Traumatic brain injury, or TBI, is known as the signature injury of soldiers returning home from Afghanistan and Iraq. Blast forces sustained in combat often cause damage to parts of the brain critical to high-level functions influencing memory, attention, decision-making and motor skills. Many veterans developing symptoms after TBI also suffer from post-traumatic stress disorder (PTSD), according to the Department of Veterans Affairs (VA).

“Working with the VA, the Department of Defense and private research entities, we will develop novel studies – everything from drug discovery and preclinical work to clinical, social and behavioral trials,” said principal investigator Dr. Paul R. Sanberg, USF senior associate vice president for research and innovation and director of the USF Center of Excellence for Aging and Brain Repair. “Our multidisciplinary work will provide critical knowledge about TBI and its complications that could lead to more effective diagnosis and treatments for soldiers and veterans, as well as skills to improve their physical and psychological adjustment into civilian life.”

“This new federal award is a tremendous boost to USF’s efforts to build a research infrastructure to support our veterans reintegration strategy,” said Karen Holbrook, PhD, USF senior vice president for research, innovation and global affairs.

The two-year, DOD-funded grant joins faculty from across colleges and disciplines.

The grant involves four major projects:

• Researchers will assess in animal models how granulocyte colony stimulating factor (GCSF), a growth factor that mobilizes the body’s own stem cells, may help treat traumatic brain injury.
• A clinical trial will test whether GCSF reduces neurological damage and improves recovery of memory, decision-making and other cognitive functions in soldiers and veterans with TBI, even when administered a month or two after the initial injury. Patients will be recruited from the polytrauma rehabilitation and blast injury programs at James A. Haley Veterans’ Hospital.
• In an attempt to identify better diagnostic measures for mild TBI, a frequently underdiagnosed condition, a study will compare the balance, gait, hearing and vestibular functions of otherwise healthy USF student veterans with and without self-reported TBI to those of non-veteran students. Evaluations will be conducted at the USF School of Physical Therapy & Rehabilitation Sciences Human Functional Performance Laboratory.
• Using advanced technology researchers will monitor changes in patterns of everyday movement and the cognitive function of TBI patients undergoing smart house-based rehabilitation at the Tampa VA hospital’s Polytrauma Transitional Rehabilitation Program. The study will evaluate whether scientific analysis of movements, tracked by devices like radiofrequency identification and global positioning systems, can help assess therapeutic improvement. A second arm of the study will investigate whether variability in walking patterns is greater for USF student veterans reporting mild TBI than for those without this diagnosis.

The new DOD award adds momentum to USF’s plans to work with the VA and DOD to build a first-of-its kind Center for Rehabilitation, Science, Engineering and Medicine, an interdisciplinary research, education and treatment facility. Over the last three years, the university’s Veterans Reintegration Strategy program has joined researchers across colleges and disciplines to work on studies in areas including TBI, PTSD, robotics and prosthetics, gait and balance, and aging-related disorders.

“This award reflects USF’s collaborative efforts to leverage our research and academic expertise to enhance the quality of life of our men and women in uniform, and their families, who have so selflessly served this country,” said Lt. Gen. Martin Steele (USMC retired), executive director of USF Military Partnerships. “It builds, not only upon interdisciplinary research within the university, but also strengthens our longstanding ties with Tampa Bay’s military community through two major VA hospitals, MacDill Air Force Base, U.S. Central Command and U.S. Special Operations Command.”

According to Accentia’s President and General Counsel, Samuel S. Duffey, “By monetizing a non-core asset to eliminate all short term debt payable in cash, and structuring a mutually beneficial agreement with our senior secured lender to extend all principal and interest payments into mid-to-late 2013, we have strengthened Accentia’s financial position, improved its balance sheet and secured access to potentially non-dilutive funding to support development plans for our immunotherapy pipeline.”

Under the terms of the Analytica sale, including a schedule of expected performance-based milestone payments, Accentia anticipates up to an additional $6 million which will be used to advance its Revimmune™ development program for the treatment of autoimmune disease, as well as to potentially provide support for its majority-owned subsidiary, Biovest International, which is advancing its BiovaxID® personalized cancer vaccine for the treatment of non-Hodgkin’s lymphoma. With the sale of Analytica’s assets and business, Accentia also secured a pre-paid credit for future services from Analytica to support pricing and reimbursement strategies.

“Ovarian cancer is a deadly disease. If we are to improve outcome for patients, it is essential that we develop tools to support biologically-informed clinical decision-making” said Johnathan Lancaster, MD, PhD, Director of Center for Women’s Oncology at the Moffitt Cancer Center.  ”As such, we are excited about our new partnership with OvaGene. It will enable us to accelerate our microRNA laboratory findings towards the clinic, as personalized medicine tools that may benefit patients in the near-term.”

“We are delighted to partner with a molecular diagnostics company dedicated to taking important technologies from the bench to the bedside,” said Haskell Adler PhD MBA, Senior Licensing Manager at the Moffitt Cancer Center.  ”Because of the shared vision between our two organizations, we are optimistic this is the beginning of a long and fruitful relationship involving a number of technologies developed here at Moffitt.”

The technology, licensed from The Moffitt Cancer Center, includes proprietary microRNA-based biomarkers that can be used to predict response to chemotherapy in a variety of tumor types. Initially, OvaGene intends to develop a specific microRNA-based profile to predict drug response in advanced ovarian cancer.   Following the development of the ovarian cancer assay, OvaGene will focus on creating additional assays for drug response in a variety of gynecologic cancers and pursue strategic partnerships to develop similar profiles in other tumor types.  Developmental studies, CLIA lab validation, and subsequent commercialization are expected to occur over the next eighteen to twenty-four months.

“We are looking forward to developing and commercializing the very first cancer microRNA diagnostic assay related to drug response,” said William Ricketts, PhD, OvaGene Chief Scientific Officer. “We are at the forefront of molecular diagnostic development for gynecologic cancers and we are excited about the innovative and clinically useful microRNA drug response panels we will be bringing to market”

Along with the good news of the Center’s new 10,000-square-foot home, the day included announcements of two new grants for diabetes research: a $3.5 million grant from the Juvenile Diabetes Research Foundation (JDRF) and a $55.9 million grant from the National Institutes of Health (NIH).

The first — a three-year, $3.5 million grant from JDRF — will help researchers determine whether earlier diagnosis and intervention leads to improved long-term outcomes for children and adults with Type 1 diabetes.

The second — a five-year $55.9 million grant from the NIH – will build upon preliminary findings from TEDDY, or The Environmental Determinants of Diabetes in the Young study, which is investigating the role that diet, infections and other environmental factors may play in triggering autoimmunity and type 1 diabetes.

“This new grant will help initiate a new era of discovery in looking at causes related to diabetes,” said Dr. Krischer, the pediatric endocrinologist who led the effort to build the Center. “It will enable us to apply human genomics, metabalomics and epigenetics – all cutting edge science – to new investigations of gene-environment interactions as potential contributors to the development of Type 1 diabetes.”

The purpose of the research is to apply near-infrared spectroscopy during cardiac catheterization and look deep into the coronary arterial wall to identify hidden pools of lipids, or fats, that can suddenly cause a heart attack months or years in the future. Currently, hidden fats in artery walls cannot accurately be detected by conventional techniques such as angiography, ultrasound, CT imaging or MRI.

“There is solid evidence that the presence of these lipid pools is a major risk factor for stable patients to become suddenly unstable with chest pain and heart attacks,” said Dr. Charles Lambert, medical director of the Florida Hospital Pepin Heart Institute. Dr. Lambert is also the principal investigator who will lead the hospital’s team of physicians, nurses and researchers over the next several years and beyond to study the use of this new technology with patients.

“We are excited because it’s going to be a compelling study that should help the U.S. Department of Defense predict cardiac events during high stress periods like combat, and even for astronauts involved in prolonged space travel,” said Dr. Lambert. “Military scientists are interested in trying to predict individual cardiac health and risk in the years ahead and we are very pleased to join their effort here at the Florida Hospital Pepin Heart Institute.”

Dr. Lambert and his team plan to enroll 230 patients in the study who are undergoing cardiac catheterization; the study will use the near-infrared spectroscopy investigative technique and follow the patients closely for years. The $700,000 grant allows the Florida Hospital Pepin Heart Institute to purchase hi-tech infrared equipment while training physicians and cardiac catheterization teams about the new investigative technique, in addition to establishing an image database to share with the U.S. Army and other investigators.

“IRX’s choice of Florida confirms that our state has set the stage successfully for a future that’s rich in science, research and innovation,” said Governor Rick Scott. “I am pleased to support the company’s continuing growth and job creation, which puts us one step closer to creating the jobs needed to get our state back to work.”

IRX develops therapies to treat cancer and infectious diseases. The company has raised $90 million to fund preclinical research, manufacturing and clinical development of IRX-2, a cancer treatment and IRX’s chief product. Initially, IRX will employ 40 people to begin a Phase 3 trial. The additional staff will work in commercial-scale manufacturing and expanded development functions in anticipation of a potential commercial product launch.

IRX’s move actually marks its return to Florida and the Tampa Bay Region, where at the University of South Florida the company developed its technology.

“This ‘homecoming’ exemplifies the strength of Florida’s research and development capabilities and the rising stature of the state’s life sciences sector,” said Florida Secretary of Commerce Gray Swoope, who heads Enterprise Florida, the state’s primary economic development organization. “And I credit the effective collaboration of our academic, economic development, government and community partners for bringing this visionary project to fruition.”

To seal this business development prize for Florida, the state awarded IRX $600,000 from its Innovation Incentive Fund, which targets R&D catalyst projects. Local provisions included $275,000 from Pinellas County, a $275,000 credit toward land owned by the City of St. Petersburg in the Dome Industrial Park (for future expansion), and $50,000 from the University of South Florida. The Florida High Tech Corridor Council and Pinellas County Economic Development were also partner organizations in the economic development project.

According to Biovest’s consulting medical advisor, Dr. J. David Gangemi, Ph.D., Professor Emeritus, Microbiology and Molecular Medicine, Clemson University, “Biovest’s hollow fiber systems have proven to be highly efficient, cost-effective bioreactors for the production of monoclonal antibodies, recombinant proteins and personalized cancer vaccines. We are now evaluating if Biovest’s novel hollow fiber technology also represents an ideal cell culture platform for the rapid propagation of virus for the efficient manufacture of many kinds of vaccines and other products of military importance. Encouragingly, our preliminary viral growth results suggest multiple key fundamental advantages not found in other bioreactor systems currently used for virus production.”

Biovest’s Chief Scientific Officer, Dr. Mark Hirschel, Ph.D., added, “We are collaborating with NHRC to conduct multiple viral growth studies using our hollow fiber bioreactor systems. The intent is to demonstrate the key benefits and advantages of this technology over more established conventional methods routinely used for the production of viral vaccines. It is our goal to position the AutovaxID™ and our other hollow fiber systems as a preferred flexible, robust manufacturing platform for the production of emerging pandemic viruses and vaccines.”

Biovest is a Tampa-based majority-owned subsidiary of Accentia Biopharmaceuticals, Inc.

From ABC

“We have weathered the economic crisis and feel honored by the confidence our long-term clients have shown in us throughout. Now, as our business experiences a strong rebound, we are poised to ensure that we have the capacity and staff to maintain the highest level of quality for our rapidly-expanding customer base,” says CEO and President Derek Hennecke.

Tampa Mayor Bob Buckhorn applauded the expansion as a boost to local efforts to grow the Tampa Bay area’s biotechnology industry. Says Buckhorn, “Xcelience’s expansion further demonstrates that Tampa is the perfect environment to successfully start and grow biotech companies. We are extremely proud to join in today’s announcement and look forward to the company’s continued success.”

Xcelience will be expanding its 24,000 square feet existing facility with the addition of nine rooms (1,000 square feet), as well as developing a brand new 24,000 square feet facility a short distance away to help accommodate 45 new employees. The new jobs made the company eligible for a Florida Qualified Targeted Industry Tax Refund incentive award of $135,000. To qualify for QTI, the new jobs must pay average salaries meeting or exceeding 115% ($46,833) of the Tampa-St. Petersburg-Clearwater MSA’s average annual wages. “Xcelience’s expansion is great news for the state of Florida as well as for Tampa,” says Enterprise Florida President Gray Swoope. “It demonstrates the successful outcomes we’re achieving toward job creation, thanks to strong partnerships between our local communities and the business, economic development and government sectors.”

Xcelience headquarters is located in Tampa where there is a good base of talented workforce to build upon. “Our goal is to remain in this community”, says Hennecke. “We are excited to be a part of the local economic turn-around that we see beginning to occur in the Tampa Bay area.” Hillsborough County Commission Chairman Al Higginbotham thanked the company for expanding in Tampa and says, “We welcome Xcelience’s news of its expansion within Hillsborough County, and look forward to many years of future success from this good corporate neighbor. Nurturing the life sciences industry and support for firms such as Xcelience, will provide dividends to our economy and quality job opportunities for our citizens.”

Xcelience is poised to begin hiring, and is currently seeking chemist-II and manager positions for preformulation/formulation. Jobseekers may find more information and apply for open positions on the Xcelience website, at www.xcelience.com/formulation-development-careers/ .