8
Nov
2017

The Long Run Podcast: Elias Zerhouni on the Role of Immigrants In Science

Today’s guest on The Long Run podcast is Elias Zerhouni.

He’s the president of global R&D at Sanofi, one of the world’s biggest makers of drugs and vaccines.

Elias Zerhouni, president of global R&D, Sanofi

Zerhouni, for those unfamiliar, started out as an academic researcher in radiology at Johns Hopkins. He then became an entrepreneur, and worked his way up at Hopkins as an academic administrator. He then moved into science politics on the national stage, as director of the National Institutes of Health under President George W. Bush.

He took his current job at Sanofi in 2011.

Zerhouni also happens to be an immigrant. He’s a native of Algeria, a Muslim-majority country in North Africa. I wanted to ask him about that life experience, and how he got to where he is today.

In this episode of The Long Run, we spoke about the crucial role of immigrants in the scientific enterprise. We also talked about the threats to government budgets for scientific research, and what would happen if budgets get slashed at a time of so much possibility in biology.

The next episode of The Long Run will feature Steve Holtzman. He’s a veteran biotech executive. Holtzman is currently the CEO of Boston-based Decibel Therapeutics, a startup working to treat hearing loss. Holtzman has mobilized other biotech CEOs to speak out this year on political issues they have historically avoided. Watch for that episode in your iTunes or Stitcher feed.

Special thanks to EBD Group for sponsoring The Long Run podcast. EBD Group is the co-producer of the Biotech Showcase coming up Jan. 8-10 at the Hilton Union Square in San Francisco. I’ll be there on a media panel, plus doing a lot of networking with interesting people and picking up story ideas for the year ahead. I look forward to seeing some Long Run podcast listeners there.

When registering here or by clicking the banner at the bottom, please add a brief comment to say you heard The Long Run podcast and you appreciate EBD Group’s support for quality biotech journalism. You’ll get to go to a great conference and support quality journalism in one fell swoop.

Now, join me and Elias Zerhouni for The Long Run.

 

26
Oct
2017

VIDEO: Climbing Mount Everest to Support Cancer Research at Fred Hutch

Hi, I’m Luke Timmerman, a biotech journalist.

I’m carrying my 80-pound training backpack, up and down the hills of Seattle, for a reason.

I’m training to climb Mt. Everest, the highest mountain in the world, in 2018.

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Why do this?

Of course, I love the mountains.

But mostly, I’m doing it to support the top-notch research at the Fred Hutchinson Cancer Research Center. I’m doing it to support my hometown of Seattle. And I’m doing it to support science itself.

As a biotech journalist for 15 years, I’ve had the privilege to meet scientists around the country doing amazing work. I see a cancer revolution happening. Immunotherapies are emerging that harness the power of the immune system to attack cancer cells much like the viruses and bacteria that we fight off every day. Fast DNA sequencers and other sensitive instruments are making it possible to detect cancer earlier than ever before, when it’s most easily treated.

Fred Hutch is at the leading edge of cancer cures. Their pioneering research is helping people with many types of cancer live longer, and lead better lives. We’re seeing just the beginning of what is possible.

We can’t let up — especially during this time of so much thrilling progress.

So I ask you to please give generously to this important cause at a crucial moment in time.

Let’s take this all the way. Donate to the Climb to Fight Cancer at Fred Hutch, and you’ll help scientists push to the top of the mountain – the cure.

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25
Oct
2017

Richard Pops on Fighting the Opioid Painkiller Crisis

Today’s guest on “The Long Run” podcast is Richard Pops.

He’s the chairman and CEO of Alkermes. He is one of the seniormost executives in the biopharma industry, having joined Alkermes as CEO back in 1991. The company is known for its technology around making long-lasting injectable drugs, especially for mass-market chronic diseases like schizophrenia and diabetes.

Richard Pops, chairman and CEO, Alkermes

I’ve known Pops for years, and know him to be a thoughtful and intense conversation partner on many biopharma issues. This particular talk was focused on Alkermes’ effort to fight one of our country’s most troubling public health threats – the opioid addiction crisis. Alkermes markets an injectable drug called naltrexone (Vivitrol).

It’s the only anti-addiction drug approved by the FDA that interferes with opioid receptors. It is designed to block the feeling that makes people get high. The Alkermes drug has an undeniably important role to play.

The drug, however, got off to a slow start in the market since FDA approval in 2010. Alkermes has gone up against an entrenched competitor, buprenorphine (marketed as Suboxone). The competitor is a mild opioid that’s supposed to help wean people off the opioid painkillers prone to abuse like Oxycontin, Vicodin, Percocet or Fentanyl.

The media has started paying more attention to the opioid crisis this year, and Alkermes has taken some heat along the way. The New York Times and NPR published hard-hitting works that wondered whether it is profiteering off this heartbreaking national tragedy, with limited data to support its drug’s efficacy and over-aggressive marketing.

It’s true that Alkermes has made political contributions to officials that had a hand in the 21st Century Cures Act, which put an additional $1 billion of government resources toward combatting the opioid epidemic. Alkermes has also done some consumer-focused advertising about Vivitrol and some targeted marketing outreach to drug courts and criminal justice authorities. It’s also true that Vivitrol sales are growing. They grew by 40 percent in the second quarter, according to Alkermes. The drug had sales of $66 million in the quarter ended June 30.

No one had reported on a head-to-head comparison of the two main anti-addiction treatments (Suboxone and Vivitrol) until recently. Researchers from Norway published work in the Journal of the American Medical Association Psychiatry, from a randomized study of 159 people with opioid dependence, which showed that Vivitrol met its goal of demonstrating that it’s not inferior (roughly equivalent) at helping people reduce their opioid dependence.

It’s fair to ask hard questions about what Alkermes is doing, like with any company. But fundamentally in my view, it has a drug that can be part of the solution, not a driver of the problem.

There are other companies that over-marketed opioid painkillers. There are distributors that kept opioid painkillers flowing like a river through their supply channels, turning a blind eye to the crisis. There are unscrupulous doctors running pill mills. There’s a lot of blame to go around.

No one company, or government agency, can fix this problem singlehandedly. This will take a long-term push from multiple players – doctors, public health authorities, law enforcement, the pharmaceutical industry and more. I hope by listening to this conversation, you’ll gain some appreciation for the complexity.

Now, join me for The Long Run.

(Get new episodes every other week on iTunes or Stitcher.)

23
Oct
2017

BioMarin Book Contains Rare Insight Into the Rare Disease Business

Companies, usually around an anniversary, often pat themselves on the back with airbrushed or whitewashed coffee table books. They chronicle all the wonderful things they’ve done. Maybe there was an amusing screw-up or two along the way. Toss in a few funny photos of the founders in Coke-bottle glasses and fat ties, and call it good.

As for the nitty-gritty of what went down on the jagged path to success? The inside dirt that people want to read, and that people can learn from? Most of that gets left out, swept under the rug, or forgotten.

Biotech as an industry doesn’t do a good job of recording its history in archives, or codifying its knowledge in books that pass down hard-won lessons. There’s always more to look forward to, another thing to discover, right? Sure, but in my view, understanding of the present requires some knowledge of the past. As William Faulkner once wrote “The past is never dead. It’s not even past.”

BioMarin Pharmaceutical CEO Jean-Jacques Bienaime recognized that when Dan Maher, a senior vice president of product development and 13-year veteran of the company, said he was retiring. Knowing that Maher knew a lot of the company’s up-and-down history, and that BioMarin was hiring a lot of people who knew little of the rare disease drug developer’s past, Bienaime had a request: Would you write a company history book?

Maher was energized. After interviewing quite a few former employees, and gathering a lot of source material, veteran biotech journalist Daniel Levine, principal of Levine Media Group, was brought in as a co-author to help tell the story.

The end result, “A Rare Breed: How People and Perseverance Built BioMarin Into One of the World’s Most Innovative Companies” (Available on Amazon, 245 pages, $23.79) is a rare — sorry for the pun — biotech corporate history book worth reading. I read an advance copy, and interviewed the co-authors on stage at an event for BioMarin employees earlier this month. While on campus, I spoke to R&D employees about my book, which made for something of a literary day at the company.

The story relies heavily on more than 150+ interviews with current and former employees, plus a lot of document-digging through quarterly reports, analyst conference calls and more. There’s a judicious use of telling details. The story doesn’t get bogged down with a bunch of irrelevant details. You learn about the humble beginnings, making Aldurazyme for kids with MPS-1 in a Quonset hut near UCLA. There was a church near headquarters known as the “Church of PowerPoint” (good grief), where the company had an all-company meeting at a tense moment. There was the CEO who liked to call himself “The Prince” as in Machiavelli. There were the tensions with Genzyme.

This story moves briskly. As the story goes on, the reader gets a sense for the rare disease business and how it’s different from conventional pharma. The company gets to know a determined and resourceful patient advocate trying to save his son, and begins to see itself serving an almost missionary purpose. When the company strays from that purpose, reaching for a blockbuster drug, things go badly.

Looking at the first 5-10 years of BioMarin, it’s kind of remarkable the company exists today, has six marketed products, and is worth $15 billion. The first CEO developed a drinking problem, which prompted him to miss a lot of work. Factions competed for power. A more authoritarian CEO followed. While he brought some needed focus, he also led the company to a near-death experience.

Maybe the most important lesson from the book is the emphasis on underrated aspects of biotech. Reading the daily news, you’d think clinical trial results and business development deals/M&A are the key value-creating events. Those things are certainly important. But by reading “A Rare Breed” you get a real sense of some behind-the-scenes factors that count. People must be organized to properly tap into their strengths and work as a coherent group. Nobody does this stuff alone.

Manufacturing of complex biologics is another underrated factor. By building up its own ability to make biologics, BioMarin put itself in a position of bargaining strength. Having invested in its own manufacturing meant that BioMarin wouldn’t be forever at the mercy of a big partner or contract manufacturer every time it had a new product to roll out. It wouldn’t be stuck with the short end of the stick.

The latter part of the book left me wanting more. BioMarin and CEO JJ Bienaime gets a free pass for the costly blunder that was the $680 million acquisition of Prosensa, the Duchenne Muscular Dystrophy drug developer. Mistakes happen in business development, we are told. Yes, but this could also be seen as a case of a company suffering from hubris, a company that thinks it can take a failed Phase III trial and ram it through the FDA because of some anecdotal successes in kids with DMD.

The book also contains scant discussion of drug pricing — a major issue in rare disease drug development through BioMarin’s entire 20-year history. How did corporate executives arrive at the prices for Aldurazyme, for Naglazyme, for Kuvan, for Brineura? What were the trade-offs considered at the low end and the high end of the ranges considered? What happened with patients who couldn’t get access right away, for whatever reason? There must have been some meaty and revealing material that sheds light on these fundamental tensions. We don’t read about it here.

Maybe that’s too much to ask. This is a company-sponsored book. BioMarin’s CEO didn’t edit any of the book or encourage any self-editing of critical material, Levine says.

To me, that mainly says there’s room for other stories and other storytellers.

Emil Kakkis, a pivotal figure in BioMarin’s history and now the CEO of Ultragenyx Pharmaceutical, told me he hasn’t read the BioMarin book. “My history there stopped in 2009 but the company did finish many of the projects from that time and is doing well.” But he says he is writing his own book about “Saving Ryan.” It’s about a boy named Ryan Dant whose life was changed by being one of the early Aldurazyme patients. Kakkis should be proud, as he worked so long and hard to help the boy and others like him. The Dant family is featured in ‘A Rare Breed,’ but they also could be the protagonists of a family drama, not unlike the Crowley family was in “The Cure” by Geeta Anand.

That kind of family tearjerker may have more mass-market appeal, depending on how it’s told. But there’s not much there for a biotech reader seeking to understand what makes a great company tick, how it got over the hump. There’s a niche for such books.

As the authors of “A Rare Breed” say:

Few companies ever succeed in getting a drug to market. Even fewer are able to achieve that milestone again and again. One of the questions we set out to answer in writing this book is, what accounts for BioMarin’s success? In answering that question, we also wanted to see whether it pointed to ways to continue that success or allow others to replicate it.

Biotech life would be enriched by more efforts like this one. We all work hard and fast, and have our goals. But sometimes with the benefit of hindsight, we can gain wisdom. Then, hopefully, we can pass it on to others who can learn what it takes to really serve people like Ryan Dant.

11
Oct
2017

George Yancopoulos on Threading the Price Needle, and Building a Biotech to Last

George Yancopoulos, the president and chief scientific officer, started his biotech career in 1989 at Regeneron Pharmaceuticals. He’s been there ever since, and has pretty much seen it all.

It was a pleasure to have him as the guest for Episode 3 of The Long Run podcast.

Yancopoulos, in this recording at Regeneron offices in Tarrytown, NY, talks about how he and CEO Len Schleifer built the company together.

George Yancopoulos, president and chief scientist, Regeneron Pharmaceuticals

These two recall the lean years when investors wondered if they were running a science project, or building a real drug company. But Regeneron has broken out as one of biotech’s big successes. The company has developed 6 FDA-approved drugs so far. It’s the third-best performing stock in the S&P 500 over the past decade. Now Regeneron is attempting to the lay the foundation for many more drugs by investing in an ambitious genomics-based discovery center.

Yancopoulos is a forceful personality. You’ll hear his passion for science come through clearly in this conversation.

Before you take a listen, a couple quick plugs. If you like this show, you’ll love my subscription newsletter, Timmerman Report. You can go to timmermanreport.com to subscribe, either as an individual, or with a group discount for your company or university.

If you are interested in sponsorship opportunities for this podcast, this will be a great way to get your company’s name in front of a high-value audience of biotech executives and investors. Send me an email. luke@timmermanreport.com.

The next episode of The Long Run will feature a conversation with Richard Pops, the CEO of Alkermes, about his company’s anti-addiction drug, and the role it can play in combating the opioid painkiller epidemic.

This was a serious conversation, and an uncomfortable one at times. Some in industry have been irresponsible in overmarketing opioid painkillers. There is no silver bullet for this scourge. This will take a long-term push from multiple players – doctors, public health authorities, law enforcement, and the pharmaceutical industry. You won’t want to miss that upcoming conversation with Richard Pops.

Now, join me for The Long Run. Thanks for listening.

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