Priority Generic Drug Reviews: New FDA Draft Guidance
Thursday, June 22, 2017 12:00 AM
In preparation of its commitments under the second Generic Drug User Fee Amendments (GDUFA II), the US Food and Drug Administration (FDA) on Monday released a draft guidance laying out how sponsors can qualify for shorter review times for priority generic drugs.

Under GDUFA II, FDA agreed to shorten its review of eligible priority generics by two months if sponsors submit a complete and accurate pre-submission facility correspondence (PFC) two months ahead of their abbreviated new drug application (ANDA), prior approval supplement (PAS) or amendment.

"This critical 2-month lead time provides the agency the opportunity to determine whether facility inspections will be needed, and, when they are, to initiate inspection planning earlier in the review of the ANDA, enabling FDA to meet the shorter review timeframe," FDA writes.

In the draft guidance, FDA details the information and format it says sponsors must include in their PFCs, which includes:

  1. General information, including the planned ANDA pre-assignment number (which the applicant must request from FDA before submitting the PFC), PFC submission date, and the applicant's identifying information;
  2. Statement of ANDA eligibility for priority review;
  3. Manufacturing process and testing facility information; and
  4. Bioequivalence summary and site/organization information.

To attest that an ANDA is eligible for priority review, FDA says sponsors must include a statement detailing which criteria for priority review the submission meets, pointing sponsors to its Manual of Policies and Procedures (MAPP) on ANDA prioritization.

Under the MAPP, FDA lays out eight criteria that may qualify an ANDA for an expedited review, such as applications for sole-source generics, products in shortage, first generics and generics that could help address public health emergencies.

However, FDA cautions sponsors to ensure they get everything right in the PFC the first time around, or else risk receiving a standard review timeframe.

"Absent extraordinary circumstances, FDA does not expect to utilize its limited resources to review a second PFC on the same submission if the first one is deficient," FDA writes.

The agency also says that PFCs must be submitted between two and three months before the planned ANDA submission, as submitting the PFC less than two months would give the agency too little time to assess the information and more than three months ahead would put the information at risk for being out-of-date.

 
110 Women Who Are Making Their Mark In The Medtech Industry
Thursday, June 22, 2017 12:00 AM

Tiffany Wilson Named one of the 110 medtech women leaders to know by Becker’s Hospital Review

There is quite a network of women leading the medical technology industry- such an impressive network that Becker’s Hospital Review recently published a list of 110 medtech women executives and leaders to know. Each woman on the list is leaving their mark on the medtech field in health IT, medical devices and technology and acting as a driving force for their organizations and industries.

Among the list of rockstar medtech ladies is GCMI and T3 Labs CEO Tiffany Wilson. Tiffany is a real mover and shaker in the Southeast’s medical device community, spending over a decade bringing innovative medical technology from bench top to bedside. 

“She (Tiffany) joined the Global Center of Medical Innovation in 2011 to launch the Southeast’s first medical device innovation center,” says Laura Dyrda, Becker’s Hospital Review contributor. “Her team works with inventors and companies to accelerate the development, testing, training and commercialization of innovative medical products. She serves as Past-President of the Board of the Southeast Medical Device Association (SEMDA), Founding Member of Medtech [email protected], the Georgia Bio Board of Directors and a member of the National Advisory Council on Innovation and Entrepreneurship the U.S. Department of Commerce.”

Congratulations Tiffany!

To see the full list and read about the other 109 ladies making strides for medtech, click here

Stay up to date with the latest news from GCMI and T3 Labs by following us on Linkedin and Twitter.

About GCMI and T3 Labs
The Global Center of Medical Innovation (GCMI) and its wholly owned subsidiary T3 Labs, is the world’s leader in driving efficient medical product innovation. Using our proven high-quality processes, our expert staff works alongside physician innovators, hospital teams, Fortune 500s, start-ups, academic and government funded innovators every day to commercialize innovative medical devices and products, including drugs and biologics, that improve quality based outcomes and delivery of healthcare for patients.

Are you a physician innovator or engineer with an innovative medtech idea seeking a quality partner to help navigate the pathway from concept to cure to commercialization? GCMI and T3 Labs can help. Contact GCMI and T3 Labstoday!

 
Georgia State Hosts First International Triple Negative Breast Cancer Conference
Thursday, June 22, 2017 12:00 AM

ATLANTA—Georgia State University will host the First International Triple Negative Breast Cancer Conference from Sept. 18 to 20.

The two-day conference is focused on advancing scientific knowledge about the aggressive triple negative breast cancer (TNBC) subtype with the goal of improving patients’ lives and eliminating racial breast cancer-related disparities. The conference theme is “Illuminating Actionable Biology.”

Conference topics will include “The Biology of Triple Negative Breast Cancer,” “Predictive and Prognostic Biomarkers,” “Strategies for Reducing Disparities,” “Therapeutic Targets and Treatment Strategies” and “Epidemiology and Precision Oncology.”

Speakers include Dr. Ian O. Ellis of the University of Nottingham, United Kingdom; Dr. Charles M. Perou of the University of North Carolina, Chapel Hill; and Dr. Otis Brawley of the American Cancer Society.

“We envision this conference as representing the confluence of scholarship, research talent, excellence in medicine and compassion,” said Dr. Ritu Aneja, conference chair and Distinguished University Professor and director of the Molecular Basis for Disease Program at Georgia State. “It will bring together patients, researchers, clinicians and students to brainstorm, learn and conceive innovative ideas to tackle the challenges associated with TNBC management and breast cancer-related racial health disparities. In doing so, it will catalyze the transformation of Georgia State into a premier international hub for breast cancer research.”

Conference co-chairs are Dr. Emad A. Rakha, chair of the Department of Histopathology of Nottingham University, United Kingdom, and Dr. Mylin A. Torres, director of the Glenn Family Breast Center and the Louisa and Rand Glenn Family Chair in Breast Cancer Research at Winship Cancer Institute of Emory University.

The last date for abstract submission is July 15. Travel awards are available for minority student researchers.

The conference is supported by the Glenn Family Breast Center at Winship Cancer Institute of Emory University, the International Consortium for Advancing Research on Triple-Negative Breast Cancer and the Georgia Center for Oncology Research & Education.

The conference is open to the public. For details about registration and eligibility criteria for travel awards, visit www.tnbcconference.org.

 
Georgia State Spin-Off, Inlighta Biosciences LLC, Receives $2 Million Grant To Develop Enhanced MRI Contrast Agents For Liver Cancers And Metastasis
Wednesday, June 21, 2017 12:00 AM

ATLANTA—A local start-up, life sciences company founded by Dr. Jenny Yang, Regents’ Professor of Biochemistry at Georgia State University, has received a $2 million federal grant to develop improved magnetic resonance imaging (MRI) contrast agents for the early detection of liver cancers and other cancers, such as uveal melanoma or eye cancer, that have metastasized to the liver.

Yang, who is also the director of the Center for Diagnostics and Therapeutics, is the principal investigator for the grant from the National Cancer Institute of the National Institutes of Health (NIH) via the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs. The research and development work will be done through a collaboration among startup company Inlighta, Georgia State and Emory University. The focus of the project is on optimizing a novel, protein-based contrast agent called ProCA32, the company’s first candidate for clinical development. Next-generation agents that target cancer cells will also be developed.

The funding will support fine-tuning of in vivo imaging protocols, validating the benefit of the agent and conducting animal toxicology studies needed to support an application to the United States Food & Drug Administration for human clinical trials.

“We are very excited by receiving this Phase II STTR funding to support our Investigational New Drug enabled studies,” Yang said. “Our proposed studies in precision imaging address major medical gaps, including early detection of small lesions and biomarker expression, especially for high-risk patients, and monitoring the dynamic changes of biomarkers during disease progression and following therapeutic treatment. Success in our proposed studies will have immediate clinical implications in the diagnosis of liver metastasis from various cancers, primarily liver cancer, and other liver diseases’ accurate staging and follow-up of high-risk patients, evaluating treatment effect and image-guided interventions. We are also very grateful for the previous support from Georgia State, Georgia Research Alliance and funding of STTR Phase I from the National Cancer Institute.”  

The innovative design of ProCA32 allows it to bind tightly with two gadolinium (Gd3+) ions, resulting in a 10-fold increase in relaxivity and significantly enhanced MRI image contrast compared to conventional MRI contrast agents.

Yang has previously conducted preclinical studies in collaboration with clinicians and other researchers, including Drs. Hans Grossniklaus and Pardeep Mittal at Emory, investigating uveal (eye) cancer, which is treatable in the eye but often fatal if it metastasizes to the liver. In rodents, conventional contrast agents are unable to detect liver tumors smaller than 1 cm, while ProCA32 has detected liver tumors as small as 0.24 mm. By detecting tumors earlier, clinicians will be able to pursue better treatment options for their patients and potentially improve their odds of recovery.

Yang has also found ProCA32 can be modified to detect other types of cancers, as the contrast agent may be linked with a receptor-targeting moiety so that it can bind to disease biomarkers such as CXCR4 on liver tumors, HER2 on breast tumors and collagen at liver fibrosis. Further modifications of the agents will allow for mapping of heterogeneously expressed biomarkers that are often missed by blind biopsy, enabling early detection and characterization of metastatic tumors and distinguishing among different types of liver metastases (nodular or invasive).

Georgia State, in downtown Atlanta, is rapidly becoming a hub for research in the Southeast, and administrators at Georgia State are focused on providing a supportive environment for basic and applied research and translational studies aimed at developing marketable products.

“Supporting innovative and entrepreneurial Georgia State investigators’ efforts to access funds critically needed to advance early-stage technology toward the market is a high priority for Georgia State,” said Dr. James Weyhenmeyer, vice president for research and economic development at Georgia State. “We expect a substantial increase in the number of Georgia State investigators applying to the small business research programs sponsored by NIH and other federal agencies to support the further development of their technology.”

For more information about Inlighta Biosciences LLC, visit http://www.inlighta.com/.

 
GeoVax Awarded NIH Grant for Zika Vaccine
Wednesday, June 21, 2017 12:00 AM

GeoVax Labs, Inc. (OTCQB: GOVX), a biotechnology company developing innovative human vaccines, announced today that the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), has awarded the Company a Small Business Innovative Research (SBIR) grant of $600,000 in support of its novel Zika vaccine development program.

The grant, entitled “Advanced Preclinical Testing of a Novel Recombinant Vaccine Against Zika Virus”, will support preclinical testing of GeoVax’s vaccine candidates in non-human primates in preparation for the initiation of a Phase 1 human clinical study.

GeoVax is developing two novel Modified Vaccinia Ankara (MVA) vaccine candidates against Zika virus (ZIKV): one expressing the ZIKV NS1 protein (designated GEO-ZM02), and a second expressing the ZIKV Envelope protein. In the studies supported by this grant, GeoVax will evaluate the immunogenicity and protective efficacy of these two vaccine candidates in non-human primates.

Farshad Guirakhoo, Chief Scientific Officer at GeoVax, commented, “The studies funded by this grant will build upon previous work that demonstrates the protective efficacy of recombinant vaccines using GeoVax’s MVA live viral vector. We are particularly excited about GEO-ZM02, which recently demonstrated 100% single-dose protection in normal mice against a lethal dose of ZIKV delivered by intracerebral inoculation. GEO-ZM02 not only has the potential of a single-dose vaccine, which is practical to combat epidemics in resource-strained countries, but also does not bear the risk of enhancing other flavivirus infections, such as Dengue and West Nile viruses, in vaccinated subjects. This phenomenon, called Antibody Dependent Enhancement (ADE) of infection, has been shown to increase severity of DENV infection in vivo, and is a safety concern for other Zika vaccines under development that utilize the structural Envelope (E) protein of ZIKV for their vaccine construct. GEO-ZM02 is based on the non-structural-1 (NS1) protein of ZIKV, which is not packaged into the virions and is not involved in ADE. Moreover, the NS1 protein is abundantly secreted into the blood of a ZIKV-infected individual and plays a critical role in flavivirus acquisition by mosquitoes by overcoming the immune barrier of the mosquito midgut. Therefore, GEO-ZM02 has the potential to protect both humans and mosquitoes from ZIKV infection; a novel vaccination strategy that could stem epidemics at a low vaccine coverage.”

About GeoVax
GeoVax Labs, Inc., is a clinical-stage biotechnology company developing human vaccines against infectious diseases using its Modified Vaccinia Ankara-Virus Like Particle (MVA-VLP) vaccine platform. The Company’s development programs are focused on preventive vaccines against HIV, Zika Virus, hemorrhagic fever viruses (Ebola, Sudan, Marburg and Lassa fever), and malaria, as well as therapeutic vaccines for chronic Hepatitis B infections and cancers. GeoVax’s vaccine platform mimics a natural infection, stimulating both the humoral and cellular arms of the immune system to recognize, prevent, and control the target infection. For more information, visit www.geovax.com.

Certain statements in this document are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act. These statements are based on management's current expectations and are subject to uncertainty and changes in circumstances. Actual results may differ materially from those included in these statements due to a variety of factors. GeoVax assumes no obligation to update these forward-looking statements, and does not intend to do so. More information about these factors is contained in GeoVax's filings with the Securities and Exchange Commission including those set forth at "Risk Factors" in GeoVax's Form 10-K.

 
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