
Artificial intelligence (AI) software can improve patient care, but a key market failure is preventing…
Opinion: STAT+: Pharma’s role in value-based care starts with value-based research
Modern medicine has been sculpted by the ever-expanding knowledge of biological processes in conjunction with…
Opinion: STAT+: Incentives to spur repurposing of existing generics for novel uses would open a new paradigm in drug R&D
The Drug Price Competition and Patent Term Restoration Act of 1984, better known as the…
Opinion: STAT+: Reimagining R&D can cut drug development costs from billions to millions
In the course of our work advising biopharma companies, we are often asked how they…
Opinion: STAT+: What biotech can learn from past stock market downturns
“Dumpster fire.” “Biotech bear market.” “A market rout.” Going by recent descriptions of the performance of…
Opinion: STAT+: Building a better on-ramp for health innovation
The pandemic crisis has illuminated a stark reality that innovators, particularly those in biotech, have…
Opinion: STAT+: Forget the hype and embrace the reality: How AI can improve health outcomes right now
The story of artificial intelligence (AI) driving better health care outcomes has been a convoluted…
Opinion: STAT+: 8 reasons ‘move fast and break things’ doesn’t work for health care companies
Entrepreneurs at tech startups are likely to hear the Mark Zuckerberg adage that it’s important…