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.

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.

He Jiankui, a researcher in Shenzhen, China, claims he utilized CRISPR-Cas9 gene editing to alter the DNA of embryos for seven couples.

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

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.

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

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.

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.

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.

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.

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.”

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

A Zika vaccine candidate co-developed by Emergent BioSolutions and Valneva has turned up positive early-stage results, laying the groundwork for a potential technology transfer to Emergent.

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.

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.

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.

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.

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.

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.

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:

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.

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.

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.

California Life Sciences Association (CLSA), the trade association representing California’s life sciences industry, and PwC US, are proud to release the 2019 California Life Sciences Industry Report. With over 350 data points, this 2019 Report provides a snapshot of California’s life sciences community, and how the world’s largest life sciences cluster remains a global hub for innovation, creating high-wage jobs, bringing new therapies and technologies to patients, and attracting significant investment from venture capitalists, the NIH and more.

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.

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.

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.

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.

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.

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.

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

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.

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.

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.

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.