The Regenstrief Institute Inc., is licensing its technology that runs the Indiana Network for Patient Care and DOCS4DOCS clinical results delivery software to the new organization. The spin off is so new that it doesn’t have a name yet.

Jim Hill, chief revenue officer for IHIE, said that the new company will hire some new hires and take some staff members from IHIE.
To find new customers for the software that manages information and access to it, the new company help health systems build both public and private HIEs. Hill said potential clients include three types of organizations:

• Health systems using or moving to the ACO model
• Fast growing health systems that want a private exchange
• Long-term care organizations that need to manage transitions of care

“With payment reform on its way, people are more inclined to figure out how to bring data together,” Hill said.

Indiana is ahead of the game with many aspects of its exchange. Emergency room doctors can get access to a state resident’s medical records if she or he is admitted to the hospital while away from home. Some nursing homes and EMS crews in Indianapolis are using the exchange and one lab is too. The INCP also communicates with smaller information exchanges in the state and the one used by metro Cincinnati health system.

Currently 94 hospitals and 25,000 doctors in 17 states use the Indiana information exchange, which includes the Indiana Network for Patient Care and DOCS4DOCS.

The systems were created by the Regenstrief Institute’s Center for Biomedical Informatics and launched in 2004. According to IHIE, the INPC handles more than half a million secure transactions of clinically important data on an average day, including medical histories, laboratory test results, medication records, treatment reports in a standardized, electronic format.

Hill expects a strong selling point for the new company to be the team’s successes and failures from running the IHIE for the last seven years, including bringing many groups to the negotiating table and getting them to agree how to set up data sharing.

“HIEs are not about technology but governance of the data,” Hill said.

There is a professional services group already within IHIE. The for-profit organization will offer both software and consulting.

“We haven’t closed any deals yet, but adjacent markets are of great interest, Chicago, Louisville, and southern Michigan,” Hill said. “Now that we have this agreement behind us, we can make promises within the marketplace.”

IU Health Bloomington Hospital plans to cut jobs in the coming months, but officials will not yet say how many.

The losses will accompany consolidation of IU Health's information technology system, may be accomplished partly by attrition, and are part of an effort to keep costs down in light of recent health care reform measures, according to a hospital spokesman.

"We are trying to get a handle on our costs based on the health care landscape, one in which the reimbursement model is changing," said Steve Deckard, the hospital's vice president of human resources, referring to the Affordable Care Act, which calls for $716 billion in Medicare cuts, much coming from payments to doctors and hospitals. Additionally a 2 percent cut in Medicare payments to doctors and hospitals went into effect April 1.

"The IU Health system, as well as our entire industry, is trying to figure out how to make health care cost less so we can continue providing high-quality health care to the community," Deckard said.

Deckard said the IU Health System is involved in an ongoing process that will lead to the conversion of all hospital information technology systems in the IU system to a single IT system by early to mid 2015. He said the conversion will make it easier for the hospitals to gain access to patient information and lab reports.

The framers of the Affordable Care Act anticipate that the Medicare cuts to providers will be offset by payments from insurance companies for medical services to the roughly 30 million newly insured Americans who will be required to buy health insurance when the law goes into effect Jan. 1. Additional new revenue also would come from the expansion of Medicaid, which may or may not happen in Indiana.

Deckard said once the system conversion has been completed, he anticipates there will be some job consolidation -- perhaps in support areas such as accounting, payroll and IT -- in which job positions would be transferred to Indianapolis.

"It won't be the same for all support areas," he said. "We will do an analysis in each area to determine the number of people we need to provide services in that area. Those analyses have not been completed, but it appears that in some areas we may need fewer folks by the time we get to the end of the system conversion in 2015."

Deckard emphasized that he did not anticipate any job losses at the hospital in the near future, other than through attrition. He said it is too early to estimate how many jobs might be lost two years from now.

"I can't tell you what that number might be, but we think it will be minimal," he said. "Because the system changes will not be completed until early to mid 2015, a lot can happen between now and then. Some people will decide to leave, for example, but I can't predict how many. But if this affects just one person, that would be too many."

Hospital spokeswoman Amanda Roach said she could not estimate the number of support area jobs the hospital has at this time.

Deckard said in the near future the hospital's IT and financial services managers will be reporting to IU Health leaders in Indianapolis rather than Bloomington Hospital's administration.

"It's easier to standardize processes and policies and protocols if the reporting tree includes Indianapolis more directly than it has in the past," Deckard said. "By having a common reporting relationship rather than having one that involves multiple leaders who are separated geographically, it helps everyone in the system get on the same page."

Deckard said IU Health Bloomington Hospital is participating in an ongoing, system-wide effort to establish the same procedures, protocols and standards at all IU Health hospitals

"By standardizing procedures, protocols and systems, we will be able to provide the same level of care, regardless of where within the system it is provided," he said. "The level of care may not be to the same degree, but if you're talking about primary care, for example, we want patients to get the same level of primary care at Bloomington Hospital as they would at any other hospital within the system." ___

(Reuters) INDIANAPOLIS - Eli Lilly and Co said two additional late-stage studies testing its experimental diabetes drug dulaglutide met the main goal of reducing hemoglobin A1c levels, a measure of blood sugar.

Along with positive results from three other late-stage trials announced in October, the data will support a marketing application for dulaglutide, Lilly said in a statement.

In the study named AWARD 2, the company said a 1.5 mg dose of its drug proved superior to Sanofi's Lantus, at 52 weeks in type 2 diabetes patients, who are already on two other diabetes drugs, metformin and glimeperide.

Dulaglutide also trumped insulin lispro, in combination with Lantus, at 26 weeks of treatment in a study dubbed as AWARD 4, Lilly said.

The company said the most frequently reported adverse events were gastrointestinal.

In October, Lilly reported positive results of the other three studies in which dulaglutide was compared with other diabetes medications.

Lilly's shares closed at $56.49 on Monday on the New York Stock Exchange.

(Reuters) INDIANAPOLIS - Drugmaker Eli Lilly and Co plans to layoff about 1,000 domestic sales representatives to reduce costs, as it faces daunting generic competition, the Wall Street Journal reported, citing a person familiar with the matter.

The restructuring would affect about 30 percent of the company's U.S. sales force and includes both full-time and contract employees, the Journal reported.

At the end of this year Lilly's current biggest product, the antidepressant Cymbalta, will lose patent protection while copycat forms of its $1 billion-a-year Evista osteoporosis drug are due to arrive in early 2014.

Cost controls partly helped Lilly beat Wall Street expectations for the October-December quarter but profit fell on competition from generic forms of its schizophrenia drug Zyprexa.

During the quarter the Indianapolis-based drugmaker took a $74.5 million charge on global restructuring, that included the U.S. sales layoffs, a company spokesman told the paper. At the time of the charge, the drugmaker did not specify how many employees would be losing their jobs.

Lilly had forecast aggressive company wide cost controls for 2013 in January.

The layoffs and reorganization are scheduled to be completed by July, the paper said.

Lilly could not be immediately reached for comment outside regular business hours.

(Reporting by Garima Goel in Bangalore; Editing by Edwina Gibbs)

TONY MILANO KNOWS NUMBERS -- he's an accountant by training -- but the financial impact of the new federal health-care law on his chain of Indianapolis-area pet supply stores still managed to surprise him.

Initially, Milano thought his five Pet Supplies Plus stores would be exempt from the law's requirement to supply insurance for his employees. That provision applies only to companies with more than 50 full-time employees. His company had 40.

But like many retailers, the company also employs a large number of part-time workers. He employs about 40. And under the Affordable Care Act, the hours of those part-time workers are added up and then divided to crank out a tally called "full-time equivalencies." Turned out, Milano has about 60 full-time equivalencies.

As a result, his company will be required beginning in 2014 to offer insurance to employees who work at least 30 hours a week. The insurance plan also must offer a certain level of benefits and can't require workers to contribute more than 9.5 percent of their household income.

"It's a very costly change for us," he said. "Probably 10 times as expensive as our previous plan."

Although health-care reform is expected to dramatically boost the number of people who have insurance, the impact of the new law is weighing heavily on employers across the state. Those businesses and organizations are now making health-care decisions for next year, when most provisions of the law go into effect, and they expect significant new costs.

Two drivers of those increased costs will be a health insurance tax expected to disproportionately affect small businesses and the employer mandate, which requires employers such as Milano who have more than 50 full-time equivalencies to offer health insurance or face penalties of up to $3,000 per worker.

But beyond the new federal taxes and mandates, there is another less tangible issue: uncertainty. Many small businesses feel paralyzed by the complication of the new law.

"When looking at 2,400 pages in the law and 15,000 pages in regulations, and even really smart attorneys don't have it figured out, what's the company with 65 employees supposed to do with it?" said Matt Thomas, president of WorkSmart Systems, an Indianapolis company that provides human resources services to small businesses, including a pooled health insurance plan.

He expects business at his firm to double from 2012 to 2014 as small businesses look to professional help to manage increasingly complicated health insurance matters.

The Affordable Care Act is intended to expand the number of people who have access to health care and to create minimum coverage standards.

It provides federal funding if states are willing to expand Medicaid and creates new state health insurance exchanges in which those who earn 100 percent to 400 percent of the poverty level ($23,050 to $92,200 for a family of four) can receive federal subsidies to buy coverage.

It also requires insurers to cover people regardless of pre-existing conditions. About 30 million uninsured Americans are expected to eventually gain coverage.

Details about the potential costs to businesses still are emerging.

A study from Jackson Hewitt Tax Services indicates that if Indiana doesn't expand Medicaid -- an expansion expected to cover many part-time workers -- businesses in the state would pay up to $54.8 million a year in penalties because of the employer mandate.

Gov. Mike Pence has opposed a Medicaid expansion in Indiana unless federal officials allow the state to use the Healthy Indiana Plan, the state's alternative that he says would give Indiana more control over health-care options and costs than the normal path prescribed under Medicaid.

The expansion would offer health insurance to about 400,000 more Hoosiers.

In addition to the employer mandate, businesses are bracing for an estimated 2 percent to 3 percent increase in premium costs because of a new health insurance tax on the fully insured market, according to the National Federation of Independent Businesses.

The health insurance tax, which begins in 2014, will be levied on insurance companies, but they are expected to pass it through to businesses. Nationally, the tax is expected to cost businesses $8 billion, said Barbara Quandt, state director for the federation.

She says the tax will disproportionately affect small businesses, which tend to purchase fully insured plans under which the insurance company, rather than the employer, bears the risk of covering workers' medical costs.

"They're frightened," Quandt said. "In many cases, they are paralyzed. They're making no decisions. They're not growing. They are trying to sort out how this law is going to impact their business."

The choices won't be easy. Some employers are cutting workers' hours or have stopped hiring to avoid the mandated insurance coverage provision for companies with more than 50 workers.

"They are looking at their growth strategy -- should they shrink, should they revise their workforce to get under 30 hours?" said Kimberly Hollis, director of business solutions with Tilson Inc., a human resources outsource firm in Greenwood.

Timothy Slaper, director of economic analysis at Indiana University's Indiana Business Research Center, said he expects the health-care law to have "a detrimental effect" on Indiana businesses. In a study last year, he took data from 2003 to 2008 and modeled what the impact of the Affordable Care Act would have been. He found that about 12,700 new jobs would have been at risk. Given the sluggish economic recovery, the impact today could be even greater, he said.

Some employers already are making cuts. In south-central Indiana, Bartholomew County's Board of Commissioners voted last week to limit part-time government workers to 28 hours.

About 40 employees -- mostly in the jail, courthouse and probation services -- will have their hours cut, but the county will save as much as $550,000 as a result, County Commission Chairman Carl Lienhoop said.

To what degree such moves by employers could affect employees seeking insurance remains to be seen. It depends on whether the state expands Medicaid and on the cost of insurance on the new state health exchanges.

For businesses, however, a new truth about the law is emerging.

"The law itself is not written to lower costs," Thomas said. "It was written to insure people who aren't insured."

Milano, owner of the pet stores, admits the increased costs will impact his business.

"This is the biggest single change to anything in our business equation that we've had to wrestle with," he said. "Will it impact store expansion or an ad campaign or that next piece of equipment we need? Yes, it will."

But he said he has been seeking ways to retain good employees for a while now and already was considering beefing up the mini-medical plan he previously offered employees.

"Every day there are things we can't control," he said. "As a business person, you've got to take them one at a time and get back to what's most important. For us that's the customer service business." ___

BioRegeneration Technologies co-founders Darryl Dickerson and Eric Nauman say InMotion has the potential to be a one-time-only, permanent solution for joint pain and degeneration.

InMotion is a porous scaffolding made of a nonbiodegradable, collagen-based substance. It is implanted in a cavity in an area of joint loss or damage. The scaffolding has “a transition zone” that consists of hard and soft segments — hard to provide support and soft to nurture tissue growth. This allows for optimum tissue-bone connection.

InMotion’s primary focus is cartilage regrowth in knees, hips, shoulders and back pain related to cartilage damage. Athletes with knee and hip injuries and people with osteoarthritis are the initial customer target.

But BioRegeneration is hopeful that InMotion also could repair damaged or deteriorated ligaments and tendons, and reverse muscle degeneration.

“The hope is to reduce the overall healthcare burden by having fewer people living with pain and needing joint replacement,” Nauman said.

Microfracture surgery, a common approach to joint repair, involves creating tiny fractures in underlying bone to allow cartilage to develop from a sort of super-clot. But the procedure lacks a successful interfacing of tissue and bone. Within two to five years after surgery, Dickerson said, scar tissue forms or good tissue is compromised by acidic leakage from the biodegradable joint repair material, which means pain returns.

Dickerson is president and chief scientific officer, and Nauman is vice president for development of new technologies and an associate professor of mechanical engineering at the university.

Nauman said Dickerson came up with the idea for InMotion in late 2004. Dickerson, then a student in one of Nauman’s labs, said he was looking for a thesis topic for his Ph.D.

BioRegeneration got funding from AMIPurdue for initial research and patent work. The company also received an SBIR phase 1 grant of $99,394 in 2010.

Dickerson and Nauman said three years of testing on rabbits and sheep has produced positive results. A patent for InMotion is pending.

INDIANAPOLIS - Five months after breaking ground on a $140 million insulin plant at its Harding Street campus, Eli Lilly and Co. has decided that the plant needs to be a lot bigger.

The drug maker will spend $180 million more to double the plant's capacity to fill cartridges for insulin-injecting pens.

Lilly will officially make the announcement today that it is broadening its vision for the plant, which will be the first U.S. site to fill cartridges in the increasingly popular pens that diabetics use to inject insulin to control their blood sugar.

The additional investment will add 84,000 square feet and a second cartridge line to the original 80,000-square-foot footprint of the plant. Construction started in November and is visible from the main South Harding Street gate of the Lilly Technology Center campus, where the company does much of its pharmaceutical production.

The expanded plant is needed to serve new Lilly insulin products that the company expects to hit the market in the next few years, said Lilly's president of global manufacturing, Maria Crowe.

"We'll be able to utilize the facility for multiple products," she said. "Our goal wherever we can is to make common manufacturing platforms."

The first cartridge line will open in 2016 and the second a year later.

Lilly currently fills the cartridges only in Italy and France. But the market for the pocket-portable pens, which replace the traditional vial and needle, is growing in the United States, and the new cartridge plant will supply that market, Lilly said.

Lilly also will use some of the $180 million to expand a separate plant at the Harding Street campus that makes the active insulin ingredient as a powdered crystal that is later liquified and put into the cartridges, Crowe said.

Under an initiative it calls the insulin technical agenda, Lilly is streamlining and updating its insulin production processes as it tries to produce insulin more cheaply. Insulin makers are coming under stiffer pricing pressure from governments that pay for drugs. The coming expiration of patents on bio-synthetic insulins is expected to bring lower-priced bio-similar products onto the market in a few years.

Insulins are a key product line for Lilly, making up about 16 percent of sales. The company has four would-be insulin products in late-stage development.

The new, brick-sided cartridge plant here will be capital-intensive and labor-light, employing about 175 people when fully open. Those jobs will be filled by existing Lilly workers and new hires.

The Indianapolis lines will use a new technology that is not in the European plants, Crowe said. "We hope it's faster and we get a bit more output from it," she said.

The look of the cartridges won't change from what patients are used to now, she said.

The cartridge filling plant is the largest construction project that Lilly currently has under way around the world. ___

INDIANAPOLIS - So artfully done was the overnight theft of more than $60 million worth of drugs from an Eli Lilly and Co. warehouse in Connecticut that it seemed an inside job.

It essentially was, contends a lawsuit filed last month by the company that insured the Lilly building.

The brazen March 2010 break-in was made possible, the lawsuit says, because thieves got their hands on a proprietary report, done for Lilly by its security firm, which pointed out weaknesses in the warehouse's security system. The insurer is seeking tens of millions of dollars in damages from the security company.

Using the report, the two Cuban brothers who were arrested and indicted in the theft could know the warehouse's security system inside and out, the lawsuit says. They knew where every security camera was, every motion detector and every glass-break sensor. And how to disarm them.

In particular, the lawsuit says:

-- They knew where to cut through the roof to avoid security detectors.

-- They knew where to rappel down on ropes so they landed at the only point on the warehouse floor invisible to surveillance cameras.

-- They parked the tractor-trailer used to haul off the stolen drugs at the sole loading bay that surveillance cameras couldn't see.

The thieves "utilized unique and confidential knowledge of the security system ... to effectively infiltrate the warehouse without triggering the security monitoring system," says the lawsuit, filed by National Union Fire Insurance Co.

The lawsuit seeks damages of $42 million against ADT Security Services, whose corporate security business is now operated by Tyco Integrated Security of Boca Raton, Fla.

Although the lawsuit alleges that an ADT-compiled security review for the warehouse, done just before the 2010 break-in, fell into the hands of the thieves, it doesn't say how they got it or give any proof they had it.

The report was done to highlight vulnerabilities in the building's security and was intended to be seen only by the Indianapolis pharmaceutical company so that it could decide whether it needed to upgrade security measures in the warehouse, the lawsuit says.

The lawsuit's allegations, if true, would explain how the largest-ever U.S. heist of pharmaceutical products was carried out almost flawlessly, despite a host of high-tech security measures in Lilly's Enfield, Conn., drug distribution center.

In 2012, the FBI arrested Amaury and Amed Villa, Cuban natives who lived in Miami, and charged them with the theft. They are awaiting trial in Connecticut.

The lawsuit's charges are sending shock waves around the security industry because Tyco is the world's largest security firm and more than 500,000 businesses use its services to protect their buildings, employees and products.

Richard Sem said this is the first time he has heard allegations in a lawsuit about a major security firm's customer security plans being used like a road map to carry out a burglary. Sem, a security consultant in Lake Geneva, Wis., has testified numerous times in court about security issues,

"This could be a wake-up call" to the security industry, he said. "The question is how careful (security firms) are with these plans and how they protect them."

An attorney for National Union, Elisa Tara Gilbert, New York, refused to discuss the allegations in the lawsuit, saying her client won't let her comment on the case while it's pending.

The 23-page lawsuit notes that the thieves broke into the warehouse by exploiting the specific security vulnerabilities that were highlighted in the ADT report. And it also points out that three other warehouses protected by ADT in Texas, Florida and Illinois were broken into between 2008 and January 2010 by burglars who gained access without triggering alarms and escaped unnoticed, just as they did in the Lilly burglary.

The lawsuit also notes that ADT in 2010 stored security information about its clients' facilities in Florida, which is the home state of the Villa brothers.

Sem said it's possible that the thieves in the Lilly break-in "could have gotten an employee (planted) into ADT or paid somebody off" to hand over the proprietary report. "These are very sophisticated theft rings," he said.

Matt McDonough, a senior vice president at Lo/Jack SCL, a Texas security company specializing in preventing cargo theft, said: "Cuban gangs traveling in teams of eight to 20 members, conducting methods of surveillance on various goods and cargo targets, is not very surprising. The possibility that they may possess such highly confidential and proprietary information as security schematics has been a new development."

The lawsuit says ADT never notified Lilly about the three other break-ins "despite ADT's knowledge that ... other burglaries had taken place utilizing information only available to individuals with access to sensitive information about the ADT security system."

A Tyco spokesman, Brett Ludwig, said company policy is not to comment on pending litigation. As for Tyco protecting information about its customers' properties, he said, "We take very, very stringent and solid precautions to safeguard all our customer information."

Ludwig said Tyco continues to contract with Lilly to provide security at its buildings. "They remain a valued customer of ours," Ludwig said.

Greg Kueterman, a spokesman for the Indianapolis drugmaker, said, "we recognize the right of the insurer to pursue this litigation, but we have no other stake in the lawsuit."

National Union, based in New York, said that it paid off a $42 million insurance claim to Lilly to cover the theft. It seeks a like amount of damages from Tyco, plus legal costs.

The Villa brothers were arrested along with nine other people who federal authorities say were part of a prescription drug burglary ring. Federal authorities said fingerprints left on water bottles inside the Lilly warehouse helped them break the case.

Many of the stolen drugs, which included cancer drugs and antipsychotics, were recovered but will be destroyed after they are no longer needed as evidence in the criminal case.

Maria Elena Perez, a Cora Gables, Fla., lawyer for Amaury Villa, said until the insurer's lawsuit was filed she "never heard" of the allegations that her client had access to the ADT security report on the Lilly warehouse.

"I have extensive knowledge about that case," she said. "I don't know where that allegation comes from. It's never been alleged by the government."

Amaury Villa pleaded guilty last September in Florida to possession of stolen goods and conspiracy to sell stolen goods in connection with the Lilly drug theft. He is appealing the plea agreement while he awaits the theft trial. ___

TIPTON -- According to newly elected Rep. Susan Brooks, reducing the cost of Medicare is the biggest issue facing Congress. It needs to be fixed right away as a means to reduce the national debt, she said.

Brooks, R-5th District, visited with Tipton residents Thursday at the Pizza Shack to address national issues in her first visit to the community since taking office.

"A number of freshmen members from both parties believe Medicare and Social Security have to be changed in the future," she said.

Brooks said the House budget contains "a premium support option" that will give people the opportunity for private health insurance or traditional Medicare. She said the plan is to have the government pay for those taking the private insurance option.

Under this approach, Medicare enrollees would choose a private health plan and the federal government would pay a predetermined contribution to that plan.

"With reimbursement to doctors and hospitals being reduced, there is a concern that there will be a shortage of primary care physicians," she said. "There are 10,000 seniors rolling onto the Medicare roles daily."

Brooks said there should be needs-testing that ensures wealthy people are not forced to sign up for Medicare. Benefits should be based on fiscal need, she said.

"When it was created, they didn't expect people to depend on the program for their medical care," Brooks said. "There are not enough young people paying into the system."

Brooks said Congress is focused on the national debt, noting the "No Budget-No Pay" legislation was passed by the House and Senate.

"If each house didn't pass a budget, we wouldn't get paid," she said. "The plan to reduce the debt has to be balanced."

For the first time in four years, the Senate passed a budget. And now that both chambers have a spending proposal, the priorities are known, she said.

"We have to work together to reduce the debt," Brooks said. "Republicans don't want to raise taxes, and Democrats want to increase revenues."

She expects the vote to increase the debt ceiling not to take place until the end of May.

Brooks said when the sequester bill was signed, President Barack Obama never thought budget cuts would be implemented.

The $85 billion in cuts that took place earlier this year amount to 2 percent of the federal budget, she said.

"Across-the-board cuts were not a smart way to put them into place," she said. "We are now leaving it up to the administration of each agency to implement the cuts."

Brooks said there have been positive discussions between members of both political parties about tax reform.

"There will be a change of rates," she said. "It will include changes in how deductions are taken and will close loopholes. We're falling behind the rest of the world. We're losing our competitive edge."

She also expects legislation to be passed concerning immigration reform.

"We're waiting on the Senate legislation," Brooks said. "It may happen this session.

"Right now there are too many undocumented workers in the country that are not paying taxes and receiving benefits," she said. "We need to reform the guest-worker program because there are a lot of people that want to work in this country and return to their native country." ___

NEW YORK (Reuters Health) - For those who are able, exercising once or twice more weekly may alleviate some symptoms of a chronic pain condition without making joints feel worse, according to a new study.

Previous studies have found short-term benefits of exercise for fibromyalgia, a poorly understood disorder that includes joint pain, tenderness, fatigue and depression and affects an estimated 5.8 million Americans, according to the Centers for Disease Control.

But many fibromyalgia sufferers fail to keep up with exercise programs out of fear that it will worsen pain, Dr. Eric Matteson, a rheumatologist who was not involved in the study, told Reuters Health.

"This study shows that if they're able to stay with the exercise program in the long term it actually is helpful to them," said Matteson, chair of the department of rheumatology at the Mayo Clinic in Rochester, Minnesota.

As part of a larger study funded by the National Institutes of Health, researchers recruited 170 people who had been diagnosed with fibromyalgia, had been on medication for the condition for at least a month and reported low levels of physical activity.

Each person received a personalized aerobic exercise "prescription" based on their current fitness level, which usually meant walking around a track, according to lead author Anthony Kaleth, who designed the regimens.

Over three months the exercise programs gradually increased in intensity from twice weekly 10-minute sessions to up to four weekly 30-minute sessions of moderate exercise achieving 60 percent of maximum heart rate.

"It would be considered low to moderate intensity for the average individual," Kaleth, who specializes in exercise testing at Indiana University - Purdue University Indianapolis, told Reuters Health.

Over the three months of the program and for the next six months the participants reported their activity levels in a questionnaire.

Other questionnaires assessed how their fibromyalgia symptoms changed, including muscle impairment, overall wellbeing, pain levels and depression.

At the end of the study, 27 people said they'd sustained the exercise over all nine months, 68 increased their workout efforts for three months then decreased again and 75 were no more active than when they started.

The first two groups also reported less physical impairment and better overall wellbeing than those who did not increase their activity at all. A steady increase in intensity was linked to a slight decrease in pain, although a temporary bump in exercise was not. Depression levels did not change in any group.

"One of the best known therapeutic activities for fibromyalgia patients is exercise," Kaleth said. "Our study confirmed that result."

Any increase in activity, whether or not it was maintained, resulted in positive changes in symptoms and no increased pain, according to the findings in Arthritis Care and Research.

If they had followed the participants for a longer period of time, they might have seen more benefits for people who maintained the program, Kaleth said.

Most people use a combination of medications, including pain relievers, antidepressants and anti-seizure drugs to alleviate fibromyalgia symptoms. Doctors also recommend keeping active with walking, swimming or water aerobics, but many patients are reluctant to start exercising.

"They're more worried that it's going to be painful, but that's more of a psychological effect," Kaleth said.

Starting off too vigorously before building up endurance can be painful for anyone, with or without fibromyalgia, Matteson said.

"This is a stepping stone I think in terms of the actual result that we found," Kaleth said.

SOURCE: http://bit.ly/VQuyoP Arthritis Care and Research, online February 11, 2013.

Dr. Jake Chen

The Indianapolis bioanalytical CRO says its informaticians and medical scientists can accurately predict a drug’s potential and likely success in the approval process, said Dr. Jake Chen, company founder.

Pharmaceutical companies often don’t have the staffing to do the analysis themselves and need an outsourced partner. When they come to MedeoLinx for help, the company draws from a network of experts in applied mathematics, machine learning, bioinformatics, cloud computing, genome technology, and pharmaceutical research and development.

Each team collects and analyzes the big data in genomics, identifies the drug’s complex target network of inside cells, projects its likelihood of advancing to the clinical trial stage and predicts the drug’s maximum efficacy for treating a disease.
“We help companies when they have challenging drug efficacy and safety modeling problems. We make sense of the data and come up with solutions,” Chen said.

MedeoLinx’s clientele includes one of the Top 10 pharma firms, he said.
Chen is associate professor of informatics and computer science at Indiana University-Purdue University Indianapolis. He is founding director of the Indiana Center for Systems Biology and Personalized Medicine and founder of the Discovery Informatics and Computing Laboratory at IUPUI. He has designed GeneChip microarrays at Affymetrix in the Silicon Valley, Calif., and mapping the first draft human protein interactome at Myriad Proteomics Inc.

One of MedeoLinx’s most recent innovations is its drug companion diagnostic biomarker software suites, which combine advanced visual analytics, disease network biology and machine learning. Normal research methodology to identify cancer molecular biomarkers — single proteins or genes that show differential modification — can take 10 to 15 years before obtaining FDA approval, said Steven A. Ramos, MedeoLinx’s chief of operations. In the past 30 years, fewer than 20 cancer protein biomarkers have been accredited by the FDA for clinical use. MedeoLinx’s tool, Ramos said, can help customers discover and validate molecular “ensemble biomarker panels” with both high sensitivity and specificity.

MedeoLinx’s information technology takes advantage of microarray and next-generation sequencing data and cloud-computing-based mathematical signal processing software tools that can accelerate this process, Ramos said.

The approach helps drug companies come up with predictive models and create molecular profiles for patients. This information can identify patients most likely to respond to a drug and to have side effects from its use. This information, in turn, can help determine a drug’s chances of advancing to the clinical trial stage, Chen said. It also helps with repurposing.

The company also has patent-pending tools to help with “drug repositioning” — finding new uses for old or withdrawn drugs. These tools have generated lots of interest from overseas funds, Ramos said, and that promises to enable scientists at the FDA and drug companies to assess new or repurposed drugs for efficacy and side-effect profiles at the molecular level before extensive clinical trials.
“These tools help them make better go-or-no-go decisions,” Ramos said.

So far, pharmaceuticals — big and small — have been MedeoLinx’s primary focus, but Chen said the company is currently building relationships with insurance companies also.

“They have data that shows clinical pathology tests on patients, and information on drug treatment of those patients, and the long-term outcome of these patients,” Chen said, data that could be very useful in evaluating such things as expanding a drug’s potential success in other therapeutic areas.
Chen is also planning a trip to China to explore the building of a research institution in one of the country’s largest hospitals.

These new approaches to help clientele are a major reason why TechPoint, a statewide advocate for Indiana’s information technology sector, recently named MedeoLinx one of seven finalists in the Health Information Technology Excellence and Innovation category of the 2013 Mira Awards. It is MedeoLinx’s fourth consecutive year as a finalist.

Chen also is a finalist this year for TechPoint’s award for Technology Educator of the Year. Winners will be announced April 20.
MedeoLinx, which has its headquarters at the IUPUI Center for Innovation, won the Innocentive.com 2012 Cancer Systems Biology Grand Challenge. More than 1,000 entries competed to seek series of functional genomic data sets aimed at determining whether cancer could be prevented using an undisclosed drug.

MedeoLinx, which Chen launched in 2006, controls or has applications pending for five patents, and Chen said the company plans to apply for two more patents this year.

Diagnotes Inc

The Indianapolis startup is on the verge of launching a two-part strategy to enable on-call clinicians and physicians to provide care faster and to ensure the patient gets proper follow-up care.
Diagnotes Chief Executive Officer David Wortman says one component of the innovation, Diagnotes Mobile, uses a smartphone application to securely deliver patient medical information to on-call clinicians and physicians. After the doctor-patient encounter, Wortman says, Diagnotes Manager, a web-based tool, gets patient records updated promptly and ensures proper follow-up care. It also allows administrators and supervisors to track data related to on-call services, he said.
Diagnotes Inc. has a physical office, but in reality, its 10 employees — much like the app component of its on-call product — is largely mobile, Wortman said.
“Most of our efforts right now are going toward trying to commercialize,” he said.
Diagnotes Mobile and Manager won top honors last fall in two inaugural competitions in Indiana — the BioCrossroads New Venture and the Hoosier Healthcare Innovation. And just last week, Diagnotes learned it was one of seven finalists in the Health Information Technology Innovation and Excellence category of TechPoint’s 14th annual Mira Awards  for technology and innovation (winners will be announced April 20).
Wortman, who earned bachelor’s and master’s degrees in industrial engineering from Purdue University, remains involved in several other tech companies, including Spring Mill Venture Partners, Carmel; SonarMed, Indianapolis; and Akoya, Chicago. He knows of no other devices on the market that promise to do what his company’s device does.
“We believe it is unique and has a chance to change the way healthcare is delivered,” he said.
The product was tested last year at two Indianapolis hospitals, Community and St. Vincent, where the reaction to its functionality was enthusiastic and welcoming.
Dr. Ram Yeleti, a cardiologist and president of the Community Physician Network, had a hands-on experience with the product. He was on-call during the first night of the pilot program — a night with an inordinately high volume of on-call traffic — and the device did just what it was supposed to do, he said.
“The first night I had it, there were no major glitches at all,” Yeleti said. “I was really grateful to have it. It made my life a lot easier.”
Troy Reiff, chief operating officer of St. Vincent Seton Specialty Hospital, also tested the product. He said Diagnotes Manager “has the business intelligence to show the workload of clinicians and physicians. We get to see all the analytical data.”
This data helps verify physician claims of heavy workloads and confirm that they meet their obligation to provide care within contractually required time frames.
Diagnotes has a patent application pending for Diagnotes Mobile and Manager, and both hospitals plan to purchase when the product hits the market.
The company also disclosed in a securities filing that it has raised about $450,000 of an expected $1 million round.

Nussbaum, the chief medical officer and executive vice president, clinical health policy at WellPoint Inc. (NYSE:WLP), was referring to a study by the RAND Corporation which found that patients treated for asthma and other obstructive lung diseases get only half of the proper medical care. Speaking at the CED Life Science Conference in Raleigh on Wednesday morning, he also pointed to commonly cited statistics that 30 to 40 percent of healthcare spending is wasteful and inefficient.

Of course that’s part of the drive behind the Patient Protection and Affordable Care Act. And to do its part in this whole bit, WellPoint has led a push to tie payment for medical treatment to their demonstrated effectiveness, in much the same way that the government is tying Medicare reimbursement for physicians and hospitals to outcomes.

Here’s a skeletal look at how it does that, according to Nussbaum. At the core of every decision is not cost but scientific evidence. For drugs, that’s a two-step process.

“There are about 30 physicians and scientists and practicing physicians, none of whom are employed by WellPoint, who actually review the science,” Nussbaum said. They designate certain medicines for certain conditions.

Then drugs are reviewed by the Value Assessment Committee, which looks at clinical trial data and comparative effectiveness to determine their clinical value. “It involves looking at the overall cost of a treatment, looking at a treatment beyond a specific drug, and its adoption by patients in the real world setting,” he said.

The idea is that before WellPoint is willing to invest in new technologies, it needs to know the impact of the technology. But is it getting all of the data on which it bases those decisions?

There are a few ways. Several years ago, the insurer bought an outcomes research company called HealthCore through which it collaborates with a string of universities to evaluate effectiveness of treatments. That company also helped develop the Sentinel System with the FDA to track the safety of drugs, biologics and medical device once they’re approved. And, WellPoint has been working with IBM to use its Watson technology to help determine best treatment options.

Moving forward, WellPoint’s philosophy is to pay only for quality and performance. “If a treatment is truly superior, let’s embrace it and let’s make sure everyone can get that treatment,” Nussbaum said. “If it’s comparable, then let’s look at the value and the affordability versus the outcome. If it’s personalized, we need to invest in that future. And if it’s ineffective, let’s stop doing it.”

And while it does that, the insurer with 34 million customers is also putting a priority on keeping patients in the loop. “All of our policies – we’re very transparent about this – are available on our website,” Nussbaum added. “We give detailed rationale behind them, we invite participation and comment. Ultimately, these policies need to be reviewed frequently because science changes.”

Midwest VC firm Allos Ventures has $40 million in tow and is looking to use it to back a handful of emerging technology companies in the region.

Allos’ recently closed second fund will follow the path of its first by targeting early-stage companies in high-growth sectors, namely software and technology-enabled business services, specialty healthcare providers, later-stage medical devices and diagnostics, and advanced manufacturing, since that’s where the fund’s directors have the most experience.

Those directors are Don Aquilano, John McIlwraith and Dov Rosenberg, all principles from Cincinnati VC firm Blue Chip Venture Co. They spun off and created their own firm in 2010 to specialize in early-stage investments in companies that have raised seed money from friends and family or angels and are ready for their first round of institutional capital.

Companies they’ll consider are ones with a validated product or service that are generating revenue but are still a year or so from profitability. In terms of location, Allos likes its portfolio companies to be within driving distance of its offices in Cincinnati and Indianapolis – so, generally somewhere between Chicago, Nashville, St. Louis and Pittsburgh. Allos also likes to lead or co-lead rounds between $3 million and $6 million, with initial investments of about $2 million.

Although the team won’t invest in pharmaceutical or biotech companies, McIlwraith said health technology is one big area of interest. “We absolutely focus on healthcare IT, and what we would call technology-enabled business services,” he said. “That’s a horizontal, but one of those verticals within it would be business services in healthcare space.”

With its $11 million first fund, the team invested in four companies, including Cincinnati-based AssureRx Health, a bioinformatics company that develops tests to help doctors pick the right psychiatric drugs for patients based on their genes.

And although medical devices aren’t a likely fit to meet the firm’s investment criteria, they aren’t an automatic no. “If it’s a medical device, it would have to be a fairly unusual combination of late-stage, low capital need and low-risk,” McIlwraith said.

As part of Blue Chip, McIlwraith has invested in a number of health-focused companies including Medhost (sold to HealthTech Holdings in 2010), Renal Solutions (bought by Fresenius Medical Care in 2007) and Endocyte.

Other companies in Allos’ portfolio include BidPal, which builds technology to help non-profits run their events and fundraisers; IT infrastructure company Scale Computing; and WebLink International, which makes web-based software for professional associations and their members.

[Cincinnati photo from Flickr user savrae]

When it comes to entrepreneurial hubs and good places to start a business, reports that name Silicon Valley and Boston as technology and healthcare clusters are only telling part of the story.

Those places may have the greatest volume of health and technology companies, but from another angle, cities like Salt Lake City, Utah, and Indianapolis, Indiana, may have just as many advantages.

The Ewing Marion Kauffman Foundation took a different approach to identifying entrepreneurial clusters and plotted the geographies of companies on nearly 30 years’ worth of Inc. 500 lists to identify areas where the fastest-growing, privately held companies are located.

In a series of reports called The Ascent of America’s High-Growth Companies, the foundation notes that while many high-growth companies were located in Austin, Boston and Silicon Valley, cities like Salt Lake City, Indianapolis, Raleigh and Buffalo have been home to similar volumes of fast-growing companies over the past three decades. And while most states’ “Inc. scores” remained relatively flat over three decades, Washington, D.C. and Utah became especially fruitful in terms of growing companies.

What’s also interesting about the findings is the startlingly low number of health companies that have been named to Inc.’s list. If you look at the 2012 list, only 35 of the top 500 companies (7 percent) are health-related. Maybe that’s partly due to the slower growth of traditional life sciences companies.

To see the entire series of reports, click here.

[Map and infographic from Ewing Marion Kauffman Foundation]

“The Markov Decision Processes and Dynamic Decision Networks enable the system to deliberate about the future, considering all the different possible sequences of actions and effects in advance, even in cases where we are unsure of the effects,” said Casey Bennett, a doctoral student at IU’s School of Informatics and Computing, in a university release.

The non-disease-specific AI system created by Bennett and Kris Hauser, an assistant professor of computer science, was recently put to the test in a study using electronic health record data from 500 patients with clinical depression. By comparing the real outcomes and costs associated with the 500 cases to the hypothetical models their computer algorithms generated, they estimated that AI could improve patient outcomes by 30 to 35 percent.

“Modeling lets us see more possibilities out to a further point, which is something that is hard for a doctor to do,” Hauser said in a statement. “They just don’t have all of that information available to them.”

But the researchers don’t think the kinds of frameworks they’re developing will ever be able to actually replace doctors. “We believe that the most effective long-term path could be combining artificial intelligence with human clinicians,” Bennett said. “Let humans do what they do well, and let machines do what they do well. In the end, we may maximize the potential of both.”

Read the entire study published in a January edition of the journal Artificial Intelligence in Medicine.

[Photo from Wikipedia]

A new initiative headed up by the Indiana Department of Labor is calling some attention to safety in healthcare facilities. Not patient safety though. It’s engaging businesses, labor and trade associations and schools to spread the word about best practices for healthcare worker safety.

In the state, the rate of injury and illness among healthcare workers is the second highest of all industries. It’s even higher than the rates in manufacturing and construction. While that may not hold true nationally, cases of workplace injury and illness in healthcare are among the highest of any sector.

The most common culprits? Muscle sprains, strains and tears; falls; workplace violence; incidental needle sticks and exposure to blood-borne pathogens.

The first collaborator on Indiana’s initiative is Union Hospital in Terre Haute, which recently reduced lost work time by 84 percent. It did so with continual safety and best practice education for staff, but also with evaluations of equipment, tools and staff behaviors, including the use of devices to prevent employee injuries like those caused by lifting patients.

Musculoskeletal injury, especially to the back and neck, among healthcare workers has actually inspired quite a bit of innovation among medical device makers across the country. For example, to reduce the risks associated with patient lifting, companies have created a wide range of mobility devices, including portable patient lifts and automated patient transfer devices.

Another type of occupational injury, needle sticks, has also inspired a broad range of innovative products. Various kinds of safety syringes have come from the likes of BD and Minnesota’s Protectus Medical. Revolutions Medical, SafeShot Technologies and Globe Medical Tech also make one-handed, autoretractable syringes. Additionally, the quest for a needle-free injector has also seen quite a bit of activity lately.

But a syringe is only one way needle sticks occur. Other products, like Tangent Medical’s and B.Braun’s closed-loop catheter systems, are hoping to make catheters safer for patients and healthcare workers. And, just recently, the New Jersey Health Foundation issued a grant to a surgeon to develop puncture-resistant gloves for surgery using a flexible, thin material.

What other companies or groups are making the workplace safer for healthcare workers? Share them in the comments or on Twitter @medcitynews.

In April 2012, Golden LivingCenters became the first post-acute health care provider to join the INPC. Recently, the Indiana Health Care Association interviewed Golden LivingCenters to find out how this new technology affects their work.

IHCA: What are some of benefits to your staff?

GL: In the past, when we took a new patient [from a hospital], we might only have records about what sent that patient to the hospital this time. Maybe she fell and fractured her hip. Now we can see that she’s been hospitalized 10 times in the last five years. With INPC we can manage the long term underlying diagnoses. If we don’t, patients may end up back in the hospital because we haven’t really addressed the root cause of the hospitalization. Think of it like a picture. With INPC we have the whole scrapbook of a patients life, not just the snapshot of what brought them to Golden LivingCenters today. The INPC gives us a much more holistic way of taking care of our patients.

Let me give you an example. One woman came to one of our centers with a hip fracture. When we pulled up her information, we saw that she’d had four hospitalizations in the last two years, all brought on by high calcium levels. As caregivers, we knew to run frequent calcium level tests. Had we not known this, her calcium levels would have gone up and she would probably have gone into kidney failure. Instead, we managed her calcium levels and she was able to stay in our center and continue rehab instead of ending up back in the hospital.

IHCA: How does the INPC help Golden LivingCenters work more effectively with hospitals?

GL: We had a resident who had been with us some time. To her, the living center was “home.” When her cancer worsened. she was hospitalized. Because of the INPC, we could follow her tests and procedures in real time. We saw that they were putting a chest tube in her, but our center didn’t have much experience with that type of chest tube, so our education director and unit manger went to the hospital to receive training on it. She wanted to return to the living center; we were able to bring her back and make her comfortable in her last days because we were able to see what was going on through INPC.

IHCA: So using INPC improves communication between hospitals and your living centers?

GL: Absolutely. We can see procedures. lab tests and notes from physicians so that we are ready to care for a patient when he or she is discharged. There is wonderful cooperation between Golden LivingCenters and area hospitals because the hospitals know we are willing to be educated on how to best care for our patients. This willingness decreases hospitalization days and gets patients more quickly back to our centers, which is where they want to be.

IHCA: So INPC improves your ability to care for your patients – does it improve the hospital’s ability to care for them as well?

GL: Yes. Once one of our patients goes to the hospital, we can let the floor nurses know that there is information on that patient in INPC. The nursing staff can know the patient’s normal habits – read dietary notes, activity levels – so they can provide better care, make that person more comfortable and be alerted to abnormal behavior. In the past. the hospital staff may have only had the SBAR (situation, background, assessment, response). Now,the SBAR alerts the ER doctors that there is Information in the INPC on this person, making continuity of care so much better.

IHCA: So how does it work? How user-friendly is it?

GL: When you put in a patient’s name, you will first see all the hospitals and facilities – any place that has electronic information on that patient – available for you to look at. You can choose to view all patient records, or those from a particular facility. Then there’s a sidebar menu to choose from: lab results, admission and discharge summaries, cardiology notes, radiology notes. and an information sheet on the patient. You can look at notes by topic or in chronological order. You can click to read a doctors note on a particular procedure or test. Every medical record of that patient in Indiana since records started being electronically recorded is there at your fingertips.

IHCA: So what are the environmental benefits of using INPC?

GL: The amount of paper saved is staggering. In addition, it improves patient privacy and record accuracy. Before, we may have had a complete chart pionted out – discharge sum manes, labs, etc that can get lost or slipped into someone else’s chart. We no longer have pieces of paper that can be displaced or lost.

IHCA: How does using INPC benefit you financially?

GL: It’s too early to tell what the reduction will be in the cost of supplies and redundant laboratory tests, but we expect to see significant reductions If you are operating in silos, it’s not unusual to repeat tests. That not only increases cost. but means additional (and unnecessary) needle sticks for the patient.

IHCA: Thanks so much for sharing your experience with us. Is there anything else you’d like to say to other living centers?

GL: Just do it. Begin where you are. Then you can continue to build upon your electronic health record. You will find that by having more efficient and better data from the onset, you will be able to provide the right care in the right place at the right time, reducing hospitalizations and improving the experience of the patient, which, after all, should be our top priority.

Interview conducted by Lise Caldwell and published originally in the Fall/Winter 2012 Indiana Health Care Association Newsletter.
[Image from flickr user Official US Navy Imagery]

A few years ago, Purdue University speech scientist Jessica Huber had the idea that the same effect could have applications in addressing speech disorders, particularly those associated with Parkinson’s disease.

As many as 90 percent of the estimated 1 million Americans with Parkinson’s disease experience hypokinetic dysarthria, a series of changes to speech that can include a reduction in the volume and clarity of their voice and changes in the speed at which they talk. Many of them, as a result, turn to speech therapy.

The idea of using the Lombard Effect to help these patients has been around for years, and one company has even developed an app for PD patients that uses it. But Huber has taken the idea and turned it into a device that’s being commercialized at the Purdue Biomedical Technology Incubator with the hope of helping PD patients improve their speech without training or behavior modifications.

The SpeechVive device, which sits in the ear and looks similar to a Bluetooth headset or a kind of hearing aid, is activated by an accelerometer that touches the area behind the ear. Vibrations that occur when people talk trigger the start of gentle background noise that sounds similar to people talking in a crowded restaurant. That, in turn, causes the person wearing it to involuntarily increase the volume and clarity of their speech.

In an initial clinical study in 38 Parkinson’s disease patients, all of them experienced improved speech by talking louder, articulating better or normalizing their speech rate when wearing a prototype of the device, said Steve Mogensen, managing director at the Purdue BTI.

Since then, a team at the incubator has worked with an industrial design firm to take that prototype and create a more commercial-ready device (as shown in the photo above). Now, Mogensen said, they’re in the process of validating all of the technology in another study being conducted at Purdue, James Madison University and the University of Florida.

The next step, he said, is manufacturing. SpeechVive is a Class I medical device exempt from 501(k) clearance, so there won’t be any holdups there. Mogensen said a contract manufacturer is in place to produce the first 500 devices, which could be ready by this summer.

Early work on the project, before it was brought to Purdue BTI, was funded mostly through grants. The incubator works with faculty to provide financial, development and business assistance in bringing intellectual property from Purdue to the commercial market.

[Photo from Purdue BTI]

Energy drinks are in the news again this week as members of Congress call on the companies that make them to provide data about their ingredients and marketing claims. But this isn’t a new conversation. In fact, it’s one that’s been going on for more than 10 years now. And it’s one example of an information gap that a new digital health company is hoping to fill.

“We’ve been talking about this for years, but it’s not getting done,” said Neil Thanedar, a former product safety lab owner and CEO of LabDoor Inc. “No one’s come out and given us data. One of the things we can do is lead that charge.”

Today, LabDoor is launching a mobile and Web application to help consumers make sense of advertising claims, safety labels and ingredient labels on supplements — and eventually, on over-the-counter medicines too.

Thanedar used to run a U.S. Food and Drug Administration-registered product safety lab that did quality and safety testing on these kinds of products. He saw that the data his team was producing would be useful to consumers but never got to them. So he sold the company and launched LabDoor in Indianapolis. Last fall, the company relocated to San Francisco to participate in Rock Health’s fourth incubator class.

The first version of LabDoor’s app includes 7,000 vitamins, protein powders, energy drinks and other nutritional supplements. Thanedar’s team of co-founders spent months curating original and existing lab research, plus existing government reports and peer-reviewed medical studies on those products and their active and inactive ingredients.

To turn that scientific information into something that consumers could use, they built an app that uses proprietary data algorithms to crunch that data and assign products a letter grade from A to F, plus a score for ingredient quality, clinical efficacy, regulatory environment and label accuracy.

“Building a mobile app should take a few months, but we took almost a year to put out our first product,” he said.

Similar to GoodGuide, Fooducate and the Consumer Reports mobile app, LabDoor lets shoppers use their smartphone to scan a product’s bar code and bring up its profile, which contains the ratings, plus product reviews and a way to search for similar products. Users can also scan products they’d like to see reviewed into LabDoor’s database.

Future iterations of the app will really hit the sweet spot by including over-the-counter drugs that comprise a $17 billion market. It would allow drugstore shoppers to compare, say, Claritin with the other allergy medicines they’d find on the shelves next to it. The app is free to consumers, so LabDoor makes its money by providing some of the data it generates and curates to retailers for quality control purposes.

So far, the company has raised a $350,000 seed round from Aberdare Ventures, Kleiner Perkins Caufield & Byers, Mayo Innovation Fund and Mohr Davidow. Thanedar said his short-term goals include building out new business partnerships and raising a new round of capital.

[Screen cap from LabDoor]

Indiana’s life sciences industry has a $50 billion total impact on the state’s economy, according to recently updated data gathered by the Indiana Business Research Center at the Indiana University Kelley School of Business and BioCrossroads, Indiana’s initiative for investment, development and advancement of the state’s signature life sciences strengths.

Now with a workforce of 55,000 people at nearly 2,000 companies in the areas of drugs and pharmaceuticals, medical devices and equipment, agricultural chemicals and feedstock, medical, research and testing laboratories and biologistics*, Indiana is ranked as one of the top five states in the life sciences industry – based on the highest number of employees in the sector, the highest number of companies and the highest concentration of employees (BIO/Battelle State Bioscience Industry Development Report 2012).

Indiana’s life sciences exports totaled $9.3 billion (one-third of Indiana’s total exports), ranking as the third highest in the United States, behind only California and Texas.

These companies are also continuing to discover and commercialize new products. There were 489 patent filings for life sciences-related innovations in 2011, and 173 new products approved by the U.S. Food and Drug Administration.

“These statistics just continue to get better for us, and demonstrate across the board that the life sciences are a robust industry and a valuable driver of Indiana’s economic growth. It is imperative that we continue the momentum, and BioCrossroads has several initiatives in progress to capitalize on our unique strengths,” said David L. Johnson, president and CEO of BioCrossroads. “These data elevate Indiana to the same company as America’s other world-renowned centers of healthcare innovation: Massachusetts, California, North Carolina and New Jersey.”

Other key findings:

• Indiana’s life sciences venture capital investments rose in 2012 to $64.7 million.
• The average annual wage for a life sciences worker is now $88,504, compared to $40,272 for the average private sector wage.
• Indiana life sciences workers earn nearly $5 billion in annual wages.

Indiana is home to the global headquarters for: Biomet, Cook Medical, DePuy Orthopaedics, Dow AgroSciences, Eli Lilly and Company, WellPoint, and Zimmer and the North American headquarters of Roche Diagnostics; Beckman Coulter, Boston Scientific, Covance, Express Scripts, Mead Johnson, and Medtronic have major operations located within the state.

BioCrossroads’ 2012 annual report which includes this information is available at www.biocrossroads.com

Unless otherwise noted, the most recent statistical data is from 2011.

Source: BioCrossroads/Indiana Business Research Center.

*Biologistics is a new sub-sector that BIO/Battelle added in their State Bioscience Industry Development Report 2012. BioCrossroads included biologistics as a new sub-sector for the 2011 data represented within this news release.

Live tweeting a surgery isn’t exactly a novel social media tactic anymore. Since 2009, dozens of hospitals have narrated procedures with 140-character tidbits, from hand transplants to hysterectomies.

So it wasn’t particularly earth-shattering that Elkhart General Hospital live tweeted a partial knee replacement surgery yesterday. Ohio State University Medical Center tweeted a knee replacement surgery back in June of 2011, and I’ve followed others’ live tweets that were much more interactive.

But we’ve been writing so much about the growing number of joint replacement surgeries, and how hospitals and medical device companies are trying to figure out how to make surgery more efficient, that I couldn’t help but take interest in EGH’s live tweet through the 45-minute procedure.

It’s a relatively small hospital system, but its communications team did an especially good job of sharing relevant, nonsquirm-worthy photos and giving an up close look at some of the technology used during these procedures, like the Oxford Partial Knee implant distributed by Biomet and barbed sutures.

Check out some of the highlights below.

]]> http://medcitynews.com/2013/01/indiana-hospital-gives-twitterverse-a-front-row-seat-in-the-or-for-a-partial-knee-replacement/feed/ 0 http://medcitynews.com/2013/01/investors-have-put-15-5m-behind-this-cancer-drug-startup-reviving-a-shelved-hsp90-inhibitor/ http://medcitynews.com/2013/01/investors-have-put-15-5m-behind-this-cancer-drug-startup-reviving-a-shelved-hsp90-inhibitor/#comments Thu, 10 Jan 2013 20:14:35 +0000 Deanna Pogorelc http://medcitynews.com/?p=184458 A cancer pharmaceutical startup called Esanex generated lots of reader interest back in May when it began raising a $15 million round.

The latest U.S. Security and Exchange Commission filing from Esanex (in December) shows that the round was completed with $15.5 million, and today, the Indiana Seed Investment Fund II said it participated in Esanex’s series A with a $500,000 investment.

Managed by life sciences trade group BioCrossroads, the fund has $8.25 million to invest in early stage companies. A statement from BioCrossroads explains that Esanex will put the investment toward a phase 1 study of its oncology drug in patients with solid tumors as well as multiple phase 2 studies.

Here’s what we’ve learned about Esanex since May: It’s apparently a resurrection of Serenex, a North Carolina-based cancer drug company that was acquired by Pfizer in 2008 when it was in phase 1 development. Several former Serenex executives appear to be involved in Esanex and in regulatory filings, Esanex lists its business address as the office of Lilly Ventures, a former Serenex investor. Life sciences investor Intersouth Partners, another Serenex investor, also lists Esanex as a portfolio company.

The drug they’re working with is SNX-5422, an experimental drug that “deactivates” the ability of tumor cells to survive and grow by blocking Hsp90.

Hsp90 is a molecular chaperone protein that guides the integration of many key cancer-causing proteins within cells. It’s been an attractive target for cancer researchers, but one that’s been difficult to capitalize on because of side effects associated with the impairment of normal cellular function. Apparently, Pfizer shelved Serenex’s drug due to ocular toxicity in canine studies. Similarly, AstraZeneca returned the rights of two Hsp90 inhibitors it was developing to their original owner, Infinity Pharmaceuticals, in 2008, and Bristol-Myers Squibb halted development on tanespimycin in 2010.

But the climate for Hsp90 inhibitors today may be more amenable than it was just a few years ago. Last year, Novartis presented results from phase 1 and 2 studies that found its candidate, AUY922, had an acceptable safety profile and produced “manageable” side effects. Swiss company Debiopharm is also developing an Hsp90 inhibitor, Debio 0932, and delivered positive safety results in a study last year.

It appears that Esanex has acquired the rights to SNX-5422 and is preparing to take it to phase 1 safety trials in patients with blood cancers and solid tumors.

It’s one thing to read about companies developing amazing medical technologies, but it’s a completely different thing to actually see them in use.

Pauline Tam, a writer for Postmedia News in Canada, apparently got to sit in on a minimally invasive brain tumor removal performed by renowned surgeon Dr. Amin Kassam at The Ottawa Hospital. In a piece called “Journey Inside the Mind,” she recounts the procedure in stunning detail.

During his 12-year tenure at University of Pittsburgh Medical Center, Dr. Kassam was instrumental in pioneering novel techniques in neurological surgery, including the Expanded Endonasal Approach. In this case, he uses a different technique called “the brain port,” which reportedly only a handful of surgeons in the world have the tools and expertise for.

Before the procedure, scanners and imaging software translate information from MRIs into coordinates that help Kassam determine the precise location of the tumor. Then, through a dime-sized hole in the skull and a portal called the BrainPath (made by NICO Corp., an Indiana company we’ve written about on a few occasions), Kassam is able to insert various tools to shave and suck up pieces of the tumor. Meanwhile, navigation software and an instrument tracker that uses sensors embedded in a mask placed on the patient’s face guide him through a carefully calculated path to the tumor – like a GPS.

Perhaps most interesting is that Tam makes note of a dozen people in the room, including software designers and engineers from various equipment makers. Truly, innovation in action.

Lysomics founder Norb Wiech with students.

Ara Parseghian is most known for his 11-year run as coach of the University of Notre Dame football team, which went 95-17-4 while he was coach and won two national championships. But in his post-football life, Parseghian has created a legacy even more meaningful.

The former coach (and former Cleveland Browns player) founded the Ara Parseghian Medical Research Foundation, which supports work toward a cure for Niemann-Pick Type C, a lethal neurodegenerative disease that struck his three youngest grandchildren.

The rare disease is caused by genetic mutations that make the body unable to transport cholesterol and other lipids in and out of cells properly, which results in a buildup of lipids in the liver and the brain that initiate neurodegenerative processes.

There are currently no treatments for the disease in the U.S. Actelion Pharmaceuticals’ drug Zavesca is approved in Canada and Europe to slow the progression of Type C, but it was rejected by the U.S. Food and Drug Administration in 2010 with the request for more data.

The foundation has brought awareness to the disease and has inspired collaborative work among several universities including Notre Dame, said Norb Wiech, the founder of Lysomics LLC.

Wiech, himself a Notre Dame alumnus, founded Lysomics in 2010 to bring some of that research out of the lab and into the clinic. The startup is developing a treatment based on the work of Notre Dame researchers Olaf Wiest and Paul Helquist, and Frederick Maxfield of Cornell University’s Weill Medical College. They identified a class of compounds called histone deacetylase inhibitors that demonstrated the ability to correct the cholesterol issue in the lab.

Lysomics is commercializing an FDA-approved small molecule anticancer drug in that class called vorinostat (marketed by Merck under the name Zolinza) for treatment of NP. Wiech has met with the FDA and is doing preparation work for an Investigational New Drug application. According to Notre Dame, clinical trials could start as early as next year.

That is if the company can find funding. Orphan drug development is so challenging because, while the National Institutes of Health and foundations will fund discovery research, the next stage is not an academic exercise. “That’s one of the big gaps for some of these diseases: they’re so small that companies can’t find any sponsors because people aren’t sure it will be able to recover their money,” Wiech said.

The trials won’t be that expensive, relatively speaking, because they will be so small (the total number of children with Type C in the U.S. is estimated to be less than 200). And because the drug has been through clinical trials and has already been used in a small number of pediatric patients, Lysomics will be able to save about a year’s time by starting in late phase 1/early phase 2. So, Wiech said he thinks benefactors and angel investors, not VCs and Big Pharma companies, are the most likely targets for funding.

Then there’s the issue of what the drug will actually be able to do. A true cure for NP would involve gene therapy and the reversal of neurological damage, which researchers aren’t yet able to do. But if the treatment were given to patients at an early enough stage, Wiech thinks the drug could slow or stop the progression of the neurodegeneration and improve the quality of life for the patient and the parents.

That brings up another challenge. In the most quickly progressing cases, the first signs of neurological damage become apparent in early childhood. These are the children who could most benefit from the drug. “Starting a drug treatment at such an early age is really a quandary for FDA [...] because it’s an age when the body is growing rapidly and any drug could interfere with growth,” Wiech said. So the FDA is very cautious — and rightfully so. “I think there’s a tremendous awareness of respect to the patient,” he said.

So he’s working carefully to iron out the design of the clinical trial, working with the FDA to determine the best endpoints to measure and how to best work within the guidelines to demonstrate safety with such a small population of patients.

“In part, the degree of rareness is because it’s so lethal,” Wiech explained. “Ninety percent of those who have it do not live beyond their teenage years.”

[Photo from Notre Dame newswire]