BHI Weekly News Archives

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.

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Top 3 by 2023

State of the BioHealth Capital Region’s EcoSystem

Rich Bendis

President & CEO, BioHealth Innovation Inc.

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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. 

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Are you a start-up in Maryland, DC or Virginia seeking feedback on your biohealth business idea, pitch deck, or commercialization plan? business/commercialization plan, pitch deck, or idea?

Schedule your feedback session with BHI EIRs on one of the following dates: 

• 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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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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

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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.

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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.

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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.

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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. 

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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

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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.

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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.

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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.)

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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.

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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.

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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.

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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.)

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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.

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

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

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

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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.

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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.”

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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.

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

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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.

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

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Are you a start-up in Maryland, DC or Virginia seeking feedback on your biohealth business idea, pitch deck, or commercialization plan? business/commercialization plan, pitch deck, or idea?

Schedule your feedback session with BHI EIRs on one of the following dates: 

• 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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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.

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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. 

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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

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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.

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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

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

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BioHealth Innovation, Inc. (BHI), is a Montgomery County innovation intermediary which translates market-relevant research into commercial success by bringing together management, funding, and markets.  BHI is seeking an experienced life science professional with entrepreneurial and investment experience to join the BHI EIR team and serve as an 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 EIR will provide product, corporate and private investment strategy for companies which have SBIR/STTR awards and are ready for the next step towards commercial success.

The NIH is the world’s largest early stage biomedical investor providing nondilutive funding for US companies in the form of grants and contracts through the SBIR/STTR program. In FY19 the Congressional funds set aside for company funding exceeds $1B USD. The EIR program supports NIH interests in commercial success of its SBIR/STTR portfolio companies. 

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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

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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.

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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.

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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.

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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.

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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 (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.

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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.

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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.

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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.

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

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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.

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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.

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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.)

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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.

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Are you a start-up in Maryland, DC or Virginia seeking feedback on your biohealth business idea, pitch deck, or commercialization plan? business/commercialization plan, pitch deck, or idea? Schedule your feedback session with BHI EIRs on one of the following dates: 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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Jeff Gallagher, CEO of Virginia Bio sits down with BioTalk host Rich Bendis to discuss accomplishments, challenges, and initiatives in his state and the BioHealth Capital Region.

Jeff is responsible for leading the premier statewide trade group that promotes the considerable scientific and economic impact of the life sciences industry in the Commonwealth of Virginia. Prior to taking on the leadership of Virginia Bio in May 2012, Jeff was a co-founder and served as VP & General Counsel for Lyotropic Therapeutics. This small specialty pharma company used its proprietary formulation technology to create new drug products based on both NCIs and already approved API for license, further development and commercialization by mid and large pharma. Previously he practiced corporate law in Richmond, focusing on new technology company formation, international business and intellectual property transactions. He was a co-founder and longtime Chairman of the Richmond based nonprofit World Pediatric Project. He holds an A.B. in Government from Harvard, a J.D. from the University of Wisconsin Law School, and an LL.M in Public International Law from the University of Virginia School of Law. He resides with his family in the Ginter Park area of Richmond, VA.

Listen now on iTunes , Google Play , and TuneIn. 

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Last week to register for BioBowl…only a few spots left…and it’s free!

Join us for the 5th Annual BioBowl! You and your company team will be competing against other biotech firms to win the coveted BioBowl Trophy! But first you have to RSVP to claim your spot in the competition.

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BioHealth Innovation, Inc. (BHI), is a Montgomery County innovation intermediary which translates market-relevant research into commercial success by bringing together management, funding, and markets.  BHI is seeking an experienced life science professional with entrepreneurial and investment experience to join the BHI EIR team and serve as an 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 EIR will provide product, corporate and private investment strategy for companies which have SBIR/STTR awards and are ready for the next step towards commercial success.

The NIH is the world’s largest early stage biomedical investor providing nondilutive funding for US companies in the form of grants and contracts through the SBIR/STTR program. In FY19 the Congressional funds set aside for company funding exceeds $1B USD. The EIR program supports NIH interests in commercial success of its SBIR/STTR portfolio companies. 

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Montgomery County has awarded a total of $425,000 in matching grants to 12 small companies who applied for the County’s new Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Matching Grant Program.

In order to qualify, eligible companies must have been awarded a SBIR or STTR Phase 1 or Phase II grant during the current calendar year by the National Institutes of Health (NIH), and 51 percent of research and development operations must be conducted in Montgomery County.

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BHI and Launch Workplaces are co-hosting a series informational programs on topics of interest to early stage companies in Montgomery County’s innovation network. Geared toward biohealth and technology startups, 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).

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 session to discuss their specific scenarios more in depth. Mark your calendars (more details to follow):

10/24 – CMS Reimbursement

11/28 – Legal Issues for Early Stage Companies

1/24 – Tax Implications for Startups

1/29 – Fundraising (SBIR)

2/27 – Fundraising (nonSBIR nondilutive and dilutive)

3/27 – Successful Marketing & PR Strategies

4/24 – Selling to the Government

5/15 – Pricing Factors

6/12 – Staff Recruitment and Retention

For more information/to hold your spot for one of the dates now, email BHI.

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Are you a start-up in Maryland, DC or Virginia seeking feedback on your biohealth business idea, pitch deck, or commercialization plan?  Schedule your feedback session with BHI Entrepreneurs-in-Residence 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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Viral clearance is not a new challenge for the biopharmaceutical industry. However, regulatory demand for better data combined with the growing recognition of the shortcomings of current virus removal and inactivation methods are fostering innovation, according to industry experts.

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ReveraGen BioPharma, Inc. recently announced the initiation and first patient enrollment in a double-blind, placebo- and prednisone-controlled clinical trial (VBP15-004) of vamorolone, a first-in-class dissociative steroidal anti-inflammatory, in Duchenne muscular dystrophy.

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The National Institutes of Health (NIH) Office of Extramural Research (OER) provides the corporate framework for NIH research administration, ensuring scientific integrity, public accountability, and effective stewardship of the NIH extramural research portfolio. The OER is seeking a Supervisory Medical Officer (Research) or Pharm.D. or Ph.D. Clinical Research Nurse to serve as the Director of a new division with oversight for human subjects research and clinical trial policy and process implementation.

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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.)

Read More

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.

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Summer 2018 may have brought more rain than sun, but when it comes to funding at Maryland startups, things have been hot, hot, hot. With top-notch research institutions, an unparalleled technical workforce, and a network of accelerators, Maryland is a hotbed for innovation, so it’s no wonder venture capitalists want Maryland startups in their portfolio. Here’s a snapshot of companies that have recently received VC investments.

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Baltimore-based Cerecor announced the acquisition of Ichorion Therapeutics, a New York–based biopharmaceutical company.

The deal includes an all-stock transaction worth up to $26.6 million, with potential for an additional $15 million in milestones, which could be paid in cash or stock.

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Qiagen announced today that the US Food and Drug Administration has approved the expanded use of the company’s Therascreen EGFR RGQ PCR Kit to allow its use as a companion diagnostic for Pfizer’s Vizimpro (dacomitinib) for first-line treatment of patients with non-small cell lung cancer with EGFR exon 19 deletions or exon 21 L858R mutation.

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CASI Pharmaceuticals, Inc. (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 George Chi to the position of Chief Financial Officer. Dr. Wei-Wu He, Executive Chairman of CASI Pharmaceuticals, commented, “I’m very pleased to announce George’s appointment and welcome him to CASI. George joins us at an opportune time as our company prepares for the marketing and sales of our first oncology product in China. He will be integral to help transition the Company’s financial operations to commercial stage as we launch EVOMELA® and other additional products from our pipeline.”

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New cases of sexually transmitted diseases are on the rise worldwide, and some strains have become resistant to the antibiotics commonly used to treat them.

With the support of a $5.1 million grant from the National Institutes of Health, Jeff Wang a professor in the Whiting School of Engineering’s Department of Mechanical Engineering and member of the school’s Institute for NanoBioTechnology, is leading a team that is creating a device that not only rapidly tests for gonorrhea, but detects if a particular bacterial strain is resistant to antibiotics.

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UM Ventures – College Park, part of the University of Maryland Division of Research, is pleased to announce the addition of new talent to its innovation and commercialization efforts: Ken Porter, director of the Office of Technology Commercialization (OTC) and Stan Smith, venture investment manager. These new hires build on UM Ventures’ strategic goal of unleashing innovation.

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Innovating medical technologies in emerging markets Medical device company with the potential to save up to 2.6M newborn lives a year

In developing countries, many hospitals are overcrowded, understaffed, and lack standard medical equipment, leading to preventable newborn deaths. Neopenda is a for-profit public benefit corporation that is developing technologies to prevent these deaths, including a wearable that captures newborn vital signs so nurses in resource-constrained hospitals can attend to babies in distress.

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When: Thursday, October 11, 20184:30 – 7:30 PM EST Where: UM BioPark801 West Baltimore StBaltimore, MD 21201

bwtech @UMBC Cyber Incubator and Anchor Ventures will co-host a special event celebrating the cybersecurity industry in Maryland. The first part of the event will include an Anchor Ventures Panel discussing “Cybersecurity Issues in Healthcare” from 4:00 PM to 5:30 PM, immediately followed by the renowned CyberTini Networking Reception from 5:30 PM to 7:30 PM. This double feature event will attract C-Level Executives and cybersecurity practitioners and will include comments by the “movers and shakers” in the cybersecurity world.

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Fina Biosolutions announces that the United States Patent and Trademark Office has issued a patent for expression and purification of the conjugate vaccine protein CRM197 in E. coli. CRM197 is a key component of many vaccine formulations utilized worldwide.

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The Biotechnology Innovation Organization applauds the House and Senate’s bipartisan passage of the Small Business Innovation Protection Act. The bill directs increased cooperation between the Small Business Administration (SBA) and the U.S. Patent and Trademark Office (PTO) to improve intellectual property protections for small businesses.

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We are pleased to announce a pitch event will be hosted by MITRE Corporation at the Tysons, VA campus in the Metro DC area on Wednesday, October 10th from 9am-6pm EST.

Join us to hear 10 new startups present their innovations to our ecosystem of industry experts. This will be Starburst’s annual east coast selection committee, so don’t miss out! It’s a great way to make the most of your trip for those of you who plan to be in the DC area for the AUSA conference Oct 7-10.

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Swiss-based Roche announced it is buying UK-based Tusk Therapeutics in a deal that could hit $758 million (U.S.).

Under the terms of the acquisition, Roche is paying $81 million upfront with another possible $677 million in various milestone payments.

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A report released this week at the annual conference of the trade association for medical device and diagnostics companies had a stark message to deliver: invest in customer-centric capabilities and digital collaborations to build personalized health solutions or die.

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Across the state, nearly 120,000 scientists are developing biologically advanced materials with the potential to change the course of our health, environment and even the foods we eat. It’s expanding New Jersey’s reputation from the “medicine chest of the world” to a hub for the life sciences.

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The Collegiate Inventors Competition®, an annual competition that rewards innovations, discoveries and research by college and university students and their faculty advisors, announced today its 2018 Finalists.

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The 2018 Nobel Prize in Physiology or Medicine was awarded on Monday to James P. Allison of the United States and Tasuku Honjo of Japan for their work on unleashing the immune system’s ability to attack cancer, a breakthrough in developing new cancer treatments.

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BioHealth Capital Region moves up one spot to number four, closing in on our goal to be a Top 3 by 2023.

What makes a top-tier biopharma cluster? The standard answers involve a critical mass of resources including the brightest scientific and business minds capable of attracting public and private funding; powerhouse universities and healthcare systems, with endowments reaching into the billions; research institutes, often named for billionaire benefactors; and drug and tools & technology developers that can translate investment into net income.

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Dr. Bill Hearl is the Founder and Chief Executive Officer of Immunomic Therapeutics, Inc. (“ITI”).  He is an experienced and successful scientific businessman and bio-entrepreneur, having founded both ITI and formerly Capital Genomix in 2000.   Dr. Hearl has moved ITI steadily forward from an initial license agreement with the Geron Corporation in 2006 to an animal health license in 2012 and then most recently to two license deals with Astellas Pharma for the treatment of allergies, one for Japanese red cedar and a second global allergy license.  The second deal brought ITI an upfront payment of $300,000,000 and established the Company as one of the leading entities in nucleic acid research.   Dr. Hearl funded the Company by following a strategy of seeking a series of angel investment rounds which raised in aggregate over $12 million to drive the development of its allergy products.   Prior to founding ITI and Capital Genomix, he was a senior executive at Kirkegaard & Perry Labs and then held various R&D positions at Life Technologies and Pharmacia.   Dr. Hearl holds a Ph.D. in Biochemistry from the University of Tennessee (Oak Ridge & Knoxville) and holds multiple patents in the field of gene immunization.

Listen now on iTunes , Google Play , and TuneIn. 

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The Maryland Tech Council (MTC), the state’s largest trade association supporting the technology and life sciences sectors, today announced the appointment of Marty Rosendale as Chief Executive Officer (CEO), effective immediately.

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Join us for the 5th Annual BioBowl! You and your company team will be competing against other biotech firms to win the coveted BioBowl Trophy! But first you have to RSVP to claim your spot in the competition.

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Six companies presenting innovative medical devices that address significant unmet needs in pediatric healthcare were awarded a total of $150,000 in grants yesterday in Philadelphia, Penn.at the Sixth Annual Pediatric Device Innovation Symposiumorganized by the Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National Health System.

The “Make Your Medical Device Pitch for Kids!” competition this year focused on pediatric cardiovascular devices, an area where new devices can make a life-changing difference, especially for younger children. The Centers for Disease Control and Prevention estimate that 40,000 children are born annually in the U.S. with a congenital heart defect (CHD) and approximately 1 million U.S. children currently live with a CHD.

The pitch competition was originally slated to award $100,000 in grants; however, because of the judges’ response to the quality and potential of the technologies presented, Children’s National expanded the award grants to $150,000 to include six awardees.

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Autolus Therapeutics is a promising clinical-stage biotech that is a leader in T-cell programming and manufacturing technology. They have seen rapid growth since launching in 2014, and recently executed a successful US IPO in June that raised $160.4M at a $17 share price and landed them on the Nasdaq (AUTL).

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Samumed said it has sold North American rights to its Phase I idiopathic pulmonary fibrosis (IPF) candidate SM04646 to United Therapeutics, in a deal that could generate more than $350 million for the privately-held San Diego biotech.

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The Association of University Research Parks (AURP) and the University of Maryland have teamed up to present the AURP 2018 International Conference from October 22nd to October 26th. The International Conference attracts 200+ park leaders from around the world for knowledge exchange and networking with industry expert presenters.

AURP is a not-for-profit international organization that focuses on creating communities of innovation and education for university research parks both operating and planned, innovation districts, incubators, accelerators and businesses that cater to the research park industry.

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The Maryland Tech Council (MTC) concluded its Bio+Tech18 Conference yesterday in Baltimore with the announcement of Remedy Plan Therapeutics as the winner of its Inaugural Start-Up Pitch Contest. Remedy Plan Therapeutics is a biotechnology company developing drugs that target cancer stem cells to inhibit tumor growth and proliferation.

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WellSpan Health and Johns Hopkins Kimmel Cancer Center have partnered to launch a grant program to support cancer research.

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In its most recent look at states where innovation and entrepreneurship rank high, the U.S. Department of Commerce Foundation rated Maryland third, highlighting the state as a “national leader in bioscience, biotechnology, and health innovation.”

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Even under the no-holds-barred rules of biotech, it’s a particularly shrewd move, one that might prompt guffaws from knowing insiders.

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On September 23rd, Montgomery County residents will gather at the Music Center at Strathmore in North Bethesda for the Leggett Legacy Forward event celebrating County Executive Ike Leggett and his wife Catherine’s years of outstanding service and their commitment to higher education. The event is a culmination of their effort to establish a legacy gift that will serve the county in perpetuity — the Ike and Catherine Leggett Scholarship. The scholarship will benefit the county’s historically underrepresented students in higher education through the Achieving Collegiate Excellence and Success (ACES) program.

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Monday, October 1, 2018

ACGT and Alexandria Real Estate Equities, Inc., invite you to an Intimate Conversation with Crystal Mackall, MD

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Learning Undefeated is a mobile education program serving Southeast Texas schools devastated by Hurricane Harvey. Using a self-contained science classroom on wheels as its home base, the program provides teaching space and scientific equipment, lab supplies, during- and after-school activities, and public outreach to communities whose classrooms and science labs were destroyed during the August 2017 hurricane.

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