Thursday, December 7, 2017

The Readout by Damian Garde & Meghana Keshavan

Welcome to The Readout, where we keep you on top of the latest in biotech. For more in-depth coverage of biopharma, subscribe to STAT Plus. On Twitter: @damiangarde@megkesh, and @statnews.

The fallout from the allegations against Isaly


OrbiMed founder Sam Isaly is no longer listed among the speakers at an upcoming CNBC conference. (Screen capture via CNBC)

As Wall Street reacts to allegations of sexual harassment against OrbiMed Advisors founder Sam Isaly, the legendary biotech investor has been dropped from the list of speakers at an upcoming conference and ducked a dinner with analysts, according to a person familiar with the matter.

Isaly is no longer listed among the speakers at a CNBC health care conference scheduled for March. He was prominently featured on the schedule before STAT reported the allegations against him Tuesday. A CNBC spokesperson declined to comment.

Meanwhile, one of OrbiMed's clients said it is "reviewing" the claims against Isaly, "which we take very seriously." Others, including the multibillion-dollar pension funds of California and Ohio, did not respond to questions about the future of their relationships with OrbiMed.

Read more.

Looking at a merry biopharma new year

The new year will be a prosperous one for the biotech and pharma sectors, according to new report from the folks over at EP Vantage. FDA will remain business-friendly, they project, and we’ll likely see a surge in M&A — largely because the life sciences industry will need to refill its drug pipelines through acquisition. 

It’ll be the year of hi-fi drugs going commercial, with gene therapies and CAR-Ts hitting the market. Gilead’s new HIV drug, however, has the most blockbuster potential — with sales forecasted to reach $5 billion by 2022. The IPO window will remain wide open for cash-heavy private companies, and venture capital will be particularly strong.

Importantly, the drug pricing debate’s projected to ease up. So, happy new year, industry!  

Sponsor content by Halloran Consulting

Seven trends in clinical trial data

We’ve entered an unprecedented era of big data, where the world’s data volume doubles every two years! And this data explosion is just as apparent within clinical trials. Non-CRF data now represents 70 percent of clinical data and is growing 40 percent per year.

It’s hard to understate the potential change this will bring to clinical development, but how do you extract value from all of this? Seven key trends critical to clinical development teams have been identified.

Collins contemplates mutant DNA

NIH is backing researchers who are tinkering with the building blocks of life: A team at The Scripps Research Institute has been working on an expanded DNA alphabet for years, adding two base pairs — X and Y — to the standard A-C-G-T mix. (They've also launched a company, Synthorx, which we wrote about last year.) 

NIH Director Francis Collins is clearly a cheerleader for the science, and blogged this week on the researchers’ progress — including how the added base pairs can substantially expand the number of amino acids manufactured, in E. coli, by the lab-enhanced DNA. It could be a real win for protein engineering and drug development, he says. But he does admit that “caution is warranted.” 

Much like Jurassic Park dinos, the bacteria engineered to carry six base pairs “can’t survive without being fed the right ingredients to make the unnatural gene sequences and proteins they encode,” Collins writes.

Our take: Let’s just hope Scripps doesn’t start relying on frog DNA. Life, as the great Ian Malcolm likes to put it, finds a way.

An eggcellent choice of attire

FDA fashion wars continue: 

Poor Scott.

He's gotten an earful in recent days. Earlier this week, Nielsen Hobbs, the editor of The Pink Sheet, introduced an on-stage interview with Gottlieb by reminding the audience that the FDA commissioner raises his own chickens. Then he announced that the commissioner was featured on last month's cover of Backyard Poultry — and flashed a mock-up of the magazine with a cover shot of Gottlieb on the big screen.

Alas, it disappeared before STAT reporter Ike Swetlitz was able to snap a photo. (Hobbs declined to share the image later, calling it an "in-house joke.")

More reads

  • A deadly drug cocktail shines light on AstraZeneca blockbuster. (Bloomberg)
  • Sex, drugs, and that little blue pill. (Bloomberg View)
  • Spark gene therapy nearly eliminates bleeding episodes in hemophilia B patients. (STAT Plus)

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Thanks for reading! Until tomorrow,

Damian & Meghana

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