Lyden possesses an extensive background in biostatistical analysis in pharmaceutical, biotechnical and medical device clinical research. Prior to founding BioStat International, Inc., Lyden served as the Manager of Clinical and Statistical Affairs at Bausch and Lomb Pharmaceutical Division.

“It can be challenging to get young people interested in biostatistics.” said Lyden. “Biostatistics can be a very rewarding career and it is the goal of this panel to impart students contemplating a future in biostatistics with career possibilities, industry challenges and rewards that exist in our field.”

The discussion panel occurred on the first day of the SIBS six-week learning program. Undergraduate students from across the nation interested in pursuing a graduate program in Biostatistics enroll in the program to learn more about graduate studies and gain insight from biostatistics experts. Participants have access to the university’s computing systems and libraries and will also receive hands-on training from top biostaticians, clinicians and epidemiologists.

Following the discussion panel, the students were invited to a reception with the SIBS staff to kick off the six-week program. Upon completion of the program, students may transfer 3 college credits to their home institution.

Biovest based its decision to pursue EU marketing approval on pre-filing clinical advisory meetings with EU-member national regulatory agencies. Under the EMA centralized procedure, Biovest will simultaneously seek approval for BiovaxID for all EU-member countries.

Samuel S. Duffey, Esq., Biovest’s President & CEO, stated, “Biovest’s EU regulatory strategy focused on conducting pre-filing clinical meetings with national regulatory agencies to obtain scientific advice regarding our BiovaxID clinical data and to facilitate a more predictable marketing approval process in the European Union. Today’s announcement confirms that pre-filing meetings have been conducted in Europe, and the Company intends to file a marketing application with the EMA. This is a major regulatory milestone, and it builds on Biovest’s recently announced plans to seek marketing approval in Canada following a pre-filing meeting with Health Canada. We next look forward to meetings with the FDA to define the path to U.S. registration as well.” Bi0vest is a majority-owned subsidiary of Accentia Biopharmaceuticals, Inc.

According to Alexander R. A. Anderson, Ph.D., chair of the IMO, mathematical models can be useful tools for the study of cancer progression as related to understandings of tumor ecology.

“Cancer is a complex disease driven by interactions between tumor cells and the tumor’s microenvironment,” Anderson said. “By developing mathematical models that describe how tumors grow and respond to changes in their surroundings (such as treatment), we can better understand how an individual patient might respond to a whole suite of different therapies.”

Robert Gillies, Ph.D., chair of imaging and metabolism at Moffitt, is working closely with Anderson and Robert Gatenby, M.D., chair of Diagnostic Imaging. They say it is important to pair tumor imaging with mathematical model building.

“Imaging is a key to validate mathematical modeling,” Gillies said. “Because imaging can be conducted over time, it affords us a good look at the actively changing systems in tumors that are predicted by the models.”

For Gatenby, because cancer is an evolving, always changing nonlinear system, it must be monitored over time and space.

“Imaging noninvasively captures tumor changes, and the mathematical models, which are much more rigorous than language, can then be used in cancer research,” Gatenby said.

Clinical imaging and mathematical modeling combined will afford clinicians a valuable predictive tool. One tool will be familiar. Just as meteorologists develop “spaghetti models” from satellite images to predict the myriad possible paths of hurricanes, Anderson said, they will be able to generate similar models to inform clinicians about a patient’s risk, which treatments may be best and whether recurrence is possible.

“By incorporating specific information about a patient, such as the size of their tumor, the treatments they have had, the organ that the cancer is growing in, we can predict forward in time how the tumor will grow, shrink, and respond to different combinations of therapies. By the results of imaging, biological experiments and mathematical models, we are leading the world in patient-specific medicine,” Anderson said.

Mathematical models generated by IMO researchers are already finding clinical uses.
Fibroblasts contribute to melanoma tumor growth

“We used an integrated mathematical and experimental approach to investigate whether melanoma cells recruit, activate and stimulate fibroblasts to deposit certain proteins known to be pro-survival for melanoma cells,” Anderson said.

Fibroblasts, the most common connective tissue functioning in the extra cellular matrix, were known to be activated by and drawn to cancer cells. When they investigated the relationship between fibroblasts and tumors using mathematical models, Anderson and colleagues found that fibroblasts have direct effects on melanoma tumor behavior, including aiding tumor growth and tumor drug resistance. They published their findings in Molecular Pharmaceutics.
Deadly glioblastomas better understood through mathematical models

IMO researchers and colleagues also developed mathematical models for investigating the progression of glioma, an aggressive and fatal form of brain cancer. The mathematical models augment imaging and histologic grading of gliomas, graded on their blood vessel growth patterns (an angiogenic feature) and incorporating the tumor’s cellular and microenvironmental changes.

When the researchers observed a disparity between grading schemes and tumor activity observed through imaging, they developed a mathematical model based on changes in cell appearance, proliferation and invasion rates. The new model improved predictive and prognostic ability.

“Being able to identify and predict patterns of dynamic changes in glioma histology as distinct from cellular changes in appearance and proliferation may provide a powerful clinical tool,” Anderson said.

They published this study in a recent issue of Cancer Research.
IMO gets $3 million from NIH to develop mathematical models of prostate cancer

As 2011 closed out, a group led by Anderson and colleagues landed a $3 million grant from the National Institutes of Health to create mathematical models to predict prostate cancer aggressiveness. It is well known that some prostate cancers are slow growing while others are aggressive. To be able to discriminate between them is critical if we want to treat only the aggressive ones, and there are potentially many patients that might not need treatment if we can make this distinction.

To construct the models, researchers will use tissue samples donated from prostate cancer patients to capture signaling mechanisms in tumor cells and understand how the different signaling in tumor cells alters how they behave. Using this data they will be able to identify and model the characteristics of aggressive prostate cancers. A second key step will be to clinically validate these newly constructed mathematical models, against an independent group of patients, as predictors of aggressive prostate cancers.

One signature event of this series will be the “Why Florida, Why Now” summit which will invite national and global chief executive officers from a range of industries targeted specifically for their high potential contributions to the diversification of the state’s economy.  The series, which will use the Tampa Bay region as its backdrop, represents a collaborative effort between the Office of Florida Governor Rick Scott and leading business groups, including the Florida Council of 100, the Florida Chamber of Commerce and Associated Industries of Florida.

“The Sunshine State is poised for a robust economic expansion thanks to a unique combination of logistics, infrastructure and geography,” said Florida Governor Rick Scott.  “When combined with business friendly policies, low taxes, affordable housing, and beautiful beaches and weather, no other state can match Florida as the best place in America to live, work and play.”

“The Host Committee is working with Governor Rick Scott and key business groups to enhance the dynamic economic development of the Tampa Bay area, as well as showcasing the state’s full inventory of competitive advantages,” said Host Committee President and CEO Ken Jones. “While the Convention itself will only last for one week, we have a tremendous opportunity to solidify a long-lasting economic impact to our entire region.  The Host Committee and the community will continue to take full advantage of this opportunity to bring lasting benefits to Florida.”

“The state of Florida is re-emerging as an economic powerhouse, now driven as much by market access and innovation as by beaches and sunshine,” said Host Committee Executive Board member Kathleen Shanahan.  “A Florida location is attractive to manufacturers seeking access to key Southern U.S. markets expected to account for more than 50 percent of population growth in the next 20 years, while also providing the gateway to South American economies.”

• Brian D. Athey, Ph.D., Professor of Biomedical Informatics and Chair of the Department of Computational Medicine and Bioinformatics at the University of Michigan Medical School – Dr. Athey is recognized as one of the nation’s experts in the field of Translational Bioinformatics, and has served as a special advisor to the Chief Information Officer of the U.S. National Institutes of Health (NIH). He is a founder of ‘tranSMARTproject.org’, an open source software community that supports one of the leading pharmaceutical data sharing and analysis software platforms used worldwide
• J. David Gangemi, Ph.D., Professor Emeritus, Microbiology and Molecular Medicine, Clemson University – With his doctorate in virology and biophysics and having formally served as a Senior Science Advisor to the Assistant Secretary of Defense, Dr. Gangemi has been directing Biovest’s hollow fiber perfusion technology viral bio-manufacturing collaborations with the Naval Health Research Center and Max Planck Institute.
• Larry W. Kwak, M.D., Ph.D., Chairman of the Department of Lymphoma/Myeloma and Associate Director of the Center for Cancer Immunology Research at the University of Texas MD Anderson Cancer Center – Internationally recognized for his 20-year commitment to the science of cancer vaccines, Dr. Kwak developed Biovest’s BiovaxID® personalized lymphoma cancer vaccine while at the U.S. National Cancer Institute. In 2010, Dr. Kwak was the first active MD Anderson faculty member to be named to TIME Magazine’s “TIME 100” annual list of the 100 most influential people in the world for his contributions to the advancement of cancer vaccines.
• James J. Mulé, Ph.D., Executive Vice President & Associate Center Director for Translational Research, H. Lee Moffitt Cancer Center & Research Institute – Dr. Mulé is an internationally known senior cancer immunologist and gene therapist, and at Moffitt, holds the Michael McGillicuddy Chair in Melanoma Research and Treatment. Dr. Mulé is also a special government employee advising the National Cancer Institute and the FDA-CBER, and is on several industry and publication advisory boards, having published over 200 scientific papers in the field of tumor immunology and immunotherapy.
• Dayton Reardan, Ph.D., R.A.C., Vice President, Regulatory Affairs, Eleos, Inc. – Dr. Reardan previously held the position of Vice President of Regulatory Affairs at Orphan Medical Inc., a public drug development and marketing firm (acquired by Jazz Pharmaceuticals). He has additionally served as Director of Development at CV Therapeutics and Xoma Corporation, and has twice received the FDA Commissioner’s Special Citation for his work in developing pharmaceuticals for patients with rare diseases. Dr. Reardan is directing the global regulatory strategy for BiovaxID.
• Stephen J. Schuster, M.D., Robert and Margarita Louis-Dreyfus Associate Professor in Chronic Lymphocytic Leukemia and Lymphoma Clinical Care and Research and Director, Lymphoma Program, Abramson Cancer Center of the University of Pennsylvania – Instrumental in the clinical development of BiovaxID and continuing to advise on new study designs to expand the vaccine’s indications, Dr. Schuster presented the Phase III study results at the Plenary Session of the 2009 American Society of Clinical Oncology (ASCO) Annual Meeting and at the 2010 American Society of Hematology (ASH) Annual Meeting.

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”