Tag: In The News

National Cancer Institute extends toxicology contract with Southern Research

Posted on October 5, 2016
NCI extends long-term toxicology contract with Southern Research.
NCI extends long-term contract with Southern Research for preclinical toxicology screening of cancer drugs.

Southern Research has been awarded a five-year IDIQ contract with a potential value of $19 million from the National Cancer Institute (NCI) to study the preclinical toxicology of new drugs under development for the treatment of cancer — contract number HHSN261201600018I.

The contract is one of three ongoing contracts between Southern Research and the NCI, and has been in place continuously since 1979. This is the latest in a series of contract extensions for the organization.

The two additional ongoing contracts between Southern Research and the NCI are for research on the pharmacology of potential new cancer drugs, and for evaluation of drugs intended for the prevention of cancer.

“Our ultimate goal with this contract is to help the NCI develop an understanding of how different drug candidates interact with and affect living systems,” said Charles Hébert, Ph.D., senior program leader and principal investigator on the project for Southern Research. “The collection of this information is necessary so the FDA can determine whether a particular drug candidate is safe for clinical trial testing in humans.”

Toxicology testing is an integral part of the drug development process. In order to determine the safety of a new drug candidate, researchers must first conduct dose range-finding studies to establish the maximum tolerated dose, and to aid in the selection of dose levels for use in further testing.

Once the appropriate dose range has been established for the selected species, larger and more detailed definitive studies are conducted. Those definitive studies differs from dose range-finding studies in that they require deeper and more thorough analysis of the ways a particular drug may affect animals, and by extension, humans. Ultimately, the definitive studies provide key information that is used by the FDA to determine the recommended dose options for any drug candidate approved for clinical trial.

“Southern Research has been at the pioneering forefront of cancer research for more than 70 years, and we are particularly proud of our work with the National Cancer Institute,” said Art Tipton, Ph.D., president and CEO of Southern Research. “We have invested heavily to develop unique capabilities and institutional knowledge in this field, and work diligently to stay on the forefront of the field enabling us to improve people’s lives by finding cures to some very challenging diseases.”

Southern Research studies ways to spur innovation, new jobs in Alabama coal country

Posted on August 30, 2016

Southern Research will use a $60,202 grant from the Appalachian Regional Commission (ARC) to develop a strategic plan to foster job creation and entrepreneurial activity in 19 Alabama counties hurt by the decline of the coal industry.

This downturn has struck a blow to portions of northwest and central Alabama, wiping out thousands of jobs and creating economic hardships, said Corey Tyree, Ph.D., director of Energy & Environment – Alabama, who is leading the project.

Alabama has lost more than 21,000 coal-related jobs.
Alabama has lost more than 21,000 coal-related jobs.

Tyree said employment in Alabama coal fields decreased 43 percent between 1990 and 2014 as the number of mines fell by half. Over this time frame, more than 21,000 coal-related jobs disappeared in these 19 counties, costing their economies more than $1.8 billion in lost wages.

“Looking at the coal mining industry from a long-term perspective, with production at a low point and no clear economic drivers to reverse the negative trends, it’s difficult to see how coal will be a source of job creation in this region of Alabama,” Tyree said.

IDENTIFYING RESOURCES

Southern Research’s strategic plan will examine ways the Alabama coal region can create new jobs that help spur an economic revival.

On the project, Southern Research will team with the University of Alabama at Birmingham (UAB) to identify business sectors ripe for new entrepreneurial activity, given a higher level of investment. The organizations are frequent collaborators and have forged partnerships for drug discovery and medical device development.

Corey Tyree, director, Energy & Environment - Alabama.
Corey Tyree, director, Energy & Environment – Alabama.

Tyree’s project team will also study how similar revitalization projects in the nation achieved successful outcomes and assess how the two organizations’ long-standing R&D experience can support programs that stimulate start-up activity. The goal will be to capitalize on the strengths and capabilities of the existing workforce and put people back to work in new industries fueled by creativity and innovation.

As part of the 12-week project, the team will engage with educators, economic development professionals, investors and others in the coal region to build a broad coalition of advocates for a renewal effort.

The team will also work with partners such as Alabama Department of Economic and Community Affairs, the Energy Institute of Alabama, the Alabama Department of Agriculture and Industries, and the Alabama Department of Commerce.

“Areas that lose their historical economic base must recognize future opportunities for industrial development and growth, and they must put assets in place that fuel job creation and enhance competitiveness,” Tyree said.

FUELING INNOVATION

Included in the study are Alabama’s three top coal-producing counties – Walker, Jefferson and Tuscaloosa. The other counties are Lauderdale, Franklin, Marion, Lawrence, Winston, Colbert, Lamar, Fayette, Pickens, Greene, Bibb, Hale, Shelby, Chilton, St. Clair and Blount.

While some of the counties don’t have significant coal-mining activity, they may house a coal-fired power plant that’s closed or undergone a conversion to natural gas, or they may simply be part of a regional economy that historically included jobs in the coal supply chain. All the counties are in economic development regions drawn by the Alabama Legislature in 2015 to encourage collaboration in job-creation initiatives.

Though Alabama and the coal region have taken steps to put resources in place for entrepreneurs, actual start-up activity remains low, with Alabama ranking No. 49 in new business creation in a 2015 study by the Ewing Marion Kauffman Foundation.

To attack challenges, Tyree said the team will focus on ways to introduce new levels of innovation into the region’s business environment.

“Productivity is the fundamental driver of prosperity, and innovation is the driver of productivity,” he said. “The focus of economic development must be on supporting all forms of innovation as that will fuel the growth of new business in the region by fostering new ideas, technologies and jobs.”

Southern Research’s ARC grant was among $38.8 million in awards announced last week by the Obama Administration for programs to assist communities hurt by the downturn in the U.S. coal industry and changes in the power section.

The ARC is a regional development agency that represents a partnership between federal, state and local government.

FDA advises testing for Zika virus in all donated blood and blood components in the US

Posted on August 29, 2016

This article originally appeared as a news release from the U.S. Food and Drug Administration (FDA) on Friday, August 26.

Food and Drug Administration
FDA announces blood drive advisory to screen all blood donations for Zika virus.

As a further safety measure against the emerging Zika virus outbreak, today the U.S. Food and Drug Administration issued a revised guidance recommending universal testing of donated Whole Blood and blood components for Zika virus in the U.S. and its territories.

“There is still much uncertainty regarding the nature and extent of Zika virus transmission,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “At this time, the recommendation for testing the entire blood supply will help ensure that safe blood is available for all individuals who might need transfusion.”

The FDA first issued guidance on Feb. 16 recommending that only areas with active Zika virus transmission screen donated Whole Blood and blood components for Zika virus, use pathogen-reduction devices, or halt blood collection and obtain Whole Blood and blood components from areas of the U.S. without active virus transmission. All areas with active transmission in the U.S. are currently in compliance with this guidance. The revised guidance announced today recommends that all states and U.S. territories screen individual units of donated Whole Blood and blood components with a blood screening test authorized for use by the FDA under an investigational new drug (IND) application, or a licensed test when available. Alternatively, an FDA-approved pathogen-reduction device may be used for plasma and certain platelet products.

The FDA is updating its guidance after careful consideration of all available scientific evidence, consultation with other public health agencies, and taking into consideration the potential serious health consequences of Zika virus infection to pregnant women and children born to women exposed to Zika virus during pregnancy.

Testing of donated blood is already underway in Florida and Puerto Rico, as well as in other areas, and it has shown to be beneficial in identifying donations infected with Zika virus. Expanded testing will continue to reduce the risk for transmission of Zika virus through the U.S. blood supply and will be in effect until the risk of transfusion transmission of Zika virus is reduced.

Zika virus is transmitted primarily by the Aedes mosquito. Zika virus can also be spread by sexual contact. Although 4 out of 5 people infected with Zika virus never develop symptoms, when symptoms do occur they may include fever, arthralgia (joint pain), maculopapular rash (red area with small bumps), and conjunctivitis (red, irritated eyes). In addition, Zika virus infection during pregnancy can cause serious birth defects and is associated with other adverse pregnancy outcomes.

“As new scientific and epidemiological information regarding Zika virus has become available, it’s clear that additional precautionary measures are necessary,” said Luciana Borio, M.D., the FDA’s acting chief scientist. “We are issuing revised guidance for immediate implementation in order to help maintain the safety of the U.S. blood supply.”

The first local or non-travel related transmission of Zika virus in the U.S. by mosquitoes was reported from Puerto Rico in December 2015; and soon thereafter, local transmission was reported in American Samoa and the U.S. Virgin Islands. In July 2016, the first cases of local or non-travel related transmission of Zika virus in the continental U.S. were reported in Miami-Dade County, Florida.

In addition to protecting the nation’s blood supply, the FDA works to protect the safety of our nation’s supply of human cells, tissues, and cellular and tissue-based products; supports the development and availability of diagnostic tests that may be useful for identifying the presence of or prior exposure to the Zika virus; works with commercial and government developers to advance the development of investigational vaccines and therapeutics; and monitors for fraudulent products and false product claims related the Zika virus.

The FDA, an agency within the U.S. Department of Health and Human Services, promotes and protects the public health by, among other things, assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Battling Zika: Southern Research expert on Bio Report podcast

Posted on August 29, 2016

“To borrow a line from Jurassic Park, life finds a way.” – Jim Pannucci, Ph.D., senior director of Infectious Disease Research at Southern Research.

Bio Report podcastPannucci appeared on the Bio Report podcast with Daniel Levine to discuss his new role with the organization and the battle to find a vaccine therapeutic for Zika and other diseases.

In the conversation, Pannucci spoke about the way infectious disease researchers approach an outbreak. He also connected the spread of the Zika virus, and other diseases that had once been considered tropical diseases, to global climate change, the evolution of mosquito species, and increased rates of travel among humans.

“Due to environmental changes, and species changes, and changes in the mosquitoes themselves, viruses are able to get places that they certainly have not been before.

And, the world is a lot smaller place than it used to be, so people are traveling more often — in and out of endemic areas — and with this come an increased risk of those travelers bringing them [diseases] back.”

Listen to the full podcast to learn more about Southern Research and how the organization contributing to the global effort to find a vaccine or therapeutic cure for this disease.

Tune in here, or stream directly from Soundcloud.

Industry Vet Tim McGrath Tapped to Lead Drug Development

Posted on August 10, 2016

Concluding a national search, industry veteran Tim McGrath has been named the new vice president of the Drug Development division at Southern Research.

With over 30 years of general management and global operations experience, McGrath has worked in laboratory and commercial settings, most recently with North Carolina based Q2 Solutions, a Quintiles/Quest Diagnostics joint venture. There he served as the Global Head for the company’s Bioanalytical and Absorption, Distribution, Metabolism and Excretion (ADME) labs responsible for multiple sites in the U.S. and Europe.

In joining Southern Research, McGrath has one primary goal in mind — embracing market opportunities and maximizing scalable growth potential for the division.

“Throughout the course of my career, I have had the fortune of leading several highly scientific teams with the mandate of building world-class scalable operations in GLP [Good Laboratory Practices] regulated environments,” said McGrath. “Southern Research is positioned as well as, if not better than, any other organization I have seen in terms of growth potential. The breadth and depth of their work is truly impressive.”

McGrath’s experiences in management and business development run deep. He started his career in Massachusetts with the Foxboro Company, where he spent 18 years in commercial operations working his way up the ranks to ultimately serve as a global director responsible for project support services for Foxboro’s Distributed Control Systems Division. In 1999, he left the multi-billion dollar company to join Biotage, LLC, a venture backed start up in Charlottesville, Virginia.

At Biotage, McGrath served as vice president of operations where he helped grow the business 12-fold over six years before assisting the company leadership in selling the company to Pyrosequencing AB located in Uppsala, Sweden. Following the sale of Biotage, McGrath joined Ithaca, New York based Advion Biosciences in 2006 as executive vice president of Operations to manage their product and lab divisions.

This move launched the start of a new phase in McGrath’s career — one in which he spent the next decade leveraging his strengths in operations to help expand the size and capabilities of several highly scientific companies, product lines, and research-based teams. Quintiles Transnational then acquired the laboratory business of Advion Biosciences in 2011 – Bioanalytical and ADME Labs – before becoming part of Q2 Solutions in 2015.

“Drug Development at Southern Research is a broad area — our largest division — where we help government and commercial clients develop potential treatments for HIV/AIDS and cancer, as well as Zika, influenza and other infections,” said Art Tipton, Ph.D., president and CEO of Southern Research. “I am enthused by the growth the division has had in recent years, and even more enthused that Tim will be joining our team to lead and accelerate that growth. His incredible track record, and the strategic direction he brings to the team, coupled with our great scientific depth will add up to a very bright future for Southern Research.”

To echo this point, McGrath was quick to explain his thought process on the new role. “My job is to lead a team of brilliant scientists, while creating the optimum collaboration between science and operations in order to deliver world class project execution. Southern Research has rightfully earned a solid reputation in the scientific community, and I cannot be more excited to work with the team to determine where we want to be 5 and 10 years down the road.”

McGrath is married and has three grown sons and one daughter who is in her second year at Georgia State in Atlanta, Georgia. Originally from Massachusetts, he and his wife are huge fans of their beloved Boston Red Sox and New England Patriots.

 

About the Southern Research Drug Development Division
Southern Research is a 501(c)(3) not-for-profit research organization with four key divisions: Engineering; Energy & Environment; Drug Discovery and Drug Development, the largest of the four. The division has broad capabilities in toxicology, and serves as a contract research organization (CRO) with more than fifty years of experience providing preclinical research and testing for pharmaceutical and biotechnology companies, as well as government agencies. The nationally-accredited, board-certified staff conducts research in facilities that are FDA inspected, AAALAC accredited, and registered with the CDD and USDA for work with Select Agents including Tier 1 agents.

Southern Research Leads ‘Innovation Week’ Panel on Zika Response

Posted on August 8, 2016

Southern Research’s rapid and multi-faceted response to the emerging threat of the Zika virus will be explored in a panel discussion held as part of this month’s “Innovation Week” in Birmingham.

The session, called “Advances in Zika Research,” is scheduled for 4:30 p.m., August 25, at Southern Research’s Southside campus.

“The more we learn about Zika, the more we realize how complex this virus truly is.”

Infectious disease scientists at the Birmingham-based non-profit organization have been heavily involved in efforts to understand and combat Zika, which has been linked to severe birth defects and other neurological conditions.

Southern Research panelists are Jonathan Rayner, Ph.D., director of infectious disease research, Drug Development; Timothy Sellati, Ph.D., chair of the Infectious Diseases Department, Drug Discovery; Sarah Ziegler, Ph.D., responsible official and biosafety professional; and Rossi Carlson, advanced marketing specialist.

“The more we learn about Zika, the more we realize how complex this virus truly is,” Rayner said.

The panel will explain how the organization has approached research into the poorly understood mosquito-borne virus while also engaging in community and public relations outreach to increase awareness and preparedness. Key points in this effort include:

  • Southern Research proactively self-funded internal Zika projects to advance the scientific understanding of the viral infection and set the stage for external research projects.
  • An internal, multidisciplinary committee now meets weekly to share updates on Zika-related research projects, funding opportunities, and more.
  • Southern Research groups such as the Drug Discovery and Drug Development divisions are collaborating on Zika work being done in each division.
  • Ziegler has been working with a Jefferson County Department of Health team to provide guidance to law enforcement, firefighters, first responders and local hospital staffs about how to respond to the Zika threat.
  • The public relations team has actively shared basic Zika awareness guidance, including protective measures, and highlighted the progress of Southern Research’s research programs.

The organization’s infectious disease scientists in Birmingham and Frederick, Maryland, have already made notable advances.

Earlier this year, Southern Research scientists developed a unique antiviral assay, a test that researchers worldwide can use to detect Zika in cell cultures. The organization’s scientists are also developing animal models for the evaluation of candidate vaccines and drug therapies.

In July, Southern Research received a contract worth as much as $3.9 million from the National Institute of Allergy and Infectious Diseases to expand its Zika work and support the quest for a vaccine.

What to know about Zika virus transmission

Posted on June 24, 2016

With mosquito season upon us, here are some facts about how the Zika virus is transmitted so you can take the necessary precautions to protect yourself and stay healthy during your summer travels.

The most common method of transmission is through the bite of an Aedes aegypti or Aedes albopictus mosquito. However, Zika can also be transmitted sexually from an infected man to his partners.

In order to carry the Zika virus, a mosquito must first draw blood from a human or animal that is already infected. Once a mosquito comes in contact with the virus, however, she can pass it along to other humans through the saliva she secretes when biting — this is the same chemical that irritates human skin and can leave welts.

The average lifespan of a mosquito is approximately two weeks. During this time, an infected mosquito may bite several people and can spread the virus with each bite. This process is compounded as the number of mosquitoes in a given area is increased.

Once a human is infected, he or she is most at risk of spreading the virus during the first two weeks of infection. After this time, the virus usually subsides and most people will develop an autoimmunity to be protected from future infections.

It’s important to know: not everyone who has Zika will experience symptoms. However, the most common symptoms are fever, rash, joint pain and conjunctivitis (red eyes). There is also a rare chance of contracting a more severe condition like Guillain-Barré Syndrome.

Therefore, take proper precautions to protect yourself from becoming infected or contributing to the spread of the virus:

Wear protective clothing: Long-sleeved shirts and pants help protect your skin from exposure to mosquitoes. You can also spray your clothes with insect repellant, or for extra protection, treat your clothes with permethrin.

Use insect repellant: Be sure to look for active ingredients including DEET, PICARIDIN, IR3535, OIL of LEMON EUCALYPTUS, and PARA-MENTHANE-DIOL.

Remember, daytime is the most dangerous: A. aegypti and A. albopictus are aggressive daytime biters, so take proper precautions and be aware that these mosquitoes also like to live indoors.

Zika and Sexual Transmission
Men are the only ones who are able to pass the Zika virus to their sexual partners. According to the World Health Organization (WHO), if a man has been diagnosed with Zika, or has experienced Zika-type symptoms, he should abstain from sex or wear condoms for up to six months. Women cannot transmit Zika through sex.

Additionally, any individual who has travelled to areas where the virus is spreading is advised to abstain from sex, or use a condom for eight weeks after travel.

For more information, visit the CDC website on Zika and sexual transmission.

Zika and Pregnancy
Zika virus can have a damaging effect on the development of a fetal neural system if a pregnant woman is infected during the early stages of her pregnancy. According to a recent study published by researchers from Harvard and the CDC, a woman infected by Zika during her first trimester is shown to have a 13 percent risk that the child will develop microcephaly.

This same study found “negligible” risks for women infected with the virus late in second or third trimesters. To date, there are no reports of Zika being passed to infant children through breastfeeding. More research is needed before the health community is able to make a definitive statement about the risks associated with microcephaly or other birth defects.

For more information about Zika and pregnancy, visit the CDC page for Pregnant Women.

Additional resources for Public Health Officials, and State and Local Governments:

A copy of the CDC Interim Response Plan for how to deal with a local Zika outbreak.

Recommendations for Zika Vector control (CDC)

Additional resources for Individuals and Businesses:

How to protect against mosquito bites (2 page PDF from the CDC)

Additional resources for Doctors and Health Professionals:

Resources in multiple languages are available through the Centers for Disease Control and Prevention.

How Mosquitoes Bite: Get smart quick

Posted on June 22, 2016

Summer has arrived in Birmingham, and with it comes mosquito season. Given our research on Zika, and other mosquito-borne diseases, we would like to share some facts about how mosquitoes bite as part of our “Get Smart Quick” content series.

So, in 400 words, how do mosquitoes actually bite?

First, only female mosquitoes bite. They require the nutrients found in blood to produce eggs. Male mosquitoes feed mostly on flower nectar.

When feeding, the mosquito uses her proboscis — the long needle-like feature on her snout — to identify and extract blood from its target. However, this process is slightly more involved than most people think.

The proboscis (pro-boss-sis) is made up of six needles hidden under a protective sheath called a labium. When she bites, the labium folds backwards, exposing the six needles that make up her proboscis. These include:

A pair of maxillae, which have tiny saw-like teeth at their tips, used to pierce and cut the skin.

A pair of mandibles, inserted alongside the maxillae, used to spread the skin. The mandibles also provide leverage for digging the other needles deeper into the skin.

The Hypopharynx is a hollow needle used to secrete a saliva-like chemical that prevents blood from clotting. This saliva also causes the itchy reaction people experience, and serves as the fluid through which a female mosquito can transfer disease.

The labrum, the largest of the six needles, is a flexible straw-like feature used to explore for blood. Receptors at the tip of the labrum can detect naturally-occurring chemicals found in blood vessels, and guide the needle to its source. Like a modern oil or gas drill, the labrum can maneuver at sharp angles and explore horizontally underneath the skin surface (Check out this video captured by researchers at the Institut Pasteur in Paris). Once a vein is found, she uses the labrum to suck the blood.

While feeding, a mosquito will separate water from the blood and squeeze the water out of her rear end. This allows her to retain the greatest possible amount of nutrient-rich blood in each feeding.

The A. aegypti and A. albopictus will produce between 100-200 eggs per batch, and may lay approximately three batches in their 8-10 day lifecycle.

Eggs are often laid in, or near, standing water. However, A. aegypti eggs can survive in dry climates for periods longer than a year before hatching. Under these conditions, they hatch immediately after being submerged in any amount of water. Thus, the A. aegypti mosquito population is very difficult to control.

To learn more about how to protect yourself from A. aegypti and A. albopictus, visit the CDC page on Zika prevention.

Not all mosquitoes are created equally

Posted on May 27, 2016

This may come as a surprise to some people, but there are over 3,500 different species of mosquitoes in the world. Of these, it is believed that approximately 175 can be found in the United States, two of which are known to serve as vectors for the Zika virus — the Aedes aegypti and Aedes albopictus. 

Aedes aegypti, also known as the yellow fever mosquito, is the primary species responsible for transmission of the Zika virus. It is an aggressive mosquito that originated in Africa, but has spread invasively throughout the equatorial and warmer regions of the world via modern trade routes. Unlike some mosquitoes, A. aegypti feed only on humans, and are capable of breeding virtually anywhere, requiring very little amounts of water in which to lay their eggs. This species also likes to live in urban environments, which has helped it emerge as such a highly effective vector for the spread of Zika across Brazil and throughout the Western Hemisphere.

Aedes albopictus, commonly known as the Asian tiger mosquito, has long been known as a vector for dengue, yellow fever, and chikungunya. However, researchers in Mexico recently found it to also carry Zika. This discovery has led the global health community to question whether A. albopictus will exacerbate the rate and number of Zika outbreaks as we enter deeper into mosquito season.

A. albopictus differs from A. aegypti in two important ways. First, it can survive in more temperate climates and is, therefore, more widespread throughout the continental United States. It is also less aggressive towards humans, and known to enjoy feeding on birds and other animals. This means that even though A. albopictus is a source of concern, it is not believed to pose the same level of threat as A. aegypti.

Other distinctions of note

Unlike the Anopheles, or malaria mosquito, which only bites at night, A. aegypti and A. albopictus are day feeders and can breed virtually anywhere, requiring only small amounts of water in order for their eggs to hatch. Additionally, both species like to live near humans and can  often be found living in homes and under beds. Combined, these traits render traditional mosquito prevention methods — such as bed nets, fumigation, and staying indoors — as insufficient tools for effectively controlling the spread of Zika virus.

Fast facts about the A. aegypti and A. albopictus mosquitoes:

  • The average lifespan for the Ae. aegypti is only 10 days.
  • Females are the only mosquitos that take a blood meal.
  • Mosquitoes don’t actually “bite” — rather, their tubular mouth parts (proboscis) are used like needles.
  • When feeding, mosquitoes secrete saliva to prevent the blood from clotting.
  • An average female can lay 1,000 eggs in her lifetime.
  • They prefer to feed during the day.
  • It takes only a couple of infected mosquitoes to cause an outbreak.

To learn more about how to protect yourself from A. aegypti and A. albopictus, visit the CDC page on Zika prevention.

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