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Wednesday, June 8, 2011
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Cancer Patients Protest at Biotech Conference

By Toni Waterman   |   Friday, June 22, 2012
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June 22, 2012

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.”



The First Total Artificial Heart Transplant

By Toni Waterman & Jordan Weinstein   |   Friday, June 22, 2012
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June 22, 2012

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.

Leading the Fight Against Childhood Cancer

By Jordan Weinstein   |   Tuesday, May 1, 2012
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May 2, 2012

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.

Xconomy Report: (Re)generating Excitement

By Gregory T. Huang, Editor, Xconomy Boston   |   Friday, April 20, 2012
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April 20, 2012

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. …

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

Xconomy Report: Video Game Medicine

By   |   Friday, March 16, 2012
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Mar. 16, 2012

Dr. Mario

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?

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

About the Authors
Jordan Weinstein Jordan Weinstein
Jordan Weinstein is a news anchor for NPR's All Things Considered on WGBH, 89.7 FM in Boston.


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