The Congressionally Directed Medical Research Programs (CDMRP’s) issued annually by the Department of Defense, are an excellent source of funding for several key areas of research ranging from ALS, through various Oncology programs to Multiple Sclerosis.

Awards up to $400,000 for Autism Spectrum Disorders(ADS) are the latest opportunities to be issued by the CDRMP. Pre-applications are due June 20th, 2012. 

The FreeMind Group has extensive experience in assisting clients in completing and winning such complex and competitive proposals. Through our methodical and proven professional process we will guide your efforts through to submission and subsequent award.

Idea Development Award

Funding: $400,000 for direct costs (plus indirect costs) for up to 3 years

Pre-application: (required): June 20, 2012

Full Application (upon invitation): September 20, 2012

Scope: Supports the development of innovative, high-impact ideas that advance the understanding of autism spectrum disorders (ASD) and lead to improved outcomes.

Applications in the following areas are encouraged:

• Improved sub-grouping of individuals with ASD to inform the mechanisms, natural history, and response to treatment (e.g., biomarkers, risk factors, sex ratio).
• Identification of therapeutic targets, excluding new gene discovery.
• Psychosocial research across the lifespan, including  influences in brain function/structure.
• Co-morbid conditions across the lifespan, especially sleep disorders and gastrointestinal issues.

Preliminary data are required. Clinical trials are not allowed.

  For more information

Pilot Award 

Funding: $100,000 for direct costs (plus indirect costs) for up to 2 years

Pre-application (required): June 20, 2012

Full Application (upon invitation): September 20, 2012

Scope: Supports conceptually innovative, high-risk/high-reward research that could ultimately lead to critical discoveries or major advancements that will drive the field of ASD forward.

Applications in the following areas are encouraged:

• Improved sub-grouping of individuals with ASD to inform the mechanisms, natural history, and response to treatment (e.g., biomarkers, risk factors, sex ratio).
• Identification of therapeutic targets, excluding new gene discovery.
• Psychosocial research across the lifespan, including  influences in brain function/structure.
• Co-morbid conditions across the lifespan, especially sleep disorders and gastrointestinal issues.

Preliminary data not allowed. Clinical trials are not allowed. Not intended to support the continuation of existing studies or the next logical extension and/or incremental step.

For more information

For additional information please contact Hannah Rosencweig at:

(617) 648-0340, hannah@freemindconsultants.com

Best regards,

Ayal Ronen
Vice President
FreeMindGroup

www.freemindconsultants.com

Why Exhibit at BIO?

BIGGEST VALUE EXHIBITORS RECEIVE

The BIO Exhibition proves to generate new business with the global industry at your fingertips. It’s where participants create partnerships, showcase new innovations and products, network, and much more.  Of the many important values in attending the BIO Exhibition, global networking was the single greatest in 2011. For more information on who exhibits and attends the BIO International Convention, click here.

We are looking forward to being there and invite Montana organizations to participate.   There are endless opportunities available – including one on one meetings with potential partners.   We have two full conference passes available with the booth and 10 exhibition passes.    It is a few days of fascinating speakers and something going on every minute.  Please let me know if you are able to attend.  And know that I will be contacting you to send promotional  information for the booth to Boston.  Take a look at the website www.convention.bio.org and view the huge list of attendees and programs.

2.  We are in the process of writing our spring/summer newsletter and need articles/employment opportunities –  anything that is going on with your organization – Please plan to get those to me by next  Thursday if possible.  We are working with Alpha-Graphics in Billings and they have updated our website and facebook page.  Please check on those often and Like us on Facebook.

3.  Save the date for our annual meeting.   The meeting will be in Bozeman on August 28.  We are working with Innovate Montana to coordinate the days events.    More information to follow.

Written by
AMIE THOMPSON

Research is the key to ending Alzheimer’s disease, and the McLaughlin Research Institute in Great Falls is doing some of the leading research in the world on the disease.

From testing on mice models to administering clinical trials on Alzheimer’s patients, Great Falls is progressive in its attack on the disease.

“The McLaughlin Research Institute is working on the basic science of it in mice, and I’m working on clinical trials in people,” said Great Falls neurologist Dennis Dietrich, who is the only doctor in the state currently enrolling patients in Alzheimer’s clinical trials. “I’m on one end and McLaughlin is on the other. Both are critical to advance medical science and develop new treatments.”

One of the most exciting revelations researchers have uncovered is the link between various diseases.

“Everything is coming together,” said McLaughlin Director George Carlson. “They are all caused by misfolded proteins.”

McLaughlin has evolved into a degenerative brain disease institute, Carlson said. And not only could the research specific to Alzheimer’s disease be the key to unlocking its mystery, so could the research from a whole class of deadly brain diseases the institute is studying, including prion diseases, Parkinson’s and Huntington’s disease.

These diseases start in one area of the brain and spread to the rest. Now that scientists know these misfolded proteins spend part of their time outside of cells — traveling from one cell to another — new drugs can target them there. This could help prevent or at least block the progression of these diseases.

“Aggregated protein causes the normal protein to misfold and spread from cell to cell,” Carlson said.

Research breakthroughs on any of these diseases could offer the missing puzzle piece to Alzheimer’s, or at least lead scientists toward a treatment that could delay the onset of Alzheimer’s.

While scientists and doctors ultimately want to find a cure for this disease that affects 5.4 million people in the United States, delaying the onset of Alzheimer’s would be a huge step in the right direction.

Delaying the onset of this disease, which is the sixth-leading cause of death in the United States, could drop the numbers of those ever affected as many people may reach the end of their lives before symptoms emerge.

Nearly half — 43 percent — of Americans older than age 85 suffer from Alzheimer’s, which is the most common form of dementia.

Delaying the disease also could greatly reduce health care costs.

“The research that leads to a treatment that would delay Alzheimer’s by five years would cut government spending for Alzheimer’s disease by 45 percent by 2050,” said Suzanne Belser, executive officer of Alzheimer’s Association Montana.

Looking at the growing number of dementia patients in Montana’s nursing homes and assisted-living facilities is worrisome, Dietrich said. Few people are wealthy and able to pay privately, some are poor and their care is paid through Medicare and Medicaid programs, while others pay with long-term care insurance.

“You’ll spend $60,000 to $80,000 a year (for a care facility). There are very few people who can afford it,” he said.

And with fewer people paying into those programs as the large numbers of baby boomers hit retirement age, “something has to give,” he said.

A lack of funding is slowing research.

Belser said the United States spends far less on Alzheimer’s research than other diseases.

About $6 billion was spent on cancer research, $4 billion on heart disease research and $3 billion on AIDS research in 2011, Belser said. Approximately $480 million was spent on Alzheimer’s research.

Change may be coming, however.

The Alzheimer’s Association, which is the leading global voluntary health organization in Alzheimer’s care and support, and the largest private, nonprofit funder of Alzheimer’s research, spearheaded a national push that is leading to more funding.

The Obama administration recently released a draft national plan to address Alzheimer’s disease, which included $130 million in new funding for Alzheimer’s research over the next two years.

Belser will go to Washington, D.C., this week to lobby for several U.S. House and Senate bills aimed at increasing the commitment to and funding for Alzheimer’s research, and expanding diagnosis of the disease.

Currently, the diagnosis of Alzheimer’s relies largely on recognizing memory loss. Typically, a loved one notices the patient has been making out-of-the-ordinary decisions. By the time the patient sees a doctor and is diagnosed, there already has been significant brain damage.

“If we have a treatment to slow down the disease, when would you want to start it?” Dietrich asked. “Before the signs are obvious.”

Researchers hope a biomarker can be found that would serve as an early indicator of the disease, much like high cholesterol can indicate increased risk for coronary heart disease. They are working to “validate” a biomarker, which means it needs to be confirmed by multiple studies in large groups of people.

Current research is working toward identifying biomarkers using several tools, including brain imaging, levels of proteins in cerebrospinal fluid, levels of proteins in blood and genetic risk profiling.

There isn’t a treatment available to slow or stop the deterioration of brain cells in Alzheimer’s disease, but the U.S. Food and Drug Administration has approved five drugs that lessen symptoms and improve daily functioning for six to 12 months, but do not prevent the disease progression.

There also are about 100 experimental therapies in clinical testing in human volunteers across the world, according to the Alzheimer’s Association.

Carlson said once family members complain about dementia in their loved ones, it is less likely that newly developed therapies will be successful. Brain changes in those with Alzheimer’s are thought to begin 10 years or more before the appearance of symptoms such as memory loss, according to the Alzheimer’s Association.

Another research obstacle is a lack of trial participants.

“It’s easy to get approval for Alzheimer’s patients, but it’s too late,” Carlson said.

However, people who have a family history of three rare familial forms of Alzheimer’s have helped researchers.

In these trials, the drugs can be given to patients who know they carry the tainted gene but haven’t yet displayed symptoms.

A Colombian family of more than 5,000 people is among those involved in research.

The hope is that researchers will find a drug that will work on familial forms of the disease and it also will work on the sporadic, more common form of the disease, Carlson added.

He said the McLaughlin Research Institute made its first mouse model to research Alzheimer’s in 1988. These transgenic mice express a faulty human gene, called APP, which is a cause of familial early onset Alzheimer’s. There are several mouse models in labs across the world, all mimicking Alzheimer’s, but the disease behaves differently in mice and humans, Carlson said.

Human brains with Alzheimer’s first develop beta-amyloid plaques, followed by tangles that lead to the death of brain cells. The APP mice don’t develop tangles.

“These Alzheimer’s mice only have plaques,” Carlson said. “We’d really like to reproduce the whole (spectrum of) Alzheimer’s disease.”

Scientists used to think tangles came before the beta-amyloid plaques, but it has been discovered that the plaques occur first. Mice expressing a different mutant gene have been developed that accurately model the tangles seen in Alzheimer’s disease and frontotemporal dementia.

This is important to researchers working on a biomarker, with advances being made in the ability to detect the accumulation of beta-amyloid plaques and neurofibrillary tangles in the brain.

“What we think is that the mice with plaques are models for pre-clinical Alzheimer’s, while the mice with tangles are more relevant to later-stage disease,” Carlson said.

Dietrich has administered clinical trials on promising Alzheimer’s drugs for 20 years. The drug he currently has in clinical trials, Bapineuzumab, is being tested by Janssen Pharmaceuticals and Pfizer, Inc.

The school of thought is to passively vaccinate against beta-amyloid plaques in the brain.

“If you develop an antibody, then you can attack the target with it,” Dietrich said. “Bapineuzumab attaches to beta-amyloid and helps remove it from the brain.”

The drug, which is administered through an IV, already has been shown to reduce the plaques in the brain, Dietrich said.

Scans have shown the drug’s success in reducing beta-amyloid plaques in the brain, but researchers still are unclear as to whether it slows the progression of the disease.

“We hope to have some results from our first study by the end of this year,” he said.

Dietrich is enrolling patients in a second trial for Bapineuzumab, this one through Pfizer. The trial is scheduled for completion in 2014.

To be eligible for the trial, patients need to be experiencing only mild to moderate symptoms of Alzheimer’s, and be between the ages of 50 and 88, with no other major health issues, he said. Great Falls is one of 292 trial sites.

“I’m not seeing hundreds of people in this trial. It’s a very small trial,” Dietrich said.

To measure whether the drug works, patients will undergo extensive cognitive testing and need to sit still through a 45-minute MRI.

“If the brain shrinks, it may indicate that you’ve lost brain cells,” Dietrich said.

The ratio of phosphorylated tau and the decreased a-beta in spinal fluid also is measured as a means of determining if the drug is working.

Though these trials look promising, Dietrich stops short of saying researchers are near a cure.

“I think it’s incredibly complicated,” he said. “We need a breakthrough, and we don’t know where it’s coming.”

Dietrich said that one thing’s for sure, however: People who enter clinical trials are heroes.

When a patient of his even considers participating in a clinical trial, he tells that person, “Without people like you, we wouldn’t have any new treatments.”

Amie Thompson is the specialty publications editor at the Great Falls Tribune. Reach her at 1-800-438-1431 or 791-6531 or email her at athompson@greatfallstribune.com.

Due to the overwhelming response from applicants, we are opening another 20 slots for presenting companies at Life Science Innovation Northwest (LSINW) 2012. The new deadline for presenting organization applications is May 18, 2012.

Apply to present today at our website!

Who Should Apply to Present?

• Life Sciences Organizations in the discovery, development or commercialization stage of business wanting to showcase their organizations to qualified regional, national and international investors.

• Organizations interested in meeting one-on-one with investors, analysts, business development executives and strategic partners.

• Organizations that want to learn about the latest Life Sciences investment trends from sophisticated investment and partnering executives.

• Organizations that want to get their name out to Life Sciences community leaders, scientists, business development professionals and C-level executives.

• Organizations seeking to gain access to key Life Sciences leaders throughout the Pacific Northwest and beyond.

Apply to present today at our website!

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In a glass-walled laboratory on the edge of this tiny bedroom community, half a dozen men in spacesuits are crafting the latest in skeleton repair, a spongelike scaffold on which the human body will naturally produce new bone. With this creation, backs can be fused without metal rods, skulls mended without metal plates. Bones pitted by cancer can be made whole again.

“You want to talk about accelerated medicine? This is accelerated medicine,” said Jesus Hernandez, a very proud vice president of Belgrade-based Bacterin International.

A Gallatin Valley-grown biomedical company, Bacterin has managed to expand from a handful of employees less than 10 years ago to a publicly traded company with 120 people on payroll. Its creations, ranging from bone grafts to infection-preventing coatings, have given it a toehold in a $7 billion industry. In a rough economy, Bacterin continues to develop new products, nail down research grants and expand its laboratories.

Bacterin is what Bureau of Business and Economic Research director Patrick Barkey calls the bright spot in the region’s economy, stepping beyond the recession-strapped local market to tap into more stable industries such as health care. High-tech and manufacturing businesses make up more than 20 percent of the region’s wages, second only to Montana State University’s 29 percent.

What Bacterin has managed to do is take donated human bone tissue, demineralize it and wash it free of blood lipids while leaving its growth factors and morphogenetic proteins intact. The result is a bone sponge the body doesn’t reject and in fact uses as a trellis for making new bone in as few as 60 days. The product is known as OsteoSponge.

“We can take something that’s hard bone and make it pliable. You can cut it with a pair of scissors, you can squeeze it, suture it, you can anchor it,” Hernandez said. “We are the inventors of the OsteoSponge. This is the original product that everyone on the planet wants to mimic. What they haven’t been able to mimic is the process.”

In other words, the competition hasn’t succeeded in getting the body to naturally attach to its products and grow bone as Bacterin’s products do. The company has adapted its technology to reattaching skull cutouts after brain surgery, connecting knee tendons, repairing eye sockets and relieving back pain by stabilizing vertebrae.

Now the company is applying its technology to skin grafts. Down the hall from where workers are turning femur material into OsteoSponge, two researchers are developing a graftable skin, free of DNA and donor coloring that will be used to treat skin sores in diabetic patients and hopefully prevent amputations.

“The incidents of diabetes are very, very high, so you have patients who develop ulcers. And when these ulcers don’t heal, they cut your foot off, or you lose your leg,” Hernandez said. “So, what we’re doing is creating a product that will help heal the ulcer and save your foot.”

The skin graft should be on the market in the first quarter of next year.

This lab is Hernandez’s baby. The OsteoSponge work area is so clean that particles 200 times smaller than a human hair are constantly scrubbed, filtered and radiated from existence.

Shoes, triple-bagged in the lab, are replaced every couple of months. Surgical gloves are changed 106 times a day. There are freezers at the other end of the building where donor tissue is stored at minus 80 degrees Centigrade and every donated cell is tracked from the time it arrives to the time it is either destroyed or implanted.

Everything here is something one would expect to find in the shadow of a major research hospital or university. But this is Belgrade, a come-one, come-all community that never took a shine to zoning or planned unit developments. Bacterin is flanked by a modest apartment complex to the south, the end of an airport runway to the east and to the north a warehouse used by a traveling magician to house tigers.

It is because Belgrade threw out the welcome mat so easily that Bacterin is here, said Guy Cook, company founder, CEO and president.

“Belgrade was willing to help us out,” Cook said. The community helped the startup secure small-business funding that it wasn’t able to line up in Bozeman where it spent time in TechRanch, a nonprofit business incubator.

Bacterin was started in 1997 on research Cook performed at Montana State University. MSU houses the Center of Biofilm Engineering, a National Science Foundation Engineering Research Center.

The company’s big break came in the early part of the last decade when the U.S. Department of Defense gave it two $1 million contracts to develop a special bacteria-fighting coating for medical devices used in mobile army surgical hospitals where three-fourths of the battlefield injuries were open fractures to arms or legs.

As Cook thinks about those defense contracts today, he can’t help but think how today’s politics may have affected them. The contracts came in the form of earmarks from then-Republican Sen. Conrad Burns. They launched the company to a new development stage.

Today, Bacterin is the biggest Federal Express customer in Montana, dependent on timely incoming shipments of donated bone and outgoing delivery of its unique products. Hernandez would like to see the company become more active in the donation process. He would like to be able to offer Montanans the chance to become bone tissue donors for a Montana-based biomedical company, but that could be a ways off.

State law prohibits donations to for-profit companies. The nonprofit company that services Montana is based in Seattle. Donors can specify Bacterin as a recipient, which gives the company first rights to see if a donation passes muster. The ideal donor, said Hernandez, is about 53 years old.

The company is still a leader in the biofilm industry.

Reporter Tom Lutey can be reached at (406) 657-1288 or at tlutey@billingsgazette.com.

BIO Applauds House and Senate for Reaching Deal on SBIR Reauthorization
Small Business Innovation Research (SBIR) grants provide critical funding for the development of innovative medical therapies for Cancer, Diabetes and HIV

WASHINGTON, Dec 13, 2011 (BUSINESS WIRE) — The Biotechnology Industry Organization (BIO) today praises the House and Senate for reaching a deal on Small Business Innovation Research (SBIR) Reauthorization as an Amendment to the National Defense Authorization Act (HR 1540).

Yesterday, lawmakers announced that an agreement had been reached to reauthorize and amend the SBIR/Small Business Technology Transfer (STTR) program, which was set to expire on December 16th. House and Senate lawmakers agreed to amend and extend the program for another six years.

BIO President and CEO Jim Greenwood made the following statement today:

“BIO is pleased that an agreement has been reached to amend and extend the SBIR program. SBIR provides much needed funding for the development of innovative medical therapies for debilitating diseases including cancer, diabetes and HIV.

“In particular, BIO applauds House and Senate leadership, including Rep. Sam Graves (R-MO), Rep. Nydia Velazquez (D-NY), Rep. Ralph Hall (R-TX), Rep. Eddie Bernice Johnson (D-TX) and Sen. Mary Landrieu (D-LA) and Sen. Olympia Snowe (R-ME) for their efforts in moving this measure forward.

“This measure allows companies that are majority-owned by multiple venture capital firms to compete for SBIR awards once again, which is critical for emerging biotechnology companies working on tomorrow’s breakthrough cures and treatments. Updating the SBIR program to address the current economic realities and capital formation challenges facing small, innovative American companies is necessary to ensure that these companies can once again compete for SBIR grants — based on the promise of their science rather than the structure of their capital.

“The importance of supporting continued advancements in science has never been more important as companies are struggling to recover from the economic crisis, and accelerate research, growth, and hiring. At the very earliest stages of development, alternate sources of financing, such as SBIR grants, have been instrumental in furthering research and development in biotechnology.

“BIO applauds the Congress on this important and timely agreement, and hopes that the Congress now moves this legislation forward as expeditiously as possible to help fulfill federal research and development goals of bringing cures and breakthrough medicines to the public.”

The role of the SBIR program in bringing breakthrough therapies to the American people is a matter of record. There are 252 FDA-approved biologics that have been developed by 163 companies. Thirty-two percent of those companies have received at least one SBIR/STTR award.

In recent months, at least 25 U.S. public biotech companies have either placed drug development programs on hold or cut programs all together. These programs include promising therapies for HIV, cervical cancer, Multiple Sclerosis, and diabetes.

For additional data and analysis on the U.S. biotechnology industry, please visit www.bio.org

About BIO

BIO represents more than 1,100 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products. BIO also produces the BIO International Convention, the world’s largest gathering of the biotechnology industry, along with industry-leading investor and partnering meetings held around the world. BIO produces BIOtech Now, an online portal and monthly newsletter chronicling “innovations transforming our world.” Subscribe to BIOtech Now.

Upcoming BIO Events

BIO Asia International Partnering Conference January 31 — February 1, 2012 Osaka, Japan

BIO CEO & Investor Conference February 13-14, 2012 New York, NY

World Congress on Industrial Biotechnology & Bioprocessing April 29-May 2, 2012 Orlando, FL

2012 BIO International Convention June 18-21, 2012 Boston, MA

SOURCE: Biotechnology Industry Organization (BIO

Component Topics	Last Modified	Format
		HTML	PDF	MS Word
DoD Instructions: 2012.1 SBIR	November 9, 2011
Army	December 12, 2011
Navy	December 13,, 2011
Air Force	December 13, 2011
DARPA	December 12, 2011
DTRA	December 12, 2011
OSD-R&E	December 12, 2011
SOCOM	December 12, 2011

Important Note: A list of modifications made to the solicitation since its release to the Internet is available here.

More Information: Click Here