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578th Edition, October 10, 2023

By BHI Weekly News Archives

 

 

 

BioHealth Innovation, Inc. Announces Strategic Agreement to Provide ARPA-H with Entrepreneurs-in-Residence
 

ROCKVILLE, MARYLAND, October 5, 2023 – BioHealth Innovation, Inc. (BHI) is proud to announce a pivotal agreement with the Advanced Research Projects Agency for Health (ARPA-H) to provide Entrepreneurs-in-Residence (EIRs) in support of ARPA-H’s mission. This collaboration aims to bolster the development and commercialization of transformative health solutions.

Under the agreement, BHI’s EIRs will offer strategic guidance to ARPA-H Program Managers (PMs) in areas including technology development, intellectual property, and small business needs. They will assist in the development and execution of programs, evaluate partnership opportunities with government biomedical and health research agencies, and leverage industry associations to support funded performers.

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Amgen Completes Acquisition of Horizon Therapeutics PLC
 

Advances Amgen’s Mission to Serve Patients With First-in-Class Rare Disease Medicines

THOUSAND OAKS, Calif., Oct. 6, 2023 /PRNewswire/ — Amgen (NASDAQ: AMGN) today announced that it has completed its acquisition of Horizon Therapeutics plc for $116.50 per share in cash, representing a transaction equity value of approximately $27.8 billion.

“Today marks an exciting milestone as we welcome Horizon employees to Amgen and begin working together to serve even more patients around the world suffering from serious illnesses,” said Robert A. Bradway, Amgen’s chairman and chief executive officer. “We have strong momentum in our core business and the addition of Horizon will further position Amgen as a leader across a broader range of diseases.”

 

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Unveiling Key Insights with Pete Briskman: A Comprehensive Update on the BioHealth Capital Region
 

In the 9th Annual BioHealth Capital Region Forum, Pete Briskman, Executive Managing Director and Co-Lead for the Mid-Atlantic Life Sciences Practice, offered a thorough update on the BioHealth Capital Region (BHCR) and its significant strides in the life sciences sector.

BHCR’s Noteworthy Achievements:

  • Securing the #3 rank among Life Science Clusters.
  • Leading the nation in the number of biotechnology patents.
  • Holding a prominent third position in total NIH grant funding.
  • Establishing itself robustly as the third-largest science cluster.

 

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Navigating 2023’s BioPharma Clusters with Alex Philippidis
 

Alex Philippidis, Senior Business Editor of Genetic Engineering and Biotechnology News, for the 4th consecutive year, attended the 9th Annual BioHealth Capital Region Forum, presenting his expert insights into the “Top 10 U.S. BioPharma Clusters, 2023,” providing a detailed analysis and overview of the current state and future prospects of the BioPharma industry.

 

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Revisiting Rich Bendis’s Welcome at the 9th Annual BioHealth Capital Region Forum
 

In a year that underscored “Global Breakthroughs for a Healthier Future,” Rich Bendis, President and CEO of BioHealth Innovation Inc (BHI), extended a heartfelt welcome to attendees, marking the 9th consecutive year of the Annual BioHealth Capital Region Forum.

Take a moment to reflect on Rich’s thorough review of the region’s transformative journey from its inception to its present-day stature, proudly holding a #3 ranking in the GEN Top 10 BioPharma Clusters in the United States. This achievement is a testament to its prowess in NIH Funding, Venture Capital Funding, Patents, Lab Space, and Jobs.

Rich highlighted the global impact of the term “BioHealth,” which has become more woven into the fabric of health discussions and innovations over nearly a decade.

 

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Emmes Acquires VaxTRIALS
 

VaxTRIALS Adds a New Latin America Base and Greater Vaccine Research Depth

Rockville, MD, October 5, 2023 – Emmes, a global, full-service Clinical Research Organization (CRO) dedicated to supporting the advancement of public health and biopharmaceutical innovation, today announced the acquisition of VaxTRIALS. Headquartered in Panama City, Panama, VaxTRIALS’ 160+ staff members manage and monitor vaccine clinical trial activities throughout Latin America.

“Today’s clinical trials are both more complex and more global in nature than ever before,” said Emmes Executive Chairman Sastry Chilukuri. “Combining VaxTRIALS’ depth of expertise in Latin America and Emmes’ strengths, particularly in technology, biostatistics and data management, will give clients an unmatched partnership experience in conducting their clinical trials.”

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Maryland based United Therapeutics is leading a medical revolution
 

Imagine a world where unhealthy organs are replaced with transplants constructed with a 3D printer using the patient’s own cells. No more agonizing waits and desperate searches for a suitable donor organ, and, because the printed organs use cells from the patients themselves, no more fear of organ rejection. It might sound like science fiction set in the far off future, but thanks to the pioneering work of United Therapeutics , it may become a reality a lot sooner than you think, and it’s happening here in Maryland.

Co-headquartered in Silver Spring, United Therapeutics was founded in 1996 by Dr. Martine Rothblatt, a mom who wanted to save her 7 year-old daughter Jenesis who’d been diagnosed with a rare and serious disease called pulmonary arterial hypertension. Twenty seven years later, Jenesis has defied the odds and works at the company her mother founded to save her life.

 

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Novavax 2023-2024 COVID-19 Vaccine Now Authorized and Recommended for Use in the U.S.
 

GAITHERSBURG, Md., Oct. 3, 2023 /PRNewswire/ — Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its novel Matrix-M adjuvant, today announced that the Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) (NVX-CoV2601) has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for active immunization to prevent COVID-19 in individuals aged 12 and older. Immediately upon authorization, Novavax’s vaccine has also been included in the recommendations issued by the U.S. Centers for Disease Control and Prevention (CDC) on September 12, 2023.

Doses will be available nationwide at thousands of locations, including national and local retail pharmacies and physicians’ offices, following the Center for Biologics Evaluation and Research release of vaccine batches, expected in the coming days.

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IndoUSrare Announces Bridging RARE Summit to Combat Rare Diseases by Fostering Cross-Border Collaborations, Data Sharing, and Clinical Trials
 

With an increasing number of U.S. biopharmaceutical firms feeling the financial constraints imposed by the Inflation Reduction Act (IRA) and subsequently shutting down or suspending their research programs in the rare disease domain, hundreds of millions of patients in both the U.S. and India face the grim prospect of not receiving a breakthrough treatment for their condition within their lifetimes. IndoUSrare, a US-based nonprofit committed to stanching rare diseases, launches the inaugural Bridging RARE conference to forge a path for affordable clinical innovation via strengthened Indo-US collaborations and more inclusive clinical trials for minimizing the devastating health consequences arising from this policy shift.

(HERNDON, Va.) October 10, 2023: Rare diseases, as defined by the World Health Organization (WHO), refer to some 10,867 medically significant conditions, each with a prevalence of one or less per 1,000 individuals. With only about 8% of them being treatable,1 rare diseases include congenital malformations, autoimmune disorders, lysosomal storage disorders, thalassemia, muscular dystrophies, and infrequent forms of cancer and infections. Despite substantial progress during the 40 years since the enactment of the Orphan Drug Act of 1983, which incentivized the U.S. private sector to develop 1,100 FDA-approved orphan treatments,2 the global thrust against rare diseases is on the verge of losing steam.

 

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Gain Therapeutics Announces Dosing of First Two Subjects in Phase 1 Clinical Trial of GT-02287, a Novel GCase-targeting Small Molecule Therapy for GBA1 Parkinson’s Disease
 

First small molecule allosteric binder discovered with Gain’s computational drug discovery platform enters clinical development

BETHESDA, Md., Oct. 04, 2023 (GLOBE NEWSWIRE) — Gain Therapeutics, Inc. (Nasdaq: GANX) (“Gain”, or the “Company”), a clinical-stage biotechnology company leading the discovery and development of the next generation of allosteric small molecule therapies, today announced dosing of the first two subjects in a Phase 1 clinical trial of GT-02287, Gain’s lead drug candidate for the treatment of GBA1 Parkinson’s disease. The Company expects to complete this trial in the first half of 2024.

“Initiating first-in-human dosing with GT-02287 is an important milestone for Gain as we enter a new era as a clinical-stage company,” said Matthias Alder, Chief Executive Officer of Gain Therapeutics. “I am very proud of the work accomplished by the entire Gain team to get us to this stage today, and we are eager to advance our understanding of the safety, tolerability and effect of GT-02287 in humans. This represents another major step forward toward providing a treatment for Parkinson’s patients and their families impacted by this devastating disease.”

 

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Welldoc Expands Chronic Care Digital Health Platform to Include Weight Management
 

Welldoc’s industry-leading holistic platform now incorporates AI-driven digital coaching and features specifically designed to support individuals throughout the complex journey of weight management

COLUMBIA, Md., October 4, 2023 — Welldoc®, a digital health leader revolutionizing chronic care, today announced the expansion of its platform to support weight management. Welldoc’s comprehensive chronic care platform now provides multi-condition support across prediabetes, diabetes, hypertension, heart failure and weight management, along with integrated mental wellbeing and sleep apnea support. Welldoc’s weight management solution is currently available to all customers and will be launching in early 2024 with two of the leading health care companies in the U.S.

Nearly two-thirds of U.S. adults are overweight or obese, which increases their risk of developing chronic comorbid conditions like type 2 diabetes, hypertension, heart failure, and sleep apnea.  As part of Welldoc’s total health approach to chronic care, AI-driven, personalized digital coaching is available 24/7 to help individuals navigate weight management whether they are just beginning their weight management journey with lifestyle changes or are prescribed a GLP-1 medication. Welldoc enables individuals to understand and connect with their health data in a meaningful way, making the achievement of weight and overall health goals more attainable. Welldoc also provides clinical escalations and decision support for the care team when needed.

 

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Luminoah Wins 8th Annual Crab Trap Competition at BioHealth Capital Region Forum
 

Luminoah Wins 8th Annual Crab Trap Competition at BioHealth Capital Region Forum

Rockville, MD, September 22, 2023 — Luminoah, a MedTech startup located in Charlottesville, VA, dedicated to improving the lives of people requiring enteral feeding, emerged as the top company at the 8th Annual Crab Trap Competition, held as part of this year’s BioHealth Capital Region Forum. The event, which took place on September 20th, showcased Luminoah’s innovative wearable system, designed to optimize compliance and clinical outcomes through the integration of durable medical equipment, consumable nutrition pouches, and remote patient monitoring.

Neal Piper, Founder & CEO of Luminoah, delivered an outstanding presentation highlighting the company’s groundbreaking technology. Luminoah’s wearable system represents a significant advancement in the field of enteral feeding, offering an innovative solution to enhance patient care.

 

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Copyright  BioHealth Innovation 2023
All Rights Reserved.

 
 

 

 

577th Edition, October 03, 2023

By BHI Weekly News Archives

 

 

 

Navigating the Future of Autoimmune Medicine: A Conversation with Dr. Theresa Podrebarac, Senior Vice President, Clinical Development at Horizon Therapeutics
 

How can patients help shape the future of scientific innovation? What’s the vital role of the patient’s voice in developing life-changing medicines? In this captivating episode, fresh off her thought-provoking appearance at the 9th Annual BioHealth Capital Region Forum, Dr. Theresa Podrebarac takes us on a journey through the dynamic landscape of autoimmune medicine.

Dr. Podrebarac is a renowned physician scientist with a wealth of expertise in the biotech industry. As the Senior Vice President of Clinical Development at Horizon Therapeutics, she’s at the forefront of bringing hope to patients with rare, autoimmune, and severe inflammatory diseases. Join us as we explore pivotal questions:

  • What is Horizon Therapeutics’ mission, and what are Dr. Podrebarac’s primary responsibilities in this quest for life-changing medicines?
  • How has Dr. Podrebarac’s background as a rheumatologist influenced her belief in the importance of the patient’s perspective in drug development?
  • Discover Horizon’s impressive journey in clinical development, with a sharp focus on autoimmune diseases.
  • Dive into Horizon’s global presence and the crucial role of its Maryland operations.
  • What are the clinical goals that will shape the future of autoimmune medicine?

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Innara Health Acknowledges BioHealth Innovation, Inc. (BHI) and Ethel Rubin for Their Role in Joining Cardinal Health
 

Innara Health has extended their recognition to BioHealth Innovation, Inc. (BHI) and Ethel Rubin for our significant contributions to Innara Health’s journey. BHI is acknowledged for our confidence and insight in introducing Innara Health to the BioHealth Capital Region, while Ethel Rubin is thanked for her expert counsel, candor, and influential role on the Board, along with her valuable network. Our support has played a crucial part in Innara Health’s mission to improve the lives of premature newborns and infants.

 

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Israeli BioHealth Companies Shine at BioHealth Capital Region Events
 

The BioHealth Capital Region recently played host to a series of significant events that drew attention from the global biopharma community. Notably, several Israeli BioHealth companies, some traveling directly from Israel, participated in these events, underscoring the region’s growing prominence, especially after being recognized by GEN as a Top 3 BioPharma Cluster in the United States. This remarkable participation was made possible with the dedicated efforts of Aisha Espey, Director of Commerce, Head of Science and Technology from the Embassy of Israel in Washington DC, and Andrea Yonah, Director of Business Development for the U.S. East Coast/Midwest at the U.S. Israel Binational Industrial R&D (BIRD) Foundation.

The BioHealth Capital Region Forum serves as the region’s premier gathering for the biopharma sector, fostering collaborations and discussions that advance public health and economic outcomes. The Crab Trap, now in its 8th year, is a competition spotlighting entrepreneurs with transformative health solutions. The Investment Conference is a platform for companies and investors to create partnerships, featuring brief presentations highlighting BioHealth opportunities and innovations.

 

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Deka Biosciences Closes USD $20 Million Series B2 Financing Led by MPM BioImpact
 

GERMANTOWN, Md., Sept. 28, 2023 /PRNewswire/ — Maryland-based biotech company Deka Biosciences (“Deka”) today announced that it has successfully closed a USD $20 Million Series B2 financing with a syndicate of life science investors led by MPM BioImpact, and joined by additional investors including Leaps by Bayer, Lumira Ventures, O-Bio (Echo Investment Capital), Viva BioInnovator, Alexandria Venture Investments, Amana Investments, Plains Ventures, ATEM Capital and CEO John Mumm. The proceeds of the financing will support the advancement of Deka’s pipeline and drug product manufacturing as they continue clinical trials following the receipt of a notice to proceed letter from the FDA for their investigational new drug (IND) application to evaluate DK210 (EGFR). Additionally, Detlev Biniszkiewicz, Ph.D. of MPM-BioImpact, will join the Deka board.

 

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Maryland Department of Commerce: Maryland, together with D.C and Virginia, now a “Top 3” biopharma cluster
 

The latest rankings from Genetic Engineering & Biotechnology News  (or GEN) included some long-awaited good news for Maryland: the Biohealth Capital Region (BHCR) had moved up to No. 3 on the publication’s list of the top ten biopharma clusters in the United States.

Leaders in Maryland’s biohealth industry have been working to make the BHCR a “Top 3 by 2023” since back in 2016. In recent years, the region (comprising Maryland, Virginia and Washington, D.C.) has ranked No. 4.

“It’s been an incredible journey working with so many dedicated individuals and organizations in the region over the years to meet this goal,” Rich Bendis, president and CEO of BioHealth Innovation, Inc., said in a statement . “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.”

Click here to read the entire article.

 

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Emmes Introduces Telehealth Capabilities into Advantage eClinical
 

The latest upgrade is part of wider goals to create the industry’s first unified digital data platform for decentralized and hybrid trials

ROCKVILLE, Md., Sept. 27, 2023 /PRNewswire/ — Emmes, a global, full-service Contract Research Organization (CRO) dedicated to supporting the advancement of public health and biopharmaceutical innovation, announces the addition of telehealth capabilities within Advantage eClinical. The new application means any scheduled visit can become virtual with video calls augmented directly through the platform and patients signing in through their existing participant portal. Advantage eClinical is designed to enable a simple, intuitive experience that fits seamlessly into the everyday lives of study participants and sites.

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Maryland Department of Commerce Webinar Event: Reach Your Raise: Attract Investors with Maryland’s Biotech Tax Credit
 

If your Maryland-based life sciences company is doing R&D in biotechnology and preparing to raise equity funding, your investors may be eligible to benefit from tax credits from the State of Maryland through the Biotechnology Investment Incentive Tax Credit (BIITC) program. Join the Maryland Department of Commerce on October 2nd to learn about the program benefits and how you can work with your investors to enhance their returns by investing in you. 

Click here to learn more and register.

 

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Anzu Partners Closes Third Venture Fund Focused on Companies Enabling Next-Gen Solutions in Clean Tech, Industrial, and Life Sciences Technologies
 

Fund III cohort accelerates the energy transition, facilitates discovery of better therapeutics and advances critical industries

ATLANTA & BOSTON & SAN DIEGO & TAMPA, Fla. & WASHINGTON–()–Anzu Partners, an investment firm delivering capital and strategic support to early-stage breakthrough technology companies, today announced it has raised more than $200 million at the close of its third venture capital fund.

Fund III was established to invest in companies developing next-generation solutions in clean technology, industrial innovations, and life sciences. Investors in Fund III include new and returning public and private institutions, single and multifamily offices, and accredited investors across the U.S. and overseas.

 

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TEDCO invests in AGED Diagnostics
 

COLUMBIA, Md. (September 28, 2023) –TEDCO, Maryland’s economic engine for technology companies, announced a recent $200,000 Seed Funds investment into AGED Diagnostics, a biotechnology company. Previously, AGED Diagnostics received a $250,000 investment from TEDCO’s Builder Fund, a funding opportunity that is under the umbrella of our Social Impact Funds.

“1 in 3 Americans have liver disease, but many remain unaware of it until the disease progresses to a stage when it is no longer curable, patient outcomes are poor and/or healthcare costs are burdensome,” said Rachel Zayas, CEO of AGED Diagnostics. “Thanks to TEDCO’s investment we are able to continue our research and development, working towards a future where liver disease can have early detection.”

 

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The BioHealth Capital Region Successfully Hosted Its Annual Forum, Crab Trap, and Investment Conference
 

The BioHealth Capital Region continued its tradition of fostering innovation, collaboration, and growth in the life sciences sector with its series of events in 2023. The highlights included the 9th Annual BioHealth Capital Region Forum, the 8th Annual BioHealth Capital Region Crab Trap, and the 6th Annual BioHealth Capital Region Investment Conference, bringing together industry, academic, government, entrepreneurs, and investors.

 

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WBJ: Dr. Kurt Newman’s journey from surgeon to CEO
 

The Greater Washington area has a long history of influential business leaders powering the growth of our region and the strength of their communities. On Dec. 5, the Washington Business Hall of Fame will welcome five such leaders to receive our region’s signature lifetime business achievement award. The Hall of Fame brings these visionaries (the best in business) to the table with the next generation of leaders (the next in business), through an experience that connects and inspires us all.

The 2023 Hall of Fame Laureates are no strangers to media coverage. If you live in the Washington region, chances are you’ve seen their names in headlines for years. What you may not have witnessed is these trailblazers telling their stories in their own words. That’s what this series brings you – the look back, lessons and life advice that these Laureates have to offer based on a lifetime of success.

 

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Luminoah Wins 8th Annual Crab Trap Competition at BioHealth Capital Region Forum
 

Luminoah Wins 8th Annual Crab Trap Competition at BioHealth Capital Region Forum

Rockville, MD, September 22, 2023 — Luminoah, a MedTech startup located in Charlottesville, VA, dedicated to improving the lives of people requiring enteral feeding, emerged as the top company at the 8th Annual Crab Trap Competition, held as part of this year’s BioHealth Capital Region Forum. The event, which took place on September 20th, showcased Luminoah’s innovative wearable system, designed to optimize compliance and clinical outcomes through the integration of durable medical equipment, consumable nutrition pouches, and remote patient monitoring.

Neal Piper, Founder & CEO of Luminoah, delivered an outstanding presentation highlighting the company’s groundbreaking technology. Luminoah’s wearable system represents a significant advancement in the field of enteral feeding, offering an innovative solution to enhance patient care.

 

Read More

 

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Copyright  BioHealth Innovation 2023
All Rights Reserved.

 
 

 

 
BHCRRichy

576th Edition, September 26, 2023

By BHI Weekly News Archives

 

 

 

The BioHealth Capital Region Successfully Hosted Its Annual Forum, Crab Trap, and Investment Conference
 

The BioHealth Capital Region continued its tradition of fostering innovation, collaboration, and growth in the life sciences sector with its series of events in 2023. The highlights included the 9th Annual BioHealth Capital Region Forum, the 8th Annual BioHealth Capital Region Crab Trap, and the 6th Annual BioHealth Capital Region Investment Conference, bringing together industry, academic, government, entrepreneurs, and investors.

Read More

 
 

Luminoah Wins 8th Annual Crab Trap Competition at BioHealth Capital Region Forum
 

Luminoah Wins 8th Annual Crab Trap Competition at BioHealth Capital Region Forum

Rockville, MD, September 22, 2023 — Luminoah, a MedTech startup located in Charlottesville, VA, dedicated to improving the lives of people requiring enteral feeding, emerged as the top company at the 8th Annual Crab Trap Competition, held as part of this year’s BioHealth Capital Region Forum. The event, which took place on September 20th, showcased Luminoah’s innovative wearable system, designed to optimize compliance and clinical outcomes through the integration of durable medical equipment, consumable nutrition pouches, and remote patient monitoring.

Neal Piper, Founder & CEO of Luminoah, delivered an outstanding presentation highlighting the company’s groundbreaking technology. Luminoah’s wearable system represents a significant advancement in the field of enteral feeding, offering an innovative solution to enhance patient care.

 

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Immediate Opening for a Technical Grant Writer and Project Manager with BioHealth Innovation, Inc.
 

Opening – Technical Writer and Project Manager

BioHealth Innovation (BHI) is an innovation intermediary that facilitates commercialization of emerging technologies in the BioHealth Capital Region (Maryland, DC and Virginia).

BHI is seeking a Technical Writer and Project Manager to join its team remotely. This position provides the opportunity to leverage scientific knowledge to evaluate the commercial potential of emerging technologies and provide recommendations on go-to-market strategies. This is a customer facing role with a focus on supporting clients in the development of commercial analyses and federal grant proposals. This position is geared toward an early-career scientist with extensive writing experience and a history of funded grant proposals.

This position could be either employee or part time contractor depending on applicants experience and availability. Compensation will be competitive but dependent based on experience.

 

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FDA awards nearly $7.5 million to pediatric device consortium led by Children’s National Hospital
 

Federal funding fosters development and commercialization of medical devices designed for children

WASHINGTON, D.C., Sept. 19, 2023 (GLOBE NEWSWIRE) — To foster the development and commercialization of medical devices designed for children, the Food and Drug Administration (FDA) has awarded a nearly $7.5 million grant to the Alliance for Pediatric Device Innovation (APDI), a consortium led by Children’s National Hospital. The nonprofit group, which is one of five in the FDA’s Pediatric Device Consortia (PDC) program, will utilize the five-year grant to provide a platform of services, expertise and funding that supports pediatric innovators in bringing medical devices to the market that specifically address the needs of children. New in this cycle, APDI will provide expertise on evidence generation, including the use of real-world evidence (RWE), for pediatric device development.

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BizJournals – D.C. startup Nanochon raising money to fund trials of 3D-printed knee cartilage implant
 

D.C.’s Nanochon LLC is raising $3.5 million to make it through the final leg of its journey to bring a 3D-printed knee cartilage implant to market.

The company has already raised $1.8 million toward the round, according to a Securities and Exchange Commission filing. The company said it plans to use the funds to begin human trials and ultimately get Food and Drug Administration approval for its 3D-printed implant.

 

Nanochon has raised $5 million since its founding in 2016 to fund the clinical trials needed to bring its medical device to market.

 

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Emmes Appoints Peter Ronco as Chief Executive Officer
 

Ronco’s Global Pharmaceutical Experience Will Support the Next Chapter of Emmes’ Growth and Technology Enablement

Rockville, MD, September 20, 2023 – Emmes, a global, full-service Clinical Research Organization (CRO) dedicated to supporting the advancement of public health and biopharmaceutical innovation, today announced that Peter Ronco has been named Chief Executive Officer, effective immediately.

Mr. Ronco succeeds Dr. Christine Dingivan, who will serve as a senior advisor to Executive Chairman Sastry Chilukuri, and Emmes’ Board of Directors.

 

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United Therapeutics Announces Recent Milestones for its Heart and Kidney Xenotransplantation Programs
 

SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)– United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, today announced the achievement of two milestones for its xenotransplantation programs in September: the second transplant of a UHeart™ xenoheart into a living person, and a 61-day study of the UThymoKidney™ xenokidney and thymus in a human pre-clinical model.

United Therapeutics’ organ manufacturing efforts consist of seven investigational programs: xenoheart, xenokidney, xenothymokidney, regenerative lungs, 3D-printed lungs, 3D-printed livers, and 3D-printed kidneys. These groundbreaking programs are intended to address the ongoing shortage of transplantable organs for patients with end stage organ disease.

 

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TEDCO Invests in Natáur
 

COLUMBIA, Md. (September 25, 2023) – TEDCO, Maryland’s economic engine for technology companies, announced a recent $200,000 investment into Natáur. This recent investment came from TEDCO’s Social Impact Funds.

“Natáur is creating bio-based taurine—an essential nutrient for brain development, healthy aging, heart health, and microbiome balance,” said Kathleen Turano, Natáur CEO. “Taurine occurs naturally in animal products but it is missing in plants. With shifts towards more plant-based diets, taurine will need to be added as an ingredient or taken as a supplement to maintain healthy taurine levels. With TEDCO’s investment, we move closer to launching our bio-based taurine.”

 

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Seraxis Announces Closing of Second VC Tranche and Successful Completion of Preclinical Studies of Pancreatic Organoids From Seraxis’ Novel Pancreas-Derived Stem Cells
 

Leadership team expanded with addition of Chief Corporate Development Officer, Ted Hibben, a 25-year venture-stage business development biotherapeutic industry veteran Total venture funding tops $50M to date

GERMANTOWN, MD / ACCESSWIRE / September 21, 2023 / Seraxis Inc., a cell therapy company developing a pancreatic organoid cure to transform the lives of patients with Type 1 and insulin-requiring Type 2 diabetes, today announced the closing of the second tranche of its inaugural VC round to bring total equity investment in the company to over $50 million. Frazier Life Sciences, Polaris Partners, Eli Lilly and the JDRF T1D Fund participated in the step-up triggered by Seraxis’ achieving the completion of preclinical milestones of Seraxis’ novel pancreatic organoids, SR-02.

 

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Washington DC’s VerImmune Announces Over $3M Additional Funding
 

WASHINGTON, Sept. 20, 2023 /PRNewswire/ — VerImmune Inc. (“VerImmune”), an early-stage biotechnology company specializing in the development of innovative products based on a novel Virus-inspired Particle (ViP™) technology platform, announced today the securing of an additional $3.125 million from follow-on Seed financing and a partnership milestone payment.

The follow-on financing was led by previous investor, Proxima VC, a specialist seed-to-growth healthcare venture capital firm with participation from other previous investors such as Gaingels, Mana Ventures and others. In addition to this financing, a milestone payment from Fosun Pharma USA was triggered by  the successful completion of a process development milestone.

 

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Maryland Stem Cell Research Fund’s Ruchika Nijhara, PhD, selected as one of The Daily Record’s 2023 Influential Marylanders
 

Impactful leader of the Maryland Stem Cell Research Fund recognized

COLUMBIA, Md. (September 21, 2023) – TEDCO, Maryland’s economic engine for technology companies, announced that Maryland Stem Cell Research Fund (MSCRF) executive director, Ruchika Nijhara, PhD, was named one of The Daily Record’s 2023 Influential Marylanders.

“Although a new addition to 1TEDCO, it’s already evident why Ruchika was chosen to be an Influential Marylander,” said Troy LeMaile-Stovall, TEDCO CEO. “Her dedication to supporting researchers is unwavering; she actively works to improve processes, support others and so much more. We are proud to be working with someone as talented and influential as Ruchika.”

 

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Women Building Bio 2023
 

Virginia Bio’s Women Building Bio Conference celebrates the contribution of women to the life sciences in the Commonwealth and beyond. The 8th annual conference theme, Building Better, will prompt us to explore how life sciences contribute to building a better future and highlight the increasingly significant role of women in it.

 

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Copyright  BioHealth Innovation 2023
All Rights Reserved.

 
 

 

 
Crabby

575th Edition, September 19, 2023

By BHI Weekly News Archives

 

 

 

5 Excellent Finalists Chosen for the 8th Annual BHCR Crab Trap
 

Rockville, Maryland – September 13, 2023 – BioHealth Innovation, Inc. (BHI), a leading regional innovation intermediary, is thrilled to announce the five outstanding finalists for the 8th Annual BioHealth Capital Region Crab Trap competition. The Crab Trap is a competition designed to identify and showcase promising life sciences and biotechnology startups from around the world. These finalists have demonstrated exceptional innovation, vision, and potential to significantly impact the healthcare industry.

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Last Chance to Register for the BioHealth Capital Region Forum 2023!
 

We’re just ONE DAY away from the FREE 9th Annual BioHealth Capital Region Forum, and there’s still time to register! Don’t miss out on this incredible opportunity to join nearly 500 other registrants on September 19th and 20th. ?️

Location: US Pharmacopeia (USP), 12601 Twinbrook Pkwy, Rockville, MD 20850
Attire: Business/Business Casual
Parking: Paid-parking garage across the street or metered-street parking
Metro: Twinbrook Metro stop on the Red Line (8-minute walk)

Why Attend?

  • Network with esteemed government officials, academic leaders, and industry executives.
  • Explore new avenues for growth within the BioHealth Capital Region.
  • Engage in thought-provoking discussions and knowledge sharing.
  • Discover investment and partnership opportunities in the vibrant biohealth industry.

? The BioHealth Capital Region is a thriving hub of innovation and opportunity, boasting over 2,300 life science companies, 78 federal labs, and renowned academic institutions.

? Register now to be a part of this prestigious event and help shape the future of the BioHealth Capital Region!

Visit https://bit.ly/BHCRForum2023 to register now. 

 

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Federal Trade Commission allows Amgen’s $27.8 billion acquisition of Horizon Therapeutics
 

THOUSAND OAKS, Calif. and DUBLIN, Sept. 1, 2023 /PRNewswire/ — Amgen (NASDAQ:AMGN) and Horizon Therapeutics plc (NASDAQ:HZNP) today announced the entry into a consent order agreement with the Federal Trade Commission (FTC) that resolves the pending FTC administrative lawsuit. This clears the path to take the final steps to close Amgen’s acquisition of Horizon.

As a result of the consent order agreement, Amgen and Horizon expect that the parties will jointly file stipulated proposed orders to dismiss the preliminary injunction motion and dissolve the temporary restraining order (TRO) in the U.S. District Court for the Northern District of Illinois, and that Amgen and Horizon will quickly seek the final approvals required under Irish law to close the acquisition.

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Accelerate Investor Conference Returns to Showcase Leading Early-Stage Companies to National Investors
 

ARLINGTON, Va.–()–The Accelerate Investor Conference is back for its third year at George Mason University’s Arlington Campus, November 1-2, 2023. Spurring the region’s innovation and entrepreneurship engagement to a new level, the conference will showcase the Virginia, Maryland, and metropolitan DC region as a destination for business development, venture investment, and job creation.

Top venture firms from across North America participate to attend top keynotes and industry panels and watch 40+ high growth tech and life science companies pitch for their next round of capital. These cutting-edge startups compete for top prizes and are joined by 25 regional student teams presenting business concepts.

 

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Gain Therapeutics Receives Approval to Commence Phase 1 Clinical Study of GT-02287 from the Human Research Ethics Committee (HREC) in Australia
 

BETHESDA, Md., Sept. 12, 2023 (GLOBE NEWSWIRE) — Gain Therapeutics, Inc. (Nasdaq: GANX) (“Gain”, or the “Company”), a biotechnology company leading the discovery and development of the next generation of allosteric small molecule therapies, today announced that the Company has received approval from the Bellberry Human Research Ethics Committee (HREC) in Australia to initiate a Phase 1 clinical study of its lead drug candidate GT-02287 in development for GBA1-Parkinson’s disease (GBA1-PD). Dosing in healthy volunteers to assess the safety and pharmacokinetics of GT-02287 is expected to begin in the near term.

 

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Altimmune Announces Completion of Dosing in the Phase 2 MOMENTUM Trial of Pemvidutide in Subjects with Obesity or Overweight
 

GAITHERSBURG, Md., Sept. 12, 2023 (GLOBE NEWSWIRE) — Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced the completion of dosing (last subject last dose) in its 48-week Phase 2 MOMENTUM trial evaluating the efficacy and safety of pemvidutide in subjects with obesity or overweight. Pemvidutide is a novel, investigational GLP-1/glucagon dual receptor agonist under development for the treatment of obesity and non-alcoholic steatohepatitis (NASH).

 

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PQE Group Opens Office in Montreal, Quebec, Canada
 

PQE Group is excited to announce the opening of its newest office in Montreal, Quebec, Canada, marking a significant expansion for the company. The expansion aims to provide enhanced services to both existing and potential clients across various regions in Canada. The Greater Montreal area, located along North America’s east coast, is renowned for its vibrant life sciences community, featuring prestigious universities, leading hospitals, and innovative life sciences companies. Notably, Quebec serves as a hub for the development and acceleration of artificial intelligence (AI), reflecting its forward-thinking approach to shaping the future. Canada’s expertise in AI, characterized by its high-quality research, skilled workforce, and contributions to AI innovation on a global scale, has been a key source of inspiration for PQE Group.

 

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oneweekbhcr

574th Edition, September 12, 2023

By BHI Weekly News Archives

 

 

 

REGISTER NOW – The 9th Annual BioHealth Capital Region Forum: A Week Away and a World of Opportunity
 

One week away from the 9th Annual BioHealth Capital Region Forum (https://bit.ly/BHCRForum2023), a cornerstone event for anyone involved in the biopharma sector. Scheduled for September 19th and 20th at the US Pharmacopeia in Rockville, Maryland, this year’s forum promises to be an enriching experience for all attendees. Even better, thanks to the generosity of our sponsors, attendance is entirely free of cost!

A Gathering of Minds

The forum is a unique confluence of thought leaders, industry executives, academic pioneers, and government officials. This year, the keynote addresses promise to be particularly illuminating. Rachel King, the CEO of BIO, will speak on biotechnology’s accomplishments and challenges in her talk titled “Biotechnology: What We’ve Accomplished and the Challenges Before Us.” On the other end of the spectrum, Lance Liotta, Co-Director of the Center for Applied Proteomics and Molecular Medicine at George Mason University, will explore the cutting-edge intersection of AI and BioHealth in his keynote, “Hijacking Cellular Communications using AI Tools: A New Frontier in BioHealth.”

Read More

 
 

Seize Opportunities at the 6th Annual BioHealth Capital Region Investment Conference: Applications Due September 12th
 

Your Invitation to apply to a Key Investment Event in Rockville, Maryland Awaits

There’s still time if you haven’t yet marked your calendar for the 6th Annual BioHealth Capital Region Investment Conference. The one-day event will also be held at the US Pharmacopeia (USP) in Rockville, Maryland, and is free to attend, thanks to our generous sponsors. Applications to attend are due by September 12th!

A Unique Investment Opportunity: September 21st

The Investment Conference brings together investors and companies seeking funding. With a strong track record of fostering successful financial engagements, this conference is an unparalleled opportunity for those eyeing transformative funding.

 

Read More

 

 

Pioneering Biotech Advancements: A Conversation with Rachel King, CEO of BIO
 

Join us for an insightful episode of BioTalk as host Rich Bendis welcomes back Rachel King, the visionary CEO of the Biotechnology Innovation Organization (BIO), bringing with her a remarkable journey spanning roles as an entrepreneur, board member, and advocate for the biotech industry.

In this engaging installment, Rachel offers a glimpse into her evolution from consulting to industry, including her role as co-founder and former CEO of GlycoMimetics, Inc. (GMI). Discover the essence of BIO, its mission, and the global perspective it brings to the biotech landscape. Delve into Rachel’s advocacy role and the critical issues facing the industry today, including pricing, congressional relations, and investment challenges. Gain insights into the state of the biotech industry and Rachel’s projections for both the near and long term.

Listen as we unravel the dynamic journey of Rachel King, a trailblazing leader in biotechnology, and gain a comprehensive perspective on the industry’s present and future. Available now on all major podcasting platforms.

 

Listen now via your favorite podcasting platform:

Read More

 
 

Adaptive Phage Therapeutics CEO Greg Merril and His Father’s Journey Highlighted in BBC StoryWorks’ Documentary, ‘Race Against Resistance’
 

The documentary-style film addresses the urgent global health crisis of antimicrobial resistance, which is causing widespread concern in the scientific and medical fields. The film highlights the dire consequences of this growing issue and showcases the relentless efforts of doctors, scientists, and experts who are working on innovative research and solutions to protect future generations.

https://www.youtube.com/watch?v=5U3k9ruszxI

Read More

 

 

Rockville’s Supernus Announces New Qelbree® Data Showing Improvement in ADHD Symptoms
 

ROCKVILLE, Md., Sept. 09, 2023 (GLOBE NEWSWIRE) — Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, announces the presentation of two posters at Psych Congress 2023 with new data showing improved efficacy in children ages 6 years and older with ADHD when Qelbree is added to a stimulant, as well as in adults with ADHD who undergo long-term treatment with Qelbree.

“While ADHD is recognized as one of the most common psychiatric diagnoses, affecting approximately 16.1 million individuals in the United States, patients are in need of alternative or additional options to stimulants that allow them to manage their symptoms with a safe and tolerable treatment option,” says Jonathan Rubin, Chief Medical Officer and Senior Vice President of Research & Development. “The new Qelbree data presented during Psych Congress 2023 reinforce the efficacy and safety of our novel nonstimulant treatment in addition to existing stimulant therapy in children ages 6 and older with ADHD and in a long-term setting in adults with ADHD.”

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NextCure and Nordic Bioscience Publish Review Article on the Regulation of Tumor Immunity by Tumor Collagen
 

BELTSVILLE, Md., Sept. 07, 2023 (GLOBE NEWSWIRE) — NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class immunomedicines to treat cancer and other immune-related diseases, today announced the publication of a review article in the online journal Frontiers in Immunology, highlighting the need for targeting tumor collagen in the extracellular matrix (ECM) in the tumor microenvironment to enhance anti-tumor immunity.

“Emerging data on the effects of dysregulated collagen in the ECM show that it modulates accessibility and activity of immune cells within the TME, leading to suboptimal oncology treatment outcomes,” said Solomon Langermann, Ph.D., NextCure’s chief scientific officer. “A key aspect of what we highlighted in this review is that an expanded understanding and cross-fertilization within the fields of tumor matrix biology, cancer biology, and immunology will contribute to improving the efficacy of cancer therapeutics. Importantly, it will enable the development of new classes of therapeutics to address the unmet needs of cancer patients who do not benefit from current therapies. This is a key focus of our ongoing NC410 clinical trial.”

Read More

 

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All Rights Reserved.

 
 

 

 
Rachel King and Rich 250 250 px

573rd Edition, September 6, 2023

By BHI Weekly News Archives

 

 

 

 

 

Pioneering Biotech Advancements: A Conversation with Rachel King, CEO of BIO
 

Join us for an insightful episode of BioTalk as host Rich Bendis welcomes back Rachel King, the visionary CEO of the Biotechnology Innovation Organization (BIO), bringing with her a remarkable journey spanning roles as an entrepreneur, board member, and advocate for the biotech industry.

In this engaging installment, Rachel offers a glimpse into her evolution from consulting to industry, including her role as co-founder and former CEO of GlycoMimetics, Inc. (GMI). Discover the essence of BIO, its mission, and the global perspective it brings to the biotech landscape. Delve into Rachel’s advocacy role and the critical issues facing the industry today, including pricing, congressional relations, and investment challenges. Gain insights into the state of the biotech industry and Rachel’s projections for both the near and long term.

Listen as we unravel the dynamic journey of Rachel King, a trailblazing leader in biotechnology, and gain a comprehensive perspective on the industry’s present and future. Available now on all major podcasting platforms.

Listen now via your favorite podcasting platform:

Read More

 
 

Still Time to Register: Unlock Collaboration at the 9th Annual BioHealth Capital Region Forum
 

Your Invitation to a Pivotal BioHealth Event in Rockville, Maryland Awaits

If you haven’t yet marked your calendar for the 9th Annual BioHealth Capital Region Forum, it’s not too late. The event will be held at the US Pharmacopeia (USP) in Rockville, Maryland, and is free to attend, thanks to our generous sponsors.

Two Days of In-Person BioHealth Exploration: September 19th and 20th

The Forum is just weeks away and promises an in-person experience under the theme “Global Breakthroughs for a Healthier Future.” This cornerstone event offers industry experts, academic trailblazers, and government representatives a unique opportunity to reconnect in this “Top 3” BioPharma cluster.

Read More

 
 

Seize Opportunities at the 6th Annual BioHealth Capital Region Investment Conference: Applications Due September 12th
 

Your Invitation to apply to a Key Investment Event in Rockville, Maryland Awaits

There’s still time if you haven’t yet marked your calendar for the 6th Annual BioHealth Capital Region Investment Conference. The one-day event will also be held at the US Pharmacopeia (USP) in Rockville, Maryland, and is free to attend, thanks to our generous sponsors. Applications to attend are due by September 12th!

A Unique Investment Opportunity: September 21st

The Investment Conference brings together investors and companies seeking funding. With a strong track record of fostering successful financial engagements, this conference is an unparalleled opportunity for those eyeing transformative funding.

 

Read More

 
 

BIO Podcast Episode 87: The Horseshoe Crab Saved Us. Can We Save the Horseshoe Crab?
 

The horseshoe crab has endured for over 450 million years.In this episode we talk with three experts about how this animal’s unique blue blood has become essential to modern medicine. We also talk about why horseshoe crab populations are dwindling, and what biotech is doing to address the shortfall.

Click here to listen.

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VLP Therapeutics group announces 2nd closing of funding to develop cancer, infectious disease vaccines, establish investigational vaccine manufacturing facility
 

US-based biotech company VLP Therapeutics, Inc. (VLPT) and its Tokyo-based group company VLP Therapeutics Japan, Inc. (VLPT Japan) together announced on September 5 the second closing of its financing round, which secured investments from two existing investors: MUFG Bank, Ltd., and Miyako Kyoto University Innovation II L.P., as well as two new investors: FFG Venture Business Partners Co., Ltd. and toberu Fund run by Phoenixi Co., Ltd.

With this funding the VLPT group plans to: 1) bolster its vaccine research and development underway in the US for cancer treatment and infectious disease prevention, such as malaria and dengue; and 2) establish a manufacturing facility, which is expected to begin operation in 2024–2025 and will enable VLPT Japan to produce investigational vaccines in-house in Fukuoka, Japan.

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Rockville’s MacroGenics Announces Achievement of $15 Million Milestone Related to Gilead’s Nomination of a Bispecific Research Program
 

ROCKVILLE, MD, Sept. 05, 2023 (GLOBE NEWSWIRE) —  MacroGenics, Inc. (NASDAQ: MGNX), a biopharmaceutical company focused on developing, manufacturing and commercializing innovative antibody-based therapeutics for the treatment of cancer, today announced that its partner, Gilead Sciences, Inc. (NASDAQ: GILD), nominated the first of two research programs, leveraging MacroGenics’ DART® and TRIDENT® platforms for generating bispecific antibodies. This nomination grants Gilead an exclusive option, upon achievement of a pre-defined preclinical milestone, to license worldwide rights to the research program.

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Emergent BioSolutions’ NARCAN® Nasal Spray Launches Over the Counter Making it Possible for Everyone to Help Save a Life from an Opioid Overdose Emergency
 

GAITHERSBURG, Md., Aug. 30, 2023 (GLOBE NEWSWIRE) — Today, Emergent BioSolutions Inc. (NYSE: EBS) announced NARCAN® Naloxone HCl Nasal Spray 4 mg will be available on shelves nationwide and online beginning in September. Over-the-counter (OTC) access to NARCAN® Nasal Spray offers more people the ability to respond in an opioid emergency, helping to save lives and keep loved ones and communities safe. Expanding access and awareness is critical given the staggering toll of the epidemic mainly driven by synthetic opioids, like fentanyl.1 Last year, approximately every seven minutes one life was lost due to an opioid overdose, and today it is the leading cause of accidental death in the U.S.2,3 The average response time for emergency services to arrive is approximately 10 minutes.4 Having NARCAN® Nasal Spray in a first-aid kit, or carrying it on the go in case of an opioid emergency, can make a difference and help reverse the effects of opioids while waiting for emergency personnel to arrive.

Read More

 
 

CellKey, a BHI Partner Company, Emerald Cloud Lab (ECL) Partner to Co-Develop Advanced Glycoprotein Analysis Platform
 

Los Angeles, CA; September – CellKey, a leading provider of innovative bioanalytical solutions, is thrilled to announce the signing of a Memorandum of Understanding (MOU) with Emerald Cloud Lab (ECL), a pioneer in cloud-based laboratory facilities, to collaborate on the development of a cutting-edge glycoprotein analysis platform. This strategic partnership aims to revolutionize glycosylation studies, essential for diagnosing and treating cancer and various other diseases, as evidenced by the groundbreaking work of the recent Nobel laureate in Chemistry at Stanford University.

Read More

 
 

Adaptive Phage Therapeutics CEO Greg Merril and His Father’s Journey Highlighted in BBC StoryWorks’ Documentary, ‘Race Against Resistance’
 

The documentary-style film addresses the urgent global health crisis of antimicrobial resistance, which is causing widespread concern in the scientific and medical fields. The film highlights the dire consequences of this growing issue and showcases the relentless efforts of doctors, scientists, and experts who are working on innovative research and solutions to protect future generations.

https://www.youtube.com/watch?v=5U3k9ruszxI

Read More

 
 

Project NextGen Awards Over $1.4 Billion to Develop the Future of COVID-19 Vaccines and Therapeutics
 

Funding includes $1 billion for vaccine clinical trials, $326 million for a new monoclonal antibody, and $100 million to explore novel vaccine and therapeutic technologies

Today, the U.S. Department of Health and Human Services (HHS), through the Administration for Strategic Preparedness and Response (ASPR), awarded more than $1.4 billion for Project NextGen to support the development of a new generation of tools and technologies to protect against COVID-19 for years to come.

The awards announced today follow extensive coordination with industry partners and include support for clinical trials that will enable the rapid development of even more effective and longer-lasting coronavirus vaccines, a new monoclonal antibody, and transformative technologies to streamline manufacturing processes.

“Project NextGen is a key part of the Biden-Harris Administration’s commitment to keeping people safe from COVID-19 variants,” said HHS Secretary Xavier Becerra. “These awards are a catalyst for the program – kickstarting efforts to more quickly develop vaccines and continue to ensure availability of effective treatments.”

Read More

 
 

The Johns Hopkins Bloomberg School of Public Health Reaches Next Stage in City Planning Process
 

The new 250,000-square-foot facility will support the Bloomberg School’s mission through dynamic workspaces, state-of-the-art classrooms, and a variety of study, collaboration, and event spaces.

The Johns Hopkins Bloomberg School of Public Health shared the latest updates on their planned new building at the Baltimore City Urban Design & Architecture Advisory Panel (UDAAP) meeting this morning.

The new building will be located on existing Johns Hopkins property at the corner of McElderry and Washington streets—adjacent to the division’s main Wolfe Street building and at the heart of the East Baltimore campus. The school has been working with award-winning, London-based architectural firm Hopkins Architects as design architect and Baltimore-based Hord Coplan Macht Inc. as architect of record to design a facility that will meet the demands of public health education, research, and practice well into the future.

Totaling approximately 250,000 gross square feet across seven floors, the new facility will support the school’s mission of inspiring and educating the next generation of public health leaders through dynamic workspaces, state-of-the-art classrooms, and a variety of study, collaboration, and event spaces, including for events and meetings with community groups.

Currently, the school’s academic departments have outgrown their existing spaces, primarily comprised of two separate buildings on North Wolfe Street and North Broadway. The new facility will connect to the Wolfe Street building, bring the core activities of all 10 departments together in one location, and accommodate the Bloomberg School’s growth. The new building will also add much-needed green space to the campus, including an expansion of the existing School of Nursing courtyard that will provide a shared collegial space for rest and relaxation between the two schools.

“We are thrilled to be able to move this building to the next phase of planning, with a thoughtful design for a modern facility that connects to our current Wolfe Street building, in order to foster interdisciplinary collaboration, enhance our teaching and learning experience, and provide new opportunities for community engagement and convening,” said Bloomberg School of Public Health Dean Ellen J. MacKenzie. “Our goal is to create a vibrant space where researchers, practitioners, policymakers, and students collaborate seamlessly to address the most pressing challenges facing us today. We are excited to create an environment that nurtures innovation and incubates ideas that can advance public health globally.”

Click here to read more via JHU’s HUB.

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2023 Technology Showcase: A Hub for Biotech Innovation and Collaboration
 

The Frederick National Laboratory Advanced Technology Research Facility in Frederick, MD, is set to host the 2023 Technology Showcase on September 6, 2023. This annual event serves as a platform for potential industry partners to engage with the National Cancer Institute (NCI) and Frederick National Laboratory (FNL).

Registration and Attendance

Interested parties can register to attend the showcase either in person or online. Each mode of attendance has its own unique registration link, offering flexibility for participants.

What to Expect

The Technology Showcase is a free hybrid event featuring a variety of activities and opportunities:

  • Inventor Highlights: NCI and FNL inventors will present technologies ripe for commercialization and collaboration.

  • Programmatic Insights: Leaders from NCI and FNL will share avenues for potential collaboration.

  • Partnership Perspectives: The event will provide insights into what partnering with NCI and FNL entails, including viewpoints from companies that have successfully collaborated.

  • Panel Sessions: These will feature success stories and topics relevant to the commercialization of biomedical technology.

  • Lightning Pitch Competition and Poster Session: These segments will spotlight NIH technologies available for co-development or licensing, presented by the NCI Technology Transfer Ambassadors Program.

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Rich and Judy 250 250 px

572nd Edition, August 29, 2023

By BHI Weekly News Archives

 

 

 

 

 

Nurturing Tomorrow’s STEM Leaders: A Conversation With Dr. Judy Staveley, Biotechnologist And STEM Advocate
 

Explore the world of scientific mentorship and education with Dr. Judy Staveley, an accomplished Chief Biotechnologist and STEM advocate. In this episode of BioTalk, Dr. Staveley discusses her journey in supporting young scientists and her roles in organizations like the National Association of Academies of Science (NAAS) and the American Junior Academy of Science (AJAS).  

Discover the upcoming NAAS/AJAS STEM EDUCATION CONFERENCE/FUNDRAISER on September 16th and its impact on inspiring the next generation of innovators. Learn about AJAS’s life science support programs that encourage young talents to pursue careers in STEM.  

Dr. Staveley shares insights into STEM education in the BioHealth Capital Region and her personal goals for nurturing young scientists. Join us to uncover the pivotal role of mentorship in shaping the future of STEM.

Listen now via your favorite podcasting platform:

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One Week Left to Apply for the 8th Annual BioHealth Capital Region Crab Trap: Don’t Miss Your Chance to Win Over $50,000 in Prizes!
 

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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BioHealth Innovation Partners with Big4Bio to Amplify the Voice of the BioHealth Capital Region
 

Rockville, MD – BioHealth Innovation (BHI), a founding member of the BioHealth Capital Region (BHCR), announces its strategic partnership with Big4Bio, an national aggregator of news and developments in the life sciences sector. This collaboration aims to share pivotal news and information from the BHCR, which has recently achieved a significant milestone by ranking as a Top 3 BioPharma Cluster in the Genetic Engineering & Biotechnology News “Top 10 US Biopharma Clusters” rankings, to a larger audience beyond the region.

In an era where the life sciences sector is experiencing unparalleled innovation and investment, staying updated with key information is paramount. Big4Bio, focused on its comprehensive coverage of the cornerstone “Big 4” in biosciences and health – drugs, devices, diagnostics, and digital (the “four D’s”), offers daily email newsletters that provide readers with easy-to-scan headlines sourced from hundreds of credible industry sources across eight US Biotech markets. Their commitment to producing individual summaries for the world’s most significant life sciences markets aligns with BHI’s and the BHCR’s vision of fostering growth and innovation in the biotech and life sciences industries.

 

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Welldoc Receives 11th 510(k) Clearance from FDA for Award-Winning Diabetes Platform BlueStar®
 

COLUMBIA, Md., August 23, 2023 — Welldoc®, a digital health leader revolutionizing chronic care, today announced the receipt of its 11th 510(k) clearance from the Food and Drug Administration (FDA) for its award-winning diabetes digital health solution, BlueStar® . This clearance immediately follows Welldoc’s 10th 510(k) clearance announcement earlier this month, solidifying the company’s continued leadership in chronic care innovation.

Welldoc’s latest 510(k) enables BlueStar to provide bolus insulin dose recommendations based on the most recent glucose reading and rate of change from a compatible continuous glucose monitoring (CGM) device. This feature enhances BlueStar’s existing digital coaching capabilities, which guide dietary and lifestyle decisions and assist individuals in self-managing their diabetes. Welldoc is the first company to receive clearance for a CGM-informed bolus calculator specifically designed for adults who manage their diabetes with multiple daily injections of insulin.

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CANVASREBEL: Q&A with Gillian Henker, President & Co-Founder, Sisu Global Health.
 

We’re excited to introduce you to the always interesting and insightful Gillian Henker. We hope you’ll enjoy our conversation with Gillian below.

Hi Gillian, thanks for joining us today. So let’s jump to your mission – what’s the backstory behind how you developed the mission that drives your brand?

At Sisu Global, we set our vision for a world where medical technology enables access to healthcare in every community. In 2010 at Komfo Anokye Teaching Hospital (KATH), I set out to create medical devices to fit the unmet needs of those in resource-limited settings — medical devices that are simple in nature yet impactful in design, serve as a lifesaving intervention for patients, and directly influence the entire healthcare ecosystem.

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TEDCO Announces SSBCI Investment in Polaris Genomics
 

Maryland-based veteran-owned biotech company is working to transform mental health care

COLUMBIA, Md. (August 28, 2023) – Charles Cathlin, CEO of Polaris Genomics (TEDCO Portfolio company)TEDCO, Maryland’s economic engine for technology companies, announced its Venture Funds invested $500,000 State Small Business Credit Initiative (SSBCI) funds in Polaris Genomics, a Maryland-based biotech company.

 

Read More

 
 

CellKey, a BHI Partner Company, Emerald Cloud Lab (ECL) Partner to Co-Develop Advanced Glycoprotein Analysis Platform
 

Los Angeles, CA; September – CellKey, a leading provider of innovative bioanalytical solutions, is thrilled to announce the signing of a Memorandum of Understanding (MOU) with Emerald Cloud Lab (ECL), a pioneer in cloud-based laboratory facilities, to collaborate on the development of a cutting-edge glycoprotein analysis platform. This strategic partnership aims to revolutionize glycosylation studies, essential for diagnosing and treating cancer and various other diseases, as evidenced by the groundbreaking work of the recent Nobel laureate in Chemistry at Stanford University.

Read More

 
 

 

The BioHealth Capital Region’s Adaptive Phage Therapeutics lands on Fierce Biotech’s Fierce 15
 

It’s been a tough year for biotech, so how about a little good news? In between all the layoffs, restructurings and last-ditch strategic option hunting, we wanted to take a moment to shine a spotlight on 15 innovative and truly fierce biotechs.

That didn’t surprise us, because everyone we talk to in the Fierce Biotech universe tells us that science doesn’t stop for the markets. Financing might be a little tough right now, but innovation, breakthroughs and discoveries are all still being made. 

The latest crop of Fierce 15 honorees consists of companies pushing the envelope not only in the lab, in the clinic or on the conference circuit: They are also defining what it means to be a modern biotech company, with modalities ranging from radiopharmaceuticals to cell therapy. Indications as diverse as oncology, neurodegenerative disorders, Pompe disease and even pregnancy complications made the list this year.

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Immunomic Therapeutics Doses First Patient in its Phase 1 Clinical Trial of ITI-1001, a pDNA Vaccine for the Treatment of Glioblastoma Multiforme
 

ROCKVILLE, Md.–(BUSINESS WIRE)–Immunomic Therapeutics, Inc., a privately held, clinical-stage biotechnology company pioneering the study of nucleic acid immunotherapy platforms, today announced dosing of the first patient in its Phase 1 clinical trial evaluating ITI-1001, a plasmid DNA (pDNA) vaccine, for the treatment of Glioblastoma Multiforme (GBM), a rare but aggressive form of brain cancer. The study is being conducted at the Dana-Farber Cancer Institute in Boston, Massachusetts and is being led by Dr. David Reardon, Clinical Director, Center for Neuro-Oncology.

“Dosing of the first patient in the Phase 1 clinical trial of ITI-1001 in patients with GBM is a significant clinical development milestone for Immunomic, representing the first time this pDNA vaccine is being administered in humans,” stated Dr. Teri Heiland, Chief Scientific Officer of Immunomic Therapeutics. “We are eager to evaluate the safety and preliminary efficacy in this patient population, who have only limited treatment options for this devastating disease and expect to read out top-line data in the second quarter of 2025.”

Read More

 
 

MM+M: Roche, Horizon lead way for pharma reputation among rare disease patient groups
 

Horizon Therapeutics and Roche rank among the top pharma companies in terms of reputation among rare disease patient groups, according to a recent report compiled by U.K. consultancy PatientView. 

Published Tuesday, the 2022 Corporate Reputation of Pharma survey asked 426 rare disease patient groups representing some 3.3 million patients to assess the performance of 34 drugmakers in the space.

The report noted that pharma has steadily improved its reputation among rare disease patient groups over the past five years. Most respondents praised drugmakers’ abilities to provide products that are beneficial to patients and innovating on breakthrough treatments.

Still, the industry scored lower in 2022 for key activities that are meaningful to these patient populations, including fair pricing policies and access to medicines.

Out of the 34 companies, Horizon was ranked first among rare disease patient groups familiar with the brand, followed by Roche and Takeda Pharmaceuticals. Out of 31 companies, Roche was assessed as the top company by rare disease patient groups working with the company.

Click here to continue reading.

Read More

 
 

Project NextGen Awards Over $1.4 Billion to Develop the Future of COVID-19 Vaccines and Therapeutics
 

Funding includes $1 billion for vaccine clinical trials, $326 million for a new monoclonal antibody, and $100 million to explore novel vaccine and therapeutic technologies

Today, the U.S. Department of Health and Human Services (HHS), through the Administration for Strategic Preparedness and Response (ASPR), awarded more than $1.4 billion for Project NextGen to support the development of a new generation of tools and technologies to protect against COVID-19 for years to come.

The awards announced today follow extensive coordination with industry partners and include support for clinical trials that will enable the rapid development of even more effective and longer-lasting coronavirus vaccines, a new monoclonal antibody, and transformative technologies to streamline manufacturing processes.

“Project NextGen is a key part of the Biden-Harris Administration’s commitment to keeping people safe from COVID-19 variants,” said HHS Secretary Xavier Becerra. “These awards are a catalyst for the program – kickstarting efforts to more quickly develop vaccines and continue to ensure availability of effective treatments.”

Read More

 
 

The Johns Hopkins Bloomberg School of Public Health Reaches Next Stage in City Planning Process
 

The new 250,000-square-foot facility will support the Bloomberg School’s mission through dynamic workspaces, state-of-the-art classrooms, and a variety of study, collaboration, and event spaces.

The Johns Hopkins Bloomberg School of Public Health shared the latest updates on their planned new building at the Baltimore City Urban Design & Architecture Advisory Panel (UDAAP) meeting this morning.

The new building will be located on existing Johns Hopkins property at the corner of McElderry and Washington streets—adjacent to the division’s main Wolfe Street building and at the heart of the East Baltimore campus. The school has been working with award-winning, London-based architectural firm Hopkins Architects as design architect and Baltimore-based Hord Coplan Macht Inc. as architect of record to design a facility that will meet the demands of public health education, research, and practice well into the future.

Totaling approximately 250,000 gross square feet across seven floors, the new facility will support the school’s mission of inspiring and educating the next generation of public health leaders through dynamic workspaces, state-of-the-art classrooms, and a variety of study, collaboration, and event spaces, including for events and meetings with community groups.

Currently, the school’s academic departments have outgrown their existing spaces, primarily comprised of two separate buildings on North Wolfe Street and North Broadway. The new facility will connect to the Wolfe Street building, bring the core activities of all 10 departments together in one location, and accommodate the Bloomberg School’s growth. The new building will also add much-needed green space to the campus, including an expansion of the existing School of Nursing courtyard that will provide a shared collegial space for rest and relaxation between the two schools.

“We are thrilled to be able to move this building to the next phase of planning, with a thoughtful design for a modern facility that connects to our current Wolfe Street building, in order to foster interdisciplinary collaboration, enhance our teaching and learning experience, and provide new opportunities for community engagement and convening,” said Bloomberg School of Public Health Dean Ellen J. MacKenzie. “Our goal is to create a vibrant space where researchers, practitioners, policymakers, and students collaborate seamlessly to address the most pressing challenges facing us today. We are excited to create an environment that nurtures innovation and incubates ideas that can advance public health globally.”

Click here to read more via JHU’s HUB.

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2023 Technology Showcase: A Hub for Biotech Innovation and Collaboration
 

The Frederick National Laboratory Advanced Technology Research Facility in Frederick, MD, is set to host the 2023 Technology Showcase on September 6, 2023. This annual event serves as a platform for potential industry partners to engage with the National Cancer Institute (NCI) and Frederick National Laboratory (FNL).

Registration and Attendance

Interested parties can register to attend the showcase either in person or online. Each mode of attendance has its own unique registration link, offering flexibility for participants.

What to Expect

The Technology Showcase is a free hybrid event featuring a variety of activities and opportunities:

  • Inventor Highlights: NCI and FNL inventors will present technologies ripe for commercialization and collaboration.

  • Programmatic Insights: Leaders from NCI and FNL will share avenues for potential collaboration.

  • Partnership Perspectives: The event will provide insights into what partnering with NCI and FNL entails, including viewpoints from companies that have successfully collaborated.

  • Panel Sessions: These will feature success stories and topics relevant to the commercialization of biomedical technology.

  • Lightning Pitch Competition and Poster Session: These segments will spotlight NIH technologies available for co-development or licensing, presented by the NCI Technology Transfer Ambassadors Program.

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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.

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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.”

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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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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.”

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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.

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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

 

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