By Max Donley

EVP, Internal Operations and Strategy at Aurinia Pharmaceuticals Inc.

Last month, I was chosen to speak on a panel with leaders in the biotech industry and we all had two things in common: a great appreciation for this emerging life sciences region along with office headquarters in Montgomery County, MD.

It’s no secret the Maryland/DC region has been up-and-coming as a Life Sciences hub over the last decade or so, and I’m proud to say that Aurinia is part of leading this growth. With our move last year to establish a U.S. hub here in Rockville and build on our headquarters in Victoria, B.C., we’ve played a role in making this area a more powerful life sciences destination.

At Aurinia, our mission is to transform people’s lives by delivering therapeutics that change the course of autoimmune disease. We view improving the health of patients and helping patients with chronic unmet needs like lupus nephritis as our responsibility. It is not just a privilege to be working in the lupus space, but an obligation, and the county and the state’s recognition and support of this obligation is a tremendous resource for our ability to support our patients.

We established our U.S. commercial headquarters in Montgomery County in the midst of lockdown with a long-term view that this move to a growing life sciences sector would only serve to advance the development of our company over the coming months and years. We were not alone – as Washington Post columnist Robert McCartney noted in a recent article, the area has continued to grow and thrive through the pandemic, a small silver lining in this unimaginable crisis. Since establishing our local presence, the Aurinia team has been proud to have received FDA approval for our new therapy earlier this year, and for our new Montgomery County hub to serve as home base for our early commercialization efforts.

I feel fortunate to have witnessed the growth in the Montgomery county area over my career, with companies including Medimmune, Sucampo and now Aurinia, and to have seen and worked with the strong talent that exists in this region. It shouldn’t be a huge surprise that Montgomery County has attracted such strong biopharma expertise over the years. Home of the National Institutes of Health (NIH), the FDA and 38 federal labs, and with nearly $8 billion in funding flowing into the life sciences sector in 2020 alone, this area is a hotbed of scientific research and accomplishment.

Over the years, the investment that the county, the state and the region have put into supporting biopharma here has transformed the landscape and we’re now seeing the fruits of this labor in the incredible accomplishments achieved throughout the region. This has created a more diverse and supportive landscape for companies like ours to grow and flourish in the biopharma space. It’s been a fun journey, and there is certainly plenty more opportunities for those currently here and future tenants to make meaningful impacts in treating diseases for patients and their families in need of support.

I couldn’t be happier to be able to call Montgomery County my home for over 20 years. Not only is it a fantastic place to both work, but live as well. The Nation’s capital is right down the road, there is a fantastic network of school systems across all levels of education and the more people that flock towards the region only increase its liveliness and diversity. Not to mention our hometown Washington Nationals and Capitals bringing two championships home to add to our hometown pride!

For all of the above reasons I’m proud to be a part of the change happening in Montgomery County, to build our Aurinia team in the U.S. here, and to share our culture with the local community.

June 23, 2021 07:05 AM Eastern Daylight Time

BALTIMORE, Md.–(BUSINESS WIRE)–Vita Therapeutics, a cell engineering company harnessing the power of genetics to develop cellular therapies that follow an autologous and universal hypoimmunogenic approach, today announced the completion of an oversubscribed $32 million Series A. The financing was led by Cambrian Biopharma with participation from Kiwoom Bio, SCM Life Sciences, and Early Light Ventures.

“At Vita Therapeutics our mission is to deliver long-term disease-modifying cell engineered treatments for patients living with muscular dystrophies and other high unmet medical needs,” said Douglas Falk, M.S., Chief Executive Officer of Vita Therapeutics. “We are pleased this high-caliber group of new and existing investors share our enthusiasm and belief in Vita’s ability to progress our innovative treatments to help these patients. This oversubscribed round of financing will enable the company to take the next steps toward achieving our mission.”

“Cell therapies have two grand challenges – getting enough cells and differentiating them into the right cell type to make a long-term impact on a patient’s disease,” said James Peyer, PhD., newly appointed board member of Vita and Chief Executive Officer of Cambrian Biopharma. “By mastering the transition from iPSC to muscle stem cell, Vita can make an unlimited amount of carefully defined muscle stem cells, which has never been possible before. I am so glad to count Vita as a Cambrian affiliate, and I have no doubt Vita will become a genre-defining cell therapy company.”

Vita’s lead therapy, VTA-100, is currently undergoing investigational new drug (IND)-enabling studies for the treatment of limb-girdle muscular dystrophy (LGMD) 2A/R1. It is designed to be an autologous treatment that combines gene correction and induced pluripotent stem cell (iPSC) technology to help repair and replace muscle cells. Vita’s second therapeutic, VTA-200, is a genetically engineered iPSC derived hypoimmunogenic treatment designed to treat multiple types of muscular dystrophy.

The Series A financing will support the completion of all remaining IND-enabling studies for VTA-100 and its subsequent IND submission to the U.S. Food and Drug Administration. This funding will also support the manufacturing of cells needed for clinical evaluation as well as patient recruitment efforts for the first clinical trial. In addition, this financing will be used to further the development of VTA-200 and the development of VTA-300, an undisclosed cell type.

About Limb-Girdle Muscular Dystrophy

Limb-girdle muscular dystrophy (LGMD) is a group of disorders that cause weakness and wasting of muscles closest to the body (proximal muscles), specifically the muscles of the shoulders, upper arms, pelvic area, and thighs. The severity, age of onset, and disease progression of LGMD vary among the more than 30 known sub-types of this condition and may be inconsistent even within the same sub-type. As the atrophy and muscle weakness progresses, individuals with LGMD begin to have trouble lifting objects, walking, and climbing stairs, often requiring the use of assistive mobility devices. There is currently no cure for LGMD, with treatments limited to supportive therapies such as corticosteroids.

About Vita Therapeutics

Vita Therapeutics, a Cambrian Biopharma affiliate, is a cell engineering company harnessing the power of genetics to develop cellular therapies that follow a dual manufacturing strategy, first beginning autologously before moving to a universal hypoimmunogenic cell line. Vita was originally founded out of the labs of Dr. Gabsang Lee and Dr. Kathryn Wagner at Johns Hopkins University and the Kennedy Krieger Institute in 2019 by Douglas Falk, M.S. and Peter Andersen, PhD. The company utilizes induced pluripotent stem cell (iPSC) technology to engineer specific cell types designed to replace those that are defective in patients. We are currently working to progress our lead therapeutic, VTA-100, for the treatment of limb-girdle muscular dystrophy (LGMD), into clinical trials. For more information and important updates, please visit www.vitatx.com or follow us on Twitter @Vita_Tx and LinkedIn.

Contacts

info@vita-therapeutics.com

MacDougall
Susan Sharpe
ssharpe@macbiocom.com
781-235-3060

June 3, 2021 (Washington, D.C.)— The once-in-a-generation pandemic highlighted both the region’s continued lag in economic competitiveness and the absence of a cohesive and coordinated economic development strategy. The Regional Economic Development Strategy (REDS) initiative, launched by Connected DMV, has released the first regional cross-sector blueprint to advance economic opportunity and social equity in Greater Washington, the culmination of a year of work by the REDS Steering Committee.

The REDS 1.0 Report, “One: A Blueprint for Enduring Collaboration to Advance Economic Opportunity and Equity in Greater Washington,” lays the foundation for a long-term collaborative framework to improve the competitive advantage of the region both nationally and around the world by operationalizing an enduring cross-sector model made up of leaders from the public sector, industry, academia, community nonprofits and philanthropy working together to advance equitable economic development to improve opportunity for all. Further, it makes the case that the region can only solve structural regional problems that have been endemic constraints by coming together as a table of equal stakeholders across jurisdictions and sectors.

“This moment is a turning point for Greater Washington. Let’s choose to work together. Only then can we recover from the losses suffered during the pandemic and achieve unimaginable results to ensure no matter what neighborhood you’re from, Greater Washington becomes an even better place to live and work,” the Steering Committee wrote in the Report’s foreword.

The report lays out key challenges that have historically kept many communities within the region from prospering, often starkest along an east-west divide in the region, and outlines the planned path forward through 2024. It also confirms the early focus areas for joint programming to be further designed, developed, and implemented, aligned with an integrated vision for social equity and economic development.

Key recommendations for high-potential entry points for greater regional collaboration:

Regional Economic Growth

• Plan, design and build the first release of a collaborative, data-driven DMV Atlas (DMV Atlas: Accelerating Equitable Regional Growth) with pilot use cases synthesizing cross-sector data sets to unearth new equitable growth opportunities and improve regional planning, investment, and programming

• Launch a regional leadership workstream focused on closing the region’s East-West divide along ten equity impact areas, and informing DMV Atlas development, as well as other REDS join programs

Regional Branding and Marketing

• Host visioning sessions to include full cross-sector representation to define a joint regional branding and marketing program

• Organize the first joint regional outreach delegation to attend a national or global tradeshow

• Launch planning of a major, local, net-new event focused on a regional industry cluster growth area

Regional Talent Pipeline

• Initiate development of a regional career opportunities platform with available upskilling/reskilling resources, internships, apprenticeships, and jobs

• Establish a forum to develop coordinated regional actions to secure federal, state, and philanthropic funds, resources, and programs related to talent and workforce development

In addition to REDS, Connected DMV’s COVID-19 Strategic Renewal Task Force has launched a number of other specific initiatives that provide early proof points in shaping large-scale, net-new growth opportunities across the region through deliberate public-private-academia-community collaboration. They include the Global Pandemic Prevention & Biodefense Center, the National Capital Hydrogen Center, Connectivity for All and the Potomac Quantum Innovation Center (PQIC). REDS will serve as a mechanism to deepen coordination around these initiatives and other regional strategic initiatives with broad economic development scope or potential.

About REDS and Next Steps:

REDS 1.0 is the culmination of intensive work that was undertaken from September 2020 to May 2021 by the REDS Steering Committee and Working Group. The Steering Committee consists of 23 results-driven cross-sector leaders from across the region. Their work represents the first time that a cross-sector and cross-jurisdictional group has come together with a shared vision and purpose of laying out guiding principles and goals for collaborative regional economic development. The initiative was approved by Connected DMV’s COVID-19 Strategic Renewal Task Force, a group formed to improve the long-term social, physical and digital infrastructures for inclusive economic growth and renewal across the entire DMV region, post-pandemic.

Over the remainder of 2021, the REDS team will continue to convene regional stakeholders, launch joint economic development programs, unearth new opportunities for equitable growth, and take the necessary steps to formalize an enduring regional economic development collaborative.

While REDS 1.0 laid the groundwork, two other phases will build a structured, long-term cooperative mechanism to drive equitable economic growth through joint programs. In REDS 2.0 (Timeframe: June-December 2021) the blueprint will continue to be refined and REDS stakeholders will formalize collaboration and launch joint programs. In REDS 3.0 (Timeframe: 2022-2024), the focus will be on operationalizing collaboration and delivering sustained programs.

Quotes from REDS Steering Committee members follow below:

“We are creating something new: a more economically equitable and collaborative region. Imagine what we could achieve by doing bigger and better things together, from developing a regional talent pipeline to marketing the region to the world. Only by collaborating regionally on economic development can the entire Washington region reach its full potential as a global technology and innovation hub.”

• Victor Hoskins, Fairfax County Economic Development Authority

“Years and years of fragmented policy and decision-making by both the public and private sectors has led to inequitable and non-inclusive economic development in the region. Instead of every jurisdiction fending for itself, we need new thinking to place facilities and capacity equitably across the entire region as one marketplace. Working together on economic development activities collectively as a region would be an important step in that direction.”

• David Iannucci, Prince George’s County Economic Development Corporation

“Working within each of our jurisdictions, we have found that we share similar interests in certain sector strategies and local priorities. Coming together to find common ground as a region allows us to amplify our individual assets and strengths. A strong, resilient, and inclusive regional economy in the Greater Washington area benefits us all.”

• Benjamin H. Wu, Montgomery County Economic Development Corporation

“In order to reach our region’s true economic and equitable growth potential, we must meaningfully collaborate to jointly tackle our shared regional challenges and opportunities. We are in a much stronger position to do this, building on the success that the NOVA EDA has experienced since our establishment in 2019 – and with the understanding that success grows exponentially as the entire region collaborates on shared economic development goals.”

• Stephanie Landrum, Alexandria Economic Development Partnership

“The Washington DC region is uniquely positioned for economic prosperity, both nationally and internationally. The Regional Economic Development Strategy provides economic development leaders with the framework and tools necessary to work collaboratively and ensures that we realize our potential and grow together.”

• Keith Sellars, Washington DC Economic Partnership

“The DMV has lacked a strategy and forum for cross-sector regional economic development. REDS fills this void, as commissioned by the COVID-19 Strategic Renewal Task Force. Connected DMV will continue to bring the region together to drive collaborative net-new economic growth opportunities that deliver tangible social equity benefits.”

• Stu Solomon, Connected DMV

“The unique neighborhoods and jurisdictions that make up our region are deeply interconnected. That’s why our region deserves a collaborative approach to economic development that includes everyone and lets all our assets shine. The work highlighted in this report represents another step forward towards that goal.”

• Jack McDougle, Greater Washington Board of Trade

“COG recognizes the great strides that have been made recently in economic development collaboration with the NOVA EDA and MDNCREDA. Charting a more equitable development path for Metropolitan Washington is needed, and we look forward to further alignment between REDS and COG planning committees and the Region Forward Coalition moving forward.”

• Chuck Bean, Metropolitan Washington Council of Governments

“Greater Washington’s racial and socioeconomic divisions are real, and they are regional. It is critical for leaders across business, government, civil society, academia, and philanthropy to come together now to do the hard work of creating a better regional environment for uplifting all of our communities.”

• Rosie Allen-Herring, United Way of the National Capital Area

As a long-standing anchor institution in the region, Pepco applauds the development of a regional forum for economic development collaboration that enables dialogue across sectors to shape data-driven inclusive growth opportunities for the communities we serve.”

• Felecia Greer, Pepco

“Every decision we make as regional economic development and planning leaders should be addressing the socioeconomic divide through an equitable growth lens. We must engage existing residents who are chronically and structurally marginalized first. This region is fortunate to have the resources to resolve our persistent and inexcusable economic disparities, and we will become a more desirable region for growth and investment by letting the outside world know that we take care of our own.”

• Shyam Kannan, Washington Metropolitan Area Transit Authority

“Metropolitan Washington is the world’s greatest college town, research park, and showcase for human intellectual and cultural excellence. In many ways, the region leads the world in scientific research, education, culture, and the arts in addition to power and policy. The region is intertwined with, and inseparable from, its educational and research institutions, museums, and international presence. We don’t acknowledge this boldly enough as a community.”

• Andrew Flagel, Consortium of Universities of the Washington Metropolitan Area

“The Regional Economic Development Strategy initiative is about finding what we can do together as a region that we can’t do alone, showing the world that we are ready for the next iteration of how we’re going to live, work, and thrive. Regional interconnectivity will be even more important going forward.”

• Bob Buchanan, The 2030 Group

“As the official destination marketing organization for Washington, DC, we focus on economic development through business and leisure travel. Working with regional partners to market Greater Washington and plan events that attract national and international attention makes economic sense and can move the needle for our region in the long term.”

• Elliott L. Ferguson, II, Destination DC

“As a region, we must build a talent and workforce pipeline that is interconnected and multi-level, one that provides more equitable economic opportunity. It is critical that we work together to attract a more diverse, future-focused talent pool. Collectively, we can address talent development from a supply and demand side, delivering an inclusive labor market that complements the needs of emerging industries in the region such as Healthcare, IT, Cybersecurity, and Quantum.”

• Dr. Anne Kress, Northern Virginia Community College

“Equitable places are attractive places. Especially in light of the past year’s long-overdue racial justice reckoning, creating a diverse and well-educated talent pipeline is a stake in the ground for regional longevity and attracting private sector investment.”

• Travis Reindl, Bill and Melinda Gates Foundation

“We must build a broader pipeline and network for investing that is reflective of the diversity of our region. Venture capital and other forms of private investment must be at the table to contribute to equitable economic development in our region.”

• Phil Bronner, Ardent Ventures

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. https://www.connecteddmv.org/

FOR IMMEDIATE RELEASE

Contact:

Toni DeLancey

tonidelancey@connecteddmv.org (703) 980-5935

Gaithersburg, MD. (May, 25 2021) miRecule, Inc. (“miRecule”), an emerging biotech company focused on the development of cutting-edge RNA therapeutics, announced today it has closed over $5.7M in seed funding. The funding round was led by Alexandria Venture Investments, along with Boutique Venture Partners, Pathway Bioventures, Alumni Ventures Group, and national angel investors, with additional funding coming from the Maryland Momentum Fund and the FSHD Society. This funding includes a non-dilutive $2M Phase II SBIR grant from the National Cancer Institute.

miRecule will utilize the funding to drive its lead microRNA therapy (MC-30) towards clinical development for head & neck cancer, the 6th most common form of cancer worldwide. “We are hopeful MC-30 could be a real game-changer. By correcting the underlying mutation that creates resistance to treatment, we think we can triple response rates and give years of quality life back to many patients,” commented CEO Anthony Saleh.

miRecule’s DREAmiR^TM discovery platform was developed through over a decade of research in collaboration with the National Institutes of Health in Bethesda Maryland. DREAmiR integrates genomic and clinical outcomes data from thousands of patients to identify underlying genetic drivers of disease, and then designs matching RNA therapeutics that directly correct those abnormalities. miRecule is applying its platform to a range of diseases, including cancer, muscular dystrophy, and even viruses such as HIV and COVID-19.

miRecule has also utilized DREAmiR to develop MC-DX4, an antisense oligonucleotide treatment for Facioscapulohumeral Muscular Dystrophy (FSHD). FSHD is one of the most common muscular dystrophies, with over 40,000 patients in the US (many of whom are children). Currently, there are no FDA approved treatments for FSHD. “The FSHD Society is excited to be a funding partner in this endeavor, which aligns strongly with our mission to reduce obstacles inherent in the clinical & regulatory process for FSHD,” said Mark Stone, CEO of the FSHD society.

miRecule was founded in 2017 in Montgomery County, Maryland in BioHealth Innovation’s (BHI) incubator by CEO Anthony D. Saleh, PhD and Chief Operating Officer Ashwin Kulkarni, MS. miRecule has been able to raise much of its seed funding from investors in the BioHealth Capital Region. “BHI is proud to have been a co-founder with miRecule, and assist in their fundraising and growth here in Maryland. Anthony is a role model having transitioned from an academic scientist to a successful entrepreneur, and we are glad to have supported him through this process” said Rich Bendis CEO of BHI. miRecule was able to utilize two programs to leverage their investment and grant funding. The Maryland Biotechnology Investment Tax Credit program, which provided a 50% match to their investors, and the Montgomery County SBIR matching funds grant which provided $25,000 on top of their NCI grant.

“We think miRecule’s therapeutics will vastly improve the lives of patients by changing the course of their serious diseases” said Dr. Rami El Assal, Managing Partner & Co-founder of Boutique Venture Partners. “miRecule’s innovative, data-driven discovery engine shows true platform potential for the next generation of RNA therapeutics. We were really glad to have miRecule participate in Alexandria’s Seed Capital Platform, and ultimately participate in the company’s seed round,” said Conley Jones from Alexandria Venture Investments.

D.C. Mayor Muriel Bowser addresses cross-sector regional organization’s final COVID-19 Strategic Renewal Task Force meeting

The joint statement affirming the Task Force and its work from Mayor Bowser and Governors Hogan and Northam read:

“Whereas the greater Washington metropolitan area is a diverse and complex region with abundant assets and resources; and Whereas the opportunities for economic growth and social equity are fully achievable only by working together across our jurisdictions and sectors to improve our physical, digital, economic and social infrastructures so that all who live, work and play in the DMV region can thrive, especially those in our most vulnerable and underserved communities; Now, therefore, we hereby affirm the benefits of co-equal, cross-sector regional collaboration, as demonstrated by the work of the Connected DMV COVID-19 Strategic Renewal Task Force, and the enduring leadership of the resulting DMV Regional Congress.”

“Greater Washington is one of the most dynamic, diverse and fastest growing regions in the country and we want to ensure that everyone who calls the DMV home has the opportunity to thrive,” said Richard Bynum, Chief Corporate Responsibility Officer, PNC Financial Services Group and COVID-19 Task Force Member. “With a keen understanding that a going it alone approach was not an option, Connected DMV has been able to successfully bring the unique perspectives and strengths of all those invested in our region to the table for a common purpose of improving our region economically and equitably for the long-term. While there is much work left to do, the Task Force should be proud of what they have accomplished to date. I am excited for what’s to come as we advance our current initiatives and create new ones.

Connected DMV works with regional organizations across Washington D.C., Maryland and Virginia — the DMV — to deliver initiatives that provide a stronger and more equitable future for all who live, learn, work, and prosper in Greater Washington. Last year, Connected DMV and its regional partners created the organization’s COVID-19 Strategic Renewal Task Force that brought the region together with a mission of improving the long-term social, physical, and digital infrastructures for inclusive economic growth and renewal across the entire DMV region.

The 51-member Task Force, representing the CEOs of 17 regional organizations along with leaders from private industry, government, academia, philanthropy and community convened monthly to approve 13 region-wide key initiatives that address economic renewal and social equity in response to the pandemic in 10 key areas that are critical to making an impact on some of our region’s most vulnerable communities: technology and connectivity, finance, workforce development, education, public safety, transportation, food and water, energy, healthcare and housing.

These programs represent billions of dollars in net-new opportunities and jobs for Greater Washington and a major step forward in the work to close the stark East-West socioeconomic divide in the region. Key initiatives include creating a Global Pandemic Prevention & Biodefense Center, establishing a state-of-the art Hydrogen Center, positioning the region as a leader in next generation quantum technology through the launch of the Potomac Quantum Innovation Center (PQIC), and helping to close the digital divide in the region through its Connectivity for All initiative.

What the last year of collaboration by the Task Force and through the strategic initiatives has revealed is that this kind of cross-sector, co-equal collaboration works. As such, the Task Force has agreed to make this model sustainable and transition to a new body called the DMV Regional Congress. Its role will be to serve as an enduring body in the region, representing private industry, academia, philanthropy, and the community and ensure that all representatives have a co-equal seat at the table to continue the work already underway to bring further economic renewal and social equity to the region, as well as considering and approving new initiatives to solve some of the region’s greatest challenges.

“I want to thank all the members of the COVID-19 Strategic Renewal Task Force who came together, especially in a moment of crisis in our region, and worked hard and collaboratively on key innovative initiatives that help point the DMV towards sound economic footing while removing barriers to achieving a more equitable society,” said Stu Solomon, President & CEO, Connected DMV. “Their commitment to a single, results driven mission for our region was as unprecedented as it was remarkable. I’m thankful and encouraged by the Task Force commitments to be part of the DMV Regional Congress to further advance the important work that is already underway.”

One of the Task Force’s founding members was Major General Omar Jones, whose command of Joint Force Headquarters-National Capital Region will end in June. He also addressed the meeting and thanked Task Force Members on all that they have accomplished over the past two short years. “It has been a privilege and an honor to serve as a liaison to the Connected DMV’s COVID-19 Strategic Renewal Task Force, a group comprised of highly accomplished individuals in their respective fields,” said Major General Jones. “While we are a diverse group, we are united in a singular mission to ensure that we create thoughtful, responsible and achievable results driven initiatives to help our region grow economically, equitably and safely now and in the years to come. In terms of getting these initiatives off the ground, I am proud to say our mission is accomplished.”

In June, Connected DMV’s Regional Economic Development Strategy (REDS) Steering Committee – made up of 23 cross-sector organizations from around the region – will publish the Regional Economic Development Strategy Report, a blueprint for enduring cross-sector collaboration for regional economic development and equity. The REDS initiative was approved by the Task Force last year. The report is the culmination of a year of collaboration and will be the first time in our region’s history that a group of leaders from private industry, economic development and planning organizations, academia, philanthropy, and community organizations has come together to improve Greater Washington’s competitive advantages and focus directly on delivering equitable regional economic outcomes to improve the lives of all who live and work in Greater Washington.

The REDS report will also include a vision for the DMV Atlas: Accelerating Equitable Regional Growth, a collaborative platform and program that will aggregate, map, and analyze data from key regional stakeholders to inform better and more efficient cross-sector planning, partnerships, investment, programming, and tracking. It will help to drive improved leadership decision-making across sectors and jurisdictional boundaries, grounded in a nuanced regional context that advances equitable economic growth. Moving forward, the REDS effort will help generate, prioritize, and advance prospective strategic initiatives of regional economic development significance for consideration by the DMV Regional Congress.

The first meeting of the newly assembled DMV Regional Congress is slated for September of this year.

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. https://www.connecteddmv.org/

Contact

Toni DeLancey

tonidelancey@connecteddmv.org (703) 980-5935

New methods were created in collaboration with public health organizations, pharmacopeias, regulators, and manufacturers to help ensure quality and improve public trust

Rockville, MD, May 17, 2021 – The U.S. Pharmacopeia (USP) announced the release of a range of tools and resources to help reduce risks from substandard and falsified COVID-19 treatments, and to assist manufacturers, regulators, and quality control laboratories in helping to ensure quality COVID-19 treatments are being procured, produced, and distributed.

“While COVID-19 vaccines are essential to end the pandemic, treatments are a critical component to help patients, particularly those who are hospitalized with COVID-19,” said Jaap Venema, Ph.D., USP’s Chief Science Officer. “It is vital that regulators and manufacturers ensure approved therapeutics, like remdesivir, meet quality expectations. We have already seen the demand versus supply imbalance result in substandard and falsified remdesivir, particularly in low- and middle-income countries. USP is committed to helping to ensure quality throughout the medicines supply chain.”

The antiviral drug VEKLURY® (remdesivir), invented, developed and manufactured by Gilead Sciences, Inc., was the first U.S. Food and Drug Administration (FDA) approved treatment for pediatric and adult patients at least 12 years of age and weighing at least 40 kg who are hospitalized with COVID-19.  It was granted emergency use authorization by the FDA in May 2020 and was approved by the FDA under the tradename of VEKLURY on Oct. 22, 2020.^[i] As a standard of care, healthcare providers around the world are using remdesivir not only to treat patients, but also in clinical trials to understand its efficacy and safety in different patient populations and in combination with other investigational treatments.^[ii]

The USP Methods to Detect Falsified Remdesivir publication includes procedures developed by USP for determining the identity and strength of the remdesivir active pharmaceutical ingredient (API) and drug product – essential tools for detecting substandard and falsified medicines. The publication includes procedures using infrared spectroscopy (IR), ultra-high performance liquid chromatography (UHPLC), and nuclear magnetic resonance spectroscopy (NMR) technologies along with supporting validation results. It also features USP’s first quantitative NMR (qNMR)-based digital spectra for determining the identity of remdesivir API using either high field or benchtop qNMR instruments.

In addition to the USP Methods to Detect Falsified Remdesivir publication, USP announced other resources to help combat substandard and falsified COVID-19 treatments including:

Minilab’s Screening Tools for Dexamethasone:

In collaboration with USP, the Global Pharma Health Fund developed two new test methods on dexamethasone for the Minilab testing platform. These screening tools complement USP’s compendial standards available in the USP-NF for dexamethasone, a corticosteroid being widely used to treat COVID-19 patients.

IMWP draft monographs for Favipiravir

Pharmacopoeias around the world continue to work together to support the COVID-19 response. As part of the World Health Organization’s (WHO) International Meeting of World Pharmacopoeias (IMWP),  pharmacopeias have developed and made available two IMWP draft monographs for Favipiravir and Favipiravir Tablets to be used on a voluntary basis. Favipiravir is an antiviral approved for COVID-19 treatment in Japan, Russia and India.

Substandard and falsified medicines pose a threat to global health security and hinder the ability of strong and resilient public health systems to prevent, detect, and respond to infectious disease threats.

“Major public health events can increase the vulnerability of medicines to the threat of substandard and falsified products,” said Jeff Moore, Ph.D., Senior Director, Scientific Affairs & Strategy at U.S. Pharmacopeia. “These resources to help combat substandard and falsified COVID-19 treatments were created in collaboration with public health organizations, pharmacopeias, manufacturers, and regulators from around the world and are an important example of the value and importance of collaboration in times of need.”

For over 200 years, USP has supported the development, manufacturing, and distribution of quality medicines through development of standards and other tools that help ensure the quality of medicines. USP is working with government organizations, other pharmacopeias, manufacturers of drugs and other health products, and healthcare professionals in the US and around the world to help build the public’s trust in vaccines and treatments for COVID-19.

These resources are for informational purposes only and intended to provide tools to address substandard and falsified treatments during the COVID-19 pandemic. They are intended to complement standards developed by USP and other organizations by providing validated methods with supporting results to verify the ingredients and quality of these treatments. These tools are not part of the U.S. Pharmacopeia-National Formulary and does not reflect USP’s opinions on future revisions to official text of the USP–NF. Parties relying on these resources bear independent responsibility for awareness of, and compliance with, any applicable federal, state, or local laws and requirements.

About USP
U.S. Pharmacopeia (USP) is an independent, nonprofit, scientific organization that sets quality standards for medicines, dietary supplements and food ingredients worldwide. USP’s quality standards are legally recognized in the United States and elsewhere and are used in more than 140 countries. These standards, which are continuously developed and revised by more than 800 volunteer experts in science, industry, healthcare and academia. Learn more at www.usp.org.

For additional information about how USP is working to improve the supply of safe, trusted COVID-19 vaccines, treatments, and preventatives, visit www.usp.org/covid-19

• U.S. authorization gives healthcare professionals access to portable rapid testing device that can monitor immune status in relation to COVID-19
• Test based on QIAGEN partner Ellume’s proprietary eHub technology and helps ease testing shortfalls by using automation and providing easy-to-read results
• eHub digital device can handle eight tests at once, all working independently of each other, can process up to 32 samples per hour, can eventually be used simultaneously with the antigen test

GERMANTOWN, Md. & HILDEN, Germany–(BUSINESS WIRE)– QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced it has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the fast and easy-to-use QIAreach^® Anti-SARS-CoV-2 Total Test.

The authorization means QIAGEN can start making its portable antibody testing device available to health-care professionals in the U.S. Each antibody test takes only about 10 minutes to identify whether a person carries antibodies to the SARS-CoV-2 virus as a result of prior infection. Individual test results are read on a digital eHub device that can process up to 32 tests per hour – and will eventually also run the antigen test.

The QIAreach Anti-SARS-CoV-2 Total Test is a serological test that has been shown to have a sensitivity of 93.85% (CI 84.99–98.30%) and a specificity of 97.83 %–%% (CI 95.00–99.29%). QIAGEN’s technology detects total antibodies (Total immunoglobulin) specific to SARS-CoV-2 immune response – while most other tests currently identify only selected antibodies.

The QIAreach Anti-SARS-CoV-2 Total Test was developed in partnership with Ellume, an Australian digital diagnostics company. It is the first of two QIAGEN COVID-19 tests to make use of Ellume’s digital eHub and eStick system: QIAGEN in early September 2020 presented the QIAreach SARS-CoV-2 Antigen Test to detect active SARS-CoV-2 infection, which has been submitted to the FDA for an EUA.

Research into the SARS-CoV-2 pandemic also requires the monitoring of the immune status of individuals. QIAGEN is the only company that has developed both an antibody and a T-cell test to track immune responses. In November, it also launched the QuantiFERON SARS-CoV-2 test (for research use only) that can detect T-cell responses in people who have had natural infection or vaccination.

“Serological testing for antibodies is central to identifying people who have been recently infected by the virus or have been infected in the recent past, especially those who did not show any symptoms and therefore might not know of an infection,” said Davide Manissero, Chief Medical Officer of QIAGEN. “As societies are now returning to normal daily routines, understanding the COVID-19 immunity in a population can help guide public health measures.”

Traditional rapid lateral-flow antibody tests are hard to automate and results can be hard to read. The QIAreach Anti-SARS-CoV-2 Total Test generates easy-to-read results on the digital eHub platform. Each QIAreach eHub can handle up to eight samples on eight eSticks simultaneously, with each eStick test running independently. QIAGEN is using the same platform to develop QIAreach^® QuantiFERON^®-TB, a new testing solution for identifying latent tuberculosis (TB) infections in low-resource regions.

Further information on QIAGEN’s response to the coronavirus outbreak can be found here.

About QIAGEN

QIAGEN N.V., a Netherlands-based holding company, is the leading global provider of Sample to Insight solutions that enable customers to gain valuable molecular insights from samples containing the building blocks of life. Our sample technologies isolate and process DNA, RNA and proteins from blood, tissue and other materials. Assay technologies make these biomolecules visible and ready for analysis. Bioinformatics software and knowledge bases interpret data to report relevant, actionable insights. Automation solutions tie these together in seamless and cost-effective workflows. QIAGEN provides solutions to more than 500,000 customers around the world in Molecular Diagnostics (human healthcare) and Life Sciences (academia, pharma R&D and industrial applications, primarily forensics). As of March 31, 2020, QIAGEN employed approximately 5,700 people in over 35 locations worldwide. Further information can be found at http://www.qiagen.com.

Forward-Looking Statement

Certain statements contained in this press release may be considered forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended. To the extent that any of the statements contained herein relating to QIAGEN’s products, including those products used in the response to the COVID-19 pandemic, timing for launch and development, marketing and/or regulatory approvals, financial and operational outlook, growth and expansion, collaborations markets, strategy or operating results, including without limitation its expected adjusted net sales and adjusted diluted earnings results, are forward-looking, such statements are based on current expectations and assumptions that involve a number of uncertainties and risks. Such uncertainties and risks include, but are not limited to, risks associated with management of growth and international operations (including the effects of currency fluctuations, regulatory processes and dependence on logistics), variability of operating results and allocations between customer classes, the commercial development of markets for our products to customers in academia, pharma, applied testing and molecular diagnostics; changing relationships with customers, suppliers and strategic partners; competition; rapid or unexpected changes in technologies; fluctuations in demand for QIAGEN’s products (including fluctuations due to general economic conditions, the level and timing of customers’ funding, budgets and other factors); our ability to obtain regulatory approval of our products; difficulties in successfully adapting QIAGEN’s products to integrated solutions and producing such products; the ability of QIAGEN to identify and develop new products and to differentiate and protect our products from competitors’ products; market acceptance of QIAGEN’s new products and the integration of acquired technologies and businesses; actions of governments, global or regional economic developments, weather or transportation delays, natural disasters, political or public health crises, including the breadth and duration of the COVID-19 pandemic and its impact on the demand for our products and other aspects of our business, or other force majeure events; as well as the possibility that expected benefits related to recent or pending acquisitions may not materialize as expected; and the other factors discussed under the heading “Risk Factors” contained in Item 3 of our most recent Annual Report on Form 20-F. For further information, please refer to the discussions in reports that QIAGEN has filed with, or furnished to, the U.S. Securities and Exchange Commission.