BOSTON — More than 15,000 life science professionals from around the globe have descended on Boston for the BIO International Convention. The annual gathering showcases the latest advancements in science, from drugs to biofuels to cell therapy. And while the inside remained relatively calm, about a dozen demonstrators gathered outside the convention center on June 19. The protesters wanted the U.S. Food and Drug Administration to speed up the approval process for an experimental cancer treatment known as T-DM1, which they say can save lives.

Looking for effective treatment

In the fall of 2006, Lorraine Heidke-McCartin, 54, was diagnosed with one of the deadliest forms of breast cancer: HER2-positive. The cancer is less responsive to hormone treatment and has a high recurrence rate.

“Right from the beginning I was a Stage 4 patient because the cancer had gone to my liver,” said McCartin.

Immediately she started undergoing treatment, which for the better part of 4 years, kept her cancer to a minimum. But in the spring of 2010, the medicine that had kept her stable stopped working.

“It started to grow again in the liver and I was now up to about seven tumors in my liver,” said McCartin. The lymph nodes in the area were getting enlarged and cutting off my kidney and my bladder."

So she agreed to participate in a clinical trial at Dana-Farber Cancer Institute in Boston. The experimental drug, called T-DM1, is specifically designed to attack cancer cells in HER2-positive patients.

A change in plans

Just as she was to start treatments, the Food and Drug Administration shut down the program at Dana-Farber. But there were still 13 other locations where trials were still going on. The closest one for McCartin was in Fairfax, Va.

“So we started traveling to Virginia in October and I got approved to be in the program. And we travel every 3 weeks to go to Virginia back and forth,” said McCartin.

McCartin said it was a hassle, and expensive — but within months, her tumors were shrinking.

“And in November of 2011 I was told they couldn’t see anything,” said McCartin.

She said her doctors won’t explicitly tell her that she’s in remission, but they haven’t been able to see any cancer over a year. And McCartin said the medication doesn’t have the same debilitating side effects as other treatments.

The next step: blocked

Still, the FDA has denied the application for accelerated approval from Genentech and ImmunoGen, the two companies that make the drug, and instead has sent the companies back to do more clinical trials.

Geoff MacKay is the chairman of the Massachusetts Biotechnology Council. He said the FDA has a tough job trying to measure the risk versus the benefit of any drug.

However, he said, “I don’t know why they didn’t approve this and I think that really needs to be questioned. Anything that has the potential to save lives should go through what is called an ‘expedited review process.'"

He said the process should be made as quick as possible without skirting regulations or lowering the bar. Right now, it can take up to 15 years and hundreds of millions of dollars — sometimes billions of dollars — to bring a new drug to market.

McCartin has been staging demonstrations, protesting what she calls the FDA’s slow approval process. During the week of June 18, she and about two dozen other people protested outside of the BIO International Convention at the Boston Convention and Exhibition Center. She said the FDA is holding up a drug that is saving lives.

“What we’re protesting about or demonstrating about is Stage 4 people who need this drug should be given a chance to try the drug,” said McCartin. “We need something and this might be the drug that works for us.”

BOSTON — At Brigham and Women's Hospital, retired high school teacher James Carelli Jr. talked about the pioneering heart surgery. In order to put himself through it, he needed faith.

 
BOSTON — There's been a hopeful development in the fight against one form of cancer. Sarcoma is rare in adults but rather prevalent in children. For the first time in 30 years, a drug to treat soft-tissue sarcoma has been approved by the FDA. The news coincides with a fundraiser this Saturday in Hudson to raise money for the Jennifer Hunter Yates Sarcoma Foundation. WGBH News' Jordan Weinstein talked with Dr. Edwin Choy from Massachusetts General Hospital to see how fundraisers like these generate awareness and money. Choy said the foundation led the way.

 
CAMBRIDGE, Mass. — A couple of Cambridge companies are gaining ground with their regenerative medicine technology, which uses living cells and other natural materials to promote healing. InVivo Therapeutics says it will soon get the FDA go-ahead to start human trials of its implant for healing spinal cord injuries. Meanwhile, Pervasis Therapeutics, whose technology might help dialysis patients better withstand their treatment, is being acquired by the Irish pharmaceutical giant Shire. Both companies come out of the lab of MIT professor and prolific inventor Robert Langer.
 
In deals news, the venture capital numbers are in from the first quarter of 2012 and Bay State startups continue to outdo their rivals down the coast. In the last three months, VCs invested $650 million in 76 Massachusetts companies compared to just $333 million in 81 companies in New York state. Both states still trail California in VC investment, however.
 
And finally, what’s with all these companies looking to be Facebook killers? The social network is looking a bit vulnerable ahead of its rumored IPO next month. One local startup getting in on the action is Cambridge-based PowerInbox, which is trying to turn email into an interactive platform where you can access social media. Now if it could just get all of our inboxes down to a manageable size. …
 

The weekly roundup of business, technology and life science news from our partners at Xconomy.com airs every Friday on 89.7 Boston Public Radio.

 
CAMBRIDGE, Mass. — Could your child leave his next checkup with a prescription for a video game? Akili Interactive Labs, founded by Boston’s PureTech Ventures, is hoping its game — designed to treat ADHD, autism and the like — will be the first one approved by the Food and Drug Association as a medical device. Akili was co-founded by San Francisco-based neuroscientist Adam Gazzaley. It’s unclear at this point how the game will work, but Akili is betting it can improve cognition by tapping into the brain’s capacity to overcome interruptions through practice. That’s more than Angry Birds can say. 

In other innovation news …
 
Burlington-based Demandware is the latest local tech company to go public, joining the ranks of TripAdvisor, Brightcove and Carbonite. The e-commerce software firm raised $88 million in its IPO and is valued at around half a billion dollars.
 
Not to be outdone, Lowell-based semiconductor firm M/A-COM Technology (pronounced "May-com") has also gone public this week, raising over $100 million in its offering.
 
And our quote of the week comes from Ted Morgan, CEO of Boston-based Skyhook, who offered this advice for companies building mobile software, platforms and apps: “Google and Apple want to own the whole stack. It’s hard for startups, but that doesn’t mean you can’t do it.”

p.s. Dr. Mario, anyone?

The weekly roundup of business, technology and life science news from our partners at Xconomy.com airs every Friday on 89.7 Boston Public Radio.

The weekly roundup of business, technology and life science news from our partners at Xconomy.com airs every Friday on 89.7 Boston Public Radio.

CAMBRIDGE, Mass. — While most of the tech world is analyzing Facebook’s impending IPO, a new effort at Harvard University is trying to find the next Facebook — and keep it in Cambridge. The Experiment Fund, an unusual partnership between the university and venture capital firm N.E.A., will make seed investments in student-led startups across software, energy and health care. The aim is to support the best young talent while contributing to the growing early-stage funding ecosystem in Boston.
 
In life sciences news, the FDA this week cleared three drugs developed in part by Boston-area biotechs: a treatment for cystic fibrosis from Vertex Pharmaceuticals, a once-weekly diabetes injection from Alkermes and its San Diego partner Amylin Pharmaceuticals and a skin cancer drug developed by Curis and Roche unit Genentech.
 
Finally, iRobot announced it has backed inTouch Health to the tune of $6 million, in a move aimed at breaking into the health care market. InTouch makes robotic devices that allow physicians to care for patients from afar. 

The weekly roundup of business, technology and life science news from our partners at Xconomy.com airs every Friday on 89.7 Boston Public Radio.

CAMBRIDGE, Mass. — Medicine could be the latest field to join the natural ingredients craze, thanks to a new startup in Cambridge. Warp Drive Bio came out of the woodwork this week with $125 million in new funding. The company hopes to examine the genetic makeup of plants, animals and other organisms to find hot new drugs. Warp is backed by Boston firm Third Rock Ventures, Greylock Partners and French pharmaceutical giant Sanofi. The startup has an elite roster of founders, including Harvard genomics expert George Church.

In mobile innovation news, Mitt Romney is using software from Cambridge-based Jumptap to create targeted mobile campaign ads. And Boston-based Apperian has been selected to power AT&T’s new mobile app management system.
 
Meanwhile, Massachusetts regained the number-two spot in venture funding and deals last quarter, behind California and ahead of New York, according to a report from CB Insights. Nationally, 2011 saw the most venture dollars and deals of any year in the past decade.
 
And on a sad note, Jerome Rubin, a cofounder of Massachusetts-based E Ink, which makes the display for the Amazon Kindle, passed away this week. He was 86.
 

The weekly roundup of business, technology and life science news from our partners at Xconomy.com airs every Friday on 89.7 Boston Public Radio.

 
CAMBRIDGE, Mass. — On a weekday afternoon, six women gathered with their newborns on a carpeted family room floor in an apartment in Cambridge. All new moms, they came together to learn a thing or two about sign language for their hearing babies.
 
“I had heard about baby sign before I had my baby,” said Courtney Horwitz, the mom who hosted the party. “People talk about it all the time now. It’s like a big thing."
 
A playgroup with a purpose
 
A big thing, but not a new thing. Sign language for babies has been popular among parents for a decade. What is new — at least for these moms — is the methods of Jill Tully.

Tully teaches the babies a word. (Courtesy of Brea Ashcraft)

Tully, a mother of three, is what you might call a traveling teacher. She lives in Melrose, but teaches “Sign to Me, Sing to Me” playgroups all over the North Shore and Greater Boston Area. She charges $40 for the playgroup, which came out in this case to a little more than $6 per mom.
 
Tully showed up at Horwitz's apartment with an apple-green-and-white, polka-dot suitcase in tow. Attached to the outside of the bag was a round speaker and a tiny green mp3 player. As soon as Tully got through the door, she turned on the music.
 
The babies ranged from 6 months to 8 months old and collectively displayed all the signs of baby-ness: crawling, cooing and crying. But when Tully started singing and gesturing with her hands, the babies were mesmerized.
 
Tully’s exposure to American Sign Language, or ASL, began when she worked as a teacher for young children with language delays. She learned about its use with hearing babies after she had her first child. She loved the idea and took her daughter to a couple of classes, but then the instructor moved away.
 
“I was really bummed out cause I wanted to continue with it,” Tully said. “So I figured, I guess I’ll start teaching classes because no one else is and it is too cool to let it go.”
 
That daughter is now 7 and Tully has been developing her method of teaching sign to babies ever since.
 
Some people teach baby sign to parents in a workshop, Tully said, but she didn't like that approach. "I’m a teacher by nature so I wanted it to be engaging for both the parents and the children, so that the children are getting some music enrichment and learning some signs,” she said.
 
Baby sign language proponents say the primary purpose of teaching sign to infants is to increase early communication in order to decrease frustration. So if your baby knows the sign for milk — which, by the way, is similar to squeezing the udder of a cow—then she might not have to wail in order to get what she wants.
 
A medical perspective
 
Critics fear teaching sign language to babies might delay verbal speech. Kevin Shapiro, a pediatric neurology resident at Massachusetts General Hospital, said there is a dearth of data on the effects of teaching sign to hearing babies.
 
"There’s some research that indicates that children who are exposed to symbolic gesture and develop larger gestural repertoires do a little better on measures of expressive and receptive language in the first two years of life,” Shapiro said. “But that advantage pretty much disappears by 30 months. Then their verbal language takes off and they are pretty much indistinguishable from other typically developed infants.”
 
But Shapiro said that babies are predisposed to pick up on symbolic gestures and primed to learn language. In fact, whether the language is spoken or signed, the regions of the brain involved in language development are similar — mostly in the left hemisphere, part of the inferior frontal lobe and part of the temporal lobe. And, Shapiro said, "We know that early exposure to language is a good predictor of language development down the line.”
 
So teaching your baby sign language might not make him smarter in the long run, but it might allow him to choose the topic of conversation. Shapiro used the example of an infant who makes the sign for “bird.”
 
“The parent knows that the infant is engaged in the birdie and will respond by saying, oh yes, it’s a birdie,” said Shapiro. “It’s a way of eliciting conversation from the parents, which we know is good for child language development.”
 
Baby sign language in the real world
 
The parents in Tully’s class were eager to know when their babies would start communicating through sign. She said that if babies are exposed to consistent signing, they can usually master simple signs by 16 to 20 months.
 
However, one mother in the group said her daughter, Aurora, used her first sign — "milk" — when she was only 6 months old. Brea Ashcraft said she and her husband had been signing "milk" every time they fed Aurora. One day, while taking a break from a feeding, Aurora looked right up at her mother and clenched her fist.
 
“I could hardly believe it,” Ashcraft said. “Over the next few days she started doing it more and more, and now does it a lot of times when she wants it and even when she’s eating.” If somebody walks in the room during a feeding, Aurora will stop, look up at the person, sign that she’s having "milk" and then go back to eating.
 
Ashcraft said Aurora now knows a second sign: diaper.
 
“On Saturday my husband was holding her and she was frantically signing for diaper,” Ashcraft said. “So he takes her into the bedroom, takes off her diaper and her diaper is dry, and he’s like, you don’t need your diaper changed, and then she peed all over him.”
 
The takeaway from that story? Some things clearly get lost in translation.

BOSTON — Burlington, Mass.–based Coronado Biosciences is creating buzz in the medical community for betting that worms can treat autoimmune diseases such as multiple sclerosis and Crohn’s disease.

Dr. Bobby Sandage, president and CEO of Coronado, has administered whipworm eggs, harvested from pigs in Europe, to MS patients in the relapse/remittance stage of the disease. Once in the body, the eggs hatch and the worms cause the re-regulation of the immune system. That results in less of the inflammation that is the hallmark of autoimmune diseases.

After doing their work, the worms “die and are simply shed from the body harmlessly,” Sandage said. “Because this is such a natural triggering of the total immune system we actually have a real interest,” with researchers pursuing applications for other autoimmune diseases.

This research is currently in the early stages of testing.

Learn more about the research.

Extended Audio

• Dr. Bobby Sandage talks about the "hygiene hypothesis”
• Why pigs?
• The hoped-for outcome for people with MS

WELLESLEY HILLS, Mass. — In a backstreet office park in Wellesley Hills, Dr. Richard Dupee ushers Phil and Judie Fasano down a long blue hallway to an exam room at the far end of his office. For 26 years, the Fasano have been making the 20-mile trek from Braintree to Wellesley to see Dr. Dupee.
 
“People say to me, ‘why do you go all this way to see a doctor?’” says 72-year-old Phil. “Well, I think it speaks for itself. We go to him because he treats us well.”
 
And, more importantly, Dr. Dupee accepts Medicare patients -- at least for now.
 
“My fear is losing him as my doctor,” says 71-year-old Judie, whose laundry list of medical problems includes kidney disease and diabetes.
 
The Fasanos, like millions of seniors across the county, may have to start looking for a new doctor unless Medicare reimbursements soon change. Low reimbursement rates have already prompted some doctors to opt out of Medicare, and many more would be expected to if Congress doesn’t shore up the system with additional money.
 
In Massachusetts, rising business costs are compounding the problem. Dr. Alice Coombs, president of the Massachusetts Medical Society, says that over the past 10 years, the cost of doing businesses in Massachusetts has increased by 35 percent, while Medicare reimbursements have gone up 1 percent. 
 
“It’s creating an environment that’s not conducive for physicians to survive in terms of practicing medicine with predominant Medicare patients. Doctors want to take care of all patients,” Coombs said. “However, it becomes increasingly difficult for them to have an operational budget to be able to do that.”
 
That means the one million seniors who already rely on Medicare in Massachusetts aren’t as secure with their health care providers as they would like to be. With the first of the baby boomers hitting the age of 65 this month, that number is only growing.
 
An Unbalanced Budget
 
When Medicare was signed into law in 1965, it was designed as a medical safety net for the elderly. But as the years have passed, spending has quickly outpaced budget. Right now, it would take $600 billion just to balance the Medicare budget.
 
While the program has been riddled with financial headaches from the beginning, the latest round of problems stem back to 1997, when, in an effort to control spending, Congress came up with a complex formula to reign in ballooning Medicare costs. Basically, Congress capped yearly expenses, so if the costs for a given year went over the limit, the excess would be deducted from the following year’s budget. 
 
“You can’t go about that ceiling, whatever that figure was. And if you go above that ceiling, the only way to stay below that ceiling of cost is to reduce either services or fees,” Dr. Dupee said.
 
At first, it worked. Medicare costs were kept below the yearly limit, so neither services nor doctor reimbursements were cut. But by 2002, the ceiling had been shattered – expensive tests like MRIs became popular, new treatments for diseases like cancer meant people were living longer and the number of people on Medicare skyrocketed.
 
The solution? Cut the amount of money paid to doctors – a solution that Dr. Dupee says has been looming for a decade.
 
The Medicare Deficit Comes Home
 
“We heard about a 9 percent reduction in fees as of January 1, 2010. Then this summer we’re hearing it will be a 25 percent reduction as of December 1, 2010 to try and catch up for all the years Congress kicked the can down the road.”
 
But Congress is still kicking. In December, the rollback was delayed another year, with President Barack Obama signing the ‘doc-fix’ into law in the 11th hour.  Many, including Dr. Dupee, say a 25 percent cut in pay to doctors would become a national disaster.
 
“Many physicians would stop seeing Medicare patients, not accept new Medicare patients, some would completely withdraw from Medicare completely,” Dupee said.
 
No one has a solution at this point, but Dr. Coombs says one part of the fix is prevention.
 
“If we look at things like ER visits and preventable hospitalizations, they contribute to close to a billion dollars in the state.”
 
Meanwhile, the Fasanos are left in limbo, not knowing where they’d turn if Dr. Dupee closes up shop.
 
“Whatever Dr. Dupee gets paid, I think he’s well worth it,” says Judie.
 
Right now, Phil says their only hope is that a solution is found in the next year.
 
“Someone’s got to pay for this and it can’t be all the seniors. We’re the ones who are sick. We’re the ones who are aged. We’re the ones who need the most help.”
 
But at this point, the Fasanos are in better health than their health care.