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For augmenting readability, The Research Insights has added a fresh market study, titled Vaccines Market to its flared database. The report has been put together in a chapter-wise arrangement, by separating required illustrations transversely. This report is an expedient tool to get responses to some of the queries that hold significance for the growth of the Vaccines Market during the forecast period. The evidence in the report was congregated from qualified organizations & dependable sources and was further authenticated by industry specialists for increased integrity

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The Biotechnology Innovation Organization (BIO) released “Transforming Ideas into Advances: Best Practices in State and Regional Bioscience Economic Development Initiatives” today at the 2019 BIO International Convention.

The fifth edition of the Best Practices Guide is the bioscience industry’s leading comprehensive analysis of state legislative and regulatory initiatives in support of economic development.

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Whether you have a medical device, diagnostic, health IT app, or therapeutic, if you have to obtain FDA approval to commercialize your product, you should attend this event! Learn about the obstacles, opportunities, draft guidances and new pathways you must consider when creating a regulatory strategy. In this ever-changing environment, the key to success is both transparency and a keen understanding of the options available for your regulatory pathway. 

June 19, 2019 6:00pm-8:30pm

Hood College, 401 Rosemont Avenue, Frederick, MD 21701

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Emergent BioSolutions Inc. (EBS) today announced approval by the U.S. Food and Drug Administration (FDA) of the Prior Approval Supplement (PAS) submitted by the company for its oral cholera vaccine, Vaxchora® (Cholera Vaccine, Live, Oral). The PAS supports the change in storage conditions of the vaccine from frozen to refrigerated at 2-8°C and the transfer of bulk drug substance manufacturing from Emergent’s product development facility in San Diego to its manufacturing facility in Bern, Switzerland. The PAS also covers changes in labeling regarding these developments. The company’s oral cholera vaccine is the only FDA-licensed vaccine for the prevention of cholera caused by Vibrio cholerae serogroup O1, a potentially serious intestinal disease.

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Catalyze and BioHealth Innovation announce transatlantic partnership.

Amsterdam and Rockville, Maryland — Catalyze and BioHealth Innovation, Inc. have entered an agreement to actively bridge the Life Sciences communities in the US and the EU. This transatlantic partnership will increase opportunities for translating biohealth discoveries to market through grant writing services, expanded technology commercialization and international soft-landing support. The two parties have a wide range of resources and knowledge which combined will better aid in delivering high-impact, customer-specific solutions.

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Dr. Andrew Lees, founder and Chief Scientific Officer of Fina Biosolutions, holds over 25 patents and is the author or co-author of more than 70 peer-reviewed papers. He holds a B.S. in Chemistry from Harvey Mudd College and a Ph.D. in Biophysics from The Johns Hopkins University. GlaxoSmithKline, the Serum Institute of India, the Chengdu Institute of Biological Products, and others all use conjugation chemistry (CDAP) developed by Dr. Lees in their S. pneumonia and meningococcal conjugate vaccines. He received the Johns Hopkins University Distinguished Alumni Award in 2019 for his efforts in making conjugate vaccines affordable for low-income countries.

Dr. Lees is also an associate professor at the University of Maryland School of Medicine’s Center for Vaccine Development, an affiliate at the University of Maryland Bioprocessing Scale-Up Facility, and an adjunct professor in the Department of Medicine at the Uniformed Services University. He teaches protein chromatography through the post-graduate level and is a frequent speaker on conjugation chemistry and biotech entrepreneurship. 

Listen now on Google Play bit.ly/2CzdnA9, iTunes, apple.co/2Arsfze, TuneIn bit.ly/2M60Wmx.

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The great American political divide shows no sign of ending as the United States lurches toward the 2020 presidential election. However, one of the few areas where the parties have joined together in recent years has been where NIH funding is concerned.

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Emergent BioSolutions Inc. (NYSE: EBS) today announced a contract award by the Office of the Assistant Secretary for Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services (HHS) valued at approximately $535 million over 10 years for the continued supply of Vaccinia Immune Globulin Intravenous (VIGIV) into the U.S. Strategic National Stockpile (SNS) in support of smallpox preparedness.

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REGENXBIO Inc. (Nasdaq: RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV® Technology Platform, today announced the first U.S. Food and Drug Administration (FDA) approval of a gene therapy that leverages REGENXBIO's proprietary NAV Technology Platform, Novartis AG's ZOLGENSMA® (onasemnogene abeparvovec-xioi; AVXS-101). ZOLGENSMA was approved by the FDA as a one-time infusion for pediatric patients with spinal muscular atrophy (SMA) who are less than two years of age.

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Today, the Biotechnology Innovation Organization (BIO) released the 2019 Emerging Therapeutic Company Trend Report, highlighting ten years (2009-2018) of biotechnology funding and deal making across five areas: venture capital, Initial Public Offerings (IPOs), follow-on public offerings, licensing, and acquisitions. The report also contains a 2019 snapshot of the industry’s clinical pipeline to highlight the significant contribution of emerging companies.

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For aspiring entrepreneurs, the thought of building a company from scratch can be daunting. What if no one wants to buy what you're selling? Where will the money come from to grow the business? And what will happen if you fail?

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June 12, 2019! 

Register now for the 3rd annual Technology Showcase! The 2019 Technology Showcase will again highlight technologies being developed at the NCI and Frederick National Laboratory for Cancer Research (FNLCR) to encourage technology licensing and collaborations, startup company formation and the translation of NCI discoveries into solutions to benefit patients.

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QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the immediate launch of its therascreen® PIK3CA RGQ PCR Kit (therascreen PIK3CA Kit) after it received U.S. regulatory approval as a companion diagnostic to aid in identifying breast cancer patients eligible for treatment with PIQRAY (alpelisib), a newly approved therapy developed and marketed by Novartis.

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Regenxbio (RGNX) announced that a gene therapy developed based on its technology was approved by the FDA. This gene therapy product is known as Zolgensma, which Novartis (NVS) now owns after acquiring AveXis for $8.7 billion back in 2018. While Novartis does own Zolgensma, it will have to pay royalties to Regenxbio on net sales for it. That means Regenxbio can start earning revenue for one of its very first products. The company is in good shape because it has many other gene therapy programs in its pipeline. The most notable one would be RGX-314, which is being developed to treat patients with wet age-related macular degeneration.

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Funding and Research Opportunities

The following funding opportunity announcements from the NHLBI or other components of the National Institutes of Health, might be of interest:

 

Notices

Notice of Intent to Publish a Funding Opportunity Announcement for Maximizing the Scientific Value of Existing Biospecimen Collections: Scientific Opportunities for Exploratory Research (R21 Clinical Trial Not Allowed)

(NOT-OD-19-100)National Heart, Lung, and Blood Institute

Notice of Intent to Publish a Funding Opportunity Announcement for Secondary Analyses of Existing Datasets of Tobacco Use and Health (R21 Clinical Trial Not Allowed)

(NOT-OD-19-104)National Heart, Lung, and Blood Institute

Notice of Correction to Award Budget for RFA-HL-19-024 "Short-Term Research Education Program to Increase Diversity in Health-Related Research (R25 Clinical Trial Not Allowed)"

(NOT-HL-19-698) National Heart, Lung, and Blood Institute

Notice of Change to Key Dates in RFA-RM-19-005 " NIH Directors Pioneer Award Program (DP1 Clinical Trial Optional)"

(NOT-RM-19-007) Office of Strategic Coordination (Common Fund)

 

Program Announcements

Lasker Clinical Research Scholars Program (Si2/R00 Clinical Trial Optional)

(PAR-19-262) National Heart, Lung, and Blood Institute

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Rexahn Pharmaceuticals, Inc. (NYSE American: RNN), a clinical stage biopharmaceutical company developing innovative therapies to improve patient outcomes in cancers that are difficult to treat, today announced that it will voluntarily transfer its stock exchange listing to the Nasdaq Capital Market from its current listing on NYSE American.

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The BioHealth Capital Region (BHCR) continues to grow rapidly with new startups and a greater number of clinical and commercial stage companies. The region expects to add approximately 2,000 life science-related jobs in the near term with more on the way. Whether it’s Kite Pharma building a new manufacturing site in Frederick County, MD, the growth of cell and gene therapy companies such as Autolus, Inc., REGENEXBIO, and RoosterBIO, Inc. or recent acquisitions of companies like Paragon BioServices, Inc., it’s evident that the BHCR is thriving.

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A group of high school girls who wanted to create a local community for other young ladies interested in STEM subjects (science, technology, engineering and math) did so by organizing an all-girls math competition. Things turned out better than they expected at the inaugural InteGIRLS math competition on May 18 at Montgomery College in Rockville, Maryland.

AURP Bio Health Caucus

Meet Up with AURP at BIO in Philadelphia for
AURP's BIO Health Caucus
#AURPBHC2019

June 2 - 3, 2019

At AURP’s BIO Health Caucus, we will explore trends in life science research, opportunity zone funding resources, the marriage of life science and philanthropy in global partnership opportunities. Discover the unique roles that biomedical innovation cluster and research parks play in innovation ecosystems around the globe. Translating discoveries from the lab to the market has never been more important. Connect with AURP at booth #3955 or One-on-One Partnering! 

Register Now!

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Crystal R Icenhour, PhD, is one of the rising stars of American biotechnology. After more than 25 years in medical research and biotech, she was named founding CEO of Aperiomics, a company that harnesses the power of next-generation sequencing to identify any known pathogen (bacteria, virus, fungi or parasite) in a single test. Aperiomics is the only company of its kind and scope in the world. Throughout Dr.Icenhour’s career, she has demonstrated strong leadership in business and science and has dedicated herself to “bridging the translational gap between these two worlds.”

Dr. Icenhour is an expert in infectious disease diagnostics and her mission is to change the entire thinking about pathogen diagnosis. Up to 75% of infections are never accurately diagnosed, leaving millions of people suffering from chronic infection. Aperiomics, under her leadership, has developed a technology that identifies all known pathogens – every bacteria, parasite, virus, and fungus – from clinical samples in one test.

Dr. Icenhour holds two patents, has authored and co-authored numerous research articles and theses, and has been a prolific speaker and presenter at scientific conferences.  She has served on review panels for National Science Foundation and Environmental Protection Agency and National Institutes of Health Small Business Innovation Research (SBIR) grants.  She is also an adjunct assistant professor at Duke University Medical Center’s Division of Infectious Diseases in their Department of Medicine.

Before Aperiomics, Dr. Icenhour was president and chief science officer for Phthisis Diagnostics in Charlottesville, VA, a research and development company focused on development of easy-to-use molecular diagnostics for intestinal parasites. While a postdoctoral fellow at the Mayo Clinic College of Medicine, she was the first to identify and characterize Pneumocystis melanins.

Dr. Icenhour serves as Chairman of VirginiaBIO and was chosen to participate in the SpringBoard Enterprises 2016 class of women-led companies.  She is a member of, Sigma Xi, Medical Mycology Society of the Americas, Association for Molecular Pathology, and the American Society for Microbiology. The Kauffman Foundation and Center recognized her as 2012 Entrepreneur of the Year.

Dr. Icenhour received her PhD in Pathobiology and Molecular Medicine from the University of Cincinnati Medical School of Graduate Studies in 2002.  She conducted postdoctoral research in the Thoracic Diseases Research Unit at the Mayo Clinic College of Medicine from 2002-2005 and in the Department of Infectious Diseases at Duke University Medical Center from 2005-2006.  She has been involved in local and national postdoctoral associations including the Mayo Research Fellows Association Executive Committee (president), the Duke University Postdoctoral Association (chair of membership committee), and the National Postdoctoral Association (2008 chair).

Listen now on Google Play bit.ly/2CzdnA9, iTunes, apple.co/2Arsfze, TuneIn bit.ly/2M60Wmx.

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Viral safety is a critical focus during biopharmaceutical manufacturing (1–5). Although well-characterized mammalian cells such as the Chinese hamster ovary (CHO) line have been used for decades, both endogenous expression of retroviral-like particles and exogenous contamination events from viruses warrant continued vigilance (6, 7). International regulatory agencies require biomanufacturers to validate the “viral clearance” efficacy of their downstream manufacturing process steps before resulting products can be awarded clinical trial or commercial approval (8–10).