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571st Edition, August 22, 2023

By BHI Weekly News Archives

 

 

 

BioTalk Discusses Breaking Frontiers in Immunotherapy: A Conversation with Bill Enright, CEO and Board Director at Vaccitech
 

What does it take to pioneer groundbreaking T-cell immunotherapies and vaccines for infectious diseases and cancer? Join us for this episode of BioTalk, where we sit down with Bill Enright, a seasoned biotech executive with a remarkable track record spanning over three decades. Bill brings a wealth of experience in building and financing both privately held and publicly traded companies, making his mark in various roles within the life science/biotech industry.

Bill offers a compelling update in this installment since his previous appearance on BioTalk. Learn about the intriguing journey that led Vaccitech, a clinical-stage T cell immunotherapy and vaccine company, to select Montgomery County, MD, within the thriving BioHealth Capital Region, for its new site. Delve into the intricacies of their pioneering platform, which harnesses the power of immunotherapy to elicit robust T cell responses and antibodies against infectious agents and tumors.

Listen now via your favorite podcasting platform:

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International Delegation from Japan Visits BioHealth Innovation, Inc. in a Bid to Strengthen Biotech Ties
 

On August 16th, BioHealth Innovation, Inc. (BHI) in Rockville, Maryland, hosted a distinguished group of professionals from Japan, representing the International Visitor Leadership Program (IVLP) in collaboration with the U.S. Department of State. This visit marked a significant step towards fostering international relations in the biotechnology sector.

The delegation from Japan arrived with specific objectives for their visit. They aimed to deepen their understanding of technology transfer and the best practices in commercialization. Additionally, they sought to forge strong ties with U.S. technology transfer experts, laying the groundwork for future collaborations. A significant focus was on amplifying biotechnology research and fostering commercial partnerships between the U.S. and Japan. They also aspired to strengthen Japan’s bioeconomy sector, envisioning it as a global epicenter for biotech products and ensuring its biotechnology ecosystems resonate with democratic principles. Furthermore, the delegation intended to heighten the interest of U.S. investors in early-stage biotechnology towards Japanese startups and to broaden the horizons for Japanese companies in the global venture capital arena.

The esteemed group from Japan comprised:

  • Dr. Rei Uematsu, Deputy Director, R&D Division, Industrial Science, Technology and Environment Policy Bureau, Ministry of Economy, Trade, and Industry (METI)
  • Dr. Jun Sato, Attending Physician, Department of Experimental Therapeutics, National Cancer Center Hospital of Japan
  • Dr. Eriko Ogawa, Manager, R&D Division, Amino Up Co., Ltd.
  • Dr. Noriyuki Nishimura, Principal Scientist, National Agriculture and Food Research Organization (NARO)
  • Dr. Masahiro Taniguchi, R&D General Manager, KAICO Ltd.
  • Dr. Minako Sumiyoshi, Regulatory Affairs Officer, Sanatech Seed Co., Ltd.

Representing BioHealth Innovation were Rich Bendis, President and CEO; Luis Gutierrez, Executive in Residence; Albine Martin, Entrepreneur in Residence; and Ethel Rubin, Entrepreneur in Residence.

The visit provided an opportunity for the delegation to learn more about BHI’s mission and services, fostering a deeper understanding and potential for future collaborations.

Rich Bendis, President and CEO of BHI, remarked, “It’s always an honor to host international delegations, especially one as esteemed as this group from Japan. Collaborative efforts like these pave the way for global advancements in biotechnology. We look forward to a future filled with shared knowledge and mutual growth.”

This visit underscores the importance of international collaboration in the biotechnology sector. As the world becomes more interconnected, partnerships like these will be crucial in driving innovation and ensuring the global community benefits from advancements in biotechnology.

 

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Frederick’s Zalgen Immunotherapeutic Confers Complete Protection Against Advanced Multilineage Lassa Infections in Nonhuman Primates
 

FREDERICK, Md., Aug. 18, 2023 /PRNewswire/ — Zalgen Labs LLC (Zalgen), a biotechnology and diagnostics company focused on high-impact, neglected infectious diseases, including Lassa Fever (LF), today announced publication of data demonstrating that Arevirumab-3®, its lead immunotherapeutic candidate, is an effective therapeutic for the treatment of Lassa virus infections, with activity against all major viral lineages that cause severe disease in humans, and at very low dosages. 

The study emanated from an extensive and ongoing research collaboration of Zalgen, Tulane University (Tulane), UTMB, and other members of the Viral Hemorrhagic Fever Consortium (VHFC) [www.vhfc.org] and the Viral Hemorrhagic Fever Immunotherapeutic Consortium (VIC) [www.vhfimmunotherapy.org] working on advanced alternatives to treat Lassa fever and other hemorrhagic viral infections.

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Global Breakthroughs for a Healthier Future – Registration for the 9th Annual BioHealth Capital Region Forum Now Live
 

Get ready for an exceptional experience at the 9th Annual BioHealth Capital Region Forum. Registration is now live for this highly anticipated event, taking place on September 19th and 20th, 2023, at the US Pharmacopeia (USP) facility located at 12601 Twinbrook Pkwy, Rockville, MD 20850.

Step into a world of innovation as we proudly present an entirely in-person experience under the theme “Global Breakthroughs for a Healthier Future.” After a period of remote events, we’re thrilled to bring together industry professionals for face-to-face interactions once again with no registration fees, thanks to our generous event sponsors!

Prepare to be part of the premier gathering for the biopharma sector, as the in-person BioHealth Capital Region Forum attracts over 1,100 registrants annually. Esteemed government officials, academic leaders, and industry executives will converge at this prestigious event, creating a vibrant atmosphere for reconnection, partnership rekindling, and exploration of new growth avenues within the region.

Read More

 
 

Applications to Compete in the 8th Annual BioHealth Capital Region Crab Trap are Now Being Accepted!
 

Now in its 8th year, the BioHealth Capital Region Crab Trap continues to grow, attracting applicants from around the region, country, and internationally. The competition highlights entrepreneurs with commercially relevant diagnostics, medical devices, therapeutics, and other transformative health solutions.

This year’s Crab Trap winner will be eligible for a package of prizes worth more than $50,000. Prizes for the qualifying Crab Trap winner include:

  • A $10,000 cash prize from Greenberg Traurig
  • A $25,000 cash prize from Montgomery County (for a firm headquartered in Montgomery County)
  • A one-year residency at JLABS @ Washington, D.C. (for a firm of their choice)
  • $10,000 in Preclinical CRO services from Noble Life Sciences.

Read More

 
 

Apply Now for the 6th Annual BioHealth Capital Region Investor Conference: Uniting Visionary Entrepreneurs and Pioneering Investors for Transformative Funding
 

The 6th Annual BioHealth Capital Region Investor Conference is just around the corner! Taking place on September 21st, 2023, at the US Pharmacopeia, this in-person event brings together ambitious entrepreneurs, startup-up companies and innovative BioHealth companies with a diverse group of influential investors, offering funding opportunities ranging from pre-seed to Series A.

The BioHealth Capital Region is renowned for its vibrant biotechnology and life sciences community, a breeding ground for groundbreaking advancements and success stories. The conference’s history is marked with exceptional achievements, from initial funding rounds to subsequent financings, successful IPOs, and engaging M&A activities.

Read More

 
 

Home | About BHI | BHI News | Programs | Partners | Contact

Copyright  BioHealth Innovation 2023
All Rights Reserved.

 
 

 

 
BHCR Top 3 image

570th Edition, August 15, 2023

By BHI Weekly News Archives

 

 

 

BioHealth Capital Region Achieves Top 3 Ranking: A Triumph of Collaboration and Innovation
 

In 2016, during the Annual BioHealth Capital Region Forum at MedImmune/AstraZeneca in Gaithersburg, Maryland, an ambitious goal was set: to make the BioHealth Capital Region (BHCR) a Top 3 BioHealth cluster in the United States by 2023. That vision has been realized in the latest Genetic Engineering & Biotechnology News “Top 10 U.S. Biopharma Clusters” rankings, marking a significant milestone in the region’s relentless pursuit of excellence, collaboration, and innovation in the BioHealth field.

Rich Bendis, President & CEO of BioHealth Innovation, Inc., stated, “It’s been an incredible journey working with so many dedicated individuals and organizations in the region over the years to meet this goal. The spirit of collaboration and innovation that defines the BioHealth Capital Region has been the driving force behind this success, and I’m proud to be part of this remarkable community.”

Read More

 
 

How the BioHealth Capital Region Became a Top 3 BioPharma Cluster: Insights from Alex Philippidis, Senior Business Editor at Genetic Engineering & Biotechnology News
 

How does a BioPharma Cluster ascend the ranks to secure a Top 3 position? What are the key factors propelling the BioHealth Capital Region to achieve its ambitious goal of ranking 3rd by 2023? Join us in this episode of BioTalk, where our host Rich Bendis speaks with Alex Philippidis, Senior Business Editor at Genetic Engineering & Biotechnology News.

In this installment, Alex unveils the intricacies behind his latest Top 10 U.S. Biopharma Clusters, highlighting the impressive rise of the BioHealth Capital Region to its 3rd position. Learn about the origins of these rankings, the trends that have been identified for 2023, and the dynamic shifts within the BioPharma landscape on a regional scale.

Listen now via your favorite podcasting platform:

Read More

 
 

Global Breakthroughs for a Healthier Future – Registration for the 9th Annual BioHealth Capital Region Forum Now Live
 

Get ready for an exceptional experience at the 9th Annual BioHealth Capital Region Forum. Registration is now live for this highly anticipated event, taking place on September 19th and 20th, 2023, at the US Pharmacopeia (USP) facility located at 12601 Twinbrook Pkwy, Rockville, MD 20850.

Step into a world of innovation as we proudly present an entirely in-person experience under the theme “Global Breakthroughs for a Healthier Future.” After a period of remote events, we’re thrilled to bring together industry professionals for face-to-face interactions once again with no registration fees, thanks to our generous event sponsors!

Prepare to be part of the premier gathering for the biopharma sector, as the in-person BioHealth Capital Region Forum attracts over 1,100 registrants annually. Esteemed government officials, academic leaders, and industry executives will converge at this prestigious event, creating a vibrant atmosphere for reconnection, partnership rekindling, and exploration of new growth avenues within the region.

Read More

 
 

Applications to Compete in the 8th Annual BioHealth Capital Region Crab Trap are Now Being Accepted!
 

Now in its 8th year, the BioHealth Capital Region Crab Trap continues to grow, attracting applicants from around the region, country, and internationally. The competition highlights entrepreneurs with commercially relevant diagnostics, medical devices, therapeutics, and other transformative health solutions.

This year’s Crab Trap winner will be eligible for a package of prizes worth more than $50,000. Prizes for the qualifying Crab Trap winner include:

  • A $10,000 cash prize from Greenberg Traurig
  • A $25,000 cash prize from Montgomery County (for a firm headquartered in Montgomery County)
  • A one-year residency at JLABS @ Washington, D.C. (for a firm of their choice)
  • $10,000 in Preclinical CRO services from Noble Life Sciences.

Read More

 
 
 

Gaithersburg’s Georgiamune Inc. Achieves US FDA Clearance for Investigational New Drug (IND) Application and Secures $75 Million in Series A Financing
 

GAITHERSBURG, Md., Aug. 9, 2023 /PRNewswire/ — Today, Georgiamune Inc., a privately held, clinical stage biotechnology company, announced the clearance of its Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA) for GIM-122, a dual-functioning monoclonal antibody. Furthermore, the company successfully completed a $75M Series A financing, positioning Georgiamune as a promising new biotechnology company in the fields of oncology and autoimmune diseases.

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Addimmune, a Clinical Stage Hiv-Focused Gene Therapy Company, to go Public Through Business Combination With 10x Capital Venture Acquisition Corp. III
 

NEW YORK CITY, NEW YORK and ROCKVILLE, MARYLAND, Aug. 09, 2023 (GLOBE NEWSWIRE) — NEW YORK CITY, NEW YORK and ROCKVILLE, MARYLAND, Aug. 9, 2023 (GLOBE NEWSWIRE) – American Gene Technologies International Inc. (“AGT”) and 10X Capital Venture Acquisition Corp. III (“10X III”) (NYSE: VCXB), a special purpose acquisition company, today announced that they have entered into a merger agreement for a business combination that would result in the combined company being a publicly listed company (the public company following the business combination to be renamed “Addimmune”). The combined company is expected to trade under the ticker symbol “HIV”. Addimmune is a clinical-stage gene and cell therapy company developing a functional cure for HIV. Prior to the combination, the non-HIV assets will spin-off into an entity that will retain the American Gene Technologies name.

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Precigen Announces FDA Confirmation that the Ongoing Phase 1/2 Study of PRGN-2012 AdenoVerse Immunotherapy Will Serve as the Pivotal Study to Support Accelerated Approval
 

GERMANTOWN, Md., Aug. 9, 2023 /PRNewswire/ — Precigen, Inc. (Nasdaq: PGEN), a biopharmaceutical company specializing in the development of innovative gene and cell therapies to improve the lives of patients, today announced that the US Food and Drug Administration (FDA) has agreed that the ongoing Phase 1/2 single arm study (NCT04724980) of the first-in-class investigational PRGN-2012 AdenoVerse immunotherapy for the treatment of recurrent respiratory papillomatosis (RRP) will serve as pivotal for the purpose of filing an accelerated approval request for licensure. The FDA also confirmed no additional randomized, placebo-controlled trial will be required to support submission of a biologics license application (BLA). Based on the FDA guidance, the Company plans to initiate a confirmatory study prior to submission of the BLA.

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FDA Accepts Baltimore’s MyMD Pharmaceuticals’ Investigational New Drug Application (IND) for Phase 2 Study of oral TNF-α inhibitor MYMD-1® in Rheumatoid Arthritis (RA)
 

BALTIMORE–()–MyMD Pharmaceuticals, Inc.® (Nasdaq: MYMD) (“MyMD” or “the Company”), a clinical stage biopharmaceutical company committed to developing novel therapies for age-related diseases, autoimmune and inflammatory conditions, announced today that the U.S. Food and Drug Administration (FDA) has accepted the Company’s Investigational New Drug Application (IND) to evaluate the safety, efficacy, pharmacodynamics and pharmacokinetics of oral TNF-α inhibitor MYMD-1® in patients with active rheumatoid arthritis (RA). The application was based on preclinical data showing that MYMD-1 significantly reduced swelling and other clinical arthritis measures compared to widely used RA therapy, Enbrel® (etanercept).The Company plans to initiate discussions with CRO vendor IQVIA on timing of a Phase 2 study in this indication.

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BioBuzz: Catching Up with 2022 Crab Trap Winners Neuroene and Polaris
 

With federal funding and solutions that address major risks and aim to improve outcomes for warfighters and civilians, Polaris and Neuroene are set to continue their momentum as showcase companies in the DMV life science scene.

By Sam Hopkins

August 8, 2023

As the BioHealth Capital Region and other life sciences sectors continue to evolve and innovate, it’s crucial for start-ups and entrepreneurs to seize every opportunity to showcase their groundbreaking work. 

One of those incredible opportunities is this year’s 8th Annual BioHealth Capital Region Crab Trap competition, part of the 9th Annual BioHealth Capital Region Forum. This event has evolved significantly over the years, attracting applicants not only from the region but also from across the country and around the world. 

 

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The Technology Transfer Society – Washington D.C. Chapter will be offering an Introduction to Technology Transfer and Commercialization Fall 2023 course in conjunction with Montgomery College
 

The Technology Transfer Society – Washington D.C. Chapter will be offering an Introduction to Technology Transfer and Commercialization Fall 2023 course in conjunction with Montgomery College. The course will be given in a hybrid format to allow for both virtual and in-person attendance.

This course is intended to provide students with an overview of the entire technology transfer process – moving technologies from the lab to market. This course is a great overview for anyone interested in learning more about the operations of a technology transfer office or those looking to understand how to commercialize their own invention. Students will hear from experienced professionals, including those from federal labs, to broaden their understanding of technology transfer.

 

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Home | About BHI | BHI News | Programs | Partners | Contact

Copyright  BioHealth Innovation 2023
All Rights Reserved.

 
 

 

 
BHCR Top 3 image

569th Edition, August 9, 2023

By BHI Weekly News Archives

 

 

 

 

BioHealth Capital Region Achieves Top 3 Ranking: A Triumph of Collaboration and Innovation
 

In 2016, during the Annual BioHealth Capital Region Forum at MedImmune/AstraZeneca in Gaithersburg, Maryland, an ambitious goal was set: to make the BioHealth Capital Region (BHCR) a Top 3 BioHealth cluster in the United States by 2023. That vision has been realized in the latest Genetic Engineering & Biotechnology News “Top 10 U.S. Biopharma Clusters” rankings, marking a significant milestone in the region’s relentless pursuit of excellence, collaboration, and innovation in the BioHealth field.

Rich Bendis, President & CEO of BioHealth Innovation, Inc., stated, “It’s been an incredible journey working with so many dedicated individuals and organizations in the region over the years to meet this goal. The spirit of collaboration and innovation that defines the BioHealth Capital Region has been the driving force behind this success, and I’m proud to be part of this remarkable community.”

Read More

 
 

Navigating Growth and Collaboration in Life Sciences: A Conversation with Brad L. Stewart, SVP of Business Development, MCEDC
 

How does a region evolve to become a leading driver in the BioHealth Capital Region? What are the secrets behind the successful collaboration between various organizations like MCEDC (Montgomery County Economic Development Corporation), MTC (Maryland Tech Council), and the Maryland Department of Commerce? How does a serial biotech entrepreneur leverage his experience to grow a diverse cross-section of businesses, including life sciences, technology, cybersecurity, defense, and hospitality?

In this episode of BioTalk, host Rich Bendis chats with Brad L. Stewart, SVP of Economic Development for Montgomery County Economic Development Corporation (MCEDC). Brad’s multifaceted career spans from being a Chief Executive Officer to leading expert teams in strategy and innovation, plus economic development specialists in Montgomery County.

Listen now via your favorite podcasting platform:

Read More

 
 

Global Breakthroughs for a Healthier Future – Registration for the 9th Annual BioHealth Capital Region Forum Now Live
 

Get ready for an exceptional experience at the 9th Annual BioHealth Capital Region Forum. Registration is now live for this highly anticipated event, taking place on September 19th and 20th, 2023, at the US Pharmacopeia (USP) facility located at 12601 Twinbrook Pkwy, Rockville, MD 20850.

Step into a world of innovation as we proudly present an entirely in-person experience under the theme “Global Breakthroughs for a Healthier Future.” After a period of remote events, we’re thrilled to bring together industry professionals for face-to-face interactions once again with no registration fees, thanks to our generous event sponsors!

Prepare to be part of the premier gathering for the biopharma sector, as the in-person BioHealth Capital Region Forum attracts over 1,100 registrants annually. Esteemed government officials, academic leaders, and industry executives will converge at this prestigious event, creating a vibrant atmosphere for reconnection, partnership rekindling, and exploration of new growth avenues within the region.

Read More

 
 

Applications to Compete in the 8th Annual BioHealth Capital Region Crab Trap are Now Being Accepted!
 

Now in its 8th year, the BioHealth Capital Region Crab Trap continues to grow, attracting applicants from around the region, country, and internationally. The competition highlights entrepreneurs with commercially relevant diagnostics, medical devices, therapeutics, and other transformative health solutions.

This year’s Crab Trap winner will be eligible for a package of prizes worth more than $50,000. Prizes for the qualifying Crab Trap winner include:

  • A $10,000 cash prize from Greenberg Traurig
  • A $25,000 cash prize from Montgomery County (for a firm headquartered in Montgomery County)
  • A one-year residency at JLABS @ Washington, D.C. (for a firm of their choice)
  • $10,000 in Preclinical CRO services from Noble Life Sciences.

Read More

 

 
 

Emergent BioSolutions Awarded 10-Year BARDA Contract Valued at up to a Maximum of $704 Million for Advanced Development and Procurement of Ebanga™ Treatment for Ebola
 

GAITHERSBURG, Md., July 31, 2023 (GLOBE NEWSWIRE) — Emergent BioSolutions Inc. (NYSE: EBS) announced today that it was awarded a 10-year contract by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS), valued at up to a maximum of $704 million, for advanced development, manufacturing scale-up, and procurement of Ebanga™ (ansuvimab-zykl), a licensed treatment for Ebola virus disease (EVD).

“For almost 25 years, Emergent has tackled the most serious diseases to assist governments in their preparedness and response strategies,” said Dr. Kelly Warfield, senior vice president, science and development at Emergent. “Ebola virus has the ability to emerge unexpectedly posing a risk to global health. Its elusive nature makes it difficult to predict when and where an outbreak may occur, which underscores the importance of preparedness efforts against this public health threat.”

Read More

 

 

MaxCyte Signs Strategic Platform License with Prime Medicine to Advance Next-Generation Gene Editing Therapies for Patients
 

Prime Medicine to use MaxCyte’s Flow Electroporation® technology and ExPERT™ platform to advance their innovative Prime Editing technology and develop a new class of one-time, potentially curative therapies

ROCKVILLE, Md., Aug. 01, 2023 (GLOBE NEWSWIRE) — MaxCyte, Inc., (Nasdaq: MXCT; LSE: MXCT), a leading, cell-engineering focused company providing enabling platform technologies to advance the discovery, development and commercialization of next-generation cell-based therapeutics and to support innovative, cell-based research, today announced the signing of a strategic partnership with Prime Medicine, Inc., a biotechnology company committed to delivering a new class of differentiated one-time curative genetic therapies.

Read More

 
 

miRecule and Sanofi drive the emergence of RNA therapeutics for Rare Diseases
 
 

After the race to find a COVID-19 vaccine, researchers set off to explore other disease areas with similar RNA vehicles. miRecule, a US biotechnology company, is on a different path, leveraging advances in RNA therapeutics to find treatments for rare diseases.

Today, Sanofi and miRecule are joining forces to pioneer innovative approaches in rare diseases and drive the creation of new medicines for patients in need.

In 2022, Sanofi announced its partnership with miRecule, combining Sanofi’s experience and best practices with the biotech’s speed and ability to drive novel therapies forward. And according to miRecule CEO Anthony Saleh, we’ve only seen the beginning of the exciting potential of RNA therapeutics.

 “As we learn more about patient genetics and data analytics, we can more quickly design and discover new RNA therapies,” said Saleh.

Read More

 
 

Record Growth in Research Funding and Startups: Highlights from the 2022 AUTM Licensing Survey
 

The Association of University Technology Managers (AUTM) has released its annual Licensing Survey for 2022, revealing promising trends in technology transfer across the United States and Canada. The survey’s findings underscore the significant growth in research funding, the robustness of startup companies, and the evolving landscape of licensing.

U.S. Survey Highlights

In the United States, the survey reported record-breaking research expenditures, topping $91 billion in 2022. This marks a 9.5% increase from the previous year and the highest total in the survey’s 30-year history.

 

Read More

 
 

Apply Now for the 6th Annual BioHealth Capital Region Investor Conference: Uniting Visionary Entrepreneurs and Pioneering Investors for Transformative Funding
 

The 6th Annual BioHealth Capital Region Investor Conference is just around the corner! Taking place on September 21st, 2023, at the US Pharmacopeia, this in-person event brings together ambitious entrepreneurs, startup-up companies and innovative BioHealth companies with a diverse group of influential investors, offering funding opportunities ranging from pre-seed to Series A.

The BioHealth Capital Region is renowned for its vibrant biotechnology and life sciences community, a breeding ground for groundbreaking advancements and success stories. The conference’s history is marked with exceptional achievements, from initial funding rounds to subsequent financings, successful IPOs, and engaging M&A activities.

 

Read More

 

Home | About BHI | BHI News | Programs | Partners | Contact

Copyright  BioHealth Innovation 2023
All Rights Reserved.

 
 

 

 
 
SanofiMirecule

568th Edition, August 1, 2023

By BHI Weekly News Archives

 

 

 

 

miRecule and Sanofi drive the emergence of RNA therapeutics for Rare Diseases
 

After the race to find a COVID-19 vaccine, researchers set off to explore other disease areas with similar RNA vehicles. miRecule, a US biotechnology company, is on a different path, leveraging advances in RNA therapeutics to find treatments for rare diseases.

Today, Sanofi and miRecule are joining forces to pioneer innovative approaches in rare diseases and drive the creation of new medicines for patients in need.

In 2022, Sanofi announced its partnership with miRecule, combining Sanofi’s experience and best practices with the biotech’s speed and ability to drive novel therapies forward. And according to miRecule CEO Anthony Saleh, we’ve only seen the beginning of the exciting potential of RNA therapeutics.

 “As we learn more about patient genetics and data analytics, we can more quickly design and discover new RNA therapies,” said Saleh.

Read More

 
 

Emergent BioSolutions Awarded 10-Year BARDA Contract Valued at up to a Maximum of $704 Million for Advanced Development and Procurement of Ebanga™ Treatment for Ebola
 

GAITHERSBURG, Md., July 31, 2023 (GLOBE NEWSWIRE) — Emergent BioSolutions Inc. (NYSE: EBS) announced today that it was awarded a 10-year contract by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS), valued at up to a maximum of $704 million, for advanced development, manufacturing scale-up, and procurement of Ebanga™ (ansuvimab-zykl), a licensed treatment for Ebola virus disease (EVD).

“For almost 25 years, Emergent has tackled the most serious diseases to assist governments in their preparedness and response strategies,” said Dr. Kelly Warfield, senior vice president, science and development at Emergent. “Ebola virus has the ability to emerge unexpectedly posing a risk to global health. Its elusive nature makes it difficult to predict when and where an outbreak may occur, which underscores the importance of preparedness efforts against this public health threat.”

Read More

 
 

Baltimore’s AsclepiX Therapeutics Raises $10 Million to Advance Clinical Study
 

Perceptive Advisors leads round to execute study in patients with wet age-related macular degeneration (wet AMD)

BALTIMORE, MD, July 26, 2023– AsclepiX Therapeutics, Inc., a clinical-stage biotech company leveraging computational biology from Johns Hopkins to identify and develop peptides for improved treatments of retinal diseases, announced today that it has secured a $10 million Series A-3 financing. The round was led by Perceptive Advisors with participation from the existing investors Hibiscus Capital Management Fund II and Rapha Capital Management and its managed fund, Rapha Capital PE Life Sciences Fund VI, in addition to a new outside investor.

Read More

 
 

Virginia Workforce Award to AMPEL BioSolutions
 

Virginia officials recognized AMPEL BioSolutions today for their dedication to identifying, training, and retaining STEM-trained workers, especially in the area of precision medicine.

The annual Virginia Talent + Opportunity (V-TOP) award is given on National Intern Day to employers who provide work-based learning opportunities, particularly to interns, who are essential to Virginia’s economy and play a crucial role in developing the necessary skills for career success, as stated by Kirk Cox, President of VA Bus Higher Ed Council. Internships are the foundation for workforce development.

Read More

 
 

Global Breakthroughs for a Healthier Future – Registration for the 9th Annual BioHealth Capital Region Forum Now Live
 

Get ready for an exceptional experience at the 9th Annual BioHealth Capital Region Forum. Registration is now live for this highly anticipated event, taking place on September 19th and 20th, 2023, at the US Pharmacopeia (USP) facility located at 12601 Twinbrook Pkwy, Rockville, MD 20850.

Step into a world of innovation as we proudly present an entirely in-person experience under the theme “Global Breakthroughs for a Healthier Future.” After a period of remote events, we’re thrilled to bring together industry professionals for face-to-face interactions once again with no registration fees, thanks to our generous event sponsors!

Prepare to be part of the premier gathering for the biopharma sector, as the in-person BioHealth Capital Region Forum attracts over 1,100 registrants annually. Esteemed government officials, academic leaders, and industry executives will converge at this prestigious event, creating a vibrant atmosphere for reconnection, partnership rekindling, and exploration of new growth avenues within the region.

Read More

 
 

Applications to Compete in the 8th Annual BioHealth Capital Region Crab Trap are Now Being Accepted!
 

Now in its 8th year, the BioHealth Capital Region Crab Trap continues to grow, attracting applicants from around the region, country, and internationally. The competition highlights entrepreneurs with commercially relevant diagnostics, medical devices, therapeutics, and other transformative health solutions.

This year’s Crab Trap winner will be eligible for a package of prizes worth more than $50,000. Prizes for the qualifying Crab Trap winner include:

  • A $10,000 cash prize from Greenberg Traurig
  • A $25,000 cash prize from Montgomery County (for a firm headquartered in Montgomery County)
  • A one-year residency at JLABS @ Washington, D.C. (for a firm of their choice)
  • $10,000 in Preclinical CRO services from Noble Life Sciences.

Read More

 

 

 

Charlottesville’s RIVANNA receives $30.5 million from BARDA to advance the Accuro XV musculoskeletal imaging system
 

CHARLOTTESVILLE, VA, JULY 26, 2023 — RIVANNA®, developers of imaging-based medical solutions, announced that they have received funding totaling $30.5 million over 39 months from early execution of an option by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS). The funding will support the further advanced development of the Accuro® XV for comprehensive point-of-care musculoskeletal diagnostics as well as submission of an application for FDA clearance.

“Completing our base-stage performance milestones ahead of schedule is a testament to our organization’s dedication and commitment to healthcare innovation,” said Delphine Le Roux, PhD, PMP, Director of Program Management. “As a direct consequence of this accomplishment, the project received early option one funding, expediting Accuro XV’s product development and initial clinical evaluations for FDA clearance. The continued support of our funding partners underscores the strong collaboration built on trust among all stakeholders involved in this effort,” added Le Roux.

Read More

 
 

Virginia’s Solar Biotech Acquires VC-Backed Digital Biotech Noblegen
 

NORTON, Va. and PETERBOROUGH, ON, July 25, 2023 /PRNewswire/ – Solar Biotech Inc., a Norton, Virginia-based provider of complete sustainable and scalable biomanufacturing solutions, continues to build out its vertically integrated organization by acquiring Noblegen, an advanced digital biology company based in Peterborough, Ontario, Canada.

Noblegen will now operate under the name Solar Biotech Canada, continuing as the organization’s food-grade-certified (SQF9) biomanufacturing and research & development hub in Canada. The new company will leverage both partners’ strengths in microbiology and biomanufacturing to offer revolutionary biotech and synthetic biology (“SynBio”) solutions for a wide range of applications.

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United Therapeutics Wins Appeal in Dry Powder Inhaler Patent Litigation
 

SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)– United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, announced today that the United States Court of Appeals for the Federal Circuit affirmed the district court decision in the patent litigation United Therapeutics brought against Liquidia Technologies, Inc. The Federal Circuit affirmed that Liquidia’s proposed Yutrepia™ product infringes a United Therapeutics’ patent, U.S. Patent No. 10,716,793 (the ’793 patent). As a result, the U.S. Food and Drug Administration (FDA) cannot grant Liquidia final approval for its Yutrepia product until expiration of the ’793 patent, May 14, 2027, except in certain circumstances discussed below.

 

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Fierce Biotech: Previous Crab Trap Winner Galen Robotics nets FDA de novo clearance for ENT surgery helper
 

Galen Robotics has claimed a de novo device clearance from the FDA for its digital surgical assistant, designed to provide a helping hand during ear, nose and throat operations.

The motorized ES system helps stabilize the surgeon’s direct manual control of their instrument—with the goal of reducing natural hand tremors and other movements—to supply greater precision in minimally invasive procedures on soft tissue, as well as offer the ability to let go of the swappable tool and have it remain in place.

The Baltimore-based company, with technology originally spun out of Johns Hopkins University, also aims to promote the device through a “digital-surgery-as-a-service” platform. 

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Apply Now for the 6th Annual BioHealth Capital Region Investor Conference: Uniting Visionary Entrepreneurs and Pioneering Investors for Transformative Funding
 

The 6th Annual BioHealth Capital Region Investor Conference is just around the corner! Taking place on September 21st, 2023, at the US Pharmacopeia, this in-person event brings together ambitious entrepreneurs, startup-up companies and innovative BioHealth companies with a diverse group of influential investors, offering funding opportunities ranging from pre-seed to Series A.

The BioHealth Capital Region is renowned for its vibrant biotechnology and life sciences community, a breeding ground for groundbreaking advancements and success stories. The conference’s history is marked with exceptional achievements, from initial funding rounds to subsequent financings, successful IPOs, and engaging M&A activities.

 

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567th Edition, July 25, 2023

By BHI Weekly News Archives

 

 

 

Applications to Compete in the 8th Annual BioHealth Capital Region Crab Trap are Now Being Accepted!
 

Now in its 8th year, the BioHealth Capital Region Crab Trap continues to grow, attracting applicants from around the region, country, and internationally. The competition highlights entrepreneurs with commercially relevant diagnostics, medical devices, therapeutics, and other transformative health solutions.

This year’s Crab Trap winner will be eligible for a package of prizes worth more than $50,000. Prizes for the qualifying Crab Trap winner include:

  • A $10,000 cash prize from Greenberg Traurig
  • A $25,000 cash prize from Montgomery County (for a firm headquartered in Montgomery County)
  • A one-year residency at JLABS @ Washington, D.C. (for a firm of their choice)
  • $10,000 in Preclinical CRO services from Noble Life Sciences.

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Emergent BioSolutions Receives U.S. FDA Approval of CYFENDUS™ (Anthrax Vaccine Adsorbed, Adjuvanted), previously known as AV7909, a Two-Dose Anthrax Vaccine for Post-Exposure Prophylaxis Use
 
  • Emergent has been delivering CYFENDUS™ vaccine to the U.S. Department of Health and Human Services since 2019, under pre-Emergency Use Authorization status, and will continue to work with the U.S. government to transition to post-approval procurement

GAITHERSBURG, Md., July 20, 2023 (GLOBE NEWSWIRE) — Emergent BioSolutions Inc. (NYSE:EBS) announced today that the U.S. Food and Drug Administration (FDA) has approved CYFENDUS™ (Anthrax Vaccine Adsorbed, Adjuvanted), previously known as AV7909, for post-exposure prophylaxis of disease following suspected or confirmed exposure to Bacillus anthracis in persons 18 through 65 years of age when administered in conjunction with recommended antibacterial drugs. The efficacy of CYFENDUS™ vaccine for post-exposure prophylaxis is based solely on studies in animal models of inhalational anthrax.

“The approval of CYFENDUS™ vaccine is symbolic of Emergent’s longstanding partnership with the U.S. government and our shared commitment to helping protect public health,” said Dr. Kelly Warfield, Emergent’s senior vice president, science and development. “The 20-year journey from early development to approval is a major milestone that attests to Emergent’s scientific and technical prowess and partnering capabilities. We are grateful for the yearslong collaboration with the Biomedical Advanced Research and Development Authority (BARDA) and early support from the Defense Advanced Research Projects Agency (DARPA) and the National Institute of Allergy and Infectious Diseases (NIAID). Congratulations to the Emergent team and all our partners for advancing this product to approval.”

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FinaBio’s Andrew Lees Wins Derek Horton Award in Industrial Carbohydrate Chemistry
 

Andrew Lees has received The Derek Horton Award in Industrial Carbohydrate Chemistry for outstanding contributions to industrial carbohydrate chemistry.

The Derek Horton Award in Industrial Carbohydrate Chemistry is awarded by the CARB division of the American Chemical Society and acknowledges distinguished achievements in and outstanding contributions to industrial carbohydrate chemistry.  Lees’ award was for his contributions to the field of protein polysaccharide conjugate vaccines, including the development of CDAP chemistry and a low-cost CRM197 carrier protein.

Andrew Lees is the founder and CEO of Fina Biosolutions, LLC (Rockville, MD), a company focused on promoting affordable conjugate vaccines, a class which includes vaccines for S. pneumoniae and meningococcal disease. Among his contributions to the field, Dr. Lees developed CDAP chemistry for activating carbohydrate hydroxyls, allowing for the efficient linking of proteins to polysaccharides. The chemistry has helped to reduce the cost of these vaccines as proteins can be directly coupled to CDAP-activated polysaccharides, eliminating many manufacturing steps. CDAP has largely replaced the older cyanogen bromide method and is now widely used in conjugate vaccines. CDAP chemistry also scales more easily than other conjugation chemistries and has enabled the manufacture of the Serum Institute of India’s low-cost pneumococcal and meningococcal vaccines, Pneumosil® and MenFive®, respectively. At Fina Biosolutions, Dr. Lees also introduced a low-cost version of CRM197, a genetically detoxified diphtheria toxin commonly used as the protein component of protein-polysaccharide conjugate vaccines, increasing access to the protein for both basic research and vaccine manufacturers.

Before starting Fina Biosolutions in 2006, Dr. Lees was Director of Vaccine Development at biotech companies Virion Systems, Inc (1993-1999) and Biosynexus, Inc (1999-2006). He was also an associate research professor at the Uniformed Services University (1993-1999). Andrew is now an adjunct professor at the University of Maryland School of Medicine Center for Vaccine Development, the Uniformed Services University, Dept. of Medicine, and the University of Toledo, Dept of Chemistry. He has over 75 publications and 25 patents, primarily in the subject area of conjugate vaccines. He received his BS in chemistry from Harvey Mudd College in chemistry (1976) and his Ph.D. in Biophysics from Johns Hopkins (1984). Honors include the Uniformed Services Meritorious Service Award, the Harvey Mudd College Outstanding Alumni Award, and the Johns Hopkins University Distinguished Alumnus Award. On graduating from Hopkins, he was on the cover of Baltimore Magazine as one of “84 people to watch in ‘84” due to his role as a leading Baltimore area magician.

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Fierce Biotech: Previous Crab Trap Winner Galen Robotics nets FDA de novo clearance for ENT surgery helper
 

Galen Robotics has claimed a de novo device clearance from the FDA for its digital surgical assistant, designed to provide a helping hand during ear, nose and throat operations.

The motorized ES system helps stabilize the surgeon’s direct manual control of their instrument—with the goal of reducing natural hand tremors and other movements—to supply greater precision in minimally invasive procedures on soft tissue, as well as offer the ability to let go of the swappable tool and have it remain in place.

The Baltimore-based company, with technology originally spun out of Johns Hopkins University, also aims to promote the device through a “digital-surgery-as-a-service” platform. 

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TEDCO Announces FY24 Board of Directors
 

Talented, diverse, and experienced leaders tapped to support Maryland’s economic engine for technology companies

 

COLUMBIA, Md. (July 20, 2023) – TEDCO, Maryland’s economic engine for technology companies, held its annual election for the board of directors’ executive officers, reaffirming another term for Chair Omar Muhammad of Morgan State University (MSU).

TEDCO’s full slate of executive officers are:

“I’m excited to continue serving on the board of directors. Our work has focused on supporting TEDCO’s mission of creating an enhanced, diverse and inclusive ecosystem throughout the state, and we look forward to continuing this mission through the various resources and programs TEDCO has to offer,” said Omar Muhammad, chair of the board. “In particular, I am excited to move forward with the Cultivate Maryland initiative, a major project that will support the growth of a diverse innovation economy thereby increasing Maryland’s competitiveness as an innovation economy and supporting larger retention and attraction of trained workers.”

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Baltimore’s Vita Therapeutics Collaborates with MilliporeSigma to Advance Preclinical Program for Vita’s Preclinical Cell Therapy for Limb-Girdle Muscular Dystrophy (LGMD2A)
 

Licensing agreement utilizing MilliporeSigma’s CRISPR genome-editing technology supports the advancement of Vita’s pipeline

‍Baltimore, MD, July 18, 2023 – Vita Therapeutics, Inc. today announced a licensing agreement between Vita and MilliporeSigma, the U.S. and Canada Life Science business of Merck KGaA, Darmstadt, Germany. Under the agreement, Vita will leverage MilliporeSigma’s foundational CRISPR patents to advance the development of its preclinical asset VTA-100 for the treatment of limb-girdle muscular dystrophy (LGMD2A). Financial and other terms of the agreement were not disclosed.

“Our purpose is to impact life and health with science, empowering customers to deliver breakthroughs such as Vita’s impactful, health-advancing research,” said Christopher Arnot, Director of Licensing and Business Development, Gene Editing, MilliporeSigma.

“For people with limb-girdle muscular dystrophy, the calpain 3 (CAPN3) gene is mutated in satellite cells,” said Douglas Falk, MS, Chief Executive Officer at Vita Therapeutics. “MilliporeSigma’s proprietary CRISPR genome-editing technology will allow us to insert a functional copy of the gene into those cells, taking us an important step forward in advancing the development of VTA-100 as a potential cell therapy.”

 

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566th Edition, July 18, 2023

By BHI Weekly News Archives

 

 

 

Introducing the NCI Small Business Transition Grant: A Pathway for Academic Scientists to Entrepreneurship
 

The Small Business Transition Grant application period is now open, providing a valuable opportunity for early-career academic scientists to transition into entrepreneurship. Graduating students and postdoctoral researchers who have engaged in technology discovery during their academic pursuits and are prepared to embark on a small business venture are encouraged to apply. The eligible technology must fall under one of the following categories: therapeutics and preventive agents, imaging technologies, interventional devices, and in vivo diagnostics, as well as in vitro and ex vivo diagnostics and prognostics.

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NasaClip Unveils Groundbreaking Baltimore-Made Medical Device Transforming Nosebleed Treatment with Hands-Free Compression
 

New Device Provides an Effective, Hands-Free Solution to Stop Nosebleeds in Children and Adults

Adult and Pediatric NasaClip Sizes Provide Easy-To-Use Options for Chronic Nosebleed Sufferers, Healthcare Professionals, Parents, and Schools; First Available, U.S. Food and Drug Administration Registered Device with Age-Appropriate Sizing for Patients Aged 2 and Older

BALTIMORE, MD. (PRWEB) JULY 11, 2023

NasaClip, Inc., a Baltimore-based medical device company focused on improving the lives of patients with nosebleeds and the healthcare professionals who treat them today introduced the NasaClip, an easy-to-use device that provides constant, comfortable hands-free compression combined with intranasal sponges to stop nosebleeds quickly. NasaClip comes in an adult size for ages 14+, and pediatric size for children ages 2 to 13. It is the first nosebleed rescue device that provides adjustable nasal compression for children and adults and is registered with the U.S. Food and Drug Administration (FDA).

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University System of Maryland Momentum Fund Invests in Impruvon Health Alongside TCP Venture Capital, New Dominion Angels
 

Baltimore-based Digital Health Startup is Working to End Medication Errors and Streamline Workflows in Long-Term Care Settings

Baltimore, Md. (July 11, 2023) – Impruvon Health (“Impruvon”), a Baltimore-based digital health startup, announced today that it closed a financing round to support surging demand from healthcare organizations for its enterprise medication management platform. The round is led by The Propel Baltimore Fund from TCP Venture Capital, with participation from the University System of Maryland (USM) Momentum Fund (Momentum Fund) and New Dominion Angels.

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BizJournals: Johns Hopkins University partnership with the Maryland Innovation Initiative looks to eliminate risks mosquitoes bring
 

By Tammi Thomas – Chief Development and Marketing Officer – TEDCO July 15, 2023, 06:00am EDT – Summer is upon us. Warmer months in the mid-Atlantic often conjure thoughts of flowers, trips to the beach or lake, and backyard cookouts. However, these increased temperatures also mean the emergence of annoying pests, like the mosquito.

Most of us associate mosquitos with mean red, itchy welts and having to bring insect repellents along on outdoor adventures. However, for others, particularly those living in hotter, more humid climates, mosquitoes are more than pests – they can be deadly transmitters of viruses such as malaria, dengue, yellow fever, Zika virus fever or West Nile fever.

Mosquitoes are one of many vectors – insects that can transmit infectious pathogens among humans, or from animals to humans. According to the World Health Organization, “vector-borne diseases account for more than 17% of all infectious diseases, causing more than 700,000 deaths annually.”

This is where Maryland Innovation Initiative (MII) awardee George Dimopoulos, Ph.D., MBA, is stepping in. A professor of molecular microbiology and immunology at Johns Hopkins University’s Bloomberg School of Public Health, Dimopoulos is studying vector-borne diseases and possible ways to render mosquitoes – what he deems “the deadliest animal on the planet” – incapable of transmitting human pathogens.

His research could help to reduce the number of vector-borne diseases. With the aid of a grant from MII, Dimopoulos is seeking to commercialize a nontoxic, environmentally friendly biopesticide. He has developed a cost-effective biopesticide that can target and kill adult and larval stages of mosquitoes and other agricultural pests, such as the Western corn rootworm that causes more than $1 billion in damages each year.

Click here to read more via the BizJournal.(subscription may be required)

 

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NIH 2023 SBIR and STTR Omnibus Notices of Funding Opportunity Have Been Published
 

Applicants are encouraged to review the 2023 SBIR and STTR Omnibus Notices of Funding Opportunity (NOFOs).These NOFOs encourage small businesses to submit grant applications to NIH, CDC, and FDA for innovative ideas across the HHS mission space. The new NOFOs are listed below:

 

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BARDA seeks Consortium Management Firm to run new Rapid Response Partnership Vehicle
 

Responding faster and more effectively to future public health challenges and emergencies will require the development of a specific, rapid acquisition vehicle. To achieve this, BARDA is launching the Rapid Response Partnership Vehicle (RRPV), the next generation of acquisition partnering to support U.S. health security.

In alignment with objectives outlined in the 2022-2026 Strategic Plan, BARDA seeks to leverage its Other Transaction Authority (OTA) to develop the RRPV. The RRPV will complement BARDA’s existing acquisition vehicles such as the Broad Agency Announcement (BAA) and the Easy Broad Agency Announcement (EZ-BAA) and will expand the mechanisms through which BARDA can rapidly partner with product developers prior to and during an emergency response. With the RRPV in place, BARDA will be able to leverage OTA agreements to meet the dynamic needs of the BARDA mission through a streamlined, expedited process.

 

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Maryland Tech Council Announces New Chair and Board
 

The Maryland Tech Council, the largest technology and life sciences trade association in the state, today welcomed a new chair and slate of technology and life sciences leaders to its board of directors. The new members join the board as MTC enjoys rapid growth in its membership, educational programs, and workforce development initiatives.

“I am thrilled to welcome these new members, who represent some of the most respected companies in Maryland’s innovation ecosystem,” said Kelly Schulz, CEO of the Maryland Tech Council. “Our ability to educate, connect, and advocate for members depends on diverse perspectives from creative and forward-thinking board members. I look forward to working with our board as we seek to make our state the destination of choice for innovators.”

 

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565th Edition, July 11, 2023

By BHI Weekly News Archives

 

 

 

 

 

 

Building Better Medicine, and Transformative Partnerships: Insights from Joy Polefrone, Ph.D. on BioTalk
 

Ever wondered how public-private partnerships can make a significant difference in the field of life sciences? Curious about the goals, expected impacts, and timeline of the Alliance for Building Better Medicine (ABBM)? Interested in exploring the transformative potential of the Virginia BioHealth ecosystem and its role in advancing the life sciences industry?

Listen now via your favorite podcasting platform:

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BioHealth Innovation and Fhi 360 collaborate in developing a Life Science Tech Transfer and Commercialization Center in Sfax, Tunisia
 

The long-awaited grand opening of the Sfax University Simulation Center has finally arrived, marking a new era of innovative learning and development in Sfax, Tunisia. The cutting-edge center promises to provide a hub for experiential learning, creating a springboard for high-potential projects to flourish. In the run-up to the opening, the team at the Simulation Center, supported by Johns Hopkins University,  held a series of fruitful meetings with local stakeholders. During these sessions updates were shared, and attendees were encouraged to submit their high potential projects for consideration, initiating direct engagement with the local community.

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Applications to Compete in the 8th Annual BioHealth Capital Region Crab Trap are Now Being Accepted!
 

Now in its 8th year, the BioHealth Capital Region Crab Trap continues to grow, attracting applicants from around the region, country, and internationally. The competition highlights entrepreneurs with commercially relevant diagnostics, medical devices, therapeutics, and other transformative health solutions.

This year’s Crab Trap winner will be eligible for a package of prizes worth more than $50,000. Prizes for the qualifying Crab Trap winner include:

  • A $10,000 cash prize from Greenberg Traurig
  • A $25,000 cash prize from Montgomery County (for a firm headquartered in Montgomery County)
  • A one-year residency at JLABS @ Washington, D.C. (for a firm of their choice)
  • $10,000 in Preclinical CRO services from Noble Life Sciences.

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Children’s National Hospital, Virginia Tech unite to advance AI for pediatric health
 

Expectations are high for combining human and artificial intelligence against health problems.

“Start by determining the problem you desire to solve, then decide on the technology to solve it,” said Subha Madhavan, vice president and head of clinical artificial intelligence/machine learning with global biopharmaceutical company Pfizer. 

Madhavan was the keynote speaker at AI for Pediatric Health and Rare Diseases, an inter-institutional meeting of scientists and innovators co-led by Children’s National Hospital and the Virginia Tech Sanghani Center for Artificial Intelligence and Data Analytics to discuss the potential of artificial intelligence (AI) to understand pediatric health.

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George Mason University/USDA team find probiotics may play a pivotal role in preventive medicine
 

George Mason University/USDA team find probiotics counter high fat diets in pigs

FAIRFAX, Virginia – According to a new study published by George Mason University researchers Dr. Robin Couch and Dr. Allyson Dailey, in collaboration with researchers at the U.S. Department of Agriculture (USDA), showed probiotics may play a pivotal role in preventive medicine.

High fat diets are a leading cause of obesity and can trigger the onset of metabolic syndrome. The research team found that probiotic intervention has significant potential for addressing obesity-related diseases.

 

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Theradaptive Awarded Manufacturing Assistance Grant by the Maryland Stem Cell Research Fund
 

FREDERICK, Md., July 6, 2023 /PRNewswire/ — Today, Theradaptive, a biopharmaceutical firm pioneering advancements in targeted regenerative therapeutics, has been awarded the Manufacturing Assistance Program grant by the Maryland Stem Cell Research Fund (MSCRF). The grant will help Theradaptive develop their GMP Manufacturing Facility in Frederick, stimulating economic development in the state and bolstering Maryland’s reputation as a hub of biotechnological innovation.

Theradaptive seeks to significantly improve patient outcomes by producing targeted therapeutics that can be used to coat implants, devices, and injectable carriers. Their proprietary protein-engineering platform aims to provide greater efficacy, safety, and ease of use across multiple clinical indications including orthopedics, immuno-oncology and dental.

 

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MarylandToday: $4.4M NIH Award Supports UMD Research on Enzymes to Combat Pneumonia
 

The National Institutes for Health (NIH) has awarded $4.4 million to a University of Maryland researcher and a colleague to develop both a novel therapeutic and a vaccine approach to address Streptococcus pneumoniae, which is the leading cause of bacterial community-acquired pneumonia and the cause of death for about 1.6 million people annually.

Pneumococcal vaccinations are very effective, but target just a few of the more than 100 different strains of pneumococcus; they’re also unavailable in many developing countries. Additionally, antimicrobial resistance is on the rise globally, and poses a risk of pneumococcal disease that is increasingly difficult to combat.

 

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BioFactura and CuraTeQ Sign Exclusive License for BFI-751—A Biosimilar to Stelara
 

FREDERICK, MARYLAND, July10, 2021: BioFactura, Inc. today announced that CuraTeQ Biologics Private Limited, a wholly owned subsidiary of Aurobindo Pharma Limited, has entered into an exclusive license to commercialize BFI-751, BioFactura’s proposed biosimilar to Stelara (Ustekinumab). Ustekinumab is a recombinant monoclonal antibody that works by blocking both interleukins IL-12 and IL-23 and is used for treating Crohn’s disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis. The global drug sales of Ustekinumab stood at close to 10 billion in 2022 presenting a significant opportunity with a good number of indications and a wider use.

 

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MaxCyte and Vittoria Biotherapeutics Sign Strategic Platform License to Advance Next Generation Cellular Therapies
 

MaxCyte’s Flow Electroporation® technology and ExPERT™ platform will support Vittoria’s Senza5™ technology to enhance efficacy and improve clinical utility of T-cell therapies.

ROCKVILLE, Md. and PHILADELPHIA, July 10, 2023 (GLOBE NEWSWIRE) — MaxCyte, Inc., (Nasdaq: MXCT; LSE: MXCT), a leading, cell-engineering focused company providing enabling platform technologies to advance the discovery, development and commercialization of next-generation cell-based therapeutics and to support innovative, cell-based research, and Vittoria Biotherapeutics (Vittoria), a leading edge, gene-edited cell therapeutics company with novel platform technologies poised to develop a pipeline of highly differentiated cellular therapies for both oncology and immunology indications, today announced the signing of a strategic platform license (SPL) of MaxCyte’s Flow Electroporation® technology and ExPERT™ platform to Vittoria Biotherapeutics.

 

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MaxCyte Signs Strategic Platform License with Lyell Immunopharma
 

Lyell Immunopharma to use MaxCyte’s Flow Electroporation® technology and ExPERT™ platform in its T cell product candidates targeting solid tumors.

ROCKVILLE, Md., July 06, 2023 (GLOBE NEWSWIRE) — MaxCyte, Inc., (Nasdaq: MXCT; LSE: MXCT), a leading, cell-engineering focused company providing enabling platform technologies to advance the discovery, development and commercialization of next-generation cell-based therapeutics and to support innovative, cell-based research, today announced the signing of a strategic platform license (SPL) with Lyell Immunopharma, Inc., a clinical stage T cell reprogramming company.

 

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BARDA seeks Consortium Management Firm to run new Rapid Response Partnership Vehicle
 

Responding faster and more effectively to future public health challenges and emergencies will require the development of a specific, rapid acquisition vehicle. To achieve this, BARDA is launching the Rapid Response Partnership Vehicle (RRPV), the next generation of acquisition partnering to support U.S. health security.

In alignment with objectives outlined in the 2022-2026 Strategic Plan, BARDA seeks to leverage its Other Transaction Authority (OTA) to develop the RRPV. The RRPV will complement BARDA’s existing acquisition vehicles such as the Broad Agency Announcement (BAA) and the Easy Broad Agency Announcement (EZ-BAA) and will expand the mechanisms through which BARDA can rapidly partner with product developers prior to and during an emergency response. With the RRPV in place, BARDA will be able to leverage OTA agreements to meet the dynamic needs of the BARDA mission through a streamlined, expedited process.

 

Read More

 

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564th Edition, July 6, 2023

By BHI Weekly News Archives






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July 06, 2023

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Trailblazing in the BioHealth Capital Region: A Conversation with MedTech Innovator Accelerator Company Leaders

Join us on a compelling episode of BioTalk as we sit down with three dynamic leaders from groundbreaking MedTech companies based in the thriving BioHealth Capital Region. These companies, JuneBrain, Xcision Medical Systems, and Sonavi Labs, were recently selected for the prestigious MedTech Innovator Accelerator, the world's largest accelerator of medical technology companies. Discover their innovative solutions and the transformative impact they are making in healthcare.

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Emergent BioSolutions Announces CEO Transition

GAITHERSBURG, Md., June 27, 2023 (GLOBE NEWSWIRE) — Emergent BioSolutions (NYSE: EBS, “Emergent” or the “Company”) today announced that Robert G. Kramer Sr. has informed the Board of Directors of his intention to retire from Emergent. Mr. Kramer will step down from his role as President and CEO of Emergent and as a member of the Company’s Board, effective immediately. The Board has appointed Haywood Miller as interim CEO while it conducts a search to identify a new permanent CEO, considering both internal and external candidates and with the assistance of a leading executive search firm. Mr. Miller, Managing Director at Berkeley Research Group (“BRG”), has served as an advisor to the Company and its executive management team for the last several months. In order to ensure a smooth transition, Mr. Kramer will serve as an advisor to the Company until August 1, 2023.

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TEDCO Seed Funds Invest in Galen Robotics, Inc.

Galen Robotics, Inc. was the winner of the 2018 BioHealth Capital Region Crab Trap Competition

COLUMBIA, Md. (June 27, 2023) – TEDCO, Maryland’s economic engine for technology companies, announced a recent $500,000 Seed Funds investment into Galen Robotics, Inc. This round of seed funding is from the Life Sciences Investment Fund.

Bruce Lichorowic, Galen Robotics CEO“In 2017, Galen successfully secured our first MII Phase III grant which led us to make the decision to relocate our headquarters from Silicon Valley to Baltimore. Now, as we receive a follow-up investment, it is evident that TEDCO remains committed to supporting and nurturing its portfolio companies. Despite the macroeconomic challenges associated with early-stage funding, TEDCO has established itself as a leader in investing in high-quality startups based in Maryland. Their dedication to supporting local entrepreneurship is commendable and sets them apart in the startup ecosystem,” said Bruce Lichorowic, president and CEO of Galen Robotics. “TEDCO serves as a valuable resource for Maryland's early-stage technology companies, offering not only funding opportunities but also mentorship, marketing strategies and introductions to key leaders within the government and industry. With these comprehensive support services, TEDCO becomes an indispensable resource that empowers startups to progress and reach the next level of their development.”

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George Mason University/USDA team find probiotics may play a pivotal role in preventive medicine

George Mason University/USDA team find probiotics counter high fat diets in pigs

FAIRFAX, Virginia – According to a new study published by George Mason University researchers Dr. Robin Couch and Dr. Allyson Dailey, in collaboration with researchers at the U.S. Department of Agriculture (USDA), showed probiotics may play a pivotal role in preventive medicine.

High fat diets are a leading cause of obesity and can trigger the onset of metabolic syndrome. The research team found that probiotic intervention has significant potential for addressing obesity-related diseases.

Read More

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563rd Edition, June 20, 2023

By BHI Weekly News Archives

 

 

 

 

 

 

From Vision to Action: MEDCO’s Role in Economic Development and Partnerships on BioTalk with Rich Bendis
 

In this captivating episode of BioTalk, Rich Bendis sits down with Tom Sadowski, the Executive Director of the Maryland Economic Development Corporation (MEDCO). With over 30 years of experience in economic development, Tom has played a pivotal role in translating vision into action. Together we explore MEDCO’s significant contributions to economic development and their strategic partnerships across Maryland.

Tom shares his remarkable career accomplishments, including successful projects valued at over $10 billion and the creation of 50,000 jobs. His expertise in fostering research partnerships, technology commercialization, and his role in launching the Maryland Momentum Fund bring invaluable insights to the conversation. We uncover MEDCO’s focus on real estate development, financing, infrastructure, and public/private partnerships, all aimed at fueling business retention, development, and employment growth.

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BHI and KOSME Foster Korean Companies’ US Market Entry Program for the Third Consecutive Year Beginning June 20th, 2023
 

BioHealth Innovation, Inc. (BHI), in collaboration with the Global Business Center (GBC) – Washington, D.C. of Korea SMEs and Startups Agency (KOSME), is excited to announce the continuation of their highly successful program aimed at facilitating Korean companies’ entry into the US market. As the program enters its third year, it continues to empower Korean biotech enterprises, enabling them to establish a strong foothold in the BioHealth Capital Region. KOSME is a Korean-government funded non-profit, currently led by President, Dr. Hakdo Kim, created over forty years ago to support small and medium enterprises in Korea.

“We are thrilled to continue our partnership with BHI for the third year in a row. The program has consistently provided guidance and market knowledge, proving invaluable to Korean biotech companies. We anticipate that our latest cohort will benefit greatly from this collaboration,” says Rich Bendis, President and CEO of BHI.

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Welcome Ashleigh Acker and Sebastian Chung: BHI’s Newest Interns
 

BioHealth Innovations (BHI) is thrilled to welcome Ashleigh Acker and Sebastian Chung as the newest additions to our internship program. Their diverse backgrounds and passion for biotechnology make them valuable assets to our organization.

Sebastian Chung, a graduate student at Johns Hopkins University, is on track to complete his Master’s in Biotechnology in the spring of 2024. During his undergraduate years at the University of Washington in Seattle, Sebastian excelled in the study of physiology and sales, all while co-captaining the men’s club golf team. His expertise lies within the multi-omic space, having worked as an account manager at NanoString Technologies, a leading biotechnology company. Sebastian’s extensive experience in consulting on sequencing and spatial biology projects, particularly with large pharmaceutical companies in the greater New England area, will undoubtedly contribute to our innovative research initiatives. When he’s not immersed in the world of biotechnology, Sebastian enjoys playing golf and watching premier league soccer.

 

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AlphaTech Welcomes Diverse Cohort of Emerging Companies with Live Event
 

AlphaTech, an esteemed initiative focused on fostering innovation within the cybersecurity, big data, analytics, and digital health sectors, is thrilled to announce the induction of a new cohort consisting of exceptional companies. The program, designed to engage with Founders and CEOs of emerging growth companies, aims to provide valuable resources, educational programming, networking opportunities, and meaningful interactions.

Over the course of eight months, this select group of CEOs will have the privilege of connecting with AlphaTech’s advisors, speakers, alumni, and industry luminaries. The program’s comprehensive approach encourages collaboration and knowledge sharing, ensuring participants gain insights from experienced professionals and industry veterans.

 

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2022 BHCR Crab Trap Winner Neuroene Therapeutics Receives NIH SBIR Award for Novel Antiseizure Drug with Potential for Public Health Emergency Response
 

Neuroene Therapeutics has been awarded a Small Business Innovation Research (SBIR) grant by the National Institutes of Health (NIH). The award supports Neuroene’s ongoing research and development of a novel class of well-tolerated compounds protects and ameliorates mitochondrial and neurological diseases.

Neuroene’s lead antiseizure drug (ASD) candidate has demonstrated broad-spectrum antiseizure activity in several animal models of pharmacoresistant seizures and Parkinson’s disease, showcasing its potential both as a fast-acting rescue agent and long-term chronic therapeutic. Intriguingly, the compound’s stability offers significant advantages for long-term storage and stockpiling in case of public health emergencies or bio-incidents.

 

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TDR: Frederick’s Theradaptive Closes $26M Series A
 

Frederick-based biopharmaceutical company Theradaptive Thursday announced it has closed a $26 million Series A funding round to advance development of its targeted regenerative therapeutics.

The funds are intended to enable the company to continue its work to meet regulatory requirements and scale up Good Manufacturing Practices in preparation for first-in-human clinical trials later this year. Investment will also support the expansion of the Theradaptive platform beyond orthopedics to additional indications such as oncology and dental. The round brings Theradaptive’s total funding to more than $50 million.

The company has previously been awarded non-dilutive grant funding from the Department of Defense, as well as the Maryland Stem Cell Research Fund.

Click here to read more via The Daily Record.

 

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NIH Releases Licensing Public Health & Economic Impact Study
 

The long-anticipated intramural licensing impact study was officially released in conjunction with the BIO Annual Meeting and is now posted to a special section of the NIH Community Tech Transfer Website for further reading and utilization.

The year-long study involved a full download and analysis of NIH TechTracs licensing data and demonstrates the true impact and power that our NIH intramural licensing program has had in three major areas:

 

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TEDCO Announces Recent Investment in Aidar Health, Inc.
 

Maryland health technology company developing innovative medicine solutions to promote more personalized care

 

COLUMBIA, Md. (June 14, 2023) – TEDCO, Maryland’s economic engine for technology companies, announced a recent Seed Funds investment of $250,000 into Aidar Health, Inc., a health technology and digital medicine company. TEDCO’s Seed Funds invest in early-stage, technology and life sciences companies and provide access to gap financing.

 

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Addimmune

562nd Edition, June 13, 2023

By BHI Weekly News Archives

 

 

 

 

 

 

citybiz: American Gene Technologies Launches New Spinoff Company “Addimmune” to Focus Exclusively on Development of HIV Cure
 

Addimmune will build upon the success of American Gene Technologies Phase 1 HIV clinical trial, accelerating the clinical development with dedicated investment and singular focus on HIV.

American Gene Technologies, a clinical-stage biotechnology company based in Rockville, Maryland, is launching a new company — Addimmune — to continue to develop gene and cell therapy technologies to cure HIV. Addimmune will focus solely on advancing an HIV cure, building upon more than a decade of work by AGT that led to a successful Phase 1 HIV gene and cell therapy clinical trial.

Addimmune aims to create tremendous benefits for HIV patients, payers, and the public. Its gene therapy technology has the power to transform millions of lives. The new company’s name represents a fusion of two fundamental concepts: using gene and cell therapy to add new capacity to the human T cell to create an improved immune system to fight HIV.

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TEDCO Invests SSBCI Funding into Hememics Biotechnologies, Inc.
 

Maryland biotech company revolutionizing point-of-care testing for viruses and environmental toxins

COLUMBIA, Md. (June 7, 2023) – TEDCO, Maryland’s economic engine for technology companies, announced a $500,000 State Small Business Credit Initiative (SSBCI) investment into Hememics Biotechnologies, Inc., a biotechnology company. The investment came through TEDCO’s Venture Funds.

“I am extremely proud of what the company has achieved,” said John Warden, Jr., CEO and co-founder of Hememics Biotechnologies, Inc. “We have generated favorable results from more than 100,000 biosensor tests in the past nine months. The new funding will allow us to put the final touches on our product, and continue to develop early commercial customers.”
Hememics Biotechnologies, Inc., based in Gaithersburg, Md., is using graphene monolayer biosensors to revolutionize point-of-care testing for viruses and environmental toxins. The HemBox™, a cellphone-sized reader and chip platform, allows users to test for multiple viruses and toxins from samples as diverse as soil, water, saliva and blood.

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University of Maryland’s Center of Excellence in Regulatory Science and Innovation (M-CERSI) signs MOU with Korean Regulatory Science Center
 

On Monday, June 5, 2023, members of the University of Maryland’s Center of Excellence in Regulatory Science and Innovation (M-CERSI) met with Korean Regulatory Science Center (KRSC) members Dr. In-sook Park and Mi-rim BaekDr. Kyenghee Kwon, a representative from Dongguk University, was also in attendance. The meeting was hosted by Dr. Jim Polli, M-CERSI Co-Director, at the University of Maryland, Baltimore, in the School of Pharmacy building. 

“It is an exciting endeavor to work with the Korean Regulatory Science Center and its universities,” said Dr. Bill Bentley, M-CERSI Co-Director. “I am delighted to see M-CERSI’s success inspire others.” 

At the meeting, the KRSC expressed interest in sending students to participate in UMB’s Master of Science and Graduate Certificate in Regulatory Science, in addition to learning more about the projects, financials, and activities of M-CERSI to learn how to run a similar organization in Korea. 

The KRSC team plans to host their own version of M-CERSI’s America Got Regulatory Science Talent Competition in July, with eight universities and colleges participating. The KRSC competition, open to undergraduate students, has more than 17 teams formed already. The goals of the competition are to spread positive regulatory science awareness and encourage the next generation of scientists.

Click here to read more.

 

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PQE Group sets the pace for new FemTech related services, empowering new development of therapies in the clinical space
 

Recently recognized as a Great Place to Work in the US for the second consecutive year, PQE Group, the woman-owned global consulting company, announces its mission towards innovation in the development of therapies for women’s health challenges.

A year after the foundation of GQC, an internal start-up of the Group focused on medical cannabis therapy solutions, Gilda D’Incerti – CEO and Founder of the company – is now dedicating her interest to FemTech (Female Technology) and the so-called SHEconomy: these primary market trends forecast tremendous growth in terms of profit and growth in the next decade, accelerating drug development for women’s health and well-being.

 

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TEDCO signs partnership intermediary agreement with the National Cancer Institute Technology Transfer Center
 

New agreement will allow more collaboration to advance technology and life sciences innovations across the state

COLUMBIA, Md. (June 7, 2023) – TEDCO, Maryland’s economic engine for technology companies, announced the signing of a Partner Intermediary Agreement (PIA) with the National Cancer Institute Technology Transfer Center (NCI TTC).

“NCI and TEDCO have collaborated for more than a decade on a variety of initiatives to bring the latest advancements in cancer research and technology to the public through Maryland businesses. These collaborations have helped create a thriving innovation ecosystem that benefits both patients and the economy,” said Tom Stackhouse, PhD, director, NCI TTC.
This agreement will codify the relationship between NCI and TEDCO, allowing the two organizations to help promote and foster more opportunities for Maryland’s life sciences community to work together with NCI on cooperative research.

 

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TEDCO Announces an SSBCI Investment into Nanocrine
 

Maryland biotechnology company creating methods for more efficient and reliable research

COLUMBIA, Md. (June 8, 2023) – TEDCO, Maryland’s economic engine for technology companies, announced a recent State Small Business Credit Initiative (SSBCI) investment of $300,000 into Nanocrine, a biotechnology company.

“Without a steady and reliable foundation, research can be unreliable and unpredictable,” said Patrick Calhoun, president and chief science officer of Nanocrine. “Unfortunately, this is where many researchers are when studying living cells; many surfaces that cells interact with are uncharacterized or not made with appropriate lab-specific protocols—Nanocrine is working to change this and advance the scientific research and exploration of living cells.”

 

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OPEN CHALLENGE – BLUE KNIGHT QuickPitch: Activating for the Future
 

Recent global disease outbreaks have had devastating impacts, triggering a renewed emphasis on preparation for potential known and unknown health threats. By proactively enhancing preparedness against emerging pathogens, we aim to minimize the scale of future outbreaks, protect vulnerable populations, and ultimately safeguard our health security. 

To that end, Johnson & Johnson Innovation, together with the Biomedical Advanced Research and Development Authority (BARDA), is proud to launch the BLUE KNIGHT™ QuickPitch: Activating for the Future. Innovators are invited to submit potentially ground-breaking ideas or technologies that aim to enhance preparedness toward future known and unknown health threats, including emerging pathogens.

Up to 10 innovator(s) with the best potential solution will earn the opportunity to pitch to a panel of industry experts including Johnson & Johnson and BARDA leadership at JLABS @ Washington, DC on August 29. ** In addition, applicants may be invited to join Blue Knight through residency at the hub at JLABS @ Washington, DC, based on their applications and/or presentations.

**No travel costs will be reimbursed for applicants to attend live pitch event in Washington, DC.

For more information on this challenge, click here.

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