Year: 2015

How Drug Development Works

Posted on April 20, 2015

It can take 10 to 15 years for scientists to begin the journey of understanding a disease, to creating a drug that fights it.

  • IND Application: File Investigational New Drug application with the FDA before clinical testing.
  • Phase 1Clinical Trial: Perform human testing in a small group of healthy volunteers to determine if the drug is safe for people. (20-100 people)
  • Phase 2 Clinical Trial: Test in a small group of patients with a disease to evaluate drug effectiveness. (100-500 patients)
  • Phase 3 Clinical Trial: Test in a larger group of patients to determine safety, efficacy and risk/benefit (1,000-5,000 patients)
  • NDA: Submit New Drug Application to the FDA.
  • Manufacture the drug on a small or large scale
  • Phase 4 Trial: Pharma companies continue to monitor the drug and submit reports to the FDA re: any adverse effects.

Southern Research Names Alan Stokes Director of Toxicology and Pathology

Posted on April 6, 2015

BIRMINGHAM, Ala. –  April 6, 2015 – Alan Stokes, Ph.D., today joined Southern Research’s drug development division as the director of toxicology and pathology at its Birmingham headquarters. In this role, Stokes will manage groups of toxicologists, laboratory technicians, project team members, and formulation scientists for contracted studies in support of drug development activities.

“We are extremely pleased to have Dr. Stokes join the Southern Research drug development team,” said Andrew Penman, vice president of drug development at Southern Research. “He is bringing with him invaluable experience both in interacting with regulatory agencies and representing the non-clinical toxicology function for therapeutics at all stages of development.”

Stokes has more than 14 years of combined experience in pharmaceutical drug development for leading pharmaceutical companies including Schering-Plough, Wyeth Consumer Healthcare, and most recently, GlaxoSmithKline, where he was head of toxicology at Research Triangle Park, North Carolina.

He is a diplomate to the American Board of Toxicology, and he is a member of the Society of Toxicology, the American College of Toxicology, and the editorial board for the International Journal of Toxicology.

Stokes earned a doctorate in pharmacology with a focus on neurotoxicity from Wake Forest University and completed a post-doctoral fellowship at the Robert Wood Johnson Medical School Department of Neurology at Rutgers University.

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 energy and environment research. Approximately 500 team members support clients and partners in the pharmaceutical, biotechnology, defense, aerospace, environmental, and energy industries in facilities in Alabama, Maryland, North Carolina, Georgia, and Texas.

 

Southern Research Announces Inaugural Advisory Board

Posted on March 19, 2015

BIRMINGHAM, Ala. – March 19, 2015 – Southern Research announced today the launch of its foundational advisory board. The 10-person board was established to engage young professionals in the Birmingham community who are committed to enhancing Southern Research’s mission of scientific and engineering advancement.

Southern Research has a rich history of achievement throughout its 74-year existence, and appointing this group of young professionals in Birmingham will ensure the next generation of community leaders is familiar with Southern Research’s role in the city and its ongoing efforts to make the world a better place in which to live.

“The history of Southern Research is linked to the industrial history of Birmingham, from 1941 onward. Looking forward, we knew it was important to establish an advisory board of local, young leaders to be community ambassadors who are well-informed about this organization and the breadth of our work,” said Southern Research President and CEO Art Tipton, Ph.D. “We anticipate developing mentorships between advisory board members and Southern Research leadership, and, in turn, having members help broaden our external view and our preparation for ongoing growth.”

As an organization that is dedicated to solving the world’s hardest problems, Southern Research is proud to solicit the input and feedback from this group of men and women who are already contributing a great deal in their respective professions. Through quarterly meetings, the advisory board will hear from leading scientists and engineers regarding the latest updates on not only the work that is ongoing at Southern Research, but also the recent trends and issues associated with the organization’s multi-disciplinary portfolio.

“In forming the advisory board, I worked closely with Dr. Tipton to identify successful professionals in Birmingham who are committed to our city and who could share their diverse business experience and success with the Southern Research team,” said Mitesh Shah, Shareholder, Maynard, Cooper & Gale, PC. “The Southern Research advisory board provides a unique opportunity to gather together these talented, exceptional business leaders.”

The 10-member advisory board is comprised of the following community and business leaders:

  • Stephen Black, Director, Center for Ethics & Social Responsibility, University of Alabama
  • Jay Brandrup, Principal, Kinetic Communications
  • Nick Irvin, Program Manager, Advanced Energy Systems and Emissions Control R&D, Southern Company
  • Santhosh Keshavan, Executive Vice President, Chief Information Officer, Regions Financial Corporation
  • G.T. LaBorde, Principal, IllumiCare, and CEO, Malcovery Security
  • Danny Markstein, Managing Director, Markstein
  • David Perry, Vice President, Operational Risk, Protective Life Insurance Company
  • Liz Pharo, Chair, Momentum Telecom
  • Shannon Riley, President and CEO, One Stop Environmental
  • Mitesh Shah, Shareholder, Maynard, Cooper & Gale, PC

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 energy and environment research. Approximately 500 team members support clients and partners in the pharmaceutical, biotechnology, defense, aerospace, environmental, and energy industries in facilities in Alabama, Maryland, North Carolina, Georgia, and Texas.

 

Southern Research Engineering to Exhibit at AUSA ILW Global Force Symposium and Exposition

Posted on March 17, 2015

BIRMINGHAM, Ala. – March 17, 2015 – Southern Research will participate in the Association of the United States Army (AUSA) Institute of Land Warfare (ILW) Global Force Symposium in Huntsville, Alabama, March 31 – April 2, 2015, at booth #1001.

The annual meeting relocated to Huntsville from Orlando two years prior to be closer to the U.S. Army acquisition community. Huntsville is home to the Redstone Arsenal, headquarters of the Army Materiel Command, and the city has one of the largest numbers of general and flag officers outside of northern Virginia. The conference provides unique opportunities for vendors to meet with senior Army leadership and acquisition and technical professionals and learn about emerging Army requirements.

Southern Research is a leader in research and development in aerospace engineering, thermal and structural behaviors of advanced composite materials, advanced material processing techniques, computational sciences and data processing, as well as design, fabrication, integration, and field support for electro-mechanical systems for ISR, test, and tracking requirements.

Southern Research engineering is widely recognized as a leader in contract research and development services in highly technical industry sectors. It provides clients with turrets and pods for ISR and test applications with extremely accurate and highly stabilized pointing capabilities. It also offers advanced materials development expertise and resources for extreme atmospheric and structural testing.

Clients include most federal agencies and numerous commercial companies worldwide. Southern Research welcomes opportunities to provide contract research and development services to clients and partners in pursuit of new technologies. Please visit Southern Research at booth #1001 to meet engineers who will be able to answer your questions and discuss new business opportunities.

About AUSA
Since 1950, the Association of the United States Army has worked to support all aspects of national security while advancing the interests of America’s Army and the men and women who serve. AUSA is a private, non-profit educational organization that supports America’s Army – Active, National Guard, Reserve, Civilians, Retirees, Government Civilians, Wounded Warriors, Veterans, and family members. AUSA provides numerous Professional Development Opportunities at a variety of events both local and national. For more information about AUSA, visit www.ausa.org.

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 energy and environment research. Approximately 500 team members support clients and partners in the pharmaceutical, biotechnology, defense, aerospace, environmental, and energy industries in facilities in Alabama, Maryland, North Carolina, Georgia, and Texas.

 

Southern Research Drug Development to Exhibit at SOT 54th Annual Meeting and ToxExpo

Posted on March 11, 2015

BIRMINGHAM, Ala. – March 11, 2015 – Southern Research – developer of seven FDA-approved cancer drugs – will be exhibiting at the Society of Toxicology (SOT) 54th Annual Meeting and ToxExpo, March 22 – 26, 2015, in San Diego, at booth #1301.

A science-driven, client-focused, preclinical contract research organization, Southern Research has more than 50 years of experience in drug development. Services include efficacy testing, with special expertise in anti-cancer drugs and anti-infective drugs (antibacterial and antiviral, supported by BSL-2 and BSL-3 laboratories and animal facilities), and a complete range of safety testing, including reproductive toxicology, with extensive bioanalytical, PCR and anatomic/clinical pathology facilities.

Utilizing comprehensive, in-house in vitro and in vivo capabilities, Southern Research’s experienced scientists work closely with clients in providing expert guidance and advice during all phases of preclinical development. A key hallmark of its program is the capability to provide custom-designed assays and studies to meet clients’ specific research needs.

In 2014, Southern Research, along with four other research organizations, formed the Southern Biologics Network (SBN) to create advanced biologics faster and less expensively for biopharmaceutical companies of all sizes. SBN provides comprehensive biologic development services, which include the manufacture, discovery, preclinical development, and early-stage clinical development of biologics.

Most recently, Southern Research expanded preclinical service offerings in drug development with the addition of GLP-compliant in vitro safety pharmacology testing on CytoPatch™. With the CytoPatch system, Southern Research successfully demonstrated in vitro hERG ion channel blocking by drug candidates at a physiologically relevant 37 degrees Celsius.

In addition to its scope of drug development services, Southern Research also offers pharmaceutical consulting in formulation, processing, manufacturing, and business operations.

Please visit Southern Research at booth #1301 to meet Director of Business Development Robin Akers, who will be able to answer your questions and discuss new business opportunities.

About SOT
Founded in 1961, the Society of Toxicology (SOT) is a professional and scholarly organization of more than 7,800 scientists from academic institutions, government, and industry representing the great variety of individuals who practice toxicology in the U.S. and abroad. SOT is committed to creating a safer and healthier world by advancing the science of toxicology. SOT promotes the acquisition and utilization of knowledge in toxicology, aids in the protection of public health, and has a strong commitment to education in toxicology and to the recruitment of students and new members into the profession. For more information about SOT and toxicology, visit www.toxicology.org.

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 energy and environment research. Approximately 500 team members support clients and partners in the pharmaceutical, biotechnology, defense, aerospace, environmental, and energy industries in facilities in Alabama, Maryland, North Carolina, Georgia, and Texas.

 

Alabama Drug Discovery Alliance Receives $2 Million Gift

Posted on February 23, 2015

BIRMINGHAM, Ala. – February 23, 2015 – Tokyo, Japan-based Dai-ichi Life Insurance Company, Limited, and Birmingham-based Protective Life Corporation announced today a $2 million gift to the Alabama Drug Discovery Alliance (ADDA) – a collaboration between Southern Research and the University of Alabama at Birmingham (UAB) – that funds, tests, and develops new drugs to combat diseases.

“This generous gift from Dai-ichi and Protective Life will strengthen a longtime, productive partnership between our university and Southern Research,” said UAB President Ray L. Watts. “We have about 18 new disease-changing therapies with tremendous commercial potential in the ADDA pipeline, and we are pushing hard to bring them to market as rapidly as possible. This gift will help us accelerate that process for these new treatments that promise such an incredible impact on patient care and our economy.”

Among the treatments in the ADDA discovery pipeline are therapies for diabetes, kidney disease, myeloma dysplastic syndrome, multiple myeloma, Parkinson’s disease, Alzheimer’s disease, many types of cancers and more. The pledged funds from Dai-ichi and Protective Life will be used to assist efforts across all stages of the ADDA’s drug discovery process, from testing to clinical trials.

“We are thrilled to be part of the generosity that Dai-ichi and Protective Life announced today, which will allow us to accelerate the search for new drugs,” said Southern Research President and CEO Art Tipton, Ph.D. “At Southern Research, we have developed seven anti-cancer drugs that are currently on the market, and using the deep science and development tools that we used at Southern Research to develop those drugs, we have been working with UAB to jointly develop life-changing drugs in a range of disease indications. The Dai-ichi mission of ‘By your side, for life’ exemplifies what we and UAB are pursuing in our quest for new cures.”

The ADDA network aligns scientists with necessary chemists, pharmacologists, clinicians, and intellectual property professionals to develop new disease treatments. The ADDA facilitates drug discovery and development in utilizing the resources that exist at both Southern Research and UAB, funding pilot projects at different stages of the drug discovery and development process.

From discovery to clinical trials, Southern Research contributes to the search for new and better drugs and vaccines through a comprehensive continuum of capabilities including medicinal chemistry, preclinical drug development, and clinical trial support. One of Southern Research’s key assets is its state of the art High Throughput Screening Center, which allows researchers to quickly conduct millions of chemical, genetic, or pharmacological tests. UAB’s School of Medicine, the Center for Clinical and Translational Sciences, and the Comprehensive Cancer Center are all crucial collaborators with Southern Research as part of the ADDA.

The ADDA, the University of Alabama, and the Birmingham Botanical Gardens each received substantial gifts from Dai-ichi and Protective Life, whose formal merger was effective Feb. 1. The three groups are the recipients of the company’s initial $4.1 million of a total $23 million, five-year commitment in community gifts.

“We worked diligently and in tandem with Protective leadership to identify recipients that align with our company’s mission of ‘By your side, for life,’” said Koichiro Watanabe, Dai-ichi president and representative director, and Shinichi Aizawa, managing executive officer. “Each recipient in some way reinforces our company values, our culture, and our commitment to improving the lives of the people and communities we serve.”

“Through Dai-ichi’s tremendous generosity, Protective is able to enhance its level of corporate giving and provide extended assets to these and other entities over the next five years,” said John D. Johns, Protective chairman, president and CEO. “These pledgees reinforce the Protective Life Foundation’s commitment to the community and to the spirit of volunteerism, which will remain at the core of our daily operations.”

“We are incredibly grateful to Dai-ichi Life Insurance Company and Protective Life Insurance for investing in UAB, our city and our state,” said Shirley Salloway Kahn, UAB senior vice president of Development, Alumni and External Relations. “Both companies’ visionary philanthropy will help UAB through our collaboration with Southern Research and the ADDA to continue to pursue groundbreaking research to ultimately create new treatments and potential cures for cancer and other devastating diseases. This gift will play a vital role in enhancing UAB and Southern Research’s reputation as leaders in research and development and help boost economic development in our city and state.”

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 energy and environment research. Approximately 500 team members support clients and partners in the pharmaceutical, biotechnology, defense, aerospace, environmental, and energy industries in facilities in Alabama, Maryland, North Carolina, Georgia, and Texas.

 

Southern Research Names New Director of Alabama Energy and Environment

Posted on February 11, 2015

BIRMINGHAM, Ala. — February 11, 2015 – Southern Research has named Corey Tyree, Ph.D., its Director of Energy and Environment for Alabama operations. In this role, Tyree will lead teams of engineers and technicians focused on ground-breaking technical solutions for industrial and government clients in a variety of industries including water, analytical services, selective catalytic reduction (SCR) catalysts, mercury control, coal combustion, carbon capture, and carbon sequestration.

“Dr. Tyree brings to Southern Research a wealth of knowledge in engineering, technology development, and complex project management,” said Michael D. Johns, vice president of engineering for Southern Research. “In addition, his solid leadership background and extensive experience in the utility industry will be valuable assets to our organization.”

Tyree comes to Southern Research from Georgia Power, where he was engineering manager at Plant Bowen near Cartersville, Georgia. Prior to that role, he was engineering manager at Georgia Power’s Plant Wansley in Heard County, Georgia. Tyree also worked as principal engineer with Southern Company, where he was responsible for emission control technology development.

Tyree earned a bachelor’s of chemical engineering from the University of Kentucky and a doctorate in chemical engineering from Arizona State University.

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 energy and environment research. Approximately 500 team members support clients and partners in the pharmaceutical, biotechnology, defense, aerospace, environmental, and energy industries in facilities in Alabama, Maryland, North Carolina, Georgia, and Texas.

Southern Research Launches New Branding Initiative and Video

Posted on February 3, 2015

BIRMINGHAM, Ala. – February 3, 2015 – Southern Research has introduced a new branding initiative for the 74-year old scientific and engineering research organization that includes a new design and logo, position statement, a website redesign (ongoing), and a new three-minute video that summarizes the key purpose of Southern Research.

“The video captures the significance of what our organization strives to do, each day, for the betterment of mankind,” said Southern Research President & CEO Art Tipton, Ph.D.

Southern Research ­­— which was called Southern Research Institute (SRI) for years –– dropped the word “Institute” from its name to make it simpler, and to further differentiate it from other organizations with similar acronyms.

The branding initiative also brings greater unity to Southern Research’s four divisions:

  • Drug discovery
  • Drug development
  • Engineering
  • Energy and environment

“Brand identity is a critical component of any organization,” said Tipton. “Throughout the course of our 74-year history, we have advanced science and technology in a number of different areas, ranging from the discovery of seven FDA-approved cancer drugs, to developing materials and imaging monitoring for safe space travel. This branding initiative continues the legacy of our people, and our accomplishments, and further defines Southern Research as an organization that is truly dedicated to solving the world’s hardest problems.”

Southern Research is evolving, as it becomes a more diversified research organization.

Last year, Southern Research launched:

 

  • The Alliance for Innovative Medical Technology (AIMTech) in partnership with the University of Alabama at Birmingham. Southern Research and UAB researchers are working together to create medical devices in cardiology, orthopedics, ophthalmology, rehabilitation engineering and trauma.
  • The Southern Biologics Network (SBN), in partnership with four other biopharmaceutical research organizations in Birmingham, Baton Rouge, Raleigh, and Research Triangle Park. SBN would create biologics, which are genetically engineered proteins from plant, animal and human cells, faster and less expensively than traditional methods. The biologics would 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 Southeastern Solar Research Center (SSRC), to create the optimal design of solar photovoltaic systems for utility companies.

 

Southern Research has 500 employees in Alabama, Maryland, North Carolina and Georgia.

Southern Research Announces Two New Board of Directors Appointments

Posted on January 8, 2015

Price-and-Crosswhite-WebBIRMINGHAM, Ala. – January 8, 2015 – Southern Research welcomes to its board of directors retired U.S. Army Major General N. Lee S. Price and Alabama Power Chairman, President and CEO Mark Crosswhite. Their appointments were effective January 1, 2015.

“We are pleased to welcome Lee and Mark to the Southern Research Board of Directors,” said Southern Research President and CEO Art Tipton, Ph.D. “Both of these individuals have tremendous experience that will help guide our organization in the years to come. With our strategic focus on defense, intelligence, and energy and environment, in addition to our life science disciplines, their expertise and involvement will be a significant asset as we map our future direction.”

Price has years of experience leading military and government organizations and is currently president and CEO of Price Solutions, LLC. She has been presented with numerous military awards including the Army Distinguished Service Medal, the Defense Superior Service Medal, the Legion of Merit, the Bronze Star, and the Combat Action Badge.

Prior to starting her consulting firm Price Solutions in 2014, Price built a 38-year career in the U.S. Army. She served as Major General from 2012 to 2014; Program Executive Officer, Command, Control, Communications – Tactical from 2009 to 2013; Deputy Program Manager, Integration from 2008 to 2009; Deputy Acquisition Executive for U.S. Special Operations Command from 2005 to 2008; and Project Manager, Defense Communications and Army Transmission Systems from 2002 to 2005.

Price holds a bachelor’s degree from the University of Alabama at Birmingham, Master of Science in Management Information Systems from the University of Arizona, and Master of Science in National Strategy and Resource Management from the Industrial College of the Armed Forces.

Price is a member of the boards of MTN Government, Thayer Leader Development Group at West Point, Alabama Military Hall of Honor, and Red Gate Group.

Before Crosswhite stepped into his current role at Alabama Power in 2014, he served as executive vice president and chief operating officer of Southern Company, Alabama Power’s parent company, and he served as president and CEO of Gulf Power, also a Southern Company subsidiary. Crosswhite worked for Alabama Power from 2008 to 2011 as executive vice president for external affairs and from 2006 to 2008 as senior vice president and counsel. He joined Southern Company in 2004 as senior vice president and general counsel for Southern Company Generation. Prior to Crosswhite’s 10-year career at Southern Company, he was a partner in the law firm of Balch & Bingham LLP in Birmingham, where he practiced in the energy section for 17 years.

Crosswhite received a bachelor’s degree from the University of Alabama in Huntsville and a J.D. degree from the University of Alabama School of Law.

Crosswhite is chairman of the Economic Development Partnership of Alabama and chairman of the board of the Birmingham Business Alliance. He serves on several corporate, civic and nonprofit boards including Mercedes-Benz U.S. International Inc., the University of Alabama Law School Foundation, and the Virginia Samford Theatre.

“This is great news for Southern Research and Birmingham,” said University of Alabama at Birmingham President Ray L. Watts, who is chair of the Southern Research Board of Directors. “It is exciting to know that the best and brightest in our city value Southern Research and the contributions it continues to make from discovery and economic development standpoints. Lee’s and Mark’s perspectives and talents are sure to make invaluable contributions to the Board.”

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