328th Edition – November 6, 2018

In the U.S. alone, there are over 100 million chronic wound visits every year. By 2020, the general wound care market is expected to hit about $20.5 billion. Maryland’s Gemstone Biotherapeutics aims to address this market with a highly tunable, novel biosynthetic wound healing product that is heading towards FDA review. Now with a 2019 Maryland Stem Cell Research Fund (MSCRF) grant award they are drawing a lot of attention as a company to watch in the regenerative medicine space.

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Novavax, Inc., (Nasdaq:NVAX) today announced the appointment of Rachel King, Co-Founder and Chief Executive Officer of GlycoMimetics, Inc., to its Board of Directors. In addition to extensive experience as an executive in the biotechnology industry, Mrs. King has also worked in the venture capital side of life sciences, and has held executive positions within a global multinational pharmaceutical company.

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OpGen, Inc. (NASDAQ: OPGN) today announced a collaboration with QIAGEN N.V. to advance rapid diagnostics for antimicrobial resistance (AMR). Strengthening OpGen’s entry into the United States market, the companies have entered into an agreement to commercialize a new solution for the detection of multidrug resistant bacterial pathogens based on QIAGEN’s EZ1 Advanced XL automated nucleic acid purification instrumentation (EZ1) and kits for the United States. The EZ1 will be utilized in the test workflow for the Acuitas® AMR Gene Panel u5.47 products. The AMR Gene Panel family of rapid diagnostics tests has been designed to detect and identify multidrug-resistant bacterial pathogens in urine and bacterial isolates in approximately two hours. The test was developed for use with the Acuitas Lighthouse® Software for predicting antibiotic resistance and high-resolution pathogen tracking. The AMR Gene Panel u5.47 and the Acuitas Lighthouse Software are currently available for Research Use Only (RUO).

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The Emmes Corporation today announced that it was named one of the largest women-owned businesses in the Washington metropolitan area by the Washington Business Journal. Emmes was ranked the sixth largest women-owned business in the Washington region, up from number seven last year.

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• How do you obtain coverage and payment for your technology?
• Is the process different for medical devices from diagnostics or therapeutics?
• Can digital apps be reimbursed?
• How do I work with bundled payments?
• What is the process for securing reimbursement codes?  Do I need different strategies based upon the point of care?
• How much do I need to budget for a reimbursement strategy?  When do I need one?
• How to I talk to investors about my reimbursement strategy? 

Learn the answers to these questions and more through the November 14th PathFinder Innovation Program. (There is no charge to attend in person or by videoconference, however, pre-registration by NOON, 11/13 is required).

• 8:15 a.m. Networking and Coffee
• 8:30 a.m.  – Issues Overview (in person/by videoconference)
  • Speakers:  Brian Abraham, Founder, Lara Reimbursement Advisory
  • Luis Gutierrez, Entrepreneur-in-Residence, NHLBI and BioHealth Innovation
• 9:30 a.m. – 1:1 Office Hours (in person/by videoconference)*

This program is cosponsored by BioHealth Innovation, Launch Workplaces, TEDCO and Montgomery County. It is open to anyone in the BioHealth Capital Region.  

To register/For more information, email:  BHI@BioHealthInnovation.  (In person 1:1 scheduling:  www.tinyurl.com/BHIappointments.)

*Attendance at Overview in person/by videoconference required to participate in 1:1 sessions.

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A ‘Direct-to-Phase II’ SBIR award is a Phase II award issued to a small business that did not receive a Phase I award for that research/research & development. Recent legislation has re-instated this SBIR Direct Phase II provision through Fiscal Year 2022 and NIH is re-implementing the SBIR Direct-to-Phase II program. The prior program had specific SBIR Direct-to-Phase II funding opportunity announcements (FOAs). These will not be needed now. The transition to FORMS-E allows NIH to track SBIR Direct-to-Phase II applications using a new check-box on the SBIR/STTR Information Form for Direct Phase II

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Thermo Fisher Scientific, a biotech product development company, has inaugurated a new business center and biorepository in Frederick, located in the US state of Maryland.

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Cerecor Inc. (NASDAQ: CERC), a biopharmaceutical company focused on becoming a leader in development and commercialization of treatments for rare and orphan diseases in pediatrics and neurology, announced today that it has submitted to the U.S. Food and Drug Administration (FDA) three Orphan Drug Designation (ODD) Requests for substrate replacement therapies to treat ultra-rare inherited metabolic disorders known as Congenital Disorders of Glycosylation (CDGs).

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With a symposium about „Personalized Medicine Depends on Tissue Quality“ and an opening ceremony in presence of Benjamin Wu, Maryland Deputy Secretary of Commerce, Jan Gardner, Frederick County Executive and members of the County Council as well as 120 international guests the new Indivumed Headquarter was officially opened.

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Southern Research marked the completion of a $13 million renovation project at its Frederick Infectious Disease Research Center with a ribbon-cutting ceremony today attended by local leaders, state officials and research sponsors.

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Sierra Madre, California-based Wound Care Advantage, a manager of outpatient wound treatment centers, has partnered with Baltimore-based Tissue Analytics to use the digital health startup’s technology to measure wounds and develop improved treatment protocols.

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AstraZeneca PLC’s research and development arm MedImmune Inc. spun off a small biotech startup company called Viela Bio.

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BioHealth Innovation, Inc. (BHI), is a Montgomery County innovation intermediary which translates market-relevant research into commercial success by bringing together management, funding, and markets.  BHI is seeking an early stage life sciences professional with market research or portfolio management experience to join the BHI EIR team and serve as an associate Entrepreneur-in-Residence (EIR) at the National Institutes of Health (NIH). This position will report to and work closely with our lead at the NIH Office of the Director, Office of Extramural Research (OER) at the Bethesda, MD campus. The Associate will provide analyst and project support to the EIR team on product, corporate and private investment strategy advisory for companies which have SBIR/STTR awards. This will entail market, technology, regulatory and other business intelligence research to support EIR consulting and coaching of companies. The Associate will also undertake the alliance management responsibilities with collaborating organizations such as the Angel Capital Association or others with which the OER establishes relationships.

The NIH is the world’s largest early stage biomedical investor providing nondilutive funding for US companies in the form of grants and contracts through the SBIR/STTR program. In FY19 the Congressional funds set aside for company funding exceeds $1B USD. The EIR program supports NIH interests in commercial success of its SBIR/STTR portfolio companies.

POSITION DESCRIPTION – Associate Entrepreneur-In-Residence

The Associate EIR will work directly with BHI EIRs, NIH program staff and NIH portfolio companies to provide financial and technical analyst services for both SBIR/STTR portfolio companies and NIH programs. As the program grows to encompass relationships and collaborations with outside organizations and entities, the Associate will also manage projects, alliances and deliverables as necessary. In addition, the Associate EIR will support both support existing trans-NIH initiatives for early stage companies and as support the growth of new initiatives.

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The PIC MC Foundation Board of Directors invites you to celebrate a significant milestone in the development of PIC MC. Join us, along with state and local leaders, for the

PIC MC RISE Zone Celebration and Ribbon Cutting

Date:

Monday, November 26, from 2–3:30 p.m. (Program begins promptly at 2:15 p.m.) Speakers to include Montgomery County Executive Isiah Leggett

Location:

PIC MC Germantown Campus High Technology and Science Center (HT), Globe Hall (click on map for parking) 20200 Observation Drive Germantown, Maryland 20876 Parking for this event will be in LOT 4.

For more information on this event or to RSVP, contact Melanie Kandel, 240-567-8062

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Bethesda health tech company RightEye LLC is finally moving beyond the research and development phase.

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Joel Marcus, chairman at Alexandria Real Estate Equities, discusses the risk of rising interest rates, how government action on drug pricing could impact the firm’s pharmaceutical tenants, and exploring opportunities in the agriculture technology sector. He speaks with Bloomberg’s Erik Schatzker from the Robin Hood Investors Conference on “Bloomberg Markets.”

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Although we’re told business isn’t personal, the reality is that business is built on relationships.

In other words, it’s not what you know, it’s who you know. And if the numbers tell us anything, it’s that socially and economically disadvantaged entrepreneurs need more chances to connect to new networks that have the resources to push their businesses forward.

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QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the launch of major enhancements to QIAGEN Clinical Insight (QCI) bioinformatics solutions to deliver expanded Sample to Insight workflows for clinical next-generation sequencing (NGS). QIAGEN introduced QCI Analyze Universal for full end-to-end workflow support of all major clinical sequencing platforms and assay types, along with expanded QCI capabilities for interpretation of biomarkers in immuno-oncology as well as other enhancements, at the Association for Molecular Pathology (AMP) Annual Meeting & Expo from November 1-3, 2018, in San Antonio, Texas.

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CEL-SCI Corporation (NYSE American: CVM) announced today it has received just under $8 million through the exercise of warrants to purchase shares of the Company’s common stock during the past 3 months. As of October 22, 2018, CEL-SCI had 28,271,615 outstanding shares of common stock.

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Tuesday ,November 6, 2018 6:15 PM – 8:30 PM, Hotel Annapolis126 West StreetAnnapolis, MD 21401

FounderTrac invites you to Demo Day!

The FounderTrac accelerator ‘connects the dots’ by creating an inclusive environment that combines curriculum, capital, mentorship, and community. FounderTrac is an elite accelerator where impactful founders work in a high-performance environment that inspires and weaponizes them to become “fulfillionaires” (founders who achieve venture success while doing fulfilling work). FounderTrac is a Partnership between The Maryland Tech Council, LAUNCH! Annapolis, MCVC Partners and TEDCO to bring a community-based accelerator to Annapolis, MD.

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Neuralstem, Inc. (Nasdaq:CUR), a biopharmaceutical company focused on developing novel treatments for nervous system diseases, today announced that it has entered into definitive agreements with institutional investors for the purchase of 3,000,000 shares of its common stock, at a purchase price per share of $0.70, in a registered direct offering. Additionally, Neuralstem has also agreed to issue to the investors unregistered warrants to purchase up to 3,000,000 shares of its common stock. The closing of the offering is expected to take place on or about October 29, 2018, subject to the satisfaction of customary closing conditions.

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RegeneRx Biopharmaceuticals, Inc. (OTCQB: RGRX) (“the Company” or “RegeneRx”), a clinical-stage drug development company focused on tissue protection, repair and regeneration, today announced a clinical trial update provided by GtreeBNT, RegeneRx’s partner for development of RGN-259 and RGN-137 in the U.S.:

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Epigenomics AG (FSE: ECX, OTCQX: EPGNY) today announced that it has received CE Mark for its blood test to aid in detecting liver cancer among patients with cirrhosis two months ahead of schedule. The test will be commercialized under the brand name “HCCBloodTest”. In 2019, the company plans to initiate a prospective clinical trial in the U.S. for submission to the FDA. Additionally, Epigenomics is evaluating options to expedite CFDA approval in China.

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The Shore Hatchery here at Salisbury University has become one of the premiere opportunities for local entrepreneurs and Friday over a dozen were making their pitch in hopes of receiving part of $200,000 in funding.

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The new funding includes a $15 million investment from Palo Alto-based Meritech Capital Partners.

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CollPlant, an Israeli regenerative medicine company focused on 3D bioprinting of tissues and organs, signed a license, development and commercialization agreement with United Therapeutics Corporation of Maryland for 3D bioprinted lung transplants.

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Venture capital investing has already reached a 10-year high in 2018, according to a report last week. However, while investment trends in life sciences have been similar to those in technology generally, a venture capital investor specializing in life sciences said there are some significant underlying differences too.

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New Enterprise Associates this spring appointed former General Partner Ravi Viswanathan to the job of selling about $1 billion of its portfolio holdings in an unusual secondary transaction. This week, Viswanathan filed a regulatory document to raise a $1.35 billion

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One of the largest companies involved in next-generation sequencing technology is buying a rival that manufactures genomic analysis systems.

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On November 9th, 3675 Market Street will officially open its doors to the public about two years after its ceremonial groundbreaking. So far, the 14-story building is exactly what its partners — the Science Center, Cambridge Innovation Center (CIC), Wexford Science and Technology, BioLabs and Ventas — promised it would be, a 345,000 square foot mixed-use property that houses lab, clinical, office, educational, event and co-working space. The Science Center is relocating its headquarters there, leasing 50,000 square feet of the property, and the organization has even turned is ever-popular Quorum entrepreneur’s clubhouse into a two-story 15,000-square-foot hub that’s now accessible from the ground level.

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In what appears to be a trend, big pharma company AbbVie is leasing 479,000 square feet of space in BioMed Realty’s Gateway of Pacific project in South San Francisco. It is an example of big pharma companies setting up offices and labs in the midst of one of the country’s biggest biotech clusters.

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On November 1, the Centers for Medicare and Medicaid Services finalized changes to the 2019 Physician Fee Schedule and the Quality Payment Program.

One of the adjustments involves telehealth.

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Johnson & Johnson Innovation announced the extension of the Johnson & Johnson Innovation Partnering Office at Queensland University of Technology (JJIPO @ QUT) for three years in collaboration with the Queensland State Government at the AusBiotech National Conference in Brisbane yesterday.

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