Monthly Archives

September 2021

Adaptive Phage Therapeutics Awarded Additional $8 Million from U.S. Department of Defense for Clinical Advancement of Phage to Address Unmet Needs in Infectious Diseases

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GAITHERSBURG, MD, September 30, 2021 – Adaptive Phage Therapeutics, Inc. (APT), a clinical-stage biotechnology company dedicated to providing therapies to treat infectious diseases, today announced that the Department of Defense (DoD) has awarded the company an additional $8 million for the continued development of bacteriophage therapies (PhageBankTM) for the treatment of infectious diseases. The new funding brings the total contract awarded to APT to $31.2 million.

“We are thrilled to have the ongoing support of the DoD in the advanced development of our PhageBank platform to treat drug-resistant infections across multiple indications,” said Greg Merril, CEO and co-founder of Adaptive Phage Therapeutics.  “We are thankful for the opportunity to collaborate with the U.S. military to create potentially lifesaving therapies for our nation’s service members.”

Adaptive Phage Therapeutics, Inc.

Adaptive Phage Therapeutics (APT) is a clinical-stage company advancing therapies to treat multi-drug resistant infections. Prior antimicrobial therapeutic approaches have been ”fixed,” while pathogens continue to evolve resistance to each of those therapeutics, causing those drug products to become rapidly less effective in commercial use as antimicrobial resistance (AMR) increases over time.

APT’s PhageBank™ approach leverages an ever-expanding library of bacteriophage (phage) that collectively provide evergreen broad spectrum and polymicrobial coverage. PhageBank™ phages are matched through a proprietary phage susceptibility assay that APT has teamed with Mayo Clinic Laboratories to commercialize on a global scale.

APT’s technology was originally developed by the biodefense program of U.S. Department of Defense. APT acquired the world-wide exclusive commercial rights in 2017. Under FDA emergency Investigational New Drug allowance, APT has provided investigational PhageBank™ therapy to treat more than 40 critically ill patients in which standard-of-care antibiotics had failed.

For more information, visit http://www.aphage.com.

Adaptive Phage Therapeutics
Investor Relations:
Gilmartin Group, LLC.:
Laurence Watts
laurence@gilmartinir.com
619-916-7620

Cartesian Therapeutics to double footprint, headcount in Gaithersburg

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Gaithersburg’s Cartesian Therapeutics Inc. is expanding its local footprint and initiating an aggressive hiring spree as the company bolsters its leadership team — and looks to get a cell therapy candidate through the clinic.

The biopharma, which already occupies about 4,500 square feet at 704 Quince Orchard Road, is taking over another 3,500 square feet adjacent to its existing space in the building, Dr. Murat Kalayoglu, president and CEO of Cartesian, told the Washington Business Journal.

The company declined to disclose the projected cost of the expansion, citing confidentiality reasons per its contract with Alexandria Real Estate Equities Inc. (NYSE: ARE), which in partnership with South Duvall — an affiliate of Rockville’s Scheer Partners — paid $6.9 million for the 80,000-square-foot office building in 2018. The building in the Gaithersburg biotech corridor is also home to a flurry of local players, including Novavax Inc. (NASDAQ: NVAX), miRecule Inc.VLP Therapeutics Inc. and others.

Cartesian’s footprint expansion is necessary, the company said Tuesday, to provide more space for manufacturing and clinical operations. And that’s critical to the biotech’s long-term strategy “to pioneer RNA cell therapy as a new therapeutic modality,” Dr. Metin Kurtoglu, co-founder of Cartesian, said in a statement. The biopharma has a pipeline of RNA cell therapies — yes, which are typically used in cancer — that it’s applying to other arenas, including autoimmune diseases and respiratory disorders.

click here to read more via the WBJ

Mayor Bowser Tours New Children’s National Research & Innovation Campus and Welcomes JLABs @ Washington, DC to the District

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(Washington, DC) – Today, Mayor Muriel Bowser and Deputy Mayor for Planning and Economic Development John Falcicchio toured the new Children’s National Research & Innovation Campus (CNRIC). This one-of-a-kind research and innovation hub creates an ecosystem of top-tier partners and will produce nearly 1,000 new jobs. Mayor Bowser also welcomed JLABs @ Washington, DC, a 32,000-square-foot incubator housed at CNRIC, to the District. The premier life science incubator is one of 13 around the world and a direct result of the Mayor’s delegation to Canada in September 2017 with Maryland Governor Larry Hogan and former Virginia Governor Terry McAuliffe, where she toured a JLABS incubator and advocated for one in Washington, DC.

“When we visited JLABS in Toronto, I knew then that they had to come to Washington, DC – the capital of inclusive innovation and home to the greatest talent, ideas and passion in the world,” said Mayor Bowser. “Today, we can celebrate that the community’s vision for this campus – a vision of jobs, innovation, housing, and community resources – is coming to life.”

The Children’s National Research & Innovation Campus marks the first time the nation’s capital will create a unique ecosystem that can help accelerate scientific discoveries into new treatments and technologies for children in the District. The CNRIC is being developed in phases, gradually generating employment and access to health resources. Phase 1 of the campus, will have approximately 300 employees from Children’s National and another 150 from Virginia Tech and JLABS. After Phase II opens, employment will reach 1,000 people.

“All this movement of innovation and discovery in the healthcare industry will not only strengthen DC’s tech scene and biotech sector, but will provide new opportunities to entrepreneurs and employees in these industries” said Deputy Mayor John Falcicchio. “DC is open and we welcome all innovative early-stage companies to the District so they can participate in our dynamic entrepreneurial ecosystem and contribute to important health solutions for our residents.”

In May, the Bowser Administration partnered with Johnson and Johnson JLABS@ Washington, DC on the Washington, DC Health Innovation QuickFire Challenge. Through QuickFire Challenge, innovators from around the world were invited to submit potential science and technology solutions aimed towards addressing racial and socioeconomic disparities that impact health outcomes in communities of color. Last week, Mayor Bowser announced the awardees of the Quickfire Challenge, which provides awardees $50,000 in grant funding to transform health outcomes in the District’s communities of color, and an invitation to reside at JLABS @ Washington, DC on the CNRIC campus. JLABS @ Washington, DC, will host up to 50 startups spanning pharmaceuticals, medical devices, consumer and health tech companies. The campus is an enormous addition to the BioHealth Capital Region, the fourth largest research and biotech cluster in the US, with the goal of becoming a top 3 hub by 2023. The CNRIC represents the District’s commitment to building the partnerships necessary to drive discoveries, create jobs, promote economic growth, treat underserved populations, and improve health outcomes. JLabs @ Washington, DC and the Children’s National Research & Innovation Campus are adjacent to the District’s Parks at Walter Reed redevelopment of 66 acres of the former Walter Reed Army Medical Center.

https://mayor.dc.gov/release/mayor-bowser-tours-new-childrens-national-research-innovation-campus-and-welcomes-jlabs

Novavax EVP: It’s up to policymakers to decide use of COVID-19 vaccine

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A senior official for American biotech company Novavax said the company is committed to equitable COVID-19 vaccine allocation and has made a “great effort” to manufacture its vaccine in different sites across the globe. However, whether its vaccine will be used as booster shots or prioritized in countries struggling with supply will be up to policymakers, he said.

Speaking at a Devex event held on the sidelines of the 76th United Nations General Assembly, John Trizzino, executive vice president at Novavax, said policymakers are responsible for determining how the COVID-19 doses will be used.

“We’ve taken our responsibility seriously in making [COVID-19 vaccine] doses available across the globe. Now, it’s up to a variety of policymakers to decide where and how those are prioritized,” he said.

Click here to read more via dexex

Viewpoint: Ready for an HQ2 redux? It’s time to come together for new regional tech collaboration

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Remember the frenzy in 2017 when over 200 cities and towns across the U.S. bid to house the second headquarters for Amazon? Northern Virginia in the D.C. region won that bid ultimately.

But cities, states and regions might want to dust off those bids to enter a new $1 billion competition by the U.S. Economic Development Administration (EDA) that promises more winners across the country in applied science areas to help make the U.S. more technologically competitive and inclusive. Thankfully, this competition will look more like the Olympics with many gold, silver and bronze winners compared with the winner-take-all approach of Amazon HQ2.

EDA will grant $500,000 in technical assistance to 50 to 60 regional coalitions to develop and support three to eight projects to support a regional growth cluster this fall. Next year, EDA will award 20 to 30 regional coalitions $25 million to $100 million to implement those projects from among those that were successful in Phase One.

Universities, states, counties, cities, economic development districts and other nonprofit organizations are eligible to compete. The EDA is expecting regional coalitions, including industry and community partners, to build and scale strategic industry clusters. Accordingly, the old Amazon HQ2 regional alliances might be useful in going after these new funding sources. States are receiving separate allocations of up to $1 million directly from EDA to also create roadmaps for this competition and related purposes.

What might some of these clusters and projects be? Perhaps precision agriculture in Nebraska, space tech in Alabama, computer chip manufacturing in New York, immersive media in Southern California and quantum computing in Maryland, with advanced manufacturing incorporated in each hub and strategies to involve underrepresented populations in the cluster. It will be up to each region, however, to understand its strengths, weaknesses and comparative advantages in new technology clusters.

Importantly, the EDA funding is just the first of many new programs that will build other regional tech hubs. Billions more dollars in new regional hubs are in the offing through the U.S. Innovation and Competition Act, the new Science Directorate at NSF, the proposed ARPA-H biotech agency, proposed at $6 billion alone, among other programs expected to pass Congress and signed into law later this year or next.

The problem? It can take many years to plan, build and open new research and technology facilities since obtaining zoning, environmental review, community acceptance and funding for projects is complicated and time consuming. Existing research and tech spaces can take some of the load. But it is not as if there are large swaths of unused research and innovation space in regions. This is where research parks, innovation districts, incubators and accelerators offer ready-made solutions. These community-based entities have existing infrastructure, zoning, research space and partnerships with developers skilled in quickly constructing new facilities adjacent to universities, federal labs, hospitals and other anchor institutions.

But Congress needs to help create these hubs and make the U.S. more competitive by taking three additional steps:

  • Reform IRS rules on corporate research taking place in university research facilities financed with tax-exempt bonds. Complicated IRS rules on patent ownership when corporations sponsor research in these types of university facilities inhibit public-private partnerships and sometimes move corporate research overseas. Now that more university research hubs are expected to be built with the EDA and other funding, Congress should fix that.
  • Give all federal labs the tools to engage with the local community. Billions of dollars of research sponsored by Nobel Prize-winning scientists takes place in federal labs across the region. But all federal labs don’t have the same tools to use their land for public-private partnerships, engage technology intermediaries to spin out technologies or have consistent pathways for federal researchers to be engaged with entrepreneurial activities. We should support ideas like the FASTER Fed Labs Act.
  • Create more U.S. patents through existing federal research funding. Patents are critical factors in building a strong tech-based economy. But other countries are investing in more patents than the United States. In 2020, China knocked the U.S. from being No. 1 in the global patent race. The current Office of Management and Budget policy should be changed to allow — but not require — universities to charge the cost of patent filings directly on federal grants and contracts.

The clock is ticking on the Oct. 19 planning grants EDA deadline. Real estate developers should be working with local universities and economic development groups to plan strategies now. And Congress should do its part to help create more regional tech hubs in the U.S. by tweaking some existing policies and laws.

Brian Darmody is CEO of the Association of University Research Parks, whose D.C.-area office is based in College Park.

 

Want to learn more about new federal funding to build tech hubs and communities of innovation?

Join us in Salt Lake at the AURP International Conference, Oct 19-21, 2021 to hear from the US Economic Development Administration and a leading government relations expert on latest updates from Washington D.C.

https://international.aurp.net/

AURP EVENT

INNOVATION INFRASTRUCTURE: HOW CONGRESS AND THE WHITE HOUSE ARE SUPPORTING INNOVATION

Congress and the Biden Administration are proposing unprecedented funding opportunities for technology-based research clusters across the United States. New initiatives at the National Science Foundation (NSF), National Institute for Standards and Technology (NIST), NIH (National Institutes for Health) and EDA (Economic Development Administration) offer incredible opportunities that research parks, innovation districts, universities, cities, and regions need to prepare for. Hear the latest developments (on Wed., Oct. 20, 8:15am-9:00am MT) from Washington DC-based representatives on actionable ideas on how to leverage these opportunities.

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.

Click here to read more via BioBuzz.

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.”

Click here to read more via BioBuzz

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

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