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Real-World Evidence (RWE) holds out the promise of reducing time and costs of product approvals, identifying new uses for existing products, increasing our ability to treat rare diseases, and improving clinical practices for using drugs and medical devices. The 21st Century Cures Act, enacted in 2016, requires FDA to evaluate the use of RWE in approving new drug indications. FDA in 2017 issued a final guidance document regarding RWE in regulatory decisions involving medical devices. The private sector is also focusing on RWE: more than half the pharmaceutical companies in a recent survey say they are significantly expanding their involvement in RWE. Nonetheless, misunderstandings and uncertainties remain, both about what constitutes RWE and its potential role in regulatory and other aspects of precision medicine.

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As a business owner, I’m often asked to speak to groups about my entrepreneurial journey. One component of my talk involves the importance of long-term thinking. Too often, businesses and politicians fall into the trap of short-term thinking. They focus on making a profit this quarter or succeeding in their re-election campaign without considering the impact of their decisions five, 10 or 20 years down the road.

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The University of Maryland, College Park is seeking a Director for its Office of Technology Commercialization.  The Director leads and manages the OTC, overseeing personnel, budgets, and all aspects of intellectual property cultivation, assessment, protection, and commercialization. The Director establishes and implements strategies to maximize the social and economic impact of University research and discoveries through OTC’s commercialization efforts and its support of related entrepreneurial endeavors. The Director is responsible for developing and meeting annual OTC licensing goals and acts as primary point of contact and steward to resolve problems and issues affecting intellectual property and licensing at all levels within the University.

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In 2017, 25.7 percent of all angel capital group deals went to a founding team with at least one female founder, up from 17.0 percent in 2016, according to the Angel Resource Institute’s (ARI) HALO Report: 2017. The report also found a sizeable increase in the number of deals made for companies that included at least one minority female founder – 5.5 percent in 2017 (1.0 percent in 2016).

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The Biohealth Capital Region–DC, Maryland and Virginia – plans to be a top 3 biohealth hub in the US by 2023. What will it take to get there?

The Biohealth Capital Region is already a top 5 location as ranked by NIH and venture capital funding, patents, lab space, and jobs. The 1,100 participants at this week’s 2018 Biohealth Capital Region Forum agreed on the area’s strengths: a highly educated and diverse workforce, leading universities and research institutions, strong healthcare organizations, hundreds of companies, and broad-based policy commitment to the biohealth industry.

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Competition held during 2018 BioHealth Capital Region Forum

Wilson Sonsini's Charlie Andres and BHI’s Rich Bendis present the team from Galen Robotics
 their award for winning the 2018 Crab Trap competition

ROCKVILLE, MARYLAND, April 26, 2018 – Galen Robotics, a Johns Hopkins University spinout, was chosen from five finalists as the company with the most commercial potential by judges at the 3rd Annual Crab Trap Competition. This year’s judges included industry leaders Amgen’s Bethany Mancilla, AstraZeneca’s Shaun Grady, Blu Venture’s Dr. Paul Silber, J.P. Morgan’s John T. Rubin, New Enterprise Associates’ Sara Nayeem, Roche’s Robert Silverman, and Sands Capital Ventures’ Stephen Zachary. They were impressed with a presentation by Lead Hardware Engineer, Yunus Sevimli, on Galen Robotics’ low-cost, compact, and intuitive to use novel microsurgical robotic platform designed to assist surgeons with minimally-invasive applications in otolaryngology, neurosurgery and similar critical fields. Galen Robotics is the third Johns Hopkins University spinout to win this competition following  LifeSprout (2017) and Sonavex (2016).

Strong presentations also were made by the other finalists--AlgometRx, Cellth Systems, Renalert, and Reveragen Biopharma—whose technologies originated at Children’s National Medical Center, the University of Maryland, and Johns Hopkins University.

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Are you involved in the fight against drug resistant bacteria?  Between June 1 and June 8th, organizations seeking funding to advance antimicrobial technologies (diagnostics, therapeutics or devices) will have the opportunity to submit Expressions of Interest (EOI) to CARB-X.  CARB-X is dedicated to accelerating global antibacterial innovation through targeted funding of focused projects. Only technologies specifically focused on the Pathogens outlined in the CARB-X 2018 Funding Round 2 Scope will be considered.  Now is the time to beginning preparing your EOI.  More information is available on the CARB-X website: http://www.carb-x.org/application

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Is your employee compensation package competitive? 

Help us help you.  Complete the 2018 BHCR Industry Compensation Survey by June 1, 2018 to receive an anonymized summary of salaries and benefits specific to positions in biohealth and to this region.  A pdf version of the survey is available here or you can use the online version of the survey to complete your information.  All company specific information will be kept confidential.  This survey is a joint project among BioHealth InnovationWorkSource Montgomery, and UMBC-Shady Grove’s Industrial Organizational Pyschology Program.  If you or your Human Resources colleagues have any questions about the survey, please contact This email address is being protected from spambots. You need JavaScript enabled to view it..

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MaxCyte, the global cell-based medicines and life sciences company, announced today that it has appointed Claudio Dansky Ullmann, MD, a 25+-year expert in clinical oncology and pharmaceutical research, as its Chief Medical Officer (CMO). In his new role, Dr. Dansky Ullmann is responsible for overseeing clinical development of MaxCyte’s CARMA™ drug development program as the company’s first candidate, MCY-M11, is expected to enter the clinic this year.

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George Mason University President Angel Cabrera said more restrictive immigration policies could threaten the future of regional and national biotechnology industries.

“It is critical for universities to act both as producers of [science, technology, engineering and math] talent and as magnets for top STEM faculty and researchers from around the world. That is our biggest role in the ecosystem,” Cabrera said. “When we mess with immigration policy, our whole system of science and innovation is at stake.

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The Emmes Corporation today announced the creation of an internship program in which the company will offer one fellow from Egypt's Children Cancer Hospital an internship to gain training and experience in clinical research. Under the new program, one fellow will be selected each year to travel to Emmes' headquarters in Rockville, Maryland, to work with its clinical research experts. The duration of each internship will be determined on a case-by-case basis.

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Q Therapeutics, Inc., a developer of clinical-stage cell therapies for central nervous system (CNS) diseases, and REPROCELL Inc., Japan’s first induced pluripotent stem cell (iPSC) company, announced the formation of MAGiQ Therapeutics, Inc., a Japanese joint venture company. MAGiQ will develop iPSC-derived, glial-restricted progenitor cells (GRPs), in collaboration with Q Therapeutics and REPROCELL, to treat demyelinating and degenerative diseases of the CNS.

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QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the U.S. regulatory approval of PartoSureTM , which is a novel test for assessing the risk of spontaneous preterm birth in patients with symptoms of preterm labor. The pre-market approval of PartoSure by the U.S. Food and Drug Administration (FDA) follows successful uptake of the rapid, accurate test in more than 35 countries across Europe, the Middle East, Asia and Latin America. U.S. commercialization of the PartoSure test is expected to begin in 2018.

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More than a dozen biotech companies or researchers from the Maryland biotech cluster, which some have also dubbed ‘Vaccine Alley’, were among the most recognized finalists at this year’s Vaccine Industry Excellence (ViE) Awards in Washington, DC at the World Vaccine Conference.  In fact, 15 out of the 54 finalists, or 27%. were from right here in Maryland.  This year’s conference was held in Washington, DC so could this have been a case of home court advantage?  Probably not. More than likely it’s because this region holds 20% of the top influencers worldwide in vaccine development.

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We hear a lot these days about the so-called “rise of the rest”—the ascent of second-tier American cities such as Pittsburgh, St. Louis, Detroit, and Nashville as challengers to the established tech capitals of the Bay Area, New York, Boston, and Seattle. But the reality is that the rise of the rest is happening mainly in cities outside of the United States.

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On Tuesday, April 3, 2018 TEDCO Incubation Challenge finalist FounderTrac had their first Demo Day at Host Sponsor Loews Annapolis Hotel. After a 12 week, rigorous program 10 FounderTrac finalists pitched to a standing room only atrium of over 200 attendees. Over 50 angel investors and venture capitalists were in attendance creating an energy at the event that truly represents the essence of entrepreneurship. Tami Howie, CEO of the Maryland Technology Council says, “We had a huge number of high quality investors attend our showcase to see the amazing growth of our companies over the last 12 weeks of our FounderTrac program.”

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The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL), a proud member of Manufacturing USA® is pleased to welcome Genentech, Celgene, Merck, MilliporeSigma and EMD Serono (the U.S. businesses of Merck KGaA, Darmstadt, Germany), among others, to its growing membership base.

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The first quarter of 2018 saw a decline in investments, given that global deal activity decreased by 4 percent. Despite the fewer deals, global investment reached $46.5 billion, invested across 2,884 deals. The data was revealed as part of a larger report titled Money Tree, put together by CB Insights and PricewaterhouseCoopers, with focus on the latest trends in venture capital funding globally.

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Don't let your colleagues miss out -- Forward this message to other senior leadership in the Region to invite them to attend the 2018 BioHealth Capital Region Forum. Register with the password: bhcrforum18

The Planning Committee has recently confirmed the participation of Secretary of Health & Human Services, Alex M. Azar II as a keynote speaker. His presentation is an exciting addition to an already robust lineup of speakers.

Check out the BioHealth Capital Region Forum website for regular updates on confirmed speakers and Forum agenda. Download our event application to interact with other attendees and post to the social wall - search for BHCR Forum 2018 in the AppStore or Google Play Store.