Lieutenant Governor Casey Cagle Named Georgia Bio Lawmaker of the Year
Wednesday, January 25, 2017 12:00 AM

ATLANTA, GA (January 25, 2017) -- Georgia Bio has announced that Lieutenant Governor Casey Cagle has been selected as the 2017 Lawmaker of the Year for his support of the life sciences industry and university research in Georgia during the 2016 General Assembly.

Mr. Cagle is being recognized for his leadership in economic growth, innovation, education and workforce development. Mr. Cagle continues to champion legislation to support growth of innovative companies in biosciences and other sectors via programs like Invest Georgia, and he has collaborated with the Georgia BioEd Institute on STEM education and workforce development programs.

“Lieutenant Governor Cagle recognizes the importance of medical technology and life sciences to the future of our state. He is a leading advocate for improving education and positioning Georgia as one of the strongest states in the nation for innovation jobs,” said Russell Allen, president and CEO of Georgia Bio.

Lieutenant Governor Cagle will be honored at the Georgia Bio Annual Awards Dinner, January 26, 6 pm to 9 pm, at the Westin Atlanta Perimeter North. Other leading companies, executives, researchers and dedicated individuals will receive Georgia Bio Awards. Learn more and register at www.gabio.org/awards.

Biography of Awardee

Lieutenant Governor Casey Cagle 

A successful entrepreneur and respected former State Senator, Casey Cagle made history in 2006 by becoming the first Republican elected to Georgia’s second highest office.  In November of 2010 and 2014, in recognition of his outstanding efforts on behalf of the state his family has called home for seven generations, Georgia voters overwhelmingly re-elected Lieutenant Governor Cagle.

After a leg injury ended his dreams of playing college football, Casey returned to Gainesville in 1986 and became the proprietor of his first small business, a tuxedo rental company. At just twenty years old, Casey began realizing the American dream as his business expanded throughout North Georgia. After founding Southern Heritage Bank in 1999 and earning his reputation as a community and business leader in Gainesville, Casey focused his efforts on serving the citizens of Georgia.

In 1994, he was elected the youngest state Senator at just 28 years old, and was overwhelmingly reelected five times. In the Senate, Casey rapidly established himself as a capable and effective lawmaker. He was appointed to serve as Chairman of the Finance Committee, Vice Chairman of Science and Technology, and as a member of the Appropriations Committee and Natural Resources Committee. Casey’s ability to build consensus made him a successful leader in lowering taxes, protecting private property rights, and standing up for Georgia’s families.

 

In 2006, Casey Cagle became Georgia’s 11th Lieutenant Governor. As the first ever Republican in Georgia to serve in that office, Casey focused his conservative principles to help make Georgia a place where businesses could grow and families could prosper. Championing the Charter Systems Act, Casey improved education in our state while providing a path to career technical education for Georgia’s high school students.

 

Additionally, he launched the Georgia College and Career Academy Network, a partnership between local community leaders, school systems, and Georgia’s technical colleges.  The college and career academies provide a relevant and rigorous curriculum aimed at preparing students for a highly skilled, 21st-Century economy upon graduation.  Thanks to Casey’s leadership, Georgia has 37 College and Career Academies today with additional academies planned each year.

An avid triathlete, Casey leads Healthy Kids Georgia, an effort to encourage local partnerships that introduce children to healthy lifestyle options.  Under the slogan of “Be Fit.  Be Healthy. Be You.” the initiative helps acquaint children with ways to improve their health and wellness.  Working together, local communities are beginning to stem the tide of childhood obesity in ways that are proven to increase academic achievement and reduce long-term healthcare costs.

Notwithstanding his many accomplishments in private and public life, Casey is most proud to be a husband, father and grandfather.  He has been married to Nita, his high school sweetheart, for 30 years and they are the proud parents of three sons – Jared and his wife Kaylan, Grant and his way Meghan, and Carter – and grandparents of a beautiful granddaughter – Everette Grace.  They live in Flowery Branch and are active members of Blackshear Place Baptist Church.

For a list of past Georgia Bio award recipients, click here.

Georgia Bio (www.gabio.org) is the state’s life science industry association whose members include pharmaceutical, biotechnology and medical device companies, medical centers, universities and research institutes, government groups and other business organizations involved in the development of life sciences related products and services.

 
Marc Pedersen of Paulding County High School Named Biotech Teacher of the Year
Tuesday, January 24, 2017 12:00 AM

ATLANTA, GA (January 24, 2017) – Marc Pedersen, Ed.S. of Paulding County High School in Dallas, GA has been selected as the 2017 Georgia Bio Biotechnology Teacher of the Year.

The Teacher of the Year award recognizes excellence in STEM teaching and support for the biotechnology pathway, part of Georgia’s Career Clusters, by a current high school biotechnology teacher. The award winner is nominated by peers and selected by the Georgia BioEd Institute Board of Advisors.

Marc Pedersen has been a science teacher at Paulding County High School for the past 12 years where he has taught science content ranging from biotechnology to chemistry, environmental science, and physics. Mr. Pedersen earned a B.S. in science education from Indiana University, a M.S. in biology from the University of Wisconsin-Milwaukee, and an Ed.S. in teacher leadership from Piedmont College.

As a published research scientist and former molecular ecologist, Mr. Pedersen brings his expertise and passion for biotechnology into the classroom. In addition to teaching the biotechnology pathway curriculum, his students are conducting exciting and innovative research. Currently, Mr. Pedersen’s students are using newly emerging molecular techniques such as environmental DNA, CRISPR-Cas9 genome editing, and DNA barcoding of Georgia aquatic species. His students are encouraged to publish their research and to enter various competitions throughout the year.

“Teachers like Mr. Pedersen are helping to prepare students to enter the STEM workforce and become tomorrow’s biotech industry leaders,” said Jordan Rose, Executive Director for the Georgia BioEd Institute. “His enthusiasm encourages young minds to see themselves improving the world through biotechnology.”

Mr. Pedersen has received numerous recognitions for his dedication and commitment to education. Having been named the 2013 Paulding County School District teacher of the year, he went on to become a 2015 Georgia Teacher of the Year finalist and he now serves as president-elect of the Georgia Teachers of the Year Association. Last June, Mr. Pedersen was recognized nationally by the Biotechnology Institute as the recipient of the 2016 BioGENEius Mentor Award, which was awarded during the Biotechnology Innovation Organization International Convention in San Francisco, CA. In September, Mr. Pedersen received the 2015 Presidential Award of Excellence in Science Teaching. This is the single highest honor a science teacher can receive in the United States. Most recently, Mr. Pedersen was named a 2016 Claes Nobel Top Ten National Educator of the Year, which is an award given through the National Society of High School Scholars.

Mr. Pedersen is dedicated to all facets of the teaching profession. He shares his pedagogical strategies and research with other educators at conferences and seminars nation-wide. He has also served on numerous committees and advisory boards, such as the Governor’s Teacher Advisory Committee and the State Superintendent’s Advisory Council. He is an inaugural member of the Georgia BioEd Institute’s Teacher Advisory Council.

Mr. Pedersen will be honored at the Georgia Bio Annual Awards Dinner, January 26, 2017 from 6 pm to 9 pm, at the Westin Atlanta Perimeter North. Other leading companies, executives, researchers and dedicated individuals will receive Georgia Bio Awards. Learn more and register at www.gabio.org/awards.

For a list of past Georgia Bio award recipients, click here.

Georgia Bio (www.gabio.org) is the state’s life science industry association whose members include pharmaceutical, biotechnology and medical device companies, medical centers, universities and research institutes, government groups and other business organizations involved in the development of life sciences related products and services.

 
GeoVax draws a bead on hep B with therapeutic vaccine deal
Monday, January 23, 2017 12:00 AM

GeoVax has partnered with Georgia State University to try to pursue an elusive goal—the development of an effective therapeutic vaccine for hepatitis B virus (HBV) infections.

The treatment of chronic hepatitis B has improved dramatically in recent years thanks to new antiviral drugs, but efforts to develop a therapeutic vaccine have largely ended in disappointment. Recent casualties among therapeutic HBV vaccines include GlobeImmune's GI 13020/GS-4774 which failed a Phase II trial causing partner Gilead to terminate a license for the candidate last November.

A therapeutic vaccine could boost chances for a functional immunological cure of the disease that could do away with the current need for lifelong suppression of the virus using nucleoside analog drugs like Gilead's tenofovir and Bristol-Myers Squibb's entecavir and interferon.

Chasing that goal, GeoVax and Georgia State say they are working on developing several vaccine candidates. The biotech—also based in Georgia—will contribute its modified vaccinia Ankara virus technology platform, which can be used to stimulate virus-like particles (VLPs) against specific antigens in patients and is already being used in vaccines against Zika and other serious diseases.

The university will contribute VLP design and functional assays developed by professor of chemistry Dr. Ming Luo, with assistance from Peking University Shenzhen Graduate School in China. Luo's work has focused on teasing out the molecular mechanisms that come into play during immune responses to HBV.

"The combined technologies and already defined functional assays will serve to rapidly test this innovative concept," said GeoVax' chief scientific officer Farshad Guirakhoo.

Hepatitis B is spread through blood and body fluids, attacking the liver and resulting in an estimated 650,000 deaths each year—most  of them in low- and middle-income countries, according to the World Health Organization (WHO).

In the U.S. there are somewhere between 700,000 and 1.4 million people infected with HBV, say the Centers for Disease Control and Prevention (CDC), with 20,000 new infections every year.

Other companies in pursuit of therapeutic HBV vaccines include Abivax, whose ABX203 candidate is in mid-stage clinical testing, and Inovio Pharma with INO 1800 in Phase I testing, although that program took a knock when former partner Roche handed rights back last August. Altimmune has its HepTcell immunotherapy in Phase I, while another candidate from Chinese firm Kangtai Biologicals Products is also reported to have reached the clinical testing stage.

Aside from therapeutic vaccines, hopes of achieving a functional cure in HBV could also be met by new drug classes, including encapsidation inhibitors, entry inhibitors and TLR7 agonists, which are in various stages of development.

 

Source: Fierce Biotech

 
UCB files BRIVIACT® (brivaracetam) CV in the U.S. as monotherapy treatment for adult epilepsy patien
Thursday, January 19, 2017 12:00 AM

Brussels (Belgium), Atlanta (Georgia, USA), 19 January 2017 – 18:30 (CET): UCB has today announced the filing of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for BRIVIACT® (brivaracetam) CV as monotherapy in the treatment of partial-onset seizures in patients 16 years of age and older with epilepsy within the U.S.

BRIVIACT® is currently approved in the U.S. as adjunctive therapy in the treatment of partial-onset seizures in patients 16 years of age and older with epilepsy1. The most common adverse reactions (at least 5% for BRIVIACT® and at least 2% more frequently than placebo) in adjunctive therapy clinical trials were somnolence and sedation, dizziness, fatigue, and nausea and vomiting symptoms. Please see additional BRIVIACT® Important Safety information below.  Brivaracetam is not currently approved as monotherapy.

UCB submitted its supplemental application taking into account a recent General Advice Letter issued by the FDA2 which stated that it is “acceptable to extrapolate the efficacy and safety of drugs approved as adjunctive therapy for the treatment of partial onset seizures (POS) to their use as monotherapy for the treatment of POS”. The communication stipulates that, to support extrapolation, proposed dosages of a drug when used as monotherapy should result in exposures similar to those demonstrated to be safe and effective when the drug is used as adjunctive therapy and that adequate pharmacokinetic information must be provided “to demonstrate such similarity, taking into consideration possible drug-drug interactions (inhibition or induction) that may alter the metabolism of the drug”. UCB has included this information within its BRIVIACT® monotherapy supplemental application.

“We are very pleased to be able to submit a label change for brivaracetam to the FDA, to include its use as monotherapy for partial-onset seizures. The FDA’s agreement to the principle of extrapolation from existing data in their assessment of antiepileptic drugs has enabled us to base this submission on the existing wealth of brivaracetam data, less than a year after its launch as an adjunctive therapy in the U.S., and could improve patient access to the medicine if approved,” said Professor Dr. Iris Loew-Friedrich, UCB’s Chief Medical Officer.  “This submission, under the FDA’s extrapolation principle, allows us to use the strength of our brivaracetam clinical trials data, involving more than 2,400 adult patients with partial-onset seizures, and reinforces our longstanding commitment to develop and make available meaningful treatment solutions to improve the lives of people living with epilepsy.”

While the supplemental application of BRIVIACT® as monotherapy in the treatment of partial-onset seizures in patients 16 years of age and older with epilepsy in the U.S. has been accepted by the FDA, acceptance of this submission does not necessarily mean BRIVIACT®will be approved for this indication.

About Epilepsy3,4
Epilepsy is a chronic neurological disorder of the brain. It is the fourth most common neurological condition worldwide and affects approximately 65 million people. In the U.S., 3 million people have epilepsy. Anyone can develop epilepsy; it occurs across all ages, races and genders, and is defined as one or more unprovoked seizures with a risk of further seizures. One third of patients with epilepsy live with uncontrolled seizures.

About UCB in Epilepsy
UCB has a rich heritage in epilepsy with over 20 years of experience in the research and development of antiepileptic drugs. As a company with a long-term commitment to epilepsy research, our goal is to address unmet medical needs. Our scientists are proud to contribute to advances in the understanding of epilepsy and its treatment. We partner and create super-networks with world-leading scientists and clinicians in academic institutions, pharmaceutical companies and other organizations who share our goals. At UCB, we are inspired by patients, and driven by science in our commitment to support patients with epilepsy.

About BRIVIACT®1,5

BRIVIACT® is a new molecular entity that was rationally designed and developed by UCB. Brivaracetam displays a high and selective affinity for synaptic vesicle protein 2A (SV2A) in the brain, which may contribute to the anticonvulsant effect. However, the precise mechanism of action by which BRIVIACT® exerts its anticonvulsant activity is not known. In the U.S. and European Union, BRIVIACT® is approved as adjunctive therapy (a therapy used together with primary treatment) in the treatment of partial-onset seizures in patients 16 years of age and older with epilepsy. BRIVIACT® is available in three formulations (film-coated tablets, oral solution, and injection).

 

Source: UCB

 
Flow MedTech Announces Vice President of Medical Affairs (VPMA)
Monday, January 09, 2017 12:00 AM

DALLAS, TX — JANUARY 9, 2017 — Flow MedTech — Today Flow MedTech, Inc., an early-stage company developing an implantable medical device to prevent strokes in people with irregular heart rhythms, announces the appointment of Senthil Thambidorai, MD, FHRS, as Vice President of Medical Affairs.

Dr. Thambidorai completed a Cardiac Electrophysiology Fellowship at Cleveland Clinic in Ohio and a Cardiology Fellowship at the Creighton University-Department of Medicine in Nebraska. Dr. Thambidorai received his Doctor of Medicine, Bachelor of Medicine, Bachelor of Surgery from Kilpauk Medical College in India.

“With Dr. Thambidorai’s extensive training in left atrial appendage closures and experience with left atrial appendage closure devices, he is an incredible addition as well as a strong asset for our team,” said Arnab Chakraborty, Chief Product Officer and Chairman, Flow MedTech.

Dr. Thambidorai will lead Flow MedTech’s efforts by providing clinical input and vision during the research and development phase. He will also facilitate strategic partnerships to strengthen and further Flow MedTech’s position in the left atrial appendage closure market. His leadership to the Flow MedTech team will ensure the delivery of key objectives.

“We are thrilled to have Dr. Thambidorai join the Flow MedTech team. He brings a tremendous amount of perspective due to his experiences of implanting left atrial appendage closure devices in the Dallas/Fort Worth area,” said Christine Hang, Chief Executive Office, Flow MedTech. “It was important to us to bring someone on board who has the hands-on clinical experience to lead our medical affairs. Dr. Thambidorai will add profound value as we continue the development of Flow MedTech’s technology.”

Dr. Thambidorai will also continue his roles as the Regional Director of Electrophysiology for HCA North Texas, cardiologist and cardiac electrophysiologist in Fort Worth, TX, and a part of the academic core faculty for the Internal Medicine Residency Program at the University of North Texas in Fort Worth, TX. Dr. Thambidorai is a member of the American College of Cardiology and American Heart Association. He is the author of more than 13 peer-reviewed articles and more than 25 scientific presentations at national and international forums.

Source: Flow MedTech

 
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