Tag: Drug Development

Southern Biologics Network Established to Create Biologics Faster and Less Expensively

Posted on December 8, 2014

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BIRMINGHAM, BATON ROUGE, RALEIGH and RESEARCH TRIANGLE PARK – December 8, 2014 – Five biopharmaceutical research organizations with operations in Birmingham, Baton Rouge, Raleigh and Research Triangle Park have formed a new public-private partnership called the Southern Biologics Network (SBN) to create biologics faster and less expensively.

The five research organizations will work together to create advanced biologics for biopharmaceutical companies of all sizes.

Biologics are genetically engineered proteins from plant, animal and human cells. They’ll be used to create therapeutics, vaccines, diagnostics and drug targets to treat and prevent diseases, assist in drug discovery, and improve the lives of tens of thousands of patients across the United States.

The five research organizations are:

  • Birmingham-based Southern Research Institute, which has created seven FDA-approved cancer drugs. Scientists there are discovering and developing treatments in multiple disease areas including oncology, Parkinson’s, Alzheimer’s, diabetes and infectious diseases.
  • Pennington Biomedical Research Center at Louisiana State University in Baton Rouge is at the forefront of medical discovery on understanding and combating obesity, diabetes, cardiovascular disease, cancer, dementia, and other chronic diseases with the goal of improving human health across the lifespan.
  • The Center for Structural Biology at the University of Alabama at Birmingham is a leading structural biology research center providing scientists with biophysical and structural information on protein and protein/drug complexes.
  • ProteoVec, Inc., in Baton Rouge, Raleigh and RTP. PV’s scientists develop and scale biologics production processes earlier in development, and more cost effectively, than previously possible.
  • Soluble Therapeutics, Inc., in Birmingham, can determine optimized formulations that maximize solubility and stability for protein-based therapeutics in less than 60 days.

Biologics have revolutionized the treatment of rheumatoid arthritis, Crohn’s disease, multiple sclerosis and different types of cancers. Development of new biosimilar versions of existing breakthrough biologics are key to making healthcare more affordable and improving outcomes.

Pharmaceutical Companies Will Bring More Life-Saving Treatments to Market by Using SBN’s Services

SBN is the first organization in the Southeastern United States to provide truly comprehensive biologic development services. Pharmaceutical companies will be able to save time and money because they’ll be able to select one organization, SBN, instead of trying to coordinate the work of several biopharmaceutical research firms for the manufacture, discovery, preclinical development, and early-stage clinical development of biologics.

“More affordable production and more mature early-stage process development will lead to a greater number of breakthroughs making it to market,” said ProteoVec CEO Michael Crapanzano, M.D. “Not only does that save time; that saves money, too.”

That’s a significant point of difference, considering the business risks and costs of drug development. According to the Pharmaceutical Research and Manufacturers of America, it can take up to15 years to create an FDA-approved drug. Research and development costs can exceed $1 billion, and only 20 percent of marketed drugs break even or turn a profit. Still, medicine can make a huge difference. Since 1980, 83 percent of life expectancy gains for cancer patients can be attributed to new treatments. The HIV/AIDS death rate has dropped more than 80 percent since the use of antiretroviral treatments in 1995.

“SBN combines some of the brightest minds in biologics, helps reduce the risk that pharmaceutical companies take at the earliest stages of biologics discovery and development, and allows our five entities to work together more efficiently with clients to do what we all do best — create biological therapeutics for our customers that will dramatically improve patients’ lives,” said Art Tipton, Ph.D., president and CEO of Southern Research Institute.

“We are excited to be part of this network, since we have many of the components necessary to quickly advance high value drug targets using our expertise in protein characterization, target validation, and the ability to optimize preclinical candidates for clients,” explained Dr. Larry DeLucas, director of the Center for Structural Biology at UAB.

About the Southern Biologics Network

Southern Biologics Network service offerings include: initial characterization of protein structures and protein-drug interactions; protein expression, purification and formulation; preclinical in-vitro/in-vivo IND enabling studies; and Phase I clinical studies. SBN’s customer service focus includes close consulting and assistance in the design and execution of all aspects of early-stage biologic development using cost effective, creative, and customized approaches. For more information, please visit http://www.proteovec.com/southern-biologics-network/.

Southern Research Continues 24 Years of HIV Work with New NIH Contract

Posted on December 1, 2014

BIRMINGHAM, Alabama – December 1, 2014 – Southern Research has been awarded a $24 million, seven-year contract with the Division of AIDS, part of the National Institutes of Health, to provide drug discovery and development services to develop products that have the potential to become drugs for the treatment and prevention of HIV. The contract supports high throughput screening and preclinical studies to discover and develop novel antiretrovirals, with a focus on topical microbicides and unique or unexploited viral targets.

24 Years of HIV Research

For 24 years, Southern Research has been meeting the HIV drug discovery and development needs of the government and pharmaceutical industries, with more than 30 HIV assays and over 200 strains of HIV and SIV in production. This contract renews two previous contracts into one award.

“We received word on the award earlier this year, but we chose to make the announcement December 1 – World AIDS Day – to recognize this special day of awareness and to emphasize the work we have been doing, and continue to do, in the fight against this devastating disease,” said Art Tipton, Ph.D., Southern Research president and CEO.

The Facts on HIV

Currently, there is no cure for AIDS caused by HIV, and the virus continues to spread despite the increased global commitment to controlling the pandemic.

  • According to the World Health Organization, in 2013, globally, there were more than 35 million people living with HIV: 2.1 million people became newly infected and 1.5 million died.
  • In the U.S., there are more than 30 FDA approved HIV medicines.
  • A variety of interventional agents are used in combination to control virus replication and successfully manage the disease, resulting in a functional cure for millions and showing promise in prevention of new infections.
  • Millions are relying on antiretroviral therapy (ART) until a sterilizing cure can be identified, but according to the latest Centers for Disease Control and Prevention’s Vital Signs report, only 3 in 10 people living with HIV have achieved viral suppression.
  • Oral administration of ART, including Option B and Option B+, was approved worldwide to inhibit transmission in high risk populations and mother-to-child transmissions.
  • In 2013, approximately 12 million people received ART, but drug resistance is an ongoing issue.

“Southern Research has a well-equipped, integrated team of biologists and medicinal, combinatorial and bioanalytical chemists whose experience in drug discovery and development provide significant technical support for products being developed to treat HIV patients,” said Marintha Heil, contract PI and project leader in Southern Research’s drug development division.

About Southern Research

Founded in 1941 in Birmingham, Alabama, Southern Research is a not-for-profit 501(c)(3) scientific and engineering research organization that conducts preclinical drug discovery and development, advanced engineering research in materials, systems development, and environment and energy research. Approximately 500 scientific and engineering team members support clients and partners in the pharmaceutical, biotechnology, defense, aerospace, environmental, and energy industries in laboratories and facilities in Alabama, Maryland, North Carolina, Georgia, and Texas.

Southern Research and LSU Health Sciences Study Validates Using Imaging to Study the Progression of Parkinson’s Disease in Preclinical Animal Studies

Posted on July 2, 2012

BIRMINGHAM, Ala. and SHREVEPORT, La. — Using preclinical molecular imaging, scientists from Southern Research Institute and LSU Health Sciences Center in Shreveport have published data which could lead to better diagnosis and treatment of Parkinson’s disease.

Their study — “PET Imaging a MPTP-Induced Mouse Model of Parkinson’s Disease Using the Fluoropropyl-Dihydrotetrabenazine Analog [18F]-DTBZ (AV-133)”— was published in a recent edition (June 18, 2012) of PLoS ONE—an online scientific publication which provides free access to scientific studies that will accelerate progress in science and medicine.

Study findings suggest that MPTP-induced Parkinson’s disease in a mouse model is appropriate for following the degeneration of the dopaminergic system and that the[18F]-DTBZ analog is a potentially sensitive radiotracer that can be used to diagnose changes associated with Parkinson’s by positron emission technology (PET) imaging in mice.

The paper was co-authored by James Toomey, DVM, and Andrew Penman, Ph.D., of Southern Research Institute in Birmingham, and Michael Mathis, Ph.D., of LSU Health Sciences Center in Shreveport. It is available online at http://dx.plos.org/10.1371/journal.pone.0039041.

Many scientists believe finding the cure for Parkinson’s will require a much deeper understanding of what causes the disease.

“This imaging pilot validates a diagnostic approach which could lead to better diagnosis and treatment of Parkinson’s disease,” said Dr. Penman, Vice President of Drug Development at Southern Research. “By validating this imaging model we can acquire better data faster, more cheaply, and also limit the number of animals required to conduct a study in the search for new drugs to treat this debilitating disease.”

“Parkinson’s researchers who are working to develop novel therapeutics for this disease now have a new option—a validated, non-invasive model that further quantifies the use of preclinical imaging as a way to follow the degeneration process of Parkinson’s disease,” said Dr. Mathis, Director, Small Animal Imaging Facility at the LSU Health Sciences Center.

Approximately 60,000 Americans are diagnosed with Parkinson’s disease each year, with as many as one million Americans living with Parkinson’s. It is estimated that seven to ten million people worldwide are living with Parkinson’s disease. The combined direct and indirect cost of Parkinson’s including treatment, social security payments and lost income from inability to work is estimated to be nearly $25 billion per year in the U.S. alone. Medication costs for an individual with Parkinson’s disease averages $2,500 a year. Therapeutic surgery can cost up to $100,000 per patient.

Southern Research and the LSU Health Sciences Center in Shreveport, along with the Biomedical Research Foundation of Northwest Louisiana, formed a collaborative partnership last year to conduct preclinical imaging studies.

Southern Research conducts both contract research and basic research for clients, providing preclinical drug discovery, development, and clinical trial support services in cancer, infectious diseases, and CNS/neurological disease to pharmaceutical and biotechnology companies. Scientists conduct translational science to invent small molecules and advance them from the design stage to the clinic. Services available include medicinal chemistry, molecular biology, biochemistry, high-throughput screening and a full set of in-house GLP development services including toxicology, ADME/PK, animal models, formulations, and bioanalytical services.

About Southern Research

Southern Research Institute is a not-for-profit 501(c)(3) scientific research organization founded in 1941 that conducts preclinical drug discovery and development, advanced engineering research in materials, systems development, and environment and energy research. More than 550 scientific and engineering team members support clients and partners in the pharmaceutical, biotechnology, defense, aerospace, environmental and energy industries. Southern Research is headquartered in Birmingham, Ala., with facilities in Wilsonville, Ala., Frederick, Md., and Durham, NC and offices in Huntsville, Ala., New Orleans, La., and Washington, DC.

Southern Research Signs Agreement with Apath, LLC to Conduct Preclinical Studies with Virus-Based HCV Screenings

Posted on April 25, 2012

BIRMINGHAM, Ala. — Southern Research today announced that it has signed an agreement with Apath, LLC which will allow Southern Research to conduct laboratory testing, research, and/or screening of potential therapeutic agents for hepatitis C (HCV) on an exclusive, fee-for-service basis using Apath’s HCV virus-based technology.

Apath—a privately held technology company focusing on HCV and other human viral pathogens—was founded by Charles M. Rice, Ph.D., Professor at The Rockefeller University and formerly of the Washington University School of Medicine.

“Preclinical screening using a virus-based system will advance potential treatments for the disease because new therapies for HCV will be screened against the actual virus rather than a subset of the replication machinery,” said Andrew D. Penman, Ph.D. vice president of Drug Development at Southern Research. “We are very pleased to work with Dr. Rice, a world renowned HCV expert and offer this new service to our clients.”

Most preclinical drug screening for new HCV therapies use cell lines that harbor replicons—intracellular sub-genomic, self-replicating RNA molecules that contain the nucleotide sequences required for RNA replication, transcription, and translation, but are not themselves infectious.

Using a virus-based system, researchers can now develop antiviral treatments targeting viral entry into the cell, all of the replication machinery of the replicon, as well as downstream events such as viral assembly and release from the cell. As such, the entire viral life cycle is available for drug discovery and development.

“Successful treatment for chronic hepatitis C, given HCV diversity and the spectrum of disease, is likely to require combination therapy and new drugs well beyond those already approved,” said Dr. Rice.

“As part of our commitment to remaining the global leader in the sublicensing of HCV-related technologies, I am particularly pleased with the expansion of our contract services agreement with Southern Research Institute, and I am extremely encouraged by the potential of this business venture assisting our clients in the fight against hepatitis C,” said Robert M. Roth, Apath vice president, Strategic Operations.

Southern Research conducts both contract research and basic research for clients, providing preclinical drug discovery, development, and clinical trial support services in cancer, infectious diseases, and CNS/neurological disease to pharmaceutical and biotechnology companies. Scientists conduct translational science to invent small molecules and advance them from the design stage to the clinic. Services available include medicinal chemistry, molecular biology, biochemistry, high-throughput screening and a full set of in-house GLP development services including toxicology, ADME/PK, animal models, formulations, and bioanalytical services.

About Southern Research

Southern Research Institute is a not-for-profit 501(c)(3) scientific research organization founded in 1941 that conducts preclinical drug discovery and development, advanced engineering research in materials, systems development, and environment and energy research. More than 550 scientific and engineering team members support clients and partners in the pharmaceutical, biotechnology, defense, aerospace, environmental and energy industries. Southern Research is headquartered in Birmingham, Ala., with facilities in Wilsonville, Ala., Frederick, Md., and Durham, NC and offices in Huntsville, Ala., New Orleans, La., and Washington, DC.

 

Southern Research Receives BARDA Award to Develop New Models for Biological Threat Countermeasures

Posted on July 19, 2011

BIRMINGHAM, Ala. – Southern Research today announced that it has been awarded a contract from the U.S. Dept. of Health and Human Services (HHS) Biomedical Advanced Research and Development Authority (BARDA) to develop novel animal models for testing the effectiveness of medical countermeasures against biological threat agents.

“This work will play a key role in protecting against potential public health issues,” said Zara Llewellyn, Ph.D., Project Manager at Southern Research and Principal Investigator. “Our research will help to successfully develop vaccines and therapeutics that will be used to protect people against exposure to biological threat agents. This work is important, especially since drug and vaccine effectiveness against many of these diseases could never be verified in clinical studies.”

Southern Research, with significant experience in emerging infectious disease research, has played a leading role in evaluating vaccines and therapeutics for influenza and emerging biological threats, most recently evaluating vaccine candidates for highly pathogenic Avian influenza (HPAI.) This work will be conducted using Good Laboratory Practices (GLP) guidelines.

Research under this BARDA program will be conducted under Contract #HHSO100201100007I. This task order type contract has a guaranteed minimum of $50,000 and a maximum of $100 million.

About Southern Research

Southern Research Institute, founded in 1941, is an independent non-profit organization conducting basic and applied research and development. The scientific and technical staffs support commercial and government clients and partners in the pharmaceutical, biotechnology, defense, aerospace, environmental and energy sectors through technology out-licensing, sponsored research, and strategic collaborations. Headquartered in Birmingham, Ala., Southern Research has facilities in Wilsonville, Ala., Frederick, Md., and Durham, NC and offices in Huntsville, Ala., New Orleans, La., Washington, DC and Kiev, Ukraine.

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