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Author: Amanda Bosland

Emmes Acquires Casimir, a U.S.-based Clinical Research Organization

Posted on by Amanda Bosland
Image credit: Emmes

The acquisition further differentiates Emmes' industry-leading rare disease research capabilites

Emmes’ Chief Human Resource Officer, Jennifer Hester, serves as Vice Chair on Rockville Economic Development, Inc’s (REDI) Board of Directors. REDI congratulates Emmes on their growth, and are grateful for the continued involvement and guidance of Ms. Hester.
 
ROCKVILLE, Md., Mar. 10, 2022 – 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. 
 
Emmes Chief Executive Officer Dr. Christine Dingivan said, “This is the fourth acquisition for Emmes in just over a year, as we continue to add new biopharma clients and deepen our innovative research capabilities. The combination of Casimir and Emmes will further differentiate our global rare disease center of excellence, Orphan Reach™. We plan to continue and accelerate the groundbreaking work of Casimir in neurodegenerative and neuromuscular conditions with remote data capture and patient outcome standardization.”
 
Founded in 2016, Casimir is supporting 39 projects with 25 different clients. It is especially well known for its efforts in Duchenne Muscular Dystrophy (DMD) and the application of its proprietary Duchenne Video Assessment (DVA) tool that measures clinical outcomes via remote data capture. The DVA is actively being explored in a variety of other rare disease indications, as well as in other neurogenerative/neuromuscular diseases.
 
Rare disease research is a strategic priority for Emmes. The company established Orphan Reach™: Emmes’ Rare Disease Center to combine its expertise in biostatistics, data management and clinical research with Orphan Reach’s rare disease patient-centric focus. Now, with Casimir’s proprietary clinical outcomes technology, Emmes establishes itself as the industry-leading CRO in rare and orphan disease clinical research and drug development.
 
Casimir’s CEO and Co-Founder Christine McSherry said, “Emmes’ long history and passion to improve public health were instrumental in our decision to join this outstanding company. The size and reach of Emmes will give us an even greater ability to expand our current platform and outcomes development expertise to other neurodegenerative diseases and therapeutic areas.”
 
honda Henry, President of Emmes’ BioPharma Group, noted, “The combination of Emmes and Casimir will provide our clients access to full-service protocol design, strategy and trial execution services, not only for rare diseases, such as DMD, but also for a variety of myopathies and neurological conditions.”
 
She added, “Casimir is known for its virtual clinical trials and remote assessments that minimize the burden on patients and caregivers. This is something that we will build upon in other Emmes studies, as our goal is to utilize more and more real-world evidence to improve data quality and information for doctors when treating their patients.”
 
According to Dr. Dingivan, “Another advantage of Casimir’s addition to our Emmes team is that its work with biopharma companies, patient advocacy groups, regulators, and non-profits to design and validate its tools, like video assessments, has broader application to rare disease studies for Emmes’ public sector clients, such as the National Institutes of Health.”
 
 
About Casimir

Headquartered in Plymouth, Massachusetts and founded in 2016, Casimir’s CRO services begin with the patient’s perspective, as the company takes new approaches to its clinical studies that help build a better understanding of rare disease progression and treatment. It prioritizes virtual trials and remote assessments, focuses on qualitative research that centers on the patient experience, and captures the real-world impact of treatment interventions on patient quality-of-life through smart outcome measures.

About Emmes

Founded in 1977, Emmes is a global, full-service Clinical Research Organization dedicated to excellence in supporting the advancement of public health and biopharmaceutical innovation. The company’s clients include numerous agencies and institutes of the U.S. federal government and a wide range of biotechnology, pharmaceutical and medical device companies throughout the world. To learn more about how our research is making a positive impact on human health, go to the Emmes website at www.emmes.com.

Link to press release: https://emmes.com/content/emmes-acquires-casimir-its-fourth-major-acquisition

 
 
 

Rockville Business Forum: English Language Learning for Employees

Posted on by Amanda Bosland
Rockville has a multi-lingual workforce. Businesses may be wondering how they can help their employees improve their English language skills both for work and daily living.

This business forum presented by the City of Rockville, Rockville Economic Development, Inc. (REDI) and Rockville Chamber of Commerce introduces Montgomery County Coalition for Adult English Literacy (MCAEL), Literacy Council of Montgomery County, and Community Reach of Montgomery County who provide information on resources and classes available for adult English learners. Businesses will also have an opportunity to discuss their needs in this regard, including learning opportunities that best suit their employees.

The Tower Companies installs largest solar canopy in City of Rockville

Posted on by Amanda Bosland
Image credit: Prospect Solar

The new photovoltaic system will generate 20% of the Tower Building at 1101 Wootton Parkway

Press Release published by The Tower Companies

ROCKVILLE, Md., Feb. 1, 2022 – Today, The Tower Companies and Prospect Solar, LLC announced that The Tower Building, located at 1101 Wootton Parkway in Rockville, Md., flipped the switch on Tower’s largest on-site solar photovoltaic (PV) system. The project is also the largest solar PV Canopy installation in the City of Rockville and will contribute to Maryland’s long-term goal of net-zero GHG emissions by 2045.

In a statement from City of Rockville’s Mayor Bridget Donnell Newton, she said that “the installation of the solar carport and electric vehicle charging stations at 1101 Wootton Parkway is especially timely given Rockville’s work to approve our first Climate Action Plan. This is a great, innovative project that shows how Rockville businesses are contributing to clean, local renewable energy generation and helping our community meet our greenhouse gas reduction goals. We are proud that our city is home to companies like Tower that share the values of our community and are taking proactive approaches to help us meet Rockville’s climate action goals.”

The Tower Companies is a privately held and family-owned sustainable and healthy building leader that developed 1101 Wootton Parkway in 2001, continuing to own and manage the property today. The 290,000 SF, 10-story multi-tenant commercial office building is LEED® Gold Certified under Existing Buildings: Operations and Maintenance. The building is also ENERGY STAR Certified with a score of 84, which means that its energy performance is in the top 16 percent of similar buildings nationwide.

“Tower is proud to continue our long-standing commitment to sustainability and contribute to local, state, and national climate action goals that will improve the lives of generations to come” said Eric Posner, The Tower Companies’ Chief Operating Officer. “We view this project as a smart investment that not only benefits the environment but is also a real value-add for our office building tenants. These solar panels will directly improve building performance, reduce operating costs, and take pressure off the electricity grid, yielding clean and reliable energy. We hope our work will inspire other building owners to take similar action.”

Project Details:
The new half megawatt solar PV canopy system features 1,318 (435-watt) American-made panels in the adjacent parking lot, with an estimated annual production of nearly 690,000 kWh, or 20 percent of the total building energy demand. The onsite clean energy generated will be equivalent to the amount of carbon offset by 600 acres of U.S. forests annually. The project also included the installation of 4 new electric vehicle stations. Gregorio Sustainability LLC advised on, developed, and helped manage the project for The Tower Companies. Prospect Solar, a Virginia-based solar provider, designed and installed the 573-kW solar PV system. A blog about the project was posted by the Montgomery County Department of Environmental Protection to share highlights about implementation and other partners that made it a success. “Tower’s leadership on this project continues to prove that distributed renewable energy plays a major role in the future of new and existing buildings” said Andrew Skinner, VP of Prospect Solar.

The Tower Companies worked closely with the Maryland Energy Administration (MEA) to receive a generous grant from the Parking Lot Solar Photovoltaic Canopy with Electric Vehicle Charger Program. Tower is excited that this project will help make progress towards the State of Maryland’s Greenhouse Gas Emissions Reduction (GGRA) Act, which aims to reduce greenhouse gas emissions 50 percent by 2030 and reach net zero emissions by 2045. The Tower Companies shares the same climate targets, aligned with a commitment to ULI Greenprint and the Paris Agreement.

“Solar canopies are an excellent way to provide a dual purpose to land used for parking” said Mary Beth Tung, Director of the Maryland Energy Administration. “In addition to keeping cars cool and protected from the elements, the solar panels provide clean, renewable electricity to reduce the need for grid supplied electricity, while four onsite charging stations provide opportunities for employees and visitors to power their electric vehicles.”

About the Tower Companies

Headquartered in Rockville, MD, the family-owned Tower Companies has maintained a commitment to responsible development and continues to envision a world where buildings inspire and enrich the lives of their occupants and create positive social change. Tower owns and manages over 6 million square feet in the Washington, D.C. metropolitan area consisting of office buildings, retail shopping centers, lifestyle centers, and residential eco-progressive live-work-play communities, with an additional 13 million square feet in the development pipeline. Learn more at: https://towercompanies.com/

 

Immunocore announces FDA approval of KIMMTRAK® (tebentafusp-tebn) for the treatment of unresectable or metastatic uveal melanoma

Posted on by Amanda Bosland
Image credit: Immunocore

KIMMTRAK® is the first T cell receptor (TCR) therapeutic to receive regulatory approval

Press Release published by Immunocore

OXFORSHIRE, England & CONSHOHOCKEN, Penn. & ROCKVILLE, Md., Jan. 26, 2022 – Immunocore Holdings plc (Nasdaq:
IMCR) (“Immunocore” or the “Company”), a commercial-stage biotechnology company pioneering the development of a novel class of T cell receptor (TCR) bispecific immunotherapies designed to treat a broad range of diseases, including cancer, autoimmune and infectious diseases today announces approval from the United States Food and Drug Administration (FDA) of KIMMTRAK® (tebentafusp-tebn) for the treatment of
HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma (mUM).
 
KIMMTRAK’s approval establishes many firsts as the first TCR therapeutic to receive regulatory approval from the FDA, the first bispecific T cell
engager to receive regulatory approval from the FDA to treat a solid tumor, and the first and only therapy for the treatment of unresectable or
metastatic uveal melanoma to be approved by the FDA.
 
Bahija Jallal, Chief Executive Officer of Immunocore, said: “Today’s approval of KIMMTRAK is a historic milestone and the culmination of years of dedication by the Immunocore team, patients, and our healthcare partners. Every year in the United States, hundreds of people are diagnosed with
metastatic uveal melanoma who, until now, had no approved treatment options. KIMMTRAK is the first therapy to demonstrate a survival benefit to patients with this disease and we are focused on making KIMMTRAK available as quickly as possible.
 
Dr. Jallal continues, “We’re also proud to have developed the world’s first approved TCR therapeutic, which we believe validates the strength of our
platform and opens doors for us to explore further breakthrough discoveries in TCR therapeutics for the treatment of other cancers and diseases with high unmet need.”

“Uveal melanoma is a devastating disease that has historically resulted in death within a year of metastasis for our patients,” said John Kirkwood,
MD, director of the Melanoma Center at the UPMC Hillman Cancer Center. “The approval of KIMMTRAK (tebentafusp-tebn) represents a major paradigm shift in the treatment of metastatic uveal melanoma, and for the first time offers hope to those with this aggressive form of cancer.”
 
The approval of KIMMTRAK is based on the results of Immunocore’s Phase 3 IMCgp100-202 clinical trial, which were published in the September 23, 2021 issue of the New England Journal of Medicine. The randomized pivotal trial evaluated overall survival (OS) of KIMMTRAK compared to investigator’s choice (either pembrolizumab, ipilimumab, or dacarbazine) in patients with previously untreated mUM. 378 patients were randomized in a 2:1 ratio to either KIMMTRAK or investigator’s choice. Data from the trial, the largest Phase 3 trial undertaken in mUM, showed that KIMMTRAK demonstrated unprecedented median OS benefit as a first-line treatment. The OS Hazard Ratio (HR) in the intent-to-treat population favored KIMMTRAK, HR=0.51 (95% CI: 0.37, 0.71); p< 0.0001, over investigator’s choice (82% pembrolizumab; 13% ipilimumab; 6% dacarbazine). In the clinical trials, across both arms, patients stopped treatment for disease progression, unless the patient was otherwise deriving benefit, or for unacceptable toxicity.

“When my husband, Gregg, was diagnosed with metastatic uveal melanoma, it was devastating to learn that there were no treatment options shown to extend life.” said Sara Selig, MD, MPH, Co-Founder and Director of the Melanoma Research Foundation’s (MRF) CURE OM initiative. “Now, for the first time in the history of this disease, we will soon see extended survival in the next generation of metastatic uveal melanoma patients.”

In the randomized Phase 3 trial of KIMMTRAK (tebentafusp-tebn), treatment-related adverse reactions were manageable and consistent with the proposed mechanism. Among the patients treated with KIMMTRAK, the most common Grade 3 or higher adverse reactions were rash (18%), pyrexia (4%), and pruritus (5%). In the 245 patients treated with KIMMTRAK, Grade 3 cytokine release syndrome (CRS) occurred in <1% of patients and were generally well-managed. There were no Grade 4 or fatal CRS events observed in the Phase 3 trial. A boxed warning is included for CRS as it has the potential to become serious or life-threatening if not managed appropriately.

“Until now, effective treatment options for metastatic uveal melanoma patients were virtually non-existent. The approval of KIMMTRAK represents not only a new therapy but a new hope for the individuals and the families of those diagnosed with the deadliest form of eye cancer,” said Kyleigh LiPira, MBA, CEO of the MRF.

The company is ready to commercialize KIMMTRAK and expects to make the product commercially available in the United States within weeks.

KIMMTRAK was granted Breakthrough Therapy Designation for unresectable or metastatic uveal melanoma by the FDA in February 2021. The
Biologics License Application (BLA) approval followed review under the Real-Time Oncology Review (RTOR) program, an initiative of the FDA’s
Oncology Center of Excellence designed for efficient delivery of safe and effective cancer treatments to patients. The approval was granted four weeks ahead of the assigned PDUFA date of February 23, 2022. Immunocore provided an Assessment AID to facilitate FDA review. KIMMTRAK is being reviewed under the FDA’s Project Orbis initiative, which enabled concurrent review by the health authorities in partner countries that have requested participation.
 
The European Medicines Agency (EMA), the United Kingdom’s Medicines and Healthcare Regulatory Agency (MHRA), Health Canada, and the Australian Government Department of Health Therapeutic Goods Administration (TGA) have accepted the submission of the Company’s Marketing Authorisation Application. Additionally, Immunocore launched a global early access program to make KIMMTRAK readily available to mUM patients. There are currently over 200 patients in 13 countries in the early access program.

Immunocore is committed to helping patients who need KIMMTRAK obtain access via its KIMMTRAKConnect program. The program provides services with dedicated nurse case managers who provide personalized support, including educational resources, financial assistance, and site of care coordination. To learn more, visit KIMMTRAKConnect.com, which will launch later this week, or call 844-775-CARE (2273).
 
 
About Immunocore
Immunocore is a commercial-stage biotechnology company pioneering the development of a novel class of TCR bispecific immunotherapies called ImmTAX – Immune mobilizing monoclonal TCRs Against X disease – designed to treat a broad range of diseases, including cancer, autoimmune, and infectious disease. Leveraging its proprietary, flexible, off-the-shelf ImmTAX platform, Immunocore is developing a deep pipeline in multiple therapeutic areas, including five clinical stage programs in oncology and infectious disease, advanced pre-clinical programs in autoimmune disease and multiple earlier pre-clinical programs. Immunocore has locations in Oxfordshire, England, Conshohocken, PA, and Rockville, MD. Learn more about Immunocore at: https://www.immunocore.com/
 
 

Maxim Biomedical Inc. receives Emergency Use Authorization from FDA for new ClearDetect™ COVID-19 Antigen Home Test

Posted on by Amanda Bosland
Image credit: Maxim Biomedical, Inc.

MaximBio designed, tested and will manufacture ClearDetect™ in the United States to help meet the growing demand for home testing

Press Release published by PR Newswire

ROCKVILLE, Md., Jan. 25, 2022 – On January 19, 2022, Maxim Biomedical (MaximBio) received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration for their new ClearDetect™ COVID-19 Antigen Home Test. The at-home diagnostics market is growing rapidly and is expected to value over USD 7.6 billion and register a CAGR of over 5.4% by the end of 2028.  MaximBio designed, tested, and will manufacture their new assay in the United States to help meet this growing demand for home testing.
 
The ClearDetect™ COVID-19 Antigen Home Test employs proven Lateral Flow Assay (LFA) technology with a simplified workflow that can easily be done at home without the need for equipment or a reader. The test’s unique format involves only 3 components—a swab, a test strip, and a test tube pre-filled with sample buffer. This eliminates reagent measuring or the need to handle dropper bottles as required with other card-based and self-test systems.
 
To perform a test, a self-collected nasal swab is mixed with the sample buffer in the tube and the swab handle is snapped off. A test strip is added, and the tube is capped for incubation, reading and safe disposal in one tube. Results are available within 15 minutes and the signal lines can be visualized for up to 30 minutes, making the test quick and the result reviewable for a long period.
 
The ClearDetect™ COVID-19 Antigen Home Test performed well, when compared to an EUA-authorized PCR method, achieving 86.9% Positive Agreement (PPA) and 98.9% Negative Agreement (NPA), making it one of the more sensitive and specific antigen tests receiving EUA. The test also performed favorably when evaluated by the NIH with specimens positive for the Omicron variant, detecting 100% of live virus Omicron samples diluted to a PCR Ct value of 25.8. In the same study, ClearDetect™ detected the Omicron variant at a higher dilution than two other EUA-approved antigen tests.  
 

In a recent interview, Jonathan Maa, COO of Maxim Biomedical Inc. said, “Maxim Biomedical has always endeavored to provide high quality testing where it would fulfill unmet needs.  COVID-19 represents an opportunity to apply our expertise in LFA for application in the home and at the point-of-care with an accurate and easy-to-use solution.” Mr. Maa said that the ClearDetect™ COVID-19 Antigen Home Test is just the first of a series of at-home diagnostics MaximBio has in the works.

The test will be available in two kit configurations—packaged two (2) tests in a box for convenient at-home use, and in a bulk 25-test pack amenable for healthcare settings, schools, workplaces, and other high-volume testing scenarios. MaximBio expects both configurations to be competitively priced and affordable. According to Mr. Maa, the company is poised for immediate production ramp up in anticipation of a late February/early March launch.  

This project has been funded in part by the NIH Rapid Acceleration of Diagnostics (RADx SM) initiative with federal funds from the National Institute of Biomedical Imaging and Bioengineering, National Institutes of Health, Department of Health and Human Services, under Contract No. 75N92020C00020.  The Maxim SARS-CoV-2 Rapid Antigen Diagnostic Test has not been FDA cleared or approved. It is intended for use only under the Food and Drug Administration’s Emergency Use Authorization.

Press Release Link: https://www.prnewswire.com/news-releases/maxim-biomedical-inc-receives-eua-for-new-cleardetect-covid-19-antigen-home-test-301467866.html

 
About Maxim Biomedical, Inc.

Headquartered in Rockville, MD, Maxim Biomedical is a leading diagnostic healthcare company providing innovative solutions through the development and manufacture of trusted testing solutions. Our mission is to create diagnostic products that are affordable, accessible, and enable actionable testing to improve patient outcomes around the globe. For more information, visit maximbio.com

 
 
 

State Leads Delegation to Arab Health 2022, Awards 20 ExportMD Grants

Posted on by Amanda Bosland
Image credit: Maryland Department of Commerce

The delegation of Maryland companies include Get Real Health, Integrated Pharma Services and Inteleos from Rockville

Press Release published by Maryland Department of Commerce

BALTIMORE, Md., Jan. 24, 2022 — The Maryland Department of Commerce this week is leading a delegation of several Maryland companies to Arab Health 2022, one of the world’s largest healthcare exhibitions. Held in Dubai, this is the eighth year Maryland Commerce has exhibited at the trade show, promoting the state’s healthcare assets as well as a number of small and mid-size companies to a global audience. 
 
Maryland is hosting a nearly 42 square-meter booth (approximately 450 square-feet) to demonstrate company products and services, located in the U.S. Pavilion in Hall 1, Aisle E Booth 39. Exhibiting companies will receive display space and meeting areas within the booth, as well as matchmaking assistance through Maryland’s global office in the United Arab Emirates (UAE). The department will also offer a virtual participation option for companies unable to travel due to the pandemic. Prior to the pandemic, the conference attracted upwards of 50,000 attendees from more than 150 different countries around the world. 
 
“There are several reasons why Maryland has thousands of medical and life science companies—including our educated workforce, research and development contracts, and access to federal labs and facilities,” said Governor Larry Hogan. “Our attendance at Arab Health will help keep Maryland at the forefront of innovation and remind the industry’s top leaders and decision makers what our state has to offer companies interested in expanding to the United States.”
 
The 14 Maryland companies traveling to Arab Health as part of the delegation include Alliance Care Technologies (Easton); Bluffajo Cosmetics (Germantown); Get Real Health (Rockville); Global Alliant (Olney); Integrated Pharma Services (Rockville); Inteleos (Rockville); Man and Machine (Landover); OMM Collection (Kensington); Pevco (Baltimore); Restorative Therapies (Baltimore); Silbiotech, Inc. (virtual attendee) (North Potomac); Sisu Global (Baltimore); and Trinity Sterile/Sklar Instruments (Salisbury). 
 
“We have always looked forward to leading our yearly delegation to Arab Health, but now more than ever, we want to continue providing a variety of resources to help our Maryland businesses expand their customer base,” said Maryland Commerce Secretary Mike Gill. “The exhibiting spaces and matchmaking services provided through these trips offer countless benefits for our local companies. We encourage interested businesses to explore upcoming opportunities and other resources offered by our department.” 
 
Trinity Sterile and Sklar Instruments, two companies that merged in the early 2000s, are co-exhibiting for the first time at Arab Health. The Eastern Shore entities are looking forward to expanding their market shares and opening new channels of distribution throughout the Middle East and North Africa (MENA) region.
 
“We are pleased to present both of our companies, as two of the premier manufacturers of sterile procedure kits and one of the top five largest instrument manufacturers in the U.S.,” said JoAnne Stephens, director of international sales at Sklar Instruments. “We not only manufacture for our own brands, but we’re also the original equipment manufacturer for some of the larger sterile kit packers in the country.”
 
Maryland Commerce recently awarded several rounds of ExportMD grants, and many recipients utilized the funding to travel to Arab Health and last fall’s MEDICA trade show. ExportMD grants are provided to small and mid-size companies on a monthly basis to assist with travel and marketing costs associated with international trade shows. The next application deadline for the program is February 1, 2022 and eligibility requirements can be found on our website.
 
August – December 2021 ExportMD grant recipients
 
Anne Arundel County
S&M Engineering 
SpatialGIS, LLC
TRACE, Inc.
 
Baltimore City
Restorative Therapies
Sisu Global Health
 
Baltimore County
Longeviti Neuro Solutions 
LuminUltra Technologies 
mdlogix
Supplema, LLC 
Vac Pac Inc. 
 
Charles County
KM Williams & Associates
 
Harford County
Health Kiosk for All
 
Howard County
Global Alliant, Inc.
Hawkeye MedTech Inc. 
​​Hudson Global Scholars 
 
Montgomery County
Bluffajo Cosmetics
CB America Corporation
Integrated Pharma Services
Neighborhood Sun Benefit Corp.
OMM Collection
Pindox Pharma Inc.
RAZ Mobility LLC
Silbiotech Inc.
Silvec Biologics 
Trax Sports, LLC 
 
Prince George’s County
Man and Machine, Inc.
Phoebe Marketing Group 
 
Talbot County
Alliance Care Technologies, Inc.
 
Wicomico County
Trinity Sterile, Inc.
 
 
About Get Real Health

Get Real Health combines a world of new information from patients, devices and apps with existing clinical data to help individuals and healthcare professionals engage and empower each other. By giving providers and patients the information and tools they need to work together, Get Real Health helps their customers achieve a wide range of clinical and business objectives. Learn more at https://getrealhealth.com/

About Integrated Pharma Services

Integrated Pharma Services (IPS)  is an Award-Winning Contract Research Organization (CRO) and Reliable Partner to potential customers. IPS engages Ph.D. level scientists and skilled technical staff to design, troubleshoot, conduct, analyze, and report the scientific data. IPS has a strong scientific reputation and track record of providing customers the supporting data needed to advance their candidate therapeutics and diagnostics. Learn more at https://www.integratedpharmaservices.com/

About Inteleos
Inteleos is an independent non-profit, mission-based certification organization that delivers rigorous assessments and cultivates a global community of professionals dedicated to the highest standards in healthcare. Inteleos is the overarching governance and management organization for the American Registry for Diagnostic Medical Sonography® (ARDMS®) the Alliance for Physician Certification & Advancement™ (APCA™), and the Point-of-Care Ultrasound (POCUS) Certification Academy™ . Learn more at https://www.inteleos.org/

Biotech Firm, Tetracore, Secures Large Office Space in Rockville

Posted on by Amanda Bosland
Image Credit: Costar

This deal underscores the increased demand for life science space along the I-270 corridor

Article originally published by Costar on January 18, 2022

Biotechnology research and development organization Tetracore has signed a lease for a new location in Rockville, Maryland’s biotech hub.

The company agreed to take 93,400 square feet at 77 Upper Rock Circle, an eight-story building located just off Shady Grove Road near Interstate 270. Tetracore’s lease is for the third through fifth floors, as well as space on the lower level of the 235,210-square-foot building.

Tetracore creates innovative kits, assays, reagents and instruments for the detection of infectious diseases, biological warfare threat agents and biological markers. In 2020, the company developed and commercialized a real-time PCR test and serology multiplex test for SARS-CoV-2, the virus that causes COVID-19.

Th company is currently headquartered at 9901 Belward Campus Drive in Rockville, where it occupies around 50,000 square feet, according to CoStar information. Tetracore is expected to open its new office in October, Cushman & Wakefield told CoStar News in an email.

The deal underscores the increased demand for life sciences space along the I-270 technology corridor that over the last two decades has emerged as a bastion for the biotech and pharmaceutical industries.

In recent years, that demand has risen as companies look to increase their capabilities in part to combat the coronavirus pandemic, with vacancy rates in the life science market hitting an all-time low, Ben Powell of Cushman & Wakefield said in a release.

Powell, along with Gwen Fraker, brokered the deal for building owner, Bridge Investment Group.

77 Upper Rock was developed by The JBG Cos. near Shady Grove Hospital and the Rio shopping center. The building was originally constructed in 2005 as a build-to-suit for the U.S. Department of Health & Human Services to serve as a substance abuse center before the agency vacated in 2015.

DSC Partners acquired the then-vacant building in 2017 for $19.5 million and carried out a renovation program that included upgrading the conference center, gym, tenant lounge and outdoor terrace.

In early 2020, Canadian biopharmaceutical company Aurinia Pharmaceuticals selected the 77 Upper Rock Circle building to house its new U.S. commercial center of operations. The original deal was for 30,000 square feet with potential to expand to up to 120,000 square feet as the company rolled out its Maryland operations in phases.

The Aurinia deal was one of three leases signed during the contract period, when Salt Lake City’s Bridge Investment Group entered into an agreement with DSC Partners and Fortress Investment Group to buy the property for $34.3 million. Bridge completed the acquisition in March 2020.

The Tetracore lease brings the property to 96% leased, with Wilmington Trust, Nutricia North America and Cisco Systems, among others, also occupying space in the property.

 

About Tetracore

Tetracore is a biotechnology research and development organization that creates innovative kits, assays, reagents, and instruments for the detection of infectious diseases, biological warfare (BW) threat agents, and biological markers. Tetracore’s solutions have been used by various laboratorians, veterinarians, first responders, and clinicians. To learn more, visit www.tetracore.com

Thor Acquires Rockville Flex Space for $45M, Plans Life Sciences Conversion

Posted on by Amanda Bosland
Image Credit: CBRE

The properties feature approximately 70,000 square feet of vacancy available to be transformed to a life sciences use, with the potential to convert the remaining office/flex spaces

Article originally published by Commercial Observer on January 4, 2022

Thor Equities has acquired West Gude Labs, a trio of office/flex properties in Rockville, Md., for $45 million, with plans to convert them to life sciences space, according to CBRE, who represented the undisclosed seller in the deal.

Located at 20, 30 and 50 West Gude Drive in the Shady Grove neighborhood of Rockville, the properties total 231,582 square feet.

“The properties in Shady Grove presented a rare opportunity to acquire well-located assets with the potential to renovate and add value,” Jack J. Sitt, Thor Equities’ executive vice president, told Commercial Observer. “The Washington D.C., submarket has performed strongly, and we believe that trend will continue.”  

The three properties, situated within Montgomery County’s growing life sciences corridor, are ripe for being converted into first-class lab buildings, according to CBRE.

“Our team worked extensively with the seller over the past year, creatively managing the rent roll to unlock vacancy and provide a clear path to life sciences conversion,” Tommy Cleaver, an executive vice president at CBRE, said in a prepared statement. “There is an insatiable appetite within the investment community for well-located projects of scale that can deliver inventory to this market quickly. Owners that can provide that will be rewarded.”

Combined, the properties feature approximately 70,000 square feet of vacancy available to be transformed to a life sciences use, with the potential to convert the remaining office/flex spaces to more life sciences space over time, according to Cleaver, as the site’s mixed-use employment, or MXE, zoning allows for additional development by right.

Notable tenants in the portfolio include Comcast and Seco.

The most recent industrial report from CBRE revealed that the U.S. vacancy rate for existing lab and research space was at a record low of 4.9 percent, and at 1.9 percent in the Baltimore/Washington market. That has caused rents to jump 7.5 percent as of September compared to March 2021.

Thor Equities has been on a life sciences tear in the last few years, buying up properties in key markets like New Jersey and the Research Triangle in North Carolina, as well as beefing up its team to continue the expansion.

Joining Cleaver on the recent deal were CBRE’sDan Grimes and Stuart Kenny. The same team facilitated the sale of Shady Grove Bio & Tech Campus, a 435,000-square-foot life sciences property to Boston Properties in August.

The buyer’s broker was not disclosed. 

 

Emmes Acquires Institut Dr. Schauerte, Entering Real World Evidence Market

Posted on by Amanda Bosland

Emmes’ third major acquisition expands its European presence in Germany, adding a new electronic data capture tool to enhance real world evidence research

Emmes’ Chief Human Resource Officer, Jennifer Hester, serves as Vice Chair on Rockville Economic Development, Inc’s (REDI) Board of Directors. REDI congratulates Emmes on their growth, and are grateful for the continued involvement and guidance of Ms. Hester.

ROCKVILLE, Md., Dec. 21, 2021 /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 Institut Dr. Schauerte, a CRO headquartered in Munich, Germany.  Founded in 1990, Institut Dr. Schauerte is a full-service, technology-oriented CRO that specializes in late-phase, non-interventional, and post-market clinical follow-up studies.  It has conducted more than 400 studies across a range of therapeutic areas. 

This is the third acquisition for Emmes in the last year, having previously purchased Neox, headquartered in the Czech Republic, in December 2020 and UK-based Orphan Reach in May 2021.  The acquisition of Institut Dr. Schauerte augments Emmes’ global reach by expanding the company’s presence in Germany and adding new long-term strategic relationships with global biopharma companies.  With Institut Dr. Schauerte, Emmes now has more than 1,200 employees.

Emmes Chief Executive Officer Dr. Christine Dingivan said, “This is another positive step in our growth and diversification strategy.  Institut Dr. Schauerte has a 30-year history and deep expertise in the growing field of Real World Evidence (RWE) research. Its agile, technology-enabled approach is a perfect fit with Emmes and will enhance our digital capabilities.”

She added, “Emmes Europe is growing quickly, and Institut Dr. Schauerte will be joining an integrated team across the UK and EU that is successfully collaborating with colleagues in Canada, India and the U.S. to conduct global clinical trials.”

Institut Dr. Schauerte’s clinical trial operations have been conducted in more than 20 countries, and the company has seen accelerating revenues from post-approval non-interventional studies.  RWE and Real World Data have become increasingly important in improving patient care and influencing product development and lifecycle management decisions for drug, device and diagnostic manufacturers.

Institut Dr. Schauerte also expands Emmes’ technology product line with its ClinDoc tool, a secure, intuitive CFR21 Part 11 compliant Electronic Data Capture (EDC) solution.  It includes multi-language capabilities and interfaces for clinical trial management systems, electronic health records, and mobile health data from apps and wearables.  ClinDoc complements Emmes’ Advantage e-Clinical EDC system, giving the company even greater flexibility to meet diverse customer needs.

Institut Dr. Schauerte CEO and Founder Dr. Wulfram Schauerte said, “Our deep expertise in RWE and a thriving set of offices in Munich and Cottbus, Germany, will be strong assets in Emmes’ global growth plans.  We are excited about joining the company and working with our new colleagues in Emmes Europe.  We share much in common; in addition to our dedication to high research standards, we place great value on employee engagement and long-term client relationships.” 

Dr. Schauerte and Institut Dr. Schauerte’s leaders and staff will continue in their current roles. 

“Emmes and Institut Dr. Schauerte have a combined legacy of over 70 years in business,” noted Dr. Dingivan.  “Our team is looking forward to collaborating to improve the care and treatment of patients throughout the world, leveraging RWE to enhance studies ranging from Phase I to Phase IV, and using our EDC solutions to achieve greater data quality and efficiency for clients.”

About Institut Dr. Schauerte
Headquartered in Munich, Germany, and founded in 1990, Institut Dr. Schauerte is a technology-oriented full-service Clinical Research Organization that specializes in late-phase, non-interventional, and post-market clinical follow-up studies. Committed to providing high quality, bespoke RWE services and solutions, Institut Dr. Schauerte serves pharmaceutical and medical device companies across Europe in a broad range of therapeutic areas.

About Emmes
Founded in 1977, Emmes is a global, full-service Clinical Research Organization dedicated to excellence in supporting the advancement of public health and biopharmaceutical innovation. The company’s clients include numerous agencies and institutes of the U.S. federal government and a wide range of biotechnology, pharmaceutical and medical device companies throughout the world.  To learn more, visit www.emmes.com

 

Link to Press Release: https://www.prnewswire.com/news-releases/emmes-acquires-institut-dr-schauerte-entering-real-world-evidence-market-301449163.html

That’s a wrap! Rockville Economic Development, Inc. (REDI) 2021 Year in Review

Posted on by Amanda Bosland

As businesses continued weathering the pandemic, REDI bolstered its support and services to businesses and entrepreneurs, developed new programs that help Rockville’s most vulnerable industries recover, and engaged with regional organizations and institutions to prepare for the future economy.

 
Here’s a review of REDI’s impact in 2021:

Business Attraction, Retention and Expansion; Business Incentives:

  • Worked with the City of Rockville to reposition the Shady Grove Bio+Tech Campus on Choke Cherry Road as an adaptive reuse project with new Class A lab space, attracting life science businesses to the campus, including supporting changes to the City’s codes to allow for more streamlined processes for adaptive reuse projects
  • Consulted on and assisted with permit services for Duball’s Phase II of Rockville Town Center (the Ansel) multifamily project, including 400 apartment units
  • Developed a rapport with Connected DMV to provide input and support on a number of their initiatives including a Global Pandemic Prevention & Biodefense Center that located in Rockville, a center for Quantum, development of strategies to provide equal access for minorities and underserved populations to education and work opportunities, and regional economic development initiatives
  • Refined and streamlined the MOVE/Expansion and Small Business Impact Incentive Funds requirements and application process to make the programs more accessible to Rockville businesses and surveyed recipients of REDI’s MOVE/Expansion and Small Business Impact Incentive Funds to gauge the added economic impact to the City that these programs provide, as well as to provide support for REDI’s requests for additional funding for these programs
    • Provided $475,639 incentives to 5 businesses resulting in 100+ full and part time jobs retained and the creation of 35+ full-time jobs over 3 years:

Next Level Rentals

MOVE

$10,837

40 W. Gude Drive

8 FTE in Rockville with projected 7 new with move

3,136 sf

Smathers and Branson

MOVE

$34,557

1570 E. Jefferson Street

29 FTE in Rockville increase of 12+ new within 3 years

22,500 sf

Kim Engineering

MOVE

$14,245

1390 Piccard Drive

10 FTE in Rockville with 10 new in 3 years

4,122 sf

Twinbrook Dental

SBIF

$16,000

12300 Twinbrook Parkway

5 FTE with 7 new in 3 years

2,771 sf

Dawson’s Market

SBIF

$400,000

225 N. Washington Street

26 FT/33 PT employees

25,029 sf

Maryland Women’s Business Center (MWBC)/Small Business Support:

  • Supported 329 Montgomery County home-based childcare programs through one-on-one counseling and the development of a workshop series designed to strengthen financial practices
  • Launched the 14-week new program VetBizLady Grow program utilizing the GrowthWheel program with 15 Maryland participants through a partnership that includes the DC WBC, the ODU WBC, and the US Department of Veteran Affairs
  • Expanded MWBC’s Retail Incubator, ShopHer, to Union Station with a partnership with the DC WBC
  • Assisted 11 vendors receive funds from the Maryland RELIEF Act Online Sales and Telework Grant Assistance through MCEDC
  • Presented a three-part series of workshops on leadership development in the food and beverage industry to over 70 attendees


 Workforce/Talent Alignment:

 Marketing/Tourism Development: