Monthly Archives

September 2020

BioBuzz -10 International Vaccine Influencers Who Exemplify Maryland’s Leading Role in Public Health

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The state of Maryland is the global epicenter of vaccine research and development. This has never been more evident than right now as scores of Maryland companies have risen to the global challenge of developing the first approved vaccine for SARS-CoV-2.

We’ve written extensively about the region’s push to develop a viable, effective and safe COVID-19 vaccine. Companies like Novavax, Emergent BioSolutions and Altimmune are on the leading edge with some of the most promising COVID-19 Vaccine candidates progressing through clinicals.  While Maryland as a global vaccine R&D juggernaut might be news to those outside of the region, Maryland’s life science ecosystem has been a leading vaccine R&D hub for years.

In fact, by some estimates, Maryland is home to twenty percent of the top vaccine influencers in the world; the state is also home to three of the top 10 global vaccine manufacturers. The legacy of vaccine leadership and innovation runs deep in Maryland and can be found at the likes of pharma giant’s like AstraZeneca, whose acquisition of MedImmune was a watershed moment for the region, as well as privately-held, smaller companies like Immunomic Therapeutics and others.

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Novavax Executive Vice President, Chief Business Officer and Chief Financial Officer, John Trizzino, Guests on BioTalk with Rich Bendis

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John Trizzino, Novavax Executive Vice President, Chief Business Officer and Chief Financial Officer Joins BioTalk to Discuss the Company’s History, COVID-19 Vaccine Development, and Collaboration in the BioHealth Capital Region

Listen now on Apple https://apple.co/2EJ4ucS, Google https://bit.ly/36eBQLS, Spotify, https://spoti.fi/2HDE9hr, TuneIn https://bit.ly/3kS20Z1, and Youtube (audio) https://bit.ly/3kYlHyb.

Mr. Trizzino is executive vice president, chief business officer, and chief financial officer with responsibility for all pre-commercial and commercial launch strategy and execution, financial reporting, corporate funding, and investor/public relations. He previously served as senior vice president of commercial operations beginning in 2014. Mr. Trizzino originally joined Novavax in 2009 with a broad range of experiences in small-to-large, publicly held companies. He has an extensive background in the vaccine market with previous roles overseeing commercialization, vaccine policy, strategic development, business development, financing, investor relations, and public relations. In 2011, Mr. Trizzino joined Immunovaccine as its CEO and successfully led the company into clinical development of its lead candidate while securing the required funding commitments in the equity market as well as non-dilutive sources. Prior to his tenures at Novavax and Immunovaccine, Mr. Trizzino had leadership responsibilities at MedImmune, LLC (an AstraZeneca company), ID Biomedical, and Henry Schein, Inc., which were all companies focused on infectious disease vaccine markets. Mr. Trizzino received a bachelor of science degree from Long Island University, CW Post and a master of business administration degree from New York University, Stern School of Business.

Click here to download the transcript.

Johns Hopkins researchers develop system for using everyday glucose monitors to detect COVID-19 antibodies

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A trio of Johns Hopkins scientists—a pharmacologist, a biomedical engineer, and a biophysicist—are pooling their knowledge to design a device that can detect whether a person has antibodies linked to SARS-CoV-2, the virus that causes COVID-19. Antibodies are tiny proteins that the immune system produces to “remember” viral encounters and provide immunity to future infections.

To develop an antibody detector that can be deployed rapidly and inexpensively across the globe, the researchers got their inspiration from a test that is already used by millions of people: a glucose monitor.

People with diabetes use glucose monitors to measure their blood sugar levels by taking a tiny prick of blood from their finger and placing it on a paper test strip that is inserted into the monitor. This same type of tool could be reconfigured to detect glucose in a series of chemical reactions that occur when antibodies are detected in the blood, say the researchers, led by Netz Arroyo, assistant professor of pharmacology and molecular sciences; Jamie Spangler, assistant professor of biomedical engineering; and Taekjip Ha, Bloomberg Distinguished Professor of biophysics and biophysical chemistry, and a professor of biophysics and biomedical engineering at Johns Hopkins.

 

Click here to read more via JHU

BioBuzz: 2020 Virtual BioHealth Capital Region Forum Kicks Off October 19th

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by: Steven Surdez

The 6th annual Biohealth Capital Region (BHCR) Forum kicks off on October 19th. This year’s event will be held virtually and will bring together the top biotech and life science executives and expert speakers from across the industry, academia, healthcare, government, finance, and real estate development, among others.

Each year, top thought leaders and subject matter experts converge to discuss recent accomplishments and the BHCR’s path forward to becoming a top three U.S. biotech cluster by 2023. 2020 has been a year unlike any other, making this year’s forum an essential vehicle for learning more about what’s happening, what the region has learned and where it is headed.

Rich Bendis, the CEO and President of BioHealth Innovation (BHI), will kick off the event during the event’s opening remarks, which will also include Maryland’s Secretary of Commerce Kelly Schulz, Montgomery County Executive Mark Elrich, and Virginia’s Secretary of Health and Human Services Daniel Carey.

In a year that’s been defined by COVID-19 and the region’s response to the greatest public health crisis in years, the BHCR Forum opening keynote will be delivered by Biomedical Advanced Research and Development Authority’s (BARDA) Dr. Sandeep Patel. Patel is the first-ever Director of BARDA’s new Division of Research, Ventures, and Innovation (DRIVe), which oversees a diverse portfolio of health security innovations to address current and emerging threats.

The event’s closing keynote will be delivered by XXXX.

The BHCR Forum agenda includes a number of what will be informative and insightful sessions panelled by experts representing a diverse array of industries, companies and fields.

Sessions include, but are not limited to:

New Pharma in the BioHealth Capital Region. This session will be moderated by BHI’s Bendis; panelists include Sally Allain, the Head of JLABS@ Washington, D.C.; Rick Bright, the former Director of BARDA; Kurt Newman, Children’s National Hospital’s President, and CEO; Mike Friedlander, Vice President for Health Sciences and Technology; and Jennifer Butler, Executive Vice President and General Manager at Innate Pharma US.

Strength of Our Region: Combating Infectious Diseases. This session will be moderated by XXXX; panelists include Karen Smith, Executive Vice President and Chief Medical Officer at Emergent Biosolutions; Greg Glenn, President of Research and Development at Novavax; Daryl Sampey, BioFactura’s President, and CEO; and Aperiomics CEO Crystal Icenhour.

Growing and Retaining Your BioHealth Workforce. This session will be moderated by Judy Costello, BHI’s Managing Director of Economic Development; panelists include Neelima Rao, Vice President of Human Resources, Global R&D and North American Hub Leader at AstraZeneca; MiRecule’s CEO Anthony Saleh; Ed Radwinsky, Head of People Operations at RoosterBio; and Jill Hoyt, Executive Vice President, Chief Human Resources Officer at Novavax.

This year’s event will also include the 5th annual Crab Trap Competition where startups will compete to win $10K and be named the BioHealth Startup with the Most Commercial Potential.

The BHCR forum is an invitation-only event that is free for executive-level biotech leaders. The event is presented by BioHealth Innovation, VirginiaBio, Children’s National Health System, Johns Hopkins University, Maryland Department of Commerce, Quality Biological, George Mason University, University System of Maryland, and AstraZeneca.

To register for the BHCR virtual forum on October 19th, click below.

BioBuzz: Maryland’s Longhorn Vaccines & Diagnostics Set to Launch New Product that Could Revolutionize Molecular Testing

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Longhorn Vaccines & Diagnostics, which has offices in Bethesda, Maryland, and San Antonio, Texas, has been at the forefront of the battle against COVID-19. And now, the innovative company has released its latest product, PrimeStore Analyte Transport Media (ATM)Ⓡ, which could revolutionize antigen and molecular testing by completely eliminating the need for RNA and DNA extraction.

In the midst of the company’s remarkable COVID-19 push, where it has sold and distributed approximately 30,000,000 sample collection tubes containing its PrimeStore MTMⓇ product, the company released PrimeStore ATM for purchase in late August 2020 and anticipates filing for U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) in September 2020.

PrimeStore ATM is a virucidal, bacteriostatic, Guanidine-free sample collection device optimized for molecular testing while providing highly sensitive antigen testing capabilities. The product is validated for influenza qPCR (quantitative polymerase chain reaction) and antigen testing and is the first-of-its-kind extraction-less qPCR sample collection device.

Dr. Luke T. Daum, Longhorn’s Scientific Co-founder, Executive Vice President, and Chief Science Officer, invented PrimeStore ATM and has spearheaded efforts to launch the new product.

Click here to read the entire article via BioBuzz

Dr. Christine Dingivan Joins Emmes as President and CEO

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Emmes today announced that Dr. Christine Dingivan has joined the company as its new president and chief executive officer. She is succeeding Dr. Anne Lindblad, who is retiring after 38 years at the company. Dr. Dingivan will be Emmes’ fourth chief executive since the company was founded in 1977.

According to Dr. Lindblad, “Finding the right fit for Emmes was critically important during our extensive CEO search. Christine has all the attributes we were looking for, and I am excited to turn over the reins. Although I’ll remain through the end of this year to help with the transition, she is officially our leader.”

Dr. Dingivan was previously a senior executive with Novartis. She began as the global head of portfolio strategy and innovation for Novartis Global Drug Development in Basel, Switzerland, where she was responsible for prioritizing the industry’s largest drug development pipeline, and later was named the first global head of data and digital. In this role, she designed and implemented a digital development strategy, leveraging innovative digital tools and advanced analytics, to transform the company’s drug development process. In addition, Dr. Dingivan created a digital innovation lab connecting entrepreneurs with Novartis mentors, partners and datasets in order to stimulate healthcare innovation.

Before joining Novartis in 2016, she spent eight years at PPD, Inc., a leading global clinical research organization. She served as chief medical officer and global head of strategic client solutions, and was a member of the executive committee. In this role, she led the growth and innovation strategy to enhance the company’s commercial business. Earlier, as global head of partnership strategies, she built a successful sales organization focused on the top 30 biopharmaceutical companies.

Following her medical training in surgery, Dr. Dingivan began her industry career at MedImmune, a biotechnology firm later acquired by AstraZeneca. She held various positions of increasing responsibility, ultimately rising to senior vice president, clinical research and operations. In this position, she led clinical research efforts across a wide range of therapeutic areas and was directly involved in the development and launch of a number of successful products, including the influenza vaccine FluMist®.

According to Dr. Lindblad, “Christine’s 20+ years spanning the biotech and pharmaceutical clinical research industries, her reputation as an industry leader, and her experience with a global CRO are assets to Emmes as we expand our global capabilities. She combines science, medical research and business acumen with excellent strategic and communication skills.”

Dr. Lindblad continued, “Our company was built on a culture of collaboration and science, and we have been fortunate over our 43-year history to use our growth to invest in our staff and expand our collective ability to make a real difference in human health. Christine understands our dedication to science, integrity, and human health. She understands that our employees are our most important asset and that high-quality research design, execution and results are our most important deliverable.”

“I’m honored to have the opportunity to become the next CEO of this extraordinary company,” said Dr. Dingivan. “Emmes’ reputation for exceptional research stems from the high standards they set – as individuals, teams and as a company. They have a clear sense of pride in the important work that they do.”

She added, “I felt drawn as a physician to Emmes’ commitment to advance public health. It was clear, both in my prior dealings with the company and now, that its people are passionate about tackling some of the biggest challenges to human health. I am so excited about joining a company whose mission and values are so closely aligned with my own.”

Dr. Dingivan trained in general surgery at Northwestern Medical School, received her M.D. from Dartmouth Medical School, and holds a B.S. in bioengineering from the University of Pennsylvania. In addition to serving on the board of directors of two life sciences companies, Dr. Dingivan is dedicated to nonprofit work. An active member of the Washington, D.C. area community, she is a member of the Kennedy Center National Symphony Orchestra’s board of directors and is a founding board member of Young Women Lead (YWL), whose goal is to empower high school girls and offer leadership, education, and development experiences and resources.

About Emmes
Emmes is a leading Contract Research Organization working with both public and private sector organizations. We collaborate with our clients to produce valued, trusted scientific research, and our team members are passionate about making a difference in the quality of human health. Emmes has supported more than a thousand studies across a diverse range of diseases since our formation in 1977. Our research is contributing to a healthier world. For more information, visit the Emmes website at www.emmes.com.

BioBuzz: Aurinia Pharmaceuticals Prepares for Commercial Launch from New Maryland Site on the Heels of 2020 Hiring Spree

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Aurinia Pharmaceuticals (Aurinia) is a late-stage clinical biopharmaceutical company (Toronto Stock Exchange (TSX:AUP); NASDAQ (NASDAQ:AUPH) focused on commercializing therapies for rare autoimmune and inflammatory conditions. Headquartered in Vancouver, British Columbia, the company announced in March 2020 that it had established its U.S. commercial center of operations in Rockville, Maryland, which is actively staffing up with key personnel. Among the key leaders, Aurinia attracted were two veteran industry executives with deep ties to the region: former top MedImmune executives Peter Greenleaf and Max Donley are the company’s CEO and EVP, Internal Operations and Strategy, respectively. They both joined Aurinia’s leadership team in 2019

The company’s lead product candidate, voclosporin, is a potential best-in-class, first-in-class therapy for lupus nephritis (LN) in the U.S. and the European Union (EU). Aurinia just recently received Priority Review status from the U.S. Food & Drug Administration (FDA) and voclosporin has a Prescription Drug User Fee Act (PDUFA) date of January 22, 2021, making this an exciting and important time for the organization as it prepares for the potential commercialization of its first product.

“Peter and I are back together with Aurinia and we’re very excited about this opportunity to build another vertically integrated company around outstanding technology,” stated Donley. “At the end of the day what’s exciting is the patient community we are serving. We still have to get through an important gate, but this could be a meaningful medical intervention for patients that don’t currently have a lot of options.”

“When Aurinia made an announcement around voclosporin’s positive Phase III data, many major advocacy groups, unprompted by us, issued their own press releases thanking us and spurring us on to get the best label possible to the patients,” he added. “Lupus Nephritis (LN) is a nasty disease and the next progression of the lupus disease state that presents dramatic, life- altering outcomes for patients. To bring a medical intervention forward is not an opportunity, it is an obligation for us.”

Donley is no stranger to a patient-focused mission. He joined MedImmune in its earlier days when they were building a company around its eventual flagship product Synagis. Donley learned about MedImmune from the Neonatal Intensive Care Unit (NICU) staff after the birth of his daughter, who was born premature. She received Respigam, the precursor to Synagis, which protected her against respiratory syncytial virus, known as RSV.

“My daughter was a patient. When we got to a point where MedImmune was quite big, we took our leaders to an offsite in Boston. We wanted our leaders to understand why they were here…The capstone speaker was my 13 year old daughter. She told her story and how she’s a happy, healthy, successful kid and said it’s because of you. It’s still kind of hard to tell this story,” shared Donley.

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Prebeo Awarded $150,000 TEDCO MD Innovation Initiative Investment

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Award to drive development of Prebeo’s technology aimed at reducing the thousands of deaths each year caused by failure to find viable kidney matches for transplantation

September 10, 2020, Baltimore, MD – Prebeo, LLC, a medical technology company working to improve the evaluation of donor kidneys to drive more successful transplantations and save lives, announced today it has been awarded a $150,000 Maryland Innovation Initiative (MII) investment from the Maryland Technology Development Corporation (TEDCO).

The MII grant award will enable Prebeo to accelerate development of its Kidney Viability Assessment System (KVAS). This device uses optical coherence tomography (OCT), augmented by an intelligent image-analysis algorithm, to non-invasively evaluate donor kidneys in real time.

Prebeo’s proprietary method, with a scan time under five minutes, will act as a quantitative supplement to the existing standard of care – comprised of single tissue biopsy and a score created from a donor’s medical history – for assessing donor kidneys. Thousands of donor kidneys are discarded each year due to inconclusive quality-testing results. Many of these organs are likely transplantable – but only if an objective test could demonstrate their viability. Prebeo aims to provide that objective assessment.

“With Prebeo’s KVAS, we aim to save lives by making the kidney transplantation placement process more efficient and drive better patient outcomes,” said Chris Moad, Director of Business Development. “Increasing the number of donor kidneys deemed viable for transplant is crucial to improving patient outcomes. We’re grateful to TEDCO’s MII program for their support of this important project.”

Prebeo’s technology, invented by Yu Chen, PhD, formerly Associate Professor of Bioengineering at the University of Maryland, College Park, addresses a market need of roughly $458 million annually, targeting Certified Transplant Centers, Organ Procurement Organizations and hospitals throughout the US for kidney transplantations.

“As it stands, 100,000 Americans currently are on wait lists to receive kidney transplants, and 8,000 die each year from failure to find a viable kidney for transplantation,” said Moad. “With these TEDCO MII resources, our team of scientists and engineers can accelerate development of our technology for significantly improving the evaluation of donor kidneys to enable more successful transplantations.”

TEDCO’s MII was created as a partnership between the State of Maryland and five Maryland academic research institutions: Johns Hopkins University; Morgan State University; University of Maryland, Baltimore; University of Maryland, Baltimore County; and University of Maryland, College Park. The program is designed to promote commercialization of research conducted in the partnership universities, leveraging each institution’s strengths.

About Prebeo:

Prebeo, LLC is a medical technology company, based in Baltimore, MD, working to improve the evaluation of donor kidneys to drive more successful transplantations and save lives. Prebeo is a portfolio company with Early Charm Ventures.

Media Contact:

Ken Malone

410.692.8605

GlycoT Therapeutics LLC, a UM Ventures start-up company Signs Sublicense Agreement to Daiichi Sankyo

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BALTIMORESept. 14, 2020 /PRNewswire/ — GlycoT Therapeutics LLC, a UM Ventures start-up company based on intellectual property (IP) developed at the University of Maryland, Baltimore (UMB) and University of Maryland, College Park (UMCP), has executed a sublicense agreement for its glycoengineering technology with Daiichi Sankyo Company, Limited (Daiichi Sankyo; www.daiichisankyo.com). The agreement grants Daiichi Sankyo worldwide and non-exclusive rights to IP that GlycoT currently licenses from UMB and UMCP, and includes an undisclosed upfront payment, annual fees, and adequate royalties of sales to GlycoT.

GlycoT’s enzymatic glycoengineering technology provides a platform to precisely change and modify the sugars on antibodies. Daiichi Sankyo plans to use this cutting-edge technology to prepare new drug candidates.

“We are very excited to see the growing potential for GlycoT’s glycoengineering technology,” said Phil Robilotto, DO, MBA, associate vice president of UMB’s Office of Technology Transfer and director of UM Ventures, which is UMB and UMCP’s joint technology transfer initiative. “This is a great example of how university innovators continue to fuel therapeutic development across the globe.”

Lai-Xi Wang, PhD, Founder and President of GlycoT Therapeutics and UMCP Professor in the Department of Chemistry and Biochemistry, developed the technologies that are the basis for the GlycoT/Daiichi Sankyo license agreement in his lab, first at UMB and later at UMCP.

“We are pleased to provide the opportunity for Daiichi Sankyo to use this technology,” said Dr. Wang. “We believe our technology has the potential to open new avenues for developing novel therapeutics for the treatment of human diseases.”

About GlycoT Therapeutics LLC
GlycoT Therapeutics aims to apply its innovative and proprietary chemoenzymatic glycosylation technology for glycoengineering of therapeutic proteins such as monoclonal antibodies to improve their therapeutic efficacy. For more information, visit www.glycot.com.

About UM Ventures
UM Ventures, the joint technology transfer initiative of University of Maryland, Baltimore (UMB) and University of Maryland, College Park (UMCP), commercializes University of Maryland’s breakthrough discoveries, fueling the creation of innovative start-up companies and attracting industry leaders and entrepreneurs to the universities. Researchers at UMB and UMCP have created hundreds of life science innovations that are available for licensing. Our Discovery Portfolio offers a mix of cutting-edge technologies, including vaccines, therapeutics, diagnostics, devices, and software that promise to make a quantifiable impact on human health and the environment. The internationally-recognized genomics, cancer, vaccine, stem cell, pharmaceutical and bioengineering research underway at the University of Maryland provides a robust pipeline of more than 250 new innovations each year. Visit our portfolio at umventures.org.

SOURCE University of Maryland Ventures

Related Links

http://www.umventures.org

BioBuzz – In Conversation with Troy LeMaile-Stovall, TEDCO’s New CEO and Executive Director

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The Maryland Technology Development Corporation (TEDCO) announced in July 2020 that it had completed the executive search for a new leader with the hiring of Troy LeMaile-Stovall, a seasoned leader with deep ties to the BioHealth Capital Region (BCHR).

LeMaile-Stovall just recently officially took the helm of TEDCO and we thought it a great time to catch up with him for a wide-ranging and insightful conversation about his background and vision for TEDCO and the BHCR biotech and life science ecosystem.

Tell us a bit about your background and journey to becoming the new CEO & Executive Director at TEDCO.

I think your word ‘journey’ is an apt one. My career journey has prepared me for this in terms of academic preparation, career choices, and passion.

I should start with I am a native Texan, raised in Houston. And yes, even though I did not play, football it is in my blood; as in Texas, there are only 2 sports, fall football, and spring football.  I say all that to say that I am a Cowboys fan, but love rooting for the Ravens, especially their incredibly young quarterback Lamar Jackson.

In terms of academic preparation, I am an engineer/computer scientist by training who also holds an MBA. I have been able to work as an engineer, computer scientist, management consultant, private equity fund manager, venture capitalist, community developer/organizer, for-profit/nonprofit corporate board member, C-level executive, higher education administrator, and entrepreneur. 

Along the way being able to work for major entities like Rockwell International, AT&T, Bell Labs, Southwestern Bell, McKinsey, Jackson State University, the University of the District of Columbia, and Howard University, as well as smaller entities including Gulf South Capital, the family investment office I co-founded and led.

My passion along this journey has been formed by Mother’s golden rule –“The Good Lord has put you on this planet for one purpose and that is to make a difference in one person’s life; the challenge is you don’t know when that one person is coming into your life so you have to make a difference in every life you touch.” 

“I am coming to TEDCO to be a part of making a difference in the lives of those with dreams that need resources, coaching, and support to make that dream a reality. That is my purpose and my passion.”

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