Tag: Drug Development

National Cancer Institute extends toxicology contract with Southern Research

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 hires VP of Quality and Compliance

Southern Research is pleased to announce the hiring of Greg Furrow as Vice President of Quality and Compliance. As vice president, Furrow joins the executive team, and in addition to overseeing quality and regulatory compliance, will have oversight of environmental health and safety (EH&S) standards across all of Southern Research.

Prior to joining Southern Research, Furrow served as Vice President of Quality and Regulatory Compliance at WIL Research, where he was responsible for all areas of compliance and EH&S across six laboratories in the United States, France and the Netherlands. Furrow is also a board member and past-president of the Society of Quality Assurance (SQA), and is active in the quality assurance community globally.

“We are excited for Greg to join Southern Research, and look forward to the contributions he will make across our organization,” said Art Tipton, Ph.D., president and CEO of Southern Research. “Our scientists and engineers come to work every day prepared to help solve some of the world’s hardest problems, and the quality of our work and compliance to regulatory standards is of the utmost importance. This move further streamlines communication on safety issues directly to the executive team, and will strengthen our organization more broadly.”

Early Career

After receiving a master’s degree in analytical chemistry at the University of Maryland, Furrow started his career as an analytical chemist at the USDA, then with Eli Lilly and Company, where he worked for 21 years. He left the bench to oversee the company’s analytical laboratories at their Clinton Laboratories manufacturing site. This transition opened the door to a management position in human resources for global Toxicology and Drug Disposition, and ultimately a position as Manager of Quality Assurance for Global Toxicology & Drug Disposition and global Elanco nonclinical and clinical.

“Like a lot of other things, management is all about people,” Furrow added. “My role is to ensure that the people who are working in the lab are empowered with the knowledge and resources they need to be successful and accountable. I am excited to bring my expertise in the field to lead this function and work as a team to accomplish our quality and compliance goals.”

In 2006, Furrow left Eli Lilly to lead a segment of Regulatory Affairs and Quality as a senior director with Charles River, based in Shrewsbury, Massachusetts. In this role, he spent five years expanding his focus and deepening his understanding of the quality and safety standards involved with industrial chemicals and new devices.

Quality and Compliance as a tool

“I have always approached quality assurance from the position that we are not the police,” Furrow said. “The key to any successful operation is to change the perception from one where QA is the watchdog, to one where QA is a valued partner available to offer insight, feedback and guidance. Southern Research has a distinguished reputation for high quality work, and I look forward to working with teams to harmonize QA, improve quality and efficiency across the entire company and empower individuals to take ownership of their processes and improve performance.”

A past-president of the SQA, Furrow remains active in the global QA field. Additionally, he is co-chair of the committee tasked with writing a response to the GLP Notice of Proposed Rulemaking (proposed revision to the FDA GLP regulations). Furrow also has a deep appreciation for the importance of environmental health and safety and will bring an experienced viewpoint as the new leader for this critical function.

At the end of the day, it’s all about the people. For the past 75 years Southern Research has empowered its people to drive innovation within the state, region and for a global clientele. Furrow will strengthen this tradition while continuing to influence policy and advancing best practices that will lead to future scientific discoveries.

Battling Zika: Southern Research expert on Bio Report podcast

“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.

Southern Research hires Jim Pannucci to lead infectious disease research

Infectious disease research veteran Jim Pannucci, Ph.D., has joined Southern Research as senior director for infectious disease research, the largest focus area within the organization’s Drug Development division.

Jim Pannucci is senior director for infectious disease research at Southern Research.
Jim Pannucci is senior director for infectious disease research at Southern Research.

In this new role, Pannucci will direct a diverse team focused on developing vaccines and conducting ground-breaking research on a number of high-profile diseases, including HIV/AIDS, influenza, and mosquito-borne viruses such as Zika, chikungunya, dengue and yellow fever. Last month, the team received a National Institute of Allergy and Infectious Diseases contract to develop a non-human primate model for Zika drug candidate analysis.

Pannucci joins Southern Research with 24 years of life science industry experience. He previously served as vice president and Life Sciences division manager at Reston, Virginia-based Leidos.

Based at the company’s Frederick, Maryland, location, he had management responsibilities for a staff of 130 and oversaw research on vaccines and research programs related to infectious diseases, cancers and neurological disorders. He also managed client relationships and led the pursuit of new business opportunities.

LEVERAGING CAPABILITIES

Pannucci’s scientific career began with characterizing antiviral therapeutics at pharmaceutical company Schering-Plough. He conducted post-doctoral studies at the Los Alamos National Laboratory, where he became a technical staff member and a team leader in the BioScience Division over nearly eight years. He joined Leidos in 2006.

“As a scientist, I am excited that my work helps people and contributes to curing. Much of my professional success stems from the opportunities I’ve had at the intersection of business and science, and that has helped me develop skills I can take to my new role,” Pannucci said.

“Southern Research is in an incredible position to leverage its unique capabilities into new growth opportunities. We have brilliant people who have proven themselves capable of solving some of the world’s hardest problems,” he added.

Pannucci has identified four key goals for Southern Research’s infectious disease team: maximizing growth opportunities, both in size and scope; optimizing the team’s business practices; aligning capabilities with the goals of current and future customers; and retaining world-class talent.

SPEARHEADING GROWTH

“Jim joins Southern Research at an exciting time for our organization, and he is the perfect person to spearhead our continued growth in the strategically important arena of infectious disease research,” said Tim McGrath, vice president of the Drug Development division.

“Our infectious disease research team has a number of unique capabilities championed over the years by Mike Murray, Jon Rayner, and Roger Ptak, and I am eager to support Jim and the team as they continue to advance research on some of the most pressing global health issues of our time.”

Murray, formerly Southern Research’s director of infectious disease research in Frederick, Maryland, now serves as director of government business development. Rayner is director of infectious disease research in Birmingham. Ptak is program leader for in vitro antiviral drug development in Frederick.

Pannucci will work in Southern Research’s Frederick office, which has been in operation since the early 1990s. Southern Research also carries out significant infectious disease research at its campus in Birmingham, where the Drug Development division is based.

Pannucci holds a Ph.D. in microbiology from North Carolina State University, a master’s degree in biology from Seton Hall University, and a bachelor’s in pathobiology from the University of Connecticut.

Industry Vet Tim McGrath Tapped to Lead Drug Development

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.

NIAID contracts with Southern Research to study Zika

Southern Research has received a contract from the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH) to expand their research on the Zika virus (ZIKV). The award is for an initial $901,048, with a possibility of increasing up to nearly $3.9 million over the next two years, in accordance with Contract No. HHSN2722010000221.

The funds have been awarded for the development of a non-human primate model of ZIKV infection for product evaluation. Research will involve evaluating the pathogenicity of three different geographic isolates of ZIKV at increasing concentrations, and assessing the impact of prior exposure on immunity to subsequent infection with the same isolate, or a different isolate of the virus. The resulting model will serve as a resource to inform research around possible vaccines or therapeutics for ZIKV disease.

“Our ultimate goal with this project is to establish a model of Zika virus infection that can be used for the evaluation of new vaccines and therapeutics in optional efficacy studies sponsored by NIAID,” said Jonathan Rayner, Ph.D., principal investigator on the project, and head of infectious disease research, Drug Development, at Southern Research. “There is an understanding that the virus may continue to spread into new regions over the summer. Therefore, this contract from NIAID is timely and will help us to expedite efforts to understand the pathogenesis of this virus, and support the search for new vaccines and therapeutics.”

ZIKV is spread primarily through the bite of an Aedes aegypti or Aedes albopictus mosquito, but can also be transmitted sexually. An outbreak of the virus in Brazil and South and Central America has led to a significant increase in the number of children born with microcephaly, and has caused the Centers for Disease Control and Prevention to issue travel warnings to pregnant women and others considering travel to regions where the virus has spread. With a growing number of confirmed ZIKV cases in the United States, there is no known vaccine or treatment for the virus.

“Southern Research has a long history of pivotal work on infectious diseases, including mosquito-borne illnesses including dengue, chikungunya, and West Nile Virus,” said Art Tipton, Ph.D., president and CEO of Southern Research. “Our team is uniquely positioned to support the growing body of global research on the Zika virus through translational science, and we’re grateful for the solid partnerships we’ve developed over the years with the NIH and NIAID.”

The research will be led by Jonathan Rayner, Ph.D. in collaboration with Senior Project Leader Fusataka Koide, Ph.D. In addition to the non-human primate model that is the subject of this contract, Southern Research is working on other in vitro and in vivo models for ZIKV, and has previously developed a unique antiviral assay used by researchers to screen candidate therapeutics and a mouse model to evaluate the efficacy of those therapeutics. This research will also provide the foundation for Southern Research to utilize its expertise in Developmental and Reproductive Toxicology to better understand the impact of ZIKV infection on the fetus during pregnancy.

About Southern Research
Southern Research is a not-for-profit 501(c)(3) research institution with nearly 500 scientists and engineers working to solve some of the world’s hardest problems across four key divisions: Drug Discovery, Drug Development, Engineering, and Energy & Environment. Founded in 1941, 2016 marks Southern Research’s 75 Anniversary. Over this time, the institution built a trusted name for itself, and has continually worked with some of the world’s leading organizations, including the National Cancer Institute, National Institutes of Health (NIH), the U.S. Department of Defense, the U.S. Department of Energy, NASA, several major aerospace firms, the nation’s largest utility companies, and other private and government organizations. Headquartered in Birmingham, Southern Research has additional laboratories and offices in Wilsonville and Huntsville, Alabama; Frederick, Maryland; Durham, North Carolina; Cartersville, Georgia; and Houston, Texas. For more information, please visit www.SouthernResearch.org.

How Southern Research cancer advances changed a life

Allen Tucker, left, poses with his brother Alex, a member of Auburn's track team. As a child, Allen was treated for leukemia with drugs Southern Research helped develop.
Allen Tucker, left, poses with his brother Alex, a member of Auburn’s track team, at a recent meet. As a child, Allen was treated for leukemia with drugs Southern Research helped develop.

Southern Research physicist Jim Tucker has spent most of his career tackling the challenges that must be overcome to make space flight possible, so he knows all about the organization’s important contributions to the Space Shuttle and other programs.

Tucker has also seen first-hand the impact of Southern Research’s breakthrough work in a completely different field – cancer research.

His 23-year-old son, Allen, is alive today thanks to the pioneering work of Southern Research scientists who discovered the fundamentals of chemotherapy and helped developed the drugs used in his treatment.

“It has always been cemented in my mind that Southern Research is one of those bastions of research that changes your life,” Tucker said. “That was never in doubt, but this has been reaffirming for me in a powerful way.”

The story begins in August 1996, when Allen was just 3. Though he was born with Down Syndrome, Allen was a healthy child until Acute Lymphatic Leukemia (ALL) struck. At first, he was lethargic and increasingly withdrawn. Then the pain started.

The pain was so severe that Allen let out a scream when the family car hit a speed bump on the way to Children’s Hospital. By this time, Allen was running a fever and had completely stopped moving.

Tucker and his wife, Pam, were terrified when the doctor diagnosed ALL. The chemotherapy, though, restored hope.

“It was a virtual resurrection. If you’ve ever seen a child with leukemia about to start the treatment, it’s frightening,” Tucker said. “Allen was motionless and had a morphine drip. Then they started treatment, and within two or three days, he was back. It was amazing.”

TREATMENT ADVANCES

Tucker said Allen’s treatment included doses of methotrexate, 6-Mercaptopurine (6-MP), and Leucoveron — three medicines that Southern Research played a prominent role in developing.

Southern Research scientists discovered a superior method for producing methotrexate, a drug that is used against a range of autoimmune disorders, and the organization held a patent on Leucoveron’s method of production. In addition, Southern Research scientists performed the fundamental biochemistry work on 6-MP, an important chemotherapy drug.

“That was quite remarkable to me,” Tucker said.

Later, Tucker began to understand that Southern Research’s groundbreaking work on chemotherapy had played an even more significant underlying role in Allen’s treatment. That’s because Southern Research scientists led by Howard Skipper decades earlier had established many of the principles that paved the way for effective chemotherapy.

Skipper and his team showed that every malignant cell has to be eradicated to ensure patient survival and that chemotherapy drugs given in combination can overcome resistance. Skipper also introduced the concept that a dose of chemotherapy kills a specific percentage of cancer cells rather than a specific number – an important treatment insight.

“The work Howard Skipper did here essentially led to the cure for leukemia,” said Tucker, who heads Southern Research’s materials research group. “I’m a physicist, so statistics are big to me, and it was his statistical revelations that cured my son’s cancer. He made a huge impact on a lot of lives, including mine.”

17 YEARS LATER

After Allen left Children’s, he still faced a grueling 2.5 years of chemotherapy to make sure every last cancer cell was gone. Once the treatment was complete, Tucker had a message for his Southern Research co-workers.

“We want to remind people here that without their work, our son would still be in tremendous pain, battling a disease that could have taken his life,” he said in a 1999 interview for SRItems, the internal publication.

Back then, Tucker wouldn’t use the word “cure” because he feared a recurrence. Today, Allen attends an adult special-needs program three times a week, where he can enjoy art and music. He remains cancer-free.

“The concept of a cure is something I can talk about 17 years later. He was 6 when he came off chemotherapy; now he’s 23,” Tucker said. “That’s where Southern Research comes in.”

Learn more about Southern Research’s current cancer research.

BIO agenda: Advance the Alabama Drug Discovery Alliance, promote state

Southern Research
Two drug discovery scientists at work in a Southern Research lab.

A Southern Research team is showcasing the Alabama Drug Discovery Alliance (ADDA) and its pipeline of potential therapies for debilitating diseases at this week’s BIO International Convention, while also promoting Alabama’s advantages in the sector to industry leaders.

The ADDA is a strategic collaboration that unites the talents and resources of Southern Research and the University of Alabama at Birmingham School of Medicine in a coordinated drug discovery and development program.

Art Tipton, Ph.D, president and CEO of Southern Research, said the team will engage in focused talks with high-level biotech and pharmaceutical industry executives while in San Francisco for BIO. The team has more than three dozen scheduled partnering sessions, and the number of meetings could rise.

Joining Tipton for the talks are Mark Suto, Ph.D, vice president of discovery at Southern Research, and Maaike Everets, Ph.D., director of the ADDA and an associate professor in UAB’s Department of Pediatrics.

“We’re hugely excited about the pipeline,” Tipton said. “While early stage, we have some great candidates, and our approach minimizes risk as we partner academic discovery with industry diligence.”

The ADDA’s pipeline today consists of about 17 potential therapies, including possible treatments for Parkinson’s disease, diabetes, kidney disease and many forms of cancer. Last month, researchers at the two institutions received a $250,000 grant to expand an investigation into Alzheimer’s that began as an ADDA project.

BIO CONVENTION LOGO_VERTICAL_NODATES_CMYKAt BIO today, Tipton participated in a panel discussion titled “Creative Partnerships: Leveraging Economic Development Organization Support in the Life Sciences Sector.” The event was sponsored by Select USA, a U.S. Department of Commerce program that promotes the U.S. as a site for investment and commercial ties.

Tipton discussed topics including Alabama’s overall life sciences climate and the Alabama Legislature’s support of the ADDA. He also described how the Alabama Innovation Fund provided a critical grant for the Alliance for Innovative Medical Technology, another Southern Research-UAB partnership that has developed a unique treadmill.

The BIO conference in San Francisco’s Moscone Center is expected to attract 15,000 biotech and pharma leaders from around the world over a week. More than 4,000 companies are expected to attend, with 69 countries represented.

In a question-and-answer session, Tipton discusses Southern Research’s goals at the conference and how the organization’s team plans to support the Alabama delegation while in San Francisco.

 Why is Southern Research focusing on drug discovery work at BIO?

“The headline reason we’re going is everything we’re doing with the Alabama Drug Discovery Alliance. The companies want to meet with us because we have a very promising early-stage pipeline, and they need additional candidates in their pipelines. It’s that simple.

“We’re meeting with senior-level people charged with finding new molecules to fill up their pipelines. Big Pharma is there looking for blockbuster potential to add to the pipeline.”

Will Zika – a special area of interest for Southern Research – be a major topic?

 Zika will come up at the conference. It’s the hottest topic right now, and we’ll get asked about what we can do and what we are doing in Zika. We have the first cynomolgus monkey model for doing Zika work, and that’s going to attract some attention. We have the capabilities with high-throughput screening and in vitro characterization to look at new vaccines.

“We can help companies that are developing products.”

Aside from the partnering meetings, what else will you participate in at BIO?

 “There will be briefing documents coming from the federal government about what it is looking to fund in upcoming years. So, we can get, particularly in the infectious disease space but also in a number of other areas, insight into what they want to fund. That’s hugely valuable.

“The sessions on Zika are going to be packed, because the government is going to be making significant funding available. For all things related to bio-threat reduction, we’ll be able to be front and center and to see and hear about those things.”

Alabama is placing a greater emphasis on recruiting bioscience jobs. Is there a bioscience field that ideally fits with what the state can offer?

 “For me, one area we should be focusing on in the sector, from an economic development perspective, is additional biotech/pharmaceutical manufacturing. That’s where we are going to create the greatest number of jobs in Alabama. We can manufacture and produce things competitively with any other part of the country. Those jobs are a great match for the workforce we have in the state.”

How will Alabama benefit from broad involvement in BIO?

 “The companies from across Alabama will get to know each other better, get to know what their capabilities are – that’s always a good thing. We will have an opportunity, both on the exhibit floor and at the dinner, to present ourselves as a state and to show the breadth of companies in Alabama to a variety of people.

Also, many other states will have a presence at BIO. Being represented there puts Alabama in the bioscience sector, just like all the other states. That’s a positive thing. Having a continual presence at the conference is important. People know each other, they’re in the mix, they know who to contact in the state.”

Southern Research launches philanthropic outreach with $500,000 gift

BIRMINGHAM, Alabama — Southern Research, a non-profit organization marking its 75th year of operation in 2016, today launched a broad-based philanthropic outreach initiative that includes a significant employee giving campaign.

The Southern Research employee give campaign is targeting $1 million in contributions over five years to fund innovative research programs, needed capital improvements, equipment purchases, and other potential uses.

To kick start the campaign, former President and CEO John A. “Jack” Secrist III, Ph.D., has pledged a donation of $500,000 to create the Encourage Innovation Fund. The fund will be used to enhance the organization’s ability to attract talented researchers and to help them thrive once they’re on board.

Secrist is a noted scientist who retired from Southern Research in 2013 after 34 years, including seven as its top leader. His research focused on the development of new anticancer, antiviral and antibacterial agents, and he is the co-inventor of clofarabine, an FDA-approved treatment for pediatric leukemia.

“Southern Research has played a prominent role in efforts to discover more effective treatments for cancer, make man’s journeys into space safer, and develop new technologies for a cleaner environment,” Secrist said. “From its beginning, the organization has been a hotbed of innovation, and supporting it today means that it will continue to make important contributions well into the future. We appreciate being part of that future.”

To show their firm support for the initiative, Southern Research’s entire leadership team – comprised of 33 officials, from the CEO to the director level – has agreed to participate in the employee give campaign.

Before today’s public announcement, the employee give campaign had quietly generated commitments totaling $145,000, all from the organization’s leadership team. Coupled with Secrist’s substantial contribution, Southern Research is making a strong push toward the campaign’s $1 million goal.

PHILANTHROPIC OUTREACH

In addition, Southern Research is taking steps to reconnect with the philanthropic community and with donors whose generosity enabled the organization founded in Birmingham in 1941 to become a world leader in cancer research and make noteworthy advances in other fields including clean energy, vaccine development and engineering.

As a 501(c)(3) non-profit organization, Southern Research seeks charitable donations to complement its traditional funding stream of research grants and contracts secured from government and commercial sponsors.

“As we celebrate our 75th anniversary, and beyond, we’re looking forward to reengaging with the philanthropic community and with donors who have helped Southern Research make a difference in the world,” said Art Tipton, Ph.D., president and CEO. “In fact, our cancer research program, which has been instrumental in saving countless lives with drug discoveries and therapeutic breakthroughs, got its start in 1946 with a single $25,000 philanthropic gift.”

As part of this outreach, Southern Research recently brought Brynne MacCann on board to provide administrative and tactical support to the organization’s fund-raising strategy. MacCann previously served as vice president for development at the McWane Science Center, and, prior to McWane, in development roles at the Birmingham Museum of Art and the MS Society.

Today, Southern Research’s four operating divisions focus on drug discovery, drug development, engineering, and energy and the environment. Its staff of more than 400 scientists, engineers and researchers work at facilities in Alabama, Georgia, North Carolina, Maryland and Texas.

Southern Research was incorporated on Oct. 11, 1941, as the Alabama Research Institute, and its name was changed three years later to reflect its regional focus. Over the years, the organization has conducted work on behalf of the National Cancer Institute, National Institutes of Health, the U.S. Department of Defense, the U.S. Department of Energy, NASA, major aerospace firms, utility companies, and many others.

Cynomolgus macaque model for ZIKV research

Used previously for dengue virus studies, this cynomolgus macaque model will serve to better understand synergy between these viruses

In an effort to help identify a vaccine for the Zika virus (ZIKV), Southern Research is actively running experiments to study the course of ZIKV infection in non-human primates, while developing animal models for the evaluation of candidate vaccines and drug therapies. Cynomolgus macaques were chosen for these studies as they have a relatively simple HLA phenotype that allows for a reproducible immunological response. Additionally, the Cynomolgus macaque was previously established at Southern Research as a relevant animal model for dengue viruses (DENV), and has been successfully used to evaluate new candidate DENV vaccines. This model will allow the study of viral synergy to better understand the impact of cross-reactive but non-neutralizing antibodies from DENV infection/vaccination on ZIKV pathogenesis.

In this study, a total of six (6) male and female ZIKV and DENV seronegative Cynomolgus macaques were challenged with ZIKV strain isolates PRVABC59, FSS13025 or IBH 30656 subcutaneously (n=2 per strain) with a target delivery dose of approximately 1×104 or 5×105 PFU per monkey. A description of the viruses used are shown in Table 1.

After ZIKV inoculation, serum and tissue samples were collected at predetermined time points and are being analyzed by quantitative real-time polymerase chain reaction (qRT-PCR) for the detection of viral load. Additionally, Day 14, 30 and 60 serum samples will be analyzed by Plaque Reduction Neutralization Test (PRNT) for the enumeration of ZIKV neutralizing antibody (Nab) as a potential surrogate of protective immunity.

Table 1. Zika virus strains evaluated in a non-human primate model of infection.

Zika Virus Isolate Source Year of Isolation Geographical Origin
PRVABC59 CDC 2015 Puerto Rico (AM)
FSS13025 UTMB arbovirus Reference collection 2010 Cambodia (AS)
IbH 30656 BEI Resources 1968 Nigeria, West Africa (AF)

Preliminary results of this study demonstrated no significant changes in body weight, body temperature or clinical signs in animals challenged with ZIKV, as was expected from studies reported by other groups in Rhesus macaques and consistent with DENV infection of this model. However, ZIKV RNA was detected by qRT-PCR in the serum of primates challenged with the Puerto Rican strain of ZIKV (PRVABC59) as soon as 1 day post-challenged and peaked after Days 2 or 3 but remained detectable out to 14 days (Fig. 1). In contrast, ZIKV RNA concentrations in serum from those animals challenged with the Cambodian Strain (FSS13025) fell below the level of detection on Days 8 or 10 but increased again by Day 14 in at least one of the 2 animals. SR is continuing to assess viral load in serum and tissues from all primates on study, and data will be updated as soon as it becomes available.

Preliminary data for Cynomolgus Macaque model (updated: 8/03/16)

Click the images below to enlarge.

 

cynomolgus macaque_ZIKV RNA challenged with Puerto Rican strain ZIKV PRVABC59
Figure 1. Concentration of ZIKV RNA in serum samples from Cynomolgus macaques challenged with the Puerto Rican strain of ZIKV (PRVABC59).

 

cynomolgus macaque_ZIKV infection_serum viral load_qRT-PCR
Figure 3. Measurement of serum viral load in cynomolgus macaque following challenge with the Nigerian strain ZIKV IBG30656

 

cynomolgus macaque_Urine and saliva ZIKV viral load by qRT-PCR
Figure 4. Measurement of ZIKV viral load found in the urine and saliva of cynomolgus macaques challenged with the Puerto Rican strain ZIKV PRVABC59 by qRT-PCR

 

cynomolgus macaque_Neurtalizing Antibodies
Figure 5. 60-day measurement of neutralizing antibodies found in cynomolgus macaque challenged with PRVABC59.