The BIO Perspective: It Out-PhRMA's PhRMA

I emailed Blog-colleague Ramsey Baghdadi last week to agree completely with his May 11 post about the security around this year's BIO event. (Even those of us who preregistered were similarly routed 3/4 around the center, by the way...) And I agree with him that some of the sessions were surprisingly more content driven than in the past: for this meeting I always wonder whether it's more presumptuous to expect to hear nothing new at the show, or to expect to hear something of merit. The 2007 edition appeared to be fine fodder for the freelance trade press, certainly, judging from the number of surprisingly pithy story pitches in my email afterward.

But BIO has in many ways ceded its claim to be hoisting the banner of innovation, and that's unfortunate. I heard second hand that one biotech industry rep -- a former PhRMA intimate -- had commented at the meeting that "BIO is more PhRMA that PhRMA ever was." With respect to follow-on biologics, for example, its initial stance has been to stall, saying Congress shouldn't link it to PDUFA reauthorization because it was too scientifically complex to resolve in that timeframe, and besides, that the health care system should not expect to see signficant cost savings from FOBs.

Or as one ex-BIO staffer said to me, "Blocking innovation is what PhRMA does, like when it tried to stop Hatch-Waxman." Where previous BIO leadership would take the heat from big companies (in part to be seen as an alternative voice to PhRMA), advocacy on FDA policies is now set by the larger companies' Washington offices. Carl Feldbaum preached the importance of political neutrality, but the partisan, hooked-into-the-White-House Greenwood team hadn't planned for a Democratic win in '06, and has to build those bridges.

That said, there's no doubt that the spirit of innovation lives on in the hearts and minds of companies, investors, and other biotech stakeholders. And it's not even that BIO's voice is the wrong voice. It's just not -- no longer -- a voice of innovation. The Emerging Companies Section -- a notion integral to the merger between IBA and the smaller ABC that created BIO way back in 1993 -- appears to be fading away. In light of its policy positions, when the organization in its role of external advocate speaks of risk-taking, it rings hollow.

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The Import of FDA to Biotechs, CEO Entourages and a Few More BIO Thoughts

I just wanted to post a few more impressions I had from the BIO annual meeting in Boston. One thing that struck me in particular is how little high-level attention smaller biotech companies give to FDA and CMS affairs in general. I understand that CEOs travel the country trying to raise enough money just to keep the lights on, but in the end, it doesn't mean much if FDA won't approve the product or if CMS won't pay for it. The "We'll Cross that Bridge When We Come to It" strategy just doesn't work anymore. Biotechs need to be engaged in the approval process from the earliest stages to understand the types of studies FDA likes best, the benchmarks, the key people within the agency, and the approval standards in a particular disease area.

I rarely see the top management of smaller biotech companies attending FDA town hall sessions or speeches by senior FDA officials. There's also an assumption that if FDA approves it, CMS will cover and pay for it. Done and done. Outside of oncology, that is becoming less and less true. At The RPM Report, we have heard often from CMS officials that they want to see reps from a company with a developmental product when the Phase II study is getting underway in order to start reimbursement discussions.

One exception is Medimmune CEO David Mott, who has always appeared to me to be very engaged in FDA/CMS activities. How much did he get for selling Medimmune? Oh, I forgot, $400 million. I'm not saying there's a link, I'm just saying.

One thing I like to observe when I'm people-watching is the size of CEO entourages. At BIO, Biogen Idec CEO James Mullen was rolling with about five or six people when he sat in on a drug safety session featuring Biogen R&D neurology VP Alfred Sandrock. By comparison, I recall Merck CEO Richard Clark flying essentially solo at PhRMA's annual meeting in Washington a few years back. Clark's predecessor Ray Gilmartin was known to keep a fairly low profile as well.

Stepping into the political realm, HHS Secretary Michael Leavitt has a group of handlers that arrive well in advance of his speeches in order to keep improvisation to a minimum. Rep. Henry Waxman often comes to events alone, without handlers, and even drives himself, a rarity in Washington. Do any of you know of particularly large CEO entourages? Or CEOs happy to eat lunch alone? We would love to hear about it.

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BIO Security

The BIO annual meeting never ceases to amaze. This year in Boston, the conference drew over 20,000 people. The exhibit hall had the feel of a World Cup soccer event and was as creative as ever with espresso bars and great beers from all over, and Biogen Idec put together a great booklet of places to see and be seen if you decided to leave Shangri La and take a tour of the city.

I found the meeting sessions to be particularly strong in the content department, something I hadn't felt the last time I went in Philadelphia. The policy and regulatory tracks were what I stuck to, and I found myself rarely bored. By the way, Nicolas Rossignol, who heads up the European Commission's division on pharmaceutical legislation, is a rising star. I thought that when I saw him testify before the Senate HELP Committee a few months back, and that perception was reinforced during the follow-on biologics session at the conference. So, all in all, BIO and the conference team deserve a round of applause for putting on such a large and high-level event.

But what was up with the security? My decision to go to the meeting was last minute so I had to register on site. Bad choice by me. No badge, no soup. I was told to go to a side door, take an elevator down to "level zero" and then, "you'll see signs" the guard told me. As an aside, I would love to see the crime rates for the last week in Boston because all of the cops, special forces and snipers were at the convention center. I followed the guard's directions to the letter, but the "you'll see signs" part of it was a lot longer than I expected. You have to travel the entire outside perimeter of the convention center, which looks like the type of place you would get offed in the Sopranos , to get to the registration site. The badges have barcodes and you are scanned into each and every session by people guarding the doors. When did we get to this point? Where's the trust people? The head of FDA's biologics center Jesse Goodman complained that it took him 45 minutes to get into the building and they weren't going to let him in at one point.

Did anyone else have the same feelings as me on the tight security? I would love to hear some anecdotes. I know a few people missed their one-on-ones because of it.

One last note: in San Diego next year, can we please have more coffee stations separate from the exhibit hall? I went through serious withdrawal at one point and didn't have time to make it down to "level zero." Just a thought.

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