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BHI Weekly Newsletter Archives

545th Edition, February 7, 2023

By BHI Weekly Newsletter Archives
 

 

 

 

BHI EIR Feedback Day โ€“ February 15
 

This free 1:1 virtual session is an opportunity to discuss your company with experts in diagnostics, therapeutics, digital health and medical devices.

If youโ€™re a growth-stage biohealth company looking for unbiased advice on your pitch deck, commercialization strategy, evidence development or entrepreneurial challenges, our EIRs can help.

To request a feedback session, please send a non-confidential pitch deck, and a short description of the input youโ€™re seeking from the EIRs, to Sarah Miller   ‘smiller@biohealthinnovation.org’,this)” rel=”noreferrer”>smiller@biohealthinnovation.org  

The requested information should be received by our office at least 2 weeks in advance, so that we can schedule the appropriate experts. 

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Deka Biosciences Receives FDA Clearance of DK210 (EGFR) Investigational New Drug Application
 

GERMANTOWN, Md., Jan. 30, 2023 /PRNewswire/ — Deka Biosciences (“Deka”), a biotech company focused on developing novel cytokine therapies to treat cancer and inflammatory diseases, today announced that the U.S. Food and Drug Administration (FDA) has completed its review of the investigational new drug (IND) application for DK210 (EGFR) and concluded that Deka may proceed with a Phase 1 clinical trial in the United States. The Phase 1, first-in-human, multicenter clinical study seeks to characterize the safety, and biomarkers for response of DK210 (EGFR) in patients with advanced solid cancer who are overexpressing epidermal growth factor receptors (EGFR) (NCT05704985).

 

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Cartesian Therapeutics Announces Dosing of First Participant in a Phase 2b Randomized Clinical Trial for Generalized Myasthenia Gravis โ€“ Cartesian
 

 First placebo-controlled study of an engineered cell therapy

Gaithersburg, MD, January 31, 2023 โ€“ Cartesian Therapeutics, a fully integrated, clinical-stage biotechnology company pioneering RNA cell therapies for autoimmune diseases and cancer, has dosed the first participant in its Phase 2b randomized controlled trial (RCT) for generalized myasthenia gravis (MG), an autoimmune disorder that causes muscle weakness and fatigue. The RCT will evaluate the efficacy and safety of the companyโ€™s lead asset, Descartes-08, a first-in-class, RNA-engineered chimeric antigen receptor T-cell therapy (rCAR-T).

 

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Canon posts record revenues in medical business unit
 

Stronger sales in Europe and the U.S. helped offset declining demand in Japan for the Medical Business Unit of Japanese industrial conglomerate Canon for the companyโ€™s fiscal 2022. The company said that sales in the medical division grew almost 7%, to the highest level in the history of the business unit.

For the year, Canon Medical saw sales of 513.3 billion yen ($3.970 billion), representing growth of 6.9% compared to the full-year 2021 numbers. The medical divisionโ€™s income before taxes fell by 7% to 31.9 billion yen ($246.7 million) โ€“ the prior-year numbers were boosted by an increase in deductions related to a corporate acquisition.

 

 

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Montgomery County Perfect Home for ARPA-H
 

The newly established Advanced Research Projects Agency for Health (ARPA-H) will accelerate cutting-edge biomedical and health research, moving discoveries from the laboratory to patients more quickly, sustainably and equitably than ever before. As the agency seeks to remove roadblocks to solving some of the biggest challenges in health today, Montgomery County, Md., is uniquely positioned to support this crucial federal agency and the ideal home for ARPA-H.

Image: MCEDC

 

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WJLA: Maryland’s Medcura Recognized For Innovative Biosurgical Tech (Video)
 

Prince George’s County, Maryland based Medcuraโ€™s is pioneering a proprietary biosurgical technology that has repeatedly demonstrated the rapid arrest of difficult-to-control surgical bleeding. With help from TEDCO, a Maryland based venture capital leader, Medcura is working to become the next standard of care in surgical bleeding management. In the television program โ€œStephen Hawkingโ€™s Science of the Futureโ€ Medcura was featured in an episode as a top innovative product of this decade for its ability to quickly stop bleeds using naturally abundant and highly economical ingredients.

Click here for more.

 

 

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Quality Biological Inks 24,000 SF Lease at Shady Grove Development Park in Gaithersburg, MD
 

GAITHERSBURG, M.D. โ€“ Transwestern Real Estate Services (TRS) announces Quality Biological, Inc. has signed a 24,000-square-foot lease at Shady Grove Development Park, a 745,000-square-foot, 10-building mixed-use project in Gaithersburg, Maryland. Transwestern Senior Vice Presidents Guy Copperthite and Jim Darby represented Quality Biological in negotiations with property owner Minkoff Development Corporation.

Quality Biological has provided contract manufacturing solutions to the life science and biotech research industry for nearly 40 years. The company takes occupancy of its new space in July 2023.

 

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AMPEL BioSolutions’ Breakthrough Predicts Drug Options for Fibromyalgia
 

CHARLOTTESVILLE, Va., Jan. 31, 2023 /PRNewswire/ — AMPEL BioSolutions today announces a breakthrough in precision and personalized medicine that could revolutionize the way doctors treat chronic pain syndromes, such as fibromyalgia. Revealed in the peer-reviewed journal Lupus Science and Medicine, the paper details AMPEL’s breakthrough approach to characterize the underlying disease activity from gene expression data obtained from patient blood samples.

The FibroGENEยฎ lab test, only a concept for the last few years, is now ready for development for practical use as a decision support biomarker test that could greatly impact health care by allowing physicians to identify the cause of patient disease symptoms and select appropriate treatment more precisely.  AMPEL’s initial focus is fibromyalgia that affects Lupus patients, but the test can be used for millions of Americans diagnosed with fibromyalgia every year.

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Tonix Pharmaceuticals Announces Research Agreement with University of Maryland, Baltimore for Study
 

Tonix Pharmaceuticals Announces Research Agreement with University of Maryland, Baltimore, to Study TNX-1500 (Fc-modified anti-CD40L mAb) for the Prevention of Rejection in Heart Xenograft Transplantation in Animals

Research Study to Assess the Role of TNX-1500 in the Prevention of Heart Xenograft Rejection

Preclinical Xenotransplantation Studies are Expected to Support Regulatory Filings for TNX-1500

CHATHAM, N.J., Feb. 01, 2023 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced that it has entered into a sponsored research agreement with the University of Maryland, Baltimore (UMB), for the prevention of rejection in heart xenograft transplantation in animals utilizing TNX-15001, an Fc-modified humanized monoclonal antibody directed against CD40-ligand. UMBโ€™s preclinical studies will utilize genetically-modified porcine hearts supplied by Revivicor, Inc., a subsidiary of United Therapeutics Corporation. The principal investigator is Muhammad M. Mohiuddin, M.D., MBBS, Professor of Surgery, and Director, Cardiac Xenotransplantation Program, University of Maryland School of Medicine.

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TEDCO chooses 24 MD companies for SBIR/STTR Proposal Lab cohort
 

TEDCO, Marylandโ€™s economic engine for technology companies, Tuesday announced the selection of 24 Maryland companies to participate in the FY2023 FAST SBIR/STTR Proposal Lab cohort.

This program, now in its fifth year, supports companies in the cohort, allowing them to work with TEDCO experts on preparing polished proposals for up to $275,000 in federal awards through the SBIR/STTR Phase 1 program.

The companies in this yearโ€™s cohort encompass a variety of technology disciplines, from medical devices to quantum computing to even biomanufacturing.

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Intro to Tech Transfer Course Offered at Montgomery College for Spring 2023
 

The Technology Transfer Society โ€“ Washington D.C. chapter is running an Introduction to Technology Transfer and Commercialization course in conjunction with Montgomery College. The course will be given in a hybrid format to allow for both virtual and in-person attendance.

This course is intended to provide students with an overview of the entire technology transfer process โ€“ moving technologies from the lab to market. This course is a great overview for anyone interested in learning more about the operations of a technology transfer office or those looking to understand how to commercialize their own invention. Students will hear from experienced professionals to broaden their understanding of technology transfer.

This Spring 2023 course (SMB035) will take place starting February 8th  on the Montgomery College Rockville Campus each Wednesday from 6-8:40 p.m. For more details on the course see here .

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Phlow Corp. Announces Formation of Business Advisory Board, New Board of Directors Appointment and Corporate President as Company Accelerates Towards Next Stage of Growth
 

Richmond, Virginia, Feb. 02, 2023 (GLOBE NEWSWIRE) — Phlow Corp., a U.S.-based public benefit corporation leveraging advanced manufacturing processes to re-imagine the domestic production of pharmaceutical products critical to U.S. healthcare, announced today the formation of the Phlow Business Advisory Board made up of internationally recognized pharmaceutical, biotech, and healthcare leaders who bring a wealth of knowledge and industry experience to the company; the addition of Melinda Hancock of Sentara Health System to Phlowโ€™s Board of Directors; and the promotion of Dan Hackman from Chief Business Officer to President.

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AURP BIO Health Caucus 2023
 

AURPโ€™s BioHealth Caucus will examine topics, including:

  • Economic impact of the biotech industry in the U.S.
  • New biotech hubs growing in VA, NC, OK, MO, and NH
  • Building the biotechnician workforce
  • Bio innovation impact from the federal multi-billion-dollar CHIPS + Science Act
  • Significance of the Bayh-Dole Act and life science IP to keep the U.S. competitive
  • Bio manufacturing in space
  • Award winning life science incubators, accelerators, and labs
  • Importance of the business press covering the biotechnology community
  • NIH funding for small business bio hubs
  • Emerging role of quantum computing in drug discovery
  • Special presentations from state bio infrastructure in MA and MD
  • Plus, an optional tour of Harvardโ€™s Science and Engineering building and Harvard Allston Enterprise Research Park

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Biohealth geared for growth
 

WIB-Capital Region: 5th Annual HERstory Gala

Thursday, April 27, 2023 – 6:30 p.m. โ€“ 9:30 p.m. ET

Join WIB-Capital Region to honor outstanding women in our local bioscience sector!

The HERstory Gala is the premier event for our chapter and its supporters. This elegant event attracts men and women from industry, government, non-profit organizations, and academia across the Capital Region Metro Area. It provides unique opportunities to meet with some of the region’s most successful women. This event highlights women trailblazers in the life sciences who have significantly impacted the region. Additionally, awards will be presented to the 2022 WIB Inclusion Grantee and the 2022-2023 Rising Star Award Winner.

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BioTalk biz gif

544th Edition, January 31, 2023

By BHI Weekly Newsletter Archives

 

 

BHI Life Science Business Strategists join Rich Bendis on BioTalk
 

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BHI EIR Feedback Day โ€“ February 15
 

This free 1:1 virtual session is an opportunity to discuss your company with experts in diagnostics, therapeutics, digital health and medical devices.

If youโ€™re a growth-stage biohealth company looking for unbiased advice on your pitch deck, commercialization strategy, evidence development or entrepreneurial challenges, our EIRs can help.

To request a feedback session, please send a non-confidential pitch deck, and a short description of the input youโ€™re seeking from the EIRs, to Sarah Miller   ‘smiller@biohealthinnovation.org’,this)” rel=”noreferrer”>smiller@biohealthinnovation.org  

The requested information should be received by our office at least 2 weeks in advance, so that we can schedule the appropriate experts. 

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2022 Marked Record Investment in Montgomery County, Maryland Companies
 

ROCKVILLE, Md., Jan. 24, 2023 /PRNewswire/ — Montgomery County companies had a record year of investment in 2022, with more than $29.9 billion in combined initial public offering (IPO), merger and acquisition, private investment and venture capital deals. That is an increase from $4 billion in 2020 and more than $18 billion in 2021. In all, Montgomery County had 144 deals across 126 companies in 2022.

“The record investment in Montgomery County companies is a testament to the region’s remarkable climate of business growth and innovation,” said Bill Tompkins, President and CEO of the Montgomery County Economic Development Corporation. “We are a premier destination with a powerful network of existing businesses across a wide range of industries. Our deep talent pool, diverse and vibrant communities, and proximity to the federal agencies including the Departments of Transportation and Energy, FDA, and NIH position the County’s companies for success.”

 

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Frederickโ€™s QuartzBio Acquires SolveBio
 

QuartzBio, a Part of Precision for Medicine, Acquires SolveBio and Expands Software-as-a-Service (SaaS) Data Management Solutions for Clinical Research & Development (R&D)

QuartzBioโ€™s suite of end-to-end SaaS solutions provides pharmaceutical and biotech clients with a fully connected data ecosystem linking sample, biomarker, and clinical data to improve collaboration, planning, and R&D productivity.

Frederick, MD โ€“ January 24, 2023 โ€“ Precision for Medicine, the first global, precision medicine clinical research services organization, today announced the strategic acquisition of SolveBio by QuartzBio.

SolveBioโ€™s intelligent technologies and enterprise data management platform has integrated into QuartzBioโ€™s suite of SaaS solutions, providing a single, scalable solution supporting clinical sample inventory management and biomarker data management for the biotech and pharmaceutical sectors.

 

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BioBuzz: BioHealth Capital Region Eyes Continued Growth in 2023, Charts New Goals Amidst Tough Economic Headwinds
 

By Alex Keown
January 24, 2023

BioHealth Innovationโ€™s lofty goal of the BioHealth Capital Region (BHCR) achievement of โ€œTop 3 by 2023โ€ is not likely to be reached this year due to inflation and uncertain economic conditions.

Thatโ€™s the assessment of Rich Bendis, President and Chief Executive Officer of BHI, who has championed the regionโ€™s transition into a top four biopharma hub in the United States. However, given the state of the economy and the amount of money being invested, Bendis said it is unrealistic to expect the region to move up the ranking of the top 10 life sciences regions compiled by Genetic Engineering & Biotechnology News (GEN).

 

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4 startups win Children’s National, Oracle Health’s digital pediatric competition
 

The Bear Institute, a pediatric health IT collaboration between Washington, D.C.-based Children’s National Hospital and Oracle Health, has named four startup companies as the winners of its second annual pediatric digital health innovation competition.

The competition, dubbed the Bear Institute Pediatric Accelerator Challenge for Kids, allows startups to share their innovations and receive feedback from judges while competing for a chance to win an on-site pilot and software development support, according to a Jan. 17 release from Children’s National.

 

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WBJ: Germantown’s Precigen raises $75M to advance treatments for rare diseases
 

Germantownโ€™s Precigen Inc. (NASDAQ: PGEN) has raised $75 million in a public offering that closed Friday and intends to use the proceeds to speed development of its experimental treatments for multiple rare diseases.

The clinical-stage biotech, which is developing gene and cell therapies for cancers, autoimmune disorders and infectious diseases, sold 42.86 million shares of common stock for $1.75 each. The company also gave the underwriters an option to buy up to 6.43 million additional shares in the 30 days after it filed an updated prospectus Jan. 26 with the Securities and Exchange Commission.

 

 

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Chancellor’s Message: The Story of Our Success
 

As many of us were winding down our work over the winter holidays, my colleagues at the University System of Maryland were putting the finishing touches on our 2022 Annual Report. And while the new year compels us to look ahead with purpose, the report gives us a chance to look back at what’s brought us to our place of strength.

The annual report breaks down progress on our five strategic priorities: Innovate the education we provide our students. Make that education accessible to all. Prepare students for jobs that will write Maryland’s future. Conduct and commercialize research that changes the world. Center equity and justice in everything we do.

 

 

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New Enterprise Associates raises $6.2 billion across two funds – Washington Business Journal
 

It’s the largest pool of capital the company has raised in its 46-year history.

Image: Workday Inc. is among the more than 270 companies New Enterprises Associates has invested in that later went public. TODD JOHNSON | SAN FRANCISCO BUSINESS TIMES

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Novavax Announces Plan to Deliver Updated Protein-based Vaccine
 

Novavax Announces Plan to Deliver Updated Protein-based Vaccine Consistent with FDA Recommendations for 2023/2024 Vaccination Season at VRBPAC Meeting

Jan 27, 2023

FDA Advisory Committee votes to harmonize vaccine strain composition of primary series and booster doses Novavaxโ€™ protein-based option remains an important part of the current U.S. vaccine portfolio

Novavax participated in yesterdayโ€™s U.S. Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committeeโ€™s (VRBPAC) meeting, which resulted in a unanimous vote recommending harmonizing vaccine strain composition of primary series and booster doses. During the meeting, Novavax shared data demonstrating that the Novavax COVID-19 Vaccine, Adjuvanted (NVX-CoV2373), when used as a booster induces a broad functional immune response, including against forward drift variants.

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Computational Drug Discovery With Gain Therapeutics Matthias Alder
 

In conversation with Mathias Alder, CEO of Gain Therapeutics discussing his personal life insights and professional achievements in the field of Computational Drug Discovery. Matt Pillar:  A few months ago, I set out to learn as much about computational biology and as myriad applications in Biotech as I could. And on more than one occasion, that effort led me to a Zoom call with Matthias Alder. That my inquiry resulted in multiple opportunities to talk with Matthias made me happy. One, because heโ€™s a really great guy, and two, because while his companyโ€™s drug discovery model leans heavily into proprietary structure based computational methods, heโ€™s not one of these bombastic, over the top futurists whoโ€™s all in on relinquishing science to the algorithms. Just the opposite, heโ€™s pragmatic and practical about the advantages and the limitations of deploying computational tools in an industry whose mission it is to save lives by injecting things into living human bodies.

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Intro to Tech Transfer Course Offered at Montgomery College for Spring 2023
 

The Technology Transfer Society โ€“ Washington D.C. chapter is running an Introduction to Technology Transfer and Commercialization course in conjunction with Montgomery College. The course will be given in a hybrid format to allow for both virtual and in-person attendance.

This course is intended to provide students with an overview of the entire technology transfer process โ€“ moving technologies from the lab to market. This course is a great overview for anyone interested in learning more about the operations of a technology transfer office or those looking to understand how to commercialize their own invention. Students will hear from experienced professionals to broaden their understanding of technology transfer.

This Spring 2023 course (SMB035) will take place starting February 8th  on the Montgomery College Rockville Campus each Wednesday from 6-8:40 p.m. For more details on the course see here .

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3 predictions for biotech in 2023 – BIO.News
 

The biotechnology industry is one of the riskiest and the most challengingโ€”but it is also one of the few that makes the difference between life and death.

In recent years, biotech has given us major breakthroughs: vaccines that provide protection from lethal viruses; a lupus treatment approved for use in children with the first new mechanism of action in more than 50 years; and significant progress in hematology with the approval of a bispecific antibody for multiple myeloma.

Image: Dinesh Patel, PhD, CEO of Protagonist Therapeutics (PTGX)

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A $365 million development will expand the life sciences hub at Pennovation Works | Penn Today
 

Pennovation Works, the 23-acre University of Pennsylvania property just across the Schuylkill River from the core campus, has long been a site for innovation. Home to a ferry business in the 18th century, a paint company in the 19th century, and a DuPont chemical research facility for much of the 20th century, the space underwent a further transformation in 2016 with the establishment of the Pennovation Center, an incubator for science and technology startups, many of which have their origins within the University. Last year, the 65,000 square foot Pennovation Lab opened, offering larger lab spaces for companies outgrowing their previous locations.

Image: A view of the new research, development, and biomanufacturing facility from the intersection of Grays Ferry Avenue and 34th Street on the Pennovation Works property. (Image: Longfellow Real Estate Partners)

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Biohealth geared for growth
 

By Cho KyooHong

On Jan. 9, the Ministry of Health and Welfare reported to President Yoon Suk Yeol concerning its 2023 plan, of which the main tasks include leaping forward as a leading country in the field of biohealth through human resource cultivation, deregulation and export support.

Noting that a large number of quality jobs can be created as the biohealth industry grows, President Yoon called for strong support from the government for domestic enterprises to be up to global standards, which requires a tax benefit corresponding to that of the semiconductor sector, capacity development and a solid industrial ecosystem.

Image: Minister of Health and Welfare Cho Kyoo-hong

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These Venture Veterans Have Launched A $350 Million Fund Aimed At Digitizing Life Sciences
 

At first glance, it seems like a rough time for venture capital, especially in the healthcare industry. Overall, venture investments in 2022 were down 35% from 2021, according to CB Insights, with digital health investments down over 50%. Biopharma investment beat the trend a little bit, according to Evaluate Vantage, down only 23% from the year before.

Image: Dimension founders Zavian Dar, Adam Goulburn and Nan LiDIMENSION

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543rd Edition, January 24, 2023

By BHI Weekly Newsletter Archives

 

 

 

 

 

BioHealth Innovation Announces Two New Entrepreneurs-in- Residence at the National Institutes of Health
 

ROCKVILLE, MARYLAND, January 23, 2021 โ€“ BioHealth Innovation Inc. (BHI) announces the addition of Luis Gutiรฉrrez and John K. Hsu, Ph.D., J.D., to the growing Entrepreneurs-in-Residence (EIR) team. Luis will work with the NIH Office of Extramural Research (OER), while John will work with The National Heart, Lung, and Blood Institute (NHLBI).

The OER manages the NIHโ€™s extramural research program, providing guidance and support to staff, grantees, and the public on funding opportunities, policies, and regulations. It also oversees the review, award, and administration of grants and contracts for biomedical and behavioral research conducted outside of the NIH. In addition, the NHLBI conducts and supports research on the causes, prevention, diagnosis, and treatment of heart, blood vessel, lung, and blood diseases. It also works to improve the health of individuals and populations through education and public health initiatives.

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BioHealth Innovation, Inc. (BHI) and Montgomery County Announce Kevin Heller, MD as a part-time โ€œExecutive in Residenceโ€
 

BioHealth Innovation, Inc. (BHI) and Montgomery County are pleased to announce the selection of Kevin Heller, MD as a part-time โ€œExecutive in Residenceโ€โ€”a position dedicated to providing 1:1 technical assistance to Montgomery County-based biotech and medtech startups.

Heller will join two previously announced โ€œMoCoโ€ Executives in Residence, Jen Butler and Luis Guitierrez, who have been working closely with local entrepreneurs since November.

โ€œโ€‹I am eager to join Jen and Luis as we strengthen our communityโ€™s biohealth cluster,โ€ said Heller. โ€œStarting and growing a successful biotech company takes patience, perseverance, and resources. Supporting the next generation of life sciences entrepreneurs is critical from a long-term public health perspective and from a local economic development standpoint.โ€

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Immediate Opening Life Sciences Business Strategist
 

BioHealth Innovation (BHI) is an innovation intermediary that facilitates the commercialization of emerging technologies in the BioHealth Capital Region (Maryland, DC and Virginia).  We are seeking a Life Sciences Business Strategist to join our team remotely.

The right candidate will be an energetic and continuous learner who is passionate about accelerating the adoption of new technologies to improve lives. The position is geared toward an early-career scientist who wants to engage with the biohealth industry in new ways.

Our Strategists support selected growth-stage businesses beyond commercialization plans and federal grant proposalsโ€”they cultivate important relationships with client entrepreneurs and innovators. The Strategistsโ€™ work also includes collaborating with expert Entrepreneurs-In-Residence from around the country and other professionals in BHIโ€™s network who have built careers at the intersection of business and science.

 

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$100M donor gift to launch U.Va. biotech institute – Virginia Business
 

The University of Virginia will build a biotechnology institute funded with a $100 million donation from Charlottesville investor Paul Manning and his wife, Diane, the university announced Friday.

Along with the Manningsโ€™ gift, U.Va. will contribute $150 million, and the state has allocated $50 million in initial investments for the institute in its 2022-24 budget, according to the announcement.

Image: Paul Manning. Photo courtesy the University of Virginia

 

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Moore adds nine to Cabinet, including heads of Housing, Environment, Planning and Commerce – Maryland Matters
 

Ahead of his swearing-in on Wednesday, Gov.-elect Wes Mooreโ€™s Cabinet is nearly complete. Moore announced his picks for nine additional cabinet positions on Tuesday, filling out key roles including the heads of the departments of Housing, Environment, Planning and Commerce.

The latest appointments include two Maryland mayors โ€” Jake Day of Salisbury and Emily Keller of Hagerstown โ€” meaning a change of leadership elsewhere in the state.

Image: The Great Seal of the State of Maryland on the front of the Maryland State House. Photo by Danielle E. Gaines.

 

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REGENXBIO Announces Phase I/II Trial of RGX-202, a Novel Gene Therapy Candidate for Duchenne Muscular Dystrophy, is Active and Recruiting Patients
 
  • Company has initiated Phase I/II AFFINITY DUCHENNEโ„ข trial of RGX-202
  • Company also enrolling newly active observational screening study, AFFINITY BEYOND, evaluating AAV8 antibody prevalence in boys with Duchenne
  • Commercial-scale cGMP material from the REGENXBIO Manufacturing Innovation Center to be used in the clinical trial
  • RGX-202 is a potential one-time AAV Therapeutic for the treatment of Duchenne and includes an optimized transgene for a novel microdystrophin and REGENXBIO’s proprietary NAVยฎ AAV8 vector

ROCKVILLE, Md., Jan. 23, 2023 /PRNewswire/ — REGENXBIO Inc. (Nasdaq: RGNX) today announced that the Phase I/II AFFINITY DUCHENNEโ„ข trial of RGX-202 for the treatment of Duchenne muscular dystrophy (Duchenne) is now active and recruiting patients. RGX-202 is designed to deliver a transgene for a novel microdystrophin protein that includes the functional elements of the C-Terminal (CT) domain found in naturally occurring dystrophin. RGX-202 uses REGENXBIO’s proprietary NAVยฎ AAV8 vector.

AFFINITY DUCHENNE is a multicenter, open-label dose evaluation and dose expansion clinical trial to evaluate the safety, tolerability and clinical efficacy of a one-time intravenous (IV) dose of RGX-202 in patients with Duchenne.

 

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John C. Jacobs New Novavax CEO – President and Chief Executive Officer
 

John C. Jacobs joined Novavax as president and chief executive officer, and a member of the board of directors, in January 2023. He is a seasoned industry leader who has more than 25 years of commercial, operations, business and leadership experience across multiple therapeutic areas. Previously, Mr. Jacobs served as president and chief executive officer and a member of the board of directors at Harmony Biosciences from June 2018 to January 2023, and executive vice president and chief commercial officer from October 2017 to June 2018, leading the company through a successful IPO and taking its first product through FDA review, approval and commercialization. Prior to joining Harmony, Mr. Jacobs held leadership roles at Teva Pharmaceuticals beginning in 2014, including senior vice president and general manager of the Respiratory Business Unit, senior vice president of Commercial Operations in North America and general manager of Teva in Canada. Mr. Jacobs has also held positions of increasing scope and responsibility at major pharmaceutical companies including Cephalon, Wyeth and Pfizer. Mr. Jacobs has a proven track record in developing market-leading commercial strategies, major product launches and building and leading highly effective teams and organizations. He received bachelorโ€™s degree in business from State University of New York College at Plattsburgh and a master of business administration from The State University of New York at Binghamton.

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Department of Defenseโ€™s Proposed Rule Would Change SBIR/STTR Data Rights and Markings Rules – Lexology
 

On December 19, 2022, the Department of Defense (“DOD”) issued a proposed rule seeking to amend the Defense Federal Acquisition Regulation Supplement (โ€œDFARSโ€) to implement the data rights portions of recent Small Business Innovation Research Program and Small Business Technology Transfer Program Policy Directive, which emphasizes the need to protect the intellectual property interests of small businesses. In addition to addressing the small business directives, the proposed rule seeks to update markings requirements related to (1) small business data rights and (2) concerns raised by the Federal Circuitโ€™s decision in The Boeing Co. v. Secretary of the Air Force, 983 F.3d 1321 (Fed. Cir. 2020).

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Congress proposes omnibus with $1.8 billion for CHIPS & Science Act and additional innovation funding | SSTI
 

Federal innovation and entrepreneurship initiatives would receive substantial new funding under the text of the omnibus spending bill shared on the morning of Dec. 20 by the Senate Committee on Appropriations. The legislation, which totals $1.7 trillion and covers both regular FY 2023 appropriations and supplement funding, provides a total of $1.8 billion for programs authorized by this yearโ€™s CHIPS and Science Act and increases funding for multiple long-standing efforts โ€” including each of the SSTI Innovation Advocacy Councilโ€™s priority programs. The legislation is expected to pass Congress this week, before the current funding agreement expires on Dec. 23.

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New TEDCO Study Outlines Critical Steps Needed to Cultivate a Thriving, Inclusive and Growing Innovation Economy | citybiz
 

TEDCO, Marylandโ€™s economic engine for technology companies, unveiled a legislatively mandated Maryland Innovation Competitiveness Studyโ€”one that could lead to a 5-year, $250 million down payment for an Equitech Growth Fund and the establishment of a major Kirwan-type commission. The new commission would map out an in-depth strategic plan focused on ensuring Maryland becomes a national model for a thriving, inclusive tech sector and innovation economy.

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Embody-Logo

542nd Edition, January 18, 2023

By BHI Weekly Newsletter Archives

 

 

Norfolk biotech firm attracts potential $275 million acquisition deal from Fortune 500 sports medicine company
 

Norfolk biotech company Embody has racked up a bevy of accomplishments since it was founded in 2014 with just two employees.

It has attracted millions of dollars in grant funding from the Department of Defense, and millions more from local and national stakeholders. Last April, the company announced plans to spend $5 million to expand its lab space by 10,000 feet and add 92 new jobs.

And now a bigger milestone can be added to the list: Embodyโ€™s sale to a major sports medicine company.

Zimmer Biomet, a Fortune 500 medical technology company based in Warsaw, Indiana, has signed a deal to acquire Embody for $155 million at closing and an additional $120 million subject to achieving other milestones over a three-year period.

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HighTide-HighTide Therapeutics Raises $107 Million in Series C/C+ Financing to Advance Innovative Pipeline and Business Collaborations
 

ยท Global biopharmaceutical company focusing on metabolic and digestive diseases

ยท Proceeds to fund clinical and business development

ROCKVILLE, MD and SHENZHEN, CHINA,January 5, 2023โ€” HighTide Therapeutics Inc. (โ€œHighTideโ€), a globally integrated clinical-stage biopharmaceutical company developing novel multifunctional therapies for metabolic and digestive diseases, today announced the closing of a $107 million Series C/C+ financing led by the TCM Healthcare Fund of Guangdong, managed by China Development Bank Capital. Other investors included Yuexiu Fund and Yuthai Fund.

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Linshom Medical raising $3M series A to launch respiratory monitor
 

Linshom Medical raising $3M series A to launch respiratory monitor

Ellicott City startup Linshom Medical is looking to raise a $3 million round as it works to develop a medical device that catches the warning signs of a respiratory crisis.

CEO Richard Hughen plans to use the series A raise, as well as a $2.4 million grant from the National Institutes of Health, to fund a study to prove the companyโ€™s respiratory monitor is effective at detecting breathing issues. The company previously raised $1.5 million in convertible notes. Linshom has raised $1 million of its $3 million series A goal so far, with support from the Maryland Momentum Fund, the Maryland Technology Development Corp. and other investors.

Once the studies are complete, the three-person company is planning to do a soft launch in a few hospital systems late this year.

 

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Maryland’s IonQ acquired Toronto-based Entangled Networks – Technical.ly
 

Today, College Park, Maryland quantum leader IonQ announced its first-ever acquisition.

The DMV company acquired the operating assets of Entangled Networks, a Toronto, Canada-based startup founded in 2021. Entangled Networks specialized in enabling computing for multiple quantum processors, including those that are distributed. Through the deal, the Entangled team will become the staff of IonQ Canada, the quantum pioneerโ€™s first outpost in the country.

 

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Life Science Start Ups: Connect with Investors at the Investor Hub Event at JLABS @ Washington, DC
 

Life Science Start Ups: Connect with Investors at the Investor Hub Event at JLABS @ Washington, DC

Are you a promising early-stage life sciences start up seeking pre-seed or series A funding in the next 12 to 18 months?

If so, you might be a fit for the Johnson & Johnson Innovation โ€“ JLABS (JLABS) Annual East North America (ENA) Regional Investor Hub Event at JLABS @ Washington, DC, on March 9, 2023.

Visit https://jji.jnjinnovation.com/ena-investor-hub-event to learn more and register.

 

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BBJ: Kite Pharma to expand Frederick County footprint with new warehouse, 100 jobs in BioHealth Capital Region
 

Biopharmaceutical company Kite Pharma will expand its footprint in Frederick County with a new warehouse that will bring 100 new jobs to the area, the company announced Tuesday.

Kite, a Los Angeles-based subsidiary of Gilead Sciences (NASDAQ: GILD), will build an approximately 70,000-square-foot raw materials warehouse to support its global cell therapy manufacturing network. The company’s CAR T-cell therapy uses a person’s own immune system to recognize, attack and destroy certain types of cancer with a one-time, individualized treatment.

 

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George Mason University Receives $3.2 Million To Help Military Personnel Combat Hemorrhagic Diseases
 

Deployed military personnel frequently face numerous health and safety hazards as part of their daily activities in service to their nation. Among many dangers is the possibility of encountering hemorrhagic fever viruses (HFVs), a group of highly infectious pathogens such as the Ebola virus. Many of these diseases do not currently have effective therapeutics and can be prevalent in areas where service members are deployed, putting them at risk of exposure.

George Mason University infectious disease researcher Aarthi Narayanan has partnered with the United States Army Medical Research Institute of Infectious Diseases (USAMRIID) and Cyclica, a biotechnology company based in Canada, to identify potential broad-spectrum therapeutics for illnesses triggered by HFVs and similar pathogens.

 

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Sanofi pumps $750M into VC unit to push deeper into biotech investing | Fierce Biotech
 

Sanofi has thrown its financial weight behind its venture capital unit, making a $750 million, multi-year commitment to enable the financier to build on a year in which it backed 10 companies globally.

Sanofi Ventures is a well-established player in the biotech VC space, with its roots dating back to the formation of Sanofi-Genzyme BioVentures in 2011 and beyond that to the establishment of Genzyme Ventures a decade earlier. But Sanofi has largely stayed in the shadows, leaving its venture unit to build out a portfolio without publicly disclosing the details of how it supports the fund.

 

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Adaptive Phage Therapeutics Announces First Patient Dosed in the PHAGE Clinical Trial Evaluating Phage Therapy in Cystic Fibrosis-related Respiratory Infection
 

GAITHERSBURG, Md., January 12, 2023–(BUSINESS WIRE)–Adaptive Phage Therapeutics, Inc., (APT) a clinical-stage biotechnology company advancing the APT phage bank, the worldโ€™s largest therapeutic phage initiative for treatment of bacterial infectious diseases, today announced the first patient has been dosed in the PHAGE clinical trial, evaluating bacteriophage therapy in adults with cystic fibrosis (CF) who carry Pseudomonas aeruginosa (P. aeruginosa) in their lungs. The trial is evaluating whether the bacteriophage, or “phage,” therapy is safe and able to reduce the amount of bacteria in the lungs of volunteers. The trial is being conducted by the Antibacterial Resistance Leadership Group (ARLG) which consists of more than 100 leading experts, working together to combat the ongoing antibacterial resistance crisis and improve patient care. ARLG is funded by the National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health (NIH). The investigational phage therapeutic, WRAIR-PAM-CF1, was developed by the Walter Reed Army Institute of Research (WRAIR) and is licensed to and manufactured by APT. The trial is expected to enroll a total of 72 patients at multiple sites across the country.

Image: Photo: Business Wire

 

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Free 1/19 webinar: learn how MIPS grants can help you accelerate your product development!
 

The Maryland Industrial Partnerships (MIPS) program offers grants for projects that team Maryland-based companies with University System of Maryland faculty to develop technology products and processes.

Join us for a free webinar to learn how MIPS can help advance your technology-based products by leveraging the facilities, resources, and expertise within Marylandโ€™s public universities to create new products and opportunities!

Next webinar:
Thursday, January 19, 2023, at 1 p.m.
online via Zoom

Click to register

 

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Pilot Awards – Selected Awardee Institutions and Organizations – Cohort 1 – Mentia is honored to be selected as a pilot awards cohort company
 

Mentia is honored to be selected for the inaugural Artificial Intelligence and Technology Collaboratory #A2Collective #johnshopkinsuniversity The National Institutes of Health Full story at https://lnkd.in/g6ewtb9W

 

 

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Maryland Site Selection News – Jan. 2023
 

Happy New Year! Maryland is coming off of a busy and successful year of business attraction and expansion. Continue reading to see the companies that committed to Maryland in the 4th quarter of 2022.

Our momentum continues into 2023, with many exciting new projects on the horizon. We look forward to connecting with industry colleagues at events this spring, and as always, weโ€™re standing by to help you make your next project a success.

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Maryland Innovation Initiative to Partner with Leading Military Medicine Nonprofit | TEDCO
 

COLUMBIA, Md. (January 10, 2023) โ€“ TEDCO, Marylandโ€™s economic engine for technology companies, announced a new collaboration between TEDCOโ€™s Maryland Innovation Initiative (MII) and The Henry M. Jackson Foundation for the Advancement of Military Medicine (HJF). The MII Pop-up Event will take place on February 8 at HJF home office in Bethesda, Md., including the signing of the Memorandum of Understanding (MOU) and speakers from MII, TEDCO and HJF leadership.

โ€œWeโ€™re very proud of MIIโ€™s successful track record when it comes to both collaboration and outcomes,โ€ said Dr. Arti Santhanam, executive director of MII. โ€œThis MOU gives us the opportunity to expand on that success in partnership with the dedicated team at HJF. Together, we anticipate advancing new business creation with crucial military medical applications.โ€

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Top 10 technologies anchoring the future of work
 

Organizations across the globe are pivoting their workplace technology strategy and many employers are grappling with big questions about which tools are needed to create a thriving hybrid environment in 2023.

Based on a JLL survey of over 1,000 companies worldwide, a vast majority expect to make significant changes to their tech stack over the next three years. Download the infographic highlighting the workplace technologies that were consistently mentioned by employers as top priorities and discover why those technologies are prioritized and how they change workplace.

 

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Twelve Women Who Have Shaped The History of the BioHealth Capital Region  ยท BioBuzz
 

The BioHealth Capital Region (BHCR) and its life science ecosystem have a rich and deep history of pioneering scientific innovation, research, development, and commercialization. The regionโ€™s history has been written by life science anchor companies, scientific research universities, government research organizations, rich startup culture, and serial entrepreneurs, all of whom have played critical roles in transforming the BHCR into one of the most innovative and productive biocluster in the world.

Image: https://biobuzz.io/

 

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And the Galien Foundation Winners are …
 

To kick off the new year, The Galien Foundation is delighted to share with you highlights from the 2022 Prix Galien Awards Ceremony and recognize the incredible achievements of the Medalists  of the Prix Galien Golden Jubilee and the Prix Galien USA.

 

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Maryland SBDC Network News January 2023
 

A new year means new opportunities to grow your business. If you’re one of the millions of resolution makers who are using the new year to take their ventures to new heights, Maryland SBDC has the expertise to turn your goals into gains.

Whether your goal is to start a business, grow a business, or just learn something new, Maryland SBDC will jump-start your year with no-cost confidential, one-on-one consulting and low-cost training on topics ranging from business planning and financing to marketing and more.

 

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Bayh-Dole COALITION – Issue Brief: IP, Innovation, and American Universities (January 2023)
 

Total research spending at American universities reached nearly $90 billion in 2021,1 2 and university licensing revenue has climbed to almost $3 billion a year.3 From robotics to agriculture to medicine, useful discoveries constantly emerge from academic labs. Yet policymakers often fail to recognize the critical role of intellectual property in driving all that spending, income, and innovation. Standing up for strong IP rights must be a priority for American universities.

Click here to read the full PDF Briefing.

 

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Backed by the National Institute on Aging, the a2 Pilot Awards fosters age tech entrepreneurship | TechCrunch
 

There are now more Americans aged 65 and older than at any other point in history, and that number is expected to rise, according to the National Institute on Aging (NIA). With longer lifespans come challenges like Alzheimerโ€™s, which about one in nine Americans aged 65 or older have.

The a2 Pilot Awards were created to encourage the development of tech for the elderly. Funded by the NIA with $40 million over the next five years, the awards announced today the first cohort of 33 projects selected for funding. The majority use artificial intelligence or machine learning tech, and 40% are led by women.

 

 

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001505 2 494 1024x683

541st Edition, January 10, 2023

By BHI Weekly Newsletter Archives

 

 

NIH-Oxford Scholar Sooraj Achar Honored with BioHealth Innovation Award โ€“ International Biomedical Alliance
 

First awarded in 2016, the International Biomedical Research Allianceโ€™s Innovation Award recognizes novel solutions in biology or medicine and acknowledges discoveries of unusual importance, application, or magnitude that make use of new or unusual methods, paradigms, or approaches to solve important problems in biology or medicine. Once again, this year, the Innovation Award was generously sponsored by BioHealth Innovation Inc. This award was presented to Sooraj Achar, an NIH-Oxford D.Phil. Scholar in the Class of 2020 who is mentored by Dr. Gregoire Altan-Bonnet at the National Cancer Institute (NCI/NIH) and Prof. Mike Dustin at the University of Oxford.

Image: https://biomedalliance.org

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Have your company reviewed by BHIโ€™s knowledgeable EIRโ€™s on Jan 18th. Register now!
 

This free 1:1 virtual session is an opportunity to discuss your company with experts in diagnostics, therapeutics, digital health and medical devices.

If youโ€™re a growth-stage biohealth company looking for unbiased advice on your pitch deck, commercialization strategy, evidence development or entrepreneurial challenges, our EIRs can help.

To request a feedback session, please send a non-confidential pitch deck, and a short description of the input youโ€™re seeking from the EIRs, to Sarah Miller   smiller@biohealthinnovation.org  

The requested information should be received by our office at least 2 weeks in advance, so that we can schedule the appropriate experts. Thank you!

 

 

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Significant Changes to the SBIR and STTR Programs
 

On September 30, 2022, the SBIR and STTR Extension Act of 2022 (the Act) was enacted, reauthorizing the SBIR and STTR programs until September 30, 2025. The Act makes several significant changes related to national security risks and foreign influence in the programs. The changes include agency implementation of due diligence procedures, new offeror disclosure and ongoing contractor reporting requirements, and new award eligibility requirements, with an offerorโ€™s or contractorโ€™s omissions or misstatements resulting in repayment of the entire award amount, among other changes to the programs.

 

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Qiagen acquires DNA-biometrics firm Verogen in $150 mln deal
 

Jan 9 (Reuters) – Life sciences firm Qiagen said on Monday it has acquired DNA-biometrics firm Verogen in a $150-million cash deal, strengthening its forensics portfolio.

The deal builds on the companies’ existing partnership from 2021, under which Qiagen has the rights to distribute some of Verogen’s products such as its next-generation gene sequencing panels and genetic code analyzing technology GEDmatch.

 

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Emergent BioSolutions Awarded $379.6 Million Procurement Contract to Supply RSDLยฉ (Reactive Skin Decontamination Lotion Kit) to U.S. Department of Defense
 

GAITHERSBURG, Md., Jan. 05, 2023 (GLOBE NEWSWIRE) — Emergent BioSolutions Inc. (NYSE:EBS) today announced that it has signed an indefinite-delivery, indefinite-quantity procurement contract with a maximum value up to $379.6 million to supply RSDLยฎ (Reactive Skin Decontamination Lotion Kit) for use by all branches of the U.S. military. Emergent’s Canadian Subsidiary will serve as the sole subcontractor to deploy RSDLยฎ to the U.S. Department of Defense (DoD) through a new contract award to the Canadian Commercial Corporation (CCC). The new contract has a base year, which began in December 2022, and four single year option renewals.

“Emergent has a 25-year history of developing and supplying medical countermeasures (MCM) for the U.S. and other governments around the world,” said Paul Williams, senior vice president, government MCM at Emergent. “RSDLยฎ has been a routine part of the U.S. warfighters armamentarium for 13 years. This new contract award demonstrates the unique capabilities of our core MCM business to continue to meet the needs and deliver on the requirements for chemical and biological preparedness of public and military forces, which is an important part of our mission to help protect and enhance life.”

 

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AstraZeneca to Aquire CinCor Pharma, Inc
 

Today we announced an agreement to acquire CinCor Pharma, Inc., a US-based clinical-stage biopharmaceutical company, focused on developing novel treatments for resistant and uncontrolled hypertension.

The acquisition will strengthen our cardiorenal pipeline, where there is a high unmet medical need.

This acquisition is expected to close in first quarter of 2023, subject to regulatory approvals and other customary closing conditions. Additional important information can be found here: https://know.az/3IvkzkQ

 

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WuXi Biologics and GSK Enter into License Agreement on Multiple Novel Bi- & Multi-specific T Cell Engagers
 

SHANGHAI, Jan. 4, 2023 /PRNewswire/ — WuXi Biologics (“WuXi Bio”) (2269. HK), a leading global Contract Research, Development, and Manufacturing Organization (CRDMO), today announced a license agreement with GSK plc (LSE/NYSE: GSK) under which GSK will have exclusive licenses for up to four bi- & multi-specific TCE antibodies developed using WuXi Biologics’ proprietary technology platforms.

Under the terms of the agreement, GSK will be granted an exclusive global license for the research, development, manufacturing, and commercialization of a pre-clinical bispecific antibody that crosslinks tumor cells and T cells by targeting a tumor-associated antigen (TAA) on tumor cells and CD3 expression on T cells and up to three additional pre-clinical TCE antibodies currently at an earlier discovery stage. WuXi Biologics will receive a $40 million upfront payment and up to $1.46 billion in additional payments for research, development, regulatory and commercial milestones across the four TCE antibodies. WuXi Biologics is also eligible to receive tiered royalties on net sales.

 

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Matt Honan Joins Emmes as Vice President and Head of Corporate Development
 

ROCKVILLE, Md., Jan. 4, 2023 /PRNewswire/ — Emmes, a global, full-service Clinical Research Organization (CRO) dedicated to supporting the advancement of public health and biopharmaceutical innovation, today announced that Matt Honan has joined the company as vice president and global head of corporate development.

In this newly created position, Honan will lead the company in identifying and executing acquisitions that complement Emmes’ existing strong federal government client base, expand its biopharma portfolio, enhance its technology offerings, and broaden its global reach.

 

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Meet The Daily Recordโ€™s Power 100 | Congrats to BHI Board members Dr. Jay Perman and Pete Briskman for being recognized.
 

For the second year in a row, we offer readers a look at the 100 men and women who are shaping our businesses, governments, nonprofits, law firms and other key institutions.

Thomas Baden Jr.

The Power 100 List for 2022-23 focuses on the people who play an outsized role in the culture, lifestyle, civic conversation and economic fortunes of Maryland.

Image: https://thedailyrecord.com – Thomas Baden Jr.

 

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Gaithersburgโ€™s Novavax names John Jacobs as new CEO – Washington Business Journal
 

The transition will take place in late January.

Image: Stanley Erck is retiring as CEO of Gaithersburg vaccine maker Novavax. EMAN MOHAMMED

 

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NeoImmuneTech to Partner with U.S. National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH) for Drug Development in Acute Radiation Syndrome (ARS)
 

ROCKVILLE, Md., Jan. 3, 2023 /PRNewswire/ — NeoImmuneTech, Inc. (NIT or “NeoImmuneTech”), a clinical-stage T cell-focused biopharmaceutical company, today announced an agreement with the National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health (NIH), to develop NeoImmuneTech’s main asset NT-I7 (efineptakin alfa) (rhIL-7-hyFc), for the treatment of Acute Radiation Syndrome (ARS).

ARS is an acute illness caused by irradiation of most of the body by a high dose of penetrating radiation in a short period of time. These kinds of exposures can cause profound suppression of hematopoiesis and T cell depletion, significantly increasing susceptibility to infections. Currently, there is no therapeutic option for accelerating recovery of the T cell compartment following radiation exposure. NTโ€“I7, a novel long-acting human interleukin-7 (IL-7), is expected to quickly restore lymphocyte levels and reduce vulnerability to infectious disease after radiation exposure. In the clinical setting, NTโ€“I7 has been shown to increase T cell counts significantly and persistently while being safe and well tolerated.

 

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Who were the biggest employers in Maryland last year?
 

Maryland, with its six million plus residents, may not be the biggest state, but even before the creation of the United States, the colonyโ€™s location in the mid-Atlantic was key to its economic prosperity.

While the stateโ€™s central location on the Eastern seaboard is still vital for companies like Amazon and its massive Baltimore-area shipping enterprise, the proximity to another center, the federal capital, provides Maryland with its most important source of large employers.

Image: https://www.heraldmailmedia.com

 

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Whatโ€™s next for mRNA vaccines | MIT Technology Review
 

Cast your mind back to 2020, if you can bear it. As the year progressed, so did the impact of covid-19. We were warned that wearing face coverings, disinfecting everything we touched, and keeping away from other people were some of the only ways we could protect ourselves from the potentially fatal disease.

Thankfully, a more effective form of protection was in the works. Scientists were developing all-new vaccines at rapid speed. The virus behind covid-19 was sequenced in January, and clinical trials of vaccines using messenger RNA started in March. By the end of the year, the US Food and Drug Administration issued emergency-use authorization for these vaccines, and vaccination efforts took off.

Image: STEPHANIE ARNETT/MITTR; ENVATO

 

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Life Sciences Real Estate 2023: Resolutions And Recalibration For A Cautious Year Ahead
 

Looking forward to the trends that will define the new year, and predictions for 2023, a group of leading life sciences industry analysts predicted a much more cautious approach to investment, a reflection of larger macroeconomic challenges, yet continued long-term investment in an asset class that continues to grow in importance.

โ€œWeโ€™ve entered a really slow, kind of cautious period,โ€ JLL Head of Americas Work Dynamics and Industry Research Amber Schiada said. โ€œWeโ€™ve also seen valuations come back down to earth, too.โ€

 

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Technology as a New Evolution in Fighting Disease
 

Scientists and researchers have made remarkable breakthroughs in basic science to better understand the complex pathology of many diseases today. Some of that progress is through utilizing technology to uncover new insights, and some of the progress is through the incalculable capacity of the human mind to analyze problems and find solutions. With all that knowledge and all the effort put in, however, human biology and disease pathology continue to be surprising. Every day researchers continue to make profound discoveries in basic science that create new possibilities in fighting disease.

 

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523rd Edition, August 30, 2022

By BHI Weekly Newsletter Archives





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August 30, 2022

FOUNDING MEMBER OF

5th Annual BioHealth Capital Region - Investment Conference

 

BioBuzz: BioHealth Capital Region Forum 2022 Preview

The past few years in the biotech industry have been filled with challenges and promise.

From the rapid and successful deployment of the COVID-19 vaccine and the explosion of the cell and gene therapy sector to a hiring boom, remarkable advances in tissue engineering and strong biomanufacturing growth, the BioHealth Capital Region (BHCR) has played a pivotal role in it all.

To say a lot has changed is the understatement of the century. The question remains, however: Where is the BHCR headed?

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Where are they now? An Update on Former BHI Interns

Since BHI's founding in 2011, the organization has had many interns come through the doors in support of Analytics, Marketing, Communications, Social Media, Business, Legal, Accounting, and more.

BHI wanted to give an update on some names you may remember if you worked with us over the years.

Click here to download the PDF.

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BHI Seeks Senior Life Sciences Business Strategist

Currently reporting to the Vice President of Economic Development, the Senior Life Sciences BusinessStrategist evaluates the commercial potential of emerging technologies and provides recommendations ongo-to-market strategies.

This is a customer facing role with a focus on supporting clients in the development of commercial analysesand federal grant proposals.

The Senior Life Sciences Business Strategist also supervises junior Life Sciences Business Strategists andmanages consultants, as needed.

Click here for more information.

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5th Annual BioHealth Capital Region - Investment Conference

5th Annual BioHealth Capital Region - Investment Conference

Intralytix receives Phase II Fast Track NIH SBIR contract

Intralytix receives Phase II Fast Track NIH SBIR contract to continue development of a universal, scale-independent AI-based platform for manufacturing high titer bacteriophage preparations for clinical applications.

Columbia, Maryland, USA. – August 22, 2022 – Intralytix, Inc. announced today that it has received a Phase II contract in the amount of $1,498,045. This contract is made through the Small Business Innovation Research (SBIR)  program from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). This project is the continuation of a successfully completed NIAID-funded Phase I contract (see Intralytix, Inc.) and will further leverage Intralytix’s existing proprietary PhageSelector™ program, big data, and manufacturing know-how along with machine learning to advance an artificial intelligence (AI)-based universal manufacturing platform, the PhageEngine™, to deliver methods for producing high titer, high quality bacteriophage preparations suitable for clinical applications. Dr. Alexander Sulakvelidze, President and CEO of Intralytix and the Principal Investigator of the SBIR contract, commented, "We are very pleased to further extend this work with support from NIH after successfully competing Phase I of the project. The resulting technology will significantly increase Intralytix’s capabilities as well as help advance the phage biocontrol and phage therapy fields in general and will ultimately have a very significant positive impact on public health. We look forward to continuing this important project in collaboration with NIH. "

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Tonix Pharmaceuticals develops monkeypox vaccine for future by looking at past

Tonix Pharmaceuticals, a company that has a research lab in Frederick, is developing a vaccine to prepare for a future where the monkeypox virus is endemic outside of Africa.

To do that, the company is looking more than 200 years in the past.

The base infrastructure that Tonix researchers use to design vaccines for infectious diseases is based on a virus called horsepox. That’s the same virus Dr. Edward Jenner used when he started developing the first smallpox vaccine in 1796.

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Johns Hopkins Applied Physics Lab lands Pentagon RDT&E contract worth up to $10.6B

The Johns Hopkins University Applied Physics Laboratory has been awarded a contract for research, development, test and evaluation of military-related technology that could be worth up to $10.6 billion, the Defense Department announced Monday.

The lab, based in Laurel, Maryland, was awarded a $4.4 billion cost-plus-fixed-fee, indefinite-delivery/indefinite-quantity contract for RDT&E programs throughout the DOD that fall “within its core competency areas including strategic systems test and evaluation; submarine security and survivability; space science and engineering; combat systems and guided missiles; air and missile defense and power projection; information technology, simulation, modeling, and operations analysis; and mission related research, development, test and evaluation,” according to the DOD contract award announcement.

Image: Photo of the Johns Hopkins University Applied Physics Lab's Kossiakoff Center. (Photo courtesy of JHU-APL)

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Institute for Bioscience and Biotechnology Research Awarded $6.9M to Design and Test a Vaccine to Combat Hepatitis C

HCV envelope-antibody interaction

The National Institute of Allergy and Infectious Disease (NIAID) awarded a $6.9 million grant to researchers at the Institute for Bioscience and Biotechnology Research (IBBR) to design a vaccine to combat the virus that causes Hepatitis C, an illness that affects an estimated 71 million people worldwide.  Hepatitis C Virus (HCV) puts people at heightened risk for severe liver disease, including fibrosis, cirrhosis, and hepatocellular carcinoma (liver cancer).  Although treatments are available, an HCV vaccine currently does not exist to help prevent infections and reduce the global burden of the disease.

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Governor Hogan Announces Maryland’s State Small Business Credit Initiative Programs Now Open

ANNAPOLIS, MD—Governor Larry Hogan today announced Maryland programs funded by the State Small Business Credit Initiative (SSBCI) are open. Up to $198 million in federal small business relief is being administered by three state agencies: the Maryland Department of Housing and Community Development (DHCD), the Maryland Department of Commerce, and the Maryland Technology Development Corporation (TEDCO). These agencies will use funds to expand and enhance nine existing state business lending and investment programs.

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AstraZeneca Reportedly Seeking Bolt-On Opportunities, could Abandon Vaccines | BioSpace

AstraZeneca CEO Pascal Soriot raised questions Tuesday about the company’s future in vaccines while hinting at potential M&A activity on the near horizon.

In an interview with Reuters, Soriot discussed the company's plans, which he said include building on its portfolio of antibody therapies. AstraZeneca is also considering bolt-on acquisitions in oncology and cardiovascular areas, Soriot said.

Getting out of the COVID-19 Vaccine Business?

Overall, in the COVID-19 space, the company has shifted its resources to antibody therapies.

Image: Pascal Claude Roland Soriot – 23 May 1959 (age 63) France – Wikipedia

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Novel Nanotechnology Supercharges Immune System Molecules to Fight Cancer

Novel Nanotechnology Supercharges Immune System Molecules to Fight Cancer

Researchers from Cytimmune Sciences presented new data at a cancer therapeutics conference in Boston, MA demonstrating the potential of their nanoparticle-based platform to supercharge synergistic immune system stimulators called cytokines.

SUMMARY OF DATA PRESENTED

  • Data focused on industry leading, first-in-class, multi-cytokine immunotherapies
  • CYT-IFNg-TNFa (A dual cytokine immunotherapy nanomedicine)
    • 100x increase in direct cancer cell killing potency vs native cytokines
    • 30x increase in cytokine accumulation in tumor tissue
    • Induction of a cancer specific immune response after treatment
  • Other novel cytokine-based immunotherapies
    • Introduction of nanomedicines including combinations of IL-12, IL-2, IL-15 & IL-1b
    • 175x increase in potency of IL-12 presented on nanoparticles vs. native IL-12
  • CYT-6091 (high dose TNF alpha)
    • Unpublished preclinical data showing CYT-6091 induces cytotoxic T-Cell tumor infiltration
    • Phase 1 clinical safety data and preclinical mechanism of action data

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Deloitte remains largest healthcare consulting firm in United States

Deloitte Consulting remained atop Modern Healthcare’s annual ranking of the largest healthcare management consulting firms based in the US.

Deloitte US’ sizable healthcare consulting practice realized $2.698 billion in revenue in 2021, with $962.8 million coming from healthcare providers.

Guidehouse jumped from third place 2020 to second place in 2021, achieving $970 million in healthcare consulting revenue, with approximately half from providers. The firm was boosted a significant industry acquisition in 2021, adding Dovel, an 1,800-person IT consultancy with a focus on health IT, life sciences, and public safety.

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522nd edition, August 23, 2022

By BHI Weekly Newsletter Archives





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August 23, 2022

FOUNDING MEMBER OF

5th Annual BioHealth Capital Region - Investment Conference

5th Annual BioHealth Capital Region - Investment Conference

 

Maryland’s RoosterBio and Seattle’s AGC Biologics Announce Collaboration to Accelerate Manufacturing of Cell and Exosome Therapies

SEATTLE, Aug. 16, 2022 (GLOBE NEWSWIRE) — AGC Biologics, a leading global Biopharmaceutical Contract Development and Manufacturing Organization (CDMO), announced today a strategic partnership with RoosterBio Inc., a leading supplier of human mesenchymal stem/stromal cells (hMSCs), highly engineered media, and bioprocess development services.

The partnership creates an end-to-end solution for the development and production of hMSC and exosome therapeutics leveraging RoosterBio’s well-established cell and media products and process development services, coupled with AGC Biologics’ global cell and gene therapy manufacturing capabilities.

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Biotech And Drug Development (Audio) – Bloomberg

Dr. Amrie Grammer, co-founder of AMPEL BioSolutions, joins the show to discuss biotech and her company Hosted by Paul Sweeney and Matt Miller.

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Novavax Submits Application to the U.S. FDA for Emergency Use Authorization for Novavax COVID-19 Vaccine, Adjuvanted as a Booster in Adults Aged 18 and Older
  • If authorized, Novavax' vaccine would be the first protein-based COVID-19 booster for adults
  • If authorized, the Novavax COVID-19 Vaccine, Adjuvanted could be used as a booster dose for adults aged 18 and older vaccinated with any other currently available COVID-19 vaccine

GAITHERSBURG, Md., Aug. 15, 2022 /PRNewswire/ — Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that it submitted an application to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of its protein-based COVID-19 Vaccine, Adjuvanted for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) as a homologous and heterologous booster in adults aged 18 and older.

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Biotechnology Investment Incentive Tax Credit (BIITC) Accepting 2023 Applications

The fiscal year 2022 program is now closed.  The fiscal year 2023 program will begin accepting applications as follows: Commerce will begin accepting Form B QMBC applications on 8/23/2022, and Form A Investor applications on 9/7/2022. Additional information is available under the “Apply” section.

BIITC provides an investor with a refundable State income tax credit for an eligible investment in a Qualified Maryland Biotechnology Company (QMBC). The program supports investment in seed and early stage biotech companies to promote and grow the biotech industry in Maryland.

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D.C. Area Life Sciences Market Down to 1.4% Vacancy – Commercial Observer

The Washington, D.C./Baltimore region continued to see a tightening in its life sciences real estate market.

In particular, the region saw a decrease in life sciences vacancy in the second quarter of 2022, dropping from 3.6 percent to 1.4 percent since last year, according to CBRE’s latest national life sciences report.

Image: THE RECENT DEAL FOR THE TWINBROOK OFFICE CENTER HIGHLIGHTS THE DEMAND FOR LIFE SCIENCES SPACE IN THE MARYLAND SUBURBS OF D.C. PHOTO: BY NEWMARK

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8 new high priority funding opportunities

We just released 8 new high priority funding opportunities where your company can make a difference in meeting the needs of cancer patients… Please see the solicitation and join our webinar on August 24th….

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Technical.ly: 2 new medtech startups will spin out of Johns Hopkins research fund grants

Two new medical startups, focusing on addressing vision loss and catheter-associated urinary tract infections (UTIs), are on the horizon thanks to the $200,000 in grants the research teams received from the Johns Hopkins University’s Louis B. Thalheimer Fund for Translational Research.

14 researchers applied to the Thalheimer Fund, which was created to provide seed funding for proof-of-concept and validation studies of inventions coming out of Hopkins. The awards from the fund range from $25,000 to $100,000.

“We are excited to have received strong applications for disruptive technologies with commercialization potential that can have a future impact on human health and well-being,” Nicole Snell, associate director of ventures at Johns Hopkins Technology Ventures’ (JHTV) FastForward accelerator, which helps university-affiliated founders commercialize their technologies, said in a statement.

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Don’t get distracted over ARPA-H fight; let’s win the bigger prize | Maryland Daily Record

Congress has approved a new agency — the Advanced Research Projects Agency for Health (ARPA-H) — that will ‘supercharge’ breakthrough medical research and provide over $1 billion in new research funding.

A fight has broken out, however, over ARPA-H’s headquarters’ location. The Maryland congressional delegation is working to locate it in state, but when a majority in Congress senses a chance to put a prestigious scientific headquarters in their home districts, Maryland likely will not win this battle.

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521st Edition, August 16, 2022

By BHI Weekly Newsletter Archives





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August 16, 2022

FOUNDING MEMBER OF

5th Annual BioHealth Capital Region - Investment Conference

5th Annual BioHealth Capital Region - Investment Conference

 

BHI Seeks Senior Life Sciences Business Strategist

Currently reporting to the Vice President of Economic Development, the Senior Life Sciences BusinessStrategist evaluates the commercial potential of emerging technologies and provides recommendations ongo-to-market strategies.

This is a customer facing role with a focus on supporting clients in the development of commercial analysesand federal grant proposals.

The Senior Life Sciences Business Strategist also supervises junior Life Sciences Business Strategists andmanages consultants, as needed.

Click here for more information.

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Ellume welcomes Congressman David Trone, Senator Ben Cardin, Senator Chris Van Hollen and National Institute of Standards and Technology (NIST) Manufacturing Extension Partnership Director Laurie Locascio

It was a pleasure to welcome Congressman David Trone, Senator Ben Cardin, Senator Chris Van Hollen and National Institute of Standards and Technology (NIST) Manufacturing Extension Partnership Director Laurie Locascio to our new facility in Frederick this week and to see Ellume’s #manufacturing capabilities first-hand.

Ellume's Frederick facility provides a sustainable U.S. domestic industrial base for #diagnostics production and stands ready to respond to any future surge in #COVID19 demand, while accelerating #innovation to develop solutions for future public health needs. A multimillion-dollar automation program is underway to further enhance the production capability of the facility.

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Alexandria Real Estate Equities and the Transformation of Life Science Real Estate | Nareit

A quarter century after it began life as a garage start-up, Alexandria Real Estate Equities, Inc.’s (NYSE: ARE) decision to focus on the niche segment of life science real estate looks sounder than ever as demand for sophisticated lab space across major U.S. markets sits at an all-time high.

Pasadena, California-based Alexandria is the only publicly traded, pure-play office/laboratory REIT. The company, led by founder and Executive Chairman Joel Marcus, focuses exclusively on highly specialized lab space used for research and development in the booming life science industry.

Image: Lilly Institute for Genetic Medicine, 15 Necco Street, Seaport Innovation District, Greater Boston. Photo courtesy Alexandria Real Estate Equities, Inc.

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NSF Awards $10M To UMBC To Expand Successful Initiative Developing Underrepresented Postdocs In STEM – UMBC: University Of Maryland, Baltimore County

UMBC will expand its work boosting diversity in academia from Maryland to the national level through a new NSF INCLUDES Alliance: Re-Imagining STEM Equity Utilizing Postdoc Pathways (RISE UPP). The RISE UPP Alliance, anticipated to officially launch in fall 2022, is modeled after the AGEP PROMISE Academy, a high-impact initiative co-led by UMBC that supports faculty diversification in the biomedical sciences across University System of Maryland (USM) institutions.

Image: Albin O. Kuhn Library (Marlayna Demond '11/UMBC)

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Chancellor's Message: VISION 2030 — From Excellence to Preeminence

VISION 2030: From Excellence to Preeminence

This summer, the University System of Maryland unveiled a new 10-year strategic plan—Vision 2030: From Excellence to Preeminence. The plan reflects 18 months of in-depth analysis. It coalesces intense discussions among dozens of groups of people with a stake in Maryland’s public universities—people with different opinions on higher education’s main objectives and different ideas on how to achieve them.

But one theme emerged across all groups: That students must serve as our starting point. They must set our agenda. They must center our work.

Click here to view the PDF

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Q32 Bio and Horizon Therapeutics Announce Collaboration in Autoimmune Diseases

WALTHAM, Mass. and DUBLIN, Aug. 15, 2022 /PRNewswire/ — Q32 Bio, a clinical stage biotechnology company developing biologic therapeutics to restore immune homeostasis, and Horizon Therapeutics plc (Nasdaq: HZNP), today announced that they have entered into a collaboration and option agreement to develop ADX-914 for the treatment of autoimmune diseases.

ADX-914 is a fully human anti-IL-7Rα antibody that re-regulates adaptive immune function by blocking signaling mediated by both IL-7 and TSLP. Q32 has recently completed a biomarker-enabled Phase 1 study characterizing pharmacokinetics, pharmacodynamics and safety of ADX-914 that demonstrated pharmacological effect on T cells in healthy volunteers. Q32 expects to initiate a Phase 2 trial in atopic dermatitis later this year and is planning to initiate a Phase 2 trial in a second autoimmune disease next year.

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DC Inno – How 3 women-led life sciences startups thrive with TEDCO

Maryland is home to a number of STEM entrepreneurs with quality projects and the skills to succeed. What entrepreneurs often lack are the right connections and access to funding, which is especially true for women-led life sciences start-ups.

“In 2021, women founders raised just 2% of venture capital money and only 23% of biotech CEOs are women said Margia Argüello, formerly with the Maryland Department of Commerce’s Office of Life Sciences.

Image: The three busy female founders of innovative life science startups CarrTech, NasaClip and PerSoN Clinic took time to share what TEDCO’s Builder Fund and other TEDCO resources have meant to their companies.

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Ellume COVID test plant in Frederick starting to add automation to manufacturing | Coronavirus | fredericknewspost.com

Five months after the Australian-based biopharmaceutical company Ellume opened its first U.S. location in Frederick, the facility is scaling up its production of at-home COVID-19 tests by starting to automate the manufacturing process.

U.S. Rep. David Trone and U.S. Sens. Chris Van Hollen and Ben Cardin visited the sprawling campus along Executive Way on Tuesday afternoon for a tour of the company’s production capabilities and a town hall meeting with its employees.

Image: https://www.fredericknewspost.com – Staff photo by Ric Dugan

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Alexandria – 940 CLOPPER ROAD – GAITHERSBURG, MARYLAND – AVAILABLE 1Q23 – 8,867 RSF OF LABORATORY/OFFICE SPACE

TENANT AMENITIES

• 8,867 RSF lab/office suite available 1Q23

• Dedicated suite entry

• Energy efficient HVAC

• Loading dock

• Ample parking

• Complimentary access to the Alexandria FitLab

fitness center (located at 910 Clopper Road)

• On-site asset management

• Proximate to major amenities, including

restaurants, retail, lodging, and banking

Click here for more information.

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CHIPS Act Authorizes Unprecedented Support for Tech Transfer

The arc of the technology transfer profession can be tied to the Bayh-Dole Act of 1980 in the United States and similar enabling legislation from across the globe. This week  a new transformational law was passed – the CHIPS and Science Act – supporting U.S. semiconductor production and catalyzing research and development in many key technology areas and in new innovation regions of the country. Most importantly, this new law has a key provision titled “Planning and Capacity Building Awards” (Sec. 10391), which authorizes an unprecedented $3.1 billion to support technology transfer capacity building for research institutions.

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520th Edition, August 9, 2022

By BHI Weekly Newsletter Archives





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August 9, 2022

FOUNDING MEMBER OF

5th Annual BioHealth Capital Region - Investment Conference

 

BARDA Director Gary L. Disbrow, Ph.D., Joins Rich Bendis on the BioTalk Podcast

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BioBuzz: BioHealth Capital Region Forum Crab Trap Winners: Where Are They Now?

The BioHealth Capital Region Forum and Investment Conference are right around the corner on September 20th and 21st, 2022, respectively. And that means great networking opportunities, engaging panel discussions, valuable investor interaction and the celebrated and highly anticipated 7th annual Crab Trap competition.

The Crab Trap competition brings together entrepreneurs with innovative diagnostics, medical devices, therapeutics or other transformative health solutions to compete for a prize package valued at $50,000, which includes cash rewards and a one-year residency at JLABS @ Washington DC. Crab Trap finalists will earn the chance to make an in-person pitch at the BioHealth Region Investment Conference. 

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5th Annual BioHealth Capital Region - Investment Conference

Johns Hopkins spinout Emocha Health closes $6.2M series A for video-based medication adherence

Emocha Health, a Johns Hopkins University spinout tackling medication adherence with an asynchronous video platform, has announced a $6.2 million series A round led by Claritas Health Ventures.

Like many other health technology startups recently, the company’s latest raise comes after months of pandemic-boosted growth. Emocha said in its announcement that revenue has increased 300% over the last year alone, due in part to the accelerated acceptance of virtual technologies in healthcare.

Image: Emocha Health has patients record videos of themselves taking a medication and asking questions about their treatment, which are then reviewed by a live team to ensure adherence and resolve any issues. CEO Sebastian Seiguer said it's a more effective approach than others that rely on financial incentives or prescription refill rates. (emocha Health)

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Immunomic Therapeutics Announces First Patient Dosed in Phase I Clinical Trial of ITI-3000 pDNA Vaccine for the Treatment of Merkel Cell Carcinoma Member Discounts – Maryland Tech Council

ROCKVILLE, Md.–(BUSINESS WIRE)–Immunomic Therapeutics, Inc., (“ITI”), a privately-held clinical-stage biotechnology company pioneering the study of LAMP (Lysosome Associated Membrane Protein)-mediated nucleic acid-based immunotherapy, today announced dosing of the first patient in the company’s Phase 1 study evaluating ITI-3000, a plasmid DNA (pDNA) vaccine targeting patients with Merkel cell carcinoma (MCC), a rare but aggressive form of skin cancer that is typically caused by the Merkel cell polyomavirus (MCPyV). The single-center study is being conducted at the University of Washington School of Medicine and the Fred Hutchinson Cancer Center in Seattle, Washington and is being led by Drs. Paul Nghiem, Song Park and David M. Koelle.

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Emergent BioSolutions inks deal for smallpox newcomer Tembexa

Emergent BioSolutions, already flush with products against public health threats like anthrax attacks and opioid overdoses, is expanding its arsenal of medical countermeasures by scooping up global rights to smallpox newcomer Tembexa.

Emergent will furnish developer Chimerix with $225 million in upfront cash plus upward of $100 million in milestone payments for worldwide rights to the med, also known as brincidofovir. The drug last summer snagged FDA approval as the first antiviral cleared to treat smallpox regardless of a patient's age.

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Emergent BioSolutions unveils 7th pandemic CDMO contract, this time for Humanigen's late-stage antibody hopeful | Fierce Pharma

Manufacturing powerhouse Emergent BioSolutions unveiled its seventh COVID-19 CDMO tie-up Monday, this time to help crank out Humanigen’s late-stage antibody hopeful lenzilumab.

Emergent will hustle along fill-finish work on lenzilumab at its Camden plant in Baltimore, boosting supplies ahead of a possible emergency nod early this year. Humanigen’s monoclonal antibody, designed to treat and prevent the immune hyper-response known as cytokine storm, is currently in a phase 3 trial in hospitalized patients, and the company says it expects to file for an emergency use authorization in 2021’s first quarter.

Image: Emergent recently completed a new filling line at its Camden plant in Baltimore, pictured above. (Emergent BioSolutions) (Emergent Biosolutions )

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Jos Joore – MImetas CEO and BHI’s first International  soft landing company

This interview is part of a series of conversations with the people working at Mimetas. The 'I' in Mimetas focuses on the personal side of the scientists that drive our world. Today we have a chat with Jos Joore, CEO and co-founder of Mimetas.

What small things in life make you happy?

That's an interesting one. I would say it's, in particular, the small things that make me happy. Being out in nature, taking a run, being with family. People need a firm, happy basis to cope with challenges like setting up and running a company. That basis is made up of all the small things in life that are, in fact, the most important.

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What does #USPVerified mean?

What does #USPVerified mean? It means that you can trust that what's on the label is what's in the bottle. The USP Verified Mark has appeared on more than 880 million bottle labels, making quality visible so you can choose dietary supplements with confidence. Learn more about USP Verified products at quality-supplements.org #NoDoubtAboutIt

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IPO market in a ‘wait-and-see period,’ EY Americas IPO leader says

EY Americas IPO Leader Rachel Gerring joins Yahoo Finance Live to discuss the U.S. IPO market, navigating through recessionary fears, inflation, supply chain woes, volatility, and the outlook for IPOs.

Video Transcript BRIAN SOZZI: Companies are pumping the brakes on public debuts with the number of IPOs in the US plunging by 75% in the first half of this year compared to last year according to new data from EY. Joining us now to break down the latest in the IPO space is EY Americas IPO leader Rachel Gerring. Rachel, good to see you here this morning. Have we reached a bottom yet?

Image: From Video

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U.S. Department of Commerce Announces Winners of American Rescue Plan $500 Million Good Jobs Challenge to Expand Employment Opportunities | U.S. Economic Development Administration

WASHINGTON – Today, U.S. Secretary of Commerce Gina Raimondo announced grant awards to 32 industry-led workforce training partnerships across the country as part of the $500 million Good Jobs Challenge funded by President Biden’s American Rescue Plan. The Good Jobs Challenge is administered by the Commerce Department’s Economic Development Administration and will enable communities across the country to invest in innovative approaches to workforce development that will secure job opportunities for more than 50,000 Americans.

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“BioTalk with Rich Bendis” Podcast Featured in BioBuzz Podcasts to Follow Now

In a job market that’s become increasingly competitive and employer-driven, it’s imperative for both active and passive job candidates to do their homework. Understanding national biotech market trends and how those forces are impacting regional biohubs and the market at large could be a key differentiator between job seekers.

If you’re a job seeker in the BioHealth Capital Region (BHCR) or Greater Philadelphia, there are a host of valuable resources for job market research that can help target your search. The weekly BioBuzz Newsletter and Job BoardBioHealth Innovation’s newsletter, the Maryland Tech Council’s Biohub Maryland Pathways website, and Big4Bio are all just a few of the great sources of information and job opportunities.

Add to that LinkedIn and local in-person networking events, and there are many ways for job seekers to educate themselves on market conditions, specific job qualifications, and where one might fit within the overall talent market.

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REGENXBIO Announces Intention to File a Biologics License Application Using the Accelerated Approval Pathway for RGX-121, an AAV Therapeutic for the Treatment of MPS II
  • FDA will consider an accelerated approval pathway for RGX-121; BLA filing expected in 2024
  • Pivotal program is active and enrolling patients
  • RGX-121 is a potential first-in-class, one-time gene therapy for the treatment of MPS II
  • Internal cGMP manufacturing process expected to support BLA

ROCKVILLE, Md., Aug. 3, 2022 /PRNewswire/ — REGENXBIO Inc. (Nasdaq: RGNX) today announced its intention to file a Biologics License Application (BLA) in 2024 using the FDA's accelerated approval pathway for RGX-121 for the treatment of Mucopolysaccharidosis Type II (MPS II), also known as Hunter Syndrome. The Company also announced that a pivotal program for RGX-121 is active and enrolling patients. RGX-121 is an investigational, one-time AAV Therapeutic using the NAV AAV9 vector to deliver the gene that encodes the iduronate-2-sulfatase (I2S) enzyme.

"We are pleased to share that our recent discussions with the FDA support our plans to submit a BLA for RGX-121 in 2024 using the accelerated approval pathway, which was created to allow for expedited development of drugs that treat serious conditions and provide a meaningful advantage over available therapies based on a surrogate endpoint," said Kenneth T. Mills, President and Chief Executive Officer of REGENXBIO. "We believe RGX-121 for the treatment of Hunter Syndrome has demonstrated emerging positive impact on neurodevelopmental function, and we intend to advance this program as quickly as possible with the aim of providing a much-needed new treatment option for the MPS II community."

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NIH Applicant Assistance Program Accepting Applications

The National Institutes of Health (NIH) Applicant Assistance Program (AAP) is designed to assist small businesses who have never received NIH SBIR/STTR funding in preparing and submitting a Small Business Innovation Research or Small Business Technology Transfer (SBIR/STTR) application.

The goal of this program is to increase participation in the SBIR program by socially/economically disadvantaged small businesses, women-owned small businesses, and small businesses located in under-represented states.

The AAP application portal will be opening on August 5th, 2022 and information about the program is available at the NIH Application Assistance Program website. For more information about the AAP, be sure to attend the AAP Informational Webinar on August 5th at 3:00 PM ET and the Q&A Office Hours on September 15th at 2:00 PM ET. All applications must be submitted no later than September 22nd, 2022 at 5:00 PM ET.

Please note that this service is NOT available to support preparation of a Fast-Track or Phase II application. Companies who have a current SBIR/STTR application under review with the same scope of work are not eligible for AAP support.

Click here for more information.

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GSK enters agreement with 12 EU countries – BioProcess InsiderBioProcess International

GlaxoSmithKline (GSK) has signed an agreement to reserve, produce, and supply its influenza vaccine Adjupanrix to 12 European countries.

Under the terms of the deal, GSK has signed a contract with the European Commission’s (EC) Health Emergency Preparedness and Response Authority (HERA), for the reservation of future manufacture of 85 million doses of Adjupanrix (split virion, inactivated, adjuvanted).

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Biotech & Beer -NOVA – Registration

You are invited to our exclusive Biotech & Beer networking event at The Black Sheep Restaurant on August 16th from 4:30-6:30pm, where we will bring together our Northern Virginia life science community from academia, industry, and healthcare.

Learn about new resources available in Virginia to grow your research and development capabilities. Also, come hear about the latest in the life sciences by exchanging in conversation with with old and new friends!

Register to attend for free at: https://members.vabio.org/events/biotech-and-beer–nova/register

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519th Edition, August 2, 2022

By BHI Weekly Newsletter Archives





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August 2, 2022

FOUNDING MEMBER OF

5th Annual BioHealth Capital Region - Investment Conference

 

BioHealth Innovation Announces New Life Sciences Business Strategist Kelly Murphy

ROCKVILLE, MARYLAND, July 5, 2022 – BioHealth Innovation Inc. (BHI) is pleased to welcome Kelly Murphy, M.S., as a new Life Sciences Business Strategist. In this role, Murphy will evaluate the commercial potential of clients’ emerging technologies and assist start-ups with their go-to-market strategies. Her work will also focus on helping biohealth companies to secure non-dilutive funding.

Murphy is a recent graduate of the Masters of Biotechnology Program at Northwestern University. During her time at Northwestern, she gained professional experience in government affairs, project management, and corporate strategy at two life sciences companies. Prior to earning her graduate degree, she received her BS from the University of Nevada, Reno in neuroscience and chemistry.

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Arcellx inks deal for Rockville expansion – Washington Business Journal

The newly minted public company has signed a lease for 60,000 square feet.

Image: 800 King Farm Blvd. will be converted from traditional office to lab space. BANYAN

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Council Approves New Zoning Measure to Expand Biohealth in Urbanizing, Transit-Oriented Locations – EIN Presswire

ROCKVILLE, Md., July 29, 2022—The Montgomery County Council voted Tuesday to approve a new zoning measure introduced by Councilmember Andrew Friedson that will help attract and retain biohealth companies in Montgomery County and spur economic development, particularly in transit-oriented locations. The new zoning measure continues the Council’s ongoing efforts to support innovation and the biohealth sector, which is an essential part of Montgomery County’s economic engine.

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Deka Biosciences Breaks Ground on New Facility

GERMANTOWN, Md., July 19, 2022 /PRNewswire/ — Deka Biosciences announced today that it is breaking ground on a 14,000 square foot office and lab which will house a state of the art Research and Development, Process Development, and Manufacturing facility to further develop their novel cytokine therapies.  This will be the first facility to house a dual targeted cytokine development lab in the DC/Maryland/Virginia region and the only company in the US developing a therapeutic of its kind. The new headquarters will be located at 20380 Seneca Meadows Parkway in Germantown, Maryland and Deka anticipates the move to be completed in the first quarter of 2023.

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VerImmune Inc Announces Closing of Seed Financing to Further Develop Novel Virus-inspired Particle Immunotherapies

Financing led by SeedFolio, an early-stage high-tech biotech venture investment firm with participation from Ulu Ventures, Proxima VC, NuFund Venture group, Gaingels, Mana Ventures, and others.

WASHINGTON, D.C. (PRWEB) JULY 27, 2022

VerImmune, Inc. (“VerImmune”), a biotechnology company developing new therapeutic modalities that aim to redirect the body’s pre-existing immunity toward cancer, announced today the close of $2.5 million in Seed funding. The round was led by SeedFolio, a seed series venture capital firm focused on innovative, early-stage companies with game-changing impact potential. The round also included participation from US and global investment venture firms such as Ulu Ventures, and Proxima VC as well as leading private investment syndicate funds such as the NuFund Venture group (previously Tech Coast Angels- San Diego), Gaingels, Mana Ventures, and others.

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2022 Crab Trap Application

Crab Trap 2022 applications are being accepted through August 31st! Entrepreneurs with innovative diagnostics, medical devices, therapeutics, or other transformative health solutions are invited to apply to the 7th annual BioHealth Capital Region Crab Trap pitch competition. Finalists for the 2022 Crab Trap competition will pitch IN PERSON on September 21st as part of the BioHealth Capital Region Investor Conference. The winning teams will receive cash prizes from our sponsors.

Applications are due by 5pm on Wednesday, August 31st. Crab Trap finalists will be notified the week of 9/5/22. Mandatory virtual pitch coaching for all finalists will take place the week of 9/12/22.

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Children's National Hospital Innovation Day 2022

Children's National Innovation Day features the hospital's life science and healthcare projects that are looking for strategic partnership, co-development, and licensing opportunities. The event will also showcase startup companies whose mission is aligned with our quest to bring novel pediatric products to patients and families.

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BHI Seeks Senior Life Sciences Business Strategist

Currently reporting to the Vice President of Economic Development, the Senior Life Sciences BusinessStrategist evaluates the commercial potential of emerging technologies and provides recommendations ongo-to-market strategies.

This is a customer facing role with a focus on supporting clients in the development of commercial analysesand federal grant proposals.

The Senior Life Sciences Business Strategist also supervises junior Life Sciences Business Strategists andmanages consultants, as needed.

Click here for more information.

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The Galien Foundation Announces 2022 Prix Galien USA Nominees for "Best Digital Health Solution," "Incubators, Accelerators and Equity," and "Prix Galien Startup" – DEKA Nominated

NEW YORK, July 28, 2022 /PRNewswire/ — The Galien Foundation, the premier global institution dedicated to honoring innovators in life sciences, today announced the 2022 Prix Galien USA Award nominees for "Best Digital Health Solution," "Incubators, Accelerators and Equity," and "Prix Galien Startup." Winners will be announced during the Prix Galien USA Awards Ceremony on October 27, 2022, at the American Museum of Natural History in New York City.

"The Prix Galien Awards have become the most coveted prizes for those who dedicate their lives to the development of meaningful drugs and innovations," said Bernard Poussot, Director, Roche Holding, Former Chairman & CEO, Wyeth, Prix Galien Startup, Digital Health and Incubators, Accelerators and Equity Committee Chairman. "Members of the Awards Committees applaud the unwavering commitment of each nominee in their quest to provide a healthier future for the next generation."

Image: https://www.prnewswire.com

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Incubator “Cheat Sheet” for Life Science Entrepreneurs in the BioHealth Capital Region · BioBuzz

The BioHealth Capital Region (BHCR) continues to grow rapidly with new startups and a greater number of clinical and commercial stage companies. The region aims to be in the top three biohealth clusters in the country by 2023. Whether it’s Kite Pharma‘s new facility in Frederick County, MD, companies like ATCC scoring contracts for critical vaccines, or recent moves to the area by companies like Synexa Life Sciences, it’s evident that the BHCR is thriving.

Image: https://biobuzz.io

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Apply for the Maryland Global Consulting Program

Expand your company's reach to international markets with the University of Maryland – Robert H. Smith School of Business Global Consulting Program!

Develop your export capabilities and find new customers with a team of 3-5 business graduate students advised by top-rated Maryland Smith faculty, along with the Maryland Department of Commerce's Office of International Investment and Trade.

Applications close on Thursday, August 4. Learn more at: https://lnkd.in/eFfddjsA

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Medical Device I-Corps

The Fischell Institute is working with University of Maryland (UMD) I-Corps representatives to plan a Medical Device I-Corps program, targeting dates in November. I-Corps is a National Science Foundation (NSF) program designed to foster, grow, and nurture innovation ecosystems regionally and nationally. UMD is the lead institution of the NSF I-Corps Hub: Mid-Atlantic Region and a member of the larger National Innovation Network.

UMD’s Introduction to I-Corps Course is a short, intense, bootcamp-style cohort. Participants work closely with teammates, other teams, and with mentors and instructors to develop business models around their innovations. Courses are approximately two weeks in duration, with the cohort meeting three or four times during the two-week span.

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