BHI Weekly Newsletter Archives

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

Read More

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

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

Read More

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.

Read More

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

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.”

Read More

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.

Read More

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.

Read More

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

Read More

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.

Read More

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.

Read More

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.

Read More

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.

Read More

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.

Read More

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/.

{iframe}https://innovationcrossroads.ornl.gov/{/iframe}

Read More

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

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.

Read More

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.

Read More

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.

Read More

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.

Read More

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.

Read More

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

Read More

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.

Read More

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.

Read More

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.

Read More

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.

Read 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.

Read More

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.

Read More

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.

Read More

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.

Read More

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.

Read More

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.

Read More

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.

Read More

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.

Read More

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:

Read More

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.

Read More

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.

Read More

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. 

Read More

• 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.

Read More

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.

Read More

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

Read More

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.

Read More

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)

Read More

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.

Read More

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

Read More

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.

Read More

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.

Read More

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.

Read More

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.

Read More

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.

Read More

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

Read More

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.

Read More

The venture capital firm is aiming for $200 million.

Read More

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.

Read More

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.

Read More

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.

Read More

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.

Read More

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.

Read More

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.

Read More

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.

Read More

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.

Read More

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.

Read More

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.

Read More

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).

Read More

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.

Read More

• 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.

Read More

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

Read More

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.

Read More

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).

Read More

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.

Read More

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.

Read More

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.

Read More

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

Read More

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.

Read More

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

Read More

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

Read More

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.”

Read More

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.

Read More

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.

Read More

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.

Read More

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.

Read More

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.

Read More

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.:

Read More

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.

Read More

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.

Read More

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

Read More

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.

Read More

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.

Read More

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

Read More

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

Read More

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.

Read More

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.

Read More

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.

Read More

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.

Read More

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.

Read More

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.

Read More

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).

Read More

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

Read More

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.

Read More

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.

Read More

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

Read More

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.

Read More

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].

Read More

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.

Read More

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

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

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

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

Read More

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.

Read More

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.

Read More

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.

Read More

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.

Read More

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.

Read More

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