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.

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.

New York City and Northern Virginia will be the homes for Amazon.com Inc.’s second and third headquarters, according to people familiar with the matter, ending a more than yearlong public contest that started with 238 candidates and ended with a surprise split of its so-called HQ2.

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.

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.

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.

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.

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.

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.

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.

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.

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

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.

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.

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)

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.

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

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.

The venture capital firm is aiming for $200 million.

Alexandria Real Estate Equities, Inc. (NYSE: ARE), an urban office REIT uniquely focused on collaborative life science and technology campuses in AAA innovation cluster locations, today announced that it has kicked off the development of a 175,000 RSF Class A property on its flagship Maryland campus, the Alexandria Life Science and Translational Research Center at 9800 Medical Center Drive, with the signing of a long-term lease with REGENXBIO Inc. (NASDAQ: RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy. As the anchor tenant of the new sustainable office/laboratory development, REGENXBIO has executed a 15-year, 132,000 RSF lease with expansion options for its future HQ and R&D building. This strategic lease enables REGENXBIO to expand and consolidate multiple nearby sites at one campus location in the heart of the Shady Grove Life Sciences Center in Rockville, Maryland. The ground-up development project targeting LEED certification is fully entitled and is expected to be placed into service in 2020.

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.

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.

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

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.

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.

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.

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.

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.

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.

• 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 14^th 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.

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