BHI Weekly Newsletter Archives Archives - Page 34 of 66

Dec 11 2018

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333rd Edition – December 4, 2018

By admin BHI Weekly Newsletter Archives

BioHealth Innovation

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December 11, 2018

FOUNDING MEMBER OF

These Five Capital Region Biotechs Are The Fastest Growing in America · BioBuzz

In its 24th year, the Deloitte Technology Fast 500 is the premier technology awards program in North America. The program celebrates the innovation, entrepreneurship and rapid growth that these cutting-edge companies all embody. This year’s Fast 500 winners were selected based on percentage fiscal year revenue growth during the period from 2014 to 2017 across a number of sectors, including Biotechnology/Pharmaceutical and Medical Devices. Five of these fast-growing companies call the Biohealth Capital Region home.

Institute of Human Virology researchers discover that a bacterial protein promotes cancer – EurekAlert! Science News

The Institute of Human Virology (IHV) at the University of Maryland School of Medicine (UMSOM) announced today the discovery that DnaK, a protein of the bacterium mycoplasma, interferes with the mycoplasma-infected cell’s ability to respond to and repair DNA damage, a known origin of cancer.

GSK Buys Tesaro For $5 Billion In Dramatic Bet On Cancer Genetics

GlaxoSmithKline announced this morning that it will buy Tesaro, the maker of the ovarian cancer drug Zejula, for $5.1 billion in cash in a dramatic bet that the London-based drug giant can see opportunities connected to the genetics of cancer drugs better than the stock market.

BHI Entrepreneur-in-Residence Feedback Sessions

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.

Join us December 13, 2018 for PATHFINDER INNOVATION PROGRAM

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

FDA Approves Cutting-Edge Cancer Drug from Inova Schar Cancer Institute Clinical Trial – Inova Newsroom

In groundbreaking news for the medical and cancer research community, the Food and Drug Administration (FDA) approved a new, breakthrough cancer drug, larotrectinib, or Vitrakvi®, that targets specific genetic mutations in adult and pediatric patients. This is only the second tissue-agnostic drug that the FDA has approved.

Applying Deep Learning to PD-L1 Expression

Perhaps the greatest promise of Artificial Intelligence (AI) is its potential to enhance our ability to predict, diagnose, and treat disease.

That is why our researchers are continuing to look for new ways to leverage AI to aid our discovery and delivery of effective therapies.

Creatv MicroTech Receives Japanese Patent for Cancer Screening

Creatv MicroTech, Inc. (Creatv) has received notice from the Japanese Patent Office that its patent covering numerous clinical applications for the detection of cancer associated macrophage-like cells (CAMLs) in cancer patient blood samples has been issued. Clinical applications of the CAML biomarker include cancer screening, various cancer diagnostics, and early detection of disease recurrence. Approved claims cover all solid tumors. Similar patents have been issued in Europe and Australia.

QIAGEN announces new collaboration to develop companion diagnostic to guide treatment for patients with PIK3CA-mutated advanced breast cancer | Business Wire

QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced that a clinical development program is underway with Novartis to bring to market a molecular test as a companion diagnostic to guide the use of the investigational compound BYL719 (alpelisib) in combination with fulvestrant for men and postmenopausal women living with PIK3CA mutated hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer.

Commerce’s NIST Announces Actions to Stimulate Commercialization of Federally Funded R&D | NIST

The United States spends more than any other nation on research and development (R&D) each year, investing over $150 billion in federally funded R&D alone. In line with President Donald J. Trump’s Management Agenda, the U.S. Department of Commerce’s National Institute of Standards and Technology (NIST) today released a draft green paper detailing steps to modernize the U.S. system of technology transfer and innovation for the 21st century. The actions outlined in the green paper would help maximize returns on the taxpayer investment in R&D.

Greater Washington Board of Trade releases 2019-2021 Strategic Plan

The Board of Trade has served Greater Washington and its business community for 130 years. Today, it released a new three-year strategy for driving inclusive economic growth and improving livability, critical factors for the region’s long-term success.

The strategy includes nine goals related to the Board of Trade’s operations, offerings for members, and regional development initiatives.

CELLINK and Prellis Biologics announce powerful, $1.2M Holograph-X Bioprinter – 3D Printing Media Network

Swedish bioprinting company CELLINK has entered into a partnership with organ and tissue engineering company Prellis Biologics, Inc. with the goal of commercializing high-resolution holographic bioprinting technology for micro-scale printing. By combining their IP and respective expertise, the companies will introduce what they call the “first system enabling ultra-high resolution bioprinting of microstructures” for producing vascular networks.

Why do digital health startups keep failing?

A decade ago, a wave of companies promised to transform people’s health by allowing them to track data about their eating, sleep, exercise, and other habits. One hot startup of that moment, Zeo, raised more than $30 million from investors to develop a headband that tracked users’ sleep patterns and an accompanying app to serve as their personal “sleep coach.” Despite devoted users and buzz about its product in publications like Wired and Popular Science, Zeo quietly went out of business a few years later.

Cancer researchers in Australia develop universal blood test

Australian scientists have developed a simple blood test that they claim can diagnose cancer in mere minutes by identifying a unique DNA signature present in all types of the disease.

Dec 11 2018

Love0

332nd Edition – December 4, 2018

By admin BHI Weekly Newsletter Archives

BioHealth Innovation

If you are having trouble viewing this email, please click here

December 4, 2018

FOUNDING MEMBER OF

Children’s National Breaks Ground on One-of-a-Kind Pediatric Research and Innovation Hub – Benzinga

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.

A Year of Historic Action to Combat the Opioid Crisis, Emergent BioSolutions Recognized – The White House

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

Six Things to Consider When Choosing a Location for Your Bio Business – Maryland Business News

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.

REGENXBIO and Rocket Pharmaceuticals Announce New License Agreement for the Treatment of Danon Disease Using NAV AAV9 Vector

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.

RoosterBio Submits U.S. FDA Master Files for CliniControl™ Line of Human Mesenchymal Stem/Stromal Cell Products

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.

Job Opportunity: NIH Associate Entrepreneur-In-Residence

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.

BHI Entrepreneur-in-Residence Feedback Sessions

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.

Join us December 13, 2018 for PATHFINDER INNOVATION PROGRAM

Explore Legal Issues for Early Stage Companies

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

How a Chinese immigrant used WeChat to win a seat in the Maryland House of Delegates – The Washington Post

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

FDA chooses 8 medtech companies for opioid crisis challenge – MassDevice

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

Rooster Bio and Paragon Biosolutions Recognized as Champions of Manufacturing

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.

NEA completes secondary sale of 26 portfolio companies for about $1 bln – PE Hub

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

University System of Maryland: Maryland’s Most Powerful Economic Engine – USM

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.

Johnson & Johnson Innovation – Quick Pitch – JNJ Innovation

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.

Georgetown Entrepreneurship dishes out $100K at second annual pitch competition – Technical.ly DC

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.

Global biotech rankings – Measuring biotech innovation in 50+ countries

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.

Time is running out to register for SoPE National Chapter: Telemedicine: Leveraging Technology to Change the Face of Healthcare…Are you In or Out?

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!

Useful Stats: Higher Ed R&D by state, 2008-2017 – SSTI

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.

NCSES Higher Education Research and Development short form: Fiscal Year 2017 – US National Science Foundation (NSF)

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

Ten with Hopkins ties named to ‘Forbes’ 30 Under 30 list | Hub

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.

Small Business Innovation Research Program Phase I – NSF – National Science Foundation

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).

The Real Threat Of Identity Theft Is In Your Medical Records, Not Credit Cards

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.

HHS selects 15 tech leaders to discuss healthcare innovation, investment – Health Data Management

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.

BIO CEO Greenwood talks drug pricing politics after the midterms – STAT

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

The Untold CRISPR Story

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.

Despite CRISPR baby controversy, Harvard University will begin gene-editing sperm – MIT Technology Review

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.

Biotech giant Moderna Therapeutics bumps IPO goal to staggering $600M – Boston Business Journal

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.

Roche buys U.S. biotech Jecure in race for liver disease drugs

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.

Top 10 Pharma Companies of 2018 – GEN

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.

Rise of the Global Startup City

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.

Year-End Planning – The Private Bank – Wells Fargo

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.

Nov 28 2018

Love0

331st Edition – November 27, 2018

By admin BHI Weekly Newsletter Archives

BioHealth Innovation

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November 27, 2018

FOUNDING MEMBER OF

Rexahn Pharmaceuticals names Doug Swirsky new CEO – Washington Business Journal

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

PathSensors Secures 5-year Department of Defense Contract for Building Protection | PathSensors

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.

Legal Issues for Early Stage Companies

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

Emergent Bio’s Zika vaccine shows positive action in early-stage study – Seeking Alpha

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.

BHI Entrepreneur-in-Residence Feedback Sessions

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.

Adaptive Phage Therapeutics named in reporting citing Top 36 Startups Which Could Change the World – CB Insights Research

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.”

Living like a leader: A day with Children’s National Health System CEO Dr. Kurt Newman

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.

GlycoMimetics Enrolls First Patient in Global Phase 3 Clinical Trial of Uproleselan in Relapsed/Refractory Acute Myeloid Leukemia – Business Wire

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.

Protenus Co-Founders Named to Rising Stars List

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

Emergent BioSolutions Success Story – Maryland is Open for Business

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.

THE ENTREPRENEURS REPORT: Private Company Financing Trends – Q3 2018

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.

University System of Maryland: Maryland’s Most Powerful Economic Engine – USM

Capital Region Blueprint for Regional Mobility

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.

An Illustrated Subway Map of Human Anatomy

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.

Do You Have a Game-Changing Energy Innovation?

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/.

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Nov 20 2018

Love0

330th Edition – November 20, 2018

By admin BHI Weekly Newsletter Archives

BioHealth Innovation

If you are having trouble viewing this email, please click here

November 20, 2018

FOUNDING MEMBER OF

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

A Win for the Region, A Win for Montgomery County

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.

Biobuzz Directory – NextCure Raises $93 Million Investment on Heels of Eli Lilly Immune-Oncology Deal

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.

Arena Inks $1.2 Billion Deal With United Therapeutics – Arena Pharmaceuticals, Inc. (NASDAQ:ARNA) | Seeking Alpha

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.

Rexahn Pharmaceuticals Announces Leadership Transition – Rexahn Pharmaceuticals, Inc.

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.

SERAXIS Inc. publishes clinical trial considerations for a type 1 diabetes stem cell-derived therapy

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.

CRISPR, MaxCyte expand partnership into immuno-oncology – Pharmaceutical Business review

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

Paragon Bioservices Named to Deloitte’s Technology Fast 500™

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.

Baltimore-based AsclepiX Therapeutics raises $5M – Technical.ly Baltimore

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.

IBBR investigator to lead $3.9M NIH-funded project to develop next generation HIV-1 immunotherapy agents

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.

D.C.’s original site competition – The Washington Post

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.

5 Telehealth Insights from CMS’ Seema Verma – HealthLeaders Media

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.

TEDx Amplifies UMB’s Cutting-Edge Innovations – University of Maryland, Baltimore

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.

HISTORIC DAY: Virginia Tech Innovation Campus key to Virginia attracting Amazon HQ2 – Virginia Tech

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.

The Squeeze Continues…Early Stage Health Tech Deal Volume Falls to New Lows – LinkedIn

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.

A Tale Of Two Cities: Amazon Picks NYC, Northern Virginia For New HQ

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.

3 Business Models That Could Bring Million-Dollar Cures to Everyone

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.

Biopharma needs a new R&D, innovation model – MedCity News

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.

Google hires a health care CEO to organize its fragmented health initiatives – The Verge

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.

What health IT needs to look like in 2019 to be successful – MedCity News

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:

Opportunities in genomic testing and precision medicine – McKinsey

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.

Honest Tea Founder Seth Goldman Maintains His Thirst For Entrepreneurship

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.

Nov 13 2018

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329th Edition – November 13, 2018

By admin BHI Weekly Newsletter Archives

BioHealth Innovation

If you are having trouble viewing this email, please click here

November 13, 2018

FOUNDING MEMBER OF

Gemstone Biotherapeutics CEO Emily English joins Rich Bendis on BioTalk

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.

Get Paid for Your BioHealth Innovation Reimbursement Planning

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.

BioHealth Innovation, Inc. Board Member Lily Qi Elected to Maryland State Legislature

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.

RegenxBio expanding to new Rockville HQ – Washington Business Journal

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

How One Of The Most Successful Government Agencies Safeguards Our Health

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.

$2.5 Million Grant Awarded to BioHealth Capital Region Research Collaborative to Fight Deadly Virus · BioBuzz

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)

Novavax reports results, ‘preparing for success’ – Washington Business Journal

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.

Alexandria Real Estate Equities’ New Build-to-Suit In Maryland – GlobeSt

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

Lilly, NextCure Launch Cancer Immunotherapy Partnership | GEN – Genetic Engineering and Biotechnology News

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.

Baltimore’s ETC (Emerging Technology Center) Announces Eighth Year of AccelerateBaltimore

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.

Senseonics Announces FDA Approval to Expand Eversense® CGM Certification to Nurse Practitioners and Physician Assistants – Senseonics

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.

CRISPR Therapeutics and MaxCyte Expand Clinical and Commercial License Agreement into Oncology

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.

MdBio Foundation to Host 10th ATLAS College & Career Readiness Symposium

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.

Meet this year’s 10 cohort members of Hopkins’ Social Innovation Lab – Baltimore Business Journal

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

New Enterprise Associates sells stakes in portfolio companies – Pensions & Investments

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.

Revolution Ventures is raising a new fund – Washington Business Journal

The venture capital firm is aiming for $200 million.

Google taps Geisinger CEO to oversee health efforts – MedCity News

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.

Intersection between big data and therapeutic pipeline in neuromuscular disease will be life-changing for 250,000 patients and caregivers | Muscular Dystrophy Association

A new report funded by the Muscular Dystrophy Association (MDA) and released by the IQVIA Institute for Human Data Science indicates that genetic testing and breakthrough therapies will transform the diagnosis and care of neuromuscular disease within the next decade. The report, “Understanding Neuromuscular Disease Care,” highlights current gaps in care and opportunities to optimize care and accelerate the emergence of new therapies. Insights gained from a survey of health care professionals focused on the care of patients with neuromuscular disease are also included.

Leonard Freedman Named Chief Science Officer of Leidos-Operated Frederick National Laboratory | ExecutiveBiz

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.

Top 25 Biotech Companies of 2018

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.

2018’s Fiercest Women in Life Sciences – FiercePharma

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.

Cambridge’s Kendall Square, a top innovation hub, faces infrastructure challenges – Curbed

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.

NTIS.gov – NTIS Joint Venture Program

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.

Why 1776 is closing its original incubator location, and thoughts on its future in DC – Technical.ly DC

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.

Nov 06 2018

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328th Edition – November 6, 2018

By admin BHI Weekly Newsletter Archives

BioHealth Innovation

If you are having trouble viewing this email, please click here

November 6, 2018

FOUNDING MEMBER OF

Baltimore’s Gemstone Biotherapeutics Poised to Transform Wound Care Market

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.

Novavax Appoints Rachel King to Board of Directors – NASDAQ.com

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.

OpGen Collaborates With QIAGEN to Advance Rapid Diagnostics for Antimicrobial Resistant Bacteria Nasdaq:OPGN

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).

Washington Business Journal Recognizes Emmes in Two “Top Company” Lists

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.

Getting Paid for Your BioHealth Innovation – Reimbursement Planning (11/14)

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?

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.

Reinstatement of NIH SBIR Direct-to-Phase II Authority and Associated Updates to NIH SBIR Omnibus Solicitations

A ‘Direct-to-Phase II’ SBIR award is a Phase II award issued to a small business that did not receive a Phase I award for that research/research & development. Recent legislation has re-instated this SBIR Direct Phase II provision through Fiscal Year 2022 and NIH is re-implementing the SBIR Direct-to-Phase II program. The prior program had specific SBIR Direct-to-Phase II funding opportunity announcements (FOAs). These will not be needed now. The transition to FORMS-E allows NIH to track SBIR Direct-to-Phase II applications using a new check-box on the SBIR/STTR Information Form for Direct Phase II

Thermo Fisher Scientific opens new biorepository in Maryland, US – Pharma Business review

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.

Cerecor Announces Submission of Three Orphan Drug Designation Requests for Substrate Replacement Therapies to treat Congenital Disorders of Glycosylation

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).

Indivumed opens US-Headquarter in Frederick, MD: Indivumed

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.

Southern Research completes $13 million renovation of Frederick facility – Southern Research

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.

Wound Care Advantage taps Tissue Analytics for AI, smartphone offering | MobiHealthNews

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.

Here’s how an AstraZeneca spinout deal gets done – Baltimore Business Journal

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

Job Opportunity: Associate Entrepreneur-in-Residence

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.

PIC MC RISE Zone Celebration and Ribbon Cutting

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

What’s next for RightEye following FDA approval – Washington Business Journal

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

Alexandria Real Estate’s Marcus on Interest Rates, Drug Pricing – Bloomberg

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.”

TEDCO’s Builder Fund is closing the investment gap for more entrepreneurs – Technical.ly DC

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.

QIAGEN expands QIAGEN Clinical Insight software to support all major sequencing platforms and assay types

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.

CEL-SCI RECEIVES ABOUT $8 MILLION FROM WARRANT EXERCISES

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.

FounderTrac Demo Day

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.

Neuralstem Announces $2.1 Million Registered Direct Offering

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.

RegeneRx Partner Updates on Clinical Trials – Oct 29, 2018

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.:

Epigenomics AG Obtains CE Mark for Liquid Biopsy Test for Liver Cancer Detection

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.

Local entrepreneurs enter shark tank at Shore Hatchery – 47abc

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.

Aledade raises $23 million — again – Washington Business Journal

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

3D bioprinted lungs to be available for global transplants – ISRAEL21c

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.

Life sciences VC investment trends similar to tech, but there are differences – MedCity News

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.

Ex-NEA GP Viswanathan raising $1.3 bln related to secondary deal – PE Hub

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

Illumina to buy Pacific Biosciences for $1.2 billion – MedCity News

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

Inside 3675 Market, Philadelphia’s Newest Innovation Hub

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.

AbbVie Follows Trend of Big Pharma Setting Office-Labs in Biotech Clusters – BioSpace

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.

CMS will cover virtual care for the first time – MedCity News

On November 1, the Centers for Medicare and Medicaid Services finalized changes to the 2019 Physician Fee Schedule and the Quality Payment Program.

One of the adjustments involves telehealth.

Johnson & Johnson Innovation Announces Extension of JJIPO @ QUT in Collaboration with Queensland State Government to Further Boost Life-Science Innovation in Queensland | Business Wire

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.

Oct 30 2018

Love0

327th Edition – October 30, 2018

By admin BHI Weekly Newsletter Archives

BioHealth Innovation

If you are having trouble viewing this email, please click here

October 30, 2018

FOUNDING MEMBER OF

Viewpoint: We need a federal authority to boost ‘tech transfer’ – Washington Business Journal

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.

BHI Entrepreneur-in-Residence Feedback Sessions

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.

REGENXBIO Announces Additional Positive Interim Phase I Trial Update for RGX-314 for the Treatment of Wet AMD at the American Academy of Ophthalmology 2018 Annual Meeting

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).

United Therapeutics, CollPlant partner for 3D-printed organs – Washington Business Journal

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

BioHealth CEO/Consulting Opportunities

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.

Position Sought – FT, PT, Consultant (list any/all that apply)

Compensation – (Minimum hourly/annual)

Willing to take deferred compensation in exchange for equity? (Y/N)

Date available

Other

PathFinder Innovation Program

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.

MoCo college to target economic development with new ‘RISE Zone’ – Washington Business Journal

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

TaiRx, Inc. and BioHealth Innovation, Inc. Form TaiRx US to Develop and Commercialize Therapeutics and Precision Medicine Diagnostics

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.

How Stem Cell Innovation Has Advanced Neuroscience Research – Psychology Today

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].

University of Maryland School of Medicine to tackle diseases in major new Baltimore research center – Baltimore Sun

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.

10 impact-focused ventures enter Johns Hopkins Social Innovation Lab – Technical.ly Baltimore

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.

VERALOX Therapeutics and Frederick Innovative Technology Center, Inc. – Success Story – Baltimore Business Journal

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).

GSK developing TB vaccine – Livemint

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.

Altimmune CEO Bill Enright to depart – Washington Business Journal

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

AstraZeneca strengthens and expands oncology development and commercialisation collaboration with Innate Pharma

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.

U.S. Life Science Real Estate Sector Keeps Expanding

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.

United States Is The Most Competitive Economy: World Economic Forum | Newgeography.com

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.

The Galien Foundation Announces 2018 #PrixGalien Award Recipients

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.

Foundation for the NIH Bestows the Inaugural Trailblazer Prize for Clinician-Scientists to Dr. Michael Fox | FNIH

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.

How a Pharma Company Applied Machine Learning to Patient Data

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.

Railing against ‘global freeloading,’ Trump offers plan to lower drug prices – STAT

President Trump on Thursday blasted pharmaceutical companies for having “rigged the system” against American consumers by charging higher prices in the U.S. than they do abroad, announcing a new proposal he says will help even out those differences.

A Year of Historic Action to Combat the Opioid Crisis – The White House

Gotham Therapeutics Launches in New York City with $54 Million Series A Financing – BioSpace

Gotham Therapeutics launched in New York with a $54 million Series A financing. The round was co-led by founding investor Versant Ventures, Forbion and S.R. One. The investment syndicate included Celgene Corporation and Alexandria Venture Investments.

Oct 24 2018

Love0

326th Edition – October 23, 2018

By admin BHI Weekly Newsletter Archives

BioHealth Innovation

If you are having trouble viewing this email, please click here

October 23, 2018

FOUNDING MEMBER OF

TaiRx, Inc. and BioHealth Innovation, Inc. Form TaiRx US to Develop and Commercialize Therapeutics and Precision Medicine Diagnostics

2018 BioHealth Capital Region Investment Conference Presentation by Rich Bendis

Top 3 by 2023

State of the BioHealth Capital Region’s EcoSystem

Rich Bendis

President & CEO, BioHealth Innovation Inc.

La Petite Noiseuse Productions Co-Founder and Chief Science and Art Officer Monica Lopez, PhD joins Rich Bendis on BioTalk

Correction: This story originally published on 10/16 included a 2nd paragraph referencing a previous guest of BioTalk and not Monica Lopez, PhD.

La Petite Noiseuse Productions Co-Founder and Executive Scientific & Artistic Director Monica Lopez, Ph.D. joins BioTalk Host Rich Bendis to discuss her career path, their consulting services, science-art integration, multidisciplinary thinking and doing in healthcare, and STEM-STEAMM education for workplace challenges of the future.

Dr. Lopez is a multilingual cognitive scientist, educator, entrepreneur, multidisciplinary artist, public speaker, and writer. At her company, Dr. Lopez leads a unique R&D program within creativity and human intelligence with the goal of advancing artificial intelligence. The result has been a novel model that merges the cognitive brain sciences with the arts, and forms the basis of the company’s consulting services in different industries (healthcare, autonomous systems, education, entertainment, and cyber) with clients from Boston, New York, and San Francisco and Europe (France, Belgium, Austria, United Kingdom, Italy, and Germany). To prepare leaders for the challenges of tomorrow, Dr. Lopez has created since 2009, as faculty at Johns Hopkins University and Peabody Institute, a STEAMM education platform. Prior to co-founding her company, she worked in business development, product evaluation, marketing, communications, and strategic partnering in various languages. Dr. Lopez is a frequent keynote and plenary speaker and panelist at international and national venues. She holds BA degrees in Psychology and French, and a MA and PhD in Cognitive Science, all from Johns Hopkins University, a Certificate of Art in Photography from Maryland Institute College of Art, and was a postdoctoral fellow at The Johns Hopkins University School of Medicine. Dr. Lopez has been recognized as a “particularly imaginative polymath” by the Imagination Institute of the University of Pennsylvania’s Positive Psychology Center. She has been a Salzburg Global Seminar Fellow and distinguished guest with their Board of Directors.

Listen now on iTunes , Google Play , and TuneIn.

BHI Entrepreneur-in-Residence Feedback Sessions

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.

FDA again approves record-breaking number of generic drugs

The Food and Drug Administration approved or tentatively approved a record-setting 971 generic drugs in fiscal year 2018 that ended last month, the agency announced on Thursday.

Viela Bio Announces Late-Breaking Abstract Acceptance for VIB4920, a Novel Engineered CD40L Antagonist, at the 2018 ACR/ARHP Annual Meeting

Viela Bio heads to the 2018 American College of Rheumatology / Association of Rheumatology for Health Professionals (ACR/ARHP) Annual Meeting in Chicago, 19-24 October 2018, with a late-breaking poster presentation for a novel engineered CD40L antagonist, VIB4920.

VLP Therapeutics Announces Issuance of US Patent for Dengue Vaccine – VLP Therapeutics

VLP Therapeutics announced the issuance of US Patent 10,098,943 titled, “Flavivirus virus-like particle” on October 16, 2018. This patent supports VLP Therapeutics’ Native Virus Modification virus-like particle platform on which the Company’s dengue vaccine is based and which could form the basis for other flavivirus vaccines. The patent relates to a virus-like particle vaccine comprising flavivirus structural proteins to prevent or treat flavivirus infection. Flavivirus includes dengue virus, West Nile virus, Japanese encephalitis, hepatitis C virus, and Zika virus.

Rexahn Announces $7.5 Million Registered Direct Offering – Rexahn Pharmaceuticals, Inc.

Rexahn Pharmaceuticals, Inc. (NYSE American: RNN) today announced it has entered into definitive agreements with institutional investors to purchase approximately 5.77 million shares of its common stock and warrants exercisable for up to approximately 5.77 million shares of its common stock for gross proceeds of approximately $7.5 million. The shares and warrants are being sold in units, each consisting of one share of common stock and a warrant to purchase one share of common stock, at an offering price of $1.30 per unit. The warrants will be exercisable six months following the date of issuance, will expire on the fifth anniversary of the initial exercise date and will have an exercise price of $1.67 per share. The closing of the offering is expected to take place on or about October 19, 2018, subject to the satisfaction of customary closing conditions.

American Gene Technologies Granted FDA Orphan Drug Designation For Phenylketonuria | American Gene Technology

American Gene Technologies (AGT), a leading gene and cell therapy company in the discovery and development of lentiviral vector based therapeutics, announces that the U.S. Food and Drug Administration (FDA) received orphan-drug designation #DRU-2018-6572 for the treatment of phenylketonuria (PKU) using its proprietary, lentiviral vector based technology. PKU is a debilitating inherited disease affecting 1 in 13,500 children born in the U.S. Mandatory screening identifies affected children who can be supported with a strict synthetic diet that does not cure disease. If successful, AGT’s lentiviral vector approach will provide a permanent cure, improving quality of life for more than 16,000 people living with PKU in the U.S. alone.

JHU startup PathoVax raises $2.75M, grows team – Technical.ly Baltimore

PathoVax, a Johns Hopkins–born startup developing a vaccine for human papillomavirus virus (HPV), raised $2.75 million in new funding, cofounder Joshua Wang said.

Job Opportunity: VICE PRESIDENT FOR DEVELOPMENT & ALUMNI RELATIONS at Montgomery College

Based in Rockville, MD

Management Recruiters – Mid Hudson Valley is an executive search firm focused solely in serving the nonprofit sector. We have a national practice and the large majority of our placements are executive leadership and senior fundraising professionals.

Our client is Montgomery College, a community college of more than 60,000 students in Montgomery County, MD. The College is seeking a Vice President for Development and Alumni Relations who also serves as the Executive Director of the Montgomery College Foundation. The position is a College employee.

Competing for Kids’ Health – Maryland Today

Children benefit from little of the $156 billion annual U.S. market for medical devices, but a “Shark Tank”-inspired partnership between the University of Maryland and Children’s National Health System is looking to change that.

United Therapeutics to Develop CollPlant Technologies for 3D Bioprinted Lung Transplants – GEN

United Therapeutics will license, develop, and commercialize CollPlant Holdings’ recombinant human collagen (rhCollagen) and BioInk technology for 3D bioprinting of solid-organ scaffolds for human transplants, the companies said today, through a collaboration that could generate more than $44 million.

Time to Reconsider GlycoMimetics Inc After Less Short Sellers? – WhatsOnThorold

Investors sentiment decreased to 1.37 in 2018 Q2. Its down 0.26, from 1.63 in 2018Q1. It dived, as 22 investors sold GlycoMimetics, Inc. shares while 16 reduced holdings. 25 funds opened positions while 27 raised stakes. 45.91 million shares or 6.89% more from 42.95 million shares in 2018Q1 were reported.

A New Targeted Cancer Company To Watch

Jean Cui led the invention of Pfizer’s Xalkori. Now she has her own company focusing on drug-resistant cancers, and it has raised $147 million.

3 ways HHS can help medtech innovators – Medical Design and Outsourcing

The U.S. Department of Health and Human Services (HHS) is doing everything from sharing more data to cultivating entrepreneurial talent and engaging in partnerships in order to support medical device innovators, the department’s CTO Ed Simcox told than 100 industry insiders in the Twin Cities today.

Pharma firmly in the mix as healthcare embraces ‘open innovation’ – MM&M – Medical Marketing and Media

Pharma hasn’t traditionally been known as a sector that welcomed innovation from the outside. But now companies are putting “not invented here” bias aside as they seek to widen their aperture for innovation.

Maryland Cybersecurity Career & Education Fair – Nov. 9-10, Rockville, MD

The Cybersecurity Association of Maryland, Inc. (CAMI) and Universities at Shady Grove invite you to attend their November 9 & 10 Maryland Cybersecurity Career & Education Fair.

Maryland is at the forefront of our nation’s rapidly growing cyber market and opportunities abound for professionals in our region—both those who are new to the field, and long-time members of the industry. Join us at the Universities at Shady Grove for two dynamic days that put on display why Maryland is where cyber works. Friday will feature a career and education fair, connecting cybersecurity job seekers with opportunities across the state of Maryland. Those looking to expand their cybersecurity competency can also connect on-site with Maryland education and training resource. On Saturday, cyber warriors of high school through undergraduate skill levels are invited to compete in our “Catch the Phish: An AI Capture the Flag Event” cyber challenge.

The 50 Most Influential People in Health Care of 2018 – Time.com

Meet the physicians, scientists, and business and political leaders whose work is transforming health care right now

BioHealth CEO/Consulting Opportunities

Position Sought – FT, PT, Consultant (list any/all that apply)

Compensation – (Minimum hourly/annual)

Willing to take deferred compensation in exchange for equity? (Y/N)

Date available

Other

Oct 17 2018

Love0

325th Edition – October 16, 2018

By admin BHI Weekly Newsletter Archives

BioHealth Innovation

If you are having trouble viewing this email, please click here

October 16, 2018

FOUNDING MEMBER OF

Inaugural Investment Conference Marks Inflection Point for the BioHealth Capital Region · BioBuzz

The first Biohealth Capital Region Investment Conference kicks off this week in Montgomery County. The conference marks an important inflection point for a region whose entrepreneurs have been calling for more active investment resources for years. The event also fulfills a promise made by organizers at past BioHealth Capital Region Forums to bring more investment activity to the region.

Qiagen and Women in Bio Recognized at 5th Annual BioBowl

More than 300 representatives of companies from throughout the BioHealth Capital Region took over BowlMore Gaithersburg last Thursday for a fun evening of networking. The 5th annual BioBowl cohosted by MedImmune and BioHealth Innovation included teams from Baltimore and DC to Montgomery and Frederick counties. Qiagen took home the First Place prize and the Women in Bio event were recognized for their efforts with a Rubber Chicken Award.

La Petite Noiseuse Productions Co-Founder and Chief Science and Art Officer Monica Lopez, PhD joins Rich Bendis on BioTalk

Listen now on iTunes , Google Play , and TuneIn.

Montgomery County Moves Up in National Biopharma Rankings

Montgomery County is proving to be a premium address for the growing biotechnology sector.

The BioHealth Capital Region, which includes Maryland, Virginia and Washington D.C., is ranked No. 4 on the 2018 list of top biopharma centers by Genetic Engineering & Biotechnology News (GEN). The cluster moves up from a No. 5 ranking in 2017.

GEN ranks regions nationally based on several factors, including National Institutes of Health (NIH) funding, venture capital investment, patents, lab space and jobs in biotech.

Q&A With BeneVir Co-Founder, Katherine Sacksteder, PhD – The Path to a Landmark Acquisition (Part 1) · BioBuzz

This has been a year marked by many notable biotech deals, especially in the immunotherapy market. One deal, in particular, has generated more local excitement in the BioHealth Capital Region than any other; that is the BeneVir acquisition by Janssen, a JNJ company. Likewise, of the many startup stories and local entrepreneurs we’ve highlighted this past year, none is as unique and interesting as that of BeneVir Co-Founder and COO, Katherine (Katie) Sacksteder, PhD.

MaxCyte Begins Dosing in First Clinical Trial in Solid Tumors – American Pharmaceutical Review

MaxCyte announced the first patient has been dosed in its Phase I dose-escalation clinical trial in the United States with the company’s lead wholly-owned chimeric antigen receptor (CAR) therapeutic candidate, MCY-M11. The study is designed to evaluate MCY-M11, a mesothelin targeting CAR, in individuals with relapsed/refractory ovarian cancer and peritoneal mesothelioma.

Emergent BioSolutions Completes Acquisition of Specialty Vaccines Company PaxVax

Emergent BioSolutions Inc. (NYSE: EBS) announced today that it has completed its acquisition of PaxVax, a company focused on developing, manufacturing, and commercializing specialty vaccines that protect against existing and emerging infectious diseases. With the closing of this transaction, Emergent acquires two marketed vaccines – Vivotif® (Typhoid Vaccine Live Oral Ty21a), the only oral vaccine licensed by the U.S. Food and Drug Administration (FDA) for the prevention of typhoid fever, and Vaxchora® (Cholera Vaccine, Live, Oral), the only FDA-licensed vaccine for the prevention of cholera, a potentially serious intestinal disease, caused by Vibrio cholerae serogroup O1. The acquisition broadens the company’s development pipeline with vaccines that address adenovirus types 4 and 7, which are common causes of acute respiratory disease, and chikungunya, a viral disease spread to humans by infected mosquitoes that can cause severely debilitating joint pain. The acquisition also expands the company’s sales capabilities with a global specialty salesforce and marketing and distribution partners focused on the travelers’ market and establishes an international manufacturing footprint with European-based cGMP biologics facilities.

Lupin receives tentative FDA approval for generic Lurasidone Hydrochloride Tablets, 20 mg, 40 mg, 60 mg, 80 mg and 120 mg

Pharma major Lupin announced that it has received tentative approval for its Lurasidone Hydrochloride Tablets, 20 mg, 40 mg, 60 mg, 80 mg and 120 mg from the United States Food and Drug Administration (FDA) to market a generic version of Sunovion Pharmaceuticals Inc.’s (Sunovion) Latuda Tablets, 20 mg, 40 mg, 60 mg, 80 mg and 120 mg.

Lupin’s Lurasidone Hydrochloride Tablets, 20 mg, 40 mg, 60 mg, 80 mg and 120 mg is the generic version of Sunovion’s Latuda Tablets, 20 mg, 40 mg, 60 mg, 80 mg and 120 mg.

M-CERSI Cooperative Agreement Grant Renewed by Food and Drug Administration – Center of Excellence in Regulatory Science and Innovation

The University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) has been renewed for funding under a cooperative agreement grant from the U.S. Food and Drug Administration (FDA). A collaborative partnership led by James Polli, PhD, the Shangraw/Noxell Endowed Chair in Industrial Pharmacy and Pharmaceutics at the University of Maryland School of Pharmacy, and William E. Bentley, PhD, the Robert E. Fischell Distinguished Chair of Engineering at the University of Maryland, College Park (UMCP), M-CERSI is one of only four FDA-funded CERSIs in the U.S., and the only CERSI to receive continuous funding from the FDA since it first launched in 2011. This latest renewal, which allows for up to $5 million per year over five years, will allow M-CERSI to continue its mission to contribute to modernizing and improving the ways in which drugs and medical devices are reviewed and evaluated.

AgeneBio gets grants to advance therapeutics to slow Alzheimer’s disease – Technical.ly Baltimore

Baltimore-based AgeneBio announced a pair of grants from the National Institutes of Health that will assist with clinical trials of a treatment to combat the progression of Alzheimer’s disease.

15 emerging technologies that could reduce global catastrophic biological risks – EurekAlert! Science News

Johns Hopkins Center for Health Security authors recommend dedicated attention to and investment in ‘potentially transformative’ technologies to complement traditional approaches to prevention, preparedness, and response

Valneva Receives FDA Approval for Accelerated Vaccine Dosing Schedule for IXIARO® – Press Release – Digital Journal

Valneva USA, the U.S. subsidiary of global vaccine biotech company Valneva SE, today announced U.S. Food and Drug Administration (FDA) approval of an accelerated dosing regimen for IXIARO® (Japanese Encephalitis Vaccine, Inactivated, Adsorbed), the only vaccine approved in the United States indicated for protection against disease caused by Japanese encephalitis (JE) virus.

FDA awards $5 million to pediatric device consortium; New Consortium members include BioHealth Innovation – Children’s National

To foster development, production and marketing of the next generation of medical devices designed to meet growing children’s unique needs, the Food and Drug Administration (FDA) awarded $5 million to the National Capital Consortium for Pediatric Device Innovation (NCC-PDI), led by Children’s National Health System and University of Maryland, College Park. New Consortium members include BioHealth Innovation, Inc., a Maryland-based innovation intermediary that supports the transformation of research projects into new business opportunities, and MedTech Innovator, a California-based virtual startup accelerator that matches health care industry leaders with early-stage and emerging growth medtech companies for mentorship and support. NCC-PDI’s affiliated members include industry leaders such as Smithwise, Epidarex, and Cadence.

Women Building Bio 2018 – Virginia Bio

Have you register for this year’s Women Building Bio event? The third Annual Women Building Bio Conference is taking place October 17 at the Inova Center for Personalized Health. This is a one-day regional conference converging extraordinary men and women, industry and academia, researchers and innovators, professionals and decision-makers gathering together to cultivate relationships and making an impact. Click here for the agenda and more information. (For a discount code, email BHI and register by 3 p.m., Tuesday, October 16th.)

PathFinder Innovation Program

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.

Fall 2018 Inova Discovery Series Registration, Wed, Nov 7, 2018 at 6:00 PM

We’re thrilled to announce Molly McCartin, Partner, Drive Capital, will be a featured speaker at the Fall 2018 Inova Discovery Series!

Molly McCartin is an investing partner with a focus on healthcare at Drive Capital, a venture capital firm based in Columbus, OH founded by two former Sequoia partners. Molly started her career at JP Morgan Chase in Equity Research. She then moved to 7Wire Ventures investing in healthcare companies that empower the health consumer. Molly spent the last four years at Livongo Health, helping the company grow from 6 employees to over 150 and over 200 customers. Molly graduated from MIT with a degree in Applied Math and Economics.

Healthcare companies rake in $23B in venture capital funding

U.S. healthcare companies have collected $23.4 billion in venture capital funding this year — already surpassing the amount the sector obtained in all of 2017, according to a recent report from Pitchbook, which tracks VC investments.

SBIR Office Hours

BioHealth Innovation sponsors quarterly office hours in Montgomery County and at Johns Hopkins Fast Forward (Fast Forward hours are for JHU innovators only).

BioHealth Capital Region innovators not located at Fast Forward can register for SBIR office hours on the following dates.

Tuesday – Nov 6, 8:00 a.m. – 12:00 p.m. – Germantown Innovation Center
Wednesday – Nov 7, 1:00 – 5:00 p.m. – Rockville Innovation Center
Tuesday – Feb 12, 8:00 a.m. – 12:00 p.m. – Germantown Innovation Center
Wednesday –Feb 13, 1:00 – 5:00 p.m. – Rockville Innovation Cente
Wednesday – May 8, 8:00 a.m. – 12:00 p.m.- Germantown Innovation Center
Thursday — May 9, 1:00 – 5:00 p.m. – Rockville Innovation Center

To register for the open sessions, click here. (BHI also will be hosting a more general SBIR overview with office hours on January 29, 2019. Mark your calendar; more details to follow.)

BioHealth CEO/Consulting Opportunities

Position Sought – FT, PT, Consultant (list any/all that apply)

Compensation – (Minimum hourly/annual)

Willing to take deferred compensation in exchange for equity? (Y/N)

Date available

Other

SparkLabs launches DC accelerator for cybersecurity and blockchain startups – Technical.ly DC

It’s cybersecurity month at Technical.ly and this new accelerator program is here to heat up the discussion.

What drives pharma m&a – McKinsey

There are lessons for other industries in the way pharma companies use mergers to innovate, work more efficiently, and bolster product portfolios.

Jonathan Aberman: You want funding? Follow this advice. – Washington Business Journal

However long a business has operated, investors will look for three big things if they are going to invest.

Innovation challenges are all the rage with pharma, and they’re likely here to stay: study | FiercePharma

The number of open innovation challenges in pharma grows by the day. But what’s driving them? That’s what Luminary Labs wanted to know. So the consultancy, which works with pharma and other industries to design and execute those kind of challenges, surveyed the executives at companies that run the contests and asked why and how they do it.

Top 10 European Biopharma Clusters, October 2018 – GEN

Europe’s biotech industry recently celebrated its growth and progress with more than 120 events taking place across 18 European countries September 24 –30, in what organizers call “European Biotech Week.”

VC Investment Jumps 51% Year-over-Year During Q3 – GEN

Biopharma venture capital activity maintained its red-hot pace during the third quarter of 2018, driven by a handful of deals exceeding $200 million, according to a report released this week.

CIT Announces FY2019 Solicitation for Commonwealth Research Commercialization Fund

The Center for Innovative Technology (CIT) announced today the Commonwealth Research Commercialization Fund (CRCF) Request for Proposals (RFP) for FY2019.

2018 Oncologist National Workforce Study

Some big cities could see shortages of cancer specialists in the coming decade, according to a new analysis by Doximity, a social network for more than a million physicians. Researchers at the company delved into the data on oncologists and found there’s an imminent wave of retiring physicians. The areas most likely to see shortages: Miami, Virginia Beach, and Tampa. But other cities could also see large portions of the cancer physician workforce retire relatively soon. In half of the 50 metropolitan areas surveyed, more than 20 percent of practicing oncologists are over age 65.

D.C. area could see record venture funding year – Washington Business Journal

The local funding environment is mirroring the gangbusters national funding situation.

BHI Entrepreneur-in-Residence Feedback Sessions

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.

SBIR Funding Assistance

If you and your team are located in the BioHealth Capital Region, BHI may prepay for experts to help you improve your SBIR and other non-dilutive funding applications for biohealth related projects. Your only obligation is that if you win the award, you reimburse BHI for the consulting fees (typically $1500 or $3000) and a minimal program management fee (ten % of the prepaid consulting fee i.e. $150 or $300).

For more information contact BHI.

Oct 10 2018

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324th Edition – October 9, 2018

By admin BHI Weekly Newsletter Archives

BioHealth Innovation

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October 9, 2018

FOUNDING MEMBER OF

Brian Darmody, UMD Associate VP of Corporate Engagement, joins Rich Bendis on BioTalk

In this episode of BioTalk, Rich Bendis and guest Brian Darmody discuss growth across the region, the battle for talent and the upcoming AURP International Conference hosted in College Park.

Brian Darmody is responsible for developing projects, funding opportunities, and policies to support partnerships with the private sector. Previously he was the University’s Associate Vice President for Research and Development, Director of the University of Maryland Center for Applied Policy Studies, Director of State and Federal Relations in the UMD President’s Office, and served in the University’s legal counsel’s office. He serves on national and state boards, including Maryland Technology Council Executive Board, Fraunhofer USA, the Maryland Economic Development Association and is past President of the Association of University Research Parks.He has served on the staff for the U.S. House of Representatives, the U.S. Health Care Financing Administration Office of Attorney-Advisor, and the Maryland General Assembly. He holds an undergraduate degree from the University of Maryland and Juris Doctor from the University of Baltimore.

Listen now on iTunes , Google Play , and TuneIn.

Join us for an Investment Panel Discussion – BioHealth Capital Region Investment Conference

Led by Joel Marcus, Founder of Alexandria Real Estate Equities

October 9th at 4:20pm

One MedImmune Way, Gaithersburg, MD 20878

Networking Reception to follow

RSVP by 2 p.m. 10/8 to: amy@taylormadeexperience.com

County Report This Week Episode – Featuring BHI’s Rich Bendis

Anqoinette Crosby hosts County Report This Week. On this episode: Members of Governor Larry Hogan’s cabinet visited the county to discuss transportation and other topics with the Montgomery County Planning department, Artspace broke ground in Silver Spring, Biohealth Innovation will take part in an upcoming conference, Aspen Hill residents voice their opinions about cell towers, and the World of Montgomery Festival takes place on October 21 from 12-4p at Montgomery College in Rockville.

Biotech forum follow-up discuss hosted by George L. Leventhal, Montgomery County Councilmember

Dear Friend:

On Wednesday, October 17th, I will be hosting a follow up discussion to a Biotech forum held earlier this year that addressed ways to help the biotechnology sector thrive in Montgomery County. I will be joined at this discussion by Congressman Jamie Raskin, Dr. Anthony Saleh, CEO, miRecule Inc. and Dr. Chris Austin, Director of the National Center for Advance Translational Sciences (NCATS), NIH.

The topic will be whether federal ethics and conflict of interest restrictions on NIH (intramural) scientists impede the competitiveness of our region’s biotechnology enterprise by limiting incentives for starting new commercial ventures.

This meeting will be held at Johns Hopkins University Montgomery County Campus, Room 121 in the 9605 Building, which is located at Medical Center Drive in Rockville. Parking on campus is available; however, a parking permit is required. Please park in the lot adjacent to the building located at the corner of Key West Avenue and Broschart Road. To ensure you receive a parking permit you must RSVP to this event. The event begins at noon and is scheduled to end at 1:30pm. A light lunch will be provided. Please email your RSVP to Walton Harris at Walton.Harris@montgomerycountymd.gov or 240-777-7945.

Best,

George L. LeventhalMontgomery County Councilmember

How Cambridge Became a Biotech Hub – Bloomberg

Alexandria Real Estate Equities chairman and co-founder Joel Marcus sit down with Bloomberg’s Rebecca Spalding in Cambridge, Massachusetts.

Apply Now: Immediate new opening for an NIH Entrepreneur in Residence

Altimmune Raises $17 Million through Underwritten Public & Registered Direct Offerings Last Week

Altimmune, Inc. (Nasdaq: ALT), a clinical-stage immunotherapeutics company, today announced the pricing of an underwritten public offering of common units and pre-funded units for a combined total of 2,400,000 units. Each common unit is being sold at a public offering price of $5.00 and consists of a share of its common stock and a warrant to purchase one share of common stock at an exercise price of $6.00. Each warrant will be exercisable immediately and will expire five years from the date of issuance. Each pre-funded unit consists of a pre-funded warrant to purchase one share of our common stock at an exercise price of $0.01 per share and a warrant. The purchase price of each Pre-funded Unit is equal to the price per common unit being sold to the public in this offering, minus $0.01. The pre-funded warrants will be immediately exercisable and may be exercised at any time until all of the pre-funded warrants are exercised in full

CASI Pharmaceuticals Announces Appointment Of President To Its China Operations To Lead Commercialization

CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a biopharmaceutical company dedicated to the development and delivery of high quality, cost-effective pharmaceutical products and innovative therapeutics to patients in the U.S., China and throughout the world, announces the appointment of Larry Zhang to the position of President of CASI (Beijing) Pharmaceuticals Co., Ltd., the China operating subsidiary of CASI Pharmaceuticals, Inc. headquartered in Rockville, Maryland.

Danaher’s Instruments of Change

When the Danaher Corporation announced in May 2015 that it would split into two separate enterprises in 2016, it seemed at first like a reversal of the company’s history. Danaher had built itself into a remarkably successful business over four decades by acquiring and integrating new companies into a unified whole, improving them through a group of distinctive management practices known as the Danaher Business System (DBS), then holding onto them.

Montgomery County MD Broadband Summit

DATE AND TIME: Mon, October 22, 2018 8:00 AM – 1:00 PM EDTLOCATION: Montgomery College Germantown Bioscience Education Center, 20200 Observation Drive, Bioscience Education Center, Room 151/152, Germantown, MD 20876

Montgomery County Government requests that you join County Executive Isiah Leggett and Council President Hans Riemer at the Commercial Buildings Broadband Summit, Monday October 22, 2018, 8 am to 1 pm.

The purpose of the Summit is to bring together select business leaders in commercial real estate development and leasing, gigabit fiber networks and wireless 5G and IoT, and leading business sectors to discuss how broadband-ready commercial buildings can support today’s business needs and what strategic direction the County should take to prepare for tomorrow’s business growth. There is no charge to attend, but space is limited and reservations are required.

5 things to know about Georgetown University’s new venture lab – Washington Business Journal

The Georgetown Venture Lab, a university effort to support alumni startup founders, is now live at the WeWork location at 15th and G streets NW.

FDA Renews M-CERSI Grant to School of Pharmacy – University of Maryland, Baltimore

A collaborative partnership led by James Polli, PhD, the Shangraw/Noxell Endowed Chair in Industrial Pharmacy and Pharmaceutics at the University of Maryland School of Pharmacy (UMSOP), and William E. Bentley, PhD, the Robert E. Fischell Distinguished Chair of Engineering at the University of Maryland, College Park (UMCP), M-CERSI is one of only four FDA-funded CERSIs in the United States and the only CERSI to receive continuous funding from the FDA since it launched in 2011.

BIO Statement on the United States-Mexico-Canada Agreement

Biotechnology Innovation Organization (BIO) President & CEO James C. Greenwood today issued the following statement on the United States-Mexico-Canada Agreement (USMCA):

BIO supports the USMCA and appreciates the Administrations efforts to prioritize biotechnology innovation, including provisions that update intellectual property protections and agricultural market access to 21st century standards.

The Science of Beer @ CRB

When: Thursday, October 18, 2018 from 5:00 PM to 7:30 PM EDT

Where: CRB Office 1801 Research Blvd #620 Rockville, MD 20850

It’s harvest time again and we’re continuing our Fall Oktoberfest tradition with a special Open House event at CRB’s Rockville office; featuring local microbrewery, Brookville Beer Farm. Join us on Oktober 18th to help celebrate a year of tremendous growth within our region with a firm who is responsible for designing and building the facilities that many local companies are expanding into.

Maryland Tech Council’s Venture Mentoring Program Expands to Serve Entrepreneurs Across Maryland

Maryland Tech Council (MTC) announced today that, with the support of the Maryland Department of Commerce, the Maryland Tech Council Venture Mentoring Services (MTC VMS), will expand beyond Montgomery County to serve entrepreneurs throughout Maryland. The MTC VMS, which started just two years ago, has trained more than 60 mentors. The program uses a unique team approach to mentoring and is focused on technology and life sciences companies that are preparing to raise their first or second round of venture capital or institutional financing.

Aldrich Capital Partners raises new fund – Washington Business Journal

The fund aims to invest in larger, more mature companies primed for growth.

Venture Capital Gathering Showcases Michigan’s ‘Secret Weapon’: Collaboration | Benzinga

A 450-person gathering in Detroit’s Eastern Market this week made it clear Michigan sits at the intersection of development in the mobility space, Midwestern affordability and investor interest.

The right way for health systems to embrace startup innovation

Many health systems acknowledge that partnering with digital healthcare startups is a necessary step toward innovation, but if providers do not tend these partnerships carefully, they will not be able to reap their benefits.

SBIR Office Hours

BioHealth Innovation sponsors quarterly office hours in Montgomery County and at Johns Hopkins Fast Forward (Fast Forward hours are for JHU innovators only).

BioHealth Capital Region innovators not located at Fast Forward can register for SBIR office hours on the following dates.

Tuesday – Nov 6, 8:00 a.m. – 12:00 p.m. – Germantown Innovation Center
Wednesday – Nov 7, 1:00 – 5:00 p.m. – Rockville Innovation Center
Tuesday – Feb 12, 8:00 a.m. – 12:00 p.m. – Germantown Innovation Center
Wednesday –Feb 13, 1:00 – 5:00 p.m. – Rockville Innovation Cente
Wednesday – May 8, 8:00 a.m. – 12:00 p.m.- Germantown Innovation Center
Thursday — May 9, 1:00 – 5:00 p.m. – Rockville Innovation Center

To register for the open sessions, click here. (BHI also will be hosting a more general SBIR overview with office hours on January 29, 2019. Mark your calendar; more details to follow.)

SBIR Funding Assistance

For more information contact BHI.

BHI Entrepreneur-in-Residence Feedback Sessions

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.

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