332nd Edition – December 4, 2018

On Wednesday, Nov. 28, 2018, Children’s National Health System marked the official start of construction on its pediatric research and innovation campus with a groundbreaking event. It will be distinct nationally as a freestanding research and innovation complex focused on pediatric medicine.

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One year ago this week, President Donald J. Trump declared the opioid crisis a public health emergency. Ever since, the Trump Administration has applied an all-of-Government approach to the epidemic, allowing each agency and department to do their part to help the cause

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Driven by breakthrough research and innovation, biohealth and life science are high-risk, high-expense fields. The right location is critical to your success, but that doesn’t mean you need to pay Boston’s and San Francisco’s high rents for lab and office space. Maryland, a booming bio hub itself, is not only cost-efficient, but offers many advantages you may not find elsewhere. Before narrowing your shortlist for your new biotech business or expansion of existing biotech business, consider these six factors that contribute to Maryland’s innovation ecosystem.

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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, and Rocket Pharmaceuticals, Inc. (Nasdaq: RCKT), a leading U.S.-based multi-platform gene therapy company, today announced an exclusive, worldwide license agreement for Rocket to develop and commercialize gene therapy treatments for Danon disease using REGENXBIO’s NAV AAV9 vector, as well as exclusive options for two additional NAV AAV vectors for the treatment of Danon disease.

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RoosterBio Inc, a leading supplier of human Mesenchymal Stem/Stromal Cell (hMSC) working cell banks and hMSC-specific bioprocess systems, announces today it has submitted a U.S. Food and Drug Administration (FDA) Type II Master File (MF) for its CliniControl™ line of cGMP hMSC working cell banks. This MF complements the MF for the CliniControl RoosterNourish™-MSC-CC bioprocess media that was filed in 2017. The MFs contain confidential information on the products including their chemistry, manufacture, and controls. This enables RoosterBio to protect proprietary product information yet allows the FDA to review the information in support of an investigator’s submission. Upon request, RoosterBio will grant a customer authorization to cross reference the stated MF(s) to support their own regulatory filing, such as an Investigational New Drug (IND) application to the FDA. INDs are filed with the FDA prior to beginning clinical evaluation of new therapeutic products in human subjects.

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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.

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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.

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Explore Legal Issues for Early Stage Companies

Business formation and governance • Advisory Board vs. Board of Directors Equity incentive plans • NDA’s (w/ potential co-owners/joint ventures/investors and employees) • Worker classifications (exempt vs. non-exempt; W2 or 1099) Employment contracts • Lease and distributor agreements • Customer agreements (for beta testing and beyond) • CRADA’s and technology transfer agreements

Schedule

1 p.m – Networking Lunch

1:30 – Panel Discussion with Q&A 

2:45-4:15 – One-on-one  with Attorneys*

RSVP by noon, December 12 at BHI@BioHealthInnovation.org

No charge to attend • Attend in person or by videoconference

BioHealth Innovation, 1 Church Street, Suite 801, Rockville, MD 20876

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As a first-generation Asian American running for a seat in the Maryland state legislature, Democrat Lily Qi felt disconnected from the party establishment.

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The FDA has selected eight medtech companies to develop devices to help reduce the country’s opioid abuse crisis.

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On November 29, 2018 at Martin’s West, RMI’s 2018 Champions of Maryland Manufacturing Awards ceremony drew over 600 stakeholders from around the State. The evening awards program touched on the themes of togetherness and family as we celebrated a variety of different leaders from young students to business executives.

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New Enterprise Associates has completed a roughly $1 billion secondary sale of 26 portfolio companies in a deal designed to bring early liquidity to limited partners in four of its funds. T

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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.

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At Johnson & Johnson, we believe a good idea can come from anywhere. Our aim is to identify, empower and enable the best ideas to get to patients and consumers around the globe. In an effort to unearth the unseen and brightest innovations in healthcare, Johnson & Johnson Innovation is launching a Quick Pitch event where innovators can apply to present to Johnson & Johnson Innovation’s leadership during the week of the 37th Annual JP Morgan Healthcare Conference in San Francisco, CA. If you are selected, you will have an opportunity to present for 5 minutes followed by a 5 minute Q&A session with Johnson & Johnson Innovation’s leadership.

If you have a novel idea that has yet to be introduced to Johnson & Johnson and fits our areas of interest, we would like to hear from you. Apply for an open spot at the Johnson & Johnson Innovation Quick Pitch event to be held on Wednesday, January 9th from 9-11am. Limited spots available.

Applications must be submitted by December 7th.

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Georgetown Entrepreneurship hosted its second annual Leonsis Family Entrepreneurship Prize “Bark Tank” pitch competition on Nov. 28, where eight university students and alumni pitched their business ventures for a chance to win a share of the $100, 000 in cash prize.

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Why measure global biotechnology? The scope of biotechnology is broad and impacts economies, policies, and people globally.

Applications range from advanced medicines to and improvements in agriculture to feedstocks and biofuels, and further to exotic industrial materials and processes.

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The use of tele-medicine is no longer a far off, futuristic concept. It is presently being used in many medical disciplines and in institutions from academic medical centers to privately owned Assisted Living facilities. So what have we learned from utilizing this technology? Have outcomes improved and costs been curtailed? What are the current legislative hurdles regarding licensure and insurance for practitioners? Can the data be easily integrated and accessible to your EHR? Can new entrants into the tele-medicine field differentiate themselves and be fundable to investors? Can we trust the data from wearables and is there enough cybersecurity embedded in these technologies?

Come to the SoPE National Capital Chapter event on December 5th and learn from the experts!

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Higher education R&D expenditures (HERD) grew by 38.9 percent from 2008 to 2017, an increase of more than $21 billion, according to an SSTI analysis of recently released data from the National Science Foundation’s National Center for Science and Engineering Statistics. From 2016 to 2017, HERD grew by $3.8 billion, the largest year-over-year increase since 2010-2011. Higher education R&D expenditures grew the fastest in Connecticut (66.2 percent), Massachusetts (63.9 percent), and Wyoming (63.0 percent) over the 10-year period, while New York ($2.3 billion increase), California ($2.0 billion), and Massachusetts ($1.6 billion) saw the largest absolute gains during this time.

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Higher education R&D expenditures, ranked by FY 2017 R&D expenditures: FYs 2008–17

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Ten trailblazers with ties to Johns Hopkins University who have become leaders in their fields have been named to the Forbes “30 Under 30” list for 2019.

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The National Science Foundation’s Small Business Innovation Research (SBIR) program- also known as America’s Seed Fund powered by NSF – provides small businesses with equity-free funding to conduct research and development (R&D) work that will lead to the commercialization of innovative new products and services. The NSF SBIR program seeks innovative proposals that show promise of commercial and societal impact. We invite the submission of proposals in almost any area of science and technology (more information on our technical topics is available here).

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The 2017 holiday season has been complicated by data breaches that have plagued consumers all year long, such as the massive Equifax hack. As a result, consumers must worry about fraud and the misuse of our financial information during a time of increased financial transactions, tight budgets and heightened stresses.

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The Department of Health and Human Services has picked 15 technology leaders from the private sector with which to initiate a year-long dialogue on how to accelerate healthcare innovation and investment.

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BIO CEO Jim Greenwood won’t admit last month’s midterm elections spell trouble for the drug industry.

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The recent shocking reports about a human genome editing experiment have led to increased murmurings about the potential pitfalls of improved access to molecular technologies. Sharing speeds science. That’s been the driving concept behind Addgene since its founding. Nowhere has this proved more prescient than in the acceleration of basic research using CRISPR-Cas9 genome editing tools. It would be a tremendous loss of efficiency and funding if this rogue experiment resulted in a reduction in repository deposits and the sharing of research materials.

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In the wild uproar around an experiment in China that claimed to have created twin girls whose genes were altered to protect them from HIV, there’s something worth knowing—research to improve the next generation of humans is happening in the US, too.

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The biggest proposed IPO in biotech history just got even bigger.

Cambridge-based Moderna Therapeutics disclosed Wednesday that it’s hoping to raise up to $600 million in an initial public offering, an increase from the $500 million maximum it proposed earlier this month. Either sum would shatter the previous record for a life sciences IPO, both in biotech-rich Massachusetts and nationwide.

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Swiss drugmaker Roche is buying U.S.-based Jecure Therapeutics, joining Pfizer, Gilead Sciences and Novartis in pursuit of new drugs to treat fatty liver disease.

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Unlike their biotech counterparts, pharmaceutical companies have largely surpassed analyst expectations on earnings per share during the third quarter. Yet, pharma stocks have not been immune to the stock market swoon of recent weeks.

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America’s long-held singular dominance of startup and venture capital activity is being challenged by the rapid ascent of cities in Asia, Europe, and elsewhere. While the United States remains the clear global leader, the rest of the world is gaining ground at an accelerating rate.

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Recent tax-law changes may bring opportunities for you and your family, so it’s good to know what to look for and when to take action. Download our 2018 Year-End Planning Guide now to find out about potential impacts to your estate, charitable giving strategy, business, and more. Then, contact The Private Bank to discuss how our responsive, team approach to wealth planning may benefit you now and year-round.

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