Friday, March 27, 2009

The IN VIVO Blog Podcast: Sandoz's View On US Biosimilars Outcome

Yes, the IN VIVO Blog Podcast is a Wednesday thing. But sometimes there's just too much podcast for little old Wednesday, and this is one of those times. Welcome to a bonus podcast to kick off your weekend.

Did you read Melanie Senior's FOBs post on Monday? When you did, did you think 'I wonder what Melanie and Hannes Teissl sounded like when they talked about these pieces of biosimilars legislation?' Well, wonder no more, and click on the logo below to listen.

When it comes to that perma-hot topic, biosimilars, all eyes are on the US right now. There are various bills up before the House, most prominently Henry Waxman's pro-generic one, and Anna Eshoo's pro-brand one (plus, as from today, a bipartisan proposal that looks very Waxman-ish). As the debate rages on in Washington, our on-the-pulse podcaster asked Hannes Teissl, head of Biopharmaceuticals at biosimilar pioneers Sandoz, what flavor of legislation he thinks will appear.

Don't forget, you can access the podcast via iTunes also.


Anonymous said...

I still haven't found much value in your so-called analytical skills. You sure missed this one altogether. Where's Torti now ... back at Wake Forest where he said all along he would end up.

Frank Torti: The Next FDA Commissioner?
By Kate Rawson

With the presidential elections still five months away, Washington is already buzzing about FDA commissioner Andrew von Eschenbach’s successor. Industry would be wise to learn more about one potential candidate for the job: chief scientist Frank Torti.

FDA Acting Commissioner Frank Torti. It kind of has a nice ring to it, don’t you think? Given some of the things we’ve been hearing inside the Beltway recently, it may just come to pass.

Torti came on board as FDA chief scientist and Andy von Eshenbach’s second in command in April. At the time, we commented on the choice of an academic as Janet Woodcock’s successor, and Torti as a particularly non-controversial pick.

But the early word—at least from his colleagues at Wake Forest—was that Torti wasn’t long for the job, and that he’d be returning to academia as soon as the next president took office.

Some industry observers are now speculating that Torti’s tenure at FDA will be a lot longer than first thought. Conventional wisdom inside Washington has held for some time that von Eschenbach’s tenure is winding down, and that he will be asked to leave FDA the morning of November 5, regardless of who ends up in the White House.

Once that happens, Torti is likely to be asked to hold down the fort until von Eschenbach’s permanent successor is named. And depending who takes over the White House, Torti very well could be that permanent successor. That shouldn't come as much of a surprise: von Eschenbach himself was only supposed to be a temporary replacement when he came on as interim commissioner in late 2005.

Either way, Torti is someone that industry should get to know. If you’re looking for some insight into Torti’s policy plans, his May 30 appearance at the FDA Science Board might be a good place to start. You can find a partial transcript of his presentation through The RPM Report by clicking here; if you don’t subscribe, you can sign up for a 30-day trial to view the article.

In it, Torti outlined his plan for his first 100 days as FDA’s chief scientist, very much sounding like someone who is ready and willing to settle into the job for the long haul—at least until he is called up for higher service. Even the title of his speech had a political ring to it: “Science at the FDA: Vision, Plans and Timetable.”

At least for now, Torti is being coy about his future plans at FDA. When our colleagues at “The Pink Sheet” asked him about the rumors surrounding his tenure at the agency, he smiled and said, “I’m not in the habit of taking a job no one’s told me about yet.” Perhaps not. But we have a feeling his phone will be ringing soon.

Michael McCaughan said...

Thanks anonymous.
I didn't write the post you cite, but actually, ummmm, isn't it right on? "Acting Commissioner Frank Torti has a nice ring to it." Not a bad call, made in June.

Anonymous said...

who else would they have made acting commissioner... someone in the mailroom? The article and a conference you hosted made Torti out to be more than he was, which is an academic on short-term loan. Please, he oversaw the fellowship program.