china-flag-2-pixa

Perhaps the report on China’s strategy for eclipsing the U.S. lead in biopharma from the Information Technology & Innovation Foundation (ITIF) resonated so strongly with me because of several articles in The Wall Street Journal. Taken together, they present a sobering picture of what we’re up against.

useda-logo

EDA is encouraging its economic development partners to think of Opportunity Zone investment as a new arrow in their quiver to not only enhance ROI for business interests, but also to encourage the public/private partnerships needed to drive private investment to distressed areas.

dna-genes-pixa

Bayer made much of its desire to establish a cell therapy pipeline on August 8 when it announced it would shell out up to $600 million to acquire full control of BlueRock Therapeutics. But the deal is just the latest example of growing interest by biopharma giants in applying gene editing toward new treatments.

umd-ibbr-0608-logo

Institute for Bioscience and Biotechnology Research (IBBR) Fellow Dr. Daniel Nelson (Associate Professor, Department of Veterinary Medicine, University of Maryland, College Park) is working on an innovative approach to treating bacterial disease in collaboration with Dr. Rajan Adhikari, Assistant Director of Bacteriology at Integrated BioTherapeutics (IBT), and George Mason University's Dr. Ramin Hakami (Associate Professor, School of Systems Biology and National Center for Biodefense and Infectious Diseases). The group recently received a $3M Phase II STTR award from the National Institutes of Health that will fund advancement of their novel immunotherapeutic into non-human primates, as well as optimization of a cell line for biomanufacturing the drug.

eli-lilly-logo

Eli Lilly and Company (NYSE: LLY) is launching an open innovation challenge to encourage individuals and teams across the U.S. to identify and submit pioneering digital health solutions aimed at transforming inflammatory bowel disease (IBD) care. The challenge, “Transforming IBD Care: Better disease monitoring, management, and care for people with inflammatory bowel disease” focuses on innovation in IBD monitoring, condition management or care enhancements.

Newby-va-bio-logo

Virginia Bio, the statewide non-profit trade association for the life science industry, today announces that John L. Newby II is named CEO, effective August 5, 2019.

Tweet this Newby will be leaving his current role as the Commissioner of the Virginia Department of Veterans Services (VDVS), where he leads an 850-member Agency located across 50 Virginia locations, delivering employment, education, benefits, behavioral health and long term health care services to Virginia’s Reservists, Guardsmen, transitioning service members and 725,000 veterans.

salveo-immunarray-nudge-logo

Three health care-related startups based in the Richmond area have merged their operations with the goal of providing better preventative and personalized medical diagnostics.

The merger brings together Salveo Diagnostics, ImmunArray and Nudge, in what leaders of the three businesses describe as a combination “greater than the sum of its parts.”

childrens-national-7th-symposium-logo

7th Annual Pediatric Device Innovation Symposium | Pediatric Device Clinical Trials: Forging a Better Path

On September 22, 2019, one day before The MedTech Conference powered by AdvaMed, join stakeholders from the industry, government, academia and patient groups for the nation’s leading pediatric innovation symposium where we will focus on unique challenges and opportunities related to pediatric device trials. Now in its seventh year, the one-day symposium, hosted by Children’s National Health System, brings together key leaders in the device space to stimulate pediatric device innovation and bring solutions to market faster for the benefit of children everywhere. Another highlight is the 'Make Your Medical Device Pitch for Kids' competition.

childrens-national-health-system-logo

Innovators and startup companies with devices designed to improve neonatal or NICU care now have a one-week extension until Aug. 19, 2019 to apply for the $150K "Make Your Medical Device Pitch for Kids!" competition funded by the National Capital Consortium for Pediatric Device Innovation (NCC-PDI).

marcus-joel-alexandria-real-estate-image

With technological advancement occurring at an increasingly breakneck pace, it's natural the number of life science and technology innovation clusters is growing as well. These clusters result from the increasing recognition that innovators do not perform at their best in widely dispersed buildings. Instead, they gain most from highly specialized facilities and collaborative ecosystems that foster cross-fertilization of ideas.

biotalk-ethel-rubin-article-image.jpg

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).

angelmd-logo

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. 

nhlbi-small-business-logo

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 (This email address is being protected from spambots. You need JavaScript enabled to view it.) with questions.

medtech-conference-logo

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.

cb-insights-logo

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.

baltimore-inner-harbor-2-pixa

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.

rooster-bio-logo

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.

faes-nih-logo

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.

y-combinator-logo

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.