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.  

“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.

Mutual self-interest provides a strong basis for transatlantic cooperation in biotechnology based on shared recognition of its vast potential to provide solutions to some of civilization’s most pressing problems. Thanks to explosive advances in our understanding of the many ways in which promiscuous nature has been manipulating DNA and RNA for the past billion years, it is widely anticipated that the 21st century will belong to biology.1 We are now at the point where our ability to innovate is constrained less by technical capability than by the limits of our imaginations. Multiple laboratories and companies on both sides of the Atlantic (and throughout the world) are pursuing promising applications, and experience confirms progress would be accelerated by cooperative approaches. But there are some considerable challenges, especially in agricultural and industrial contexts.

Ken Malone, Co-Founder and Managing Director of Early Charm Ventures, Joins BioTalk to discuss his career path, loving Baltimore, and what he sees as next for the BioHealth Capital Region

Listen now via Apple https://apple.co/3MRn94f, Google https://bit.ly/3tTPIpg, Spotify https://spoti.fi/36gfJXw, Amazon https://amzn.to/3MNckQG, and TuneIn https://bit.ly/3i3H3e7.

Ken Malone is a co-founder of Early Charm Ventures, a venture studio founded in 2012 in Baltimore (Charm City) that converts science to business. Early Charm specializes in taking brilliant scientific discoveries made at universities and turning them into companies focused on growth. They don’t chase quick exits. They build companies that create sustainable value.

Click here to view the transcript.

-  'We Do Vaccines' and 'Know Our Vax' are new educational efforts that provide information regarding vaccines

-  Programs explain Novavax' commitment to vaccine development and innovation

GAITHERSBURG, Md., March 10, 2022 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced the launch of its global unbranded 'We Do Vaccines' and 'Know Our Vax' programs, educational efforts aimed to help protect the health of people everywhere in the fight against COVID-19 and other deadly infectious diseases, such as influenza.

GAITHERSBURG, Md., March 11, 2022 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE: EBS) today announced that it has dosed the first participant in its Phase 1 study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of stabilized isoamyl nitrite (SIAN), a treatment being developed for known or suspected acute cyanide poisoning. Under an existing multi-year contract with the Biomedical Advanced Research and Development Authority (BARDA), and in collaboration with the Southwest Research Institute, Emergent is developing a single-use intranasal spray intended for administration by first responders and medical personnel following a cyanide incident.

“Emergent’s R&D efforts are grounded in our mission – to protect and enhance life,” said Kelly Warfield, Ph.D., senior vice president, research and development at Emergent BioSolutions. “We are committed to advancing unique programs like SIAN, which addresses the need for an easily administered first-line treatment for cyanide poisoning. Intranasal SIAN is being developed for potential use by both civilians and first responders and is part of our portfolio of medical countermeasures focused on priority public health threats identified by the U.S. government.”

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.

In 2003, a group of University of Maryland officials approached then-mayor Martin O’Malley with a development plan for vacant land along West Baltimore Street, adjacent to University of Maryland, Baltimore’s campus. Today, this ambitious project, the University of Maryland BioPark, boasts nearly three dozen life science companies, ranging from leading global firms to mature companies to early-stage ventures. In recent years, the BioPark has attracted a cluster of early-stage medical device companies. For these young companies, the BioPark offers something even more important than a corporate headquarters: a location on UMB’s campus and in the heart of Maryland’s biomed ecosystem.

Image: https://technical.ly/

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 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

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

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.

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. 

Indeed, in 2021, the U.S. bioscience industry represents a unique confluence of characteristics essential for addressing these challenges and realizing societal and economic progress: extraordinary innovation that’s saving and improving lives through advancements in biomedical, energy, and advanced food and industrial technologies, along with an expanding mix of employment opportunities with incomes that support a quality standard of living.

The industry is at the forefront of a host of major global challenges related to diagnosing, treating, and curing disease—especially COVID-19 and other infections with pandemic potential. The industry is also ensuring that the world can rely on a safe, affordable, and more sustainable food supply to feed a growing population, as well as developing biobased fuels, chemicals, and other industrial products to help us address climate change.

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

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. 

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?

BALTIMORE, March 7, 2022 /PRNewswire/ -- GlycoMantra, a University of Maryland, Baltimore (UMB) startup company developing therapeutics for unmet medical needs in prostate cancer, NASH liver fibrosis, and type 2 diabetes, has been granted worldwide, exclusive rights to a UMB technology to advance the company's pipeline of therapeutics for treating drug-resistant metastatic colorectal cancer (mCRC).

According to the American Society of Cancer Oncology, colorectal cancer (CRC) is the second leading cause of cancer death among men and women in the U.S., totaling about 53,000 deaths per year. Drug resistance to CRC is a primary challenge and mCRC remains a lethal disease. Although 5-fluorouracil (5-FU)—one of the current standards of care for patients with mCRC—exerts clinical benefit, all patients have acquired resistance to the drug over time.

“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

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.

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

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.

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.

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)

D&D Pharmatech, a clinical-stage global biotech company, features a strong research emphasis, with focus on neurodegenerative brain disorders led by Johns Hopkins University School of Medicine neuroscientists, including Ted M. Dawson, MD, PhD, who is a globally recognized authority in this domain.

The company’s founder Lee Seulki, PhD, 45, also working at the university as a radiology professor, is a promising medical scientist who is the youngest `Highly Cited Researcher` named by Clarivate Analytics in 2017.

Ron Kurz, Sr. Director & GM at Canon Virginia, Inc., joins BioTalk to discuss his career, growth opportunities, and Canon’s role in the BioHealth Capital Region

Listen now via Apple https://apple.co/35BlOgJ, Google https://bit.ly/36DvurG, Spotify https://spoti.fi/3sqk8jo, Amazon https://amzn.to/3598voh, and TuneIn https://bit.ly/3Itb16Y

SOUTH SAN FRANCISCO, Calif., Feb. 22, 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 its non-invasive organ transplant surveillance solutions are being used to help monitor post-operative graft health in the world’s first successful heart xenotransplantation. A genetically modified pig heart was successfully transplanted into a patient at the University of Maryland Medical Center on January 7, 2022.

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.”

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.

Learn more

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.