325th Edition – October 16, 2018

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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