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

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.

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.

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.

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).

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.

Price controls under consideration by the administration would reduce the biopharmaceutical industry’s investment in R&D, which would slow the pace of drug discovery. It would also damage the life science innovation ecosystem because biopharma firms contribute to knowledge sharing, including through university research in all 50 states, scientific publications (over 12,500 in 2017 alone), and other activities designed to develop and disseminate discoveries.

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.

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.

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

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

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.

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.

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.

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 This email address is being protected from spambots. You need JavaScript enabled to view it., 240-567-8062

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.

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.

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.