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

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

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

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

For more information on this challenge, click here.

It was an extraordinary achievement. In less than one year, the biomedical ecosystem helped bring to life an mRNA vaccine with the power to stave off severe disease and death during the worst pandemic since 1918. Of course, this wasn’t really a miracle. It was just one example of what government and partners can do when challenged to develop disruptive innovations.

Government has been a disruptive force for innovation across many sectors, from Defense Advanced Research Projects Agency (DARPA) laying the foundation for the internet in the 1960s, to the role of the National Institutes of Health’s (NIH) and US Department of Energy in the Human Genome Project, which mapped the full genome for the first time in 2003 with an international consortium of thousands of researchers, to the U.S. President’s Emergency Plan for AIDS Relief initiative that has saved more than 25 million lives from HIV/AIDS across the globe.

Three entrepreneurial leaders discuss the support available through the MII program

COLUMBIA, Md. (June 5, 2023) – TEDCO, Maryland’s economic engine for technology companies, released a new episode of its innovation series, TEDCO’s The Leading Edge. Throughout this series, TEDCO thought leaders host a fireside chat with entrepreneurs discussing their experiences, providing advice to aspiring entrepreneurs, and more.

In this episode, TEDCO’s Maryland Innovation Initiative (MII), UM Ventures and Innovate Maryland come together at the University of Maryland, College Park (UMCP) for a live fireside chat. The discussion included Arti Santhanam, PhD, MII executive director; Ken Porter, UM Ventures, College Park director and MII Board member; and Srinivasa Raghavan, PhD, MII awardee, UMCP professor of chemical and biomolecular engineering, and entrepreneur.

Throughout the discussion, the three leaders dove into the MII program and the various support avenues it provides, as well as the success Raghavan has seen throughout his time with MII.

“It's really important [during] those early stages to have sources of support, not just funding…” said Raghavan. “That is [what’s] amazing about MII… you reach out to people who can support you… MII is a wonderful program… it is there for you, and it could really open doors and take you in a new direction.”

GAITHERSBURG, Md., June 5, 2023 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its novel Matrix-M™ adjuvant, has signed a three-year agreement with the Bill & Melinda Gates Medical Research Institute to provide its adjuvant for use in preclinical vaccine research.

"We are excited to partner with the Bill & Melinda Gates Medical Research Institute to include our unique technology in their public health-focused vaccine research efforts," said John C. Jacobs, President and Chief Executive Officer, Novavax. "Our Matrix-M™ adjuvant is proven to enhance and broaden the immune system response when included in vaccines and is already a key component of COVID and malaria vaccines on the market today. We look forward to partnering more broadly with a variety of organizations so that our technology can benefit vaccine development across many disease areas."

"The Bill & Melinda Gates Medical Research Institute is committed to developing biomedical interventions that address global health concerns for those in the greatest need," said Emilio Emini, PhD, chief executive officer of the Bill & Melinda Gates Medical Research Institute. "We look forward to working with Novavax's Matrix-M™ adjuvant in some of our early-stage vaccine programs."

The CBRE Life Sciences Research Talent 2023 Report underscores the BioHealth Capital Region's consistent position in the top three hotspots for life sciences talent in the United States. The report reveals a booming life sciences industry, with a record number of individuals graduating with degrees in biological and biomedical sciences. Over the past two decades, the number of life science professionals in the U.S. increased by 79%, in contrast to the 8% growth rate across all other occupations. This trend has led to the fastest pace of industry growth on record, particularly rebounding after a downturn in 2020.

Among the specific roles and jobs within the sector, medical scientists have seen the greatest increase. However, the report also notes a fierce competition for talent, with the industry facing a "furious search for talent" to meet escalating demands for its products and services. Despite this overall growth and competitiveness across the country, the BioHealth Capital Region stands out for its ability to attract and retain top talent, as evidenced by its position in the top three.

Charlottesville, VA - June 2, 2023 - The Charlottesville Business Innovation Council (CBIC) has awarded AMPEL BioSolutions, a leading data science company, with the prestigious "Innovator-of-Year" title. The recognition was given to AMPEL BioSolutions for the outstanding AMPEL Genomic Platform, which utilizes RNA analytics and Machine Learning for dynamic disease management, including flare prediction and personalized decision support for drug options.

AMPEL BioSolutions is currently in commercialization mode and making significant progress in executing its platform technology. This year, AMPEL is set to make LuGENE, a blood test, available nationwide in the United States through ReLATE. The CBIC award ceremony was a moment of celebration for the AMPEL team, who thanked Angel Williams Derricott, for her unwavering Advocacy for Lupus & celebrating with the AMPEL team at CBIC unwavering advocate for Lupus, joined.

The life sciences industry is seeing tremendous growth in Maryland, particularly in the D.C. suburb of Montgomery County. With nearly $6B invested in life sciences ventures in 2021 alone and more than 40,000 life sciences workers in the state, Montgomery County is the anchor of the fourth-largest biotech hub in the U.S.

The county’s life sciences market continues to expand its footprint with more biotech and pharmaceutical companies setting up shop in Rockville and other areas, drawn in by its skilled workforce. Also fueling the growth is the Montgomery County Economic Development Corp., which helps companies expand, relocate or start in the county. 

“We have the skilled labor force, the support of local universities, the Maryland Tech Council and a diverse population to help expand life sciences not only in Montgomery County but the state of Maryland,” MCEDC Senior Vice President of Business Development Brad Stewart said.

Precigen Receives FDA Clearance of IND to Initiate Phase 2 Study of PRGN-2009 Off-the-Shelf AdenoVerse Immunotherapy in Combination with Pembrolizumab to Treat Patients with Recurrent or Metastatic Cervical Cancer
Published: May 31, 2023

– HPV is responsible for more than 90 percent of cervical cancer cases globally with approximately 300,000 women living with cervical cancer in the US –

– Current response rates to second line treatments in recurrent or metastatic cervical cancer are very low and associated with a high rate of toxicity –

– PRGN-2009 is designed to generate de novo T-cell immune response against HPV 16/18-positive solid tumors cells and is differentiated from other platforms due to the ability of gorilla adenovectors to enable repeat administrations –

– PRGN-2009 Phase 1 data to be presented at the 2023 ASCO annual meeting on June 3 (Abstract # 2628); PRGN-2009 in combination with a checkpoint inhibitor demonstrated a favorable safety profile and resulted in a 30% ORR in patients with heavily pre-treated HPV-associated cancers, including those who have previously failed checkpoint inhibitors –

– Phase 2 study of PRGN-2009 is in combination with pembrolizumab in the second line setting in patients with recurrent or metastatic cervical cancer previously treated with pembrolizumab for recurrent or metastatic disease –

– CMC path in place to support delivery of product for Phase 2 study as well as future framework to support potential pivotal trials –

Entrepreneurs-in-Residence (EIR) Team Continues Growth With National Institutes of Health (NIH)

ROCKVILLE, MARYLAND, May 30, 2023 – BioHealth Innovation Inc. (BHI) proudly welcomes Claire Leurent, Ph.D. MBA, to its expanding Entrepreneurs-in-Residence (EIR) team. As part of BHI’s commitment to advancing disruptive technologies in healthcare, the Entrepreneur-in-Residence Program ensures that these innovations receive the necessary resources to transition from discovery to commercialization and make a measurable impact on human health. Claire will collaborate with the NIH Seed Program, supporting scientists, early-stage startups, and licensed technologies.

“We are excited to have Claire Leurent join our EIR team as we continue our collaboration with the National Institutes of Health,” said Richard Bendis, President and CEO of BHI. “Claire’s extensive expertise in venture capital investment and drug development perfectly aligns with our mission to drive innovation and transformative healthcare solutions.”

With a venture capital investor background and hands-on experience leading drug development from scientific discovery to registration studies, Claire Leurent is driven by her passion for science and dedication to improving lives through transformative technologies and business models. Her dynamic perspective and commitment to progress make her an invaluable addition to the BHI team.

What do you get when you combine a networking happy hour for STEM researchers, an engaging expert panel discussion and a host of exciting STEM inventions? The answer is one exciting event: the Maryland Innovation Initiative’s Pop-up at the University of Maryland, College Park (UMD) and Innovate Maryland: Invention of the Year Awards!

TEDCO and the Maryland Innovation Initiative (MII) were on hand to sponsor Innovate Maryland’s Invention of the Year Awards, held at The Hall on the University of Maryland’s College Park campus. Innovation was all around, encompassed by the various finalists and the Invention of the Year winner: a solar-powered system that uses all-natural, partly plant-based materials to extract drinkable water from the toughest environments.

Maryland is home to many talented researchers — in fact, it has the highest concentration of Ph.D.s of any state in the country, while also ranking #1 for its technology and science workforce. The MII recognizes the commercial possibilities coming out of the state’s creative faculty and supports these innovators by serving as a catalyst to both spur exciting startup projects at Maryland’s research universities and ignite an entrepreneurial mindset among faculty. Both of these elements were on

Click here to read more via Technical.ly

On May 26, 2023, Emergent BioSolutions Inc. (including its wholly-owned subsidiaries, “Emergent”), through its wholly-owned subsidiary, Emergent Product Development Gaithersburg Inc., received a contract modification from the Office of the Assistant Secretary for Preparedness and Response (“ASPR”), an agency of the U.S. Department of Health and Human Services (“HHS”), exercising and funding the third of nine annual contract term extension options (the “Third Option Exercise”) for Emergent to supply ACAM2000® (Smallpox (Vaccinia) Vaccine, Live) into the U.S. Strategic National Stockpile (the “SNS”). The Third Option Exercise is valued at approximately $120 million.

The Third Option Exercise was made under a bilateral modification of Emergent’s existing 10-year contract (the “Contract”) awarded by ASPR on August 30, 2019. The period of performance under the Third Option Exercise requires Emergent to deliver doses of ACAM2000 into the SNS by June 30, 2023.

The preceding description of the Third Option Exercise does not purport to be complete and is qualified in its entirety by reference to the Third Option Exercise. The Third Option Exercise, with relevant redactions to protect confidential and sensitive information, is expected to be filed as an exhibit to Emergent’s Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2023. The Contract is filed as a material agreement of Emergent as exhibit 10.48 with Emergent’s Annual Report on Form 10-K for the fiscal year ended December 31, 2019.

GAITHERSBURG, Md., May 25, 2023 /PRNewswire/ -- Hememics Biotechnologies, Inc., developer of first-in-class, handheld, multiplexed biosensor platform that can test antibodies, antigens and molecular targets simultaneously, announced today the closing of a $2 million Seed 2 financing round. Participants of this round include a strategic investor, existing investors and Maryland Technology Development Corporation (TEDCO).

"I am extremely proud of what the company has achieved with the limited amount of resources," said John Warden, Jr., CEO and Co-founder of Hememics Biotechnologies, Inc. "We have generated extremely favorable results from more than 100,000 biosensor experiments in the past nine months. The new funding will allow us to finalize our design, receive third-party validation, and develop early commercial customers." 

Rockville, MD, United States, May 23, 2023 – Advanced BioScience Laboratories (ABL), a global Contract Development and Manufacturing Organization (CDMO) for biotherapies,
oncolytics and viral vector vaccines, today announces it has been awarded a contract for ‘Resources to Advance Pediatrics and HIV Prevention Science (RAPPS)’ by the Division of AIDS
(DAIDS) within the National Institute of Allergy and Infectious Disease (NIAID) at the National Institutes of Health (NIH).

This seven-year contract has a total potential funding value of $98.9 million. ABL will provide DAIDS with (i) preclinical gap-filling, (ii) animal models, (iii) bioanalytical services, (iv)
product manufacturing and (v) other scientific and quality/regulatory services to support preclinical research, development of pediatric formulations and advancement of next generation non-vaccine Biomedical HIV Prevention products (nBPs) such as IntraVaginal Rings (IVRs), long-acting injectables and Multipurpose Prevention Technologies (MPTs) composed of a combination of drugs that can target prevention of pregnancy, Sexually Transmitted Infections (STIs) and/or HIV.

ROCKVILLE, Md., May 23, 2023 /PRNewswire/ --REGENXBIO Inc. (Nasdaq: RGNX) today announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation for RGX-121, an investigational one-time AAV Therapeutic for the treatment of Mucopolysaccharidosis Type II (MPS II), also known as Hunter syndrome. RMAT designation is designed to expedite the drug development and review processes for promising new treatments, including gene therapies, and recognizes that the preliminary clinical evidence from RGX-121 indicates its potential to address unmet medical needs for MPS II. RGX-121 is currently being studied in the CAMPSIITE™ trial that is enrolling MPS II patients as part of a pivotal program that incorporates material from the NAVXpress™ platform process manufactured at the REGENXBIO Manufacturing Innovation Center and continues to support plans to file Biologics License Application (BLA) in 2024 using the accelerated approval pathway.

COLUMBIA, Md. (May 23, 2023) – TEDCO, Maryland’s economic engine for technology companies, announced a Venture Funds investment of $300,000 into Pathotrak, a biotechnology company.

Javier Atencia“Until Pathotrak, producers would need to wait for the results of pathogen tests, leading to costly warehousing and refrigeration costs,” said Javier Atencia, CEO and founder of Pathotrak. “Through our innovative solution, we are eliminating this need by cutting down the time it takes to get results, which will also help prevent costly recalls and food waste.”

Pathotrak, based in College Park, Md., is a business with the mission to create a world with fresher and safer food using cost-efficient innovative technology. This technology will allow the expedition of foodborne pathogen detection, providing companies and producers with faster results, and ultimately shortening what is typically a 22-hour process down to under six hours. This rapid detection process has the potential to decrease food waste, allowing products to be placed on shelves up to an entire day earlier while also reducing the costs of food production—from the costly warehousing and refrigeration processes to the expensive recalls.

Maryland medical device company supports patients and medical professionals through safer needle filtration device

COLUMBIA, Md. (May 22, 2023) – TEDCO, Maryland’s economic engine for technology companies, announced a recent Seed Funds investment of $250,000 into CarrTech Corp., a medical device company. TEDCO’s Seed Funds invest in early-stage, technology and life sciences companies and provides access to gap financing.

“The current eight-step process healthcare professionals are required to take to administer certain medicine is inefficient and high-risk of needlestick injuries and glass shard contamination to the patient,” said Sue Carr, founder of CarrTech Corp. “By eliminating the need to attach and detach multiple needles, patients are able to get access to the medication they need faster and safer.”

The most recent round of seed funding came from its Life Science Investment Fund; investments are for companies in the process of developing a technology for a product for human health that requires approval from the United States Food and Drug Administration prior to market.

Summary and analysis of Maryland's suburban current economic and office real estate market conditions.

Click here to read the entire report.

Pharmacy Times® interviewed Harsha Rajasimha, PhD, founder and CEO of Jeeva Informatics, on the potential to accelerate patient recruitment and solve clinical trial delays. Currently, the research, development, and approval process of a new drug by the FDA can take between 12 to 15 years. However, studies have shown patient recruitment issues are the cause of 85% of clinical trial delays.

Pharmacy Times: What are the different phases of the drug approval process by the FDA?

Harsha Rajasimha: Typically, drug approval process involves a preclinical phase, which enables first-in-human clinical trial for a new drug or entity. And that goes through phase 1, phase 2, phase 3 trials, typically. And sometimes there can be phase 1 and 2, or phase 2 and 3 combined, and stuff like that, and different types of trial designs these days, but typically phase 1, phase 2, phase 3, where phase 1 is entirely looking at safety of the drug in humans, because it's only tested in animals. Phase 2, looking at safety and efficacy at very low doses to make sure there is some drug effect. And phase 3 is full-fledged in a larger population, to assess the safety and efficacy profile across the range of doses in a range of patients in the target population. And after that, all of this data gets wrapped into an FDA submission for review. And the whole process from phase 1 to phase 3 and the review process can take about 7 years, typically, sometimes longer. And so, it's a very expensive and time-consuming process. And this process is often called the “Valley of Death,” because only 1 in 9, 1 out of 10 drugs actually make it through the regulatory approval. Most of them will fail at phase 1, or phase 2, or phase 3, about 30% at each phase. So, very few drugs make it to market.