BHI Weekly News Archives

GERMANTOWN, Md., April 6, 2022 /PRNewswire/ — BiOneCure Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has cleared the IND for BIO-106, an antibody-drug conjugate (ADC) designed to target TROP-2 to treat a broad range of advanced solid tumors.

 The clinical study cleared by the FDA, known as StarBridge-1, is a Phase I/II, multicenter, open-label study to evaluate the safety, pharmacokinetics and preliminary anti-tumor activity of BIO-106 as monotherapy and in combination with pembrolizumab in patients with advanced cancers.

For months, some American and European leaders have foretold that the coronavirus pandemic would soon become endemic. Covid-19 would resolve into a disease that we learn to live with. According to several governors, it nearly has.

But we are still in the acute phase of the pandemic, and what endemic Covid might look like remains a mystery. Endemic diseases can take many forms, and we do not know yet where this two-year-old disease will fall among them.

Image: https://www.nytimes.com

GAITHERSBURG, Md., April 01, 2022 (GLOBE NEWSWIRE) — Altimmune, Inc.,  (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced that it has enrolled the first subject in the 48-week Phase 2 MOMENTUM trial evaluating the safety and efficacy of pemvidutide1 in subjects with obesity or overweight. Pemvidutide is a novel, investigational GLP-1/glucagon dual receptor agonist under development for the treatment of obesity and non-alcoholic steatohepatitis (NASH). The Company also today announced the completion of enrollment in its 12-week Phase 1b clinical trial of pemvidutide in subjects with non-alcoholic fatty liver disease (NAFLD).

As increasing effort and attention gets spent on making entrepreneur ecosystems more inclusive and diverse, women entrepreneurs still face challenges that their male counterparts may not.

That might include imposter syndrome stemming from being the only woman or person of color in a room of investors. It might mean few available business-building resources, or connections to those resources. Or a first-time entrepreneur might also be balancing uneven family responsibilities or taking care of a newborn.

Image: Startup Grind Maryland's March event speakers. (Image via startupgrind.com)

These free 1:1 virtual sessions are an opportunity to discuss your company with experts in diagnostics, therapeutics, digital health and medical devices. If you’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 sign-up for any of the EIR dates in 2022, please follow this link.

For venture capital, more money has led to new challenges. With U.S. venture smashing records for funds raised and funds deployed in 2021, the sector has become more competitive on both sides of the table: Entrepreneurs are able to be more selective about who they invite onto their cap tables, and VCs are fielding increased demand from limited partners (LPs) who want access to venture deals at earlier stages. 

What does this mean for the future of the U.S. venture ecosystem? One place to look for new trends is the formation of first funds by new venture firms, which are developing unique strategies to compete for early-stage deals. 

Image: https://carta.com/

FREDERICK, Md.–(BUSINESS WIRE)–The Maryland Tech Council, the largest technology and life sciences trade association in the state, today announced it has received $2.45 million in federal funding to accelerate innovation in Maryland. The community project funding is included in the fiscal year 2022 omnibus appropriations bill and made possible by the leadership of Senator Chris Van Hollen (MD), chair of the Senate Appropriations Financial Services and General Government subcommittee.

The Prince William County Department of Economic Development, in partnership with Holladay Properties, cordially invites you to the Northern Virginia Bioscience Center Grand Opening Celebration on March 29, 2022 at 11:30 a.m.

Join us to commemorate the completion of 30,000 square feet in new commercial wet lab space reflecting more than $17.3 million in capital investment. Meet with elected officials from the Board of County Supervisors, GMU faculty and researchers, biotech business owners, and many more.

Lunch will be provided with attendee giveaways and opportunities to tour tenant spaces. Attendance is free, but please RSVP at pwcded.org/nvbc-rsvp by Friday, March 25, to advise of your attendance. We hope to see you there!

RSVP Here

“What do you envision for your company’s future?” is a typical question for startups. And many of the 45 companies pitching in nine categories during the 14th annual SXSW Pitch Event showed they had a clear strategy for where they want to take their business next.

But no matter what the future holds, we all benefit from the inspired and imaginative minds solving today’s problems in both emerging and traditional industries like artificial intelligence and robotics, health, immersive, and transportation.

New investment will enhance immunochemistry and chromatography services, helping pharma and biotech customers accelerate drug development  

March 14, 2022 08:36 AM Eastern Daylight Time  

WILMINGTON, N.C.–(BUSINESS WIRE)–Thermo Fisher Scientific Inc., the world leader in serving science, today announced it will invest $97 million to expand its clinical research operations in Richmond, Virginia. The facilities, which include laboratory operations acquired with the purchase of PPD, Inc. in December 2021, will support increasing demand across biopharma for consistent, high-quality laboratory services to accelerate drug development.  

To make innovation a priority, hospitals and health systems must harness innovation efforts from the pandemic to stay ahead of the curve. Here, four health system and hospital innovation leaders share habits that are killing innovation.

Christine Brocato. System VP, Strategic Innovation of CommonSpirit Health (Chicago). Health systems are just recovering from the last COVID surge and there's a lot of concern about staffing levels and financials, which has hindered innovation as health systems have been focusing on immediate issues rather than future investments in innovation. 

President Joe Biden last week got his wish for a new agency to fund high-risk, cutting-edge biomedical research when Congress created the Advanced Research Projects Agency for Health (ARPA-H) and gave it a $1 billion startup investment. That’s a fraction of the $6.5 billion Biden had proposed, but advocates say it’s plenty to launch ARPA-H.

The 2022 spending bill does not resolve, however, a debate over whether to make ARPA-H a standalone agency within the Department of Health and Human Services (HHS) or part of the National Institutes of Health (NIH). Instead, it gives HHS Secretary Xavier Becerra 30 days to decide.

Image: https://no.wikipedia.org/wiki/Francis_Collins

Two years after beginning a collaborative strategic visioning process, only to pause in response to the urgent demands of the COVID-19 pandemic, Johns Hopkins University is relaunching the work of evaluating Johns Hopkins' Ten by Twenty strategic vision and mapping the next phase of the university's future.

BioHealth Innovation, Inc. (BHI), is a Montgomery County innovation intermediary which translates market-relevant research into commercial success by bringing together management, funding, and markets. BHI is seeking a life science business analyst to support the NIH SEED Office (https://seed.nih.gov/). The analyst will provide business landscape analysis and other project support on product development, corporate strategy, and private investment for NIH-funded companies. This will entail market landscape, technology, and other business intelligence research to support Entrepreneur-in-Residence and other SEED life science commercialization activities.

Download the PDF of the job description.

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Casimir Further Differentiates Emmes' Industry-Leading Rare Disease Research Capabilities

ROCKVILLE, Md., March 10, 2022 /PRNewswire/ — Emmes, a global, full-service Clinical Research Organization (CRO) dedicated to supporting the advancement of public health and biopharmaceutical innovation, today announced that it has acquired Casimir, a U.S.-based CRO. Casimir has experience in more than 20 rare diseases and has worked with regulators, sponsors and patients to develop outcome measures that capture the nuances of disease progression and treatment benefit.

– Reports Promising Early Data from Lead Clinical Program, JK07, for the Treatment of Heart Failure with Reduced Ejection Fraction –

– Initiates Enrollment in Second Cohort of JK07 Phase 1 Dose Escalation Study –

(Gaithersburg, MD) – March 7, 2022 – Salubris Biotherapeutics, Inc. (SalubrisBio), a clinical-stage biotechnology company dedicated to discovering and developing novel complex biologic therapeutics, today announced it received $32 million in financing from China-based Shenzhen Salubris Pharmaceuticals Co., Ltd. The investment, which was completed in the fourth quarter of 2021, will be used to advance the current pipeline, including continuation of an ongoing Phase 1b clinical trial and initiation of two additional Phase 1b clinical trials in 2022, and to further expand the pipeline through R&D.

BALTIMORE — The University of Maryland Medical System and Johns Hopkins Medicine have announced they will send more than $4 million worth of medical supplies to support Ukraine, and plan on sending more.

The two major hospital systems are sending items including airway aspirators, medical air compressors, beds, oxygen concentrators, positive pressure ventilators, face masks and shields, respirator kits, gowns, gloves and syringes, according to a press release.

The donation will help clinicians in Ukraine provide emergency medical care in the wake of Russia's invasion.

Mohan Suntha, president and CEO of UMMS, said he plans "to send additional supplies in the future."

Image: Photo by: University of Maryland Medical System Supplies for Ukraine

The Bethesda-based developer is preparing two developments under the moniker "EvolutionLabs" to take advantage of the growing life sciences demand in the county, including a 550K SF development near Pike & Rose, the developer announced Thursday. 

That project, EvolutionLabs at North Bethesda, is planned to include three buildings at the intersection of Old Georgetown and Banneker roads. The first groundbreaking there would be in 2024, according to the release. Stonebridge is under contract to acquire the land for that project, Stonebridge principal Kent Marquis told Bisnow in an email. 

The property will take advantage of the "urban, walkable, transit-oriented," spaces under development near the White Flint Metro station, Marquis said.

Image: Courtesy of Cannon Design Stonebridge and Principal Real Estate's EvolutionLabs concept at 9713 Washingtonian Blvd.

For a small business with a brilliant new idea in the life sciences, a funding infusion can do wonders to help translate that concept into reality. Did you know that the NIH small business programs are the largest source of early-stage capital for the life sciences in the U.S.? These programs set aside over $1.2 billion non-dilutive funds every year — specifically to support small business research and development. 

The Biotechnology Innovation Organization (BIO) and Council of State Bioscience Associations recently released Driving the Bioscience Economy Forward During the COVID-19 Pandemic: Best Practices in State and Regional Bioscience Economic Development Initiatives. The biennial report provides a summary of state programs serving the bioscience industry.

This year’s report devotes substantial attention to incentives. Many of the incentive policies are intended to support the leading trends in state bioscience support (see below). These include incentives to provide funding for companies coming out of university partnerships, industry workforce training and development, and facility development. Others are intended to provide capital to bioscience companies at the early-stage, mid-stage, and manufacturing stage of development, such as angel investor and seed capital tax credits, R&D and innovation investment tax incentives, and tax exemptions, abatements or discounts.   

Image: https://smartincentives.org

The Maryland Tech Council has launched two new regional satellite chapters to directly focus on the burgeoning technology sectors in Greater Baltimore and Prince George's County.

The tech council (MCT) is Maryland's largest technology and life sciences trade association with more than 450 members. The Baltimore and Prince George's regional councils are the first sub-chapters launched by the organization.

Image: Marty Rosendale, CEO of the Maryland Tech Council, said the organization created regional chapters "to intentionally unite and empower stakeholders through local advocacy, outreach and growth." Maryland Tech Council

FREDERICK, Md.–(BUSINESS WIRE)–The Maryland Tech Council is proud to announce the finalists for its annual Industry Awards Celebration. The event honors individuals and companies in the life sciences, technology, and government contracting industries that have made a significant impact in their respective fields. For the first time in two years, the awards ceremony will be held in person, with the winners announced live on May 12th at the Bethesda North Marriott Hotel & Conference Center. Last year over 9,000 people tuned in to the virtual Industry Awards Celebration. Click here to learn more about the event. 

Human monoclonal antibodies (mAbs) are being used in the clinic to prevent or treat SARS-CoV-2 infection, and experience thus far suggests that combinations of antibodies are potentially able to sustain broad recognition of viral variants as they arise, but developing, testing and approving mAb combination products is complex. One approach to reducing the logistical challenges of combination products is the development of bispecific antibodies (bsAbs) (Fig. 1). In this issue of Nature Immunology, Li et al. report the development and testing of an engineered bispecific human mAb against SARS-CoV-21.

Image: https://www.nature.com

SOUTH SAN FRANCISCO, Calif., March 02, 2022 (GLOBE NEWSWIRE) — CareDx, Inc. (Nasdaq: CDNA) – The Transplant Company™ focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers – today announced that it is teaming up with the National Kidney Foundation (NKF) to support National Kidney Month initiatives aimed at improving outcomes for kidney transplant recipients and those suffering from kidney failure.

This marks the seventh consecutive year that CareDx is supporting NKF’s Kidney Patient Summit on Capitol Hill, which is taking place virtually this year on March 2, 2022. Patient representatives will be advocating for more research funding to accelerate the early detection of chronic kidney disease, which could help physicians reverse or delay the need for transplantation.

March 2, 2022 — The U.S. Centers for Medicare and Medicaid Services (CMS) will offer reimbursement for software from Medimaps Group that performs osteoporosis risk fracture assessment via trabecular bone scores (TBS).

The agency assigned the Current Procedural Terminology (CPT) code 77089 for Medimaps' TBS iNsight, which provides a trabecular bone score for x-ray and dual-energy x-ray absorptiometry. It was effective January 2022.

Image: https://www.auntminnie.com

WHAT YOU'LL LEARN

• As new markets are embracing the Life Science industry, why are users feeling bullish in investing and developing in the Mid-Atlantic area? How is our region competing with different markets? 
• Strategic Design & Development: How are investors and developers meeting the latest demands when it comes to design and amenities? What is being implemented to ensure purpose-built life science facilities? 
• How are developers and tenants finding more space as demand for facilities continues to rise? Are we seeing more vacant buildings being converted into labs and other biotech facilities to meet the high demand? 
• With the rise in market opportunity, where is the public and private funding coming from for life science real estate? 
• I-270 Corridor Update: What are the newest projects and investments in the development pipeline? What is expected for this life science & biotech corridor in terms of tenants, investments and development in 2022? How are DC & NoVa competing against this corridor and securing their spot in the asset class?

“I never had been in an ecosystem that had more potential, more assets, that was more disconnected, than this region was at that time.” -Rich Bendis of BioHealth Innovation, Inc. on why Maryland was a great place to grow the BioHealth Capital Region.

Watch: https://bit.ly/3trKMYm

Maryland is home to one of the largest life science clusters in the nation. According to the Maryland Department of Commerce, the State has nearly 2,300 life science companies and 476 private research and development biotechnology firms (NAICS 541714), which represents 5.3% of this U.S. industry.

Some of the nation’s most important research occurs within Maryland at National Institute of Health (NIH), Food & Drug Administration (FDA), federal laboratories, Johns Hopkins, and the University of Maryland. In fiscal year 2018, Maryland received $1.5 billion from NIH for biomedical research, behind four other states (NIH 2018 report):

Image: https://www.americangene.com

With the Bisciotti Foundation Translational Fund, John Hopkins University School of Medicine is bringing seed funding to three teams of researchers creating innovative medical devices.

Each of these devices, which are being developed by Hopkins professors and fellows, aim to dramatically decrease costs on hospitals and improve patient care by taking anesthesia out of the equation. Recipients were awarded between $25,000 and $100,000 to conduct their work during a period of up to nine months.

Image: (L to R) Therese Canares, Mathias Unberath, Clifford Weiss and Ethan Tumarkin. (Courtesy image)

Robert Gourdie, a trailblazing cardiovascular scientist at the Fralin Biomedical Research Institute at VTC, is the first Virginia Tech researcher to receive an Outstanding Investigator Award from the National Institutes of Health (NIH).

The seven-year, $6.4 million grant is funded by the National Heart, Lung, and Blood Institute (NHLBI), part of the NIH. Known as an R35, the grant provides Gourdie with increased freedom to carry out inventive research concepts that aren’t tethered to specific, finite projects.

Image: Robert Gourdie, the Commonwealth Research Commercialization Fund Eminent Scholar in Heart Reparative Medicine Research and director of the Fralin Biomedical Research Institute’s Center for Vascular and Heart Research, is Virginia Tech’s first recipient of a National Institutes of Health Outstanding Investigator Award. Photo by Clayton Metz for Virginia Tech.

Foresite Capital, a firm that invests in early-stage healthcare and life sciences companies, today launched a $173 million fund designed to further finance startups launched by its Foresite Labs entrepreneurial innovation hub.

The new fund will be one source of capital for Foresite Labs startups, which will continue to be funded through the $969 million raised last year by Foresite Capital—consisting of the $775-million Fund V and a $193.75 million fund for selectively making additional investments in their highest conviction Fund V portfolio companies, called the Opportunity Fund.

Image: Vikram (Vik) Bajaj, PhD, a managing partner with Foresite Capital and the Co-Founder and CEO of the firm’s Foresite Labs entrepreneurial innovation hub.

POSITION DESCRIPTION – Entrepreneur-In-Residence

EIRs will work in collaboration with SEED to mentor innovators and provide guidance to help them de-risk the technical and business elements of their product development projects. EIRs will also help NIH and individual innovators ensure the long-term success of their projects by facilitating connections with investors and strategic partners who can help achieve commercial success and healthcare consumer access. To be successful in this role, entrepreneurial, commercial or product development experience in areas of social impact including wellness & prevention, healthcare access/community health and a wide network in social impact ventures is required.

This position is currently remote (with opportunity for future in-person activities) and part time (20 hrs/week with potential for expansion); occasional travel may be required (when conditions permit).

Johns Hopkins University led all U.S. institutions in total National Institutes of Health (NIH) funding for federal fiscal year 2021, with more than $820 million in awards, $824,856,274 to be exact. The rest of the top ten institutions were:

After struggling through COVID-19 vaccine production woes in 2021, Emergent BioSolutions has another surprise for its investors in early 2022. 

Last month, Emergent projected revenues of $1.4 billion to $1.5 billion for this year. Now, the company has dropped the figure to $1.3 to $1.4 billion. 

Why the adjustment?

In its quarterly report, Emergent credited its decision to undergo maintenance on its troubled Baltimore Bayview facility “earlier than anticipated,” and to expand the project to set the facility up for “future non-pandemic work.”

USP Developing mRNA Quality Guidelines to help companies and regulators bring innovative medicines to market faster   Rockville, Md., February 23, 2022 – U.S. Pharmacopeia (USP), a global independent scientific organization, is seeking scientific input on new draft guidelines, “Analytical Procedures for mRNA Vaccine Quality.” USP and a group of leading mRNA experts have identified the need for analytical procedures and best practices to support quality assessments for mRNA vaccines and therapies in development pipelines for infectious diseases, cancer, cystic fibrosis and other disorders.

To build public trust and confidence in innovative products like mRNA-based therapies, they must be of good quality, safe, and effective. Since the successful application of mRNA technology is relatively new, regulatory guidelines and industry standards are still evolving. A common approach for assessing mRNA quality would support developers, manufacturers, regulatory agencies, and national control laboratories worldwide, and provide tools to help accelerate the development of safe and effective mRNA-based products.

In a bid to keep and grow its flagship biohealth sector, Montgomery County is dramatically streamlining its regulatory review process for industry players who want to build or expand big lab facilities.

A new zoning text amendment, which the County Council unanimously approved Tuesday, will slash the lab entitlement process time from nearly two years to six months in an effort to “roll out the red carpet” for biotech industry leaders, said Councilman Andrew Friedson, D-District 1, who spearheaded the legislation.

Image: Montgomery County Councilman Andrew Friedson, D-District 1, speaks at a county event to unveil a new zoning process change. The Wednesday gathering was held outside of biotech United Therapeutics' Silver Spring campus. DAN BRENDEL

In this issue of Cell Host and Microbe, Haslwanter et al., 2022 present a comprehensive investigation into the molecular and functional basis of 17D vaccine responses and into differences between antibody neutralization of the 17D and related African lineage strains to contemporary Central/South American strains, including the emergent YFV ES-504 strain.

Image: https://www.cell.com

WILMINGTON, Del.–(BUSINESS WIRE)–Amalgam Rx, Inc., a leader in connecting healthcare providers, payers, and life sciences companies through a SaaS-enabled digital marketplace and product platform, and Privia Health Group, Inc., a national physician enablement company, announced a collaboration for multiple EHR-integrated services.

Leveraging Amalgam’s real-time, point-of-care decision support engine, the companies are working together to simplify and enhance the way providers practice value-based care, recruit for clinical trials, and ensure medication safety. Privia Health selected several offerings from Amalgam’s marketplace including:

Image: https://www.businesswire.com

The University of Maryland named Dr. Dean Chang as its new interim chief innovation officer and associate vice president for innovation and economic development of the research division, according to an email Monday from the interim and incoming vice presidents for research.

Chang served as founding associate vice president for innovation and entrepreneurship for this university’s Academy for Innovation and Entrepreneurship over the last nine years. In the position, he worked with more than 41,000 students in all 12 of the university’s colleges and schools in innovation, the email said.

The Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs of the National Institutes of Health (NIH) supported the development of 99 drugs from 1996-2020 — a total that includes 16 percent of all such treatments that made a “significant” advance over available medicines. This finding is just one of the impacts that the National Academies of Sciences, Engineering and Medicine (NASEM) attributes to the program in a new report.

The University of Maryland Baltimore County has joined the highest ranks of research universities in the country, a milestone for the young school with a reputation for producing scientists and engineers of color.

The 55-year-old university in suburban Baltimore reached Research 1, or R1, status, a distinction for universities with very high research activity.

Image: Trevor Shepard, a chemistry major, works on a viscosity experiment at the University of Maryland Baltimore County in October 2020. (Michael Robinson Chavez/The Washington Post)

The Universities at Shady Grove (USG) – with nine partner universities offering a wide range of life-changing academic programs on one convenient campus in Montgomery County – has been an innovative model for higher education delivery since its inception in 2000.

After two decades of growth, evolution and success, it’s time for the USG community to now build on the solid foundation it has established by charting a solid course for “USG 2.0.” It’s time for us to develop our first-ever Strategic Plan, to help shape the future direction of a unique University System of Maryland institution that is the largest and most comprehensive of the state’s regional higher education centers.

Image: https://shadygrove.umd.edu/about-usg/leadership-governance/office-of-the-executive-director/usg-2.0

New zoning measure spearheaded by Friedson will accelerate and streamline the regulatory process to develop and spur expansion of biohealth facilities in Montgomery County

On Wednesday, February 16 at 10:30 a.m. Councilmember Andrew Friedson and Montgomery County biohealth and economic development leaders will hold a press conference to reinforce Montgomery County’s commitment to innovation and the biohealth sector at United Therapeutics Corp. in Silver Spring.

Looking to make connections and identify partners in the life sciences industry? Use the Maryland Life Sciences Directory, a free tool for exploring more than 1,000 profiles of companies active in Maryland’s robust life science markets, including biotechnology, medical technology, pharmaceuticals, digital health, manufacturing, regulatory services, and related subsectors. Explore company profiles for an overview of business activities, products, and services, and to connect with potential partners.