• Ground-breaking approval enables adults aged 60 years and older to be protected from RSV disease for the first time
• The approval is based on data from the positive pivotal AReSVi-006 phase III trial that showed exceptional efficacy in older adults, including those with underlying medical conditions, and in those with severe RSV disease
• US launch is planned before the 2023/24 RSV season
  
  

GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved Arexvy (respiratory syncytial virus vaccine, adjuvanted) for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in individuals 60 years of age and older. This is the first RSV vaccine for older adults to be approved anywhere in the world.

Tony Wood, Chief Scientific Officer, GSK, said: “Today marks a turning point in our effort to reduce the significant burden of RSV. Arexvy is the first approved RSV vaccine for older adults, expanding GSK’s industry-leading vaccine portfolio, which protects millions of people from infectious diseases each year. Our focus now is to ensure eligible older adults in the US can access the vaccine as quickly as possible and to progress regulatory review in other countries.”

Registration is Open for the 2023 Children’s National Innovation Day & Showcase

Date: May 31, 2023 Time: 10:00 am - 7:00 pm Location: Children’s National Research and Innovation Campus (CNRIC), Washington, DC Registration Link: Click here to register

The organizers of the 2023 Children’s National Innovation Day & Showcase are thrilled to announce that registration is now open for this premier event highlighting innovation in pediatric healthcare. The event will take place on May 31, 2023, at the Children’s National Research and Innovation Campus (CNRIC) in Washington, DC.

Join us on an informative episode of BioTalk with Rich Bendis as we delve into the fascinating realm of computer systems validation (CSV) and its significant impact on quality assurance in the life sciences industry. Our guest, Mr. Gaurav Walia, Senior Global Director of Business Development at PQE Group and Principal SME of Computer Systems Validation, Computer Software Assurance, and Data Integrity and Sr. Associate Partner, brings extensive expertise in CSV and compliance consulting services.

Discover the essential role of CSV in ensuring the integrity, reliability, and compliance of computerized systems used in pharmaceutical and medical device manufacturing. Mr. Walia, a recognized authority in the field, will provide insights into CSV's challenges and best practices, emphasizing the critical importance of regulatory adherence and data integrity.

Listen now via your favorite podcast platform

• Apple - https://apple.co/40NNJRL
  
• Google - https://bit.ly/3HoBrrY
• Spotify - https://spoti.fi/3AB7EbJ
• Amazon Music - https://amzn.to/3Vc3xN3
• TuneIn - https://bit.ly/3Nj8KAH
• YouTube (Audio) - https://bit.ly/3narsja

Virginians have often sought experimental medical treatments outside the state — traveling to North Carolina, Boston or one of the Mayo Clinic’s locations. However, the Paul and Diane Manning Institute of Biotechnology at the University of Virginia aims to change that.

“We intend to tackle the biggest challenges in health care and to empower our researchers to make the life-changing breakthroughs that will transform care for people across Virginia and beyond,” says Dr. K. Craig Kent, CEO of UVA Health and executive vice president for health affairs at U.Va. “We’re on a cusp of a revolution in health care.”

Construction of the institute, which will be built in the 54-acre Fontaine Research Park adjacent to U.Va.’s Grounds, is set to be complete in 2026 or 2027. However, the university is forging ahead with hires, including about 100 scientists who will research potential treatments for diseases like diabetes and Alzheimer’s. Kent anticipates employing 1,000 to 1,400 people at the institute, which will include 30,000 to 40,000 square feet of lab space and a biomanufacturing facility.

Analysis of international public-sector contributions to Food and Drug Administration (FDA)-approved drugs and vaccines allows for a more thorough examination of the global biomedical innovation ecosystem by institution of origin. Using new and existing methods, we have identified 364 FDA-approved drugs and vaccines approved from 1973 to 2016 discovered in whole or in part by Public Sector Research Institutions (PSRIs) worldwide. We identified product-specific intellectual property contributions to FDA-approved small molecule and biologic drugs and vaccines from the FDA Orange Book, our peer network, published studies, and three new sources: reports of medical product manufacturers’ payments to physicians and teaching hospitals under The Sunshine Act of 2010, a paper by Kneller and 64 royalty monetization transactions by academic institutions and/or their faculty that one of us (AS) maintains. We include a total of 293 drugs discovered either wholly by a US PSRI or jointly by a U.S. and a non-U.S. PSRI. 119 FDA-approved drugs and vaccines were discovered by PSRIs outside the U.S. Of these, 71 were solely discovered outside the US, while 48 also involved intellectual property contributions by US PSRIs. In the context of the global public sector landscape, the US dominates drug discovery, accounting for two-thirds of these drugs and many of the important, innovative vaccines introduced over the past 30 years. Contributions by Canada, UK, Germany, Belgium, Japan, and others each amount to 5.4% or less of the total.

Click here to read more from The Journal of Technology Transfer

GERMANTOWN, Md., April 25, 2023 (Newswire.com) - Seraxis Inc., a pre-clinical stage company with a best-in-class islet replacement therapy for insulin-dependent diabetes, today announced the presentation of results from an efficacy study of Synthetic Replacement Endocrine (SRE) pancreatic clusters. These data were presented by William Rust, PhD, Chief Executive Officer at Seraxis, as an oral podium presentation at the 4th International Pancreas and Islet Transplant Association (IPITA) / Harvard Stem Cell Institute (HSCI) / Juvenile Diabetes Research Fund (JDRF) Summit, held from April 24-25, 2023 in Cambridge, Massachusetts. The presentation included an introduction to Seraxis' proprietary GMP process for manufacturing SRE clusters for nonclinical and clinical use.

Emmes collaborates with pharmaceutical companies as strategic partners, providing one-stop clinical trial services, reducing costs, and accelerating development.

SAN ANTONIO, TX. – April 25, 2023 – Frost & Sullivan researched the contract research organizations industry and, based on its analysis results, recognizes Emmes with the 2023 Global Competitive Strategy Leadership Award. Each year, Frost & Sullivan presents this award to the company that has leveraged competitive intelligence to successfully execute a strategy that results in stronger market share, competitive brand positioning, and customer satisfaction.

Emmes is a full-service, global Clinical Research Organization (CRO) committed to promoting public health and biopharmaceutical innovation. Its dedication to problem-solving, close collaboration with customers, and scientific excellence help its customers better understand complex research problems, generate higher-quality data, and enable better treatment options. The company has extensive therapeutic experience in common and rare diseases, which is backed up by specialized knowledge in biostatistics, biomedical data science and bioinformatics, and eClinical technologies.

The value of life-saving drugs for patients suffering from serious diseases is priceless. But the current economic environment is stifling the biopharmaceutical pipeline of up-and-coming clinical trials. Dr. Harsha Rajasimha, Founder and CEO of Jeeva Informatics and the visionary behind Jeeva eClinical Cloud, appreciates the significant innovations that emerging biotech companies bring to the pursuit of early clinical development of novel therapeutics. He recommends an active front-loading strategy to maximize operational efficiency of clinical trials

BioMADE Funding To Accelerate Capra Bioreactor Expansion and Technical Advancement, Aligning with New White House Bioeconomy Goals

MANASSAS, Va., April 24, 2023 (GLOBE NEWSWIRE) -- Capra Biosciences is scaling up their novel bioreactor technology to produce sustainable chemicals in Northern Virginia. This project was funded through a special BioMADE Project Call focused on advancing bioreactor design and development, thanks to support from Schmidt Futures. The expansion will jump start Virginia’s bioeconomy and place the state on the map for biochemical production.

The Manassas-based company uses a biofilm-forming microbe and its proprietary bioreactors to transform low-cost feedstocks, such as agricultural byproducts or food waste, into a variety of chemicals, including their first product, retinol.

“Our bioreactor platform is meant to handle small- or large-scale production of chemicals efficiently without a negative environmental impact,” said Dr. Andrew Magyar, Capra Biosciences’ chief technology officer. “We’ve already proved its potential on a smaller scale, and we’re excited to scale it for more chemicals and larger volumes. The new contract not only allows us to create a bigger facility, it also funds work with groundbreaking partners who will improve the efficiency and predictability of the bioreactors.”

JLABS is taking the lead in exploring new and innovative approaches to vaccinations with their upcoming event, "Breaking Dependencies on Seasonal Vaccines to Address Infectious Diseases." This forward-looking program is scheduled to take place on Wednesday, May 17, 2023, at JLABS in Washington, DC, from 11:00 AM to 2:00 PM.

The event aims to examine the potential of technology to break the dependence on annual or seasonal vaccinations and provide more durable and reliable solutions for preventing infectious diseases such as coronaviruses, influenza, and rhinoviruses. Through innovation, there is an opportunity to enhance the impact and acceptance of vaccinations, achieve more consistent and impactful outcomes, and limit the spread of infectious diseases across large populations, regardless of risk level.

Johns Hopkins University has launched a new, annual award to support promising business ventures developed by student entrepreneurs—and to encourage the creators of those startups to put down roots and grow in Baltimore.

The President's Venture Fellowship, by far the largest award for student entrepreneurship ever offered by the university, is open to any full-time Johns Hopkins student, undergraduate or graduate, who seeks to continue pursuing a business venture in Baltimore after graduation. Up to two winners will be selected annually to receive a $100,000 award, with the lead of each venture also receiving a $40,000 salary stipend.

After record years in 2020 and 2021, growth of the U.S. life sciences industry has returned to a more normal pace in 2023, although demand for lab/R&D space remains well above pre-pandemic levels. Life sciences employment reached a record high at the start of 2023, although the rate of growth slowed. The San Francisco Bay Area, Boston/Cambridge and Seattle were the fastest-growing markets last year.

Please see the reports below:

2023 U.S. Life Sciences Outlook

BioHealth Innovation is proud to announce that Rich Bendis, Founder and CEO, will be participating in the upcoming International APEC Dialogue on Strengthening the Resilience of the Medical Product Supply Chain in the Asia Pacific.

Rich Bendis will be sharing his expertise in Panel Session Four: "The U.S. Capital Region’s Role in Enabling Global Medicines Supply Chain Resilience." This session offers a unique opportunity to gain insights into building a robust and resilient medical supply chain on a global scale.

This important event, cosponsored by the U.S. Food and Drug Administration (FDA) and the United States Pharmacopeia (USP), is aimed at accelerating efforts to strengthen medical product supply chains in the Asia Pacific region and beyond. Ensuring the resilience of these supply chains is a critical topic that impacts global health.

The program will take place on April 25 and 26, 2023, and will be a hybrid event, offering attendees the option to participate both in-person and virtually. The event will be held in conjunction with the USP Asia Pacific (APAC) Regional Chapter Meeting, which is scheduled for April 27, 2023.

Don't miss this opportunity to engage with experts and industry leaders in the field of medical supply chain resilience. Register now to attend in-person or virtually at the following link: https://cvent.me/2wVPXE

Discovering treatments for patients that currently have no available disease-modifying options is the priority of Gain Therapeutics. Specifically, there is a large unmet need for patients suffering from protein misfolding disorders that alter enzyme function.

What is Gain Therapeutics approach to drug discovery?

The pipeline begins with Gain’s agnostic discovery platform for Site-Directed Enzyme Enhancement Therapy (SEE-Tx). This is a computational platform, as opposed to an artificial intelligence (AI) system. This is preferable for multiple reasons. First, AI needs a large amount of data while SEE-Tx starts with a 3D protein structure to find novel binding sites within the protein. SEE-Tx can use the already published 3D protein structures solved by cryo-EM, or alternatively, the platform can utilize 3D structural predictions from the AlphaFold Database. After the platform identifies new binding sites on a previously undruggable protein, it can also compute the druggability of the identified allosteric binding site using quantitative predictions as opposed to discovery approaches using AI technology that cannot be interpreted. Importantly, any targeted sites will allow for protein function to be restored without interfering with the active sites of the enzyme and its substrate.

April 20, 2023 / By Katie Maney

Musculoskeletal injury (MSKI) is the most common form of medical injury experienced by Service members. Clinical interventions for MSKIs lack objective measures to determine their effectiveness, putting affected military personnel at risk of further damage if they return to duty  before fully recovering.

George Mason University bioengineer Dr. Parag Chitnis, an associate professor in the Department of Bioengineering and a member of the Institute for Biohealth Innovation (IBI), and his team are developing quantitative assessments that can both prevent and monitor MSKIs in Service members.

In partnership with Cephasonics Ultrasound, an ultrasound systems and technology company in California, and Infinite Biomedical Technologies, a biotechnology company in Maryland, the team has been selected by the United States Army Medical Research and Development Command to receive nearly $3M from the United States Department of Defense, awarded through the Medical Technology Enterprise Consortium (MTEC). The award will support the team’s development of wearable, compact, and hands-free ultrasound systems to assess rehabilitation and recovery from MSKIs through measurements of muscle structure and function during physical activity, with a specific focus on knee injuries.

“MTEC aims to facilitate prototype advancement in support of the Warfighters’ MSKI needs, “ said Dr. Lauren Palestrini, MTEC’s chief science officer. “We are excited to issue this award to the team at George Mason University and believe it has the potential to make great strides in military health and ultrasound research.”

Prior to this award, Dr. Chitnis and Dr. Siddhartha Sikdar, a professor in the Department of Bioengineering and a member of the IBI, formed the Training and Recovery Augmented with Ultrasound Myography and Assessment (TRAUMA) program. With funding from the Department of Defense’s Military Operational Medicine Research Program, TRAUMA’s goal is to develop ultrasound systems that can be used to evaluate MSKIs in dynamic settings. The award from MTEC enables the team to further advance their ongoing research.

Read more ...

Proposals are due May 1!

Grants for Technology Product Development Market-driven new technology and innovation leads to new products and new jobs. Creating jobs in innovative Maryland companies is what the Maryland Industrial Partnerships (MIPS) program has been doing for 32 years: bringing the inventive minds and extensive laboratory resources of the University System of Maryland (USM) to bear on creating the new products that feed the growth of Maryland businesses. Since the program’s inception in 1987, MIPS–enabled products have generated sales of $40 B.  MIPS is nationally recognized by the U.S. Small Business Administration as a model program for best practices in transferring technology and is a proven program that contributes significantly to job creation and high tech product development in Maryland.

Click here to learn more.

Angel investors are a great way to obtain startup funding for your business. Typically, angel investors for startups fund early and seed-stage companies that show promise for high growth and scalability. However, the location and industry of your startup can also affect the angel investment opportunities available to you. 

These are the top angel investor groups based on industry, stage, and accessibility for entrepreneurs to secure capital to launch their startups.

Top Angel Investor Groups

Read more ...

A Baltimore startup that helps get patients to take their medications has raised one of the largest funding rounds in Baltimore so far this year.

Scene Health announced Wednesday the closure of a $17.7 million series B round led by ABS Capital Partners with participation from Claritas Health Ventures, Healthworx, the innovation arm of CareFirst BlueCross BlueShield, PTX Capital and Kapor Capital. The company is planning to move into an office in North Baltimore this year after it closed its Mount Vernon office during the pandemic.

Click Here to Read More

By Alex Keown
April 13, 2023

Companies within the BioHealth Capital Region hub are hiring for multiple positions in Maryland, Virginia and Washington, D.C.

BioBuzz rounds up some of the leading companies in the region seeking top talent, with examples of a few of the jobs for which they are currently hiring.

Kite Pharma

A business division of Gilead Sciences, Kite Pharma is developing innovative cancer immunotherapies. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system’s ability to recognize and kill tumors. The company currently has 28 open positions in the BHCR. You can find their open positions here.

Partnership Announced to Distribute High Potency Probiotic in Mexico to Support Patients with Gut Microbiome Imbalance

Rockville, M.D., and Charlotte, N.C., April 12, 2023 – ExeGi Pharma LLC (“ExeGi”), a leading developer of live biotherapeutic drugs and probiotics, has announced a partnership with TannerLAC, Inc. (“TannerLAC”), a division of Tanner Pharma Group, to distribute Visbiome® in Mexico. Visbiome® is a high-potency probiotic medical food that helps manage dysbiosis associated with medical conditions like irritable bowel syndrome and ulcerative colitis. With eight probiotic strains delivered in high potency, Visbiome® is one of the most extensively researched probiotics on the market, with over 80 human clinical trials performed over the last 20 years. The formulation is available in more than 40 countries.

April 11, 2023 at 7:30 AM EDT

GAITHERSBURG, Md., April 11, 2023 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company (the Company), today announced that it has completed enrollment in its Phase 2 clinical trial of HepTcell, an immunotherapeutic for the treatment of chronic hepatitis B (CHB). With the achievement of this milestone, data readout is planned for the first quarter of 2024.

The multicenter clinical trial, which is being conducted at 26 sites in North America, Europe and Southeast Asia, enrolled approximately 80 subjects with inactive CHB and low levels of hepatitis B surface antigen (HBsAg). Subjects were randomized 1:1 to HepTcell or placebo. The primary endpoint of the trial is clinical response, defined as a 1-log or greater reduction in HBsAg. Secondary endpoints include changes in the levels of hepatitis B virus (HBV) DNA, pre-genomic RNA and other markers of virologic response.

• RGX-202 is a potential one-time AAV Therapeutic for the treatment of Duchenne and includes an optimized transgene for a novel microdystrophin and REGENXBIO's proprietary NAV® AAV8 vector
• Commercial-scale cGMP material from the REGENXBIO Manufacturing Innovation Center to be used in the clinical trial
• AFFINITY DUCHENNE™ Phase I/II trial of RGX-202 is active and recruiting patients; anticipated to report initial trial data in the second half of 2023

ROCKVILLE, Md., April 11, 2023 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for RGX-202, a potential one-time gene therapy for the treatment of Duchenne muscular dystrophy (Duchenne).

The Biden administration has announced a $5 billion program to accelerate the development of next-generation COVID-19 vaccines and treatments.

Like Operation Warp Speed, which developed and distributed vaccines in the early days of the pandemic, Project NextGen will cut across government agencies and involve public-private collaborations, a senior Biden official told USA TODAY.

Image: https://www.usatoday.com - From Video

BioHealth Innovation's Renée Arnold is set to lead an insightful panel discussion at the upcoming ISPOR 2023 conference, which will take place on May 8, 2023, one at 12:45 and the other at 3:15 pm. The session, "Blazing The Trail for Digital Health Innovation: Resources and Examples Based on a Digital Health Application for Dementia Family Caregivers," aims to shed light on digital health technologies' research and development pathway. It will also cover the evolving US regulations framing evidence requirements for the approval of digital health applications.

April 12, 2023

Joining Experienced Business Executives Across Industries, Education and Government to Enhance Economic Development in Montgomery County

Rockville, MD — Under the leadership of Board Chair Kevin Beverly, Montgomery County Economic Development Corporation has added new Board Members to its roster, bringing a broad spectrum of experience, knowledge and ideas. The board reflects the diversity and wide range of talent of Montgomery County residents and businesses—working in coordination with the MCEDC team to fulfill its mission of helping businesses start, grow and relocate to Montgomery County, Maryland.

“I am pleased to welcome Dr. Anne Khadamian, Silvana Nani, and Devang Shah to the MCEDC Board, and appreciate their confirmation from the County Council,” said County Executive Marc Elrich. “The skills, experience, and relationships that these individuals have in education, workforce development, technology, communications, and other areas will help MCEDC continue their focus on attracting, retaining, recruiting, and convening in our strategic industries.”

“The impressive range of talent and expertise within our board provides a strong complement to the work we do at MCEDC,” said Bill Tompkins, President & CEO. “The board reflects the diversity that is a hallmark of Montgomery County—drawing in a wide range of business executives from healthcare and manufacturing to life sciences, finance and the nonprofit communities.”

What if the future of medicine could be personalized, predictive, and empowered by data? In this episode of BioTalk, Rich Bendis discusses this topic with Dr. Leroy Hood and Dr. Nathan Price, the co-authors of the book “The Age of Scientific Wellness: Why the Future of Medicine Is Personalized, Predictive, Data-Rich, and in Your Hands.” Together, they discuss the scientific revolution reshaping the healthcare and medicine landscape.

Dr. Hood and Dr. Price shed light on how cutting-edge technologies, such as genomics and artificial intelligence, are enabling the shift from reactive medicine to proactive, individualized care. They explore the concept of “scientific wellness,” where data-rich insights revolutionize disease prevention and unlock the potential for extended health span. Join us on BioTalk for this thought-provoking exploration of the new frontier of medicine, where health optimization is at the forefront.

Listen now via your favorite podcast platform

• Apple - https://apple.co/3mcBOyu
• Google - https://bit.ly/3Goa7d6
• Spotify - https://spoti.fi/3KF6H8b
• Amazon Music - https://amzn.to/3KlnNXk
• TuneIn - https://bit.ly/439Ths1
• YouTube (Audio) - https://bit.ly/3GpKf0t

TL/DR: For participation in the SBIR and STTR programs, agencies now have a standard set of questions to ask small business concerns about their foreign investments and affiliations. Companies can use the questions to prepare for their disclosures.

The Small Business Administration (SBA) is amending the Policy Directive of the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs to harmonize participating agencies’ collection of information about applicants’ foreign investments and affiliations. Participating agencies have been required to collect such disclosures since passing of the SBIR and STTR Extension Act of 2022.

Register to attend a free NIH webinar. Attendees will learn about a new method for administering Transcranial Magnetic Stimulation (TMS). This new method improves both the instrumentation used to deliver TMS treatment, and the treatment’s magnetic pulse pattern; which when applied to an awake rat treatment model, was shown to provide significant improvement over conventional TMS treatment methods.

Continuous manufacturing (CM) is an exciting frontier in drug manufacturing with the capacity to increase process efficiency while reducing costs. Manufacturers are now looking at ways to apply CM to make biologics. Biopharmaceutical continuous manufacturing (BCM) could increase product quality and productivity, enhance the process and product control, and increase flexibility, while also decreasing certain fixed costs associated with facility size and equipment maintenance, thereby reducing the environmental impact. There are barriers to the
widespread adoption of BCM, however

Marios Gavrielatos had never participated in a machine learning competition when he decided to enter the Eric and Wendy Schmidt Center’s Cancer Immunotherapy Data Science Grand Challenge.

Gavrielatos’ friend and colleague, Konstantinos Kyriakidis, asked him to team up in the competition after learning about it from a promotional video on YouTube.

Image: Credit: Rita Elena Serda, Duncan Comprehensive Cancer Center at Baylor College of Medicine, National Cancer Institute, National Institutes of Health A pseudo-colored scanning electron micrograph shows two T cells (red) attacking a cancer cell (white)