366th Edition – August 13, 2019

For the first time, a BioTalk look inside BioHealth Innovation, Inc. (BHI) with Entrepreneur-In-Residence (EIR) Dr. Ethel Rubin

Dr. Ethel Rubin leads a venture team that helps prepare and connect lifescience companies with capital, ensuring strategies that hit valuation inflection points, achieve strategic goals, and prepare for a product launch. She has previously held corporate leadership roles in global clinical strategy and medical affairs at Medtronic, plc, was Chief Scientific Officer of BioFortis, Inc. (acquired by Quintiles-Quest JV) and CSA Medical, Inc., is President of life sciences business development advisory firm Innovative BioStrategies, LLC, and a venture partner at various funds. She has over 25 products in the marketplace garnering 9 figure sales revenue, was instrumental in multiple M&As, partnerships & collaborations, and advises hundreds of CEOs in preparation for seed to series B financing each year. Ethel has held board seats at tech incubators and numerous business and clinical Advisory boards.  Dr. Rubin earned a Ph.D. in Biochemistry and Biophysics from the University of Rochester School of Medicine & Dentistry and a certificate in corporate governance for Board of Directors service from The George Washington University School of Business.

Listen now on iTunes (https://apple.co/318CzZv), Google (http://bit.ly/30WiQfg), and TuneIn (http://bit.ly/2LPtYab).

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Thank you to BioHealth Innovation, Inc. for this incredible experience. I learned so much from these brilliant minds, and look forward to an ongoing relationship.

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By invitation only: For questions email BHI@BioHealthInnovation.org

Gaithersburg, MD

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RoosterBio, Inc., a Frederick, MD-based human mesenchymal stem/stromal cell (hMSC) biomanufacturing company, raised in excess of $15m in an initial Series B financing.

The round was led by Dynamk Capital, with participation from existing and new investors. The Series B final round is expected to close with additional investors by the end of August, totaling approximately $22m raised.

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This just in: Maryland’s internet is the least likely to cut out right at the juicy scene in ‘The Bachelor’. According to web service provider assessment group Highspeedinternet.com, Maryland has the fastest internet speed in the country.

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Applications Due September 5

The Commercialization Readiness Pilot (CRP) Program is now open and accepting applications for the September 5th NIH SBIR/STTR receipt date. NHLBI will accept applications via PAR-19-333, PAR-19-334, and PAR-19-335 from small businesses that have had an active NHLBI SBIR or STTR Phase II or Phase IIB award within the last 36 months.

This opportunity provides up to $300,000 (PAR-19-334) or $500,000 (PAR-19-333, PAR-19-335) to support technical assistance and later stage research and development (R&D) not typically supported through Phase II or Phase IIB grants or contracts including:

• Independent replication of key studies
• Investigational New Drug (IND)-enabling studies
• Clinical studies, manufacturing costs
• Regulatory assistance

Contact NHLBI Small Business Program Coordinator Mike Pieck (NHLBI_SBIR@mail.nih.gov) with questions.

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Our map shows the top VC investing in tech companies in each state, from 500 Startups in California to Lerer Hippeau in New York.

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While medical device innovation is quite active—at the university level, within incubators, and even in the R&D labs of established firms—there is a substantial lack of products being developed for younger patients. Since pediatric devices have a limited patient base due to most children being relatively healthy (of course, a positive factor), it’s not a focus for a great number of companies as it does not offer the promise of a substantial financial return.

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Everyone knows how important funding is for starting a venture, whether you are building a small business or high-growth tech startup. The capital needs of a venture change along with the venture’s stage — early-stage ventures might need help with product development costs, while established companies may need funding to expand to a new location or market segment.

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On Thursday, August 22nd from 4-6:00 pm there will be an open house for the fall courses in the “Advanced Studies in Technology Transfer” program at the Foundation for Advanced Education in the Sciences (FAES) Graduate School at NIH in the FAES Academic Center in NIH Building 10 in Bethesda, MD. For the semester beginning on Monday, September 9th there will be 9 courses available for the program given in either Rockville or Bethesda:

• TECH 495 – The FDA, Science, Health Policy and Regulation in an Uncertain Environment
• TECH 513A – Introduction to Technology Transfer – Issues & Processes
• TECH 521 – Tools for Technology Transfer Managers–Handling Intellectual Property, Collaborations, and Agreements
• TECH 565 – Biomedical Business Development for Scientists
• TECH 567 — International Strategic Partnering and Business Development
• TECH 575 – Accounting and IP Valuation for Non-Accountants
• TECH 583 — Patent Research for Non-Legal Practitioners
• TECH 588 – FDA Regulatory Strategy in Medical Product Development
• TECH 607 – Capstone Course in Technology Transfer
• PHAR 328 – FDA Perspective on Drug Development

More details can be found in the new 2019-20 course catalog (www.faes.org) with online registration for classes available. The Advanced Studies in Technology Transfer is an open enrollment program with class credits transferable into various graduate degree programs at the University of Maryland University College (UMUC) Graduate School and the University of Maryland Baltimore County (UMBC).

Technology Transfer Scholarships

FAES offers a limited number of partial tuition-remission scholarships for self-funding students. For deadlines and details on how to apply visit https://faes.org/tuition-and-funding .

Also as Department Chair, I’m happy to assist with any questions you might have about the program or individual courses.

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Canton-based VitusVet, which built a health IT platform for vets, received investment from Nationwide Insurance as the company’s team continues to grow.

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Facility Logix, a leading life science consulting firm, has hired two new Associate Project Managers: Jocaro L. Dodd and Wayne Mitchell. The new Associate Project Managers will be instrumental in addressing the facility-related needs of the firm’s Owner’s Representation and Project Management clients.

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Back when YC was getting started about 10 years ago, Paul Graham wrote some essays that predicted the way startup fundraising would change in the next decade – accurately, it turns out. Paul Graham predicted that there would be way more startups, that they’d be cheaper to start, that new kinds of investors would fund them, that founders would be more technical, and that founders would keep control of their companies. All of those seem to have come true.

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Rising drug prices and ever-increasing costs are two of the most debated subjects in healthcare. The Centers for Medicare and Medicaid Services (CMS) predicts (PDF link) that we will see 6.1 percent annual prescription drug cost increases until at least 2027. CMS expects healthcare spending as a whole to grow by 5.7 percent per year for the same timeframe.

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The therapies saved roughly 90 percent of the patients who received them early in the course of infection. Doctors hope patients will seek out the cures, ending the outbreak.

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Researchers have been able to coax human breast cancer cells to turn into fat cells in a new proof-of-concept study in mice.

To achieve this feat, the team exploited a weird pathway that metastasising cancer cells have; their results are just a first step, but it’s a truly promising approach.

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Bayer said today it has agreed to acquire BlueRock Therapeutics for up to $600 million in a deal designed to catapult the buyer into leadership in cell therapies, nearly three years after joining with healthcare investment firm Versant Ventures to launch the company.

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The amount of deals and dollars invested in healthcare is hitting near record highs for the first half of 2019 with $26.9 billion poured into healthcare companies over 2,258 deals around the world, according to CB Insights’ Global Healthcare Report.

That represents a slight uptick from the first half of 2018 where $26.5 billion was invested over 2,223 deals.

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The growing number of private biopharma and diagnostic/therapeutic technology company financings completed in recent months masks an overall year-over-year decrease in the total value of those deals.

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