GaBio and GaBioEd Name Stratford Academy Junior as Georgia BioGENEius Finalist
Tuesday, April 04, 2017 12:00 AM

Tejas Athni is the 2017 Georgia BioGENEius!

Georgia Bio and the Georgia BioEd Institute today named Stratford Academy junior Tejas Athni of Macon, GA as the winner of the 2017 Georgia BioGENEius Challenge, the premier competition for high school students that recognizes outstanding research and innovation in the biotechnology field. As Georgia’s BioGENEius finalist, Athni will attend the 2017 BIOInternational Convention, the industry’s trade conference from June 18-21 in San Diego, where he will engage with leading companies, scientists and innovators currently transforming the scientific landscape in order to gain valuable insights into an industry making significant contributions to the world.

While in San Diego, Athni will compete against high school students from the U.S., Canada and Germany in the International BioGENEius Challenge. The student projects will represent a range of biotechnology topics such as healthcare, agriculture, and the environment.

Athni’s award-winning research is the first to report the effects of B. monnieri leaf extract in inhibiting the growth of human cancer cells. “Glioblastoma multiforme (GBM) is one of the most aggressive and deadly cancers found in the brain,” says Athni. “Unfortunately, patients have a very short median survival time as there are very few effective treatment modalities. This research presents a novel potential treatment option for such a lethal disease. With further research and testing, this avenue of work could possibly lead to an improvement in the prognosis of patients afflicted with GBM.”

The results, due to be published later this year in the journal NeuroTherapeutics, could lead to potential new therapies for this very aggressive form of brain cancer. Athni’s work was completed during a summer research experience at Fort Valley State University in Georgia and Karmanos Cancer Institute in Detroit, Michigan.

“The BioGENEius Challenge highlights the breakthroughs made when we invest in and encourage young people to pursue their ideas,” said Georgia Bio President and CEO Russell Allen. “Georgia Bio is thrilled that Tejas will represent our state at the upcoming BIO Convention. We are proud to support this Georgia scholar as he develops tomorrow’s healthcare innovations.”

Georgia Bio also congratulates the Georgia BioGENEius runner-up, Marissa McDonald of Union Grove High School in McDonough, GA. McDonald’s research characterizes the galectin-4 protein that binds to and kills certain bacteria that escape the human immune system. Better understanding of this protein may help scientists to design more targeted antibiotics so that harmful bacteria are killed without adversely affecting the helpful bacteria living naturally in our gut.

Judging the 2017 Georgia BioGENEius were Jamie L. Graham, Kilpatrick Townsend & Stockton; Kami McMillan, Chubb; Ashan Perera, VWR; Jordan Rose, Georgia BioEd Institute; and Scott Silverman, Arbor Pharmaceuticals.

The Georgia BioGENEius Challenge is made possible through the sponsorship of Arbor Pharmaceuticals.

National and International winners will be announced during June 18-21, 2017 BIO International Convention. Winners will receive cash scholarships.

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Follow the BioGENEius Challenge: Throughout the challenge, @BiotechInstitut will be tweeting interviews, photos, and engaging with the biotechnology community by using the hashtag #BioGENEius.

About the Biotechnology Institute
The Biotechnology Institute is an independent, national nonprofit organization dedicated to education about the present and future impact of biotechnology. Its mission is to engage, excite and educate the public, particularly students and teachers, about biotechnology and its immense potential for solving human health, food and environmental problems. For more information, visit www.biotechinstitute.org. 

About the GeorgiaBioEd Institute 
The Georgia BioEd Institute is a division of Georgia Bio, a 501(c)(3) nonprofit organization serving the state’s life science industry. The Institute’s mission is to strengthen Georgia’s life sciences workforce pipeline through classroom-to-career initiatives that align with industry needs. Learn more at www.georgiabioed.org | www.gabio.org.

Download this Press Release.

 
AdvaMed’s Whitaker Urges Congressional Action on MDUFA
Tuesday, April 04, 2017 12:00 AM

WASHINGTON, D.C. – Advanced Medical Technology Association (AdvaMed) President and CEO Scott Whitaker testified before the Senate HELP Committee today on reauthorization of the Medical Device User Fee Act (MDUFA), stressing the urgent need for Congress to move forward with the agreement as negotiated between FDA and industry.

“The MDUFA IV agreement lays the groundwork to build on recent FDA performance improvements through more ambitious goals, important process changes and increased accountability, supported by additional resources,” Whitaker said.

“We strongly support the vital improvements made by the new agreement and believe that a failure to act would have a destructive impact on our industry’s ability to bring new, innovative treatments, diagnostics and cures to patients,” he cautioned.

While focusing on the benefits of the negotiated MDUFA agreement for patients, FDA and innovation, Whitaker noted that there were additional legislative reforms Congress could consider outside the parameters of the negotiated agreement to “enhance and compliment the underlying user fee agreement” that will “maximize[s] the opportunity for success at the agency, which should be the shared goal of all involved.”

As one example, he cited bipartisan legislation recently introduced in both the House and Senate that designed to improve the consistency and transparency of FDA inspections and to move to a risk-based system for inspections. “These common-sense proposals will ensure that FDA’s inspections resources are best targeted to public health needs and that companies and FDA are working together,” Whitaker said.

He called on the Senate HELP Committee and its counterparts in the House to “act promptly to reauthorize this program, which is so critical to our industry, to the FDA, and to patients.”

A copy of Whitaker’s written testimony can be viewed here.

 
Sanofi and Regeneron Announce FDA Approval of Dupixent
Thursday, March 30, 2017 12:00 AM

BRIDGEWATER, N.J. and TARRYTOWN, N.Y.March 28, 2017 /PRNewswire/ -- Sanofi and Regeneron Pharmaceuticals, Inc.announced today that the U.S. Food and Drug Administration (FDA) approved Dupixent® (dupilumab) Injection, the first and only biologic medicine approved for the treatment of adults with moderate-to-severe atopic dermatitis (AD) whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable.

View the Multimedia News Release: http://www.multivu.com/players/English/7951851-dupixent-regeneron-sanofi-fda-approval/

"People with moderate-to-severe atopic dermatitis cope with intense, sometimes unbearable symptoms that can impact them for most of their lives," said Julie Block, President and Chief Executive Officer, National Eczema Association.  "To date, there have been few options available to treat people with moderate-to-severe atopic dermatitis who have uncontrolled disease.  That's why today's approval of Dupixent is so important for our community. Now we have a treatment that is expected to help address patients suffering from this devastating disease."

Dupixent is a human monoclonal antibody that is designed to specifically inhibit overactive signaling of two key proteins, IL-4 and IL-13, which are believed to be major drivers of the persistent underlying inflammation in AD. Dupixent comes in a pre-filled syringe and can be self-administered as a subcutaneous injection every other week after an initial loading dose. Dupixent can be used with or without topical corticosteroids. It should not be used in patients who are allergic to dupilumab or any of the ingredients in Dupixent.

AD, the most common form of eczema, is a chronic inflammatory disease with symptoms often appearing as a rash on the skin. Moderate-to-severe AD is characterized by rashes often covering much of the body, and can include intense, persistent itching and skin dryness, cracking, redness, crusting, and oozing.i Itch is one of the most burdensome symptoms for patients and can be debilitating.ii   Of the adults with uncontrolled moderate-to-severe AD in the United States, it is estimated that 300,000 are most in need of new treatment options.iii

"Dupixent is the result of years of tireless research by our scientists into the underlying causes of allergic and atopic diseases.  In atopic dermatitis, Dupixent was shown to help clear the skin and manage the intense itch caused by the disease," said George D. Yancopoulos, M.D., Ph.D., Founding Scientist, President, and Chief Scientific Officer, Regeneron.  "Today's approval would not be possible without the dedication of the clinical investigators and the participation of the patients who took part in the global LIBERTY AD clinical program."

Dupixent was evaluated by the FDA with Priority Review, which is reserved for medicines that represent potentially significant improvements in safety or efficacy in treating serious conditions. This followed the FDA's 2014 Breakthrough Therapy designation for Dupixent for inadequately controlled moderate-to-severe AD. Breakthrough Therapy designation was created by the FDA to expedite the development and review of drugs developed for serious or life-threatening conditions/ Dupixent represents the first time this designation was granted for a dermatological disease, other than in dermatologic cancers.iv  

"We strive to transform scientific innovation into therapeutic solutions that make a meaningful difference to people's lives,"said Olivier Brandicourt, M.D., Chief Executive Officer, Sanofi. "The approval of Dupixent offers new hope for adults with moderate-to-severe AD in the United States, and we look forward to working with regulatory authorities around the world to bring this important new medicine to patients globally." 

Sanofi Genzyme, the specialty care global business unit of Sanofi, and Regeneron will market Dupixent in the United States. Dupixent is expected to be available to patients and providers in the U.S. later this week.

Sanofi and Regeneron recognize that Dupixent can only help those uncontrolled moderate-to-severe AD patients that were prescribed the medicine if they can both access the medicine and use it properly. Therefore, the companies have launched Dupixent MyWay, a comprehensive and specialized program that provides support and services to patients throughout every step of the treatment process. 

Dupixent MyWay™ will help eligible patients who are uninsured, lack coverage, or need assistance with their out-of-pocket costs. Additionally, Dupixent MyWay™ offers personalized support from registered nurses and other specialists who are available 24/7 to speak with patients and help them navigate the complex insurance process. For more information, please call 1-844-Dupixent (1-844-387-4936) or visit www.Dupixent.com.

The Wholesale Acquisition Cost (WAC) of Dupixent in the United States is $37,000 annually. Actual costs to patients, payers and health systems are anticipated to be lower as WAC pricing does not reflect discounts, rebates or patient assistance programs.

LIBERTY AD Clinical Program and Results 
The approval of Dupixent was based on data from the global LIBERTY AD clinical program, which included three randomized Phase 3 pivotal trials known as SOLO 1, SOLO 2 and CHRONOS (enrolled 2,119 total adult patients).  The studies examined the use of Dupixent either alone (SOLO 1 or SOLO 2, 1,379 adult patients enrolled) or with topical corticosteroids (CHRONOS, 740 adult patients enrolled) in patients with inadequately controlled moderate-to-severe AD. In all these studies, Dupixent alone or with topical corticosteroids met the primary and key secondary endpoints, specifically:

  • In the SOLO 1 and SOLO 2 studies, treatment with Dupixent as monotherapy significantly improved measures of skin clearing and overall extent and severity of disease:
    • At 16 weeks, for SOLO 1 and SOLO 2, respectively, 38 and 36 percent of patients who received Dupixent 300 mg every two weeks achieved clear or almost clear skin as measured by the 5-point Investigator's Global Assessment (IGA) scale (primary endpoint), compared to 10 and 9 percent with placebo.
    • At 16 weeks, for SOLO 1 and SOLO 2, respectively, 51 and 44 percent of patients who received Dupixent 300 mg every two weeks achieved a 75 percent or greater reduction in their Eczema Area and Severity Index score (EASI-75) from baseline, a key secondary endpoint, compared to 15 and 12 percent with placebo.
    • At 16 weeks, for SOLO 1 and SOLO 2, respectively, 41 and 36 percent of patients who received Dupixent 300 mg every two weeks achieved a greater than or equal to 4 point improvement in the daily intensity of patient-reported itch, as measured by the Pruritus Numerical Rating Scale (NRS), compared to 12 and 10 percent with placebo. 
                                          
  • In the CHRONOS study, treatment with Dupixent with topical corticosteroids (TCS) significantly improved measures of overall disease severity at 16 and 52 weeks, when compared to placebo with TCS:
    • At 16 weeks, 39 percent of patients who received Dupixent 300 mg every two weeks with TCS achieved clear or almost clear skin (IGA 0 or 1), the primary endpoint, compared to 12 percent of patients receiving placebo with TCS.
    • At 16 weeks, 69 percent of patients who received Dupixent 300 mg every two weeks with TCS achieved EASI-75 (key secondary endpoint), a 75 percent reduction on an index measuring eczema severity, compared to 23 percent of patients receiving placebo with TCS.
    • At 16 weeks, 59 percent of patients who received Dupixent 300 mg every two weeks with TCS achieved a greater than or equal to 4 point improvement in the daily intensity of patient-reported itch, as measured by the NRS, compared to 20 percent of patients receiving placebo with TCS.
    • The study also met additional key secondary endpoints at 52 weeks, showing that 36 percent of patients who received Dupixent 300 mg every two weeks with TCS achieved clear or almost clear skin (IGA 0 or 1), compared to 13 percent of patients receiving placebo with TCS.

The most common adverse events that were noted to be greater than or equal to one percent with Dupixent treatment included injection site reactions, eye and eye lid inflammation including redness, swelling, and itching, and cold sores in the mouth or on the lips.

In December 2016, the European Medicines Agency accepted for review Sanofi's and Regeneron's marketing authorization application (MAA) for Dupixent for adults with uncontrolled moderate-to-severe AD. 

Dupilumab Program Overview
Dupilumab is currently being evaluated in a comprehensive development program for AD that includes studies in children with severe AD (6 months to 11 years of age) and adolescents with moderate-to-severe AD (12 to 17 years of age). In October 2016, the FDA granted dupilumab Breakthrough Therapy designation for both populations.  These potential uses are investigational and the safety and efficacy have not been evaluated nor confirmed by any regulatory authority.

Dupilumab is also being studied in other inflammatory diseases that are believed to be driven by IL-4 and IL-13 cytokines, including persistent uncontrolled asthma (Phase 3, results expected later this year), nasal polyposis (Phase 3) and eosinophilic esophagitis (Phase 2). These potential uses are investigational and the safety and efficacy have not been evaluated by any regulatory authority. For more information on dupilumab clinical trials please visit www.clinicaltrials.gov.

IMPORTANT SAFETY INFORMATION 
Do not use if you are allergic to dupilumab or to any of the ingredients in Dupixent®.   

Before using Dupixent, tell your healthcare provider about all your medical conditions, including if you:

  • have eye problems
  • have a parasitic (helminth) infection
  • have asthma
  • are scheduled to receive any vaccinations. You should not receive a "live vaccine" if you are treated with Dupixent.
  • are pregnant or plan to become pregnant. It is not known if Dupixent will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known whether Dupixent passes into your breast milk.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.  If you have asthma and are taking asthma medicines, do not change or stop your asthma medicine without talking to your healthcare provider. 

Dupixent can cause serious side effects, including:

  • Allergic reactions. Stop using Dupixent and go to the nearest hospital emergency room if you get any of the following symptoms: fever, general ill feeling, swollen lymph nodes, hives, itching, joint pain, or skin rash.
  • Eye problems. Tell your healthcare provider if you have any new or worsening eye problems, including eye pain or changes in vision.

The most common side effects include injection site reactions, eye and eyelid inflammation, including redness, swelling, itching, and cold sores in your mouth or on your lips. 

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.  These are not all the possible side effects of Dupixent.  Call your doctor for medical advice about side effects.  You may report side effects to FDA at 1-800-FDA-1088.

Use Dupixent exactly as prescribed.  If your healthcare provider decides that you or a caregiver can give Dupixent injections, you or your caregiver should receive training on the right way to prepare and inject Dupixent.  Do not try to inject Dupixent until you have been shown the right way by your healthcare provider. 

Please click here for the full Prescribing Information. The patient information is available here.

INDICATION

Dupixent is used to treat adult patients with moderate-to-severe atopic dermatitis (eczema) that is not well controlled with prescription therapies used on the skin (topical), or who cannot use topical therapies.  Dupixent can be used with or without topical corticosteroids. It is not known if Dupixent is safe and effective in children.

About Sanofi
Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Sanofi is organized into five global business units: Diabetes and Cardiovascular, General Medicines and Emerging Markets, Sanofi Genzyme, Sanofi Pasteur and Consumer Healthcare. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).

Sanofi Genzyme focuses on developing specialty treatments for debilitating diseases that are often difficult to diagnose and treat, providing hope to patients and their families.

About Regeneron Pharmaceuticals, Inc.
Regeneron (NASDAQ: REGN) is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases. For additional information about the company, please visit www.regeneron.com or follow @Regeneron on Twitter.

 
CiDrep Informatics Launches Cloud Services Platform
Wednesday, March 15, 2017 12:00 AM

ATLANTA, Georgia – March 15, 2017. CiDrep Informatics, Inc., today announced the addition of Cloud Services to its portfolio of products and solutions. CiDrep Cloud, is a fully automated ecommerce solutions that allows hospitals, health systems, independent physicians’, dental, behavioral health offices and research organizations to purchase, provision and use HIPAA compliant cloud Software-as-a-Service and Infrastructures-as-a-Service with security and ease.

Built on a single, open cloud platform, CiDrep Cloud is a comprehensive digital business platform that offers Collaboration Software Tools, Device Management, Microsoft Office 365 Plans, IBM SoftLayer, Virtual Private Systems, Hyper-V based virtual machines running Windows 2012 64bit edition, Project Management and Healthcare specific software’s designed to help increase productivity, augment decision-making and become a digital health business beyond organizational boundaries with staffs, patients, partners and vendors.

“With the rise of today’s digital workplace, where information is abundant, we can provide the latest communication tools to help cut through the noise and achieve effective collaboration and quality workplace outcomes in client’s environments. CiDrep Cloud is designed to meet the unique workstyle of every IT department, technology use and managed IT services with purpose-built, integrated applications, infrastructures and software tools to reduce costs of ownership, risk and resource demands while delivering stronger support, reliability and operational efficiency with popular cloud infrastructure applications”, said Wayne Craige, CEO of CiDrep.

CiDrep cloud solutions include and number of Infrastructure as a Service (IaaS) and Software as a Service (SaaS) products, plus:

·       Cloud Computing Infrastructure Platforms,

·       Communications and Collaborations Software Tools,

·       Acronis Cloud Backup and Disaster Recovery, 

·       Microsoft OneDrive for Business File Storage, 

·       Data and Email Migration Services, 

·       Custom Virtual Private Servers running Linux CentOS 6

·       Custom Virtual Servers running Windows 2012 64bit

·       IBM SoftLayer Dedicated Bare Metal, Power8 Servers, Virtual Servers, Storage and Networking

·       Microsoft Office 365 Productivity Plans for Healthcare Business

·       Microsoft Azure, SharePoint and Exchange Online Services for Business

About CiDrep Cloud

CiDrep cloud is a single platform for a whole new way of doing business with clients. We help transform their business, and be up and running in the cloud in minutes, with little to no investment, enabling them to deliver internal technology services, and manage their infrastructure most efficiently. To learn more about CiDrep Clouds Solutions, please visit https://www.cidrep.com

About CiDrep Informatics Inc.

At CiDrep, we are continuously developing intelligent solutions for the health care industry. CiDrep is an informatics (clinical, health, imaging and bioinformatics) services company providing a range of clinical, health, imaging and genomic informatics services and technology solutions for providers and researchers. CiDrep collaborates with clients with an aim to provide Better Technology to drive Better Outcomes and ultimately Better Care™. https://www.cidrep.com

 
GCMI Launches New Medtech Accelerator
Monday, March 13, 2017 12:00 AM

Collaboration with BD adds significant new asset to medtech development ecosystem in Atlanta and the southeast.

Media Release – February 28, 2017 (Atlanta, Ga.) – The Global Center for Medical Innovation (GCMI) announced today it is partnering with BD (Becton, Dickinson and Company) to support the launch of, and the first startup to enter, the new GCMI Medtech Accelerator.

The announcement harkens the arrival of a substantial new asset for the medtech ecosystem in Atlanta and the southeast.

“Too many medtech startups fail unnecessarily due to a lack of bridge, or seed funding, required to advance far enough in the commercialization process to attract investment by a larger device company,” says Tiffany Wilson, CEO of GCMI and its preclinical testing and training arm T3 Labs. “The new accelerator and BD’s support provides a new source of critically needed funding and support for local and regional medtech startups, and the ecosystem as a whole, to take a measurable step forward.”

According to Wilson, BD will support the first company to complete the GCMI Medtech Accelerator program through a milestone driven process and grant. Each startup or early stage company admitted to the accelerator will be selected by a team including GCMI, an industry partner, investor and other relevant subject matter experts.

BD, and other partnering companies to follow, will play key roles in milestone setting and mentoring for the accelerator’s startups. “Milestone” examples could include intellectual property (IP) protection, FDA 510(k) submission, preclinical studies or a startup’s first contract with a provider or hospital. Selected accelerator companies will live at GCMI for 6 to 12 months depending on the milestones created at admission and the tasks to be completed during their stay. 

“In spite of best efforts, medtech startups still face ‘a valley of death’ when it comes to securing funding and bringing the first product to market”, stated Ellen Strahlman, MD, MHSc, Executive Vice President R&D and Chief Medical Officer for BD. “GCMI represents a unique way to address that issue and the program dovetails nicely with BD’s global accelerator partnerships.”   

“From concept to development through clinical trials, the infrastructure needed to support successful medtech innovation resides within close proximity to our facilities,” says Wilson. “Our new accelerator fills a gap in the ecosystem which now enables us to locally support high potential young medtech companies and the associated economics gains – including new jobs – to Atlanta and the southeast.

According to Jason Rupp, executive director of the Southeastern Medical Device Association (SEMDA), the southeast led the country in [medtech] employment and establishment growth from 2012 – 2014. While overall U.S. employment in the medtech industry fell by 0.1%, employment in the southeast grew by 5.1%, adding 2,874 jobs. The region added 174 establishments during the same period, a 9.4% increase compared to a 5.5% increase nationally.

“GCMI’s Medtech Accelerator represents a profound step forward for the medtech ecosystem in the southeastern United States,” says Rupp. “It is precisely the kind of asset needed to increase regional medtech investment and maximize our local and regional resources’ capabilities to drive improvements in patient care and meaningful economic growth.”

“GCMI’s team has the track record, facilities, expertise, network and commitment to make this the first of what we believe will be many high-value partnerships for all concerned and a model for accelerating medtech innovation,” says Al Lauritano, BD’s Director, External Innovation & Partnerships.

“Medical device innovation is a complex, expensive process, yet there is a tremendous need for novel solutions to unmet clinical needs,” Wilson says. “These are the technologies that will ultimately benefit patients and lower healthcare costs by improving the way physicians diagnose and treat disease. Given Atlanta’s fantastic resources, which include expertise at GCMI, T3 Labs, Georgia Tech, Emory Healthcare, Piedmont Healthcare, Children’s Healthcare of Atlanta and now the GCMI Medtech Accelerator thanks to BD’s support, we can help de-risk many new medical technologies in a methodical way, making the process more transparent and predictable, decreasing the time required for a new device to get to market and attracting more investment.”

“GCMI levels the playing field for small medtech startups to get a toe hold, work through regulatory, make it to market and then scale. With their help, we were able to avoid millions of dollars in upfront costs,” says John O’Shaughnessy, Founder and CEO of Matrix Surgical USA.

About GCMI

The Global Center for Medical Innovation (GCMI) brings together core members of the medical device community, including universities, research centers, clinicians, established device companies, investors and startups, with the goal of accelerating the commercialization of innovative medical technology.

www.devices.net

 
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