BioHealth Innovation
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September 10, 2019


Kinexum’s Dr. Zan Fleming, M.D. and Thomas Seoh join Rich Bendis on BioTalk

Dr. Zan Fleming, M.D. and Thomas Seoh of Kinexum join Biotalk host Rich Bendis to discuss the company, Metabesity, and their upcoming 2019 Conference in Washington, DC

Listen now on Google Podcasts, iTunes, and TuneIn

Dr. Alexander Fleming is Founder and Executive Chairman of Kinexum, a company with diverse expertise in developing drugs, biotech products, medical devices and digital health technologies. He is also Executive Vice-President of Tolerion, a biotechnology company developing disease-modifying treatments for type 1 diabetes and other autoimmune diseases. Dr. Fleming received his M.D. and internal medicine training from Emory, fellowship training in endocrinology at Vanderbilt and metabolism at National Institutes of Health, where he was a senior fellow. 

At the US Food and Drug Administration from 1986-98, Dr. Fleming was responsible for the therapeutic areas of diabetes, other metabolic and endocrine disorders, growth and development, nutrition, lipid-lowering compounds, and reproductive indications.  He led reviews of landmark approvals including metformin and the first statin, insulin analog, PPAR-agonist, and growth hormone for non-GH deficiency indications. He conceived and directed the first FDA pilot project to utilize the internet for regulatory communication and represented FDA on the expert working groups for Good Clinical Practices and General Considerations for Clinical Trials of the International Conference on Harmonisation (ICH) and participated on other ICH committees including the Common Technical Document working group.  

Dr. Fleming remains active in supporting the development of diabetes-related preventions, treatments, devices, and digital technologies.  He serves on the joint technology working groups of the European Association for the Study of Diabetes and American Diabetes Association.   

Thomas Seoh is President and CEO of Kinexum, a strategic advisory firm that provides regulatory, clinical, CMC and other translational guidance for life science product development.  He is an entrepreneur/executive who has held senior leadership positions in public and private pharmaceutical, biotech and medical device companies for over 25 years. 

Mr. Seoh began his career as a corporate attorney in New York and London, then assumed legal management positions with the Consolidated Press group in Livonia, MI, then the ICN Pharmaceuticals group in Costa Mesa, CA.  He next became VP, General Counsel and Secretary, and later, SVP Corporate and Commercial Development, of Guilford Pharmaceuticals, a NASDAQ-listed company in Baltimore which commercialized GLIADEL® wafer for glioblastoma multiforme and developed the propofol pro-drug LUSEDRA® and small molecules for Parkinson’s disease.  He then became CEO of venture-backed Faust Pharmaceuticals in Strasbourg, France, with a repurposed compound in Phase II for Parkinson’s patients, a re-positioned molecule for Duchenne muscular dystrophy and a GPCR drug discovery platform. 

Mr. Seoh subsequently served in leadership positions of medical device startups developing an ex vivo liver dialysis device, a novel mechanical thrombectomy device for Deep Vein Thrombosis and stroke and a state-of-the-art neurocatheter, and a plant-based skin substitute wound dressing.  He has served on industry-university advisory boards at Johns Hopkins School of Medicine and the University of Maryland Baltimore County.  He holds an AB in Philosophy and History and a JD from Harvard University.

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Save the Date: BioHealth Capital Region Investment Conference October 15 + 16

By invitation only: For questions email

Gaithersburg, MD

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Come join us for the 6th Annual BioBowl!

You and your company team will be competing against other biotech firms to win the coveted BioBowl Trophy and bragging rights!

...Until next year

Date: Thursday, October 10th, 2019

Time: 4:00 - 6:30 PM (TBC)

Location: Bowlmor – 15720 Shady Grove Rd, Gaithersburg, MD 20877

Invitation to follow.

Hosted by BioHealth Innovation and AstraZeneca

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Startup CXO Database

Are you an experienced biohealth entrepreneur seeking new opportunities in the BioHealth Capital Region? BioHealth Innovation is developing a database of experienced industry personnel willing to work in potential C-suite positions with our university and startup partners. If you would like to have your contact information and vita included in this database for their review and have not done so already, please submit your information to BHI via this form.   

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BHI Immediate Job Opening: Analyst

BHI is looking to add to our team! We have a new opening for an Analyst. Our analysts assist in the evaluation of early-stage technologies and provide strategic planning and operational support for start-up companies. They support the BHI organization by strategically managing and providing information, intelligence and insights that drive critical business decisions. For details on this exciting role and information on how to apply click here.

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Hard to Find Small Lab Space!

708 Quince Orchard Road, Gaithersburg, Maryland

Three move-in ready laboratory/office modules; each approximately 1,200 RSF with communal services and amenities designed to facilitate collaboration.

  • Fully fit out laboratory space
  • Office space includes one furnished office and two workstations
  • Communal space includes reception/lobby area, pantry, conference rooms, IT closet, autoclave, glass wash, and ice maker
  • BioHealth Innovation will provide their Startup and Entrepreneur-in-Residence programs and various supporting services to guide and facilitate the growth of early-stage companies
  • FitLab, Alexandria’s state-of-the-art fitness center, is located in close proximity

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A Uniquely Positioned GMP BioManufacturing Facility Hits the Market in Maryland · BioBuzz

Biotech is booming across the country, especially in the top biotech clusters like Boston, San Francisco, New York and in the BioHealth Capital Region (BHCR). The global biotechnology market is expected to reach $775.2 billion by 2024 at a compound annual growth rate of 9.9 percent.

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Viela Bio Announces Publication in The Lancet of Pivotal Study Results of Inebilizumab in Patients with Neuromyelitis Optica Spectrum Disorder | Business Wire

Viela Bio today announced that peer-reviewed journal, The Lancet, has published results from its pivotal study of inebilizumab in patients with neuromyelitis optica spectrum disorder (NMOSD). NMOSD is a rare, severe, relapsing, neuroinflammatory autoimmune disease that can result in severe muscle weakness and paralysis, loss of vision, respiratory failure and neuropathic pain.

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Frederick biotech Veralox Therapeutics raises $5.4M to support drug development, trials - Baltimore Business Journal

Veralox specializes in developing drugs to address unmet medical needs. It is currently working on therapies to target type 1 diabetes and a medication-induced immune disorder.

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Machfu Awarded $1M Phase II Extension SBIR Grant from the Department of Energy | Business Wire

Machfu, an industrial Internet of Things technology company, announced today that it has been awarded the Small Business Innovation Research (SBIR) Phase II extension grant for $1 million by the U.S. Department of Energy (DOE). Machfu won the Phase II award in 2017.

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Children's National and NCC-PDI Announce $150K NICU Medical Device Competition Finalists and Symposium Keynote Speakers | BioSpace

Organizers of the $150K "Make Your Medical Device Pitch for Kids!" competition today announced the 12 finalists who are advancing to the live pitch component of the competition scheduled for Sept. 22 during the 7th Annual Pediatric Device Innovation Symposium hosted by Children's National Health System. The pitch competition, sponsored by the National Capital Consortium for Pediatric Device Innovation (NCC-PDI), focuses on Neonatal Intensive Care Unit (NICU) innovations, a pediatric subspecialty that the Food and Drug Administration (FDA) identifies as having a significant unmet need for medical devices.

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Downstream Processing of Complex Molecules, Pure and Simple

Making a therapeutic that contains biological components is just the start of creating a medicine. Then, biopharmaceutical companies must capture that drug and ensure that it’s free of contamination. New techniques and technologies can accomplish that capture and cleanup more simply and economically.

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REGENXBIO Announces Exclusive Worldwide Option and License Agreement with Clearside Biomedical for Evaluation of In-Office Delivery Platform for RGX-314

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 Clearside Biomedical, Inc. (Nasdaq: CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, today announced an option and license agreement for exclusive worldwide rights to Clearside's proprietary, in-office SCS Microinjector™ for the delivery of RGX-314 to the suprachoroidal space to treat wet age-related macular degeneration (wet AMD), diabetic retinopathy (DR) and other conditions for which anti-vascular endothelial growth factor (anti-VEGF) treatment is currently the standard of care. REGENXBIO plans to evaluate RGX-314 using Clearside's SCS Microinjector for in-office, non-surgical delivery into the suprachoroidal space, while continuing to advance its RGX-314 subretinal delivery program currently in development for wet AMD and DR.

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PeopleOnTheMove - September 2019 - BioBuzz

There were 5 New Hires and Promotions in the #BioHealthCapitalRegion in the month of August! Check out all the #PeopleOnTheMove Here Facility Logix LLC Ceres Nanosciences, Inc. Vaccitech CRB

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Built for Bio: Integrated BioTherapeutics on Vimeo

M. Javad Aman, PhD, President and CEO of Integrated BioTherapeutics, explains how his Montgomery County company is focused on discovery research for the development of new vaccines and therapies to fight emerging infectious diseases.

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Microsoft (MSFT) Teams Up With AstraZeneca on AI Incubator - Bloomberg

Microsoft Corp. is teaming up with U.K. drugmaker AstraZeneca Plc on creating a health-tech incubator in Paris aimed at bringing new solutions to the field’s most difficult problems.

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SBIR Road Tour Coming to UMD- Last Chance to Register!

College Park, Maryland, will serve as a SBIR Road Tour stop for the state of Maryland, and will provide attendees with an opportunity to hear directly from the participating federal agency program managers that administer over 5,000 new awards annually. Register today for a one-on-one appointment with your choice of agencies!

The SBIR Road Tour is a national outreach effort connecting entrepreneurs working on advanced technologies to the country’s largest source of early stage funding – the SBIR/STTR programs. Also known as America’s Seed Fund, the SBIR/STTR programs provide over $3 billion in funding to small businesses each year in a wide variety of technology areas.

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Johns Hopkins University announces new center for psychedelic research - ABC News

Johns Hopkins University is launching a new center for psychedelic research that will use psychedelic drugs to study the mind and therapies for diseases like addiction.

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Versant backs new, medtech-focused Vensana Capital fund, launching with $225M | FierceBiotech

Vensana Capital—an independent, medtech-focused venture capital investment firm supported by Versant Ventures—has launched with a $225 million fund and ambitions to support new breakthroughs in medical devices, diagnostics and data science.

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Key details in Viela Bio’s $150 million IPO - Washington Business Journal

It’s a pivotal moment for the MedImmune spinout, which has put the fate of its first prospective product in regulators' hands.

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Bristol-Myers teams with BioMotiv to build and buy biotechs | FierceBiotech

Bristol-Myers Squibb has allied with biotech accelerator BioMotiv. The deal sets Bristol-Myers up to found and fund biotechs with BioMotiv before going on to acquire them outright once a preclinical candidate is identified.

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America's Most Innovative Leaders: 24 healthcare leaders on the list

Forbes released its annual list of the country's most innovative leaders, comprising 100 founders and CEOs known for encouraging creative and highly successful innovation at their organizations.

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Here are the six winners of Johnson & Johnson's innovation challenge - Ventureburn

Healthcare giant Johnson & Johnson today announced the six winners of the Champions of Science Africa Innovation Challenge 2.0 at the 28th World Economic Forum on Africa in Cape Town.

The winning teams will get share of $300 000 prize pool, along with extensive mentoring and network building to support the expansion and sustainability of the companies and their programmes.

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2 new unicorns, over $550 million in funding, in Bay Area at end of week - Silicon Valley Business Journal

Two more Bay Area companies hit unicorn valuations of $1 billion or more at the end of the week as part of more than $550 million in funding that was disclosed in the region. Here's more on that and other venture news.

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What if aging weren’t inevitable, but a curable disease? - MIT Technology Review

Each Cyclops had a single eye because, legend has it, the mythical giants traded the other one with the god Hades in return for the ability to see into the future. But Hades tricked them: the only vision the Cyclopes were shown was the day they would die. They carried this knowledge through their lives as a burden—the unending torture of being forewarned and yet having no ability to do anything about it.

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10 Takeover Targets to Watch This Fall

Viewed simply by dollar value, the value of mergers-and-acquisitions (M&A) activity appeared to be zooming in the first half of this year: Statistics compiled for GEN by Informa Pharma Intelligence’s Medtrack and Strategic Transactions services showed a total $184.05 billion worth of deals for which values were disclosed, up nearly 38% from the $133.73 billion recorded for January–June 2018.

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The Link Between Drug Prices and Research on the Next Generation of Cures | ITIF

Congress and the Trump administration are considering proposals to reduce the price of drugs, but there is a strong causal link between current drug prices and revenues on one hand and future drug research and treatments on the other. Policymakers should keep in mind this trade-off between short-term affordability and long-term innovation: Reducing drug revenues today will lead to a decline in future R&D and a decrease in the number of new drug discoveries.

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