For aspiring entrepreneurs, the thought of building a company from scratch can be daunting. What if no one wants to buy what you're selling? Where will the money come from to grow the business? And what will happen if you fail?

The BIO International Convention is being held in Philadelphia from June 3-6, with more than 16,000 attendees expected from around the world. The convention draws a list of who’s who in drug discovery, biomanufacturing, genomics, biofuels, nanotechnology and cell therapy, with more than 7,000 companies and 47,000 partnering meetings.

June 12, 2019! 

Register now for the 3rd annual Technology Showcase! The 2019 Technology Showcase will again highlight technologies being developed at the NCI and Frederick National Laboratory for Cancer Research (FNLCR) to encourage technology licensing and collaborations, startup company formation and the translation of NCI discoveries into solutions to benefit patients.

A Baltimore-based regenerative medicine firm called LifeSprout, which makes synthetic products used to restore soft tissue, has secured $6.5 million in financing.

A newly formed Baltimore company has raised $110 million to commercialize a cancer-detecting blood test, developed by Johns Hopkins researchers, that doctors would give patients during routine physicals.

QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the immediate launch of its therascreen® PIK3CA RGQ PCR Kit (therascreen PIK3CA Kit) after it received U.S. regulatory approval as a companion diagnostic to aid in identifying breast cancer patients eligible for treatment with PIQRAY (alpelisib), a newly approved therapy developed and marketed by Novartis.

Regenxbio (RGNX) announced that a gene therapy developed based on its technology was approved by the FDA. This gene therapy product is known as Zolgensma, which Novartis (NVS) now owns after acquiring AveXis for $8.7 billion back in 2018. While Novartis does own Zolgensma, it will have to pay royalties to Regenxbio on net sales for it. That means Regenxbio can start earning revenue for one of its very first products. The company is in good shape because it has many other gene therapy programs in its pipeline. The most notable one would be RGX-314, which is being developed to treat patients with wet age-related macular degeneration.

Funding and Research Opportunities

The following funding opportunity announcements from the NHLBI or other components of the National Institutes of Health, might be of interest:

Notices

Notice of Intent to Publish a Funding Opportunity Announcement for Maximizing the Scientific Value of Existing Biospecimen Collections: Scientific Opportunities for Exploratory Research (R21 Clinical Trial Not Allowed)

(NOT-OD-19-100)National Heart, Lung, and Blood Institute

Notice of Intent to Publish a Funding Opportunity Announcement for Secondary Analyses of Existing Datasets of Tobacco Use and Health (R21 Clinical Trial Not Allowed)

(NOT-OD-19-104)National Heart, Lung, and Blood Institute

Notice of Correction to Award Budget for RFA-HL-19-024 "Short-Term Research Education Program to Increase Diversity in Health-Related Research (R25 Clinical Trial Not Allowed)"

(NOT-HL-19-698) National Heart, Lung, and Blood Institute

Notice of Change to Key Dates in RFA-RM-19-005 " NIH Directors Pioneer Award Program (DP1 Clinical Trial Optional)"

(NOT-RM-19-007) Office of Strategic Coordination (Common Fund)

Program Announcements

Lasker Clinical Research Scholars Program (Si2/R00 Clinical Trial Optional)

(PAR-19-262) National Heart, Lung, and Blood Institute

It's the local company's first step toward establishing an international presence after it was spun out last year from MedImmune.

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, today announced that it will voluntarily transfer its stock exchange listing to the Nasdaq Capital Market from its current listing on NYSE American.

The BioHealth Capital Region (BHCR) continues to grow rapidly with new startups and a greater number of clinical and commercial stage companies. The region expects to add approximately 2,000 life science-related jobs in the near term with more on the way. Whether it’s Kite Pharma building a new manufacturing site in Frederick County, MD, the growth of cell and gene therapy companies such as Autolus, Inc., REGENEXBIO, and RoosterBIO, Inc. or recent acquisitions of companies like Paragon BioServices, Inc., it’s evident that the BHCR is thriving.

If you need great photographer for your event, contact UZI Photography who covered the 5th Annual BioHeallth Capital Region Forum

This is the first raise for the business, which has been profitable and fueled growth organically up to this point.

A group of high school girls who wanted to create a local community for other young ladies interested in STEM subjects (science, technology, engineering and math) did so by organizing an all-girls math competition. Things turned out better than they expected at the inaugural InteGIRLS math competition on May 18 at Montgomery College in Rockville, Maryland.

Meet Up with AURP at BIO in Philadelphia for
AURP's BIO Health Caucus
#AURPBHC2019

June 2 - 3, 2019

At AURP’s BIO Health Caucus, we will explore trends in life science research, opportunity zone funding resources, the marriage of life science and philanthropy in global partnership opportunities. Discover the unique roles that biomedical innovation cluster and research parks play in innovation ecosystems around the globe. Translating discoveries from the lab to the market has never been more important. Connect with AURP at booth #3955 or One-on-One Partnering! 

Register Now!

Viral safety is a critical focus during biopharmaceutical manufacturing (1–5). Although well-characterized mammalian cells such as the Chinese hamster ovary (CHO) line have been used for decades, both endogenous expression of retroviral-like particles and exogenous contamination events from viruses warrant continued vigilance (6, 7). International regulatory agencies require biomanufacturers to validate the “viral clearance” efficacy of their downstream manufacturing process steps before resulting products can be awarded clinical trial or commercial approval (8–10).

Data released May 9 by the Alliance for Regenerative Medicine (ARM) illustrates the growth of clinical activity where gene therapy is concerned.

ARM’s Quarterly Regenerative Medicine Global Data Report for the first quarter of 2019 showed 372 gene therapy clinical trials were in progress as of the end of Q1. Interestingly, a majority (217 or 58%) were studies in Phase II, followed by Phase I (123 or 33%), and Phase III (32 or 9%).

There are, undoubtedly, many factors that go into a person’s weight. A new report from the lab of Sekar Kathiresan, MD, director of the Center for Genomic Medicine at Massachusetts General Hospital (MGH), documents a clear biologic basis for the predisposition of obesity. More specifically, that genetics play a role in how heavy a person gets.

There are few, if any, more innovative, more daring, and more iconic health care executives. We'll hear about the process that drives groundbreaking invention, and her dream of permanently alleviating the shortage of transplantable organs.Martine Rothblatt, founder and CEO of United Therapeutics presents her organization's latest innovation, followed by a conversation with "Fast Money" Host and "Power Lunch" co-anchor, Melissa Lee.

The Maryland Tech Council (MTC), Maryland’s largest technology trade association, announced the winners of its 31st Annual Industry Awards during a celebration and ceremony at the Bethesda North Marriott Hotel & Conference Center attended by more than 630 business leaders from around the state.

The Food and Drug Administration has put out a call for volunteer companies to test out the its digital health pre-certification program for software as a medical device (SaMD) technologies.

Coming off the record-breaking venture financing numbers of 2018, the first quarter of 2019 displayed some cooling off, in terms of pre-money valuations across all rounds and amounts raised in Series C and later rounds, although the market remained strong by historical standards. Q1 2019 had slightly fewer up rounds for Series B and later financings than did the last two quarters of 2018. Median pre-money valuations declined moderately across all equity rounds in Q1 2019. Median amounts raised remained strong for Seed, Series A, and Series B rounds, with those medians matching or exceeding those of Q4 2018. But the median amount raised in Series C and later rounds declined significantly, falling from the historic high of $31.1 million reached in Q4 2018 to $15.3 million in Q1 2019.

Maryland Commerce is leading a delegation of 20 biohealth and life sciences companies, educational institutions, federal agencies, and city and county economic development offices to the 2019 BIO International Convention in Philadelphia next month. 

Scott Gottlieb, who resigned as head of the FDA in March, has rejoined NEA as a special partner focused on healthcare investments. Gottlieb was a venture partner with the firm for 10 years before leading the FDA. Founded in 1977, the Maryland-based firm's portfolio includes Opendoor and Desktop Metal.

With expansion, Protenus recently moved to new offices in Fells Point.

The healthcare analytics company moved into a 12,000-square-foot office space that’s roughly triple the size of its previous location, according to People Operations Associate Samantha Barber, who gave us a recent tour.

Regenxbio will construct a GMP facility in Maryland to produce adeno-associated viral vectors for its gene therapy programs using its NAV technology-based platform.

The good manufacturing practice (GMP) plant will be integrated into Regenxbio’s 132,000 square-foot headquarters in Rockville, Maryland, currently under construction. Financial details have not been disclosed but the manufacturing plant is expected to be operational in 2021.

Navitas Life Sciences, a TAKE Solutions Enterprise today announced the acquisition of US based niche full service CRO and health research company, KAI Research Inc.

KAI Research brings on board top of class offerings in 3 key areas – Clinical Trial Management, Clinical Research Consultation, and Data Management & Standardization. Through this acquisition, Navitas Life Sciences expands Phase II and Phase III capabilities in North America adding to its current capabilities in Europe and APAC. KAI strengthens Navitas' therapeutic expertise in mental health, musculoskeletal diseases, neurological disorders, pain, diabetes, infectious diseases and oncology for Pharma and medical devices. The company has differentiated offerings in the areas of patient registries and e-clinical solutions as well as long-standing relationships with clinical sites and trusted network of service providers across the United States and Africa.

QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced that QuantiFERON ® -TB Access, a new solution under development for diagnosis of latent tuberculosis (TB) infection in low-resource regions with a high disease burden of tuberculosis, will be recognized by the Joint United Nations Programme on HIV/AIDS (UNAIDS) at the organization’s Health Innovation Exchange from May 21-23 in Geneva, Switzerland. The event will be held during the World Health Assembly and brings together ministers of health, nonprofits and industry to spotlight innovations with potential to change the world’s health landscape and benefit sustainable development.

NAVAN, Inc. (NAVAN), a privately-held biotechnology company enabling the development of next generation cell and gene therapies through its novel, non-viral NanoStraw platform, announced today the appointment Heidi Hagen, Co-founder and Chief Strategy Officer for Vineti, Inc., and Howard Grimes, Ph.D., Associate Vice President and Associate Vice Provost for Institutional Initiatives at The University of Texas at San Antonio, to its Strategic Advisory Board.

Most Congressional hearings are morality plays designed to reach a predetermined outcome. It wasn’t hard to predict how the second hearing on drug pricing by the House Committee on Oversight and Reform was supposed to go. If the title, “HIV Prevention Drug: Billions in Corporate Profits after Millions in Taxpayer Investments” wasn’t enough of a clue,  when Chairman  Elijah Cummings (D-MD) said it was because of the “phenomenal leadership” of freshman Rep. Alexandria Ocasio-Cortez (D-NY)  that the hearing was being held, any doubts evaporated. In an extraordinary gesture of deference for a new Member of Congress, Rep. Ocasio-Cortez was recognized for an opening statement before senior members of the committee.

Alzheimer’s disease (AD) arises from molecular events that scientists are piecing together to discern an overall story, parts of which are well known, others less so. Some of the lesser-known epigenetic events in the Alzheimer’s story have just been filled in by scientists based at the Van Andel Research Institute (VARI). What’s more, these epigenetic events, which occur early in Alzheimer’s, appear to fit well with what we know about the disease’s progression to its most devastating biological features.

Wed, Jun 12, 2019 at 11:30 AM

The 3rd Annual NCI and FNLCR Technology Showcase will showcase technologies being developed at the National Cancer Institute (NCI) in Bethesda and Frederick, and Frederick National Laboratory for Cancer Research (FNLCR) to encourage startup formation, technology licensing, and collaborations. It will introduce the local scientific community to the regional technology development stakeholders and highlight available resources.

Prospective investors, established companies, interested stakeholders, entrepreneurs and those looking to commercialize technologies are invited and encouraged to attend. The day will feature short technology summaries by NCI and FNLCR innovators, as well as presentations from regional stakeholders involved with technology development and commercialization. An interactive poster session by innovators and technology ambassadors will concurrently occur.

By the end of this year, the biotech expects to have 270 employees in Baltimore's Camden-Carroll neighborhood.

Emergent BioSolutions Inc. (NYSE: EBS) announced today that it has successfully obtained marketing authorization for its oral typhoid vaccine Vivotif® (Typhoid Vaccine Live Oral Ty21a) in five additional European Union Member States, including France, Portugal, Poland, Czech Republic and Slovakia as well as approval of harmonized prescribing information in the EU also known as the Summary of Product Characteristics or SmPC.

BioHealth Innovation has announced the schedule for the next year’s Entrepreneur-in Residence (EIR) feedback sessions.  These 1:1 Sessions with EIRs take place at BioHealth Innovation's office in Rockville OR by videoconference.  There is no charge to participate but entrepreneurs must be working on a biohealth Start-Ups/innovation in the BioHealth Capital Region (MD, DC, VA).  The upcoming dates are:  

2019:  5/22, 7/24, 9/4, 10/9, 11/20

2020:  1/22, 2/26, 3/25, 4/22, 5/27         

Schedule your appointment online here.  For questions or more information, contact This email address is being protected from spambots. You need JavaScript enabled to view it..