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Articles by Joseph V. Gulfo
Book review: "Innovation Breakdown"
Innovation Breakdown By Joseph V. Gulfo 258 pages 2014 Post Hill Press (Amazon link) Innovation Breakdown tells the story of a small startup with a promising lifesaving product that was unexpectedly screwed over by the FDA. As a result of the FDA’s actions the company’s reputation was permanently harmed, their device took several extra years to make it to market, and many people died who might have been saved. Innovation Breakdown is a remarkable account.
Drug development is failing because it's too expensive and takes too long
Innovative new drugs can be miraculous, often representing quantum advances in health. Recent examples include the unprecedented benefits of antiviral drugs to treat hepatitis C, gene therapy, checkpoint inhibitors and CAR T-cells for cancer. Many drug developers are working on complementary products and technologies to make these recent advances even better, as well as new innovative approaches.
Drug Reciprocity Could Save Lives in the U.S.
President Trump recently signed legislation permitting terminally ill patients to obtain experimental drugs directly from manufacturers, without having to wait for full approval. The medicines in question have completed only the most basic safety testing—Phase 1, usually performed on a small number of healthy volunteers.
Needed: An FDA Revolution
A progressive brain disease that destroys an individual’s memory and other mental and physical functions, Alzheimer’s disease (AD) may at first present only mild symptoms, such as slight confusion and difficulty forming new memories. Eventually, though, the afflicted person’s brain cells degenerate and die, causing a steady decline in general functioning and, eventually, death.
2016 FDA drug approval numbers - what can Trump conclude?
In 2016, the FDA approved just 22 novel new medicines, a six-year low and half of the 45 approved in 2015. That’s the top line bad news; unfortunately, there is a more disturbing message when one digs a little deeper. Forty-one percent (nine of the 22 drugs) are intended for orphan or rare diseases. Eight of of these received Orphan drug designation (the cutoff to qualify for Orphan status is 200,000 patients per year).
How Donald Trump can benefit patients by reducing red tape at the FDA
President-elect Trump has called for reform of the Food and Drug Administration (FDA) to put greater focus on the need of patients for new and innovative medical products. I outlined a method by which this could be accomplished in great part simply by returning the FDA to its lawful Congressional mission of approving drugs based on safety and effectiveness.
What President-elect Trump’s new FDA commissioner needs to do
The FDA has wavered from this mission over the past two decades such that pre-approval requirements and post approval demands have gone far beyond the Federal Food, Drug, and Cosmetic Act (FD&C) imperative to approve safe and effective drugs. Through the approval process, it has, in effect, endeavored to establish preferred treatment algorithms for physicians to follow. That is, the FDA is seemingly attempting to practice medicine from Washington, DC.
A Trumpian Cure for the FDA’s Chronic Lethargy
Among the promises in President-elect Donald Trump’s “Contract with the American Voters” is a pledge to cut red tape at the Food and Drug Administration and speed up the approval of lifesaving medications. Some FDA critics have called for more-drastic measures, such as revoking the FDA’s authority to make approval decisions on drugs, or turning it into a privatized entity. But a scorched-earth approach is not the way to get fast and effective results.
Blocking CD47 Innate Checkpoint Control for Cancer Treatment
Several companies, including Trillium, Celgene, Tioma, and Forty Seven are developing products that block CD47 for the treatment of cancer. Researchers have also shown that attacking CD47 may be a better approach to bone marrow conditioning prior bone marrow transplant. CD47 is a membrane protein, which is involved in the increase in intracellular calcium concentration that occurs upon cell adhesion to extracellular matrix.
Three Ways Millennials Made Me a Better Manager
Much has been written about the difference between Millennials and preceding generations in the workforce. Typically, these pieces mock certain behaviors of the group that will make-up 75%% of the US workforce by 2030, and lament the "good ol' days" of managing people who "get it." Initially, managing Millennials was a significant challenge for me that I did not relish. However, I began to embrace and enjoy the experience because I found that it greatly enhanced my management style in many ways.
Mechanisms of Melanoma Resistance to PD-1 Checkpoint Inhibition
It is estimated that about 40 percent of patients with advanced melanoma, the deadliest form of skin cancer, will initially respond to an immunotherapy, but about a quarter of those 40 percent will relapse within three years of treatment. In order to identify the mechanisms by which resistance to PD-1 inhibition is mediated, UCLA researchers studied biopsies of melanoma tumors taken before and after treatment with Keytruda (pembrolizumab) in patients whose cancer had returned.
Ending the Prescribe-Don’t-Tell Charade for Off-Label Drugs
Earlier this month the Food and Drug Administration reached a settlement with Amarin , a small pharmaceutical firm, allowing it to promote its drug Vascepa for treatments that the agency had not specifically approved.
FDA has lost sight of its role in medical ecosystem
If the DMV approved driver's licenses like the FDA approved new drugs, driving tests would go on for months and cost a tremendous amount of money.
The Proper Role of the FDA in the Medical Ecosystem
When I received my driver’s license my father said to me, “Congratulations, son—now you really learn how to drive.” Driver education courses only ensured that I knew how to operate the vehicle safely and appropriately to get from point A to point B. I had eight fender-benders in my first decade behind the wheel, and I haven’t had one accident for the last decade. My father was right. I learned how to operate a car very well—after I had my license for a while.
Wall Street Demands Are Driving Up Drug Prices
The New York Stock Exchange Arca Pharmacetuical Index has risen 50.15 percent over the past three years. As Credit Suisse has reported, drug price increases are a "key driver" of pharmaceutical profit growth. Despite calls, for example, for Medicare to negotiate drug prices directly with manufacturers, drug price increases are not about to stop anytime soon.
Biopharma hammered by hedge funds, reverse trolls--commentary
Prior to September 2012, a company faced with a patent-infringement lawsuit brought by a patent troll (an entity that acquires patents just to seek cash payouts from other patent holders), your only recourse to invalidate the troll's nuisance patent was through the federal courts—a very costly and time- consuming effort. In an attempt to increase efficiency and protect innovation, Congress passed the 2012 America Invents Act (AIA).
Why The 21st Century Cures Act Is A Mistake
On May 21, the 21st Century Cures Act was passed by the House Energy & Commerce Committee unanimously (fifty-one to zero). Since then, a great deal of PR has been devoted to securing its full passage in the House and Senate. I do not believe that the bill should be passed for five reasons: 1.
Guest Commentary: Clearly, the FDA is not listening
The 21st Century Cures proposal does something that is sorely needed. In bipartisan fashion, it boldly exclaims there is a problem with the Food and Drug Administration, an institution whose mandate is to "to promote health by promptly and efficiently reviewing clinical research and taking appropriate action on the marketing of regulated products in a timely fashion." (The emphasis is mine.) The FDA has a daunting mandate, and equally broad authority to fulfill its duties.
FDA's 'Orphan Drug' Designation Warps Medical Research
With Earth Day and Arbor Day now in our rearview mirror, the countdown to a host of other summertime days of celebration such as Memorial Day, Independence Day and Labor Day can begin. This reminds me of when I was 10 years old, and I complained to my father that there is a Mother’s Day, Father’s Day, Grandparents’ Day, Teacher’s Day and Secretary’s Day, but no Child’s Day.
Making A Breakthrough Mistake With Medical Devices
4544693The FDA is looking to roll out two policies “intended to expedite access to potentially life-saving devices meant for patients with life-threatening or serious conditions.” The first draft guidance document establishes pathways for the review and expedited approval “for certain medical devices that demonstrate the potential to address unmet medical needs for life threatening or irreversibly debilitating diseases or conditions.” The second draft guidance establishes parameters in which...
FDA 2014 approvals - the message behind the numbers
The FDA provided an update on new drug approvals in 2014, stating that as of December 15, thirty-five new drugs were approved, compared to 27 in 2013. Here is the high level summary: 1. Fifteen of the 35 drugs were Orphan Drugs, the highest number since the Orphan Drug law was passed in 1983. 2. Fifty-seven percent of the approved drugs had Priority Review tags. 3. Thirty-seven percent of novel drugs were on the Fast Track review route. 4.
6 big mistakes you need to avoid in your pitch deck
Dodgers pitcher Clayton Kershaw was just named the National League Most Valuable Player and Cy Young award winner, only the 11th pitcher in the history of baseball to receive both honors in the same year. The list of his accomplishments this year is nothing short of amazing. Still, it is rare for a pitcher to be awarded the MVP, which is usually given to a slugger who plays daily. Since the pitch starts every play in baseball, I wonder why MVP recognition of a pitcher is so rare.
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