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BHI Weekly News Archives

336th Edition – January 10, 2019

By BHI Weekly News Archives




BioHealth Innovation


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January 10, 2019












FOUNDING MEMBER OF



Emergent BioSolutions Announces Daniel J. Abdun-Nabi to Retire as CEO; Robert G. Kramer, Sr. to Become President and CEO | Seeking Alpha

Many thanks to Dan for his leadership of Emergent, his service as a loyal BHI Board Member, and for helping to accelerate the growth of the BioHealth Capital Region.

Emergent BioSolutions Inc. (EBS) today announced that its CEO Daniel J. Abdun-Nabi will be retiring and that its board of directors has unanimously appointed Robert G. Kramer, Sr., the company’s current president and COO, to succeed him as president and CEO, effective April 1, 2019. Mr. Abdun-Nabi has also indicated that he plans to step down as a member of the Emergent board of directors, and Emergent expects the board of directors to appoint Mr. Kramer to fill the board vacancy created by Mr. Abdun-Nabi’s retirement.

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Scoop: MedImmune chief Bahija Jallal is leaving AstraZeneca and joining the trek into biotech – Endpoints News

Congratulations to Bahija on making MedImmune the leading BioHealth company in Maryland and accelerating its growth. Also many thanks for MedImmune’s longtime support of BHI and for helping the BioHealth Capital Region become the 4th largest Biopharma Cluster in the country.

Six years after AstraZeneca’s then new CEO Pascal Soriot named Bahija Jallal president of the big MedImmune subsidiary in Gaithersburg, MD, putting her at the center of the company’s R&D turnaround plans, the longtime pharma exec is joining the great migration of industry professionals to biotech.

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Pasadena’s Alexandria Venture Investments Recognized as #1 Most Active Investor in Healthcare Startups

Congrats to Alexandria a BHI partner and Board Member for their commitment to early-stage BioHealth investing.

Alexandria Venture Investments, the strategic venture capital arm of Alexandria Real Estate Equities, Inc. based in Pasadena, was recognized by Silicon Valley Bank as the most active biopharma investor by new deal volume in 2017-2018.

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The University of Maryland Robert E. Fischell Institute for Biomedical Devices Celebrates its Official Launch

The University of Maryland Robert E. Fischell Institute for Biomedical Devices celebrated its official launch on Thursday, January 3, 2019. The event included presentations by researchers at the Institute and supported by the the Institute taking place at the A. James Clark School of Engineering, the University of Maryland School of Medicine, Children’s National Health Center, University of Maryland Insitute for Bioscience and Biotechnology Research.

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The 20 Top Universities In The United States For 2019 – Congrats to John Hopkins

What are the top universities in the United States? The list is decided by the CEOWORLD magazine university ranking which considers 7 important factors to help make a balanced comparison. These include influence, reputation, specialization, recruiters Responses and employers Feedback, which in turn help to rate and rank the top unis.

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Why Rockville – BioHealth Innovation

Why Rockville Video, produced by Rockville Economic Development, Inc., featuring BioHealth Innovation’s Judy Costello.

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BrainScope Receives FDA Clearance for Multi-Modal, Multi-Parameter Concussion Assessment — BrainScope

BrainScope Receives FDA Clearance for Multi-Modal, Multi-Parameter Concussion Assessment

New Concussion-Specific FDA Labeling Adds to Existing BrainScope Claims Complements Multi-Modal Technology Platform and Extensive Intellectual Property Portfolio To Address New Brain and Behavioral Health Conditions

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PGDx signs a pair of partnerships as it looks to expand ‘kitted’ cancer tests – Technical.ly Baltimore

Personal Genome Diagnostics is starting off the year with news of a pair of partnership agreements as it looks to expand its approach to cancer testing.

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Top University of Maryland School of Medicine Genomics Scientist Claire M. Fraser, Phd, Appointed President-Elect of American Association for the Advancement of Science (Aaas)

University of Maryland School of Medicine (UMSOM) Dean E. Albert Reece, MD, PhD, MBA, announced today that Claire M. Fraser, PhD, a pioneer in the field of microbialgenomics, who is the Dean’s Endowed Professor, Department of Medicine, and Director of the Institutefor Genome Sciences (IGS), has been chosen as president-elect of the American Association for the Advancement of Science (AAAS). AAAS is the world’s largest multidisciplinary scientific society and a leading publisher of cutting edge research through its Science family of journals.

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AGT Newsletter Volume 7

In wrapping up the year, AGT was proud to be featured as a State of Maryland “Success Story” for its growth in Maryland and achievements in the gene and cell therapy industry.

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Tax Implications & Accounting Issues for Start-ups – PathFinder Innovation Program

Wednesday, January 23, 2019, 12:00 – 4:00pm

Are you a young company or thinking of starting up a new firm.  What do you need to know related to taxes?  –tax credits? Filing? Tax liability? Other accounting issues? Learn the answers to these questions and more.

Register by noon, 1/22 to participate in person / by video conference**       

  • 12:00 p.m. – Networking Lunch   
  • 12:30-1:30 p.m. – Panel and Q&A with experts
  • 1:30 p.m. – 1:1 meetings*

*Attendance at Panel is required to participate in 1:1 meeting with expert.

**In person at BHI HQ, 1 Church Street, Rockville, MD or by videoconference.

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Md. ranks among best for tech economy – Maryland Daily Record

Maryland placed third on think tank Milken Institute’s 2018 State Technology and Science Index, ranking innovation pipelines. Maryland also placed third in 2016’s report.

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Useful Stats: NIH SBIR/STTR Success Rates by State (2008-2017) | SSTI

Here is a significant opportunity for MARYLAND to grow in SBIR success.

One of the best ways to measure the effectiveness of state programs intended to encourage the success of SBIR applications is the approval-rate of their submissions. Although this data has been historically unavailable across every federal agency, it is now accessible for the National Institutes of Health (NIH), the second largest provider of SBIR/STTR awards, according to a 2018 Digest report. The NIH distributed $446.2 million in SBIR/STTR awards in 2017, with every state except North and South Dakota receiving an award. Although California and Massachusetts had the most successful SBIR/STTR applications in 2017, accounting for roughly one-third of the total when combined, neither state ranked among the top 10 in success rate.

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J.P. Morgan healthcare conference topics January 7

Now in its 37th year, the conference has ballooned from a small event with 150 attendees that was essentially the ” birth of biotech,” to an event attended by everyone from the biggest pharma company to the smallest biotech. JPMorgan said more than 485 companies are scheduled to present this year.

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Maryland Life Sciences Breakfast – Maryland’s Advancements in Vaccines and Immunotherapeutics Event Registration | Maryland Tech Council

Tuesday, January 15, 2019 8:30AM – 10:30AM

GSK 9911 Belward Campus Drive Rockville, MD 20850

The Maryland Life Sciences, a division of the Maryland Tech Council, brings together vaccine leaders to discuss current breakthroughs in the world of vaccines and immunotherapeutics. This breakfast meeting will address innovating strategies to meet current health threats, changing technology for vaccine manufacturing and provide a snapshot of where vaccine development stands today.

Join us for breakfast, networking and a discussion to hear about the experiences and insights on the current state and projected future of treatments. Local leaders will also discuss challenges and opportunities that come with vaccine and immunotherapy development used by companies in our State.

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The most educated town in every state – Business Insider

Different places have different levels of educational achievement.

The American Community Survey is an annual survey run by the Census Bureau to allow the government, corporate and academic researchers, and anyone who is curious about demographics to better understand the US population. Among many other subjects, the ACS includes questions about respondents’ education levels.

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GAO: Agencies aren’t tapping venture capital-owned companies for innovation

Though federal agencies are hungry for new technology solutions, a report from the Government Accountability Office says they may be missing out on a key avenue of innovation.

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5 Biopharma Trends to Watch in 2019 | GEN – Genetic Engineering and Biotechnology News

“If you can look into the seeds of time, and say which grain will grow and which will not, speak then unto me,” Banquo beseeches the witches in Shakespeare’s “Macbeth,” seeking insight into the future for himself and his closest friend Macbeth.

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Key Life Science Industry Trends in 2019

The Pistoia Alliance announced key trends for the life science industry in 2019 based on The Life Sciences Innovation Report developed with Clarivate Analytics.

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State Technology and Science Index 2018

The STSI’s 107 individual indicators are sorted into five composites: research and development (R&D) inputs, risk capital and entrepreneurial infrastructure, human capital investment, technology and science workforce, and technology concentration and dynamism.

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Industry execs forecast the year ahead for gene therapy at Biotech Showcase – MedCity News

The first Food and Drug Administration approvals for cell and gene therapies are already more than a year out, but 2019 is likely to be a significant year for the field, particularly in areas like international interest, industry consolidation and pricing. That was the theme of a panel discussion Monday morning at Biotech Showcase in San Francisco, which coincides with the 2019 J.P. Morgan Healthcare Conference.

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Top 20 Life Science Startups to Watch in 2019 | BioSpace

BioSpace is proud to present its NextGen Bio “Class of 2019,” a list of 20 up-and-coming life science companies in North America that launched* no earlier than 2017.

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Biggest Pharma M&A Ever Propels Bristol to Cancer Lead – Bloomberg

Bristol-Myers Squibb Co.’s $74 billion planned purchase of Celgene Corp. puts it in line to lead the drug industry’s hottest market, cancer, as early as next year.

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Atlas Venture raises $250M for Opportunity Fund – MedCity News

A biotechnology venture capital firm is ringing in the new year with its latest fund, having raised a quarter of $1 billion.

Cambridge, Massachusetts-based Atlas Venture said Wednesday that it closed its first Opportunity Fund, or AVOF I, with an oversubscribed fund raise of $250 million. The firm plans to invest the money in companies already in its portfolio.

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Four payer market predictions for 2019 – MedCity News

Having analyzed the trends and the shifting winds in the payer marketplace, it’s time to gaze into the crystal ball and see what the future has in store.

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Home | About BHI | BHI News | Programs | Partners | Contact

Copyright © BioHealth Innovation 2017
All Rights Reserved.



335th Edition – Year in Review – January 4, 2019

By BHI Weekly News Archives




BioHealth Innovation


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January 4, 2019

BHI News Year in Review

Below are BioHealth Innovation News’ most popular articles from 2018:



Army Doctors Grew a Soldier a New Ear — On Her Forearm – Time

May 14, 2018

You’ve heard the cliché about wearing your heart on your sleeve. But a group of Army doctors did one better: They grew a new ear on a soldier’s forearm, using cartilage harvested from her ribs.

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Think Resources: BioHealth Innovation – Rich Bendis interview with MCEDC

January 20, 2018

MCEDC talks with Rich Bendis, President and CEO of BioHealth Innovation, about how his organization fuels the science industry in Montgomery County, Maryland.

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BHI CEO Rich Bendis’ Opening Presentation at The 2018 BioHeath Capital Region Forum

April 25, 2018

Welcome to the 2018 BioHealth Capital Region Forum: State of the BioHealth Capital Region’s EcoSystem

Presented by: Rich Bendis, President & CEO, BioHealth Innovation Inc.

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BioHealth Innovation Appoints Jarrod Borkat as new Vice Chairman of the Board

May 22, 2018

MedImmune Sr. Director, Partnering & Strategy filling role previously held by Emergent BioSolutions CEO, Daniel J. Abdun-Nabi

BioHealth Innovation, Inc. (BHI) announced that its Board of Directors has unanimously approved the appointment of MedImmune Sr. Director, Partnering & Strategy, Jarrod Borkat as new Vice Chairman. MedImmune, the global biologics research and development arm of AstraZeneca, is a Founding Partner of BHI and continues to be a leader in building the BioHealth Capital Region. BHI would like to thank Emergent BioSolutions CEO, Daniel J. Abdun-Nabi, for his service as Vice Chairman. He will remain as a member of the Board of Directors. Mr. Abdun-Nabi also previously served as chairman of the Maryland Life Sciences Advisory Board (LSAB) and currently serves on Maryland Governor Larry Hogan’s Excel Board.

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Galen Robotics Wins BioHealth Capital Region 3rd Annual Crab Trap Competition

April 26, 2018

Competition held during 2018 BioHealth Capital Region Forum

Wilson Sonsini’s Charlie Andres and BHI’s Rich Bendis present the team from Galen Robotics their award for winning the 2018 Crab Trap competition

ROCKVILLE, MARYLAND, April 26, 2018 – Galen Robotics, a Johns Hopkins University spinout, was chosen from five finalists as the company with the most commercial potential by judges at the 3rd Annual Crab Trap Competition. This year’s judges included industry leaders Amgen’s Bethany Mancilla, AstraZeneca’s Shaun Grady, Blu Venture’s Dr. Paul Silber, J.P. Morgan’s John T. Rubin, New Enterprise Associates’ Sara Nayeem, Roche’s Robert Silverman, and Sands Capital Ventures’ Stephen Zachary. They were impressed with a presentation by Lead Hardware Engineer, Yunus Sevimli, on Galen Robotics’ low-cost, compact, and intuitive to use novel microsurgical robotic platform designed to assist surgeons with minimally-invasive applications in otolaryngology, neurosurgery and similar critical fields. Galen Robotics is the third Johns Hopkins University spinout to win this competition following LifeSprout (2017) and Sonavex (2016).

Strong presentations also were made by the other finalists–AlgometRx, Cellth Systems, Renalert, and Reveragen Biopharma—whose technologies originated at Children’s National Medical Center, the University of Maryland, and Johns Hopkins University.

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Montgomery County, Maryland-based BeneVir Biopharm, Inc. to be acquired by Janssen Biotech, Inc. for up to $1.04B

May 7, 2018

Company’s announcement latest in recent trend of significant investment in Montgomery County biohealth companies.

BeneVir Biopharm, Inc. (BeneVir), a privately-held Montgomery County biotech company, has entered into an agreement under which it will be acquired by Janssen Biotech, Inc., a Johnson & Johnson company for up to $1.04 billion. Under the terms of the agreement, Janssen will make an upfront cash payment of $140 million at closing of the transaction, plus additional contingent payments of up to $900 million based on achievement of certain predetermined milestones. BeneVir was a client of BioHealth Innovation (BHI) from 2013 until its Series A investment in 2014.

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BioHealth Innovation Receives InBIA January IMPACT Award

March 6, 2018

BioHealth Innovation, Inc. (BHI) has received the International Business Innovation Association (InBIA)’s January 2018 IMPACT Award in Biotech/Cleantech for the management of four spaces for early stage companies: the Germantown Innovation Center, the Rockville Innovation Center, LaunchLabs, and the BHI International Innovation Center. The award is based on a variety of metrics including affiliations and partnerships, application and graduation, facilities, mission and goals. This recognition also enables this innovation activity to be considered with other leading entrepreneurial centers across the country as a finalist for the InBIA’s annual Incubator of the Year Awards.

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Maryland Biotechs Dominate 2018 Vaccine Industry Excellence Awards – BioBuzz

April 23, 2018

More than a dozen biotech companies or researchers from the Maryland biotech cluster, which some have also dubbed ‘Vaccine Alley’, were among the most recognized finalists at this year’s Vaccine Industry Excellence (ViE) Awards in Washington, DC at the World Vaccine Conference. In fact, 15 out of the 54 finalists, or 27%. were from right here in Maryland. This year’s conference was held in Washington, DC so could this have been a case of home court advantage? Probably not. More than likely it’s because this region holds 20% of the top influencers worldwide in vaccine development.

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Supernus Pharmaceuticals to acquire Biscayne Neurotherapeutics for up to $185M – Washington Business Journal

September 17, 2018

Rockville-based Supernus Pharmaceuticals Inc. has reached a deal to acquire Miami-based Biscayne Neurotherapeutics in a deal worth up to $185 million.

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BioHealth Capital Region Industry Compensation Survey™

April 25, 2018

Is your employee compensation package competitive? 

Help us help you.  Complete the 2018 BHCR Industry Compensation Survey by June 1, 2018 to receive an anonymized summary of salaries and benefits specific to positions in biohealth and to this region.  A pdf version of the survey is available here or you can use the online version of the survey to complete your information.  All company specific information will be kept confidential.  This survey is a joint project among BioHealth InnovationWorkSource Montgomery, and UMBC-Shady Grove’s Industrial Organizational Pyschology Program.  If you or your Human Resources colleagues have any questions about the survey, please contact BHI@BioHealthInnovation.org.

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Biomaterials Could Extend the Success of Immunotherapies – GEN

January 8, 2018

The use of biomaterials, such as microneedles and nanoparticles, in immunotherapy and vaccine research is a hot topic in bioengineering. But to get the maximum return on investment in these ideas, they need to be seeded among clinicians, according to Christopher Jewell, Ph.D., associate professor in the Fischell Department of Bioengineering at the University of Maryland. Jewell is the principal author on a new paper in Trends in Immunology that reviews the current state of biomaterials research with an eye toward inspiring multidisciplinary teams of engineers and clinicians to solve some of the complex problems in immunology today.

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China-based pharma firm KBP Biosciences plans HQ move to Philly area

January 8, 2018

A drug development company has raised $76 million from investors in China, the United States, and Korea to move its headquarters to the Philadelphia area from Jinan, China, and bring treatments developed by China-based scientists through U.S. clinical testing to patients here.

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TaiRx, Inc. and BioHealth Innovation, Inc. Form TaiRx US to Develop and Commercialize Therapeutics and Precision Medicine Diagnostics

October 22, 2018

TaiRx, Inc and BioHealth Innovation, Inc. (BHI) announced today the formation of TaiRx US, a new joint venture.  The mission of the new company is to develop therapeutics and precision medicine diagnostics focused on the Nodal protein, a critical mediator of aggressive cancer progression and treatment resistance.

TaiRx, Inc and BHI have formed TaiRx US, which will be based in Rockville (Montgomery County), Maryland, to develop and commercialize a unique monoclonal antibody with the potential to reverse drug resistance in various tumor types. The company is also working to develop a companion diagnostic to accurately identify those patients who can best benefit from the therapy.

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PepVax Announces Completion of Efficacy Study with Key Pre-Clinical Data to Validate PVX-009,

January 13, 2018

PepVax, Inc., an early-stage biotechnology company, announced today that it has successfully completed the efficacy study for its lead candidate, PVX-009. The Company is harnessing the power of the immune system to target a specific protein, MAGE A, in an effort to find a treatment for triple negative breast cancer (TNBC).

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Emergent BioSolutions to Acquire Specialty Vaccines Company PaxVax

August 13, 2018

Emergent BioSolutions Inc. (NYSE: EBS) announced today that it has entered into an agreement to acquire PaxVax, a company focused on specialty vaccines that protect against existing and emerging infectious diseases, for an all-cash consideration of $270 million. PaxVax is majority owned by an affiliate of Cerberus Capital Management, L.P.

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Six pediatric device innovators awarded total of $150K at Children’s National 6th Annual Pediatric Device Symposium

September 25, 2018

A total of $150K was awarded to six pediatric cardiovascular innovations during the medical device pitch competition at the 6th Annual Pediatric Device Innovation Symposium hosted by Children’s National Health System.  Award winners with Children’s National Vice President Kolaleh Eskandanian (far left) and CEO Kurt Newman, MD, (far right) include:  Ken Nelson, Bardy Diagnostics; Henri Justino, MD, PolyVascular Corp.; Corin Williams, Draper; Doug Vincent, VentriFlo; Joshua Woolley, NuPulseCV; and Kurt Newman, MD, Children’s National Health System. Peca Labs, not pictured, was also an award recipient. Photo credit: Paul Loftland Photograph

Six companies presenting innovative medical devices that address significant unmet needs in pediatric healthcare were awarded a total of $150,000 in grants yesterday in Philadelphia, Penn.at the Sixth Annual Pediatric Device Innovation Symposiumorganized by the Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National Health System.

The “Make Your Medical Device Pitch for Kids!” competition this year focused on pediatric cardiovascular devices, an area where new devices can make a life-changing difference, especially for younger children. The Centers for Disease Control and Prevention estimate that 40,000 children are born annually in the U.S. with a congenital heart defect (CHD) and approximately 1 million U.S. children currently live with a CHD.

The pitch competition was originally slated to award $100,000 in grants; however, because of the judges’ response to the quality and potential of the technologies presented, Children’s National expanded the award grants to $150,000 to include six awardees.

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Altimmune Appoints Mitchel Sayare as Executive Chairman of the Board, and Adds José Ochoa to Its Leadership Team as Chief Business Officer – NASDAQ.com

July 16, 2018

Altimmune, Inc. (Nasdaq:ALT), a clinical-stage immunotherapeutics company focused on infectious disease, today announced it has appointed Mitchel Sayare, Ph.D., as Executive Chairman of the Board, effective immediately.

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What’s next for biotech? – Innovators magazine

January 29, 2018

Innovators Magazine asked some biotech stakeholders what trends they expect to see in their markets this year.

The opinions were published in our special biotechnology edition, which was distributed to delegates at an industry conference in Glasgow this week.

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Biohealth Capital Region aiming for top 3 status – Smart Incentives

April 30, 2018

The Biohealth Capital Region–DC, Maryland and Virginia – plans to be a top 3 biohealth hub in the US by 2023. What will it take to get there?

The Biohealth Capital Region is already a top 5 location as ranked by NIH and venture capital funding, patents, lab space, and jobs. The 1,100 participants at this week’s 2018 Biohealth Capital Region Forum agreed on the area’s strengths: a highly educated and diverse workforce, leading universities and research institutions, strong healthcare organizations, hundreds of companies, and broad-based policy commitment to the biohealth industry.

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Novavax Appoints Rachel King to Board of Directors – NASDAQ.com

November 5, 2018

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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Baltimore medical device startup Perceptive Navigation LLC looks to raise $4 million – Baltimore Business Journal

March 20, 2018

Baltimore medical device firm Perceptive Navigation LLC is looking to raise $4 million in new funding, according to a recent filing with the U.S. Securities and Exchange Commission.

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Solera Health and WellDoc Partner to Offer Health Plans and Employers a Holistic Approach to Diabetes Prevention and ManagementSolera Health will integrate the BlueStar® Digital Therapeutic, a… | Markets Insider

January 20, 2018

Solera Health, an integrated benefit network, and WellDoc®, a leading digital therapeutic company, announced today that WellDoc’s BlueStar® digital therapeutic will join the Solera network as a diabetes management solution of choice. The partnership aligns both companies’ goals to improve the lives of those living with chronic diseases while enhancing clinical results and decreasing overall healthcare costs.

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Montgomery County Council provides $425,000 for fiscal year 2019 operating budget to fund Small Business Innovation Research Matching Grant Program – First County in the US to offer a SBIR matching grant program

May 29, 2018

The Montgomery County Council approved the fiscal year (FY) 2019 operating budget on Thursday, May 24, 2018. Included in the budget is a total of $425,000 for the Small Business Innovation Research (SBIR) Matching Grant Program. The program provides matching fund for businesses that receive federal SBIR and Small Business Technology Transfer (STTR) grants.

Bill 41-17, Economic Development Fund – Small Business Innovation Research and Small Business Technology Transfer Matching Grant Program established a County matching fund for businesses that receive federal SBIR and STTR grants. Councilmember George Leventhal, who serves as chair of the Council’s Health and Human Services Committee and is a member of the Planning, Housing and Economic Development Committee, was the lead sponsor of Bill 41-17. All other Councilmembers were cosponsors.

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Maryland in Top 10 States that Added Jobs (Virginia and DC in Top 30) – Governing.com

January 30, 2018

Nearly all states added jobs in 2017, but the latest Labor Department data suggests most states experienced slower growth last year than in 2016.

Still, it proved to be a particularly strong year for a select group of states — 10 of which recorded year-over-year job gains exceeding 2 percent.

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All Eyes on Better Health at CES 2018: Innovation Awards Honoree RightEye Debuts EyeQ System | Business Wire

January 9, 2018

RightEye LLC, an award-winning technology innovator using eye tracking to revolutionize patient care and vision performance, announced today it will be debuting its new RightEye EyeQ system tonight at CES Unveiled Las Vegas at 5:00 p.m. at the Mandalay Bay Shorelines Exhibit Hall in Las Vegas, Nevada. EyeQ gives people a closer look at their health using quick, computer game-style vision tests on an eye-tracking computer. The tests, which only take a few minutes, generate an instant EyeQ Report that provides results in an easy-to-understand format to support discussion with doctors on diagnosis and recommended therapies.

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Press release – KeyGene Licenses University of Wisconsin Sequence-Based Genotyping Patents – Keygene

January 16, 2018

KeyGene and the University of Wisconsin-Madison announced today that they have entered into a service license agreement to practice KeyGene’s patented Sequence Based Genotyping (SBG) methods. Under the agreement, UW-Madison, through its Biotechnology Center (UWBC), is licensed to offer SBG services in all species to research collaborators and clients worldwide.

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BIO 2018 Recap

June 19, 2018

Business partnering, education and networking was the focus of 3500 biohealth industry leaders who attended the BIO International Convention (BIO) Conference earlier this month in Boston. At the event, BIO set the GUINNESS WORLD RECORDS title for the Largest Business Partnering Event with 41,400 partnering meetings. Many of these meetings took place in the pavilion hosted by the Maryland Department of Commerce which included space for meetings BioHealth Innovation, Montgomery County Economic Development Corp (MCEDC), Rockville Economic Development (REDI), the City of Gaithersburg, Viva White Oak, PIC-MC (Montgomery College), University of Maryland Ventures, Johns Hopkins University, Fina BioSolutions, Integrated Pharma Services, Pharmaceuticals International, Inc., Emergent BioSolutions, AsclepiX, and US FDA’s Tech Transfer Office. Others from the BioHealth Capital Region who attended included: ABL, American Gene Technologies, AstraZeneca / MedImmune, Altimmune, BioMarker Strategies, Bytegrid, Children’s National Health, CRBE, Creatv Microtech, GlycoMimetics, IDT Biologica, Immunomics, Intrexon, Leidos Health, MacroGenics, Maryland Tech Council, MaxCyte, Newport Board Group, Novodux Paragon Bioservices, REGENXBIO, MacroGenics, Neuronascent, Scheer Partners, Smithers Avanza, TEDCO, the University of Maryland Baltimore, and the University of Maryland’s Institute of Bioscience and Biotechnology Research.

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Lupin receives FDA approval for generic Tamiflu Capsules

January 16, 2018

Pharma Major Lupin announced that it has received final approval for its Oseltamivir Phosphate Capsules USP, 30 mg (base), 45 mg (base), and 75 mg (base) from the United States Food and Drug Administration (FDA) to market a generic version of Hoffman-La Roche, Inc.’s Tamiflu Capsules, 30 mg, 45 mg, and 75 mg.

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Protenus plans Baltimore hiring push after raising $11M Series B – Technical.ly Baltimore

January 22, 2018

Six months after closing its most recent funding, Protenus reported raising $11 million in Series B funding, and is planning more hiring.

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TEDCO adds five companies to seed portfolio with $600,000 in new investments – Baltimore Business Journal

February 6, 2018

Maryland Technology Development Corp. made new seed investments in five Maryland startup companies, totaling $600,000.

TEDCO has invested hundreds of thousands of dollars in young, growing companies across the state. The state-backed organization has 137 active investments through its seed fund.

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AgriMetis Opens New Lab in Gaithersburg, Maryland — AgriMetis

AgriMetis, LLC is pleased to announce the opening of its new laboratory in Gaithersburg, Maryland.  The new laboratory is located at 401 Professional Drive, which is in the heart of the Maryland Biotech region along the I-270 corridor.

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Why Roche’s $1.9 Billion Deal to Buy Flatiron Health Matters – Fortune

February 19, 2018

The big headline out of the health care M&A world today is Swiss pharmaceutical giant Roche’s $1.9 billion acquisition of Flatiron Health, the Alphabet-backed, cancer-focused digital health analytics upstart that’s attempting to use real world patient information and big data to spur better oncology R&D.

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Startup with Johns Hopkins roots raising $40.5 million to develop cancer metabolism drugs – Endpoints News

February 5, 2018

A new oncology company spun out of Johns Hopkins School of Medicine is raising up to $40.5 million to develop its platform of anticancer therapies.

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Qiagen Gets FDA OK for Expanded Use of EGFR CDx for Lung Cancer Drug – GenomeWeb

January 22, 2018

Qiagen said today that the US Food and Drug Administration has extended the indications for use of its Therascreen EGFR RGQ PCR kit to guide the use of Boehringer Ingelheim’s Gilotrif (afatanib) for first-line treatment of patients with metastatic non-small cell lung cancer harboring non-resistant EGFR mutations.

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Rexahn Pharmaceuticals Reports Full Year 2017 Financial Results

March 12, 2018

Rexahn Pharmaceuticals, Inc. (NYSE American:RNN), a clinical stage biopharmaceutical company developing innovative, targeted therapeutics for the treatment of cancer, today announced financial results for the year ended December 31, 2017.

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Machfu Announces Release of MACH-3 Industrial Internet of Things Platform and Gateway | Business Wire

January 15, 2018

Machfu, an Industrial Internet of Things (IIoT) technology company, announced today the release of its MACH-3 IIoT Gateway, a device allowing companies in energy, water, oil and gas as well as other industrial segments to seamlessly connect legacy infrastructure to cloud based IoT and existing SCADA systems. The product was designed to both simplify the connection and management of devices as well as provide a secure and easily customizable application framework to process and manage data at the network edge. The versatile functionalities of the MACH-3 IIoT Gateway will be demonstrated at the 2018 DistribuTECH show, January 22-25 in San Antonio, Texas.

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Top 50 NIH-Funded Institutions of 2018 | The Lists | GEN

June 4, 2018

The National Institutes of Health (NIH) invests nearly $37.3 billion annually in medical research. More than 80% of the funding is awarded through nearly 50,000 competitive grants to more than 300,000 researchers at more than 2500 universities, medical schools, and other research institutions in every U.S. state and around the world.

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Innovation for Impact Prize – SoBran, Inc.

February 27, 2018

Tell us about the impact your research may make on the world. You could win a free pre-clinical research study valued up to $20,000 and $1,000 in cash, or additional cash prizes.

SoBran and the Maryland Tech Council are celebrating the transformational science coming out of the Maryland and surrounding area by establishing the Innovation for Impact Prize.

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Home | About BHI | BHI News | Programs | Partners | Contact

Copyright © BioHealth Innovation 2017
All Rights Reserved.



334th Edition – December 18, 2018

By BHI Weekly News Archives




BioHealth Innovation


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December 18, 2018












FOUNDING MEMBER OF



VLP Therapeutics Awarded $3.9 million Grant by Global Health Innovative Technology Fund for Further Development of Dengue Vaccine

The Global Health Innovative Technology (GHIT) Fund has awarded VLP Therapeutics a $3.9 million grant to further develop a novel tetravalent dengue virus-like particle vaccine.

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Camden Partners Nexus co-leads $3.7M investment in pharmaceutical company treating hearing loss – Technical.ly Baltimore

Early-stage pharmaceutical company Spiral Therapeutics received $3.7 million in new investment as it looks to advance treatments for hearing loss and other inner ear disorders.

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The Gene Therapy Market is going to produce a Microsoft – American Gene Technology

The most common analogy used to compare the science of DNA to other industries is that of computer software. DNA can be viewed as a series of commands (genes) that are coded in four nucleotides (represented by A, G, C, and T). Those letters are interpreted by the cellular machinery to produce cell products like enzymes, proteins, and various building blocks of the cell itself. This code somewhat parallels the “machine language” of computers. Computer’s lists of commands (coded in zeros and ones) are interpreted to work with numbers or any type of information that is converted to numbers (like audio, video, or sensor data). Resulting numbers generate numerical output for machinery such as screen displays, motors, tools, robots, digital controls, etc.

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Eversense CGM Wins a 2018 “Best of What’s New” Award – Senseonics

Senseonics Holdings, Inc. (NYSE American: SENS) a medical technology company focused on the development and commercialization of a long-term, implantable continuous glucose monitoring (CGM) system for people with diabetes, today has announced that the Eversense® Continuous Glucose Monitoring (CGM) System has been awarded one of Popular Science’s 2018 “Best of What’s New” Awards in the Health category.

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EDUCATIONAL & SCIENTIFIC, LLC AND UNIVERSITY OF MARYLAND, BALTIMORE EXPAND RELATIONSHIP THROUGH LICENSING AGREEMENT TO DEVELOP NOVEL PROSTATE CANCER TREATMENT

University of Maryland (UM) Ventures and Educational & Scientific, LLC (ESL) announced today that the University of Maryland, Baltimore (UMB) has again granted ESL an exclusive license for a novel cancer treatment. This agreement focuses on the development of Galeterone, a molecule with the potential to inhibit prostate cancer growth in patients with castration-resistant prostate cancer (CRPC). Galeterone is a steroidal antiandrogen that acts by disrupting the androgen receptor signaling pathway, which is the primary pathway that drives prostate cancer growth.

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Maryland Stem Cell Research Consortium Funding Opportunities – Deadline 1/17/19

The Maryland Stem Cell Research Fund provides a variety of grant programs for human stem cell research in the state of Maryland. Each RFA has its own timeline and review process; please read carefully the RFA when applying.

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2018 In Review with MIMETAS’ CEOs

2018 was a year in which we saw explosive growth at Mimetas. After such a hectic and promising year, it is important to take a moment to sit down and recap some of the highlights. Today, we sit down with our CEOs, Jos and Paul. In this conversation, you will read their thoughts about the Mimetas culture, corporate dynamics, amazing new products, and the strengths they perceive in each other.

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BullFrog AI Announces New Chief Technology Officer – BullFrog AI

BullFrog AI, Inc, a precision pharmaceutical company built around a powerful artificial intelligence (AI) platform, proudly announces the addition of executive Everett Lee as its Chief Technology Officer. Mr. Lee brings nearly 3 decades of technical expertise and continuous advancement in technology management, strategic business planning and IT organizational leadership at major pharmaceutical/biotech and drug development companies such as AstraZeneca, Roche/Genentech, Eli Lilly & Co., Pfizer and Covance.

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Growing our Understanding of Nanotech

Intelligent nanobots offer the promise of smart drug delivery systems for a variety of therapeutic applications. A promise that experts in the field believe will become a reality within the next 30-40 years.

But at MedImmune, we don’t think patients should have to wait.

Read More




39 years and counting: Johns Hopkins again leads country in R&D spending – Baltimore Business Journal

A large chunk of the school’s research spending — about $1.5 billion — can be attributed to Hopkins’ Applied Physics Laboratory, based in Laurel.

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Draft ROI Report is a Promising Roadmap for Accelerating Tech Transfer

After months of anticipation, the just released draft paper Return on Investment Initiative to Advance the President’s Management Agenda: Unleashing American Innovation signals that the Administration is serious about addressing a wide range of long neglected issues undermining effective technology commercialization. The paper, generated under the leadership of Commerce Under Secretary Walter Copan, who heads the National Institute of Standards and Technology (NIST), is “a discussion document” based on feedback from a series of public meetings and written comments for improving the return on investment from $150 B spent annually on government-supported R&D.

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Frederick National Laboratory, Frederick Innovative Technology Center Inc. partner for accelerator – fredericknewspost.com

The Frederick National Laboratory for Cancer Research and the Frederick Innovative Technology Center Inc. signed a memorandum of understanding with partners Monday to start an accelerator program for biotechnical companies.

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JLABS: This Incubator Knows How to Get Biotech Companies Started

When it comes to drug discovery and development, nowadays a lot of the work is done by small- or medium-sized healthcare companies. The biopharma industry heavily relies on their results, so SMEs carry an immense load on their shoulders. But without outside help, their mission is nearly impossible.

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Go inside Alexandria’s LaunchLabs incubator in Kendall Square – Boston Business Journal

The former Belly Wine Bar and The Blue Room in Cambridge’s Kendall Square has been transformed into a biotech incubator.

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The Value of Bioscience Innovation in Growing Jobs and Improving Quality of Life 2018 – BIO

This eighth, biennial report focuses on the economic progress and footprint of the industry geographically including the performance, positioning and latest trends in the bioscience industry for the nation, states and metropolitan areas. For the first time, it includes a national assessment of the full economic impact of the bioscience industry not only in terms of employment, but also with respect to economic output and fiscal impacts. In addition, the report details the nation’s academic research activities and trends in federal funding, access to critical angel and venture capital and the innovation outputs context via patent activities.

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Top 10 Molecular Millionaires of 2018

The last time GEN compiled a list of CEOs, investors, and others with the biggest stakes in biopharma companies—what GEN calls “molecular millionaires”—was last year, based on 2016 data. Only one new person who had not been listed in previous editions made the cut back then.

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Four Tips For Raising Venture Capital In The Biotechnology Sector

In a world where it seems like startups are created every other day and market economics remain largely unpredictable, securing funding for your biotech startup can prove to be an arduous task. Venture capitalists prefer tested and proven biotech enterprises, government- and NGO-backed funding remain ever so slightly out of reach, and every other funding outlet seemingly comes with its own set of hard-to-match requirements and specifications. What is the fate of the budding startup without experience in the harsh economic climate of today’s biotech ecosphere? As it turns out, it’s not quite as bad as one would expect. It’s all down to knowing the ropes and peculiarities of the market.

Read More




Why do digital health startups keep failing?

A decade ago, a wave of companies promised to transform people’s health by allowing them to track data about their eating, sleep, exercise, and other habits. One hot startup of that moment, Zeo, raised more than $30 million from investors to develop a headband that tracked users’ sleep patterns and an accompanying app to serve as their personal “sleep coach.” Despite devoted users and buzz about its product in publications like Wired and Popular Science, Zeo quietly went out of business a few years later.

Read More




Is a cancer vaccine on the horizon? – Science Focus – BBC Focus Magazine

The idea of using patients’ own immune cells to fight cancer is over a hundred years old. In the late 19th century, an American doctor called William Coley attempted to treat cancer by stimulating the immune system with dangerous bacteria, arguably the first example of what is now known as immunotherapy. His procedure appeared to shrink some patients’ tumours, but was criticised as unsafe and largely forgotten about. Chemotherapy and radiotherapy became the focus of cancer research and the standard tumour treatment for the rest of the 20th century.

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Copyright © BioHealth Innovation 2017
All Rights Reserved.



333rd Edition – December 4, 2018

By BHI Weekly News Archives




BioHealth Innovation


If you are having trouble viewing this email, please click here


December 11, 2018












FOUNDING MEMBER OF



These Five Capital Region Biotechs Are The Fastest Growing in America · BioBuzz

In its 24th year, the Deloitte Technology Fast 500 is the premier technology awards program in North America.  The program celebrates the innovation, entrepreneurship and rapid growth that these cutting-edge companies all embody.  This year’s Fast 500 winners were selected based on percentage fiscal year revenue growth during the period from 2014 to 2017 across a number of sectors, including Biotechnology/Pharmaceutical and Medical Devices. Five of these fast-growing companies call the Biohealth Capital Region home.

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Institute of Human Virology researchers discover that a bacterial protein promotes cancer – EurekAlert! Science News

The Institute of Human Virology (IHV) at the University of Maryland School of Medicine (UMSOM) announced today the discovery that DnaK, a protein of the bacterium mycoplasma, interferes with the mycoplasma-infected cell’s ability to respond to and repair DNA damage, a known origin of cancer.

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GSK Buys Tesaro For $5 Billion In Dramatic Bet On Cancer Genetics

GlaxoSmithKline announced this morning that it will buy Tesaro, the maker of the ovarian cancer drug Zejula, for $5.1 billion in cash in a dramatic bet that the London-based drug giant can see opportunities connected to the genetics of cancer drugs better than the stock market.

Read More




BHI Entrepreneur-in-Residence Feedback Sessions

Are you a start-up in Maryland, DC or Virginia seeking feedback on your biohealth business idea, pitch deck, or commercialization plan? business/commercialization plan, pitch deck, or idea?

Schedule your feedback session with BHI EIRs on one of the following dates: 

  • 12/12
  • 2/13
  • 3/20
  • 5/22

(30 minute blocks of time beginning at 9:00 in the morning. If the morning slots are filled, more time will be allotted beginning at 1 p.m.)

Pre-registration is required; sign up here (“EIR resource”at BHI). For questions/more information, contact BHI.

Read More




Join us December 13, 2018 for PATHFINDER INNOVATION PROGRAM

Explore Legal Issues for Early Stage Companies

Business formation and governance • Advisory Board vs. Board of Directors Equity incentive plans • NDA’s (w/ potential co-owners/joint ventures/investors and employees) • Worker classifications (exempt vs. non-exempt; W2 or 1099) Employment contracts • Lease and distributor agreements • Customer agreements (for beta testing and beyond) • CRADA’s and technology transfer agreements

Schedule

1 p.m – Networking Lunch

1:30 – Panel Discussion with Q&A 

2:45-4:15 – One-on-one  with Attorneys*

RSVP by noon, December 12 at BHI@BioHealthInnovation.org

No charge to attend • Attend in person or by videoconference

BioHealth Innovation, 1 Church Street, Suite 801, Rockville, MD 20876

Read More




FDA Approves Cutting-Edge Cancer Drug from Inova Schar Cancer Institute Clinical Trial – Inova Newsroom

In groundbreaking news for the medical and cancer research community, the Food and Drug Administration (FDA) approved a new, breakthrough cancer drug, larotrectinib, or Vitrakvi®, that targets specific genetic mutations in adult and pediatric patients. This is only the second tissue-agnostic drug that the FDA has approved.

Read More




Applying Deep Learning to PD-L1 Expression

Perhaps the greatest promise of Artificial Intelligence (AI) is its potential to enhance our ability to predict, diagnose, and treat disease.

That is why our researchers are continuing to look for new ways to leverage AI to aid our discovery and delivery of effective therapies.

Read More




Creatv MicroTech Receives Japanese Patent for Cancer Screening

Creatv MicroTech, Inc. (Creatv) has received notice from the Japanese Patent Office that its patent covering numerous clinical applications for the detection of cancer associated macrophage-like cells (CAMLs) in cancer patient blood samples has been issued. Clinical applications of the CAML biomarker include cancer screening, various cancer diagnostics, and early detection of disease recurrence. Approved claims cover all solid tumors. Similar patents have been issued in Europe and Australia.

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QIAGEN announces new collaboration to develop companion diagnostic to guide treatment for patients with PIK3CA-mutated advanced breast cancer | Business Wire

QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced that a clinical development program is underway with Novartis to bring to market a molecular test as a companion diagnostic to guide the use of the investigational compound BYL719 (alpelisib) in combination with fulvestrant for men and postmenopausal women living with PIK3CA mutated hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer.

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Commerce’s NIST Announces Actions to Stimulate Commercialization of Federally Funded R&D | NIST

The United States spends more than any other nation on research and development (R&D) each year, investing over $150 billion in federally funded R&D alone. In line with President Donald J. Trump’s Management Agenda, the U.S. Department of Commerce’s National Institute of Standards and Technology (NIST) today released a draft green paper detailing steps to modernize the U.S. system of technology transfer and innovation for the 21st century. The actions outlined in the green paper would help maximize returns on the taxpayer investment in R&D.

Read More




Greater Washington Board of Trade releases 2019-2021 Strategic Plan

The Board of Trade has served Greater Washington and its business community for 130 years. Today, it released a new three-year strategy for driving inclusive economic growth and improving livability, critical factors for the region’s long-term success.

The strategy includes nine goals related to the Board of Trade’s operations, offerings for members, and regional development initiatives.

Read More




CELLINK and Prellis Biologics announce powerful, $1.2M Holograph-X Bioprinter – 3D Printing Media Network

Swedish bioprinting company CELLINK has entered into a partnership with organ and tissue engineering company Prellis Biologics, Inc. with the goal of commercializing high-resolution holographic bioprinting technology for micro-scale printing. By combining their IP and respective expertise, the companies will introduce what they call the “first system enabling ultra-high resolution bioprinting of microstructures” for producing vascular networks.

Read More




Why do digital health startups keep failing?

A decade ago, a wave of companies promised to transform people’s health by allowing them to track data about their eating, sleep, exercise, and other habits. One hot startup of that moment, Zeo, raised more than $30 million from investors to develop a headband that tracked users’ sleep patterns and an accompanying app to serve as their personal “sleep coach.” Despite devoted users and buzz about its product in publications like Wired and Popular Science, Zeo quietly went out of business a few years later.

Read More




Cancer researchers in Australia develop universal blood test

Australian scientists have developed a simple blood test that they claim can diagnose cancer in mere minutes by identifying a unique DNA signature present in all types of the disease.

Read More



Home | About BHI | BHI News | Programs | Partners | Contact

Copyright © BioHealth Innovation 2017
All Rights Reserved.



332nd Edition – December 4, 2018

By BHI Weekly News Archives




BioHealth Innovation


If you are having trouble viewing this email, please click here


December 4, 2018












FOUNDING MEMBER OF



Children’s National Breaks Ground on One-of-a-Kind Pediatric Research and Innovation Hub – Benzinga

On Wednesday, Nov. 28, 2018, Children’s National Health System marked the official start of construction on its pediatric research and innovation campus with a groundbreaking event. It will be distinct nationally as a freestanding research and innovation complex focused on pediatric medicine.

Read More




A Year of Historic Action to Combat the Opioid Crisis, Emergent BioSolutions Recognized – The White House

One year ago this week, President Donald J. Trump declared the opioid crisis a public health emergency. Ever since, the Trump Administration has applied an all-of-Government approach to the epidemic, allowing each agency and department to do their part to help the cause

Read More




Six Things to Consider When Choosing a Location for Your Bio Business – Maryland Business News

Driven by breakthrough research and innovation, biohealth and life science are high-risk, high-expense fields. The right location is critical to your success, but that doesn’t mean you need to pay Boston’s and San Francisco’s high rents for lab and office space. Maryland, a booming bio hub itself, is not only cost-efficient, but offers many advantages you may not find elsewhere. Before narrowing your shortlist for your new biotech business or expansion of existing biotech business, consider these six factors that contribute to Maryland’s innovation ecosystem.

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REGENXBIO and Rocket Pharmaceuticals Announce New License Agreement for the Treatment of Danon Disease Using NAV AAV9 Vector

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, and Rocket Pharmaceuticals, Inc. (Nasdaq: RCKT), a leading U.S.-based multi-platform gene therapy company, today announced an exclusive, worldwide license agreement for Rocket to develop and commercialize gene therapy treatments for Danon disease using REGENXBIO’s NAV AAV9 vector, as well as exclusive options for two additional NAV AAV vectors for the treatment of Danon disease.

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RoosterBio Submits U.S. FDA Master Files for CliniControl™ Line of Human Mesenchymal Stem/Stromal Cell Products

RoosterBio Inc, a leading supplier of human Mesenchymal Stem/Stromal Cell (hMSC) working cell banks and hMSC-specific bioprocess systems, announces today it has submitted a U.S. Food and Drug Administration (FDA) Type II Master File (MF) for its CliniControl™ line of cGMP hMSC working cell banks. This MF complements the MF for the CliniControl RoosterNourish™-MSC-CC bioprocess media that was filed in 2017. The MFs contain confidential information on the products including their chemistry, manufacture, and controls. This enables RoosterBio to protect proprietary product information yet allows the FDA to review the information in support of an investigator’s submission. Upon request, RoosterBio will grant a customer authorization to cross reference the stated MF(s) to support their own regulatory filing, such as an Investigational New Drug (IND) application to the FDA. INDs are filed with the FDA prior to beginning clinical evaluation of new therapeutic products in human subjects.

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Job Opportunity: NIH Associate Entrepreneur-In-Residence

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.

Read More




BHI Entrepreneur-in-Residence Feedback Sessions

Are you a start-up in Maryland, DC or Virginia seeking feedback on your biohealth business idea, pitch deck, or commercialization plan? business/commercialization plan, pitch deck, or idea?

Schedule your feedback session with BHI EIRs on one of the following dates: 

  • 12/12
  • 2/13
  • 3/20
  • 5/22

(30 minute blocks of time beginning at 9:00 in the morning. If the morning slots are filled, more time will be allotted beginning at 1 p.m.)

Pre-registration is required; sign up here (“EIR resource”at BHI). For questions/more information, contact BHI.

Read More




Join us December 13, 2018 for PATHFINDER INNOVATION PROGRAM

Explore Legal Issues for Early Stage Companies

Business formation and governance • Advisory Board vs. Board of Directors Equity incentive plans • NDA’s (w/ potential co-owners/joint ventures/investors and employees) • Worker classifications (exempt vs. non-exempt; W2 or 1099) Employment contracts • Lease and distributor agreements • Customer agreements (for beta testing and beyond) • CRADA’s and technology transfer agreements

Schedule

1 p.m – Networking Lunch

1:30 – Panel Discussion with Q&A 

2:45-4:15 – One-on-one  with Attorneys*

RSVP by noon, December 12 at BHI@BioHealthInnovation.org

No charge to attend • Attend in person or by videoconference

BioHealth Innovation, 1 Church Street, Suite 801, Rockville, MD 20876

Read More




How a Chinese immigrant used WeChat to win a seat in the Maryland House of Delegates – The Washington Post

As a first-generation Asian American running for a seat in the Maryland state legislature, Democrat Lily Qi felt disconnected from the party establishment.

Read More




FDA chooses 8 medtech companies for opioid crisis challenge – MassDevice

The FDA has selected eight medtech companies to develop devices to help reduce the country’s opioid abuse crisis.

Read More




Rooster Bio and Paragon Biosolutions Recognized as Champions of Manufacturing

On November 29, 2018 at Martin’s West, RMI’s 2018 Champions of Maryland Manufacturing Awards ceremony drew over 600 stakeholders from around the State. The evening awards program touched on the themes of togetherness and family as we celebrated a variety of different leaders from young students to business executives.

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NEA completes secondary sale of 26 portfolio companies for about $1 bln – PE Hub

New Enterprise Associates has completed a roughly $1 billion secondary sale of 26 portfolio companies in a deal designed to bring early liquidity to limited partners in four of its funds. T

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University System of Maryland: Maryland’s Most Powerful Economic Engine – USM

The University System of Maryland (USM) is Maryland’s public higher education system, consisting of 11 degree-granting universities, two regional higher education centers and one environmental research institution. With approximately 170,000 students and 38,000 graduates each year, USM is the most significant producer of talented workers and educated citizens in Maryland. USM institutions, faculty, students and graduates attract billions of federal and privately funded research dollars to the state that support thousands of jobs. They also create hundreds of new companies. Combined, these activities enable USM to support one of America’s most vibrant economies.

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Johnson & Johnson Innovation – Quick Pitch – JNJ Innovation

At Johnson & Johnson, we believe a good idea can come from anywhere. Our aim is to identify, empower and enable the best ideas to get to patients and consumers around the globe. In an effort to unearth the unseen and brightest innovations in healthcare, Johnson & Johnson Innovation is launching a Quick Pitch event where innovators can apply to present to Johnson & Johnson Innovation’s leadership during the week of the 37th Annual JP Morgan Healthcare Conference in San Francisco, CA. If you are selected, you will have an opportunity to present for 5 minutes followed by a 5 minute Q&A session with Johnson & Johnson Innovation’s leadership.

If you have a novel idea that has yet to be introduced to Johnson & Johnson and fits our areas of interest, we would like to hear from you. Apply for an open spot at the Johnson & Johnson Innovation Quick Pitch event to be held on Wednesday, January 9th from 9-11am. Limited spots available.

Applications must be submitted by December 7th.

Read More




Georgetown Entrepreneurship dishes out $100K at second annual pitch competition – Technical.ly DC

Georgetown Entrepreneurship hosted its second annual Leonsis Family Entrepreneurship Prize “Bark Tank” pitch competition on Nov. 28, where eight university students and alumni pitched their business ventures for a chance to win a share of the $100, 000 in cash prize.

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Global biotech rankings – Measuring biotech innovation in 50+ countries

Why measure global biotechnology? The scope of biotechnology is broad and impacts economies, policies, and people globally.

Applications range from advanced medicines to and improvements in agriculture to feedstocks and biofuels, and further to exotic industrial materials and processes.

Read More




Time is running out to register for SoPE National Chapter: Telemedicine: Leveraging Technology to Change the Face of Healthcare…Are you In or Out?

The use of tele-medicine is no longer a far off, futuristic concept. It is presently being used in many medical disciplines and in institutions from academic medical centers to privately owned Assisted Living facilities. So what have we learned from utilizing this technology? Have outcomes improved and costs been curtailed? What are the current legislative hurdles regarding licensure and insurance for practitioners? Can the data be easily integrated and accessible to your EHR? Can new entrants into the tele-medicine field differentiate themselves and be fundable to investors? Can we trust the data from wearables and is there enough cybersecurity embedded in these technologies?

Come to the SoPE National Capital Chapter event on December 5th and learn from the experts!

Read More




Useful Stats: Higher Ed R&D by state, 2008-2017 – SSTI

Higher education R&D expenditures (HERD) grew by 38.9 percent from 2008 to 2017, an increase of more than $21 billion, according to an SSTI analysis of recently released data from the National Science Foundation’s National Center for Science and Engineering Statistics. From 2016 to 2017, HERD grew by $3.8 billion, the largest year-over-year increase since 2010-2011. Higher education R&D expenditures grew the fastest in Connecticut (66.2 percent), Massachusetts (63.9 percent), and Wyoming (63.0 percent) over the 10-year period, while New York ($2.3 billion increase), California ($2.0 billion), and Massachusetts ($1.6 billion) saw the largest absolute gains during this time.

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NCSES Higher Education Research and Development short form: Fiscal Year 2017 – US National Science Foundation (NSF)

Higher education R&D expenditures, ranked by FY 2017 R&D expenditures: FYs 2008–17

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Ten with Hopkins ties named to ‘Forbes’ 30 Under 30 list | Hub

Ten trailblazers with ties to Johns Hopkins University who have become leaders in their fields have been named to the Forbes “30 Under 30” list for 2019.

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Small Business Innovation Research Program Phase I – NSF – National Science Foundation

The National Science Foundation’s Small Business Innovation Research (SBIR) program- also known as America’s Seed Fund powered by NSF – provides small businesses with equity-free funding to conduct research and development (R&D) work that will lead to the commercialization of innovative new products and services. The NSF SBIR program seeks innovative proposals that show promise of commercial and societal impact. We invite the submission of proposals in almost any area of science and technology (more information on our technical topics is available here).

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The Real Threat Of Identity Theft Is In Your Medical Records, Not Credit Cards

The 2017 holiday season has been complicated by data breaches that have plagued consumers all year long, such as the massive Equifax hack. As a result, consumers must worry about fraud and the misuse of our financial information during a time of increased financial transactions, tight budgets and heightened stresses.

Read More




HHS selects 15 tech leaders to discuss healthcare innovation, investment – Health Data Management

The Department of Health and Human Services has picked 15 technology leaders from the private sector with which to initiate a year-long dialogue on how to accelerate healthcare innovation and investment.

Read More




BIO CEO Greenwood talks drug pricing politics after the midterms – STAT

BIO CEO Jim Greenwood won’t admit last month’s midterm elections spell trouble for the drug industry.

Read More




The Untold CRISPR Story

The recent shocking reports about a human genome editing experiment have led to increased murmurings about the potential pitfalls of improved access to molecular technologies. Sharing speeds science. That’s been the driving concept behind Addgene since its founding. Nowhere has this proved more prescient than in the acceleration of basic research using CRISPR-Cas9 genome editing tools. It would be a tremendous loss of efficiency and funding if this rogue experiment resulted in a reduction in repository deposits and the sharing of research materials.

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Despite CRISPR baby controversy, Harvard University will begin gene-editing sperm – MIT Technology Review

In the wild uproar around an experiment in China that claimed to have created twin girls whose genes were altered to protect them from HIV, there’s something worth knowing—research to improve the next generation of humans is happening in the US, too.

Read More




Biotech giant Moderna Therapeutics bumps IPO goal to staggering $600M – Boston Business Journal

The biggest proposed IPO in biotech history just got even bigger.

Cambridge-based Moderna Therapeutics disclosed Wednesday that it’s hoping to raise up to $600 million in an initial public offering, an increase from the $500 million maximum it proposed earlier this month. Either sum would shatter the previous record for a life sciences IPO, both in biotech-rich Massachusetts and nationwide.

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Roche buys U.S. biotech Jecure in race for liver disease drugs

Swiss drugmaker Roche is buying U.S.-based Jecure Therapeutics, joining Pfizer, Gilead Sciences and Novartis in pursuit of new drugs to treat fatty liver disease.

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Top 10 Pharma Companies of 2018 – GEN

Unlike their biotech counterparts, pharmaceutical companies have largely surpassed analyst expectations on earnings per share during the third quarter. Yet, pharma stocks have not been immune to the stock market swoon of recent weeks.

Read More




Rise of the Global Startup City

America’s long-held singular dominance of startup and venture capital activity is being challenged by the rapid ascent of cities in Asia, Europe, and elsewhere. While the United States remains the clear global leader, the rest of the world is gaining ground at an accelerating rate.

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Year-End Planning – The Private Bank – Wells Fargo

Recent tax-law changes may bring opportunities for you and your family, so it’s good to know what to look for and when to take action. Download our 2018 Year-End Planning Guide now to find out about potential impacts to your estate, charitable giving strategy, business, and more. Then, contact The Private Bank to discuss how our responsive, team approach to wealth planning may benefit you now and year-round.

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Home | About BHI | BHI News | Programs | Partners | Contact

Copyright © BioHealth Innovation 2017
All Rights Reserved.



331st Edition – November 27, 2018

By BHI Weekly News Archives




BioHealth Innovation


If you are having trouble viewing this email, please click here


November 27, 2018












FOUNDING MEMBER OF



Rexahn Pharmaceuticals names Doug Swirsky new CEO – Washington Business Journal

The new chief executive had joined the company in January — after selling his last biotech company for several million dollars.

Read More




PathSensors Secures 5-year Department of Defense Contract for Building Protection | PathSensors

PathSensors, Inc., a rapidly growing, Baltimore-based biotechnology company focused on delivering pathogen detection solutions, announced today that it has been awarded a $7.2 million contract from the Department of Defense – Washington Headquarters Services to provide CANARY reagents and technical support to Department of Defense Facilities in the National Capital Region. The program includes the manufacture of reagents, equipment support and the development of products for new and emerging threats. The contract extends through 2023.

Read More




Legal Issues for Early Stage Companies

Thursday, December 13, 2018

  • Business formation and governance
  • Advisory board vs board of directors
  • Equity incentive plans
  • Non-disclosure agreements (with potential co-owners/joint ventures/investors and employees)
  • Worker classifications (exempt vs non-exempt; W2 or 1099)
  • Employment contracts
  • Lease or distributor agreements
  • Customer agreements (for Beta testing and beyond)
  • CRADA’s and technology transfer agreements

Learn about these topics and more through the December 13th PathFinder Innovation Program. (There is no charge to attend in person or by videoconference. However, pre-registration by NOON, 12/12 is required).

  • 1:00-1:30 p.m. Networking Lunch
  • 1:30-2:45 p.m.– Issues Overview (in person/by videoconference) 
    • Speakers:
      • Anthony Millin, Esq. – Startups Chair, Shulman Rogers
      • Lynn Perry Parker, Esq. – Principal, LPP Law
  • 2:45 p.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.  *Participation in Overview Discussion  (in person/by videoconference) is required to attend 1:1  office hours.

Location Rockville, MD

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Emergent Bio’s Zika vaccine shows positive action in early-stage study – Seeking Alpha

Results from a Phase 1 clinical trial evaluating the safety and immunogenicity of Emergent BioSolutions’ (NYSE:EBS) Zika vaccine, VLA1601, showed a favorable safety profile for all doses and schedules tested and encouraging immunogenic activity.

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BHI Entrepreneur-in-Residence Feedback Sessions

Are you a start-up in Maryland, DC or Virginia seeking feedback on your biohealth business idea, pitch deck, or commercialization plan? business/commercialization plan, pitch deck, or idea?

Schedule your feedback session with BHI EIRs on one of the following dates: 

  • 12/12
  • 2/13
  • 3/20
  • 5/22

(30 minute blocks of time beginning at 9:00 in the morning. If the morning slots are filled, more time will be allotted beginning at 1 p.m.)

Pre-registration is required; sign up here (“EIR resource”at BHI). For questions/more information, contact BHI.

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Adaptive Phage Therapeutics named in reporting citing Top 36 Startups Which Could Change the World – CB Insights Research

As stated by Josh Wolfe, co-founder and managing partner at Lux Capital, “the gap between ‘sci-fi’ — that which was once imagined — and ‘sci-fact’ — that which becomes manifest and real — is shrinking.”

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Living like a leader: A day with Children’s National Health System CEO Dr. Kurt Newman

Between clinical objectives, financial concerns, patient needs and complex payer dynamics, there seem to be too few hours in the day for healthcare executives to address the diverse set of organizational goals they are tasked with accomplishing.

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GlycoMimetics Enrolls First Patient in Global Phase 3 Clinical Trial of Uproleselan in Relapsed/Refractory Acute Myeloid Leukemia – Business Wire

GlycoMimetics, Inc. (NASDAQ: GLYC) announced today dosing of the first patient in the company’s Phase 3 clinical trial of uproleselan (GMI-1271) in relapsed/refractory AML. The trial’s protocol provides for administration of the investigational drug in combination with MEC (mitoxantrone, etoposide and ara-C) or in combination with FAI (fludarabine, ara-C and idarubicin), both of which are standard of care for this indication in the United States. In 2017, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to GlycoMimetics for uproleselan in this patient population. The company anticipates the initiation of two complementary Phase 2/3 trials from two leading clinical consortia in early 2019.

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Protenus Co-Founders Named to Rising Stars List

Becker’s Healthcare is pleased to honor 90 healthcare leaders under 40 years old as rising stars in the industry.

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Emergent BioSolutions Success Story – Maryland is Open for Business

With preparedness solutions that address emerging infectious diseases to chemical and biological threats, protecting and enhancing lives is at the heart of everything Emergent BioSolutions does. Emergent develops vaccines, therapeutics, and devices for some of the most notable diseases and threats in modern history, including Zika, Ebola and Anthrax.

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THE ENTREPRENEURS REPORT: Private Company Financing Trends – Q3 2018

Market conditions for venture funding remained very strong in the third quarter of 2018. Deal size and pre-money valuations across all equity rounds decreased slightly but still remained high by historical standards. Median pre-money valuations inched down across the board in Q3 2018. The decline in median amounts raised was more significant, with Series B financings taking the most significant hit, and with the median size falling nearly 50% from the prior quarter. However, more post-Series A financings were up rounds, reversing the decline seen in the first half of 2018.

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University System of Maryland: Maryland’s Most Powerful Economic Engine – USM

The University System of Maryland (USM) is Maryland’s public higher education system, consisting of 11 degree-granting universities, two regional higher education centers and one environmental research institution. With approximately 170,000 students and 38,000 graduates each year, USM is the most significant producer of talented workers and educated citizens in Maryland. USM institutions, faculty, students and graduates attract billions of federal and privately funded research dollars to the state that support thousands of jobs. They also create hundreds of new companies. Combined, these activities enable USM to support one of America’s most vibrant economies.

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Capital Region Blueprint for Regional Mobility

Today, the Greater Washington Partnership unveiled the Blueprint For Regional Mobility, the first ever CEO-driven comprehensive strategy that binds the Capital Region and better connects residents in Baltimore, Washington and Richmond to opportunity.

This unified vision for the future of the region’s transportation system comes on the heels of Amazon’s commitment earlier this month to bring 25,000 jobs to the region. Executing on the seven solutions and 20 actions laid out in the Blueprint will fundamentally transform the way we move around the region, reversing our current disjointed system’s trajectory of worsening congestion and limiting access to essential destinations for many families in our region.

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An Illustrated Subway Map of Human Anatomy

What comes to mind when you think about your body?

Most people might imagine an intricate network of blood vessels or the complex neural circuits of the brain. Or we might picture diagrams from the iconic medical textbook, Gray’s Anatomy.

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Do You Have a Game-Changing Energy Innovation?

What you get

Participants selected for cohort three will receive: *

  • A two-year fellowship – Includes a personal living stipend of up to $90,000/year depending on education and experience, along with health insurance and travel allowance
  • Lab access and research funding – In addition to unparalleled access to facilities, equipment, and expertise at Oak Ridge National Laboratory, fellows receive $200,000 of R&D funding to support collaboration opportunities with researchers across the lab.
  • Business mentors, entrepreneurial training, and networking – Participants receive access to experienced business mentors, entrepreneurial training programs, and exclusive networking opportunities. Innovators are also exposed to a wide range of leaders from academia, industry, government, and finance that can serve as advisors and partners.

*All support is subject to performance and availability of funds.

Eligibility criteria

For acceptance into the program, applicants:

  • Must have PhD or equivalent experience
  • Must be focused on energy or manufacturing innovation
  • Must leverage ORNL R&D capabilities and have an impact on the Department of Energy (DOE) or Tennessee Valley Authority (TVA) mission
  • Must be willing to relocate to the Knoxville-Oak Ridge area
  • Must be a US citizen or lawful permanent resident at time of application

To learn more or to apply, please visit: https://innovationcrossroads.ornl.gov/.

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330th Edition – November 20, 2018

By BHI Weekly News Archives




BioHealth Innovation


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November 20, 2018












FOUNDING MEMBER OF

The BioHealth Innovation team would
like to wish you and your family a Happy Thanksgiving



A Win for the Region, A Win for Montgomery County

Today’s announcement that Amazon has selected New York City and Arlington, Virginia, as the locations for the company’s new headquarters is a win for Montgomery County. Amazon will invest $5 billion and create more than 50,000 jobs across the two new headquarters locations, with more than 25,000 employees each in location.

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Biobuzz Directory – NextCure Raises $93 Million Investment on Heels of Eli Lilly Immune-Oncology Deal

NextCure Inc., a privately-held biopharmaceutical company discovering and developing the next generation of immunomedicines for cancer and other diseases, today announced the completion of a $93 million series B equity financing. The financing was led by Hillhouse Capital Management and Quan Capital, and included Bay City Capital, Surveyor Capital (a Citadel company), Ping An Ventures, Taiho Ventures LLC, ArrowMark Partners and NS Investment. All existing investors also participated in this financing, including Canaan Partners, Lilly Asia Ventures, OrbiMed Advisors LLC, Pfizer Inc., Sofinnova Ventures and Alexandria Venture Investments. Additionally, Eli Lilly and Company invested $15 million in this financing in conjunction with the discovery and development partnership announced on November 5, 2018.

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Arena Inks $1.2 Billion Deal With United Therapeutics – Arena Pharmaceuticals, Inc. (NASDAQ:ARNA) | Seeking Alpha

Arena Pharmaceuticals (ARNA) and United Therapeutics (UTHR) announced on Nov. 15 that the two companies have reached a deal on the pulmonary arterial hypertension (PAH) drug Ralinepag. The $1.2 billion deal is the type of deal that many Arena investors have anticipated.

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Rexahn Pharmaceuticals Announces Leadership Transition – Rexahn Pharmaceuticals, Inc.

Rexahn Pharmaceuticals, Inc. (NYSE American: RNN), a clinical stage biopharmaceutical company developing innovative therapies to improve outcomes in cancers that are difficult to treat, today announced that Douglas J. Swirsky, who has served as Rexahn’s president and chief financial officer since January 2018, has been named the company’s president and chief executive officer and appointed to the company’s board of directors effective immediately. Peter D. Suzdak, Ph.D., chief executive officer, has departed the company and resigned as a member of its board of directors.

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SERAXIS Inc. publishes clinical trial considerations for a type 1 diabetes stem cell-derived therapy

SERAXIS Inc., a rapidly growing regenerative medicine company today announced the publication of important trial considerations for SR-01, its pluripotent stem cell-derived islet therapy for insulin-dependent diabetes.

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CRISPR, MaxCyte expand partnership into immuno-oncology – Pharmaceutical Business review

Gene editing company CRISPR Therapeutics and cell-based medicines and life sciences firm MaxCyte have expanded clinical and commercial license agreement into oncology.

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Paragon Bioservices Named to Deloitte’s Technology Fast 500™

Paragon Bioservices, Inc. (Paragon), the leading private equity-backed biologics contract development and manufacturing organization (CDMO) with proven expertise in gene therapy and next-generation vaccines, today announced it was named to Deloitte’s Technology Fast 500™ for 2018, a ranking of the 500 fastest growing technology, media, telecommunications, life sciences and energy tech companies in North America. Additionally, Paragon was named #8 to the Baltimore Business Journal’s Fast 50 for the second year in a row.

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Baltimore-based AsclepiX Therapeutics raises $5M – Technical.ly Baltimore

Johns Hopkins spinout AsclepiX Therapeutics raised $5 million in new funding that will assist in development of new treatment for eye diseases that are leading causes of blindness in adults.

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IBBR investigator to lead $3.9M NIH-funded project to develop next generation HIV-1 immunotherapy agents

IBBR researchers recently received $3.9 million from the National Institutes of Health (NIH) to develop a multi-specific, single agent antibody therapeutic against HIV-1 to block virus infection and to clear the reservoir of HIV-infected cells from the body. Dr. Yuxing Li, Associate Professor, Department of Microbiology and Immunology, University of Maryland School of Medicine, and Fellow at the Institute for Bioscience and Biotechnology Research (IBBR), will lead the project, in collaboration with colleagues Dr. Qingsheng Li, University of Nebraska-Lincoln, and Dr. Keith Reeves, Harvard Medical School/Beth Israel Deaconess Medical Center.

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D.C.’s original site competition – The Washington Post

Amazon announced its HQ2 decision last Tuesday, splitting the decision between Crystal City and New York. But an earlier competition to site the nation’s capital makes the HQ2 contest seem like a cakewalk.

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5 Telehealth Insights from CMS’ Seema Verma – HealthLeaders Media

Telehealth is changing the face of healthcare, and Medicare must adapt, said the CMS administrator.

Innovation is vital to the evolution and sustainability of the American healthcare system, and the Centers for Medicare & Medicaid Services (CMS) is working to be part of the transformation, according to its administrator.

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TEDx Amplifies UMB’s Cutting-Edge Innovations – University of Maryland, Baltimore

The audience seated in an intimate ballroom at the University of Maryland, Baltimore (UMB) on Nov. 9 turned its attention to a small stage at the front of the room. The stage filled with red light as Nadine M. Finigan-Carr, PhD, MS, a research associate professor at the University of Maryland School of Social Work (UMSSW), entered from behind a black curtain off to the right.

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HISTORIC DAY: Virginia Tech Innovation Campus key to Virginia attracting Amazon HQ2 – Virginia Tech

Virginia emerged as a winner in the fierce, nationwide competition to house a headquarters for Amazon. The commonwealth stepped up with a standout higher education package, including a new Virginia Tech Innovation Campus in Alexandria, which will be located less than two miles from Amazon’s new location in Arlington.

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The Squeeze Continues…Early Stage Health Tech Deal Volume Falls to New Lows – LinkedIn

Groundhog Day?

This month, Forbes reported that venture capital investments in healthcare startups hit record highs, despite the infamous dissolution of Theranos. While this implies it is still a buyer’s market, hundreds of quality early stage-health technology companies ready for funding are not securing investments. At Inova Personalized Health Accelerator (IPHA), we researched this trend in our Health Tech Early Stage Funding Report, which we published this month. As reported in VentureBeat earlier this year, Rick Gordon, director of IPHA, detailed a troubling trend at the pre-seed and seed stage investment level for health technology startups – early stage health technology investments are declining.

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A Tale Of Two Cities: Amazon Picks NYC, Northern Virginia For New HQ

After a highly competitive site selection process that had communities across the U.S. touting their qualifications, Amazon has selected New York City and Arlington, VA, as the locations for the company’s new headquarters. Amazon will invest $5 billion and create more than 50,000 jobs across the two new headquarters locations, with more than 25,000 employees each in New York City and Arlington. The new locations will join Seattle as the company’s three headquarters in North America.

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3 Business Models That Could Bring Million-Dollar Cures to Everyone

When the FDA issued its first approval for a gene therapy for an inherited disease nearly a year ago—a cure for a type of blindness—it was heralded as breakthrough, a moment decades in the making. With dozens of other genetically engineered therapies moving through clinical trials, the long-promised era of personalized, gene-based medicine seemed to be at hand.

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Biopharma needs a new R&D, innovation model – MedCity News

Leaders within the biopharma industry have long enjoyed the pride of knowing that their work improves millions of lives and offers great benefits to humanity. They share a collective sense of accomplishment around the eradication of diseases and improvement of daily living.

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Google hires a health care CEO to organize its fragmented health initiatives – The Verge

Google has hired Geisinger Health CEO David Feinberg to oversee its many health care initiatives, reporting to AI chief Jeff Dean and working closely with CEO Sundar Pichai to organize Google’s various health-related ventures.

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What health IT needs to look like in 2019 to be successful – MedCity News

There’s no doubt that now is an exciting time for health IT. Many forward-thinking software companies are applying predictive models to create solutions that can improve hospital operations and clinical outcomes. As president and CMO of a Silicon Valley-based healthcare company using data science to improve core processes in healthcare operations, I believe there are a few major elements that health IT companies must incorporate as they continue to evolve to address the needs of our trillion-dollar healthcare system. Here’s what I believe needs to happen in 2019:

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Opportunities in genomic testing and precision medicine – McKinsey

Advanced analysis of genomic data integrated with electronic medical records and other data sets, combined with effective reimbursement strategies and full data-regulatory compliance, will distinguish winning diagnostics companies.

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Honest Tea Founder Seth Goldman Maintains His Thirst For Entrepreneurship

Seth Goldman was bitten by the entrepreneurial bug, and throughout his life, he dreamed of ideas to pursue. That tendency was enhanced when he crossed paths with Yale School of Management Professor Barry Nalebuff while pursuing his graduate degree in business administration. The student impressed the professor with his insights, and his willingness to productively debate ideas in class. A couple of years after business school, Goldman went for a run in New York City, entered a convenience store, and despite his thirst, was not impressed by the usual suspect beverages on offer.

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329th Edition – November 13, 2018

By BHI Weekly News Archives




BioHealth Innovation


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November 13, 2018












FOUNDING MEMBER OF



Gemstone Biotherapeutics CEO Emily English joins Rich Bendis on BioTalk

Emily English, CEO of Gemstone Biotherapeutics sits down with BioTalk host Rich Bendis to discuss company’s history, the path to her role, and the evolution of their technology.

Emily English, CEO of Gemstone Biotherapeutics sits down with BioTalk host Rich Bendis to discuss company’s history, the path to her role, and the evolution of their technology. Emily P. English, Ph.D., is the Chief Executive Officer of Gemstone Biotherapeutics, LLC. Dr. English is a proven innovator and manager with a passion for transitioning early-stage technologies to operational capabilities and commercial products. In her current role, she is guiding the commercialization of Gemstone’s innovative biomaterials technology, with a goal of bringing solutions for scar-free skin regeneration to market. Prior to joining Gemstone, Dr. English spent eight years at the Johns Hopkins University Applied Physics Laboratory, where she was the Global Communications Program Manager and led a team of 35 scientists and engineers. She holds a Bachelor’s degree, Magna cum laude, in chemistry from the University of Maryland, College Park, and a Ph.D. in chemistry from the University of Wisconsin, Madison. Outside of work, Dr. English enjoys spending time with her family, and she is an avid curler.

Listen now on iTunes Google Play , and TuneIn

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Get Paid for Your BioHealth Innovation Reimbursement Planning
  • 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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BioHealth Innovation, Inc. Board Member Lily Qi Elected to Maryland State Legislature

BHI congratulates Lily Qi on her election to the Maryland House of Delegates representing District 15 in Montgomery County. Lily was one of the founding members of the working group who was instrumental in launching BioHealth Innovation well before her appointment to the Board in 2016. She has been a champion for advancing the biotech industry and is looking forward to being a strong partner for the biohealth industries in Montgomery County and Maryland. Lily ran a highly competitive race and won 2nd place both in the Democratic Primary among nine contenders (including two incumbents) and in the General Election where there were six total candidates. She became the first Chinese immigrant elected to the Maryland Legislature. Please join us in congratulating Lily Qi as we look forward to great things from her in her new role.

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RegenxBio expanding to new Rockville HQ – Washington Business Journal

Rockville-based RegenxBio Inc. is on the move — to a site about 300 yards from its current home.

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How One Of The Most Successful Government Agencies Safeguards Our Health

When the person who successfully upended the broadcast radio industry model with the launch of Sirius XM satellite radio and then successfully challenged the drug development model to create new drugs for rare diseases now tells you to focus on bio-defense, you better pay attention. So when Dr. Martine Rothblatt PhD, JD, the Founder and CEO of United Therapeutics Corp., appeared as the keynote speaker for BARDA’s Industry Day, it signaled this was not going to be business as usual, even for a government agency that must be ready to combat exotic diseases like Ebola, Zika and Pandemic flu.

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$2.5 Million Grant Awarded to BioHealth Capital Region Research Collaborative to Fight Deadly Virus · BioBuzz

Scientists from across the BioHealth Capital Region will collaborate on a five-year, $2.5 million grant from the Department of Defense to fight the Venezuelan equine encephalitis virus (VEEV), a South American-borne disease that can cause long-term neurological problems and even death.   George Mason University researcher, Kylene Kehn-Hall, PhD, lead the efforts to win the sizable grant from Defense Threat Reduction Agency (DTRA)

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Novavax reports results, ‘preparing for success’ – Washington Business Journal

Novavax is a few months away from results for its two lead vaccine programs — and it’s taking steps “to enable us to launch our products as soon as possible post licensure,” CEO Stanley Erck said on a Wednesday earnings call.

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Alexandria Real Estate Equities’ New Build-to-Suit In Maryland – GlobeSt

REGENXBIO has executed a 15-year 132000 square foot lease for the building.

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Lilly, NextCure Launch Cancer Immunotherapy Partnership | GEN – Genetic Engineering and Biotechnology News

Eli Lilly will use NextCure’s Functional, Integrated, NextCure Discovery in Immuno Oncology (FIND-IO™) platform to discover and develop cancer targets for new immuno-oncology therapies, the companies said, through a collaboration set to generate more than $40 million for the Beltsville, MD, cancer drug developer.

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Baltimore’s ETC (Emerging Technology Center) Announces Eighth Year of AccelerateBaltimore

ETC (Emerging Technology Center), Baltimore City’s award-winning technology and innovation center, announced today that its AccelerateBaltimore program will run for its eighth consecutive year, with funding from the Abell Foundation. Six companies will be competitively selected for the program, each receiving initial seed funding of $25,000 and $100,000 in follow-on funding will be awarded to one AccelerateBaltimore company judged to have the greatest potential for growth. ETC will accept applications from October 22 through December 10, 2018 at www.acceleratebaltimore.com.

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Senseonics Announces FDA Approval to Expand Eversense® CGM Certification to Nurse Practitioners and Physician Assistants – Senseonics

Senseonics Holdings, Inc. (NYSE American: SENS) a medical technology company focused on the development and commercialization of a long-term, implantable continuous glucose monitoring (CGM) system for people with diabetes, today has announced that the Eversense® Continuous Glucose Monitoring (CGM) System has received FDA approval for qualified health care providers to be trained and certified to provide patients with the highly accurate sensor that lasts up to three months. Previously, the sensor insertion and removal procedure could only be performed by trained physicians.

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CRISPR Therapeutics and MaxCyte Expand Clinical and Commercial License Agreement into Oncology

CRISPR Therapeutics (NASDAQ:CRSP) and MaxCyte today announced the expansion of their existing relationship by entering into a non-exclusive commercial license agreement that will allow CRISPR Therapeutics to deploy MaxCyte’s Flow Electroporation® Technology to develop CRISPR/Cas9-based therapies in immuno-oncology.

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MdBio Foundation to Host 10th ATLAS College & Career Readiness Symposium

MdBio Foundation, a national non-profit that provides STEM education and workforce development to underserved communities, will hosts its 10th Advancing Tomorrow’s Leaders in STEM (ATLAS) college and career readiness symposium on November 9, 2018, at Montgomery College’s campus in Germantown, Md. ATLAS brings students typically underrepresented in science, technology, engineering and math (STEM) together with Maryland’s leading employers to learn about career opportunities and foster the development of a strong pipeline of skilled STEM workers that will fuel the state’s growing science and technology sectors.

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Meet this year’s 10 cohort members of Hopkins’ Social Innovation Lab – Baltimore Business Journal

A $25,000 prize will be awarded to one of the 10 new Social Innovation Lab members at the end of the cohort session.

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New Enterprise Associates sells stakes in portfolio companies – Pensions & Investments

New Enterprise Associates has closed a deal to sell $1.3 billion of interests in about 20 portfolio companies to a new fund managed by a new venture capital firm headed by two former NEA executives, multiple sources with knowledge of the transaction have said.

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Revolution Ventures is raising a new fund – Washington Business Journal

The venture capital firm is aiming for $200 million.

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Google taps Geisinger CEO to oversee health efforts – MedCity News

Geisinger president and CEO David Feinberg is moving to tech giant Google, where he will help coordinate its moves in the healthcare space, according to CNBC.

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Intersection between big data and therapeutic pipeline in neuromuscular disease will be life-changing for 250,000 patients and caregivers | Muscular Dystrophy Association

A new report funded by the Muscular Dystrophy Association (MDA) and released by the IQVIA Institute for Human Data Science indicates that genetic testing and breakthrough therapies will transform the diagnosis and care of neuromuscular disease within the next decade. The report, “Understanding Neuromuscular Disease Care,” highlights current gaps in care and opportunities to optimize care and accelerate the emergence of new therapies. Insights gained from a survey of health care professionals focused on the care of patients with neuromuscular disease are also included.

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Leonard Freedman Named Chief Science Officer of Leidos-Operated Frederick National Laboratory | ExecutiveBiz

Leonard Freedman, founding president of the Global Biological Standards Institute, has been appointed chief science officer at a federally funded research and development center Leidos manages for the National Cancer Institute.

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Top 25 Biotech Companies of 2018

While several biopharma giants (including Amgen, Novartis, and Merck & Co.) reported third-quarter earnings that beat expectations in recent days, biotechs appear to have been caught up in the past month’s stock market swoon. As of October 26, according to Zacks Equity Research, the stock prices of companies in its “medical-biomedical and genetics” sector, which includes smaller as well as larger biotechs, had fallen 10.3% over the previous six months, compared with a 1.6% increase for the overall S&P 500.

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2018’s Fiercest Women in Life Sciences – FiercePharma

Things are looking up for women—or so they seem. In the era of #MeToo, more and more women are speaking up about workplace harassment and discrimination, and the perpetrators are increasingly held accountable. Industry groups, like the Biotechnology Innovation Organization (BIO), and states, such as California, are implementing rules to increase the proportion of women on corporate boards.

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Cambridge’s Kendall Square, a top innovation hub, faces infrastructure challenges – Curbed

In Cambridge, Massachusetts, some of the most valuable real estate in the city of 113,000 can be found clustered around the Kendall Square station along Boston’s metro, the T. This cluster of labs, research centers, and corporate offices, located within a 10-minute walk of the rail station, has been called “the most innovative square mile on earth,” according to a Boston Consulting Group report from 2009, and a birthplace of the biotech industry.

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NTIS.gov – NTIS Joint Venture Program

The National Technical Information Service (NTIS) has extended its deadline for accepting proposals from organizations interested in entering into new Joint Venture Partnerships (JVP) with the agency. As described in the Federal Register notice (Opportunity Announcement), the JV partners in collaboration with NTIS will assist Federal agencies in developing and implementing innovative ways to collect, connect, access, analyze, or use Federal data and data services.

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Why 1776 is closing its original incubator location, and thoughts on its future in DC – Technical.ly DC

The original location of 1776 is closing at the end of the year. 1776 plans to leave its current D.C. location at 1133 15th St. NW after the prominent incubator network couldn’t reach an agreement over lease renewal terms with the building’s owner, DivcoWest. The lease will expire on December 31.

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All Rights Reserved.



328th Edition – November 6, 2018

By BHI Weekly News Archives




BioHealth Innovation


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November 6, 2018












FOUNDING MEMBER OF



Baltimore’s Gemstone Biotherapeutics Poised to Transform Wound Care Market

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 Appoints Rachel King to Board of Directors – NASDAQ.com

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 Collaborates With QIAGEN to Advance Rapid Diagnostics for Antimicrobial Resistant Bacteria Nasdaq:OPGN

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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Washington Business Journal Recognizes Emmes in Two “Top Company” Lists

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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Getting Paid for Your BioHealth Innovation – Reimbursement Planning (11/14)
  • 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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Reinstatement of NIH SBIR Direct-to-Phase II Authority and Associated Updates to NIH SBIR Omnibus Solicitations

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 opens new biorepository in Maryland, US – Pharma Business review

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 Announces Submission of Three Orphan Drug Designation Requests for Substrate Replacement Therapies to treat Congenital Disorders of Glycosylation

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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Indivumed opens US-Headquarter in Frederick, MD: Indivumed

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 completes $13 million renovation of Frederick facility – Southern Research

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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Wound Care Advantage taps Tissue Analytics for AI, smartphone offering | MobiHealthNews

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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Here’s how an AstraZeneca spinout deal gets done – Baltimore Business Journal

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

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Job Opportunity: Associate Entrepreneur-in-Residence

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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PIC MC RISE Zone Celebration and Ribbon Cutting

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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What’s next for RightEye following FDA approval – Washington Business Journal

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

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Alexandria Real Estate’s Marcus on Interest Rates, Drug Pricing – Bloomberg

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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TEDCO’s Builder Fund is closing the investment gap for more entrepreneurs – Technical.ly DC

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 expands QIAGEN Clinical Insight software to support all major sequencing platforms and assay types

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 RECEIVES ABOUT $8 MILLION FROM WARRANT EXERCISES

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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FounderTrac Demo Day

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 Announces $2.1 Million Registered Direct Offering

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 Partner Updates on Clinical Trials – Oct 29, 2018

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 Obtains CE Mark for Liquid Biopsy Test for Liver Cancer Detection

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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Local entrepreneurs enter shark tank at Shore Hatchery – 47abc

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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Aledade raises $23 million — again – Washington Business Journal

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

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3D bioprinted lungs to be available for global transplants – ISRAEL21c

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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Life sciences VC investment trends similar to tech, but there are differences – MedCity News

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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Ex-NEA GP Viswanathan raising $1.3 bln related to secondary deal – PE Hub

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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Illumina to buy Pacific Biosciences for $1.2 billion – MedCity News

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

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Inside 3675 Market, Philadelphia’s Newest Innovation Hub

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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AbbVie Follows Trend of Big Pharma Setting Office-Labs in Biotech Clusters – BioSpace

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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CMS will cover virtual care for the first time – MedCity News

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 Announces Extension of JJIPO @ QUT in Collaboration with Queensland State Government to Further Boost Life-Science Innovation in Queensland | Business Wire

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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All Rights Reserved.



327th Edition – October 30, 2018

By BHI Weekly News Archives




BioHealth Innovation


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October 30, 2018












FOUNDING MEMBER OF



Viewpoint: We need a federal authority to boost ‘tech transfer’ – Washington Business Journal

By Rich Bendis and Brian Darmody

While Maryland boasts world-class universities and many private sector firms, the major reason it ranks No. 1 in the country in per capita research spending is the presence of 74 federal research laboratories, such as the National Institutes of Health.

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BHI Entrepreneur-in-Residence Feedback Sessions

Are you a start-up in Maryland, DC or Virginia seeking feedback on your biohealth business idea, pitch deck, or commercialization plan? business/commercialization plan, pitch deck, or idea?

Schedule your feedback session with BHI EIRs on one of the following dates: 

  • 10/31
  • 12/5
  • 2/13
  • 3/20
  • 5/22

(30 minute blocks of time beginning at 9:00 in the morning. If the morning slots are filled, more time will be allotted beginning at 1 p.m.)

Pre-registration is required; sign up here (“EIR resource”at BHI). For questions/more information, contact BHI.

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REGENXBIO Announces Additional Positive Interim Phase I Trial Update for RGX-314 for the Treatment of Wet AMD at the American Academy of Ophthalmology 2018 Annual Meeting

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 updated results from the ongoing Phase I study of RGX-314 for the treatment of wet age-related macular degeneration (wet AMD).

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United Therapeutics, CollPlant partner for 3D-printed organs – Washington Business Journal

United Therapeutics is putting millions more toward an effort to pioneer organ manufacturing and transplantation.

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BioHealth CEO/Consulting Opportunities

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 send your Vita to BHI@BioHealthInnovation.org.  Please include the following in your email.

  • Position Sought – FT, PT, Consultant (list any/all that apply)
  • Compensation – (Minimum hourly/annual)
  • Willing to take deferred compensation in exchange for equity? (Y/N)
  • Date available
  • Other 
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    PathFinder Innovation Program

    BHI and Launch Workplaces are co-hosting a series of education and 1:1 consulting sessions on topics of interest to early stage biohealth and technology companies. These sessions are open to all start-ups in the BioHealth Capital Region (with priority on 1:1 office hours given to Montgomery County Innovation Center tenants).  Find your path for business growth with experts on a wide range of topics. 

    Each program begins with an overview of issues related to the day’s topic with lessons learned and best practices from experts in the field and companies which have been through the process.  Attendees can sign up for 1:1 meetings with the experts after the overview sessions to discuss their specific scenarios more in depth.  Companies participating in at least 5 sessions will have the ability to apply for a small matching grant (awarded competitively) to advance their commercialization activities. [more info]

    MARK YOUR CALENDARS:

    8:15 a.m. –  Networking

    8:30 – 9:20 a.m. – Panel with Q & A

    9:30 a.m. –12:30 p.m. – 1:1 meetings*

    • 11/14 – CMS Reimbursement – Germantown Innovation Center
    • 11/28 – Legal Issues for Early Stage Companies – Rockville Innovation Center
    • 1/23 – Tax Implications for Startups  – Silver Spring Innovation Center
    • 1/29 – Fundraising (SBIR)  – Location TBD
    • 2/27 – Fundraising – Other (nonSBIR nondilutive and dilutive)  – Germantown Innovation Center
    • 3/27 – Successful Marketing & PR Strategies – Rockville Innovation Center
    • 4/24 – Selling to the Government – Silver Spring Innovation Center
    • 5/15 – Pricing Factors – Rockville Innovation Center
    • 6/12 – Staff Recruitment and Retention – Germantown Innovation Center

    *Space will be available for you to work while you are waiting for your 1:1 meeting.

    No fee but, PRE-REGISTRATION IS REQUIRED:

    To RSVP, for the overview session(s), send your contact information and the date(s) of the program(s) you plan to attend to email BHI.

    To schedule your 1:1 meeting(s) with consultant(s), click here.

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    MoCo college to target economic development with new ‘RISE Zone’ – Washington Business Journal

    Developers qualify if they fill buildings with biotech and cyber firms.

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    TaiRx, Inc. and BioHealth Innovation, Inc. Form TaiRx US to Develop and Commercialize Therapeutics and Precision Medicine Diagnostics

    TaiRx, Inc and BioHealth Innovation, Inc. (BHI) announced today the formation of TaiRx US, a new joint venture.  The mission of the new company is to develop therapeutics and precision medicine diagnostics focused on the Nodal protein, a critical mediator of aggressive cancer progression and treatment resistance.

    TaiRx, Inc and BHI have formed TaiRx US, which will be based in Rockville (Montgomery County), Maryland, to develop and commercialize a unique monoclonal antibody with the potential to reverse drug resistance in various tumor types. The company is also working to develop a companion diagnostic to accurately identify those patients who can best benefit from the therapy.

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    How Stem Cell Innovation Has Advanced Neuroscience Research – Psychology Today

    One of the gating factors in studying the human brain is having the ability to conduct research on actual functioning human brain tissue. As a result, many scientific studies are conducted on rodents as a mammalian proxy. The drawback to this approach is that rodent brains are different in structure and function. According to Johns Hopkins, structurally, the human brain is approximately 30 percent neurons and 70 percent glia, while the mouse brain has the opposite ratio [1].

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    University of Maryland School of Medicine to tackle diseases in major new Baltimore research center – Baltimore Sun

    The University of Maryland School of Medicine plans to cut the ribbon on the university system’s largest academic building ever Wednesday, a $305 million tower on Baltimore Street that officials say will vastly expand the institution’s ability to understand and treat diseases.

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    10 impact-focused ventures enter Johns Hopkins Social Innovation Lab – Technical.ly Baltimore

    Johns Hopkins’ Social Innovation Lab is kicking off a new cohort of early-stage social enterprises addressing challenges around education, health and blight, among others.

    Read More




    VERALOX Therapeutics and Frederick Innovative Technology Center, Inc. – Success Story – Baltimore Business Journal

    Thrombocytopenia is a big word that can carry big consequences for those struggling with rare blood disorders, especially among those using heparin to treat and prevent blood clots. But, help is on the way. The National Institutes of Health’s National Heart, Lung, and Blood Institute (NHLBI) recently awarded VERALOX Therapeutics, a small molecule drug discovery and development company, a $319,133 Small Business Innovation Research grant to develop a novel therapeutic for patients suffering from heparin-induced thrombocytopenia and thrombosis (HIT/HITT).

    Read More




    GSK developing TB vaccine – Livemint

    In what can be termed as a milestone in the fight against tuberculosis (TB), a vaccine by pharma major GlaxoSmithKline (GSK) could be the first new jab against the infectious disease developed in a century.

    Read More




    Altimmune CEO Bill Enright to depart – Washington Business Journal

    The chief executive will stay in his role, and on the board, until his successor is appointed or early next year, whichever comes first.

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    AstraZeneca strengthens and expands oncology development and commercialisation collaboration with Innate Pharma

    AstraZeneca, and its global biologics research and development arm MedImmune, today announced a new multi-term agreement with Innate Pharma (Innate), building on an existing collaboration, aimed at accelerating each company’s oncology portfolio and bringing new medicines to patients more quickly. The extended collaboration will enrich AstraZeneca’s immuno-oncology (IO) portfolio with pre-clinical and clinical potential new medicines.

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    U.S. Life Science Real Estate Sector Keeps Expanding

    A growing seniors population and increasing prevalence of high-cost diseases like diabetes has generated a surge in funding for healthcare research in recent years and, along with it, demand for life science-biotech lab space.

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    United States Is The Most Competitive Economy: World Economic Forum | Newgeography.com

    The United States is rated as the world’s most competitive economy according to the Global Competitiveness Report 2018, which is published by the World Economic Forum (WEF). The World Economic Forum sponsors the well publicized and invitation only annual meeting at Davos, in the Swiss Alps each winter.

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    The Galien Foundation Announces 2018 #PrixGalien Award Recipients

    The Prix Galien USA Committee last night honored excellence in the biopharmaceutical and medical industry for research, development and innovation at its 12th annual Prix Galien Awards Gala, held at the American Museum of Natural History in New York City. In recognition of the development and discovery of products that improve the human condition, a committee of highly accomplished scientific leaders, inclusive of four Novel Laureates, recognized winners in three categories: “Best Pharmaceutical Product,” “Best Biotechnology Product,” and “Best Medical Technology.” This year, the Committee has chosen two winners in the Biotechnology category.

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    Foundation for the NIH Bestows the Inaugural Trailblazer Prize for Clinician-Scientists to Dr. Michael Fox | FNIH

    The Foundation for the National Institutes of Health (FNIH) awarded to Michael Fox, M.D., Ph.D., of Beth Israel Deaconess Medical Center and Harvard Medical School the inaugural Trailblazer Prize for Clinician-Scientists (Trailblazer Prize) at the FNIH Annual Fall Board Dinner in Washington, D.C. Dr. Fox received the Trailblazer Prize and a $10,000 honorarium for pioneering innovative techniques to map human brain connectivity that can be translated into new treatments for neurological diseases, such as Parkinson’s disease and depression. The Trailblazer Prize is made possible by a generous donation from John I. Gallin, M.D., and Elaine Gallin, Ph.D., to the FNIH.

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    How a Pharma Company Applied Machine Learning to Patient Data

    The growing availability of real-world data has generated tremendous excitement in health care. By some estimates, health data volumes are increasing by 48% annually, and the last decade has seen a boom in the collection and aggregation of this information. Among these data, electronic health records (EHRs) offer one of the biggest opportunities to produce novel insights and disrupt the current understanding of patient care.

    Read More




    Railing against ‘global freeloading,’ Trump offers plan to lower drug prices – STAT

    President Trump on Thursday blasted pharmaceutical companies for having “rigged the system” against American consumers by charging higher prices in the U.S. than they do abroad, announcing a new proposal he says will help even out those differences.

    Read More




    A Year of Historic Action to Combat the Opioid Crisis – The White House

    One year ago this week, President Donald J. Trump declared the opioid crisis a public health emergency. Ever since, the Trump Administration has applied an all-of-Government approach to the epidemic, allowing each agency and department to do their part to help the cause.

    Read More




    Gotham Therapeutics Launches in New York City with $54 Million Series A Financing – BioSpace

    Gotham Therapeutics launched in New York with a $54 million Series A financing. The round was co-led by founding investor Versant Ventures, Forbion and S.R. One. The investment syndicate included Celgene Corporation and Alexandria Venture Investments.

    Read More



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