Lyman BioPharma Consulting LLC

Advice and Resources for the Biotech Industry

Advice and Resources for the Biotech Industry

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The HPV Vaccine: Preventing Cancer Beats Treating It


You don’t have to be an oncologist to know that fighting cancer is tough. Nearly 1.7 million Americans will be diagnosed with cancer this year, and about 600,000 will die from the disease. But here’s some good news: overall U.S. cancer deaths have been in a steep decline for over 25 years. Much of this reduction is tied to a decline in smoking, along with early detection of some cancers (e.g. colon), and more effective cancer therapies. While treatments against some particular types of cancer have advanced greatly, it’s still a disease no one wants to face. Fighting an opponent that you can never be really sure you’ve defeated challenges both the physical strength and mental fortitude of those who’ve been diagnosed. I know because I’ve been there.

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Data Irreproducibility: The "Waste, Fraud, and Abuse” of Scientific Research


Waste, fraud, and abuse. We’ve heard the phrase a million times. Politicians tell us the key to making things better in our society is to simply eliminate this unholy trio of troubles. They never bother to detail specifically what they’re referring to, for attempting to do so might set their lips ablaze. Their declarations always elicit feelings of déjà vu. Where, precisely, is the waste located, and how much of it is there? Who, exactly, are the specific groups or individuals that have committed fraud? What types of abuse are we talking about? Is the problem really widespread, or limited to just a few cases? If you’ve really identified the root cause of these problems, what’s it going to take to eliminate them? And since this expression is uttered so frequently, why haven’t these problems been fixed by now? Sadly, this meaningless catchphrase is trotted out whenever the speaker has no real solutions to offer but pretends to have deep insights that are never actually enunciated.

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Is Pharma Really Facing Its Demise?


A widely reported
op-ed piece recently predicted the upcoming financial demise of the pharmaceutical industry. Some have opined, “there’s nowhere to go but down.” While it’s true that the industry faces strong headwinds (many of its own making), I don’t think it’s going to fold anytime soon. Reports of its upcoming demise are, as the saying goes, greatly exaggerated. There’s been an uptick in drug approvals in 2017 (the highest in over a decade), and some of the newest drugs cost upwards of half a million dollars or more. Global sales of biopharma medicines jumped 45 percent from 2006 to 2015. Cancer drug sales in particular are soaring. New biomedical innovations, such as CAR-T immunotherapies and gene modifications using the CRISPR-Cas9 system, appear promising to help treat mankind’s ills.

Let’s take the long view: how has the industry expanded and flourished over the past century? I was recently reading the centennial issue of Forbes, which listed the top 50 U.S. companies (ranked by market cap) from 1917, 1967 (the magazine’s 50
th anniversary), and 2017 (100th anniversary). Comparing these time points provides a fine illustration of just how financially successful the pharmaceutical industry has become over the past one hundred years.
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What to Read To Get the Latest BioPharma/Healthcare Info


One question I’m frequently asked: what do you read to keep up with developments in biopharma? My recommendations are below, but keep in mind that my needs may be different from yours. It depends on an individuals background, their interests, how they plan to use that information, and how much they want to spend. Most people will give disparate answers to this question, and that’s just how it should be.
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Illustration: Josh Lyman


Non-Compete Agreements: Dangerous Liaisons


I was recently contacted by outside counsel for a large biopharma company about doing some consulting work for them. We discussed the general scope of the project by phone, and quickly reached agreement that I would be able to help them with their task. The next step was to sign a consulting agreement, which was par for the course. When I was emailed the form I was pleasantly surprised to see that the agreement was only one and half pages long. Many of the consulting contracts I’ve signed for other organizations are typically eight to ten pages. They force me to carefully step through a minefield of minutiae to ensure that the agreement is fairly written for both parties. This one, I thought, would be easy to review and sign.

Then I read it…

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Sci-Hub vs. iPubSci: Another Look at Accessing Unaffordable Science Journals


Anyone who’s ever tried to access the scientific literature knows that science journals are incredibly expensive. Subscriptions often cost hundreds, if not thousands of dollars per journal title. Purchasing individual papers online (often at $30 to $35 apiece) is equally problematic; I’ve
estimated that about three quarters of articles in the scientific literature are secured behind paywalls. Ironically, one of the articles I wrote about the problem of unaffordable science journals is now sequestered behind the Nature Biotechnology paywall (it was originally freely available). The high cost of journals hinders access by both lay people as well as physicians and many scientists (mostly those outside of academia). The unaffordability of science journals serves as an impediment to the success of small biotechnology companies. It makes it difficult for the scientists who work there to keep current with the latest developments in their fields. It’s hard to be competitive as an R&D organization when you can’t afford access to the key papers that may steer your research one way or another. Equally troubling is the other side of the coin: rising costs (to the authors) for publishing papers. These can now exceed $5,000 for some open access journals (in which those who submit the articles pay a fee, rather than the end users), and costs have been rising at a pace much higher than the overall inflation rate.
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Health Insurance Improves Patients Lives


When I was diagnosed with cancer last year, I was glad that I had good health insurance coverage. I hadn’t realized it at the time, but I now know that I really had nothing to worry about. It turns out that having insurance is not really all that important for our health and well-being. I know this because Congressman Raul Labrador (R-Idaho) told us so. As he
put it, “Nobody dies because they don’t have access to health care.” That might be true on some planet, but not on this one. Politifact, which identified a number of studies that showed having health insurance indeed prevents people from dying, later rated this ridiculous claim as “Pants on Fire.”
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Rock Lyrics Predicted Drug Discoveries


Many people know that an eternal link exists between science and music. For example, Russian composer Alexander Borodin was as well known for his
chemical work on aldehydes as his symphonies and string quartets. Many scientists have side careers, or at least hobbies, as musicians. These include NIH Director Francis Collins, who has entertained many people with his singing and guitar playing (note the inlaid mother-of-pearl double helix on the guitar’s fretboard).

Dr-Collins

What you may have missed is that many rock musicians, who’ve long been associated with illicit drug abuse, clearly envisioned numerous modern pharmaceutical innovations in their songs. I’m not talking about overt drug tracks like J.J. Cale’s Cocaine (popularized by Eric Clapton), the Beatles Doctor Robert, or the Rolling Stones’ Mother’s Little Helper. I’m talkin’ tunes that predated and anticipated later medicinal developments, as reflected in their lyrics. Let me share a few examples.

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BioPharma Haiku Round IV


This is my fourth collection of biopharma haiku. You can also follow these links to access my previous collections I, II, and III. I hope you enjoy them!

Medical update
Theranos now a zombie
Not dead or alive

Shkreli fraud trial
“Misunderstood genius” or
Liar, cheat, and thief?

FDA good news
“Yelp for drugs” will not happen
Moronic idea

The BCRA
Will McConnell find the votes?
When hell freezes over

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So What Did the March for Science Accomplish?


In the words of a wise former colleague, “don’t know, can’t say.”

With this historic event only a week behind us, it’s going to take time to figure out if the March for Science accomplished anything significant. Part of this is due to the fact that its stated goals were rather diffuse. Data, of course, needs to be collected, sorted, and analyzed, which will happen because the March was studied by a slew of sociologists. Turnouts at the more than 600 marches worldwide were high, with enthusiastic crowds displaying a diverse cornucopia of signs and slogans not usually paraded about in public. As far as I can tell, the marches were uniformly peaceful affairs, with no counter protesters demonstrating in favor of “alternative facts.” I also saw a number of people sharing religious points of view, happily conveying their opinions that one can believe in both God and science. There was even a group of Satanists marching; I didn’t know until visiting their website that they, too, take a pro-science stance.
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Why I’m Joining in the March for Science


If you haven’t heard yet, there's going to be a nationwide
March for Science on Earth Day, April 22nd. This includes a primary March in Washington, DC, as well as “sister” marches around the globe (at least 320 cities have already signed up). I’m planning on marching here in Seattle, and I’m writing this to encourage others to participate in whichever March is most convenient for you to attend. The March for Science is being supported by a number of prominent organizations, including the American Association for the Advancement of Science, the Union of Concerned Scientists, and the NY Academy of Sciences. Not all scientists think the March will be helpful (and some have voiced that it could even be harmful), but I’m not in that camp for the reasons I’ve outlined below.
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BioPharma and Hollywood: Land of the Blockbusters


When you hear the word “blockbuster”, what’s the first thing that comes to your mind?
a) A movie that earns hundreds of millions of dollars at the box office
b) A prescription drug that brings in more than $1 billion a year in sales
c) A bankrupt chain of video stores
d) A large bomb capable of destroying an entire city block

All four of these choices are valid answers, but the focus of this article is on the first two. The parallels between biopharma and Hollywood are strong. Both industries invest huge amounts of money in a large number of projects with the hope that some will turn out to be blockbusters i.e. massive money making machines. Sometimes it works out, but the failure rate is high, with most drugs (and many movies) never recouping their development costs. Both groups also love to develop sequels, which is a simpler strategy than developing riskier independent products that their fickle public may, or may not, embrace.There are many aspects of their businesses that are shared by the pharmaceutical and movie industries. Let’s see how they compare:
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Hollywood and BioPharma: Differentiated by Unique Economic Models


In my previous post, I detailed numerous similarities between the pharmaceutical and film industries. Now it’s time to point out the substantial differences between these two businesses that illustrate their different economic consumption and pricing models.

Production Costs - Big Barriers to Entry in Pharma, but Not Film
Nobody’s producing drugs in their basement that are going to earn them a ton of money. Okay, let me rephrase that. Nobody’s producing legal pharmaceuticals in their basement that are going to earn them big bucks. Creating prescription drugs is a very expensive enterprise. The cost of bringing a new drug to market has been estimated by the Tufts Center for the Study of Drug Development to be about $2.6 billion. That’s a huge hurdle to making money. There’s no getting around extensive research, filing multiple patents, complicated manufacturing steps, expensive clinical trials, and detailed regulatory and FDA filing requirements. How long might it take just to recoup those costs? Let’s return to my previously cited example of a very poor selling drug. Seattle’s CTI BioPharma sold only $3.47 M of their non-Hodgkin disease/B-cell lymphoma drug Pixuvri worldwide in 2015 (all sales were in Europe). If it cost the company the current industry “average” of $2.6 billion to develop it (which it didn’t), it would take about 749 years just to recoup that money, based on 2015 revenues. And that’s without showing a profit. It’s a pretty safe bet this drug will never recapture its development costs no matter what they were.
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