Nuventra Pharma Sciences, a clinical pharmacology and PK/PD consultancy in Durham, NC, recently offered some insights on why clinical trials fail. In addition to biological considerations—such as pharmacokinetics, pharmacodynamic, and human response to a drug varying from animal models—Nuventra presented a list of reasons that included:

Over the past couple of years, the term "record-breaking" has frequently been used to describe the state of venture capital in the US, as the space hits new heights with deal value, mega-rounds and fundraising. In 2018, some of these records reached heights not seen since the dot-com boom.

Akonni Biosystems, a molecular diagnostics (MDx) company that develops, manufactures, and intends to market advanced MDx systems, today announced receipt of a $3 million, three-year Phase II Small Business Innovation Research (SBIR) contract from the National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health (NIH). Akonni received the Phase I contract in August 2016.

The National Institute of Health awarded a University of Maryland research center team of scientists $3.6 million to help fund their work on the cells responsible for destroying cancer cells.

Emergent BioSolutions Inc. (NYSE: EBS) today announced the appointment of Seamus Mulligan to the company’s Board of Directors effective March 19, 2019. Mr. Mulligan was a co-founder and principal investor of Adapt Pharma Ltd. and served as its chairman and CEO from 2014 until 2018, when Adapt was acquired by Emergent.

A team of researchers led by the Johns Hopkins University of Medicine has developed a methylated epigenetic biomarker panel integrating a sponge-based collection tool and a methylated-bead PCR method that it believes can detect Barrett's esophagus (BE).

The life sciences industry is taking off, with the medical technology and biotech sectors expected to grow further as traditional pharmaceutical companies are joined by startups and incubator labs driving new research and development. And with life sciences innovation rising, so is demand for the space in which to innovate.

Are you an experienced biohealth entrepreneur seeking new opportunities in the BioHealth Capital Region? BioHealth Innovation is developing a database of experienced industry personnel willing to work in potential C-suite positions with our university and startup partners. If you would like to have your contact information and vita included in this database for their review, please email This email address is being protected from spambots. You need JavaScript enabled to view it. an updated vita by this Thursday, February 14th.

Are you a start-up in Maryland, DC or Virginia seeking feedback on your biohealth business idea, pitch deck, or commercialization plan.  Sign up now to schedule your feedback session with BHI EIRs on Wednesday, February 27th.  (Next sessions scheduled for 3/20 and 5/22.)  Pre-registration is required; sign up here (“EIR resource”at BHI).  For questions/more information, contact This email address is being protected from spambots. You need JavaScript enabled to view it..

University of Maryland Institute for Bioscience & Biotechnology Research, 9600 Gudelsky Drive, Rockville, MD 20850

Register NOW:  https://tinyurl.com/BHISBIR2019

• 8:00 a.m. – Networking and Registration
• 8:30 a.m. – Welcome
• 8:35 a.m. – SBIR Funding Opportunities at the National Institutes of Health
  • National Heart, Lung, and Blood Institute
  • National Institute on Aging
  • National Institute on Drug Abuse
  • National Cancer Institute  
• 9:45 a.m. – Partnership Opportunities with NCI Frederick National Lab  
• 10:00 a.m. – BREAK
• 10:20 a.m. – SBIR Funding Opportunities with the National Science Foundation    
• 11:00 a.m. – BREAK  
• 11:15 a.m. – SBIR Funding Opportunities with USAMRC    
• 11:45 a.m. –  Lunch  
• 12:45 p.m. – (1:1 Room Set)  
• 1:00 p.m. – Writing Your Specific Aims Page OR 1:1 Meetings* (available simultaneously)  
• 1:30 p.m. – Writing Your Phase II Commercialization Plan OR 1:1 Meetings* (available simultaneously)  
• 2:00 p.m. – Writing Your Specific Aims Page OR 1:1 Meetings* (available simultaneously)  
• 2:30 p.m. –  Writing Your Phase II Commercialization Plan  OR 1:1 Meetings* (available simultaneously))  
• 3:00 p.m. –  1:1 Meetings* (NIH only)  
• 4:00 p.m. – Adjourn

Pre-Registration REQUIRED: RSVP by noon, February 26 at https://tinyurl.com/BHISBIR2019
No charge for entrepreneurs to attend • If seeking 1:1 meeting(s) please include organization(s) in RSVP.

Utilization of digital health services and technologies has been on the rise since we first began surveying the US adult population in 2015. Budding choices of wearables, apps, telemedicine, and other tech-enabled services make it easy for consumers to test out what it might be like to “go digital” for their health. In the first three years, our annual survey showed that tools for fitness and wellness represented a common (and low-risk) entry point for consumers to experiment with products that fit neatly into their already tech-enabled lifestyles. In the 2018 data that we examined for this report, we saw something different.

Today we’re celebrating around the Technical.ly Slack channel. It’s the 10th anniversary of Technical.ly’s founding in Philadelphia, marking a decade of local tech news and innovation community coverage.

PitchMasters™, a workshop-style event for entrepreneurs preparing for their first institutional capital raise, held its 2019 Kick Off and Alumni Event on Jan. 30, 2019. Four emerging startup companies, Skipiit, Trove Therapeutics, Uplift and VERALOX Therapeutics, practiced their pitching skills and gained insights from experienced entrepreneurs, investors, industry influencers and fellow PitchMasters™ alumni.

The Association of University Research Parks (AURP), a professional association of university-related research and science parks, announced the appointment of Brian Darmody, Associate Vice President of Corporate Engagement at the University of Maryland (UMD), as its new Chief Executive Officer (CEO). Additionally, the association has opened a new office at the UMD Discovery District in the Washington, DC area, to be known as ‘AURP HQ2.’ Mr. Darmody will immediately assume his new role as CEO at the new location. He will continue his role at UMD and plans to transition out of UMD over time.

Shares of MacroGenics went stratospheric Wednesday following the release of data from a pivotal Phase III study of the company’s lead drug candidate in breast cancer that beat many investors’ expectations.

When construction is completed this month, 704 QO will offer ready-to-occupy lab/office spaces for companies of all sizes. What really makes this new building stand out isn’t just the fully customizable individual lab units, but the suite of amenities that are tailored to the specific needs of emerging life science companies in the BioHealth Capital Region and the employees that work for them. 

IQVIA™ (NYSE:IQV) today announced the launch of IQVIA™ Biotech and its new approach to delivering tailored clinical and commercial solutions for small biotech and biopharma companies. This solutions suite, supported by more than 1,000 dedicated employees, will deliver simplified operating procedures, specialized teams, and services to provide a more agile way for these innovators to reach their drug development and commercialization milestones. From initial planning to trial design and implementation to market launch and commercialization, IQVIA Biotech delivers a transparent and streamlined process with a deep foundation in science.

AstraZeneca and its global biologics research and development arm, MedImmune, today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for MEDI8897, an extended half-life respiratory syncytial virus (RSV) F monoclonal antibody (mAb) being developed for the prevention of lower respiratory tract infection (LRTI) caused by RSV.

VLP Therapeutics today announced that the U.S. Food and Drug Administration (FDA) has cleared an investigational new drug (IND) application for a clinical trial of the Company's VLPM01 malaria vaccine. The Phase I/IIa clinical trial will begin recruiting participants in February 2019, and is designed to assess the safety, immunogenicity and efficacy of the VLPM01 vaccine. The clinical trial will be conducted at the Walter Reed Army Institute of Research (WRAIR) in Silver Spring, MD.

Although startups based in California, New York, and Massachusetts have traditionally accounted for the majority of VC tech investment in the US, VCs are spurring other hotbeds of innovation across the country.

UMD IBBR - 9600 Gudelsky Drive, Rockville, MD 20850

February 28, 2019

Unique opportunity to meet 1:1 with multiple SBIR program managers and experts.

SCHEDULE

Like a lot of medical practices, veterinarians seek to send patients a message when they’re due for a check-up, schedule appointments and keep track of medical records. Yet Marc Olcott sees a lot of those tasks still happening by phone or on paper, and thinks it should all be available digitally.

For the people looking to move within a thriving tech community, it’s important to be able to easily call upon the key players.

Community members gathered Wednesday night at Hood College’s Hodson Auditorium to celebrate Frederick Innovative Technology Center Inc.’s 15th anniversary.

GetWellNetwork, the Precision Engagement health care company reaching 10 million patients annually, announced today a pivotal 2018 which will propel the company into 2019 as it continues to lead the evolution of patient engagement. The company furthered global expansion efforts, made several executive hires and acquired leading digital health company HealthLoop to catalyze growth in the ambulatory space.

Lung cancer may not be the first thought that crosses the mind when talking about breathalyzer tests. But, what if lung cancer detection were as easy as breathing into a device? That is the goal of a group of researchers from the University of Exeter who have recently taken a new approach to e-nose technology integrated with multi-layered graphene for early detection of lung cancer.

Explore the 2018 Global Digital Health 100.

The Global Digital Health 100 is one of the HealthTech industries foremost technology awards programmes, celebrating innovation and entrepreneurship. It recognises and supports health technology companies that are demonstrating the greatest potential to change the way that healthcare is delivered.

Rexahn Pharmaceuticals, Inc. (NYSE American: RNN), a clinical-stage biopharmaceutical company developing innovative therapies to improve patient outcomes in cancers that are difficult to treat, announced that the U.S. Patent and Trademark Office has issued a Notice of Allowance for U.S. Patent Application No. 15/683,408, “Fluorocyclopentenylcytosine Methods of Use.” The patent application covers the use of RX-3117 in a broad range of tumor types that over-express UCK2, the enzyme that activates RX-3117. The company expects the patent to be issued within a few months from the notice of allowance and provide protection to 2036. 

The extremely active lab real estate market is a bell-weather for the upcoming hyper-competitive talent market. Based on the recent real estate transactions and related hiring forecasts, we estimate the range of new positions in the Maryland life sciences market to be between 1,150 to 2,300 new hires in 2019.

The growing presence of out-of-town universities in Washington underscores what has been true throughout D.C. history: The nation’s capital is very much a college town.

The top company received more than $280 million VC funding in 2018.

Seven firms brought in over $30 million last year, and five raised more than $70 million in venture capital.

In the last decade, crowdfunding has become a popular way to finance all sorts of projects and products. Biotech is no exception, but many question whether the high risk and long term nature of investing in the biotech industry makes it a good fit for equity crowdfunding.

The premier investor network in the Mid-Atlantic has entered into a resource partnership.  Keiretsu Forum Mid-Atlantic and the CONNECTpreneur community have entered into an agreement that will advance innovation, entrepreneurship, and investment in the region.