Notes from BIO: Getting Comfortable with REMS

No one wanted to use the word ‘albatross’ in the same sentence when describing REMS, or Risk Evaluation and Mitigation Strategy, at a panel session this week at BIO about the FDA Amendments Act of 2007. But the implication was hard to miss from the tone of some of the comments and the body language of some speakers.

A REMS, for those who may not recall, is the newly upgraded program to ensure a company has a strategy in place to manage and communicate a potentially serious risk with its medicine. And the implications are being gauged closely by industry, which is assessing whether REMS will wind up conferring a greater probability of approval or result in commercial dead-ends.

Drug makers, for instance, would like more guidance, according to Jeff Francer, assistant general counsel at PhRMA, who said REMS is the key issue to watch as a result of the FDAAA. “I would say it’s the effects of REMS on the approval process and post-marketing…We should continue to study how REMS and the implementation are affecting patient care. We, in industry, would like more formal guidance…For most of industry, it’s about REMS.”

A few feet away sat Jarilyn Dupont, director of regulatory policy in the Food and Drug Administration’s Office of the Commissioner, who said that “there’s always going to be tension” over the push and pull between industry and regulators over the requirements and implications. But she noted that the REMS program, which gives FDA some enforcement powers, is still new and that guidance will be forthcoming. “It’s really only out since September, so over time, you will see more guidance. But guidance development doesn’t happen over night.”

Another industry rep, Andrew Emmett, director of science and regulatory affairs for BIO, tried a more optimistic line by saying that, as “comfort levels are built and guidance” emerges, the REMS process should become smoother. Still, his comments about forthcoming REMS evaluations suggested an air of anxiety. The FDAAA requires that all REMS must include a timetable for assessments at 18 months, 3 years and 7 years after approval of a REMS. “There are a lot of questions in industry,” he said, “about what those are going to look like.”

Notes from BIO: Toast of the Coast--Incubator vs. Pfincubator

While an earlier session on raising capital in trying times was cancelled--as if to say "yes, it really is that bad!"--it was standing room only at yesterday morning's last-day session titled “Early Stage Investment Strategies: If Not Us, Who? If Not Now, When?"

Afterward, we overheard it called by several people in the audience the best of many sessions at this year’s BIO meeting devoted to getting technologies past the infamous valley of death and into the waiting arms of big pharma.

Of course these panelists didn’t exactly solve everyone's dilemmas, but attendees left feeling better after listening to Melinda Richter, Executive Director of the San Jose BioCenter, trade jibes with Mark Benedyk, who heads Pfizer’s La Jolla Pfincubator.

Richter good-naturedly claimed that Benedyk’s incubator companies are indentured while she shops for the best deals for her companies. Benedyk says his companies are grown in a hot house with no worries, while others have to make a go in wild fields.

Richter’s project was initially funded through San Jose’s economic development efforts, initially receiving $5-10 million from the city's redevelopment agency. In three years its fledgling companies from the BioCenter have brought around $3 billion to the area economy, she claimed.

The problem?"Our companies have been very successful at growing very quickly, but then they tend to leave the area," Richter said. "From an incubation perspective, very successful," but from the point of view of the incubator's investor, San Jose, not as successful.

So where are they going? San Jose's biotechs are forced to establish facilities further up the peninsula in the Bay Area – taking jobs and business with them - because the incubator has the only lab space in the San Jose area. --Shirley Haley

image from flickr user caveman 92223 used under a creative commons license

Notes from BIO: Merck's Take on Biomarker-Based Drug Development

Merck sees itself as a leader in biomarker-based drug development. "We are toward the extreme end" of peer companies in the field, Executive Director of Licensing & External Research Reid Leonard said during a BIO breakout session May 19.

"We actually have very aggressive internal goals for the requirements for a biomarker strategy that is coincidentally built up with the drug discovery strategy for any new target."

But before you put Merck down as an advocate of personalized medicine, listen to how he described the company's approach:

"Ultimately our goal, despite the overall objective of being able to stratify patients where its appropriate and necessary, given the choice, if we are going to find a therapy that will treat a disease that many people will have, our preference is to find a way of doing that that in fact doesn't require stratification, that in fact picks a target that is intrinsically less sensitive to genetic variation than another target. So its using all the same data to try to essentially come up with a drug that in fact the physician can have some confidence will work in 80% of the people."

It's not that Merck will ignore stratification if it appears appropriate in clinical trials. That's just not the goal.

Notes from BIO: Biotech's Voice in Health Care Reform

"PhRMA doesn't speak for bio."

That message, says Bryan Cave LLC Partner Broderick Johnson, must be made very clear during the health care reform debate.

As we've noted, the Biotechnology Industry Organization has not been included in White House events on health care reform, while its Big Pharma brethren in the Pharmaceutical Research & Manufacturers of America have been.

Johnson doesn't necessarily think that's a bad thing. "A lot of these White House events get a lot of attention and that’s very important," he said during a May 19 bio session. "But I think its just as important, if not more important, that bio has a seat at the table at the roundtables being held by the Senate Finance Committee. That’s where a lot of the important decisions will be made...so don’t overlook the importance of being at that table."

Indeed, bio's leadership is reassuring its members that not being at the White House is a good thing, since bio has committed to nothing in health care reform, while PhRMA has found itself promising to play a role in delivering significant cost savings in the years ahead.

Of course, there's another way of looking at it: maybe the White House thinks it doesn't need bio involved, or--indeed--that in dealing with PhRMA it is addressing bio's interests as well.

It was that latter point that Johnson sought to address. bio should be wary of "perhaps a misconception that...bringing PhRMA into the room will get bio’s concerns addressed as well. Its really important to make the distinction clear that PhRMA doesn’t speak for bio."

A strong point. Of course it might have been stronger if the panel discussion had included Biogen Idec CEO Jim Mullen. He was a late cancellation, replaced by Allergan CEO David Pyott.

Yep. Can't let those PhRMA guys speak for bio.

Notes from BIO: A "Fire Drill" on Flu

When it comes to the "swine flu" outbreak (forgive the non-PC term), its hard not to look on the dark side. Either we are facing a catastrophic outbreak we are unprepared to prevent, or we have succumbed to yet another media-stoked panic that makes us all feel silly.

Clearly the zeitgeist has tilted heavily towards the latter view, and surely we can all agree that is the better of those two choices.

Still, we were pleased when Vertex' outgoing CEO Josh Boger offered a third way of thinking about the current outbreak during a BIO "Super Session" May 20: this is a "fire drill"--testing our pandemic preparedness rather than our evacuation procedures--and like any fire drill it is only effective if everyone takes it seriously. So, if, as we all hope, this flu outbreak proves mild and manageable, we can still feel good about taking it so seriously.

Only time will tell if this outbreak is or is not the hamageddon it sounded like a month ago, but we at least were heartened that others on the panel (including FDA's point person on the flu, Jesse Goodman) adopted the "fire drill" metaphor as well. We feel better already.

Notes from BIO: A Big Gap In Industry's Plan For Comparative Research

The biopharma industry has a big problem with the comparative effectiveness research provisions included in the stimulus bill enacted earlier this year.

As we noted in The RPM Report, it lacks several key elements that industry says need to be part of a functioning system, including an implementation process that they feel invovles their input. That sure makes a lot of folks at BIO very nervous.

Hence, an all-out lobbying campaign for new legislation to establish an independent institute to oversee comparative research.

The preferred approach was articulated by Senate Finance Committee Chairman Max Baucus in legislation introduced last year, and industry hopes to see that vision included in any health care reform bill this year, Foley Hoag Attorney Barrett Thornhill said during a breakout session May 20.

There's just one problem: even in the best case scenario, legislation won't change how the initial bolus of funding--$1.1 billion--gets spent.

Thornhill, whose firm represents the Partnership to Improve Patient Care--an association funded by BIO and PhRMA and other organizations to lobby on CER--puts the chances of getting the Baucus proposal into health care reform at just 50/50. But even it if is included and signed into law this fall, he notes, a new institute won't be set up until the end of 2010 at the earliest, with research projects beginning no earlier than 2011.

So "you have this gap between when the [stimulus] funding gets handed out until you have new framework even established," Thornhill noted. "So its hard for us to go out and lobby to have this Conrad-Baucus entity just control the funding. The pushback is 'What are we are going to do for two and a half years? Just sit on our hands?'"

"That's not what the House Democrats are interested in doing," Thornhill says, "and I guarantee that's not what they are going to do."

Notes from BIO: Positive Message from Anti-Infective Development

Cempra closed a $46 million Series C funding in mid-May. Any fund-raising in biotech these days is noteworthy, but there is an extra layer of significance to this one as a vote of confidence in anti-infectives drug development.

Capital is hard to come by for anyone, but the ability of an anti-infective development firm to raise capital from at least six private funding sources sends as strong signal that the uncertainty in anti-infective development stemming from regulatory delays experienced by projects like telavancin and ceftobiprole may be fading into the background.

Prabhavathi Fernades, the CEO of Cempra, told a BIO breakout session today that FDA's recent work on anti-infective development guidelines is starting to send a clearer message. The objectives and targets for anti-infectives are going to be tougher, she thinks, and skewed towards more serious disease, but that is adding a sense of clarity to development projects. The clarity is what is important.

Fernandes, who has extensive experience in antibiotic development at Bristol-Myers Squibb and Abbott (where she took a lead role in the regulatory development of Biaxin) prior to starting Cempra, also said that developers have learned some harsh lessons on accountability and keeping close control on clinical trials based on the non-approvable and complete response letters from FDA during the past 18 months.

Cempra's CEO thinks that sponsors were getting a little lax and failed to follow up on issues such as big geographical differences in efficacy in clinical trials. From that perspective, the reaction from FDA is not a full-stop to anti-infective development, just a reminder to sponsors to pay closer attention to the details of their applications.

To Fernandes and her backers, it looks like the period of regulatory uncertainty at FDA may be coming to a close. Cempra has a macrolide-ketolide compound, CEM-101 (oral and IV) headed into Phase II trials this year. With bacterial resistance and pandemic influenza alternating for headlines, it might just be a good time to be developing a new generation of anti-infectives -- especially with clearer guidance from FDA and a new public health-oriented team leading the agency.

Notes from BIO: NCI's Bridge Over FDA Troubles

"We're from the government and we're here to help you."

Here's a twist on that cliche: a government program that really might help. The National Cancer Institute's $100 million SBIR (Small Business Innovation Research Program) is promoting a new "bridging" program to try to carry projects that it has previously funded in early formation through the ominous "valley of death" period as the developers face the first tough requirements of preparing for contact with the Food & Drug Administration.

The NCI program's program director for therapeutics development, Ali Andalibi, was at a BIO breakout session in Atlanta on May 21 to spread the word about NCI's new largess. Andalibi was quite convincing: the center has money allocated to the bridging program (up to $10 million during the current fiscal year) and a practical model that involves trying to bring in private money and regulatory skills to make sure that projects don't die on the vine after two rounds of initial NCI funding support.

Andalibi, who has worked in academia, the biotech sector and for the National Science Foundation's SBIR program prior to joining NCI, has the range of different perspectives on government funding and resource support that could be very valuable to cancer start-ups.

As close FDA watchers, it particularly impressed us that NCI is adding regulatory consulting into its package of assistance for the start-ups. That's often a missing ingredient at that point in development. NCI wants to help the start-ups get through IND filing and safety testing before turning them loose for full private funding.

NCI and FDA have not always seen eye-to-eye on commercialization requirements, but they have been much closer partners in recent years. It cannot hurt fledgling private companies to have the assistance of NCI in finding the right advisors and coaching on regulatory strategies.

NCI is selling this new funding proposal to a relatively small group of potential prospects: only those firms that have received previous awards: Phase I (R41, R43, six-month feasibility studies) and Phase II (R42, R43 up to two-year projects with commercialization plans). The bridging grants are patterned after Phase IIB funding from NSF.

The government expects the developers to raise private money to supplement the new bridging loans. Andalibi says NCI will try to help locate angel funding sources. The private money is important to NCI as it also brings in the closer oversight and rigor of the investor community.

NCI has been selling the idea of bridging funding for at least eight months. It will be interesting to follow the projects that take advantage of the funds and to see whether a little help and advice from one of FDA's government cousins can move more projects through the IND and early human trials period.

Notes from BIO: Vaccine Applications to FDA Booming

The Food & Drug Administration expects to receive as many biological license applications for new vaccine products in a four-month period later this year as the agency has ever received in a full year.

The onslaught of applications suggest a big year for vaccine approvals in 2010.

“It is going to be a busy year” for the agency’s Center for Biologics Evaluation & Research, the head of the agency’s biologics review management, Robert Yetter, told an FDA Town Hall meeting here at BIO. FDA is planning for the uptick in applications based on conversations with sponsors and indications from the sponsors of projected filing dates.

The ramp up in applications is tangible evidence of the past five years of accelerated activity in the vaccine field. In 2008, FDA approved three new vaccines: two were new mutli-component products Kinrix (DTaP with polion from GlaxoSmithKline) and Pentacel (DTaP with polio and Haemophilus B from Sanofi-Pasteur); GSK also received approval for its rotavirus product (Rotarix).

The bolus of review applications will hit FDA at an awkward time as FDA deals simultaneously with efforts to support the preparations for a potential return of the H1N1 flu with the next northern hemisphere flu season.

Yetter reported that CBER is already looking at ways to move license applications and supplements for pandemic vaccines “as quickly as we can.” He noted that the agency has developed experience with dealing with emergency licensing procedures for vaccines in recent years. FDA licensed a Sanofi-Pasteur avian flu vaccine in 2007 to allow the federal government to purchase it for the national stockpile. Yetter said that the agency will “use every pathway” to speed vaccines for the H1N1 outbreak.

Yetter pointed out, however, that FDA is patently aware that it cannot take risks or appear to take short-cuts on vaccine approvals in an emergency. He noted that the agency has to be able to convince the public that a vaccine is safe or they went take it even if FDA gets it out for use.

At least two major vaccine manufacturers, Novartis and Wyeth, have important vaccine projects under review which also could get caught up in the increase of workflow at CBER. Novartis has its first meningitis application for Menveo for people 11-55 pending from last August. Wyeth has the key generation shift for the pneumoccoal conjuate franchise active at FDA in a BLA for Prevnar-13 since March 31. The application was okayed for a priority review in early May.

Notes From BIO: Josh Boger Goes Back to Merck

Okay, no, this isn't a news flash. We don't have a scoop on what Vertex' outgoing CEO Josh Boger plans to do once he officially leaves the company he founded at the end of this week. And we certainly aren't predicting that he will return to Merck, where he began his career in pharmaceutical R&D before leaving to found Vertex in 1989.

But we do know what Boger did when it was time to step down as chairman of the Biotechnology Industry Organization: he returned to the legendary vision statement offered by George Merck in 1950, which served as the touchstone for Merck's vision of leadership for the rest of the 20th Century.

George Merck's famous advice--usually paraphrased as "putting patients first"--is not just a slogan, Boger observed, but a business plan, complete with the assertion that the "better" industry remembers that medicine is "for the people...not for the profits," the better the profit ultimately is.

It is also a mission statement for the future: "We cannot rest until the way has been found to bring our finest achievements to everyone."

Notes from BIO: Swag Review

Although overall it's probably true that companies have toned down their exhibit hall shenanigans this year at BIO, there are still some stand-outs in the giveaways department.

Late yesterday afternoon (after a long day of working very hard, of course) we ventured into the Exhibits for the first time. We know you're curious, so here goes.

Re Louisiana: "The beer coozy technology they're developing down there really surpasses anything I could have possibly imagined," said one biotech CEO. We couldn't agree more.

Novo Nordisk was giving away drumsticks. Not the chicken-leg kind either. Proper drumsticks. We didn't pick up on why, but this will certainly make a lot of children happy and a lot of attendees eventually wonder: why on earth did i pick those up?

Argentina takes top honors for the best metaphorical exhibit, running tango demonstrations that drew large crowds. After all, everyone at BIO is interested in learning how to dance in lock-step with an attractive partner.

We couldn't pass Haiwaii by, of course. Who among us wouldn't rather our business be based there. Greeters offering leis amid the lovely strains of the hula made it seem so possible--but the gentleman in native garb looked positively frigid in the overcooled Atlanta exhibit hall.

Hungary was offering some kind of apricot cocktail. Is there a laetrile angle there?

Finally we should mention that Merck-Serono's booth lacks tchotchkes entirely--they're making a $5 donation to the National MS Society for each person who drops by their booth. Any other companies doing something similar?

We'll try to stop by the exhibit hall again today, so let us know what we missed. Also swing by the lovely Elsevier Business Intelligence booth (1737) where you can pick up some magazines and get a database lesson or two ... OK yes we're giving away puzzles.

Notes from BIO: Meet Merck-Serono's Portfolio Guru

While Big Pharma grapples with its business model dilemma and R&D structures, some of its mid-sized competition is busy reaching out in an effort to boost externalization at the early stages of the research continuum.

On Tuesday afternoon we talked with Merck-Serono's executive vice president of portfolio development Vince Aurentz, also a member of the company's executive board, who is essentially tasked with making sure the company gets value from the R&D investments it makes.

It's a unique role. "I don’t think anyone else in industry has this job description," says Aurentz, who is responsible for all business development and licensing, as well as mergers and acquisitions. If that wasn't enough, all R&D project heads report into Aurentz as well.

He has been busy. Merck-Serono has been reviewing its pipeline and deciding what to prune. Of the recent agreement to end a collaboration with NovImmune, for example, Aurentz says "These compounds just didn’t fit where we were going. We’re trying to be a good partner, and sometimes that means you need to untangle relationships." Overall he says that Merck-Serono has looked at trimming about forty ongoing projects since 2007 as part of a portfolio review.

There has also been a decided shift toward earlier stage opportunities. Merck-Serono has in the past few months announced two separate corporate venture capital initiatives and is busy funding R&D within academia as well.

The timing was right to start the corporate venture funds, says Aurentz, partly because of the lack of early-stage funding for projects that aren't quite at the licensing stage. It also reflects a dearth of quality clinical assets available for in-licensing.

"Part of it is because of the lack of [later-stage] opportunities. But it is also because it doesn't make sense for us to build these capabilities out internally," in terms of research infrastructure, says Aurentz. At this point at least 60% of the company's projects are externally sourced, a figure that is only likely to grow.

In fact, he says, "we're passed the point as an industry where recreating all these research capabilities in-house makes sense. It's inefficient. Right now it’s hard not to view business development as the natural source of our product candidates."

Other companies are coming to similar conclusions. Bayer-Schering has also redoubled its academic outreach efforts, with a grant program that is part of a broader effort to drive innovation. Though in our interview with that company's BD head Michael Yeomans on Monday he noted that Bayer's shift toward accessing earlier stage assets hasn't extended to the venture capital arena. “We don't have a corporate VC fund,” says Yeomans. “But we do make investments as a limited partner in certain cases."

Notes from BIO: BIO, Meet Sanofi; Sanofi, Meet BIO

Sanofi-Aventis, which now calls itself a US and European company, is searching aggressively for partners, according to remarks made at a press conference on Tuesday.

“The message we want to pass on at this BIO conference is we are partnering more and we wish to do more,” said Jean-Claude Muller. Muller is VP for R&D, prospective and strategic initiatives in CEO Chris Viehbacher’s plan to grow the proportion of Sanofi’s business that comes from external relationships - currently at 27 percent. The announcement was a first for Sanofi at BIO.

“Our key message is the proportion [of business] will grow through partnering because value comes from partnerships,” Muller said. With a partnering word cloud like this (see pic) it's hard to argue isn't it?

Muller and Philippe Goupit, who is VP for business development and corporate license, are charged by Viehbacher with reshaping the company’s R&D to make Sanofi a diversified global leader in health care. Viehbacher “is really turning the page and entering into the 21st century,” said Goupit, who also testified the CEO has pledged to spend 20 percent of his time on personally exploring new business opportunities. --Shirley Haley

Notes from BIO: Adimab Pulls Back the Curtain

Adimab, the yeast-platform antibody discovery play we wrote about here, has essentially been quiet about the specifics of its highly anticipated platform technology. Until today.

During a panel here at BIO founder Tillman Gerngross unveiled the details this morning: Adimab is re-engineering yeast cells to create antibody factories. The technology is completely separate from the GlycoFi yeast manufacturing system that Gerngross sold to Merck in 2006 for $400 million.

"In essence we’ve created a synthetic human immune system in yeast, and the yeast will do what a normal B cell does, which is create an antibody," Gerngross explained during his presentation. Those antibodies can then be optimized and eventually manufactured in a variety of expression systems: yeast, CHO, whatever. He claims the Adimab libraries will have a diversity that is more functional and more human than other ‘fully human’ antibody technologies, because of the way they're created.

The proof of Adimab's success will come when it executes on deals for the technology, Gerngross said in an interview. The company is currently working on three customer programs--a kind of 'try-before-you-buy' arrangement that will allow companies to kick the tires. “We want potential partners to convince themselves that it works. You send us an antigen and we either send you 100 antibodies in eight weeks or we don’t.” Gerngross promises more news on the partnering front "in the not too distant future." Given his and co-founder Dane Wittrup's track records, we have a feeling the news will be interesting.

Validation will not be coming from in-house drug discovery programs, he says. “We have no intention of becoming a drug discovery company,” says Gerngross. Why not? “Because we’re not good at it! Let everyone else do it, everyone else certainly wants to. We’re providing what we think will be the best tool to do it.”

We'll have more on Adimab's platform technology in the next issue of START-UP.

image from flickr user danagraves used under a creative commons license.

Notes From BIO: The Pathology of Personalized Medicine

Translating the vision of personalized medicine into reality is no simple matter, but here's an obstacle we hadn't considered before: the need to update the 19th century science of tumor pathology to address 21st century demands for biomarkers.

Pathologists rely on microscopic analysis of formalin-fixed, paraffin-embedded dead tumor cells--an analytical process that is logistically complicated and involves destroying most of the biological information contained in living tumor cells. For biopharma companies hoping to develop more targeted cancery therapy, there has to be a better way.

That, in a nutshell, is the business plan for Baltimore-based Biomarker Strategies, a 2007 start-up formed by Johns Hopkins professor of pathology and oncology Douglas Clark. Clark described the problem--and his company's proposed solution--during a panel discussion this morning on Integrating Genetic Markers in Drug Development.

Biomarker Strategies is developing an ex-vivo life tumor cell biomarker identification device--called SnapPath--which, Clark says, can help identify appropriate biomarkers and guide treatment choices, essentially at the patient's bedside.

We have no idea if SnapPath is a viable solution, but we appreciate the case study in the complexity involved in making targeted medicine a commercial reality. The science is revolutionary, but it will work only if there are also revolutionary changes in the practice of medicine to enable their use in the real world.

Notes from BIO: Delicious Drug Delivery

We took part in a media meet and greet this morning billed as a 'speed-dating' session. Now maybe it's been a while since we were playing the field but as we sat down at our first table to give the IN VIVO spiel we were surprised by one aspect of the modern dating ritual.

Did we get flowers, a heavily perfumed come-on? No, we were offered some peanut brittle. And then told said peanut brittle was in Phase III development for type-1 type-2 [thanks to the commenter who pointed out the error] diabetes. Is it the real deal? We don't pretend to know (and to be fair the 'drug candidate' isn't the brittle itself, but an ingredient, already FDA approved as a food additive). But that's gotta be the best drug delivery pitch we've seen in some time.

image from flickr user u m a m i used under a creative commons license.

Notes from BIO: Not Just Another Report

Has it really been just 18 months since a subcommittee of FDA's Science Board released its report, "FDA's Science and Mission at Risk?"

As Gail Cassel (Lilly VP-Scientific Affairs and chair of the committee that produced the report) pointed out in an update we checked out this afternoon, the report's message: "The demands on FDA have soared; resources have not," was "against the grain of thought at the time."

An industry spokesman, Cassel noted, wondered aloud after the report was released, whether FDA really needed more funding. That "attitude certainly has changed," Cassel noted. Industry is very much on board with advocacy for more funding for the agency; FDA's budget is now almost 50% higher from appropriated funds (based on FY 2010 proposals) than it was before the report came out.

The session included updates from several Science Board committee members, as well as former FDA Chief Scientist Frank Torti (now back at Wake Forest after a year at the agency). Torti's discussion of FDA's progress in implementing the recommendations of the report garnered praise from Cassel for "the massive change you've been able to bring about."

Notes from BIO: TOUCH for Diabetes

Biogen Idec's TOUCH program for Tysabri "gave doctors and patients confidence" in their ability to use the MS therapy safely, PDI CEO Nancy Lurker said during a panel on the Risk Evaluation & Mitigation Strategies, moderated by your humble blogger.

"I would use that as a template" for trying to market diabetes drugs in an era of focus on cardiovascular safety. The risk of cardiovascular toxicity is not as black-and-white as the risk of PML associated with Tysabri, Lurker says, but the principle is the same: a REMS can help reassure endocrinologists that they can use new medicines safely.

Lurker previously served as chief marketing officer at Novartis, at a time when the company was counting on Galvus in the US....

Notes from BIO: Hey, Where'd Everybody Go?

On the bus, from convention center to Marriott Marquis...

"Hello. Hey! Important question: are you in Atlanta? For BIO. I'm here. I was hoping maybe I'd meet you here? Uh huh. You're still in San Diego, huh?"

BIO is expecting 12,000-15,000 people in Atlanta this week. A huge crowd by any standard--except their own. BIO had well over 20,000 people the last couple of years, so attendance is down by more than a third.

Kind of like the stock market.

Notes from BIO: The Times, They Are a Changin'

"We’ve become the last or second last round investors, where as we used to be shunned from the pre-IPO rounds. Eight, nine years ago we weren’t part of the party. We were kicked out whenever we wanted to play." --Howie Furst, Deerfield Partners

The panel on private biotech financing is standing room only (IVB is actually sitting on the floor). When Tengion CEO Steven Nichtberger just identified himself as CEO of a cash-flow negative private biotech company and asked the audience if there was any other employees of comapnies like that in the audience, a lot of hands went up.

That's a lot of people chasing a lot less money than there used to be.

image from flickr user flungabunga used under a creative commons license