BHI Weekly Newsletter Archives Archives - Page 31 of 66

Jul 02 2019

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360th Edition – July 2, 2019

By admin BHI Weekly Newsletter Archives

BioHealth Innovation

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July 2, 2019

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Dr. Marco Chacón, Founder and Chairman, Paragon Bioservices, and University of Maryland Baltimore Assistant Vice President Industry Alliances, Joins Rich Bendis on BioTalk

Dr. Marco Chacón sits down for a new episode of BioTalk to talk about his Founding of Paragon to its recent sale to Catalent, his current role with the University of Maryland Baltimore, and being a Leader in the BioHealh Capital Region

Marco A. Chacon, Ph.D., is the Assistant Vice President of Industry Alliances at the University of Maryland, Baltimore. As a seasoned biopharmaceutical executive and entrepreneur, Dr. Chacon works with the leadership team at UMB leading special projects to grow the BioPark tenant base and to strengthen the University’s research collaborations with industry.

Dr. Chacon is the Founder and Chairman of Paragon Bioservices, Inc., a Contract Development and GMP Manufacturing Organization (CDMO) located at the University of Maryland BioPark in Baltimore. With ~500 employees and 230k square feet of space, Paragon specializes in the development and GMP manufacturing of viral vectors and vaccines.

Dr. Chacon is also the Founder of IRAZU Biodiscovery, a regenerative medicine company seeking to develop therapeutic interventions to induce hypoxia tolerance and neuroprotection as described in experimental models of caloric restriction and hibernation, as well as during the neonatal period in mammals.

Dr. Chacon’s academic interests include control of metabolism, oxygen homeostasis and the regenerative potential of tissues and organs.

Dr. Chacon received a B.S. degree from Youngstown State University and a Ph.D. Degree from the University of Maryland, College Park. He currently serves on the Board of Trustees of the UMB Foundation and was appointed in 2016 to the Life Sciences Advisory Board by Governor Lawrence J. Hogan, Jr.

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

A CEO who wants to genetically modify pig organs for human transplant

Sometimes a Eureka moment sparks a breakthrough in innovation; other times it’s a rush to solve a crisis plaguing society — and the ones you love. That was the case for Martine Rothblatt, CEO of United Therapeutics, a Maryland-based company she founded in 1996, and former CEO of GeoStar and creator of SiriusXM Radio.

Continuous Processing Requires a Rethink of Viral Strategies

If biopharma firms want to get the most out of continuous manufacturing, they must rethink their viral safety strategies. Existing strategies work well for batch-mode production, as hard-won experience attests. These strategies, however, are still being adapted to continuous-mode production, where protocols and equipment preferences are in flux.

AstraZeneca’s immunotherapy drug scores key Phase III lung cancer win – MedCity News

The days of Roche having an immunotherapy monopoly on the largest population of small-cell lung cancer patients appear numbered, following the release of data for a competing drug.

Novavax and Catalent Biologics Enter Strategic Partnership: Allowing Catalent Biologics to Expand Gene Therapy Footprint with Acquisition of Novavax’ Manufacturing Assets and Capabilities Nasdaq:NVAX

Novavax, Inc. (NASDAQ: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, and Catalent Biologics’ Paragon Gene Therapy unit, the leading viral vector development and manufacturing partner for gene therapies, today announced an arrangement under which Paragon Gene Therapy will assume the leases to two Novavax product development and manufacturing facilities, giving it immediate access to state-of-the-art manufacturing equipment, people and space to accelerate the growth of its gene therapy development and manufacturing business.

Child healthcare reimagined in new ACE Kids Act care model

By Dr. Kurt Newman, CEO of Children’s National Health System

We have come a long way in pediatric medicine, but not far enough.

For nearly a decade, the chief executives of the nation’s children’s hospitals and health systems have discussed challenges we face in caring for America’s very sickest children, whose life-threatening diseases and congenital conditions put overwhelming burdens on their families.

Adaptive Biotechnologies set to go public with valuation above $2B in biggest biotech IPO of 2019 – GeekWire

Adaptive Biotechnologies has raised the price for its initial public offering, putting itself in a position to raise more cash than any other biotech IPO this year. The Seattle-based company, which makes technology that can read the genetic information of the human immune system, increased its target price to $18 to $19 per share and could raise as much as $327.5 million from investors, according to a new SEC filing.

Former Walter Reed Campus Undergoes Historic Renovation | Construction Equipment Guide

At the end of November in Washington, D.C., Children’s National Health System began work on a historical renovation construction project that will result in a pediatric research and innovation campus with a focus on pediatric medicine.

University of Maryland is first in the nation to launch degree in medical cannabis science – WJLA

The University of Maryland School of Pharmacy has launched the nation’s first Master of Science program in medical cannabis science and therapeutics.

The university says the degree will provide students with the knowledge and skills needed to support patients and the medical cannabis industry.

University of Maryland BioPark plans 10-story gateway tower on MLK Blvd. – Baltimore Sun

The University of Maryland, Baltimore plans an ambitious expansion of its BioPark, with a $200 million building that will nearly double the size of the life science hub to the west of the main medical campus downtown.

Arlington Capital Partners Announces the Final Closing of Oversubscribed $1.7 Billion Fund

Arlington Capital Partners (“Arlington” or the “Firm”), a Washington, D.C. area based private equity investment firm focused on government-regulated sectors, today announced that it has successfully raised its latest fund, Arlington Capital Partners V, L.P. (“Fund V” or the “Fund”) with total capital commitments of approximately $1.7 billion – hitting the Fund’s hard cap. The fundraise, which was significantly oversubscribed, successfully reached its final closing in three months from its launch. The Fund sourced capital commitments from a hand-selected, globally diverse group of marquis investors, including public pension funds, corporate pension funds, insurance companies, fund of funds, and foundations.

MOST DYNAMIC METROPOLITANS – JUNE 2019

As the dominant economic geography of America, metropolitan statistical areas largely determine our success as a nation. These groups of counties with a large central core account for 88.6 percent of jobs, 89.1 percent of wages and 90.0 percent of Gross Domestic Product (GDP). Further, metropolitan statistical areas account for the bulk of innovation such as research and development and patenting activity. Understanding the mechanisms underpinning the growth of top-performing metropolitan areas, and sharing best practices, could assist other communities in boosting their economic fortunes. The Most Dynamic Metropolitan Index, ranking 379 metropolitan areas, seeks to provide an objective measure of the economic vibrancy of communities where the lion’s share of Americans work and live.

New Report: Health Tech Early Stage Deals Growing Again in First Quarter After Tepid 2018 – Inova Personalized Health Accelerator

Health Tech early stage (below $10 million) investing grew consistently from 2010 – 2017, but then stalled in 2018 showing declining deal count in every quarter over the previous year. At the same time, total capital invested was flat. Was it a correction?

Results from Q1 2019 show the segment is back on the growth track. Deal counts won’t yet match 2016 and 2017 levels, but they will be up from 2018 and capital invested in U.S. early stage health tech is likely to be the highest on record.

AbbVie to buy Botox maker Allergan for $63B – MedCity News

The company that makes Botox is the subject of the latest biopharma mega-deal.

Chicago-based AbbVie said Tuesday it would acquire Ireland-headquartered Allergan for $63 billion, or $78.45 per share, equal to the former’s Monday closing price. The companies said the deal would provide immediate scale and profitability for AbbVie while allowing the company to diversify into new therapeutic areas like aesthetics.

PIC MC Selects Development Team to Build $40 Million Life Sciences Building on Montgomery College’s Germantown Campus – MC News

The Pinkney Innovation Complex for Science and Technology (PIC MC) signed a development agreement today to add a state-of-the-art life sciences office building to the Montgomery College Germantown Campus.

19710 Observation Drive, LLC, a joint venture between Rockville-based, South Duvall and Germantown-based Minkoff Development, will build a $40 million facility on a 5.67-acre parcel at 19710 Observation Drive in Germantown. The 120,000 square foot building will include lab, office, manufacturing and distribution space aimed at companies focused on areas such as biotech, life sciences and cybersecurity.

Jun 25 2019

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359th Edition – June 25, 2019

By admin BHI Weekly Newsletter Archives

BioHealth Innovation

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June 25, 2019

FOUNDING MEMBER OF

How Viela Bio’s Drug Development Landed $350M in 16 Months

Just 16 months into its existence, a local biotech startup has investors swarming.

Gaithersburg, Md.-based Viela Bio has completed a $75 million Series B funding round, bringing its total raised since launching to more than $350 million.

AstraZeneca to invest $630 million in Korean biohealth sector – Korea Biomedical Review

AstraZeneca said it would invest $630 million into Korea’s biotech and healthcare sector over the next five years.

Leif Johansson, chairman of the British-Swedish drugmaker, announced the plan at the Korea-Sweden Business Summit, attended by President Moon Jae-in, Swedish King Carl XVI Gustaf, and Swedish Prime Minister Stefan Löfven in Stockholm on Friday, local time. The business summit was held as part of President Moon’s state visit.

Intrexon Signs $100Mm Deal with Surterra Wellness to Advance Commercial Scale Cannabinoid Production

Intrexon has scaled its proprietary yeast fermentation process and is on track to realize production of pure cannabinoids at a target cost of goods of <$1,000/kg. With exclusive global access to Intrexon’s technology for microbial production of cannabinoids, Surterra gains a clear research and development roadmap to:

Surterra Wellness

Immunomic Therapeutics Announces Promotion of Teri Heiland, Ph.D. to Chief Scientific Officer – Immunomic Therapeutics

Immunomic Therapeutics, Inc. (ITI), a privately held, Maryland-based biotechnology company, announced today the promotion of Teri Heiland, Ph.D. to Chief Scientific Officer. In her new role, Dr. Heiland will oversee all of research and development and will play an integral role in business development and the management of ITI’s existing and future partnerships. Dr. Heiland is a co-founder of ITI and has amassed over two decades of executive leadership experience in the biotechnology and life sciences sector. Dr. Heiland’s focus at ITI stems from her background in DNA vaccine design, optimization and development, which has created a broad pipeline of vaccines in oncology, allergy and animal health and has driven licensing deals for ITI with Astellas and Zenoaq. ITI’s investigational UNITE technology platform has the potential to utilize the body’s natural biochemistry to develop a broad immune response and is currently being employed in a Phase II clinical trial as a cancer immunotherapy.

Qiagen launches one-stop antimicrobial resistance database alongside CDC commitment | FierceBiotech

In the face of growing international concerns over antimicrobial resistance, Qiagen has launched a one-stop shop that compiles publicly available genomic data, scientific literature and phenotypic information on potential superbugs.

Job Opportunity: Head of Johnson & Johnson Innovation – JLABS @ Washington DC.

Johnson & Johnson Innovation is recruiting a Head of Johnson & Johnson Innovation – JLABS @ Washington DC. The goal of Johnson & Johnson Innovation (JJI) is to advance transformative healthcare solutions that improve the lives of people around the world and, in so doing, to deliver value to Johnson & Johnson (“J&J”). JJI accomplishes this by catalyzing new science and technology through collaboration and exchange of ideas. This growing team is looking for a colleague inspired to help build and innovate new ways of fostering a productive life-science ecosystem.

This position will be responsible for setting the strategic direction and overseeing all operational activities for JLABS in Washington DC and leading our partnership with Children’s National Health System. This position will also be part of the Global Johnson & Johnson Innovation – JLABS leadership team.

Alexandria Real Estate Equities, Inc. Announces Pricing Of Upsized Public Offering Of 3,850,000 Shares Of Common Stock

Alexandria Real Estate Equities, Inc. (“Alexandria” or the “Company”) (NYSE: ARE) announced today the pricing of its upsized public offering of 3,850,000 shares of common stock at a price of $145.00 per share in connection with the forward sale agreements described below. The Company also granted the underwriters a 30-day option to purchase up to 577,500 additional shares. The offering is expected to close on or about June 25, 2019, subject to customary closing conditions.

PIC MC Selects Development Team to Build $40 Million Life Sciences Building on Montgomery College’s Germantown Campus – MC News

A Conversation with Katharine Ku, Chief Licensing Advisor at WSGR

Attorneys Vern Norviel and Charles Andres recently sat down with Katharine “Kathy” Ku, WSGR’s new chief licensing advisor, to discuss questions and situations that come up in the licensing process. Kathy is an internationally recognized leader in the field of licensing and technology transfer, and spent almost three decades as the executive director of Stanford University’s Office of Technology Licensing. Kathy’s many accomplishments include implementation of the Cohen-Boyer DNA Cloning licensing program which contributed to the creation of the biotechnology industry, and her work on the document: In the Public Interest: Nine Points to Consider in Licensing University Technology. This document, which provides nine principles that continue to influence and guide university licensing, should be read by any start-up contemplating taking a university license.

Frederick National Labs Attract Entrepreneurs and Collaborators Seeking Leading-Edge Biomedical Technologies · BioBuzz

The National Cancer Institute (NCI) and The Frederick National Laboratory for Cancer Research (FNLCR) recently hosted the third annual Technology Showcase at The FNLCR’s Advanced Technology Research Center (ATRF) in Frederick, Maryland. The event provided industry thought leaders, inventors and entrepreneurs a platform to network, showcase their technologies, and learn more about the tech transfer process, starting a new business and various fundraising strategies.

Four BIOE Ph.D. Students Awarded NIH Fellowships | Fischell Department of Bioengineering

Fischell Department of Bioengineering (BIOE) Ph.D. students Michelle Bookstaver, John Daristotle, Mary Doolin, and Emily Gosselin were recently named recipients of the Ruth L. Kirschstein Predoctoral Individual National Research Service Award (F31) by the National Institutes of Health (NIH). Together, their NIH F31 fellowships could total up to $235,000 in funding over two years to support research in vaccine design, sprayable surgical sealants, idiopathic pulmonary fibrosis, and new therapies to treat multiple sclerosis.

Vaccines have reduced the public health threat of many infectious diseases, including polio, measles, mumps, and small pox.

NHLBI Funding & Research Opportunities and Announcements for May 31, 2019

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: General Notices

Notice of Information for RFA-HL-20-009, “BLOODSAFE: Research to enhance availability of safe blood for patients with severe anemia and hemorrhagic conditions in low or lower-middle income countries (LLMICs) in Sub-Saharan Africa (UG3/UH3 CT Optional)”(NOT-HL-19-706) National Heart, Lung, and Blood Institute

Notice of Information for RFA-HL-20-010, “BLOODSAFE: Research to enhance availability of safe blood for patients with severe anemia and hemorrhagic conditions in low or lower-middle income countries (LLMICs) in Sub-Saharan Africa-DCC (U24 CT Not Allowed)”(NOT-HL-19-707) National Heart, Lung, and Blood Institute

5 questions with Jolene Gurevich, a Venture for America alumna working with University of Maryland startups – Technical.ly Baltimore

Jolene Gurevich was going to be an investment banker on Wall Street. But her roots as a competitive Latin ballroom dancer in New York gave her the inspiration to make a move toward entrepreneurship, and Venture for America provided her a clear path into the startup ecosystem in Baltimore. Now manager of the Maryland Technology Enterprise Institute (Mtech Ventures) incubator at the University of Maryland and the Chesapeake Bay Seed Capital Fund, Gurevich guides the trajectory of scientists-turned-entrepreneurs.

Catalent Acquires BMS Manufacturing Plant in Italy, Expanding Biologics Operations

Catalent is continuing to expand its fast-growing biologics operations, agreeing to acquire Bristol-Myers Squibb (BMS)’s oral solid, biologics, and sterile product manufacturing and packaging facility in Anagni, Italy, for an undisclosed price.

NIH releases updated SBIR/STTR success rate data | SSTI

Are you looking to increase the success rate of your state’s SBIR/STTR proposals? If so, a reminder that applications for the Small Business Administration’s Federal and State Technology (FAST) Partnership Program are due next Friday, June 28, at 4 p.m. EDT. This program provides one-year funding to organizations executing programs related to SBIR/STTR outreach, technical assistance, or financial support. As a way to help inform these proposals, SSTI has updated the data from a January Useful Stats article on NIH SBIR/STTR success rates to include the most recent year available, FY 2018.

Women Who Tech Launches Their First Program Focused on HealthTech Innovation | BioSpace

Women Who Tech, one of the largest nonprofit organizations that funds and showcases women-led ventures, today opened the call for applications for the European-leg of its flagship Women Startup Challenge. Sponsored by Johnson & Johnson Innovation – JLABS, the Office of the Mayor of Paris, and Craig Newmark Philanthropies, 10 early-stage women-led startups with a focus on healthtech will be selected to compete for a $50,000 grant, equity-free, on October 7th at Paris City Hall, Hôtel de Ville.

Rise in Autism Could Be Linked to Preservative in Processed Foods

Investigators at the University of Central Florida (UCF) have just identified the molecular changes that happen when neuronal stem cells are exposed to high levels of an acid commonly found in processed foods. The research team has taken a step closer to showing the link between the food pregnant women consume and the effects on a fetus’ developing brain. Findings from the new study—which described how high levels of propionic acid (PPA), used to increase the shelf life of packaged foods and inhibit mold in commercially processed cheese and bread, reduce the development of neurons in fetal brains—were published recently in Scientific Reports through an article titled “Propionic Acid Induces Gliosis and Neuro-inflammation through Modulation of PTEN/AKT Pathway in Autism Spectrum Disorder.”

Sanofi, Google Launch “Innovation Lab” Aimed at Drug Discovery

Sanofi will apply Google’s artificial intelligence (AI) and cloud computing capabilities toward developing new drugs, through a collaboration whose value was not disclosed.

The companies said they have agreed to create a virtual Innovation Lab to “radically” transform how future medicines and health services are developed and delivered.

Pfizer to buy Array BioPharma for $11.4B – MedCity News

A large pharmaceutical company is spending more than $11 billion to acquire the maker of two drugs used to treat skin cancer.

New York-based Pfizer said Monday it would acquire Boulder, Colorado-based Array BioPharma for $11.4 billion, or $48 per share.

This Baltimore-based venture capital firm is looking to invest in D.C.-area startups – Technical.ly DC

Baltimore-Md.-based Inner Loop Capital is giving D.C.-area startups a financial boost with this new fund.

CASI Pharmaceuticals Acquires Worldwide Rights To Commercialize anti-CD19 T-cell Therapy

CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. biopharmaceutical company that is focusing on developing and accelerating the launch of innovative therapeutics and pharmaceutical products in China, the U.S., and throughout the world, announces the signing of a license agreement for exclusive worldwide license and commercialization rights to an autologous anti-CD19 T-cell therapy product (CNCT19) from Juventas Cell Therapy Ltd., a China-based domestic company located in Tianjin City, China. Juventas will continue to develop CNCT19 with CASI’s participation on the program’s steering committee. CASI will be responsible for payment of certain future development milestones and sales royalties.

Minnowtech wins $225,000 SBIR Phase 1 Grant from the NSF – Minnowtech

Minnowtech, LLC, an aquaculture technology company that provides an imaging platform to enable shrimp farmers to measure shrimp abundance to optimize feeding, announced today it has been awarded a $225,000 Small Business Innovation Research (SBIR) Phase I grant from the National Science Foundation (NSF).

Jun 18 2019

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358th Edition – June 18, 2019

By admin BHI Weekly Newsletter Archives

BioHealth Innovation

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June 18, 2019

FOUNDING MEMBER OF

Rich Bendis Presentation at NCI and FNL Technology Showcase

FREDERICK, A KEYPLAYER IN THE BIOHEALTH CAPITAL REGION

Inaugural BIO Health Caucus – A Success!

On behalf of AURP, and our BIO Health Caucus Co-Chairs Mark Romney and Rich Bendis, we would like to thank all who participated at the inaugural BIO Health Caucus, making it a grand success!

Each of our speakers and sessions shared significant insight into what is on the horizon for our global biomedical innovation district. Everyone’s active presence was paramount in our ongoing mission to help the AURP community thrive. This gathering of bio-focused professionals served as an opportunity to establish, promote, and assemble health-related anchor institutions, creating new technologies, developing biotechnology partnerships, and improving health outcomes.

The next BIO Health Caucus will converge at the AURP IC2019 on November 5, 1:00 – 4:00 pm.

The Top 10 Highest-Paid Women Executives in Biopharma – Martine Rothblatt, Chairman of United Therapeutics #2

After last year’s BIO International Convention in Boston was overshadowed by reports of topless women dancers bearing the logos of biopharma company sponsors at an unofficial party, the Biotechnology Innovation Organization in October sent its members a letter insisting that they pay more than lip service to diversifying their historically male executive suites and boardrooms.

RoosterBio Receives Grant from Maryland Stem Cell Research Fund to Commercialize MSC-EV Technology

RoosterBio, a regenerative medicine manufacturing technology leader, has received a $300,000 grant from the Maryland Stem Cell Research Commission to facilitate new product development. RoosterBio is one of three Maryland-based companies who received the Maryland Stem Cell Research Fund (MSCRF) Commercialization Program Award totaling $899,990 to assist with the creation of start-up companies or new technologies developed in Maryland.

Think Solutions: Qiagen – MCEDC Success Stories

MCEDC talks with Douglas Liu, SVP of Global Operations for Qiagen, about how his company makes improvements in life possible.

How to Woo Capitol Hill? Johns Hopkins Is Putting On a Research Extravaganza – The Chronicle of Higher Education

Hundreds of politicians, Capitol staff members, and campus top brass will gather on Wednesday in Washington to hear about researchers’ work. The scholars aren’t leaving any detail to chance.

Andrew Lees, Ph.D., Fina Biosolutions, LLC – 2019 Johns Hopkins Alumni Award Winner

Andrew Lees, Ph.D., is founder and scientific director of Fina Biosolutions, LLC (Rockville, Md.), a company focused on promoting affordable conjugate vaccines by making the technology available to emerging market vaccine manufacturers. Among his contributions in the field, Lees developed an efficient linking chemistry which is widely used in conjugate vaccines, a class that includes vaccines for S. pneumoniae and meningococcal disease. The chemistry has helped to reduce the cost of these vaccines.

REGENXBIO Announces First FDA Approval of a Gene Therapy Based on Its Proprietary NAV® Technology Platform

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.

Bayh-Dole Rocks While the Critics Play the Same False Note

A just-released study co-sponsored by the Biotechnology Innovation Organization (BIO) and AUTM provides new evidence of the significant contribution academic patent licensing makes to the U.S. economy. The report is the most recent in a series, and the numbers are astounding.

Five Companies That Are Changing the Landscape for Cell and Gene Therapy · BioBuzz

Gene therapies represent some of the most promising advancements in science and human health in recent history. The BioHealth Capital Region, and Maryland in particular, is rapidly becoming a hub for companies in this field. With the NIH and the National Cancer Institute at the nucleus, some of the most advanced scientific research and technology development in the field is happening in a short 30-mile radius around Montgomery County, Maryland.

70 Years of Scientific Research on Diseases

70 Years of Scientific Research on Diseases (1947-2017) – number of research articles published (PubMed) # For more interesting & helpful content on healthcare & data science, follow me & Brainformatika on LinkedIn.

Corvidia Therapeutics Initiates Phase 2b Dose-Finding Study for Ziltivekimab | Business Wire

Corvidia Therapeutics Inc., a clinical stage biotechnology company, announced today the initiation of patient screening for a Phase 2b dose-finding study of ziltivekimab. Previously known as COR-001, ziltivekimab is a proprietary anti-interleukin-6 ligand monoclonal antibody (anti-IL6 mAb), targeting residual inflammatory cardiovascular risk in patients living with advanced chronic kidney disease (CKD).

Frederick research centers look to advance technology through partnerships | Treatment And Diseases | fredericknewspost.com

A vaccine for HIV. Nanoparticles. A topical ointment for sickle cell disease.

Those are just three examples of technologies discussed at a showcase held by the Frederick National Laboratory for Cancer Research and the National Cancer Institute.

Alexandria Real Estate Equities, Inc. Announces Strategic Partnership With Columbia University to Open Alexandria LaunchLabs @ Columbia, Deepening Its Focus on Cutting-Edge Life Science Companies Spinning Out of NYC’s Renowned Academic Institutions

Alexandria Real Estate Equities, Inc. (NYSE: ARE), an urban office REIT uniquely focused on collaborative life science and technology campuses in AAA innovation cluster locations, today announced that it has strategically partnered with Columbia University to open Alexandria LaunchLabs®, the premier life science startup platform, at the university in the spring of 2020. Building upon the success of the flagship Alexandria LaunchLabs site at the Alexandria Center® for Life Science – New York City, Alexandria LaunchLabs @ Columbia will increasingly focus on promising life science startups emerging from Columbia and peer institutions, which serve as the greatest source of new company formation in the NYC life science ecosystem.

Women in healthcare | McKinsey

How does the healthcare sector stack up on gender equality? To answer that question, we look at pipeline practices, employee experiences, and policies and programs the industry has implemented to promote diversity and inclusion. We also hear from industry leaders on what it takes to accelerate change across the sector.

Lunch and Learn: Accessing the Virginia Neuroscience Initiative (VNI)

Wednesday, June 26, 2019 from 11:45 AM to 1:00 PM EDT

Attendees will be provided an overview of Virginia Neuroscience (VNI) Initiative and how it accelerates neuroscience research by providing strategy, infrastructure, and research tools to clinicians, researchers, and industry. VNI members conduct basic and translational research in neurobiology to advance our understanding of brain diseases.

Drop Anywhere Labs Launch Event RSVP

You are invited to join Learning Undefeated as we expand our reach again and welcome three new mobile laboratories.

Drop Anywhere Labs are the newest innovation in mobile STEM education, custom-built shipping containers that serve as flexible laboratory and classroom space for middle and high schools. Tour all six of our mobile laboratories including Drop Anywhere Labs, the Mobile eXploration Lab, MdBioLab, and Verizon explorer lab.

Event Info

Date: Thursday, August 1, 2019

Time: 4:00 – 6:00 PM

D.C.’s Top Economic Development Official Leaving To Join Amazon

D.C.’s top economic development official is leaving government to join Amazon as the tech giant builds its second headquarters in Northern Virginia.

Deputy Mayor for Planning and Economic Development Brian Kenner, who has held the position for over four years, will join Amazon to tackle regional economic development issues, the Washington Business Journal reports.

Women Building Bio 2019 – Virginia Bio

Inova Center for Personalized Health, Fairfax You’re invited to spend the day with innovative entrepreneurs, professionals and industry leaders. Discover opportunities to help you navigate through a rapidly evolving modern industry & gain access to cutting edge technologies and tools.

Join forces with industry and academia leaders, researchers and decision-makers, all gathered together, at the same time, and at the same place, bringing ideas together to make a global impact and change the world.

Women Building Bio is where the future is transformed into reality.

Concept to Clinic: Commercializing Innovation (C3i) Program | National Institute of Biomedical Imaging and Bioengineering

The C3i Program is designed to provide medical device innovators with the specialized business frameworks and essential tools for successful translation of biomedical technologies from the lab (concept) to the market (clinic). Through this program, the NIH fosters the development and commercialization of early-stage biomedical technologies by engaging investigators who are interested in better understanding the value of their innovation in addressing an unmet market need. The curriculum and customized mentoring provided by the C3i Program are intended to guide investigators as they assess the commercial viability and potential business opportunity for their innovation.

Alexandria, Verily Bring Opioid Treatment Campus to Dayton – Connect Media Commercial Real Estate News

The first facility has opened at Dayton, OH’s 4.3-acre OneFifteen campus, a treatment center for opioid addiction. The project is a partnership of life sciences REIT Alexandria Real Estate Equities and Verily, an Alphabet company, with Alexandria leading design and development.

Jun 11 2019

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357th Edition – June 11, 2019

By admin BHI Weekly Newsletter Archives

BioHealth Innovation

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June 11, 2019

FOUNDING MEMBER OF

Catalyzing Biohealth: New Transatlantic Partnership Focused on Expanding Resources for BioHealth Technology Commercialization

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.

Why Dozens of Biotechs are Moving to Maryland Each Year · BioBuzz

Whether you’re starting a business, relocating one, or just moving to live and work, there are endless reasons for why Maryland is the top state to relocate to. The BioHealth Capital Region continues to climb the GEN’s annual ranking of the nation’s top biopharma clusters, and was ranked fourth in 2018. There are many factors that make Maryland a great place to headquarter your BioHealth company. Biotech and life science companies are high-risk high expense ventures, and the location of your company is key to its success.

Johns Hopkins makes list of top 10 patent-earning universities worldwide – Baltimore Business Journal

Johns Hopkins has ranked among the top 10 patent-earners since 2014.

Emergent BioSolutions CEO on fighting drug pricing and the opioid epidemic [Video]

Emergent BioSolutions CEO Robert Kramer Sr. sits down with Yahoo Finance’s Dan Roberts, Melody Hahm and Myles Udland on “YFi AM” to discuss the fight over drug pricing and hear how the biopharmaceutical company is seeking to make Narcan, a life-saving drug that blocks the effects of an opioid overdose, more affordable and accessible.

LifeBridge, CareFirst partner on incubator, $5M fund for digital health startups – Baltimore Business Journal

The two health care organizations have been investing separately in health technology and companies for several years.

NOAA Awards $175 Million to the University of Maryland for Earth System Studies

The National Oceanic and Atmospheric Administration (NOAA) has awarded a five-year $175 million cooperative funding agreement to the University of Maryland for collaborative research in Earth system science.

BIO Releases Bioscience Economic Development Guide

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.

Altimmune Announces Important Additions to its Patent Portfolio for HepTcell and ALT-702 Programs

Altimmune, Inc. (ALT), a clinical-stage biotechnology company, today announced that it has received additional patent protection for its HepTcell and ALT-702 programs in the United States.

Maryland’s 10 largest venture capital rounds of all time – Baltimore Business Journal

Although the recent $110 million funding round for Thrive Earlier Detection Corp. was impressive — it is certainly not the biggest we’ve seen around Maryland to date.

BRAINBox Solutions™ Receives Breakthrough Device Designation from FDA for First-of-Kind Device to Aid in Concussion Diagnosis and Prognosis

BRAINBox Solutions today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the company’s BRAINBox TBI (Traumatic Brain Injury) test in development, the first to aid in both the diagnosis and prognosis of mild TBI (concussion). The BRAINBox TBI test is a multi-modality, quantitative test that combines injury-related blood protein biomarkers with computerized neurological assessments.

Angel Cabrera picked as Georgia Tech president finalist – Atlanta Business Chronicle

The Georgia Tech alum is the first Spanish-born president of an American university.

Emergent BioSolutions Announces FDA Approval of Change in Storage Conditions and Transfer of Manufacturing for Its Cholera Vaccine

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.

New BIO Chair Vows Crackdown on Biopharma’s “Bad Actors”

The new chairman of the Biotechnology Innovation Organization (BIO) is promising to crack down on “bad actors” that increase drug prices “dramatically”—in part by expelling member companies that carry out the sky-high hikes.

Governor Northam Announces Commonwealth Research Commercialization Fund Award Winners

Governor Ralph Northam today announced $2.51 million in funding in support of 41 Commonwealth Research Commercialization Fund (CRCF) awards. The projects represent exciting advancements in five industries: clean energy, cybersecurity, data analytics, life sciences, and unmanned systems.

A trio of Baltimore institutions are forming partnerships with Baxter International – Technical.ly Baltimore

Fortune 500 healthcare company Baxter International is planning to partner with a trio of Baltimore organizations.

The Chicago-based company plans to work with Johns Hopkins University, LifeBridge Health and the University of Maryland, Baltimore.

SBA launches annual Growth Accelerator Fund Competition to award $3 million for startups – Caribbean Business

The U.S. Small Business Administration (SBA) has announced the fifth round of its Growth Accelerator Fund Competition to recognize innovative accelerators, including incubators, co-working startup communities or other similar models, to compete for prizes of $50,000 each for a total of $3 million.

Johns Hopkins announces ambitious changes to the way it prepares students for careers | Hub

Johns Hopkins University is planning a bold new approach to career development for students and alumni that includes opening three new administrative offices, launching new initiatives, and better integrating career and life design into the academic and co-curricular experience of all Hopkins students and postdocs.

2 weeks left to register! Regulatory Strategies for Emerging Healthcare/Life Science Companies: Everything You Need to Know, but Didn’t Know to Ask!

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

A Foot In 2 Worlds: Chinese Immigrant, U.S. Politician : NPR

Maryland state delegate Lily Qi shares her path to becoming a first-generation Chinese-American lawmaker. Qi is from Shanghai.

Your Body’s Anti-Aging Programs May Take Early Retirement

At the molecular level, we may not age gracefully; that is, we may not follow a continuous, linear downward slope. Instead, we may fall precipitously after we lose control of our exquisitely balanced anti-aging programs, sometime in our 50s. These findings, derived from a study of tissue-coding and noncoding RNA, may help explain why human disease burden increases so sharply from the sixth decade of life onward. They may also lead to therapies that enhance longevity, provided the natural termination of protective gene expression patterns does not indicate that they have outlived their usefulness.

Cerner challenges developers to create apps for improved health record access – MedCity News

Health IT vendor Cerner has revealed a new challenge that asks developers to improve patients’ access to EHRs, according to a company news release.

Dubbed the 2019 code App Challenge, the contest encourages participants to build apps on Cerner’s platforms.

Third Rock Ventures raises $770m for its largest life sciences fund – Opalesque

Biotechnology venture capital firm Third Rock Ventures has raised $770m for its fifth fund, a sign that investor interest in funding early-stage science continues unabated despite volatile public markets.

The investment vehicle, the largest ever raised by Third Rock in its 12-year history, will support investments in 10 to 12 companies. The Boston-based firm’s new fund came together quickly.

Ceres funded to develop Liquid Biopsy Device

Ceres Nanosciences, Inc. (Ceres), University of Virginia (UVA), and George Mason University (Mason) today announced the receipt of a $600,000 award from the Virginia Catalyst for the development of a Nanotrap® liquid biopsy collection device. This award will be matched by $1.2 million in product development funding by Ceres Nanosciences.

Jun 05 2019

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356th Edition – June 5, 2019

By admin BHI Weekly Newsletter Archives

BioHealth Innovation

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June 5, 2019

FOUNDING MEMBER OF

Catalyzing Biohealth: New Transatlantic Partnership Focused on Expanding Resources for BioHealth Technology Commercialization

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.

Fina BioSolutions’ Dr. Andrew Lees joins Rich Bendis on BioTalk to discuss their technology, how they partner with Biotech companies and their future

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.

Representing Montgomery County and the BioHealth Capital Region in the Maryland Pavilion at the BIO International Convention in Philadelphia this week.

Baltimore firm raises $110 million to bring Johns Hopkins’ cancer-detecting blood test to market – Baltimore Sun

A newly formed Baltimore company has raised $110 million to commercialize a cancer-detecting blood test, developed by Johns Hopkins researchers, that doctors would give patients during routine physicals.

Emergent BioSolutions Awarded 10-Year HHS Contract Valued at Approximately $535 Million to Deliver Vaccinia Immune Globulin Intravenous (VIGIV) in Support of Smallpox Preparedness

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.

Gaithersburg’s Viela Bio strikes $220M partnership with Hansoh Pharmaceutical Group – Washington Business Journal

It’s the local company’s first step toward establishing an international presence after it was spun out last year from MedImmune.

With FDA Approval Of Zolgensma, Regenxbio Sets Out For First Revenue Stream – REGENXBIO Inc. (NASDAQ:RGNX) | Seeking Alpha

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.

QIAGEN launches first FDA-approved companion diagnostic for PIK3CA biomarkers to enhance precision medicine in breast cancer

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.

Johns Hopkins founded and BHCR Crab Trap Winner medical research firm LifeSprout gets financing boost – Baltimore Sun

A Baltimore-based regenerative medicine firm called LifeSprout, which makes synthetic products used to restore soft tissue, has secured $6.5 million in financing.

Built For Bio: Jeff Galvin, CEO & Founder of American Gene Technologies

MCEDC discovers how Jeff is using the availability of raw talent and novel technology unique to Montgomery County, MD to help cure HIV and cancers with gene and cell therapy research.

BIO Releases 5th Annual Emerging Therapeutic Company Trend Report Showing Record Year for Venture Capital Funding

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.

BIO Preview: Some of the Highlights of One of the World’s Premier Life Science Conventions | BioSpace

The BIO International Convention is being held in Philadelphia from June 3-6, with more than 16,000 attendees expected from around the world. The convention draws a list of who’s who in drug discovery, biomanufacturing, genomics, biofuels, nanotechnology and cell therapy, with more than 7,000 companies and 47,000 partnering meetings.

Tick tock: Register now, 2019 Technology Showcase

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.

NHLBI Funding & Research Opportunities and Announcements for May 3, 2019

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

Rexahn Announces Move to Nasdaq – Rexahn Pharmaceuticals, Inc.

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.

How to navigate the world of startups | Hub

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?

Gene therapy may have its first blockbuster – MIT Technology Review

A newborn. A fatal diagnosis. And soon, a one-time gene replacement cure in the first weeks of life.

The cost? You don’t want to know.

Top 50 NIH-Funded Institutions of 2019

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.

May 29 2019

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355th Edition – May 29, 2019

By admin BHI Weekly Newsletter Archives

BioHealth Innovation

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May 29, 2019

FOUNDING MEMBER OF

Crystal R Icenhour, PhD CEO and Co-Founder of Aperiomics joins Rich Bendis to discuss their Technology, Growth, and place in the BioHealth Capital Region

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.

Attend the Inaugural AURP BioHealth Caucus in Philadelphia on Monday, June 3rd

Meet Up with AURP at BIO in Philadelphia forAURP’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!

Maryland leads delegation to BIO 2019 – Meet with BHI at The MARYLAND Booth #3427

Maryland Commerce is leading a delegation of 20 biohealth and life sciences companies, educational institutions, federal agencies, and city and county economic development offices to the 2019 BIO International Convention in Philadelphia next month.

The Catalyst: Creating Innovation in Health Care – United Therapeutics’ Martine Rothblatt at Healthy Returns [Video]

There are few, if any, more innovative, more daring, and more iconic health care executives. We’ll hear about the process that drives groundbreaking invention, and her dream of permanently alleviating the shortage of transplantable organs.Martine Rothblatt, founder and CEO of United Therapeutics presents her organization’s latest innovation, followed by a conversation with “Fast Money” Host and “Power Lunch” co-anchor, Melissa Lee.

NAVAN Appoints Cell Therapy Executive and AgBio Expert to Strategic Advisory Board | National | fltimes.com

NAVAN, Inc. (NAVAN), a privately-held biotechnology company enabling the development of next generation cell and gene therapies through its novel, non-viral NanoStraw platform, announced today the appointment Heidi Hagen, Co-founder and Chief Strategy Officer for Vineti, Inc., and Howard Grimes, Ph.D., Associate Vice President and Associate Vice Provost for Institutional Initiatives at The University of Texas at San Antonio, to its Strategic Advisory Board.

2019 BioHealth Capital Region Forum Photos

If you need great photographer for your event, contact UZI Photography who covered the 5th Annual BioHeallth Capital Region Forum

Incubator “Cheat Sheet” for Life Science Entrepreneurs in the BioHealth Capital Region · BioBuzz

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.

Maryland Tech Council Announces Winners of 31st Annual Industry Awards

The Maryland Tech Council (MTC), Maryland’s largest technology trade association, announced the winners of its 31st Annual Industry Awards during a celebration and ceremony at the Bethesda North Marriott Hotel & Conference Center attended by more than 630 business leaders from around the state.

Scott Gottlieb returns to NEA | PitchBook

Scott Gottlieb, who resigned as head of the FDA in March, has rejoined NEA as a special partner focused on healthcare investments. Gottlieb was a venture partner with the firm for 10 years before leading the FDA. Founded in 1977, the Maryland-based firm’s portfolio includes Opendoor and Desktop Metal.

Rockville biotech raising $7.5M for new manufacturing facility – Baltimore Business Journal

This is the first raise for the business, which has been profitable and fueled growth organically up to this point.

Navitas Life Sciences Announces Acquisition of KAI Research, US-based Full-service Contract Research Organisation (CRO)

Navitas Life Sciences, a TAKE Solutions Enterprise today announced the acquisition of US based niche full service CRO and health research company, KAI Research Inc.

KAI Research brings on board top of class offerings in 3 key areas – Clinical Trial Management, Clinical Research Consultation, and Data Management & Standardization. Through this acquisition, Navitas Life Sciences expands Phase II and Phase III capabilities in North America adding to its current capabilities in Europe and APAC. KAI strengthens Navitas’ therapeutic expertise in mental health, musculoskeletal diseases, neurological disorders, pain, diabetes, infectious diseases and oncology for Pharma and medical devices. The company has differentiated offerings in the areas of patient registries and e-clinical solutions as well as long-standing relationships with clinical sites and trusted network of service providers across the United States and Africa.

Emergent BioSolutions adds over 100 employees at Baltimore facility, amid $50M expansion – Baltimore Business Journal

By the end of this year, the biotech expects to have 270 employees in Baltimore’s Camden-Carroll neighborhood.

Inaugural InteGIRLS math competition draws more than 100 STEM-loving girls to Rockville | WTOP

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.

25 Up-and-Coming Gene Therapies of 2019

Data released May 9 by the Alliance for Regenerative Medicine (ARM) illustrates the growth of clinical activity where gene therapy is concerned.

ARM’s Quarterly Regenerative Medicine Global Data Report for the first quarter of 2019 showed 372 gene therapy clinical trials were in progress as of the end of Q1. Interestingly, a majority (217 or 58%) were studies in Phase II, followed by Phase I (123 or 33%), and Phase III (32 or 9%).

Protenus’ Fells Point office has room to stretch out – Technical.ly Baltimore

With expansion, Protenus recently moved to new offices in Fells Point.

The healthcare analytics company moved into a 12,000-square-foot office space that’s roughly triple the size of its previous location, according to People Operations Associate Samantha Barber, who gave us a recent tour.

QIAGEN’s QuantiFERON®-TB Access development program gains recognition from United Nations initiative for health innovation

QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced that QuantiFERON ® -TB Access, a new solution under development for diagnosis of latent tuberculosis (TB) infection in low-resource regions with a high disease burden of tuberculosis, will be recognized by the Joint United Nations Programme on HIV/AIDS (UNAIDS) at the organization’s Health Innovation Exchange from May 21-23 in Geneva, Switzerland. The event will be held during the World Health Assembly and brings together ministers of health, nonprofits and industry to spotlight innovations with potential to change the world’s health landscape and benefit sustainable development.

2019 Technology Showcase – NCI & Frederick National Laboratory For Cancer Research – Bendis to Speak

Wed, Jun 12, 2019 at 11:30 AM

The 3rd Annual NCI and FNLCR Technology Showcase will showcase technologies being developed at the National Cancer Institute (NCI) in Bethesda and Frederick, and Frederick National Laboratory for Cancer Research (FNLCR) to encourage startup formation, technology licensing, and collaborations. It will introduce the local scientific community to the regional technology development stakeholders and highlight available resources.

Prospective investors, established companies, interested stakeholders, entrepreneurs and those looking to commercialize technologies are invited and encouraged to attend. The day will feature short technology summaries by NCI and FNLCR innovators, as well as presentations from regional stakeholders involved with technology development and commercialization. An interactive poster session by innovators and technology ambassadors will concurrently occur.

Emergent BioSolutions Announces Granting of Marketing Authorization in Five EU Countries for Its Oral Typhoid Vaccine; Expands Availability Across Europe NYSE:EBS

Emergent BioSolutions Inc. (NYSE: EBS) announced today that it has successfully obtained marketing authorization for its oral typhoid vaccine Vivotif® (Typhoid Vaccine Live Oral Ty21a) in five additional European Union Member States, including France, Portugal, Poland, Czech Republic and Slovakia as well as approval of harmonized prescribing information in the EU also known as the Summary of Product Characteristics or SmPC.

Regenxbio building Maryland AAV plant to support gene therapies – BioProcess InternationalBioProcess International

Regenxbio will construct a GMP facility in Maryland to produce adeno-associated viral vectors for its gene therapy programs using its NAV technology-based platform.

The good manufacturing practice (GMP) plant will be integrated into Regenxbio’s 132,000 square-foot headquarters in Rockville, Maryland, currently under construction. Financial details have not been disclosed but the manufacturing plant is expected to be operational in 2021.

FDA is looking for new companies to test out its pre-cert pilot program – MedCity News

The Food and Drug Administration has put out a call for volunteer companies to test out the its digital health pre-certification program for software as a medical device (SaMD) technologies.

THE ENTREPRENEURS REPORT: Private Company Financing Trends – Q1 2019

Coming off the record-breaking venture financing numbers of 2018, the first quarter of 2019 displayed some cooling off, in terms of pre-money valuations across all rounds and amounts raised in Series C and later rounds, although the market remained strong by historical standards. Q1 2019 had slightly fewer up rounds for Series B and later financings than did the last two quarters of 2018. Median pre-money valuations declined moderately across all equity rounds in Q1 2019. Median amounts raised remained strong for Seed, Series A, and Series B rounds, with those medians matching or exceeding those of Q4 2018. But the median amount raised in Series C and later rounds declined significantly, falling from the historic high of $31.1 million reached in Q4 2018 to $15.3 million in Q1 2019.

Alzheimer’s Map Shows Where Epigenetics Takes Wrong Turn

Alzheimer’s disease (AD) arises from molecular events that scientists are piecing together to discern an overall story, parts of which are well known, others less so. Some of the lesser-known epigenetic events in the Alzheimer’s story have just been filled in by scientists based at the Van Andel Research Institute (VARI). What’s more, these epigenetic events, which occur early in Alzheimer’s, appear to fit well with what we know about the disease’s progression to its most devastating biological features.

Modeling Virus Clearance: Use of a Noninfectious Surrogate of Mouse Minute Virus As a Tool for Evaluating an Anion-Exchange Chromatography Method – BioProcess InternationalBioProcess International

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).

Genetic Basis of Obesity Carries Weight

There are, undoubtedly, many factors that go into a person’s weight. A new report from the lab of Sekar Kathiresan, MD, director of the Center for Genomic Medicine at Massachusetts General Hospital (MGH), documents a clear biologic basis for the predisposition of obesity. More specifically, that genetics play a role in how heavy a person gets.

House Drug Pricing Hearing Goes Off Script

Most Congressional hearings are morality plays designed to reach a predetermined outcome. It wasn’t hard to predict how the second hearing on drug pricing by the House Committee on Oversight and Reform was supposed to go. If the title, “HIV Prevention Drug: Billions in Corporate Profits after Millions in Taxpayer Investments” wasn’t enough of a clue, when Chairman Elijah Cummings (D-MD) said it was because of the “phenomenal leadership” of freshman Rep. Alexandria Ocasio-Cortez (D-NY) that the hearing was being held, any doubts evaporated. In an extraordinary gesture of deference for a new Member of Congress, Rep. Ocasio-Cortez was recognized for an opening statement before senior members of the committee.

May 21 2019

Love0

354th Edition – May 21, 2019

By admin BHI Weekly Newsletter Archives

BioHealth Innovation

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May 21, 2019

FOUNDING MEMBER OF

Attend the Inaugural AURP BioHealth Caucus in Philadelphia on Monday June 3rd

Beltsville’s NextCure closes IPO – Washington Business Journal

The net proceeds from the IPO, along with NextCure’s cash on hand, will largely be used to drive its lead product, NC318, through clinical trials and testing.

Viela Bio Presents Pivotal Study Results of Inebilizumab in Patients with Neuromyelitis Optica Spectrum Disorder in a Plenary Session at the American Academy of Neurology Annual Meeting | Viela Bio

Viela Bio today announced results from a pivotal study of its anti-CD19 monoclonal antibody, inebilizumab, in patients with neuromyelitis optica spectrum disorder (NMOSD) — a rare autoimmune disease characterized by unpredictable attacks that often lead to severe, irreparable disability including blindness and paralysis. Results were presented today during the Clinical Trials Plenary Session at the 2019 American Academy of Neurology (AAN 2019) Annual Meeting held in Philadelphia from May 4-10.

5/22 – Entrepreneur- in-Residence Feedback Session (Rockville)

BioHealth Innovation has announced the schedule for the next year’s Entrepreneur-in Residence (EIR) feedback sessions. These 1:1 Sessions with EIRs take place at BioHealth Innovation’s office in Rockville OR by videoconference. There is no charge to participate but entrepreneurs must be working on a biohealth Start-Ups/innovation in the BioHealth Capital Region (MD, DC, VA). The upcoming dates are:

2019: 5/22, 7/24, 9/4, 10/9, 11/20

2020: 1/22, 2/26, 3/25, 4/22, 5/27

Schedule your appointment online here. For questions or more information, contact BHI.

BARDA will procure Emergent BioSolutions’ AV7909 anthrax vaccine in Strategic National Stockpile – Homeland Preparedness News

The Biomedical Advanced Research and Development Authority (BARDA) will begin procuring Emergent BioSolutions’ anthrax vaccine into the Strategic National Stockpile (SNS) to strengthen U.S. preparedness in the event of a public health threat, the company said on Wednesday.

FDA Approves New Combination Therapy for Type 2 Diabetes – Endocrinology Advisor

The Food and Drug Administration (FDA) has approved Qternmet XR (AstraZeneca) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes (T2D).

Q&A: Children’s National CEO talks about research ambitions for partnership with JLABS | FierceHealthcare

It’s not often a piece of property with existing research facilities in a perfect location comes on the market.

So when a 12-acre portion of the former Walter Reed Army Medical Center campus in Washington, D.C., became available a few years ago, it was too good an opportunity for Children’s National Health System to pass up. The pediatric research hospital is now in the midst of building a new $190 million pediatric research and innovation campus on the site that is expected to open in 2020.

NIST Director: Improving Tech Transfer of Federally Funded R&D Key to U.S. Competitiveness

The U.S. government invests a significant amount of money to further research and technology innovation. In 2017, the federal government invested approximately $150 billion in R&D— about one-third at the 17 federal laboratories across the country and two-thirds at universities and private sector R&D institutions, according to government reports. This represents about one-third of all U.S. R&D spending.

Amazon, JBG submit HQ2 development plans – Washington Business Journal

The submission to Arlington County ends months of speculation.

THE ANGEL MARKET IN 2018 MORE ANGELS INVESTING IN MORE DEALS AT LOWER VALUATIONS

The angel investor market in 2018 experienced an increase in market participation in more companies, albeit at smaller amounts, according to the Center for Venture Research at the University of New Hampshire. Total angel investments in 2018 were $23.1 billion, a negligible decrease of 3.4% over 2017. A total of 66,110 entrepreneurial ventures received angel funding in 2018, an increase of 7.4% over 2017 investments. The number of active investors in 2018 rose to 334,565 as compared to 288,380 in 2017, a robust increase of 16%. The change in total dollars and the number of investments resulted in a deal size for 2018 that was smaller than in 2017, reflecting lower valuations. The increase in number of investments likely offsets a decline in activity by institutional investors in seed and start-up deals and the smaller deal size may have partially contributed to the increase in angel investors.

Interview: Susan Hockfield on the Dawn of the Biotech Revolution

AS A CHILD, Susan Hockfield took apart anything she got her hands on to figure out how it worked. One time it was a watch, another time her mother’s iron. Her interest in the anatomy of the physical world grew over time: She pursued a career in neurobiology, and went on to teach at Yale University, where she eventually became provost. In 2005 she became the first female president of the Massachusetts Institute of Technology — and its first biologist-president.

Venture capital funds jump into the Opportunity Zone game – Business Insider

Venture capital firms are starting to launch and raise funds to invest in companies located in designated Opportunity Zones, where investors can get ..

Biotech’s top 10 money raisers of 2018 – FierceBiotech

If 2017 was a banner year for biotech venture capital, 2018 blew it out of the water. Last year, private biotech companies reeled in a grand total of $16.8 billion, eclipsing 2017’s then-record $12.1 billion by 39%. And it wasn’t just the total spent that smashed records: The average per financing round increased too, and so did the proportion of enormous megarounds.

How Venture Capital is Investing in Gene Therapy – Bloomberg

Alexis Borisy, Third Rock Ventures partner, discusses the fund’s biotech investment strategy on “Bloomberg Technology

Refueling vaccine innovation | McKinsey

Vaccine development has slowed over the past five years, but changes to investment strategies and a shift in focus to more technical and complex vaccines could renew the innovation engine.

Mindoula Health raising $4.25M – Washington Business Journal

The company will use the funding to grow two business lines.

Maryland Stem Cell Research Commission Announces $6.6 Million in Stem Cell Program Awards | TEDCO

The Maryland Stem Cell Research Commission (Commission) has approved funding to its second round of 2019 recipients for a total of $6,622,673.63. The Commission has also issued its Request for Applications (RFAs) for its first round of funding for fiscal year 2020.

Baltimore Start Up NextStep Robotics Receives $600,000 in Second Funding Round – NextStep Robotics

NextStep Robotics Inc., an early-stage company that has developed a personalized robotic therapy to help treat foot drop in recovering stroke patients, announces the closing of its second funding round. The $600,000 round will allow NextStep to transition from prototyping and development to manufacturing and sales. Led by the Abell Foundation, a new investor, this round includes investments from previous private investors from Vancouver, Canada and new investors the Abell Foundation, University of Maryland (UM) Ventures, and Jeff and Brad Quinn of Engineered Medical Systems, Inc. (EMS), a partner company of the newly-formed LaunchPort™ Accelerator.

Protenus raises $13 million in new funding round

Protenus, a Baltimore data security company, has raised $13 million in new equity financing, according to documents filed with the U.S. Securities and Exchange Commission.

May 14 2019

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353rd Edition – May 14, 2019

By admin BHI Weekly Newsletter Archives

BioHealth Innovation

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May 14, 2019

FOUNDING MEMBER OF

Gaithersburg-based Sirnaomics closes $47 million funding round – BioBuzz

Sirnaomics Inc. has taken in yet another $11 million in investments, closing a Series C funding round that totaled $47 million.

The Gaithersburg biopharmaceutical company kicked off the round last year with $25 million in Series C1 financing — one of the biggest venture deals of the year last year in a generous overall haul for Maryland biotech companies. That was followed by an $11 million raise as part of a Series C2 round in January.

Start-Ups Seeking Your Expertise

Are you an experienced biohealth industry executive seeking full time or part time employment as a consultant or start-up C suite executive? BioHealth Innovation is establishing a database of experienced industry executives who may be able to share their expertise with early stage/growing companies. To be considered by companies or technology transfer organizations seeking leaders for their spin-out companies and/or advisors to support their business growth, please complete the following form.

Three Examples That Show Why NCI is a Goldmine of Blockbuster Technologies for Commercialization · BioBuzz

What do the technologies that led to the success of Kite Pharma, the creation of the pioneering immune-oncology cancer treatment avelumab (BAVENCIOⓇ) and the founding of miRecule, Inc. all have in common?

With promising pivotal data, Viela Bio’s lead autoimmune drug heads for FDA filing – FierceBiotech

Viela Bio spun out of AstraZeneca last year with six autoimmune and inflammation-aimed programs and $250 million. Now, the biotech is reporting positive pivotal data for its lead drug in a rare, autoimmune disease, teeing it up for an FDA filing later this year.

The Journey To Commercialization for a Novel Medical Device Startup: Q&A with Sonavex CEO, David Narrow · BioBuzz

In the past year Sonavex has landed not one, but two FDA 510(k) clearances for their ultrasound-based medical devices. This first of its kind solution is comprised of two components, EchoMark and EchoSure, that use a customized ultrasound technology to perform real-time blood flow monitoring for postoperative patients.

Bio Lab Pilot Project — MCEDC

The Bio Lab Pilot is a reimbursement grant program created by the Montgomery County Economic Development Corporation (MCEDC) with funding support from the Maryland Department of Commerce.

MCEDC recognizes the financial challenges small BioHealth companies face when securing small wet lab space in the region. Because young BioHealth companies are not always well-suited for conventional financing mechanisms for lab and office fit-out, MCEDC’s year-long pilot project will award grants to small-scale biotech companies that are struggling to fund lab fit-out costs.

The Bio Lab Pilot will focus on growth-stage BioHealth companies that want to lease small wet lab space in Montgomery County that is less than 5,000sf. This project will not fund shared lab space or incubators.

Four biotech companies announce pricings of IPOs, looking to raise more than $300M – MedCity News

Four biotechnology companies were looking to raise a combined $303.9 million starting on Thursday as they announced Wednesday the pricings of their initial public offerings.

The companies – NextCure, Milestone Pharmaceuticals, Cortexyme and Axcella Health – all said Wednesday that they would begin trading on the Nasdaq Thursday, with their offerings expected to close Monday. BioPharmCatalyst, a biotech and healthcare investor website, had listed the companies as expected to begin trading Wednesday.

Q&A: Children’s National CEO talks about research ambitions for partnership with JLABS | FierceHealthcare

It’s not often a piece of property with existing research facilities in a perfect location comes on the market.

VideoKall, Inc. and MJ Biotech, Inc. Announce a Letter of Intent for a Strategic Partnership in Telehealth | LinkedIn

MJ Biotech, Inc. (f/k/a Michael James Enterprises, Inc.) (OTC: MJTV) announces that the Company has executed a Letter of Intent to explore a strategic relationship with VideoKall, Inc., a new player in telehealth, pioneering the first unmanned micro-clinics for indoor, mobile, and outdoor locations. Once the relationship is formalized, MJ Biotech will raise funds to pursue areas of common interests with market penetration in underserved locations across the US.

The Rise of Bio Health Innovation Districts

By: Brian Darmody, CEO, Association of University Research Parks (AURP)

Across the country and around the world, cities, research universities, government labs and other actors are reformulating the way anchor institutions can help lead technology-based economic development as the geography of innovation shifts.

Julie Wagner, Bruce Katz, Tom Osha and others have formed the Global Institute on Innovation Districts (GIID) https://www.giid.org/, which is doing research and policy implementation to advance Innovation Districts around the world. These districts, defined by GIID are “geographic areas where leading-edge anchor institutions and companies cluster and connect with start-ups, business incubators, and accelerators. Compact, transit-accessible, and technically-wired, innovation districts foster open collaboration, grow talent, and offer mixed-used housing, office, and retail.”

FDA approves first pediatric lupus treatment

The US FDA approves an extended indication of GSK’s lupus treatment, Benlysta IV, for children five years and older, giving pediatric patients a new therapeutic option. Benlysta (belimumab) from Glaxo-Smith Kline was previously approved in 2011 by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the intravenous administration in adults with systemic lupus erythematosus (SLE) – the recent approval from the FDA extends the indication to children five years and above.

Why Paragon Bioservices’ $1.2B acquisition deal matters to Baltimore – Technical.ly Baltimore

For Paragon Bioservices, news came quickly earlier this month. On a Thursday in mid-April, Gov. Larry Hogan and other state and county officials joined biotech community supporters at an Anne Arundel County site near BWI Airport that’s increasing capacity for the company’s work with large firms to manufacture new treatments. Specifically, speakers talked about the company’s expertise in gene therapy, which is an area of medicine that involves introducing DNA to fight a genetic disease.

FDA clears RemUnity drug pump co-developed by Deka, United Therapeutics

United Therapeutics and Deka Research and Development have received FDA 510(k) clearance for the co-developed RemUnity system.

The RemUnity system is a subcutaneous delivery system for Remodulin injections. The two companies have co-developed the device that is indicated to treat pulmonary arterial hypertension.

FastForward exits show success of Hopkins incubator – Maryland Daily Record

Two years after Johns Hopkins Technology Ventures opened new office and lab space for its FastForward 1812 incubator on the Johns Hopkins Hospital campus, two companies have moved on to bigger space. LifeSprout, which had been in the incubator for about a year, moved last month to City Garage, where it will have manufacturing capabilities.

Over 30% Reduction in Unnecessary Head CT Scans When Integrating FDA-Cleared BrainScope One – VentureBeat

BrainScope announced today the publication of a study conducted by physicians at Washington University Barnes Jewish Medical Center in St. Louis in the peer-reviewed journal The American Journal of Emergency Medicine entitled “Reduction in unnecessary CT scans head-injury in the emergency department using an FDA cleared device.” The study demonstrated that the FDA-cleared BrainScope One medical device reduced the use of unnecessary head CT scans by nearly one-third in a hospital emergency room setting when compared to the use of standard clinical practice.

Project Onramp Meets Its Goal of Placing 50 Mass. Students from Low-Income Backgrounds into Summer Internships at Local Biotech Companies – Massachusetts Biotechnology Council

Project Onramp today announced they have placed more than 50 students in well-paid internships with top companies for summer 2019 through its first-in-the-nation Project Onramp program. The program will give the students – many of them the first in their families to attend college – hands-on experience and a valuable start towards a career in biotechnology.

“Project Onramp has created a new model for extending opportunities in the thriving biotech industry for high-achieving students who don’t have the personal or family connections that often play a big part in awarding internships,” said David Lucchino, chairman of MassBio and CEO and co-founder of Frequency Therapeutics. “The enthusiastic response from leading life sciences companies in Massachusetts has been overwhelming.”

Virginia Outstanding Contribution to Life Science Inducts Three Award Winners

Virginia Bio, the premier statewide non-profit trade association representing the life sciences industry in the Commonwealth of Virginia, announced on May 2, 2019, during its innovative, bioscience conference, THRiVE 2019, that three new award winners are getting inducted into the prestigious Outstanding Contribution to Bioscience in Virginia Award Ceremony.

New SBIR/STTR Rules Moving Forward – Lexology

On April 2, 2019, the U.S. Small Business Administration (SBA) issued a new Policy Directive for the Small Business Innovation Research (SBIR) and the Small Business Technology Transfer (STTR) programs. All provisions in the new Policy Directive apply to both the SBIR and STTR programs unless specifically noted otherwise. The Policy Directive is available here.

BIO Continues Partnership with NIH for Fifth “Innovation Zone” Exhibit

The Biotechnology Innovation Organization (BIO) and the National Institutes of Health (NIH) today announced an agreement to feature Small Business Innovation Research (SBIR)-funded early-stage biomedical companies in an Innovation Zone at the 2019 BIO International Convention. The Innovation Zone companies, focused on drug discovery, diagnostics and other therapeutic platform technologies, will have dedicated exhibit space and participate in BIO’s One-on-One Partnering™ system. Select companies will make 15-minute company presentations in the BIO Business Forum.

VA researchers develop biomarkers, blood test that shows MS patients in relapse – EurekAlert! Science News

Dr. Horea Rus is an expert in diagnosing and treating patients with multiple sclerosis, and his research laboratory at the University of Maryland is producing new tools for treating the disease that attacks the central nervous system.

On Tuesday, Rus and former postdoc research fellow Cosmin Tegla were issued U.S. Patent 10,280,465 for developing a biomarker, using Sirtuin 1, RGC-32, FasL, and IL-21 proteins, that indicates if a patient with relapsing-remitting MS is in relapse.

MedImmune-lite? Immunocore delves into British Big Pharma’s R&D talent pool, again | FierceBiotech

Bahija Jallal, David Berman, Koustubh Ranadel, and now Mohammed Dar lines up as the latest AstraZeneca/MedImmune executive to jump ship into U.K. biotech Immunocore.

May 07 2019

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352nd Edition – May 7, 2019

By admin BHI Weekly Newsletter Archives

BioHealth Innovation

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May 7, 2019

FOUNDING MEMBER OF

Laurie Strongin, Founder and CEO, Hope for Henry Foundation, Joins Rich Bendis for a Special BioTalk

Recorded at the National Capital Consortium for Pediatric Device Innovation Competition in College Park in front of a live audience!

Laurie Strongin is Founder and CEO of the Washington, DC-based Hope for Henry Foundation which is reinventing the pediatric patient experience in hospitals around the country. Laurie’s work with Hope for Henry and the memoir she published, “Saving Henry,” have placed her at the forefront of supporting the rights of patients and their families and the responsible use of new medical technologies. Laurie’s advocacy has led her to service on the nation’s preeminent science policy and bioethics panels. Her activism has produced op-eds in national newspapers; appearances on television and radio; collaborations with Congressional leadership; and recognition from the White House. An in-demand inspirational speaker, Laurie has been featured as a People magazine “Heroes Among Us” and was the subject of profiles in the USA Today and the Washington Post and on Good Morning America. Laurie serves on the board of directors of the National Marrow Donor Program/Be the Match; on the Advisory Committee to Disney’s “Team of Heroes,” and on the Advisory Committee of the Association of Child Life Professionals. Learn more athttps://hopeforhenry.org/.

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

Inside Aperiomics, the biotech company hoping to solve medical mysteries

The 3rd hour of TODAY looks at the Virginia-based biotech company Aperiomics, which says it has technology that could shake up health care and find answers for the millions of people living with chronic and undetected illnesses.

Five winners to receive share of $250K NCC-PDI grant funding and access to unique pediatric device accelerator program

The National Capital Consortium for Pediatric Device Innovation (NCC-PDI) announced five winners of its “Make Your Medical Device Pitch for Kids!” competition who will each receive $50,000 in grant funding and access to the consortium’s first-of-its-kind “Pediatric Device Innovator Accelerator Program” led by MedTech Innovator. A panel of expert judges from business, healthcare, regulatory and legal sectors selected the winners based on the clinical significance and commercial feasibility of their medical devices for children. The competition focused solely on advancing care in pediatric orthopedics and spine, a sector that the FDA identified as an emerging underserved specialty which lacks innovation.

University of Vermont Health Network Ventures and Wilson Sonsini Goodrich & Rosati Invest in BioFactura – BioFactura

The University of Vermont Health Network Ventures and legal firm Wilson Sonsini Goodrich & Rosati recently invested in BioFactura’s $6M Series B Financing Round.

“With the commitment from the UVM fund and WSGR, BioFactura is now securing value-added institutional investors who bring significant financial and business resources to bear as we advance our biopharmaceutical products to the clinic,” said Darryl Sampey, BioFactura’s President and CEO.

SoPE National Capital Chapter: The Titanic Effect: Successfully Navigating the Uncertainties that Sink Most Startups

Wed, May 8, 2019, 6:00 PM – 8:00 PM EDT

Inova Center for Personal Health, 8100 Innovation Park Drive, Conference Center, Fairfax, VA 22031

The Titanic represents to many of us the iconic tale of what happens when an unstoppable force meets an immovable object. The tragedy is embodied in that instant when The Ship struck The Iceberg, killing over 1,500 passengers and crew—and the hubris of thinking we can build something too big to fail. But while the iceberg may have represented the killing blow, what many do not realize is that the demise of the Titanic was in fact a result of a series of small decisions and missteps across a number of dimensions.

GlycoMimetics Aiming At Tough Targets

Startups may spring from pure academics or from a healthy and heterogenous mixture of science, business experience, and inspired thinking. Rachel King, CEO of GlycoMimetics, and others brought experience to the company. Her cofounder, Dr. John Magnani, brought original science, and an expert team soon joined in response to the inspiration created by the company’s concept. The germ idea was to make a formerly “undruggable” set of disease targets druggable. Deep, careful studies of molecular structures were required, followed by rational drug design to achieve the goal of small molecule therapy mimicking natural carbohydrates critical to the “glycosylation” of cellular proteins.

Precigen Opens Gene and Cell Therapy Manufacturing Facility in Germantown, Maryland

LifeSprout is moving into Port Covington manufacturing space – Technical.ly Baltimore

LifeSprout, makers of synthetic tissues for aesthetic and reconstructive medicine, is moving from Johns Hopkins‘ East Baltimore innovation hub into a manufacturing accelerator for medical device companies in South Baltimore’s Port Covington.

This injectable gel could one day rebuild muscle, skin, and fat | Science | AAAS

Car crashes, battle wounds, and surgeries can leave people with gaping holes in soft tissue that are often too large for their bodies to repair. Now, researchers have developed a nanofiber-reinforced injectable gel that can rebuild missing muscle and connective tissues by serving as a scaffold and recruiting the body’s wound-healing cells. So far, the team has tested the material only in rats and rabbits. But if it performs as well in humans, it could give reconstructive surgeons a fast and easy way to help patients regenerate lost tissues without scarring or deformity.

Computer science facility opens at University of Maryland

The University of Maryland has opened a 215,600-square-foot computer science facility on its College Park campus.

The university says the Brendan Iribe Center for Computer Science and Engineering will support team-based, interdisciplinary research in virtual and augmented reality, artificial intelligence, robotics, computer vision, algorithms, programming languages and systems.

New development patterns likely to emerge in Maryland’s life science market

Available life science space is dwindling in Maryland’s traditional life science core.

Only six buildings currently offer space larger than 20,000 s.f.
Space with high ceilings and utility capacity are scarce.
Investor demand has increased in the last plots of vacant and underutilized land.

Xconomy: Roche Spinout Nimble Therapeutics Bags $10M to Find New Peptide Drugs

For the past five years, Jigar Patel and a group of fellow Roche employees have been quietly developing drug discovery technology at the global pharma company’s outpost in Madison, WI. Now, they’re setting out on their own to see if their approach to identifying promising peptide-based therapies can have an impact on the sector.

Annual Research Symposium to Feature Keynote Address from NCI Scientist

On Tuesday, May 7, the Center for Biotechnology Education will hold its 14th annual research symposium. During the event at the Johns Hopkins University Montgomery County Campus, biotechnology students and some high school students will participate in a poster session devoted to their research.

Following the poster session, Barry O’Keefe, a scientist at the National Cancer Institute, will give a keynote address about natural product-based drug discovery. O’Keefe is acting chief of the Molecular Targets Program at the Center for Cancer Research and chief of the Natural Products Branch, Developmental Therapeutics Program at the Division of Cancer Treatment and Diagnosis.

Biotech runs on venture capital. But not all VC models are created equal – STAT

Venture capital dollars are flooding into biotech, totaling $8.5 billion in 2017 alone. But there’s no one way to fund a startup.

Protenus Announces Former Chief Privacy Officer of HHS Office of the National Coordinator to Keynote 3rd Annual PANDAS Conference in Baltimore

The privacy and security of patient data continues to be increasingly important as access to this data increases and threats to this sensitive information continue to grow. At the same time, several new federal health information policies will make electronic health information about individuals more widely available to individuals and their caregivers and health care professionals. Lucia Savage, Former Chief Privacy Officer of HHS Office of the National Coordinator, will provide the opening keynote for the Privacy and Analytics (PANDAS) conference, focusing on innovation that equips privacy teams to effectively navigate the shift that occurs when organizations begin to more frequently utilize consumer tools to deliver healthcare.

Life Sciences Industry On Uptick In Virginia

In February 2019, the French immuno-oncology diagnostics company HalioDx opened its first laboratory in North America. The five-year-old company, a Qiagen spin-off, selected Richmond, VA, as the location of the lab, in part, because the state’s capital city is only a two-hour drive from the FDA’s headquarters in Maryland.

First Annual Patenting Trends Study Provides Decision Makers With Clear and Actionable Information

Kilpatrick Townsend & Stockton and GreyB Services released today their findings from The First Annual Kilpatrick Townsend & GreyB Services Patenting Trends Study (Study). The Study provides clear and actionable information that assists decision makers in envisioning the technological future of their respective industries and setting their companies’ strategies over the coming years and decades in an increasingly globalized economy.

Report details life science industry’s growing importance in helping transform NC economy | WRAL TechWire

The newly published document, “2018: Evidence and Opportunity: Impact of Life Sciences in North Carolina,” is a fascinating story of transformation for a state that once held the unfortunate reputation as the second-poorest in the nation.

It marks the 10th anniversary of the North Carolina Biotechnology Center’s contract with TEConomy Partners to track and evaluate the state’s life science landscape.

Apr 30 2019

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351st Edition – April 30, 2019

By admin BHI Weekly Newsletter Archives

BioHealth Innovation

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April 30, 2019

FOUNDING MEMBER OF

NextCure files for IPO on Nasdaq Global Market – Washington Business Journal

The company is seeking to go public just three years after its founding.

United Therapeutics Announces FDA Approval Of XPS™ And Steen Solution™ Used To Perform Centralized Ex-Vivo Lung Perfusion Services | BioSpace

United Therapeutics Corporation (Nasdaq: UTHR) today announced that its collaborator, XVIVO Perfusion, Inc., a subsidiary of XVIVO Perfusion AB (STO: XVIVO), has received Premarket Approval (PMA) from the U.S. Food and Drug Administration (FDA) for the products XPS™ and STEEN Solution™. This approval means that STEEN Solution, XPS and the accompanying single-use articles are the only medical device products that are approved in the United States for ex-vivo lung perfusion (EVLP) of initially unacceptable donated lungs at body temperature.

GSK receives US approval of Benlysta for intravenous use in children with lupus aged five years and above | Antibodies | News Channels

GSK today announced that the US Food and Drug Administration (FDA) has approved, under priority review, the use of the intravenous (IV) formulation of Benlysta (belimumab), a B-lymphocyte stimulator (BLyS)-specific inhibitor, in children with lupus from as young as five years of age.

Sirnaomics closes Series C funding round – Washington Business Journal

Sirnaomics Inc. has taken in yet another $11 million in investments, closing a Series C funding round that totaled $47 million.

Kite’s CAR-T manufacturing gets another boost with new Maryland facility | FiercePharma

With an FDA approval for its pricey CAR-T therapy Yescarta under its belt and more treatments in the pipeline, Gilead’s Kite Pharma was on the hunt for a new manufacturing site to fuel those hopes. The company found it in Maryland.

Precigen Opens Gene and Cell Therapy Manufacturing Facility in Germantown, Maryland

Precigen, Inc., a wholly-owned subsidiary of Intrexon Corporation (NASDAQ: XON) and a clinical stage biopharmaceutical company specializing in the development of innovative gene and cellular therapies to improve the lives of patients, today announced the official opening of its new manufacturing facility. Precigen commenced the build-out of the nearly 5,000 square foot manufacturing facility in 2018 to support gene therapy manufacturing. The good manufacturing practices (GMP) facility was designed with agility and control in mind, focusing on rapid manufacturing and the ability to scale production appropriately to meet early stage clinical trial needs. The new facility adds to Precigen’s existing footprint in Germantown, Maryland, which supports more than 95 employees. To mark the official opening, the company held a ribbon cutting ceremony attended by elected officials and local community members with remarks from Randal J. Kirk, Chairman and Chief Executive Officer of Intrexon, Helen Sabzevari, PhD, President of Precigen, United States Congressman David Trone representing Maryland’s 6th Congressional District and Jeffrey Schlom, PhD, Chief of the Laboratory of Tumor Immunology and Biology at the Center for Cancer Research, National Cancer Institute. Dr. Schlom is the principal investigator of a Cooperative Research and Development Agreement (CRADA) between the National Cancer Institute and Precigen. Under this CRADA, the National Cancer Institute and Precigen are collaborating to evaluate Precigen’s proprietary adenoviral vaccines in preclinical and clinical studies for the treatment of cancer.

Autolus Therapeutics Receives FDA Orphan Drug Designation for AUTO3 for Treatment of Acute Lymphoblastic Leukemia Nasdaq:AUTL

Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies for the treatment of cancer, announced that the United States Food and Drug Administration (FDA) has granted orphan drug designation to autologous enriched T-cells genetically modified with a retroviral vector to express two chimeric antigen receptors targeting CD19 and CD22 (AUTO3) for the treatment of acute lymphoblastic leukemia (ALL).

NIST Releases Findings on Increasing the Innovation Impacts of Federally Funded R&D | NIST

Today, the U.S. Department of Commerce’s National Institute of Standards and Technology announced 15 key findings from a final version of a new “green paper” on maximizing U.S. innovation from government-funded research.

GlycoMimetics Announces Enrollment of First Patient in NCI-Sponsored Phase 3 Trial of Uproleselan in AML – Business Wire

GlycoMimetics, Inc. (NASDAQ: GLYC) announced today dosing of the first patient in a Phase 3 clinical trial being conducted under the auspices of a Cooperative Research and Development Agreement (CRADA) between GlycoMimetics and the National Cancer Institute (NCI), part of the National Institutes of Health. The second in a series of trials designed to evaluate uproleselan across the continuum of care in AML, this NCI-sponsored study is evaluating the addition of uproleselan to a standard cytarabine/daunorubicin regimen (7&3) in older adults with previously untreated AML who are suitable for intensive chemotherapy. A third trial, to be conducted by the European HOVON consortium, is expected to initiate later this year.

CoapTech Receives FDA 510(k) Clearance for Its PUMA-G System

CoapTech LLC, a medical device company focused on delivering transformative solutions for minimally-invasive surgery, announced today that the U.S. Food and Drug Administration (FDA) on April 10, 2019 granted the company 510(k) clearance for its PUMA-G System, which enables ultrasound-based placement of percutaneous gastrostomy feeding tubes.

Key Takeaways from the Small Business Administration’s Revised Policy Directives for the SBIR and STTR Programs | Morrison & Foerster LLP – Government Contracts Insights – JDSupra

The Small Business Administration (SBA) has statutory authority to establish federal Government-wide policies to implement the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs. SBA recently issued a significantly revised final SBIR/STTR Policy Directive, which is effective May 2, 2019. See 84 FR 12794. Below we highlight the major changes implemented in the revised policy directive.

NCC-PDI Announces Finalists in $250K Pediatric Pitch Competition for Orthopedic and Spine Medical Devices

The National Capital Consortium for Pediatric Device Innovation (NCC-PDI) announces 12 finalists that will present at the “Make Your Medical Device Pitch for Kids!” competition on April 30, 2019 at the University of Maryland, College Park. The finalists, all innovators in the orthopedic and spine sector, have a chance to win up to $50,000 in grant funding and access to the newly created NCC-PDI “Pediatric Device Innovator Accelerator Program” led by MedTech Innovator.

Postdoc-Industry Happy Hour (5/8 – Rockville)

Are you excited about the work you do in the biohealth industry? How did you get to where you are? Would you like to be connected to the newest career ready talent pool?

Join us for a Happy Hour with post docs from NCI and other NIH institutes who have expressed interest in transitioning to our exciting industry! Help them learn about your work and opportunities in the field. You may find one of your best future hires in the process!

These events are being cohosted by BioHealth Innovation, American Gene Technologies and SciPhD. The events are free but registration is required.

Postdoc Industry Connections Happy Hour

5/8 – 5-6:30 p.m. – American Gene Technologies

9640 Medical Center Dr Rockville, MD 20850

3rd Annual Downstream Purification Symposium

Bio‑Rad welcomes you to attend the 3rd Annual Downstream Purification Symposium at Institute for Bioscience and Biotechnology Research. This event will include discussion of new developments in purification of biologics and key industry regulatory topics. Thursday, May 9, 2019

9:00 AM–5:00 PM

Location

Institute for Bioscience & Biotechnology Research

9600 Gudelsky Drive

Rockville, MD 20850

IBBR investigator to lead $3.5M NIH-funded project to study immune response to HIV-1

Researchers at the Institute for Bioscience and Biotechnology Research (IBBR) recently received $3.5M from the National Institutes of Health (NIH) to advance understanding of the complex process by which the immune system produces highly specialized antibodies. The goal of the project is to design and test novel vaccine candidates that improve the protective antibody response against HIV-1. IBBR Fellow Dr. Yuxing Li (Associate Professor, Department of Microbiology and Immunology, University of Maryland School of Medicine) is principal investigator on the award.

GSK ramps up investment into Shingrix production

GSK announces that it will spend $100m to expand production capacity for components of Shingrix, amid a US market where demand outstrips supply of its shingles vaccine.

How Redox Is Transforming The Way Healthcare Providers Share Data

Redox, a Madison, Wisconsin-based healthcare technology company that is transforming the way healthcare providers and software vendors share data, announced it has raised $33 million in Series C funding led by Battery Ventures. Also participating in this round is .406 Ventures, RRE Ventures, and Intermountain Ventures. In conjunction with this funding round, Battery general partner Chelsea Stoner is joining Redox’s board.

University Of Maryland Medical School Uses New Drone To Transport Donor Organs – CBS Baltimore

A pioneering medical breakthrough that will help organ transplant recipients was announced by the University of Maryland Medical School.

Drone technology was developed by the University’s School of Medicine and Engineering to transport donor organs. The LG-1,000 is the first-ever organ delivery drone and weighs 50 lbs.

THRIVE 2019: CREATING THE FUTURE OF BIOSCIENCE IN VIRGINIA

Every two years leader of the life science industry gather from across the state to connect, celebrate, learn, inspire, imagine, and drive forward the development of R&D and commercialization in Virginia in focused ways.

On Thursday May 2, 2019 we expect over 400 attendees – leaders of bioscience companies big and small, research universities, policy makers, innovative health care systems, patient groups, CROs and professionals, and others from across Virginia and beyond to gather in Richmond for THRiVE 2019: Creating the future of bioscience in Virginia.

Built For Bio: Pat Larrabee, President of Facility Logix

MCEDC learns how Pat’s love for science drove her to found a company in Montgomery County, MD that delivers the cutting-edge buildings innovators need to make the world healthier.

Ex-MedImmune exec Peter Greenleaf to lead Canadian biotech Aurinia Pharmaceuticals – Washington Business Journal

Most recently, the biotech executive helmed one of the fastest-growing public companies in Baltimore last year.

How Biopharma Companies Use NIH and Vice Versa | RAPS

An argument has been brewing on Capitol Hill and elsewhere that boils down to the theory that US taxpayers are fronting billions of dollars’ worth of public research that translates into early-stage products that are later sold to companies, go on to win FDA approval and then reap millions or billions in sales, although the government never sees a dime of those earnings.

Kite to Open Cell Therapy Manufacturing Facility in Frederick County Creating Significant Job Opportunities In Maryland – BioBuzz

Kite Pharma, a California-based biopharmaceutical company that develops innovative cancer immunotherapies, announced plans today to open a new biologics manufacturing facility in Frederick County that will produce innovative cell therapies for people with cancer. A Gilead company, Kite will open the new facility on a 20-acre site in the Urbana Corporate Center, with plans to create a significant number of job opportunities.

Y Combinator to fund more startups pursuing small-molecule drugs – STAT

The startup incubator Y Combinator plans to fund more early-stage drug makers, with a partnership designed to bring academic spinouts developing small-molecule drugs into its famed accelerator program. And in a Silicon Valley twist, the compounds it’s backing will often be recommended by an algorithm.

Three biotechs reveal some secrets about themselves as they gun for $271M-plus in IPOs – Endpoints News

Last week ended with another Friday night blitz of biotech S-1s as a fresh wave of new offerings forms to crash into Nasdaq. Entering the Wall Street spotlight now is one transatlantic operation that is out to develop a new class of meds, a Dallas biotech with a Phase III kidney cancer drug and a startup that in-licensed its lead drug from Novartis.

Illumina Accelerator Invests in Four New Startups – GenomeWeb

Illumina has added four genomics startups to its accelerator program, marking its ninth funding round, the company said on Tuesday.

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