Trials and tribulations

One of the biggest biotech disasters of the last year was the clinical trial in England where six patients got sick -- and two almost died -- after being injected with an experimental antibody in a London hospital.

The testing-gone-wrong sent shockwaves through the industry, because antibodies have been some of the most successful biotechnology drugs of the past decade. The mess in London showed that the wrong antibody can be extremely dangerous, and triggered calls for tighter controls on clinical trials.

British authorities and an independent academic panel in the UK investigated the incident and essentially cleared the German biotech firm that made the drug and the Waltham company that ran the trial. The investigators decided that the problem that caused patients' bodies to swell up was unpredictable.

But a panel of industry experts convened by BIO this afternoon attacked the British conclusions: The UK investigators simply didn't understand clinical trials, they said. The problem was avoidable -- early data on the drug should have triggered a "red flag," said one speaker, and the trial should never have happened at all.

It may not be a coincidence that the all-industry panel decided that tighter regulation isn't needed. But clearly the argument over the dangers of testing antibodies in humans is far from over.
(By Stephen Heuser, Globe staff)

Posted by Boston Globe Business Team at 06:07 PM

Print | E-mail to a friend | Permalink | Subscribe via rss

Boston bests Chicago

Boston was a big draw, according to the Biotechnology Industry Organization, which ran the just-ended 2007 BIO International Convention.

This year's conference drew 22,366 biotechies to the Boston Convention and Exhibition Center, about a 15 percent increase from last year's event in Chicago. Attendees came from 48 states and 39 countries or geographic regions.

BIO president and chief executive Jim Greenwood called the convention "a phenomenal success."

"I want to thank Governor Deval Patrick of Massachusetts and Mayor Thomas Menino of Boston, among many others, for welcoming the event to Boston and providing an ideal backdrop as one of the leading global biotech hubs," Greenwood said.

The glorious weather, which arrived just in time for the convention, also deserves some credit.
(By Mark Pothier, Globe staff)

Posted by Boston Globe Business Team at 05:55 PM

Print | E-mail to a friend | Permalink | Subscribe via rss

Taking no chances

Amid all the biotech talk of using cells and new medicines to change the world, here's a sobering reminder of the other uses that science can be put to: The BIO convention center floor was being patrolled by a roving crew of a half-dozen chemical-warfare specialists in boots, heavy vests, and a small arsenal of equipment to detect anything from poison gas to biological weapons.

The concern wasn't an accidental spill by a biotech company -- the brochures and free pens here probably aren't too toxic -- but a deliberate infiltration by animal-rights activists.

The report from one member of team: nothing detected yet. But you never know.

"If you see us running," he said, "get out."
(By Stephen Heuser, Globe staff)

Posted by Boston Globe Business Team at 04:40 PM

Print | E-mail to a friend | Permalink | Subscribe via rss

No room at the incubator?

If you're thinking about moving your start-up to the Boston area and tapping into some of the $1 billion state officials hope to put on the table to prime the industry, finding somewhere to put your scientists and equipment could become a problem. A report by NAI Hunneman Commercial, a real estate services firm, says vacancy rates for life-sciences space in Boston are dropping. Vacancy rates in lab space in Cambridge dropped to 10.6 percent at the end of the first quarter of this year, a 2.6 percent drop from a year ago, the report said. Inventory of total lab space in Cambridge increased only slightly, from 17.1 million square feet to 17.5 million square feet.

The tighter market in Cambridge is pushing some development across the Charles River to the Longwood Medical Area. The total supply of non-institutional leased lab space in Boston now stands at almost 2 million square feet with a vacancy of 3.6 percent, tightening from last year's 1.8 million square feet at 6.6 percent, according to the report. When the Center for Life Science in Longwood is completed in 2008, Boston's lab inventory will approach 3 million square feet.
(By Christopher Rowland, Globe staff)

Posted by Boston Globe Business Team at 03:25 PM

Print | E-mail to a friend | Permalink | Subscribe via rss

Ye olde biotech promo

This is not what Nathan Cleveland, a graduate of Indiana Wesleyan University, thought his career would look like. He was dressed head to toe in Colonial garb and wearing a tricorn hat in the lobby of the convention center today, handing out a news flyer to biotech executives in suits.

``I guess people think colonists when they think Boston,'' said Cleveland, 26, of Beverly, who was hired for the three-day gig through a temp agency. ``It's fun for a few days.''

He did make a peculiar sight at the glitzy, high-tech convention. The upside for Cleveland: he may soon be joining the sea of biotechies streaming past him in the aisles. He has received a job offer from Genzyme, in Cambridge. Cleveland thought about swinging by the Genzyme booth to greet some potential new colleagues, but he thought better of it. ``Not dressed like this,'' he said.
(By Christopher Rowland, Globe staff)

Posted by Boston Globe Business Team at 02:45 PM

Print | E-mail to a friend | Permalink | Subscribe via rss

Buy 10, get one free

With real estate prices being what they are, it might be surprising that anyone would pass on the chance at a free acre of land in Massachusetts.

But when the Massachusetts Biotechnology Council held a drawing today for a handful of real-estate prizes, including free rent and lease credits at various office parks around the state, it was the lease deals that attracted the most excitement from biotech companies.

“People weren’t as interested in the acre,” said Peter Abair of the MBC, who cooked up the biotech real-estate sweepstakes.

Perhaps it’s because the acre comes with a few strings: For one thing, it’s at SouthField, in Weymouth, the Property Formerly Known as the South Weymouth Naval Air Station (and not exactly known as a biotech hotspot). And there’s another catch: You can only get the “free” acre if you buy 10 more.
(By Stephen Heuser, Globe staff)

The former naval station site in South Weymouth:
A biotech cluster it's not.

Posted by Boston Globe Business Team at 02:01 PM

Print | E-mail to a friend | Permalink | Subscribe via rss

Building a better mouse scanner

Could nanotechnology result in a super-high resolution X-ray machine?

More than a century ago, Dr. Wilhelm Roentgen discovered he could use invisible rays to take a photograph of the inside of his wife's hand. Today, X-rays and million-dollar CT scanners are much faster and more accurate, but still work much the same way as Roentgen's crude machine -- they project X-rays from a single source, like a high-end light bulb.

But Otto Zhou, founder of a small North Carolina company called Xintek, showed hints of a potentially better way in a slideshow today at BIO: Using numerous tiny carbon nanotubes to generate electron beams, he took detailed, high-resolution images of an anesthetized mouse - an animal whose high heart rate and breathing rate can easily blur a normal X-ray. Among the future applications he suggested: extremely precise detection of tiny cancers.
(By Stephen Heuser, Globe staff)

Posted by Boston Globe Business Team at 01:09 PM

Print | E-mail to a friend | Permalink | Subscribe via rss

Mystery science 2007

There's a dirty secret behind the biotech industry: Despite years of work and billions of dollars sunk into research, the human body remains a mystery. All the laboratory work in the world, and the most convincing computer data, can't predict what will really happen when a drug goes into a test animal, never mind a human being.

That huge uncertainty is behind the extremely high failure rate of potential new drugs. And if you think of the billions in research money that drug companies pour into unsuccessful ideas, you realize it's also responsible for the high cost of the drugs that do succeed. So are there any ways to reduce that uncertainty?

The conclusion of a panel of American and European regulators at the convention today: Maybe. Someday.

Janet Woodcock, a high-ranking FDA official painted a dispiriting picture of an agency buried in paper filings, only slowly bringing the power of computers to bear on all the safety information it has collected over the years. A number of universities and regulators are looking for better, more reliable ways to sort "rat poisons" from the useful, effective drugs.

And in Europe, a large group of companies has created a consortium to see if they can predict which drugs will be toxic. The holy grail is finding "biomarkers" -- specific testable substances that can predict problems later. But all agreed that the vast amount of data required to find even one reliable new biomarker means that the deep uncertainty will be with us for a long, long time.
(By Stephen Heuser, Globe staff)

Posted by Boston Globe Business Team at 12:21 PM

Print | E-mail to a friend | Permalink | Subscribe via rss

Thailand gets icy reception

Dr. Pornchai Matangkasombut has been in an awkward position this week as a high-ranking representative of Thailand at the BIO convention.
Thailand wants to build drug research and development capabilities and attract more foreign investment. But the Bush administration's trade representatives on April 30 put Thailand on a ``priority watch list.'' Thailand's offense: breaking international patents and licensing generic equivalents of AIDS drugs sold by Abbott Laboratories and Merck & Co. Inc.

We spoke with Matangkasombut, president of Mahidol University, this morning in the Thailand pavilion on the convention floor. Above him were signs that gave notice for an avian flu symposium to be held in Bangkok, boasted of a large population suitable for clinical trials, and described a large population of post-traumatic stress disorder patients who survived the 2004 tsunami.

But Matangkasombut lamented that Thailand has been rebuked by the White House and by biotechnology and pharmaceutical manufacturers in the West, including Abbott, Merck, and others in attendance at the convention.

``No one takes this lightly,'' he said. ``Thailand is not a banana republic, and Thailand is not doing compulsory licensing of AIDS drugs for fun.''
Thailand's licensing program is only for AIDS drugs purchased by the government to treat the country's AIDS victims, he said. The AIDS Healthcare Foundation, an advocacy group, said Thailand took its action on one of the drugs, Abbott's Kaletra, because the government could not secure a discount from the drug maker. The discount would have knocked the cost from $2,200 to $1,000 a year, the foundation said.

By the way, Brazil also recently decided to break a Merck patent for an AIDS drug. Brazil is not listed in this year's BIO convention program.
(By Christopher Rowland, Globe staff)

Posted by Boston Globe Business Team at 12:01 PM

Print | E-mail to a friend | Permalink | Subscribe via rss

Atoning for their "sins"

The backers of the BIO conference have spent this week talking up the biotech industry's role in improving global health -- not just by making high-end cancer infusions and rare-disease treatments for American patients, but by fighting massive diseases in poor countries.

Perhaps the industry can help, but why would it? Why would a for-profit company jump into a healthcare market with millions of needy people living somewhere with no healthcare budget?

Jim Geraghty of Cambridge's Genzyme Corp., which has recently become involved in malaria research, made a blunt argument in a healthcare panel meeting this morning that good works can be good business. "It's not a humanitarian program," he said of the company's work in the developing world. Doing research in partnerships with local disease-fighters, Geraghty said, can help build support among foreign politicians who might set policies and prices for drugs actually on the market.

But Robert Sebbag, a Sanofi Aventis executive who works in Morocco, said that in much of the world it's an uphill battle for drug companies to shed their reputation as money-minded interlopers.

"The original sin of pharmaceutical industry is to make a profit on health," said Sebbag. "And that is not well accepted. People like drugs, but they don't like drug makers."
(By Stephen Heuser, Globe staff)

Posted by Boston Globe Business Team at 11:15 AM

Print | E-mail to a friend | Permalink | Subscribe via rss