Archive for the ‘Life Sciences’ Category

No fear means new scientific possibilities

Friday, December 17th, 2010

lynette_cornellBy Lynette Cornell

A middle-aged woman with no concept of fear has helped scientists learn more about how the brain not only perceives the fear of others but responds to fear-inducing stimuli itself. The study involved testing the woman by exposing her to scary stimuli and recording her responses; she showed she can feel upset or angry but not fearful. The discovery of her absence of fear, published Thursday in the journal Current Biology, holds great promise for many potential applications in managing fear, ranging from military to clinical uses.

Take the overwhelming numbers of veterans returning with trauma-related psychological issues and add to that the countless numbers of people, diagnosed and not, who struggle with debilitating anxieties, phobias and social interaction disorders. Now, imagine silencing the body’s fear response so that the perceived yet imaginary threats cease to have a physical or psychological affect.

To be practical, fear does have its place. With varying levels of success, it keeps us from doing stupid, life-threatening things and adds an adrenaline-surging aspect of thrill to relatively safe amusement park rides. But for the people whose irrational fear has become a life-limiting complication, the possibility of selective suppression of fear perception could be liberating and even life-changing.

Tucked deep within the brain, the almond-shaped amygdalae is the oft-forgotten and perhaps under-appreciated pair of organs responsible for making you gasp when an approaching car starts drifting into your lane. In the case of the 44-year-old woman without fear, referred to simply as SM in medical write-ups, a rare condition known as Urbach–Wiethe disease has destroyed her amygdalae, rendering her entirely fearless. The prospect of a head-on automotive collision wouldn’t faze her. According to the studies conducted on her, neither do snakes, spider, scary movie clips or even being held at knife point cause a fear response.

While this may prove useful for her in stressful situations, it could have far greater meaning for people coping with post-traumatic stress disorder (PTSD), according to the University of Iowa researchers who conducted the research. In a study published in the journal Nature three years ago, researchers observed combat veterans who suffered brain damage including damage to the amygdalae and were seemingly immune to PTSD . Granted, tinkering with the brain to help erase the horrifying ghosts of warfare will require a lot more time and extensive studies before it can be practically applied. It yields hope, though, for people struggling with conditions such as social anxiety disorder, which have a direct correlation to the amygdalae, to someday live normal lives.

Furthermore, in the morally grey category, military applications of fear suppression could mean truly fearless fighters unaffected in their decision-making processes by limbic response. With their military training to guide them, soldiers without fear could mean processing situational data without the physical and psychological complications of emotional response. I think I can smell the DARPA funding already.

MHT partners with MassBio

Friday, October 15th, 2010

Mass High Tech has formed a partnership with MassBio, the association of life science companies in Massachusetts. The partnership brings MassBio news to the life sciences community through MHT’s daily Bio Flash email newsletter. News of the partnership was announced to MassBio members in a letter co-signed by MassBio president and CEO Robert Coughlin and Mass High Tech publisher Douglas Banks:

To our readers and members:

MassBio and Mass High Tech are teaming up in a first-time partnership that will deliver MHT’s daily BioFlash email news alert to all MassBio members.

This partnership combines BioFlash, MHT’s top-quality daily news vehicle, with MassBio’s industry expertise and role as the voice for the industry. It represents a new channel for MassBio to deliver the most important daily news and information to members. As part of the agreement, MassBio will have a permanent position within the daily BioFlash news e-mail so we can communicate our news to not only our member readers but the larger life sciences community as well.

It’s a partnership that just makes sense — if you look at the history of both organizations, one wonders what took so long. After all, MHT has been writing and reporting on technology and life sciences since its start in 1982 — and MassBio has been the voice for the industry since its beginnings in 1985.

For MassBio, this is the latest of many successful partnerships with other industry stakeholders. In September, MassBio united with EBD Group and held the MassBio Investors Forum in conjunction with BioPharm America for the first time.

This agreement continues MassBio’s record of working with top-quality partners to deliver the most important information to members while providing Mass High Tech with a fantastic way to build its brand and reach through a premium association of more than 600 biotechnology companies, research and academic institutions and others dedicated to advancing cutting-edge research.

We are excited about the launch of this collaboration and hope it helps you to delve deeper into both organizations and the work we are doing to foster entrepreneurship, innovation and growth in the local life sciences community.

Robert Coughlin                    Douglas Banks
President and CEO                Publisher
MassBio                                   Mass High Tech

Bootcamp for Genzyme

Monday, September 13th, 2010

By Julie M. Donnelly

Julie DonnellyIn the run up to my June wedding, I bucked one current trend: Bridal Boot Camp, a 12-week exercise torment designed to give you Michelle Obama’s arms to go with your strapless dress. Instead, I reverted to the time-honored “starve yourself for several weeks, then gain it back on the honeymoon” approach to preparing for the big day. It strikes me that Genzyme might also be trimming down before a marriage – either to French drug maker Sanofi-Aventis, who has proffered a rock worth $18.6 billion, or to some white knight who could ride in at the last moment, like in chick flicks.

It leaked on Friday that the Cambridge-based company was planning to lay off 1,000 workers over the next 15 months , and state officials are holding their breath, waiting to hear how many pounds will be shed in Massachusetts. Then today, the company announced it would sell off its genetics testing unit for $925 million. Both of these moves were portended by a company announcement in May. But the timing is quite uncanny, as Genzyme holds its ground, saying it’s worth more than Sanofi is offering, because it’s “beach front property”, according to CEO Henri Termeer. It’s a beauty queen, now perhaps with the discipline to put down the cookies and do those crunches.

There is, of course, another explanation – that Genzyme is, in fact, trimming down to peak fighting weight. It may want to go in lean and mean to fend off not just Sanofi, but the doubts of activist investors who have questioned the company’s management and may look more favorably on the love match if Sanofi’s offer creeps up. Management ran into a world of manufacturing hurt, after all, and it’s still struggling to find its feet. Maybe unloading under-performing assets, and “streamlining” its workforce, will help the biotech heavyweight float like a butterfly and sting like a bee.

Shire wants you to ‘Like’ them

Friday, September 3rd, 2010

Shire plc has launched a Facebook page in honor of National Gaucher Awareness Month – a move designed to link the name of the company, and the name of the rare disease its drug, VPRIV, is treating. The drug sped to approval in March  because the FDA urgently needed to blunt against shortages of a rival drug, Cerezyme, made by Genzyme Corp.

For every visitor to the Facebook page who “Likes” it, Shire, which is based in the U.K. but has headquarters for its Human Genetic Therapies division in Massachusetts, will contribute $1 to the National Gaucher Foundation. So far, the page has 175 “Likes”, but it’s only been three days.

The question is, could an appeal to the masses ever hope to translate into new customers for VPRIV, which treats a disease that affects only a very small number – 1 in 50,000 – of people worldwide?

Possibly. Because the rare disease is often misdiagnosed or diagnosed very late, greater awareness of the disease, especially in the health care provider community, could lead to more correct diagnoses and more potential patients. But right now, Shire doesn’t need more customers. In June, the company established a waiting list for new patients who want to take the drug, as they work to ramp up capacity in Lexington.

What Shire does need is to stem possible attrition from its drug as the Genzyme shortage eases. Genzyme announced last week that U.S. Cerezyme patients will begin to receive their full doses, and no one knows how many of the 850 patients worldwide now on VPRIV could switch back to Genzyme’s drug.

Some Gaucher patients are torn between loyalty to Genzyme – the company that put Gaucher on the map – and appreciation for Shire, which has stepped in to help them when Genzyme could not.

Stem cell ruling no ‘chicken little’ moment

Wednesday, August 25th, 2010

Some local companies are saying, “Hey, the sky is NOT falling,” post-federal stem cell research funding ruling. First of all, many companies don’t get federal funding and won’t be affected. Secondly, alternatives to embryonic stem cell research may get an added boost.

Marlborough-based Advanced Cell Technology Inc. took the ruling as a good opportunity for spin. The company issued a press release saying that because its technology does not destroy embryos, it may be eligible for federal funding, and that in fact, the company may benefit by added pressure on the National Institutes of Health to find appropriate sources of stem cells.

“ACT’s ‘embryo-safe’ Single Blastomere technique for deriving human embryonic stem cells (hESCs), documented in Nature and CELL Stem Cell magazines and elsewhere, does not require destruction of the embryo and as a consequence may not be directly affected by this ruling,” the release reads.

However, the company was quick to follow up by saying that it does not rely on government funding for any of its research or product development.

The company’s CEO, William Caldwell, decried the ruling, but said “In the meantime, we will continue to work with the National Institutes of Health in order to gain approval for our embryonic stem cell lines derived using our embryo-safe Single Blastomere technology. If we are successful with the NIH to this end, we will endeavor to make approved hESCs available to the research community as a means to continue this important research, particularly in light of this court ruling.”

Boston: Global drug hub for a day

Friday, July 23rd, 2010

Politicians love to laud the centrality of the state’s biotech sector, but on Friday, Boston was, in fact, the Hub of the drug development universe.

Momenta Pharmaceuticals in Cambridge just blew open the door to bio-similiars – generic versions of biologic drugs – with its approval of a generic form of a blockbuster, $2.9 billion drug made by French pharma Sanofi-Aventis. Biosimiliars were granted a legitimate path to approval recently by Congress, and the approval gives other generic drug makers a window into what it will take to prove to the FDA that their lower-cost alternative to a drug made using living cells, is really equivalent to the original.

Sanofi-Aventis shares dropped on the news, Momenta’s surged 76 percent. And Sanofi wasn’t done drawing the world’s attention to Cambridge.

Genzyme’s shares soared this afternoon, 18 percent, on rumors that Sanofi might buy the company. The rumor mill has been churning for a few weeks, since Sanofi’s CEO said the company planned to make a huge acquisition – one worth up to $20 billion. Analysts started to do the math – Who’s worth $20 billion, and came up with a short list of likely targets, including Genzyme, and its neighbor Biogen Idec.

Now the Wall Street Journal says that early talks are in the works.

The timing of the double French dip into the Boston biotech scene couldn’t make more sense. As Sanofi, and the rest of big pharma, see their blockbuster drugs challenged by generics, and their profits eroded, they’ll have to increasingly look to biotech companies to refill those pipelines. So those shadows you see on the streets of Kendall Square, may belong to vultures from Paris, New Jersey and London, circling in search of their next local biotech company to gobble up.

New England Biolabs tops Best Place to Work list

Wednesday, April 28th, 2010

By Julie Donnelly

Julie DonnellyIf you are a biotech professional who likes long walks on Crane Beach and being treated well by your employer, you might want to apply for a job at New England Biolabs in Ipswich. The company was just named to the top spot of the list of The Scientist Magazine’s Best Places To Work survey, which included companies large and small from across the country.

Employees lauded the company for its commitment to the environment, including a LEED-certified building, a state-of-the-art wastewater treatment plant, and an aggressive recycling program that includes styrofoam and chemicals. They also complimented the cooperative research environment and the family-style atmosphere, which includes free lunch on Thursdays

The company, which has been around for 35 years, provides enzymes and reagents to life sciences companies for use in biotech research activities.

Massachusetts nabbed three other spots in the top 30 places to work. Cambridge-based Infinity Pharmaceuticals Inc. was ranked number three and was touted for its training development and integrity. Alnylam Pharmacuticals Inc., also located in Cambridge, came in at 12th place and was cited for its top management and policies and practices. EMD Serono Inc. in Rockland was listed in 24th place, with kudos for its pay, benefits, training and development.

Genzyme offers another interesting dose of news

Wednesday, April 21st, 2010

By Julie Donnelly

Julie DonnellyI just received a research note from an investment analyst titled “Genzyme: Always making life interesting.” A big understatement, especially for journalists.

Wednesday, the company revealed that it expected to pay $175 million in fines to the FDA to settle an enforcement action over its troubled Allston plant, swinging the company’s first quarter performance into the loss column.

If this were not bad enough, the company disclosed yet another hold up to its manufacturing operations. The company was having some problems with its water system, and then the plant was hit with an electric-power outage.

The result was that “the level of bioburden was above historical levels,” according to Genzyme officials during an earnings call Wednesday.

This means the water had too many contaminating microbes. The company had to stop production for several days last month. In addition, it’s not clear whether unfinished batches of two drugs, in production at the time of the power failure, will be usable. These are the same two drugs that are part of the ongoing shortage that began last summer after the plant was closed temporarily due to viral contamination. The result is that the shortage of Cerezyme, which treats the rare Gaucher disease, will be pushed out an additional two to three months. It will also rub salt in the company’s Fabrazyme-shortage wound as well.

Company officials said that the equipment was sanitized, gaskets were replaced and chemical decontamination was employed to solve the water problem. The water system is fine today, they say. The investigation will be complete this week, and the company can start shipping those medicines again next week.

But every delay exposes the company to more risk that patients will turn to competitors, since there are now two alternatives to Cerezyme on the market.

It also raises the question of the future of the Allston plant. The FDA enforcement action, called a consent decree, requires the company to relocate all of its fill/finish operations — the last part of the manufacturing process — to other locations. Currently half of that work, company wide, is done in Allston. There will also be continued scrutiny of other manufacturing functions at Allston Landing, which will be under a multi-year remediation plan that the FDA will set up soon.

Genzyme is a company with many good people, and it has an admirable mission to treat devastating diseases.

It’s unfortunate that the steady downpour of bad news there has made last month’s monsoons feel more like a passing sprinkle.

Women to Watch: What makes them special

Friday, March 19th, 2010

Jim ConnollyBy James M. Connolly

Intelligence, dedicated, leader, innovative, hard-working — they’re all words associated with the 11 women recognized with the Mass High Tech Women to Watch awards this morning. But back at the office we were talking how commonly another word has to be applied to the 2010 honorees and their 60 predecessors.

It’s their humility. It’s so striking. We at Mass High Tech see it over and over again. We contact them in January to tell them they have been selected, and their total surprise is genuine. When we interview them for profiles, they talk about other women who would be more deserving, or how they can’t believe they are in the same ranks with certain women tech leaders that they admire.

2010 MHT Women to Watch

These are inventors, heads of huge development teams and CEOs. They’ve earned the right to brag.

Instead, they stand up at a podium and praise other women. They are grateful to their parents and the members of their teams. They talk about how it just makes sense for them to give back, to help and mentor young people.

Be sure to check out their profiles in this week’s Mass High Tech or on MassHighTech.com. There’s something special about them that goes beyond bits, bytes and biotech. The 250 people who came out to honor them this morning understand it. It’s their humility.

Mass grabs three top places for scientists to work

Thursday, March 4th, 2010

By Julie Donnelly

Julie DonnellySome of the best places for scientists to work for no money are here in Massachusetts. The Scientist magazine has put out its yearly “Best Places to Work” list for post-docs, and three of the top ten are located in Massachusetts. For the uninitiated, post-docs are the low men and women on the scientific totem pole. They toil for long hours in the bowels of Harvard and MIT buildings with no one to talk to but transgenic mice. They get paid something like $40,000, even though they all have Ph.D.s already. They do it because it helps enhance their resumes or, in this economy, because it’s a good alternative to the frosty job search process.

Post-docs are the lifeblood of early stage research, and although most of that research ultimately fails, there would be far fewer drugs on the market today if the post-doc system did not exist. Treating them well would seem to be a societal good.

The most fulfilled post-docs in Massachusetts work at the Whitehead Institute at MIT, according to The Scientist. The survey ranked the institute the third best place to work, out of the top 40 listed in the survey. Workers there said they benefited from exemplary facilities, infrastructure and funding to support their research. However, they gave the Whitehead low marks for communication and being conducive to family and personal life.

The fourth favorite research institution in the national survey wasn’t at Harvard — it was at Swiss drug maker Novartis’ Institutes for Biomedical Research in Cambridge. There, workers extolled Novartis’ equitable workplace and the benefits. But there too, post-docs complained their personal lives had to suffer.

Coming in at number nine on the list was Woods Hole Oceanographic Institution. Here, the workers surveyed said their jobs allowed for family and personal life and offered great opportunities for career development. Woods-Hole post docs said the drawbacks were the facilities and infrastructure, as well as the benefits.

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