BioBuzz: Capital Region Emerges as Undisputed Leader in War on Infectious Diseases

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With the Delta variant driving over 100,000 new infections per day across the United States, the COVID-19 pandemic is far from over. While COVID continues to rage, infectious disease experts are not only battling the ongoing pandemic but are on the lookout for the next
virulent threat.

Since 1900, there have been eight different pandemics that concerned public health across the globe, such as Zika, MERS, Ebola, Swine Flu, and others, which have led to the loss of millions of people and billions of dollars in economic losses. That’s one reason for the establishment of the Global Pandemic Prevention and Biodefense Center in Montgomery County, Maryland. When COVID broke last year, a task force urged for the formation of an organization that could peer past the current crisis and put on its prognostication hat to prepare for future threats. With its long history of thought leadership in infectious diseases and vaccines development, as well as its proximity to federal health and regulatory agencies, the BioHealth Capital Region was the perfect fit for the biodefense center.

The $2.5 billion Center will work to accelerate the development of human monoclonal antibodies (mAbs) to treat the world’s top 100 pathogens across 25 pathogen families most likely to result in disease outbreaks. Not only will the Center develop the mAbs, but it will also implement distribution and delivery protocols across the global public health and pandemic prevention ecosystem.

James Crowe Jr., an immunologist, and pediatrician at Vanderbilt University Medical Center who took part in a roundtable discussion on infectious diseases during the seventh annual BioHealth Innovation Forum said the COVID pandemic is something people do not want to go through again. By establishing the Center and mAbs stockpile, Crowe said the public health community can be one step ahead of future outbreaks, particularly those viral threats that are already known to science.

“We want to make antibodies for pathogens that are likely to create future threats,” Crowe said.

Andy Weber, Senior Fellow of the Council of Strategic Risks, called stockpiling the mAbs a “pandemic assuredness policy.” He pointed to the government’s efforts to create a national stockpile of vaccines for smallpox In case it was used as a biological weapon in the wake of the War on Terror. By proactively thinking about that possibility, Weber said the government has taken that threat off the table. Through a stockpile of antibodies for those 100 threats, Weber said they can remove the threat of biological outbreaks.

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BioBuzz: BioHealth Capital Region Retains Strong Grip on No. 4 Spot of Top 10 U.S. Biopharma Hubs – Eyes Third Spot by 2023

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As a life sciences cluster, the BioHealth Capital Region is poised to become a top-three cluster in the Genetic Engineering & Biotechnology News (GEN) Top 10 Biopharma Clusters ranking on the strengths of early-stage companies becoming commercial successes and the construction of millions of square feet of new wet lab space.

For 2021, the BHCR held onto the fourth-place position behind New York/ New Jersey, San Francisco Bay Area, and the greater Boston area. The latest ranking was revealed at the seventh annual BioHealth Innovation Forum. The region held onto the coveted spot for multiple reasons, including significant funding from the National Institutes of Health, available wet lab space, and patent strength protecting intellectual property.

Pete Brisbane, Executive Managing Director JLL, Mid-Atlantic Life Sciences Practice, said that as a cluster, the BHCR is doing “fantastically well” and will only improve over the next two years. In fact, Brisbane predicted that by 2023, the BHCR could overtake the New Jersey/ New York biopharma cluster in the number three spot based on increased venture capital funding, new wet lab space, and the fact that “the region will thrive as early-stage companies become commercial companies.”

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American Gene Technologies Appoints Dr. Robert R. Redfield as Special Advisor to the CEO

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Dr. Redfield’s expertise in virology strengthens AGT’s capacity to develop innovative HIV treatments.

American Gene Technologies (AGT) announces the appointment of Dr. Robert R. Redfield, former director of the Centers for Disease Control and Prevention (CDC) and co-founder of the Institute for Human Virology, as special advisor to AGT CEO Jeff Galvin.

Dr. Redfield is well known for his decades of dedicated work in virology, immunology and clinical research. He has helped lead collaborative research into HIV/AIDS since the beginning of the epidemic during his years as a U.S. Army physician and at the University of Maryland School of Medicine. Dr. Redfield has held multiple advisory positions, including with the President’s Advisory Council on HIV/AIDS, the National Institutes of Health and the U.S. Food and Drug Administration. He was the CDC director from March 2018 to January 2021, leading the agency through a period of historic challenges, including the onset of the COVID-19 pandemic.

“It’s a great honor to have Bob back on board,” said AGT CEO Jeff Galvin. “He played a pivotal role for us as an advisor beginning in 2011, becoming chair of the Clinical Advisory Board for our HIV Cure Program before having to resign when he was appointed as director of the CDC. Bob’s passion for public service is matched only by his devotion to the cause of finding a cure for HIV. Having him on our team strengthens our capacity to achieve that dream.”

Dr. Redfield’s expertise in virology and extensive experience in HIV research will be very helpful as AGT conducts the ongoing phase 1 trial of AGT103-T, a cell and gene therapy for HIV disease. Durable viral suppression without the use of antiretroviral therapies is the goal of AGT’s phase 1, and Dr. Redfield’s long-standing commitment to the development of innovative treatments for HIV makes him well-suited to assist in the major milestones ahead.

“This is an exciting homecoming for me,” said Dr. Redfield of his appointment. “I have followed AGT’s development from the beginning, and am proud to do what I am able, to bring this therapy to patients. I look forward to once again collaborating with Jeff and the entire team as AGT continues to act as pioneers in gene therapy and the work for an HIV cure.”

Phase 1 in the Maryland/DC Area
AGT’s Phase 1 trial for AGT103-T is currently underway at trial sites in the Maryland / Washington, DC area. The recruitment status of the phase 1 RePAIR (Restore Potent Antiviral Immune Responses) clinical trial along with information of the trial sites can be found on ClinicalTrials.gov. The trial is the company’s first step in clinical testing of cell and gene therapies for HIV, cancer, and rare diseases.

About HIV
According to UNAIDS, approximately 37.7 million people worldwide live with HIV/AIDS. In the United States, government statistics show 1.2 million people have HIV and estimate that 34,800 Americans were newly infected with HIV in 2019. Across the globe, UNAIDS estimates that approximately 1.5 million individuals were newly infected with HIV in 2020. The Washington D.C./Baltimore area is often cited as a ‘hot spot’ for HIV, with Washington, D.C., having the highest rate of infection at nearly 46 cases per 100,000 population and Baltimore City having rates of 17 cases per 100,000. Maryland also ranks sixth among U.S. states and territories in HIV diagnosis rates, with more than 900 new cases in 2019 alone, according to the Maryland Department of Health.

Since the late 1980s, antiretroviral therapies have restored quality of life to persons living with HIV and, in some cases, have even been used to prevent new infections. However, no approved treatments offer durable remission or cure for HIV. AGT is committed to addressing this unmet medical need.

About AGT103-T
AGT103-T is a genetically modified cell product made from a person’s own immune cells. AGT’s unique approach is focused on repairing the key immune system damage caused by HIV. AGT’s goal is to develop a cell and gene therapy capable of repairing the immune system to provide natural control over HIV replication.

About American Gene Technologies
AGT is a gene and cell therapy company with a proprietary gene-delivery platform for rapid development of cell and gene therapies to cure infectious diseases, cancers, and inherited disorders. AGT’s mission is to transform people’s lives through genetic medicines that rid the body of disease. AGT has been granted four patents for the technology used to make AGT103-T and 11 patents for its unique gamma-delta (γδ) T cells to destroy a variety of solid tumors. The company has developed a synthetic gene for treating Phenylketonuria (PKU), a debilitating inherited disease. AGT’s treatment for PKU has been granted Orphan Drug Designation by the Food and Drug Administration (FDA), and it is expected to reach the clinic in 2022.

Emergent BioSolutions Secures Multi-Year Development and Manufacturing Agreement with Providence Therapeutics for its mRNA COVID-19 Vaccine Candidate, PTX-COVID19-B

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  • Total baseline value for Emergent is approximately $90 million USD, further expanding the collaboration between the companies, which began in February 2021

GAITHERSBURG, Md. and CALGARY, Alberta, Sept. 14, 2021 (GLOBE NEWSWIRE)– Emergent BioSolutions Inc. (NYSE:EBS) and Providence Therapeutics today announced they have entered into a five-year contract development and manufacturing (CDMO) services agreement spanning Emergent’s integrated capabilities, including development services, bulk drug substance formulation and drug product manufacturing, to support Providence’s COVID-19 messenger RNA (mRNA) vaccine development. In 2022, Emergent will manufacture tens of millions of doses of PTX-COVID19-B drug product, as well as batches of PTX-COVID19-B formulated bulk drug substance with the potential to yield hundreds of millions more doses, for global populations in need of pandemic relief.

Under the terms of the five-year agreement, Emergent will provide current Good Manufacturing Practice (cGMP) manufacturing services for two presentations of the PTX-COVID19-B vaccine product, both the formulated bulk drug substance and finished drug product (fill/finish), at Emergent’s facility in Winnipeg, MB, Canada. Additional process and analytical development services will occur from Emergent’s Center of Excellence for Development Services in Gaithersburg, Maryland. The baseline agreement signed between Emergent and Providence Therapeutics is valued at approximately $90 million, covering manufacturing services, studies to support global supply chain activities, as well as facility and equipment investments.

“Emergent’s commitment to fight the COVID-19 pandemic is anchored in our partnerships with innovators who share the same mission to address public health threats around the world,” said Adam R. Havey, executive vice president and chief operating officer at Emergent BioSolutions. “This collaboration is a testament to Emergent’s long heritage and experience in Canada. We are proud that Providence has chosen our Winnipeg team and site to manufacture its Canadian mRNA technology in Western Canada, one of the few facilities in the country manufacturing large quantities of mRNA COVID-19 vaccine doses today.”

As commented by Brad Sorenson, Providence CEO, “Providence is very pleased to have the resources necessary to ramp up commercial manufacturing of its COVID vaccine here in Canada. We look forward to working side-by-side with Emergent to deliver tens of millions, and potentially hundreds of millions of doses of our world-class vaccine to developing countries across the globe. It has always been Providence’s mission to produce the highest quality medicines at affordable prices, and with Emergent’s help we are closer to achieving this goal.”

To date, Emergent has partnered with numerous pharmaceutical and biotech innovators, as well as the U.S. government and non-government organizations in providing critical contract manufacturing services (drug substance manufacturing, drug product manufacturing and development services) in response to the COVID-19 pandemic.

About Emergent BioSolutions
Emergent BioSolutions is a global life sciences company whose mission is to protect and enhance life. Through Emergent’s specialty products and contract development and manufacturing services, Emergent is dedicated to providing solutions that address public health threats. Through social responsibility, Emergent aims to build healthier and safer communities. Emergent aspires to deliver peace of mind to its patients and customers so they can focus on what’s most important in their lives. In working together, Emergent envisions protecting or enhancing 1 billion lives by 2030. For additional information, visit Emergent’s website and follow Emergent on LinkedInTwitter and Instagram.

About Providence Therapeutics
Providence Therapeutics is Canada’s leading mRNA vaccine company, with operations in Calgary, Alberta and Toronto, Ontario. In response to a worldwide need for a COVID-19 vaccine, Providence has expanded its focus beyond oncology and devoted its energy and resources to develop a world-class mRNA vaccine for COVID-19. Providence Therapeutics is focused on serving the needs of Canada, and other countries that may be underserved by large pharma programs. For more information, please visit providencetherapeutics.com.

Emergent BioSolutions Safe Harbor Statement
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, including statements regarding Emergent’s ability to advance potential solutions to combat coronavirus disease and manufacture tens of millions of doses of PTX-COVID19-B drug product and formulated bulk drug substance, the timing of production of such doses and the potential to yield hundreds of millions additional doses and any other statements containing the words “believes,” “expects,” “anticipates,” “intends,” “plans,” “estimates” and similar expressions, are forward-looking statements. These forward-looking statements are based on current intentions, beliefs and expectations regarding future events. Emergent cannot guarantee that any forward-looking statement will be accurate. The reader should realize that if underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could differ materially from expectations. The reader is, therefore, cautioned not to place undue reliance on any forward-looking statement. Any forward-looking statement speaks only as of the date of this press release, and, except as required by law, Emergent does not undertake to update any forward-looking statement to reflect new information, events or circumstances.

There are a number of important factors that could cause the Emergent’s actual results to differ materially from those indicated by such forward-looking statements, including, but not limited to, the success of the planned development program, the timing of and ability to obtain and maintain regulatory approvals or authorization for emergency or broader patient use for the product candidate and Emergent’s manufacturing capabilities. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from expectations in any forward-looking statement. The reader should consider this cautionary statement, as well as the risk factors identified in Emergent’ periodic reports filed with the SEC, when evaluating Emergent’s forward-looking statements.

Providence Therapeutics Forward-Looking Statement
This press release contains forward-looking statements within the meaning of applicable securities laws including regarding the Providence’s development of a potential vaccine against COVID-19. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Providence’s control, and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include, among others: the fact that the safety and efficacy of PTX-COVID19-B has not yet been established; potential adverse impacts due to the global COVID-19 pandemic such as delays in regulatory review, manufacturing and supply chain interruptions, adverse effects on healthcare systems and disruption of the global economy; the fact that there are a limited number of commercial products utilizing mRNA technology approved for use; and the fact that the mRNA technology in use by Providence is still being developed and implemented. Except as required by law, Providence disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Providence’s current expectations and speak only as of the date hereof.

Emergent BioSolutions Contacts:
Media Contact:
Matt Hartwig
Director, Media Relations
hartwigm@ebsi.com

Investor Contact:
Robert G. Burrows
Vice President, Investor Relations
240-631-3280
burrowsr@ebsi.com

Providence Therapeutics Contacts:
Neil Forester
President
The Substance Group
416-722-3793
media@thesubstancegroup.com

Noy Wong
Investor Relations & Communications
Providence Therapeutics Holdings Inc.
Media.reach@providencetherapeutics.com

USP launches an Office of Organizational Culture, Equity and Inclusion Excellence headed by Chief Equity Officer and Senior Advisor Debra Joy Pérez, Ph.D.

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Rockville, MD, September 13, 2021 – The U.S. Pharmacopeia (USP) announces the launch of a new department, the Office of Organizational Culture, Equity and Inclusive Excellence (Equity Office). Headed by Chief Equity Officer (CEqO) and Senior Advisor to the CEO, Debra Joy Pérez, Ph.D. (she/her/ella), the Equity Office will shape and implement all diversity, equity, inclusion and belonging (DEIB) programs and initiatives.

“Our DEIB work should always be about seeing diverse perspectives and how to approach complex problems from different viewpoints. DEIB is all about culture building, it is a way of looking at the work and the world that fosters the best workplace for our people,” said Debra Joy Pérez, Ph.D, USP CEqO and Senior Advisor to the CEO. “Evidence shows that when more diverse perspectives are included, there is more innovation, creative thinking and better problem solving—three critical drivers in applying our science to fulfill our public health mission. Our fundamental belief at USP is that equity equals excellence – excellence in our staff and excellence in our science. Only when we fully embrace the practice of equity can we benefit from the richness and talents of our staff.”

Pérez is joined by Degie Kongsilp, who will lead DEIB program development and operations and Kristell Caballero Saucedo, who was selected to be a USP Fellow from the National Urban Fellows. The Equity Office team will be supported by USP’s Executive Team, DIB Council, and leadership, extended via a variety of affinity groups and partner groups across the organization in pursuit of USP mission priority to create enabling conditions and drive accountability in embedding the principles of diversity, equity,  inclusion, and belonging at USP.

Pérez is the founder of multiple national networks of diverse and under-represented fellows and scholars, including New Connections, Latina Researcher Network, and the LGBTQ+ Scholars of Color Network. She has facilitated the development of organization-wide equity and inclusion principles for the Patient-Centered Outcomes Research Institute and assessed national public health leadership programming for the Kresge Foundation.

USP Chief Executive Officer Ronald T. Piervincenzi, Ph.D. (he/ him/his) noted, “Led by Dr. Pérez, the USP Equity Office will champion and integrate diversity, equity, inclusion and belonging across all USP operations and mission activities, including serving as a resource for our worldwide volunteers and staff.”

About USP

USP is an independent, nonprofit, scientific organization that sets quality standards for medicines, dietary supplements, and food ingredients worldwide. USP’s quality standards are enforceable in the United States by the Food and Drug Administration and legally recognized in more than 50 countries. These standards, which are continuously developed and revised by more than 750 volunteer experts in science, industry, healthcare, and academia, are also used in more than 150 countries. Learn more at www.usp.org

Media Contact:

Anne Bell (she/her)
Senior Communications Manager – USP
Email: adb@usp.org
Office: +1-301-998-6785
Mobile: +1-240-701-3242

Sonosa Medical Spins Out of the MDC Studio

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Baltimore, August 17, 2021

The MDC Studio is pleased to announce the spin-out of the company, Sonosa Medical, Inc., as an independent entity. Founded in 2019, Sonosa Medical is developing next-generation devices poised to transform the diagnosis and treatment of obstructive sleep apnea (OSA). The company is led by Dr. Stephen Restaino as Chief Executive Officer, Dr. Jeffrey Wolf as Medical Advisor, and Dr. Gil Blankenship as Chairman of the Board. Dr. Restaino and his team have been developing novel technology for the detection and treatment of OSA using a wearable device. Their work has been funded by a $3.35 million Phase II Small Business Innovation Research (SBIR) award from the Defense Advanced Research Projects Agency (DARPA).

Dr. Restaino is also the Director of Engineering and a Partner at the MDC Studio, and has been involved in developing every technology at the MDC Studio since joining in 2017. Dr. Jeffrey Wolf is a Partner at the MDC Studio, as well as a Professor of Otorhinolaryngology – Head and Neck Surgery and Program in Oncology at the University of Maryland Medical System. Dr. Blankenship is the Founder and Chief Executive Officer of the MDC Studio, and a Professor of Electrical and Computer Engineering at the University of Maryland. The MDC Studio is dedicated to building health and medical technology companies based on intellectual property from top-tier research programs in Maryland.

“Stephen has played a critical role in developing the Sonosa technology and launching the company, and the MDC Studio looks forward to continuing to support the team to develop devices to revolutionize the treatment pathway for almost one billion patients worldwide with obstructive sleep apnea,” said Dr. Blankenship.

“Support from the MDC Studio has been critical to the success of the Sonosa project and to the development of the Sonosa Medical company. The MDC Studio’s structure of engineering development complemented by business development and support services allowed Sonosa Medical to develop both its technology and its company structure in parallel, ” said Stephen Restaino, CEO of Sonosa Medical.

About Sonosa Medical

Sonosa Medical, Inc. is developing wearable devices to improve the diagnosis and treatment of obstructive sleep apnea. The Company has developed a novel non-invasive technology that can both locate the source of an airway obstruction during sleep, and provide measures to maintain an open airway, allowing a patient to sleep normally. The development of the Company’s technology has been funded by DARPA through an SBIR contract.

About the MDC Studio

The MDC Studio is the operational unit of the Maryland Development Center Partnership, which was founded in 2016 in Baltimore, Maryland. MDC Studio functions as a MedTech Startup Studio that provides engineering support, business development services, and funding to create and support companies commercializing medical devices. The Studio works with inventors to develop their ideas into working prototypes and marketable products and form companies that will grow and create value for both their shareholders and all of society. MDC Studio Baltimore is located in the historic Wilkens-Robins building in the heart of Baltimore, near the University of Maryland Medical Center, and Johns Hopkins University where MDC’s founding partners and affiliates practice, teach, and research state of the art surgery and medicine.

MissionGO and The Living Legacy Foundation of Maryland Reshape the Future of Medical Blood Transport with Successful Unmanned Aircraft Flight

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BALTIMORE, Aug. 17, 2021 (GLOBE NEWSWIRE) — As donation and transplantation needs continue to rise in Maryland and across America, a faster, safer and more efficient solution for organ and blood transport has arrived. MissionGO, a leader in unmanned aircraft solutions, and The Living Legacy Foundation of Maryland (The LLF), the state’s organ procurement organization (OPO) responsible for organ, eye and tissue donation services, today announced a successful flight demonstration. The flight took place on August 10 using the new MissionGO MG Velos 100, a fully autonomous, high-speed unmanned aircraft system (UAS) solution for blood and organ delivery. The demonstration revealed an approximately 292 percent time improvement over ground transportation, this marks a momentous medical achievement for both organizations by being the first to demonstrate rapid UAS blood transport for fast-track lab testing, matching and transplantation of life-saving organs.

“About 20 lives are lost every day waiting for an organ transplant. As the demand of blood shipment to laboratories increases, it is imperative more than ever that we support and facilitate these types of initiatives in order to decrease the total turnaround time for donor matching results and get recipients the organs they need in time,” said Charlie Alexander, president and CEO of The LLF. “We are passionate about saving and enhancing lives through donation, while honoring the legacy and generosity of our donors and their families. Continuing to make these medical advancements furthers our mission to save more lives, and we look forward to finding more innovative ways to help those in need.”

Blood testing and travel time are integral parts of the organ donation and transplantation process, but with so many imminent variables that could threaten the viability of specimens, transporting blood in a safe, timely and effective manner is critical. Currently, The LLF send blood specimens to a minimum of three different labs by ground courier that are most frequently across a 7.1-mile distance, which takes about 38 minutes for just one shipment. This process is also subject to heavy traffic, unexpected accidents and many other unpredictable road-related factors. Once received, The LLF, donor hospitals and partner laboratories within 150 to 250 miles must create extremely efficient, logistical solutions to rapidly and rigorously test the specimen to ensure there are no communicable diseases present, identify a match and provide transport to the transplant hospital for the surgical procedure.

MissionGO recognized that a better method was needed and, with technology partners MediGO and AlarisPro, designed the MissionGO MG Velos 100, a fully integrated solution to track, deliver and monitor the entire logistics process. The LLF and MissionGO then developed a study comparing the speed and reliability of delivering blood specimens via ground transport versus unmanned aircraft. At one of MissionGO’s Maryland test sites, the UAS flew a circuit route over a 5.3-mile distance representing the direct line flight path for the blood delivery. Traveling at approximately 50 miles per hour over a 60-minute period, the UAS completed four total blood delivery shipments demonstrating that a better method is possible. Throughout the process, MediGO provided critical logistical information to all shipment stakeholders, including a chat channel for ongoing communication between the flight team to monitor each step of the specimen’s journey.

“When it comes to donation, specimen testing and transplantation, every second counts, and we found there was a lot of room for improvements within the current process,” said Frank Paskiewicz, executive vice president of UAS Cargo Operations at MissionGO. “For donation to be possible, labs must receive blood as quickly as possible so it can be matched with a waiting recipient, and we’re thrilled that the results of this flight and fully integrated UAS cargo delivery solution will help accelerate the donation process, and potentially, save more lives than ever before.”

Using the MissionGO MG Velos 100, OPOs, hospitals and laboratories will be equipped with an autonomous delivery system, which can airlift specimens over all traffic and geographical limitations for an expedient delivery that is fast, safe and effective. Working closely with the Federal Aviation Administration (FAA) to advance the MG Velos 100 through the certification process, MissionGO will be uniquely positioned to offer transplant stakeholders the only UAS capable of routine medical cargo delivery in urban environments. Combined with the complete visibility and transparency offered by MediGO and fleet and maintenance management from AlarisPro, every detail of a multi-modal organ and blood shipment is covered so that doctors and clinicians no longer have to worry about the logistics and can instead focus on their mission of saving lives.

“We’re grateful to have the opportunity to partner with The LLF, a forward-leaning, technology-focused OPO that is leading the transplant community into the future,” continued transplant surgeon Joseph Scalea, chief medical officer and co-founder of MediGO. “Now, all stakeholders can have eyes on the shipment through its entire journey to final delivery. The confidence and efficiency this brings to medical teams is a gamechanger for the industry and with our partners at MissionGO, the future of transplant logistics is here.”

There are currently about 3,000 Marylanders and more than 100,000 people nationwide waiting for a life-saving transplant. One donor can save up to eight people through organ donation and enhance more than 75 lives through tissue donation. To learn more about organ donation or to register as a donor, please visit www.thellf.org. To learn more about the MissionGO MG Velos 100 and recent flight demonstration, please visit this link.

ABOUT THE LIVING LEGACY FOUNDATION OF MARYLAND
As the organ procurement organization (OPO) for Maryland (with the exception of Montgomery, Prince George’s, and Charles Counties), The Living Legacy Foundation of Maryland (The LLF) facilitates donation and transplantation in area hospitals, provides donor family support, and educates hospitals and the general public about the life-saving power of organ, eye, and tissue donation. Learn more today at www.thellf.org

ABOUT MISSIONGO
MissionGO is setting a new standard for next-generation transportation logistics. By leveraging unmanned aircraft systems, MissionGO delivers improved reliability, reduced costs, and increased transparency to benefit multiple sectors including healthcare and critical infrastructure. The company is led by CEO Scott Plank and funded by Scott Plank Ventures Impact investments. Learn more today at www.missiongo.io

ABOUT MEDIGO
MediGO is a first-of-its-kind logistics platform that enables real time management of time-sensitive medical shipments on a centralized communication channel. With newfound supply chain transparency, care teams can be proactive in unifying stakeholders, coordinating resources, and making vital decisions- to deliver care at the speed of life. MediGO is a portfolio company within JSP Ventures. Learn more today at www.gomedigo.io

MEDIA CONTACTS:

Adam Falzarano Jane Daniel
The Living Legacy Foundation of Maryland MissionGO
afalzarano@thellf.org jdaniel@missiongo.io
410-733-0911 410-207-4494
Lindsay McFarland
The Living Legacy Foundation of Maryland
lindsay@lindsaymcfarlandpr.com
443-605-4706

Photos accompanying this announcement are available at:

https://www.globenewswire.com/NewsRoom/AttachmentNg/62c4f258-e873-4811-b55e-ebec68e72273
https://www.globenewswire.com/NewsRoom/AttachmentNg/6d546e2b-1d52-457d-8725-da125bb87762

University of Maryland, Baltimore (UMB) Grants Pumas-AI Exclusive License of Analytics Platform to Enhance Drug Development

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Company spun out of University of Maryland School of Pharmacy provides a sophisticated pharmaceutical modeling and simulation platform with upgraded Productivity and Compliance Suites

BALTIMORE, Aug. 16, 2021 /PRNewswire/ — Pumas-AI, a University of Maryland, Baltimore (UMB) startup company, has been granted worldwide, exclusive rights to enhancements to Pumas, an end-to-end pharmaceutical modeling and simulation platform for quantitative analysis across the drug development lifecycle. Pumas 2.0 builds on the company’s existing platform, which also employs technology licensed from UMB.

Pumas provides pharmaceutical and biotechnology companies and their investors usable quantitative metrics on technical, regulatory, and commercial success probabilities. Users can quickly translate predictive insight into real-world decisions, and explore a wide range of questions for more valuable insights while effectively de-risking investments.

“Pumas 2.0 is a remarkable enhancement from Pumas 1.0 because it expands the analytics to allow users to gain deeper insights using more innovative approaches such as AI/ML integrated with conventional analyses. Pumas-AI is committed to providing academic researchers access to Pumas free of cost,” said Joga Gobburu, PhD, Pumas-AI co-founder and chief executive officer and professor of pharmacy practice and science at the University of Maryland School of Pharmacy, who is also director of the School’s Center for Translational Medicine.

Vijay Ivaturi, PhD, Pumas-AI co-founder and chief scientific officer and assistant professor of pharmacy practice and science at the School of Pharmacy, added, “Companies can perform an entire project in the upgraded Productivity Suite without leaving Pumas, eliminating the need to toggle between other software packages, ultimately streamlining the workflow.”

The dedicated Compliance Suite in Pumas 2.0 meets the requirements set forth by regulatory authorities. According to the new electronic submission guidelines, FDA accepts Pumas files.

“Pumas provides deep intelligence that enables pharmaceutical scientists to continue pushing innovation,” said Phil Robilotto, DO, MBA, associate vice president of UMB’s Office of Technology Transfer and director of UM Ventures at Baltimore. “Pumas is experiencing rapid growth and UM Ventures looks forward to continuing to support the company as it elevates this integrated modeling and simulation platform as the new industry standard.”

Pumas-AI has a second healthcare data platform, Lyv, which is also based on technology licensed from UMB. Lyv is a robust clinical decision support system that leverages patient history and targeted medical data for personalized healthcare delivery.

About Pumas-AI
Pumas-AI was established by University of Maryland School of Pharmacy faculty members Drs. Vijay Ivaturi and Joga Gobburu. At Pumas-AI, we engineer solutions that empower those on the frontlines of healthcare, from discovery to delivery. With a range of software tools and consultancy expertise, we help scientists, healthcare providers, biotechnology and pharmaceutical businesses as well as regulatory bodies make better decisions. For more information, visit https://pumas.ai/.

About the University of Maryland, Baltimore and UM Ventures
The University of Maryland, Baltimore (UMB) is a fast-growing biomedical research center with nationally ranked professional schools of dentistry, law, medicine, nursing, pharmacy, social work, and an interdisciplinary graduate school. UM Ventures commercializes UMB’s breakthrough therapies, diagnostics and devices, fuels the creation of innovative start-up companies, and attracts industry leaders and entrepreneurs to the University’s thriving downtown campus. A wide portfolio of technologies is available for licensing at www.umventures.org

SOURCE University of Maryland Ventures

Connected DMV Formally Launches Global Pandemic Prevention and Biodefense Center

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August 11, 2021 (Washington, D.C.) – A bold new public-private partnership to prevent future viral outbreaks from becoming pandemics has moved one step closer to realization, as the Greater Washington cross-sector nonprofit, Connected DMV, has announced the formal launch of a Global Pandemic Prevention and Biodefense Center (GPPBC). The Center will serve as a vehicle to foster greater collaboration among pandemic prevention stakeholders to deliver on strategic projects needed to advance pandemic preparedness and avoidance. The signature initiative of the Center accelerates the development of human monoclonal antibodies (mAbs) to treat the world’s top 100 pathogens across 25 pathogen families most likely to result in disease outbreaks.

“With more than 4 million deaths and $16 trillion eliminated from global economies caused by COVID-19, we were woefully unprepared for this pandemic and can ill afford to sit back and wait for the next inevitable disease,” said Stu Solomon, President & CEO, Connected DMV. “While other organizations are keenly focused on surveillance, diagnostics, and vaccines to prevent the next pandemic, monoclonal antibodies are the key missing puzzle piece to quickly halt new outbreaks. We aim to fill that void. The GPPBC brings together the world’s top scientists, life science companies, NGOs, and community organizations in partnership with federal labs, agencies, and policy decision makers to carry out this essential mission.”

The announcement was made at the August Steering Committee meeting of the GPPBC, which convened at the formal conclusion of the successful 8-month strategy phase assessing the feasibility of this ambitious $2.5 billion project. The Center’s Steering Committee is comprised of 40 highly respected senior executives, scientists, and policy makers, and will continue throughout the Launch Phase, serving as the official Advisory Committee to the Center’s Board, providing strategic and scientific guidance and direction.

The new stand-alone Center has been incorporated as a nonprofit, nonstock corporation in the State of Delaware and a permanent board will be seated later this year. The Center will be physically located in Montgomery County, Maryland and a site selection team is working to identify and finalize a site location in the county.

The lead initiative of the GPPBC is called AHEAD100 (Advanced Human Epidemic Antibody Defenses 100). This program, led by Vanderbilt University Vaccine Center director and globally renowned infectious disease specialist, Dr. James Crowe, will develop over a period of six years a stockpile of “warm-ready” mAbs to address known and emerging pathogens among numerous viral and bacterial families. These drugs, which will be developed, tested through Phase 1 clinical trials, and stockpiled, fill the critical time gap between outbreaks and vaccines, helping to immediately contain future viral outbreaks. This is especially critical for vulnerable and underserved communities that have been adversely affected by COVID. The Center will establish global stockpiles upon successful completion of the trials.

“Monoclonal antibodies, in alignment with vaccines and antivirals, provide the comprehensive set of medical countermeasures required to prevent and treat infectious disease,” said Phyllis Arthur, Vice President, Infectious Diseases & Diagnostics Policy, Biotechnology Innovation Organization. “By resourcing AHEAD100 alongside other current funding priorities, the US government and philanthropists can accelerate innovation and fill the critical void between diagnostics and vaccines.”

Other functions of the Center include driving innovation throughout the infectious disease ecosystem by facilitating better collaboration across public health and defense, the selecting of specific R&D platforms, advancing routes of dosage administration (Intramuscular (IM) vs infusion), enhancing manufacturing capability and capacity, lowering costs, and increasing efficiency. It will also define the rapid response protocol that governs how mAbs will be used during outbreaks.

“As the world strives to contain and end this COVID-19 pandemic, new and deadly pathogens, like the Marburg virus in South Africa, remind us that danger is always on our doorstep,” said Andy Weber, former Assistant Secretary of Defense for Nuclear, Chemical and Biological Defense Programs and Deputy Coordinator for Ebola Response. “With the newly established Global Pandemic Prevention & Biodefense Center, we will be better able to harness great minds and technologies to ward off emerging threats. Confronting these challenges is not only an urgent health imperative but is also critical to our national security as bad actors use these pathogens to disrupt society.”

To date, the GPPBC has and continues to collaborate with a wide range of stakeholders across academia, government, industry and nonprofits – in the US and abroad. To validate its feasibility and support the transition to operations, the Center has received major funding from key partner organizations including the Bill & Melinda Gates Foundation, Montgomery County Maryland, the State of Maryland, S&R Foundation and the Coalition for Epidemic Preparedness Innovations (CEPI).

For more on the GPPBC, including the members of the Steering Committee, visit: https://www.connecteddmv.org/pandemic-center.

About Connected DMV

Connected DMV is an initiatives-based, charitable 501(c)(3) organization that works with regional organizations across Washington D.C., Maryland, and Virginia – the DMV – to help drive ongoing improvements to social, digital, and physical infrastructure. Connected DMV focuses on initiatives that span local jurisdictions and require public-private-academia-community collaboration to best achieve the dual objectives of enduring economic health and social equity.

The Global Pandemic Prevention and Biodefense Center is one of 13 region-wide key initiatives approved by Connected DMV’s COVID-19 Strategic Renewal Task Force, that brings the region together for inclusive economic growth and renewal across the entire DMV region in response to the pandemic.

https://www.connecteddmv.org/

Contact:

Toni DeLancey

tonidelancey@connecteddmv.org

(703) 980-5935

CvilleBioHub Announces Leadership Transition as the Biotechnology Innovation Cluster Experiences Strong Growth in Central Virginia

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Expanded entrepreneurship program will accelerate progress for new companies

August 10, 2021, Charlottesville, VA — CvilleBioHub today announces a leadership transition, naming Stephany Oettinger as Executive Director to succeed Nikki Hastings, Ph.D., who will continue to serve as Entrepreneur-in-Residence and Board Member.

Oettinger takes on the role after nearly two years serving as program and communications manager for the organization. She brings nearly 20 years of experience in strategy, communications and marketing, including consumer and industry association work. In the Executive Director role, she will work to foster an increasingly connected and diverse, equitable, and inclusive biotech community through valuable programming and events that strengthen the ecosystem to expand the industry’s impact within the region.

“I am grateful for the opportunity to work alongside this collaborative community of more than 75 companies to propel growth and share the important stories of our collective successes,” Oettinger said. “There is an impressive amount of activity with new companies forming and companies adding new jobs within the Hub. Additionally, we are seeing strong local angel and seed support, a diversity of outside investment interest and record raises for maturing companies. The industry is innovating and thriving. Charlottesville delivers both quality in innovation and quality of life. It’s an exciting time to be in biotech in our region.”

Dr. Hastings, a CvilleBioHub co-founder and the organization’s first executive director, will continue to advance entrepreneurship in a new capacity as Entrepreneur-In-Residence (EIR), bringing more than 15 years of biotech industry experience in startup environments to advise early-stage companies on commercialization, operations, talent and funding strategies.

“I have a passion for biotech entrepreneurship in all stages,” Hastings said. “I am excited by the growth of the EIR program that is following the increased activity from early-stage ventures in our region and honored by the opportunity to both broadly and deeply support emerging technologies and commercialization.”

“As an industry-led organization built from the ground up, we have accomplished so much in our first five years thanks to Nikki’s visionary leadership,” said Taylor Cope, chair of CvilleBioHub’s Board of Directors. “Stephany has worked alongside Nikki to refine our strategic plan and deliver high caliber programming for our community. We look forward to her building on our momentum, serving companies at all stages of growth, and strengthening the regional bioeconomy.”

About CvilleBioHub

CvilleBioHub is an industry-led, 501(c)(3) nonprofit organization providing engagement, resourcing and education to the Charlottesville-area biotechnology community. The organization has led the growth and expansion of the biotechnology innovation cluster in Central Virginia and has been identified as a model bio hub within the state of Virginia. Charlottesville is home to more than 75 companies working across all aspects of biotech and life sciences to advance human health through innovation, including subsectors that focus on medical devices, instrumentation, therapeutics, vaccines, health technology/software, agriculture technology, non-profit foundations, clinical research and biomanufacturing. There are more than 2,000 employees in the regional cluster and more than $400M invested in the area to date. For more information about CvilleBioHub, visit www.cvillebiohub.org.

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