nature@BIO 2007

After no sleep on the red-eye and a quick shower to freshen up, I had six meetings that pretty much had me hoppin' around the conference center straight up to 5 o'clock, when I rendezvoused with my business development team and headed to the BiogenIdec cocktail reception.

Over cocktails, the bus dev team filled me in on their seven meetings, some of which hold real promise to either help us achieve our screening revenue goals for this year or turn into more valuable collaborations. The kick I got out of the bus dev team's enthusiasm gave me the adrenaline rush I needed to shake the sleepiness that was gripping me and drive on through an hour or so of networking (bus dev execs from BiogenIdec, MedImmune, BMS, biotech colleagues and venture folks) followed by dinner with members of my Board and SAB.

When I finally got back to the hotel room at midnight, sleep came quickly... Then up at 6:30 for a quick workout before what I expected (at least according to the calendar!) to be a light day of four meetings and a panel discussion, followed by more receptions.

So much for expectations!!!

Between lengthy phone calls back to the office (hey, still got a business back in San Diego to run!), last-minute preparations for a Board meeting on Wednesday, running into "must-talk-to" people and staying on the existing meeting schedule, I barely had 15 minutes to eat at the food court (lesson learned: at a crowded food court, there's no such thing as line arbitrage... A short line means bad food!).

I did, however, have and hour in the afternoon to walk the convention floor. Amazing! I don't consider myself old, but I do remember a time when the booths at BIO's annual meeting were much, much less impressive and numerous!! Most amazing thing: Innovive's disposable animal caging systems. Best treat: Canada had a Tim Horton's serving up hot coffee and great donuts!!

Panel was fun. A way for some of us to share our experiences raising VC money to fund startups and perhaps help a new generation of entrepreneurs avoid the mistakes we made!!!!

Then on to two great receptions close by and on the water: Cooley Godward Kronish's and the swanky Novartis/MPM/Atlas reception at the Contemporary Art Museum. Again lots of networking with VCs, pharma folks and biotech colleagues. There's no other event on the annual biotech calendar that is as valuable from a schmoozing standpoint. JPMorgan in January is a distant second...

I invited a couple partners from Cooley, a few fellow CEOs, a banker, and a pharma bus dev exec to dinner. While waiting for cabs, the group grows to 12, and we ultimately descend on the restaurant with a force of 20. Great time. Who knew that Ron Cohen, Acorda's CEO, was such a crooner? Backed up quite ably by Ken Moch, former CEO now banker, Cohen serenaded the table with show tunes and doo-wop.

On to bed... Almost 1 a.m!! And worse yet, I have a 4:45 a.m. wakeup call to catch the 7:00 shuttle to LaGuardia for a 10:00 due diligence meeting.

Next year in San Diego, I vow to sleep more during BIO. We'll see....

-- Scott Salka, CEO, Ambit Biosciences

Posted by Brady Huggett on May 11, 2007
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Freelance science writer Jim Kling reports:

At a Tuesday afternoon session on biotechnology in aquaculture, a representative from HQ Sustainable Maritime Industries described a decidedly non-biotech method for raising exclusively male tilapia fish.

The females carry their eggs in their mouths and so aren't as productive as males. One approach to ensuring that you only raise males is to use hormones. HQ took a different approach. It added to the ponds a predator fish that grows at the same rate as male tilapia. It ate the slower-growing females as well as runts. It's an example of Biomimicry; taking inspiration from nature.

Another presenter pointed out that humans continue to be hunter/gatherers with respect to one protein source -- fish. Interesting point, I thought. Why is that we've embraced farming everywhere but the ocean?

Posted by Michael Francisco on May 10, 2007
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Freelancer Barbara Nasto reports from the Finance track:

During the Tuesday morning session “On Becoming a Public Company,” Annette Grimaldi, head of life sciences investment banking for New York-based Jeffries and Co., described the ideal biotech IPO candidate. Desirable characteristics included a late-stage novel product that addresses an unmet clinical need, a large market for that novel product to which the company retains all rights, cash in the bank and clearly defined interim milestone goals. Grimaldi also mentioned that such a company does not exist. Her advice for biotechs considering an IPO? "Have a clear sense of self and have the story down before you enter the market. Be able to define what you are and what you want to be when you grow up. Also consider how to create value for the investors.”

The session included other interesting perspectives from operational and legal and execs with first-hand IPO experience. Regarding timing, “You have to do it [hold the IPO] when you don't have to do it," according to Affymax CEO Arlene Morris. Laura Berezin, an attorney with Cooley Godward, advises companies to start socializing early, and getting free advice from lawyers and bankers. In addition, “Have a complete management team. Though you may be tempted to cut corners on this, it’s important to be staffed up well ahead of the IPO." Finally, Michael Lytton, a general partner with Oxford Bioscience Partners, stressed the importance of retaining some of your commercial rights even after your company has been sold.

Posted by Michael Francisco on May 10, 2007
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Be afraid. Be very afraid. The PDUFA Reauthorization Bill gives the FDA authority never before enjoyed.

At Wednesday's session "Drug Safety and PDUFA IV: Overview of Critical Issues in Congress", BIO's VP for government relations, Brent Del Monte, outlined a few "concerns" (his word) with the legislation (Senate Bill S.1082). Consider: this is the first time that economics is entering an equation (Historically the FDA has been concerned with safety and efficacy). A provision of PDUFA IV limits the period of market exclusivity of certain drugs to three months when sales exceed $1 billion. This is also the first time, according to Del Monte, that Congress is going in and making changes to the agreement. And the first time that user fees have been increased by Congress, which, by the way, under the new legislation will account for 70% of the FDA budget for drug approvals -- up from 50%.

But on the plus side, an amendment allowing the sale of baby turtles treated with proven methods for Salmonell has been introduced. Don't ask me why.

Posted by Laura De Francesco on May 10, 2007
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With M&A activity as prevalent as it has been, there's a lot of talk about just how companies should position themselves. By that, I mean should young companies grow with an eye on a buyout? Prepare to try the public markets? Both?

The answer, of course, is to grow the company as if none of this matters -- simply building value is the one way to set a company up for either end, or to go it alone. Still, it's hard for a small biotech to ignore what's happening to its brethren and not ponder what's next.

BIO has any number of panel discussions devoted to this topic, or some variation of. In a session this morning, Phil Taub, from law firm Nixon Peabody, displayed to a full audience data on buyouts of public companies in the biotech sector. In 2005, pharma bought 8 public life science firms for a total value of $13B, at an average premium of 38 percent. Biotechs that year bought 10 public firms, costing $6.9B, at an average premium of 37 percent. But things were even better last year for those being bought. In 2006, pharma bought 15 public life science firms for $16.2B at an average premium of 58 percent. Biotech companies bought 17 firms for a total of $8.9B at an average premium of 55 percent.

It's early, but this year things have continued apace. AstraZeneca is buying MedImmune for $15.6B, at a price of $58 per share. While that is a 21 percent premium to MedImmune's close the previous trading day, the stock had been running up for weeks in anticipation of the sale -- the company's trading price was just less than $32 at the end of February. Analysts had predicted the company might garner a $45 share price, so $58 per share suggests that either AZ valued MedImmune a lot differently than the analysts, or that the bidding for MedImmune behind the scenes was particularly fierce. Panicked might be a good word.

For MedImmune shareholders, it's great. And it's been great for a long list of biotechs purchased in the last couple of years. And every company I just mentioned is a public firm, but it begs the question of whether the industry is sitting on an M&A pricing bubble that could change the M&A/IPO debate for private firms. If so, does it matter? Of course -- when that bubble bursts, no one wants to be on the block and getting valued at less than the paltry amounts the public markets are providing today. But there's also really nothing to be done about it. So, ride the wave while it lasts.

Posted by Brady Huggett on May 09, 2007
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BIO has definitely become an extraordinary convention event. For many years I've been walking the hallways of ASCO, and I feel that BIO has no reason to envy the top scientific meetings that take place every year in the US. The vibrant entrepreneurial spirit, the eagerness to partner and establish genuine dialog, plus the willingness to explore outside-the-box strategies and organizational alliances makes this international conference very unique.

During the CEO Forum I had the opportunity to hear Mark McClellan and Alan Garber speak about value-based pricing and the future of biotechnology companies. It was an insightful roundtable with a very outspoken audience. One of the topics discussed by the panelists was the issue of moving to value-based pricing strategies. That is, strategies that measure and pay for the net impact of a drug on the population rather than a model based on a pill-by-pill payment. In other words, only those who benefit from a drug are the ones expected to pay.

A company representative asked: How do you measure the cost of failure so frequent in clinical development?

A biotechnology CEO added: Time is the most expensive aspect of our business, even more so than direct costs. Any delay in rewarding the research and development output may have serious consequences on innovation. How can you manage that?

Whether value-based pricing provides a better health economic framework or a greater risk for innovation will continue to be a challenging debate. In the meantime, seeing policymakers participating actively in the discussion makes me feel that the contribution of biotechnology to the present and future health of the world is significant and undeniable. Congratulations to all the researchers and leaders that are making possible the miracle of innovation.

-- Edmundo Muniz, president and CEO, Tigris Pharmaceuticals

Posted by Brady Huggett on May 09, 2007
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This is making headlines across the country this morning. Many are comparing Massachusetts’s proposed $1 billion life sciences initiative to California's $3 billion for stem cell research, although the Massachusetts plan (announced yesterday at BIO by Governor Deval Patrick) is a lot more than just a stem cell plan. Here's how the Boston Globe describes it today:

Over 10 years, the state would issue $500 million in bonds to pay for capital investments at public institutions and other facilities. It would also spend $25 million a year on direct research grants and offer $25 million annually in tax credits to biotech companies that promise to create jobs in Massachusetts.

The administration, however, has not determined how much money would be dedicated to different areas of research or how much would be available to the private sector.

So it's not clear yet how much of that money would be for stem cell research. But overall, it's meant to make up for the shortfall in NIH funding and spur more commercialization of research.

In addition to the $1 billion in state funding, the plan calls for $250 million in matching funds from the private sector.

Part of the proposal includes the establishment of the Massachusetts Stem Cell Bank, estimated to cost $66 million. The Globe said eight MA hospitals and universities, including Harvard, have already pledged to deposit their stem cell lines. The goal is to make this stem cell bank the biggest in the world. UMass Worcester would receive $38 million for a new RNA interference research center, headed up by Nobel Laureate Craig Mello. (For more details, see here.)

Posted by Corie Lok on May 09, 2007
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Energy seems to be one of the major themes here at BIO: biofuels like biodiesel and ethanol from corn and cellulose.

I went to one very full session this morning about all the other industrial chemicals, beyond ethanol, that can be made from biological, renewable sources: propylene glycol (used in a wide range of foods, cosmetics and other products), acrylic acid (used in plastics manufacture), butanol (a potential fuel) and many others.

Cargill, the food and agriculture giant moving into doing more industrial chemicals, announced today that it, in collaboration with Ashland, a chemical and petroleum company, is building a new plant to produce propylene glycol from glycerin, a byproduct of biodiesel production. As more biodiesel is being made, the companies are expecting a glut of glyerin on the market. So it's interesting to see that as a few chemical companies slowly move towards nonpetroleum-based products, it's spawning the production of more chemicals from these "green" sources.

One French company, Metabolic Explorer, was making the case for butanol as a more efficient source of energy than ethanol that can replace diesel and be added to gasoline, though the cost is still too high.

One thing that wasn't discussed was the benefits of nonpetroleum sources for carbon emissions and climate change. Because in the end, that's what really matters, doesn't it?

My colleague Brady Huggett attended the same session and gave a business perspective (I think we posted at the same time!).

Posted by Corie Lok on May 08, 2007
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Among the attendees not dressed in "business casual" were these Canadian Mounties seen roaming the cavernous exhibit hall, perhaps in search of their mounts.

More photos after the jump.

Continue reading "In character" »

Posted by Michael Francisco on May 08, 2007
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The public, investors and certainly the biotech industry are fully aware of biofuels, but what else is out there in industrial biotech? BIO scheduled a panel this morning -- it drew more than 200 people, by my estimate -- to discuss just that.

There's a lot, actually. There's the bioplastics market, for one -- Cargill is a leader there. (Producing bioplastics also would cut down on U.S. consumption of petroleum by reducing production of petroplastics, by the way.) There's syngas, and there's also butanol, which as a coating and solvent alone addresses a $3.3B market, although it has an upside of potential use as a biofuel.

As Philippe Guinot, vice president of business development at Metabolic Explorer pointed out at the panel, the chemical applications of industrial biotech address a market as large as ethanol. All of which helped his firm go public earlier this year, raising about €52 million (US$70 million) on Euronext. You can view the press release on the IPO here.

The question is how to get the word out? Without Bush mentioning bioplastics or syngas in a State of the Union address, the public hears industrial biotech and thinks just biofuels.

Posted by Brady Huggett on May 08, 2007
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While at BIO, Michael Griffith had these thoughts...

It is clear that investors and entrepreneurs have become savvier about corporate evolution and the role of outsourcing to leverage and protect core competencies. They recognize that, as their nascent companies staffed with a handful of very bright discovery scientists approach milestones requiring increased production of drug and delivery of clinical results, the mere act of investing in internal development skills sets can be daunting and very disruptive to an organization whose mission is still primarily directed toward the discovery of new drugs. Outsourcing development to consulting groups and service organizations has become a logical move for emerging companies to rapidly respond to their pipeline needs and to mitigate risk, while preserving their core mission by remaining focused on discovery.

If you find yourself in that blessed situation of having a product nearing clinical trials, my advice: seek help! If you don’t yet have a pharmaceutical partner, external consultants and outsourcing partners with hands-on experience in manufacturing and development can play a central role in moving the product forward. Evolving from an “idea” company to a “product” company is probably the trickiest transition in the business. The best way to make that transition is to work with people who have already been to “the other side,” who can weave together the various functions (formulation, scale-up, logistics, etc.) and recognize the synergies between them.

-- Michael A. Griffith, CEO and founder, Aptuit Inc.

Posted by Brady Huggett on May 08, 2007
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From The Scientist’s web editor, Simon Frantz:

There’s a rumor going round that Bono made an unannounced visit to the exhibition hall yesterday morning. The Scientist’s director of business development, Jeremy Abbate, told me that Bono was walking around the hall and even visited our exhibition stand. As the full story involves some shameless plugging for a new biotech magazine that we have just launched, I’ll resist from telling it here, and if you want to read more click here). But I’m wondering if the rock star really was at BIO. He didn’t give a speech as far as I can tell, and I remember one BIO in San Francisco where there was a whole host of celebrity lookalikes roaming round the hall. So, can anyone confirm or refute the sighting?

Posted by Michael Francisco on May 08, 2007
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From The Scientist's web editor, Simon Frantz:

One of the good things about going to BIO is that you get a very quick handle on what the community is thinking and anticipating the most. For me the most talked about subjects so far have been alternative funding methods and the large presence of Malaysia at the conference. Do you agree, or have you spotted other themes emerging at the conference?

Posted by Michael Francisco on May 08, 2007
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From the perspective of the CEO of Tacere Therapeutics, an old/new RNAi company, I’m at BIO to lay the foundation for partnering our lead clinical candidate for HCV -- an RNAi “cocktail in one drug.” We started this program four years ago in a small private CA biotech, had an excitingly public diversion overseas for a couple years then returned to our roots in the Bay Area.

So out of a desire to hear other perspectives, I attended a session this morning that was insightfully chaired by Steven Holtzman, CEO of Infinity Pharmaceuticals, on how to structure strategic relationships. His opening presentation was an unabashed comparison of a strategic alliance to a successful marriage, necessarily containing all the same components -- respect, trust, shared values, shared goals, willingness to allow the other to change, desire to see ones’ self and the other succeed. He had then paired four couples representing partnerships from early discovery stage (Novartis/Alnylam) to marketing (Millennium/J&J). And sure enough, there was no doubt that the most successful and inspired partnerships were led by two people that shared a vision and the willingness to achieve it together. There was the couple in an uncomfortable post-honeymoon, still convinced they’d done the right thing, but not really looking one another in the eye anymore. There was the couple that had sort of inherited a relationship to find, much to their pleasure, that it was a thoroughly sound one. The couple that had been on eHarmony for 18 months identifying every characteristic of the perfect partner and when they found them, hightailed it to Las Vegas and were still grinning. And then the comfortable couple that, having renewed their vows in ever more complicated ceremonies, have found that they still rather like one another. All in all a thoroughly enjoyable session with some good insights and atypically candid remarks about how to make an alliance work.

One comment made was that ego is one of the main derailers of a good strategic alliance -- that the collaboration must be able to weather changes in personnel, with a formal and informal structure in place that is focused on the product, on the patient. And that works as a company gets larger and closer to market, as the influence of the CEO on the solvency of the company decreases. But for small biotechs, where your investors have bet the jockey and it's only your perseverance that will yield an ROI, ego is a critical component. What an ask it is of pharma to suspend ego, and yet Steven Holtzman was absolutely right in that these are relationships between people and ego is always disruptive.

And speaking of partnering -- we were wondering why there was no map of the convention center in the BIO program directory. After the fourth partnering session entailing the third trek across the bridge over the exhibition halls in two minutes or less, we concluded it was because they hadn’t actually seen a map of the convention center. Well, at least everyone will leave BIO fitter!

-- Sara Hall, founder, director, president and CEO, Tacere Therapeutics

Posted by Brady Huggett on May 08, 2007
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Yesterday’s panel on bioethics was shocking -- not for its content (though I found it provocative), but for the pitiful attendance. Strange and sad that out of 20,000 plus attendees, no more than a handful have an interest in ethics. What does this say about the priorities of this group?

And unfortunately for the few of us who did come, the panel was so large that by the time they all finished speaking, little time was left for discussion. Another shame, as several of the panel members were clearly at loggerheads about how the industry should be thinking and talking about its position in the greater world stage -- which is just the kind of discussion that needs to happen at convocations like this.

One question is whether biotechnology is transformative or merely another step in the logical progression of science. At one end of spectrum was Boston University’s George Annas, who, quoting ethicist Dan Callahan of The Hastings Center, stated that biotechnology changes not only what we do, but how we think. At the other end was the UK BioIndustry Association's Simon Best, who feels that the industry takes this position at its peril. This dichotomy cried out for further discussion and debate, but none was to be had. (To hear Simon Best talk about this and other topics, go to the Nature podcasts).

After some high-minded talks on corporate responsibility by reps from large companies, Steve Holtzman, co-founder BIO’s ethics committee, brought the discussion back to reality (for biotechs) and laid out what the ethical issues are for companies big and small: how to choose what diseases to tackle, how to go about tackling them while behaving responsibly both toward employees and human subjects, and finally, what to do with the fruits of all their labor -- the accessibility problem.

This last point (which most biotech execs including Holtzman have yet to face) leads to the second central question -- how the industry can operate as a profit center, yet provide what is viewed by most as an entitlement – good health. For more on this, see an earlier post by Nature Network Boston editor Corie Lok.

Posted by Laura De Francesco on May 08, 2007
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The crowd for the luncheon speaker today proved too big for the Convention Center -- I was in line for the overflow room to hear Michael J. Fox speak and was just three people away from being let in when security stopped us, saying the overflow room was full, too. I limped away, hungry, but Ed Silverman at pharmalot covers the speech on his blog: Fox said, in part, that companies are "more interested in repackaging old ideas for profit" than chasing innovative, riskier drugs, and he added that "Levodopa is the gold-standard treatment for Parkinson's...But it's a little frustrating that the best drug we've got is one that's been around for 40 years. 40 years!"

There's more BIO coverage on pharmalot.com. The blog also is linked to our site along the left-hand side under recommended links.

Posted by Brady Huggett on May 07, 2007
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I was due to fly from San Francisco to Boston on U.S. Airways with a late Sunday arrival. Yesterday I got to SFO to find out I'd somehow booked myself into a flight route that doesn't actually exist (U.S. Airways blamed Orbitz), followed up by my rebooked flight being pushed back twice due to mechanical issues and then finally cancelled. I had to take an overnight flight with a layover in Phoenix, putting me into Logan this morning at around 6 am. Bleary-eyed and exhausted, I felt more like I'd flown to Europe than Boston.

But as I waited in line to rebook in SFO, complaining passengers grousing all around me, I started thinking about what a troubled sector the airline industry is. Consider this: Fuel costs are rising, small "specialty" airlines are undercutting the biggest flyers, the internet has made it easy for anyone to compare flight costs, and weather wreaks havoc on scheduling. And anytime a flight is grounded, 200 passengers want to point fingers and shout.

So I did some looking. This editorial in the Washington Post points out that in the fall of 2005, nearly half of travelers in the air were on planes owned by airlines operating under Chapter 11. And this PDF from the Department of Transportation shows, among other things, the percent of time certain airlines arrive on schedule. U.S. Airways hits its mark a lowly 55 percent of the time into 81 reportable airports. That's last on the list (Hawaiian Airlines was first, at about 94 percent into 14 airports).

Not good. But stack that up against biotechnology: The Tufts Center pegs the cost of developing a drug to be more than $800M, (noted here in Nature Reviews Drug Discovery) and at least 10 years of work. That figure comes from dated research, though, and most put the cost today at around $1B. Burrill and Co. reports that the chance of a drug moving from preclinical work to NDA approval is less than 1 percent. The FDA is taking fire from the public and undergoing change. And the public markets are providing valuations that most biotechs find unappealing.

Looking at that, as troubled as airlines might be, it beats working in drug discovery.

Posted by Brady Huggett on May 07, 2007
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This question came up in this morning’s session entitled "Biotechnology’s Responsibility for Human Rights?" Selling drugs isn’t like selling cars or shoes. Health is a social product, one that many feel is not just a product, but a basic human right. For-profit companies, however, are the ones making those drugs and so are also obliged to investors.

So it raises the difficult question: if you’re in the business of selling health, do you have a special responsibility to make the drugs you're making accessible to people who can’t afford them? Two people on the panel said yes, including Steven Holtzman, the CEO of Cambridge-based Infinity Pharmaceuticals. George Annas, a bioethicist from Boston University, said that it's in the interest of a company, especially a big one that can afford it, to make drugs available, or else you'll be tried in the court of public opinion and seen as pirates.

Posted by Corie Lok on May 07, 2007
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Cancer stem cell biology is a hot new area of cancer (and stem cell) research since the first cancer stem cells (tumor cells with stem cell like properties) were identified in the early 1990s. It's thought that this subset of tumor cells drives tumor growth and resists treatment, causing the tumor to come back.

I have heard biologists in Boston talk about how new the science of cancer stem cells is (and there are plenty of unanswered questions, as seen here) so I was a bit surprised (though I really shouldn't be) to hear this morning that two US biotech companies, Oncomed Pharmaceuticals and Stemline Therapeutics, are nevertheless forging ahead with the development of drugs that target receptors on the surface of cancer stem cells, in solid tumors and hematologic cancers. The hope is that going after these cells will kill the tumor once and for all.

Oncomed says it hopes to have its lead monoclonal antibodies in clinical trials by 2008. Stemline says its drug has already been tested in 25 people with leukemia in phase I clinical trials and they plan on expanding that trial. So like many biotech companies, these two aren’t waiting for all the science to be in before diving into drug development.

Posted by Corie Lok on May 07, 2007
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Freelance writer Barbara Nasto reports:

During the Monday morning session "Winning Without an IPO," among the strategies discussed for circumventing an IPO was the progressive and increasing trend of Special Purpose Acquisition Company (SPAC) deals. SPACs are publicly traded shell companies that go public with the intention of merging with or acquiring a company. With the decrease in the average number of dollars spent on life science IPOs since 2002, SPACs are taking their place among M&As, partnering and other alternative revenue streams.

To highlight their ascent, Stephen Davis, a shareholder at Heller Ehrman and the chairman of the session, cited a Wall Street Journal report from April 23, 2007 describing the increases in SPAC dealmaking. During 2005, 30 SPACs went public raising $2.1 billion, and in 2006 the number of deals increased by a third to 40 SPACs raising $3.4 billion. First quarter figures for 2007 indicate a record number of 17 deals to date.

During the session, Timothy Keating, president of Keating Investments, commented on the downside of SPACs, which he describes as an arbitration between private value and public price. The deal must fall below the public market level to be attractive to the buyer.

Posted by Michael Francisco on May 07, 2007
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From The Scientist's web editor, Simon Frantz:

Reporters entering the press room today were greeted with a sign stating that the media will not be able to attend Queen Noor of Jordan’s keynote presentation on Tuesday. BIO officials say this is at the request of Queen Noor of Jordan’s people, who are concerned about the safety of her new family, as well as guarding against being misconstrued by the press. This is not only a sad indictment of our times, it also highlights a growing trend for companies or institutions that court publicity but are unwilling to provide full access (see a recent editorial we ran in The Scientist. As regular BIO attendees will know, Bill Clinton’s keynote speech last year was closed to the media, although Clinton’s group later agreed to let trade press attend the event. What makes this a particular shame is that Queen Noor of Jordan is the founder and chair of the King Hussein Foundation International, a non-profit, non-governmental organization that aims to foster peace and security through programs that promote cross cultural understanding and social, economic and political opportunity in the Muslim and Arab world -- a worthy cause that should be promoted as much as possible. We won’t be able to tell you about the good work that the foundation is doing, but if you are attending and want to tell us, please do.

For more on this click here.

Posted by Michael Francisco on May 07, 2007
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Hectic Sunday to start the week. Redeye out of LAX made sleep impossible despite an Ambien and two gins and tonics. Arrived Boston barely in time to shower, shave, dress and make my 8:30 breakfast with a venture fund. But now I'm charged and ready to slay the day.

-- Scott Salka, CEO, Ambit Biosciences

Posted by Michael Francisco on May 07, 2007
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Freelance science writer Jim Kling reports:

At a Sunday session titled "Next Generation in Diagnostics," the talk turned to biomarkers. The panelists agreed that no one has a good handle on how well a biomarker must reflect a disease state in order to be clinically useful.

Anthony Shuber, CTO of Predictive Biosciences lamented that association studies are appearing constantly in the literature, but there is rarely any understanding of the underlying biology -- that is, an understanding of the biological consequences of an up- or down-regulated gene, or
the concentration level of a protein. The issue is specificity. Is the gene upregulation or increase in protein level specifically associated with a disease state, or does it also appear in some normal states, or perhaps related or even unrelated disease states? To determine that, companies will have to carry out large, expensive clinical trials to demonstrate a biomarker's specificity.

An understanding of the underlying biology could circumvent that. "If you understand the biology, you can go in front of an FDA panel and say, 'this is the gene, this is what it does. Therefore it's a valid biomarker. There should be no need to do a large specificity study," Shuber said.

Another panelist suggested that what we need are molecular biologists who understand physiology, who can make connections between associations and known biological mechanisms, as well as biostatisticians who know how to distinguish a valid biomarker from the biological 'noise' that permeates any cell system.

Posted by Michael Francisco on May 07, 2007
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I was at the BIO media brunch earlier today to hear the results of two polls, one an internet survey of 252 US biotech executives and another a telephone survey of 800 registered US voters conducted between April 17 to April 19 by Public Opinion Strategies and Peter D. Hart Research Associates. The conclusions weren't exactly earth shattering.

By and large, the data confirmed what we already know: drugs and therapies for unmet needs are highly valued by the public; transgenic foods are not. Industry execs cited regulations and government intervention as their biggest bugbears. Funnily enough, very few of the biotech executives surveyed were at all keen to see the FDA develop a framework for follow-on biologics like that in Europe. No surprise there then!

And of course, everybody is very excited about the potential for biotech to create a country that is self-sufficient in terms of energy generation and "independent of foreign oil." According to the PR blurb, industry leaders and voters "share high levels of optimisim about the potential for finding cures, developing clean technologies to reduce pollution and creating 'green drug factories.'"

Continue reading "Survey trivia: the biotech-pharma dichotomy and GM food on steroids!" »

Posted by Andrew Marshall on May 06, 2007
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Simon Frantz, formerly of Nature Reviews Drug Discovery and now web editor at The Scientist , sends this report on yesterday's Bioentrepreneur Roundtable:

At the Nature Biotechnology Bioentrepreneur Roundtable on Saturday evening, I heard a rare degree of candidness among the speakers that I thought was worth opening up to discussion here. The roundtable was on funding trends, but as the panel included representatives, investors and entrepreneurs from around the globe, the subject of launching start-ups in areas outside of well-known bioclusters came to the fore. Investors and entrepreneurs agreed that if a start-up company is not within a recognized biocluster, such as Boston, San Francisco and San Diego, it will find it so much more difficult to generate interest and funding, that the advice for budding entrepreneurs was to move to a biocluster. Even creating a subsidiary unit creates enough logistical difficulties to consider moving lock, stock and barrel to a biocluster. The argument from the investors is that it doesn’t just take good science to create a successful company, good experienced managers are as important, if not more so, and investors are more likely to go to where the experience is.

It wasn’t all bad news; Singapore was mentioned as an example of how to build a biocluster from scratch. Nevertheless, this focus on recognized bioclusters surely misses out of a lot of top-notch R&D going on around the globe, and it wasn’t clear whether this investor mindset would change. The general consensus on this issue at the roundtable might make for some uncomfortable reading with many geographical areas attending the conference, but I’d be interested to hear whether this fits in with your experience, and what you think can be done to attract more attention and investment to areas outside of established bioclusters.

Posted by Michael Francisco on May 06, 2007
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Greeting new arrivals in the lobby of the Boston Convention & Exhibition Center is an interactive globe showcasing biotechnology's international reach.

Continue reading "Boston globe" »

Posted by Michael Francisco on May 06, 2007
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No less a personage than Genentech chairman and CEO Art Levinson has called patents “the lifeblood of the biotech industry…crucial to spurring innovation and incenting companies to make the necessary significant investments to bring drugs to market." Law firms have been involved in the industry since its inception, first helping fledgling biotechs through the company formation process, negotiating technology licenses with universities and managing their patent portfolios. And the presence of patent attorneys at BIO -- from sessions to partnering meetings to swanky receptions -- is ubiquitous.

According to the National Law Journal, “23 law firms are each shelling out $8,500 to $100,000 for various sponsorship opportunities” during BIO, encompassing all but the highest sponsorship level (the Double Helix, province of pharma and big biotech companies). Fish & Richardson (Helix sponsor) leads all firms, followed by Wilmer Cutler Pickering Hale and Dorr (Gold sponsor). Additionally, many firms not listed as conference sponsors make their presence at BIO known by participating in various panel sessions and hosting parties. In Boston alone, firm-sponsored soirees include a clambake and events on a riverboat, at the Museum of Fine Arts and at Fenway Park. It seems law firms might be the lifeblood the BIO party circuit as well.

Posted by Michael Francisco on May 06, 2007
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