BHI Weekly Newsletter Archives Archives - Page 14 of 65

Jun 06 2023

561st Edition, June 6, 2023

By admin BHI Weekly Newsletter Archives

BioHealth Capital Region Secures Top 3 Spot in CBRE’s 2023 Life Sciences Talent Report Amidst Booming Industry Growth

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.

Precigen Receives FDA Clearance of IND to Initiate Phase 2 Study

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 –

CBIC of Virginia Names AMPEL BioSolutions as Innovator-of-Year

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.

TEDCO’s The Leading Edge Special Feature at the University of Maryland, College Park, Highlighting MII Awardee

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.”

Novavax Announces Agreement with Bill & Melinda Gates Medical Research Institute to Include Matrix-M™ Adjuvant as Potential Component in Vaccine Research

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.”

BISNOW/MCEDC: With Multimillion-Dollar Acquisitions And Developments, Life Sciences To Boom In Montgomery County, Maryland

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.

Biomedical innovation | Deloitte Insights – Unlocking the potential of biomedical innovation: The crucial role the government and partnerships play in accelerating progress

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.

May 31 2023

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560th Edition, May 31, 2023

By admin BHI Weekly Newsletter Archives

BioHealth Innovation Welcomes Entrepreneur-in-Residence Claire Leurent, Ph.D. MBA at NIH’s SEED Program

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.

Emergent BioSolutions Announces the Execution of Contract Option to Deliver ACAM2000 into the Strategic National Stockpile

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’s Adaptive Phage Therapeutics Enters Collaboration and License Agreement with Hebrew University of Jerusalem and Hadassah Medical Center

GAITHERSBURG, Md.–(BUSINESS WIRE)–Adaptive Phage Therapeutics, Inc. (APT), a clinical-stage biotechnology company pioneering the development of phage-based therapies to combat bacterial infections, is pleased to announce a collaboration and license agreement with the Israeli Phage Therapy Center (IPTC) of the Hebrew University of Jerusalem and Hadassah Medical Center. Researchers at the IPTC have discovered several phages that have exceptionally broad coverage against antibiotic resistant bacteria. Under the agreement, Hadasit and Yissum, the technology transfer companies of Hadassah and the Hebrew University, grants APT exclusive rights to make, use, and sell licensed phages for human therapy, with the right to sublicense through multiple tiers. APT also has the first right to evaluate additional phages discovered by IPTC researchers for inclusion in APT’s phage bank. As consideration for the license and first right of refusal, APT made an upfront payment and will pay royalties from net sales on any therapeutic composition comprising a licensed phage.

Rockville’s REGENXBIO Receives FDA Regenerative Medicine Advanced Therapy (RMAT) Designation for RGX-121 Gene Therapy for Hunter Syndrome

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.

ABL awarded seven-year NIH contract for continued support in HIV prevention products

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.

Hememics Biotechnologies, Inc. Announces Successful Close in $2 Million Seed 2 Financing from TEDCO and Qualified Investors to Accelerate Growth

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.”

Technical.ly: Meet the Maryland innovators behind the state’s best 2023 inventions

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

TEDCO Announces Investment into Pathotrak

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.

May 23 2023

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559th Edition, May 23, 2023

By admin BHI Weekly Newsletter Archives

From Genomic Tests to AI Predictions: Dr. Amrie Grammer, Co-Founder of AMPEL BioSolutions, Joins BioTalk

Can you envision a world where precision medicine transforms healthcare as we know it? Tune in to this exciting episode of BioTalk with Rich Bendis, featuring Dr. Amrie Grammer, Co-Founder of AMPEL BioSolutions. In this enlightening discussion, Dr. Grammer unveils the secrets behind AMPEL’s remarkable success in precision medicine, making this episode a must-listen. Learn about the groundbreaking genomic tests developed by AMPEL, providing decision support for autoimmune diseases, and delve into the role of artificial intelligence in predicting potential treatments.

Explore the immense potential for a revolution in healthcare as Dr. Grammer shares insights on understanding the human genome and AMPEL’s cutting-edge work in harnessing Big Data and Machine Learning for personalized precision medicine. Don’t miss this great episode and gain valuable insights into the future of data-driven health.

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TEDCO Announces Investment into CarrTech Corp.

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.

Virginia Catalyst Announces AMPEL as Grant Round 14 Awardee

RICHMOND, VA – May 18, 2023 – The Virginia Catalyst, also known as the Virginia Biosciences Health Research Corporation (VBHRC), today announced that it has awarded $2 million in grants to four life and bioscience projects in the Commonwealth of Virginia, pending execution of the grant agreements. These grants, which will be met with significant matching funds from partner companies, were awarded through Grant Round 14 of Virginia Catalyst’s ongoing mission to stimulate economic development by promoting collaborative projects that address large, unmet needs for improving human health, and that can create high-paying jobs in the Commonwealth.

TEDCO Announces SSBCI Investment into N5 Sensors

Maryland-based business protecting individuals and businesses from environmental hazards through the use of its innovative sensor technology

COLUMBIA, Md. (May 22, 2023) – TEDCO, Maryland’s economic engine for technology companies, announced a recent State Small Business Credit Initiative (SSBCI) investment of nearly $400,000 into N5 Sensors, Inc. This SSBCI investment was made through TEDCO’s Seed Funds.

“Environmental hazards are not always preventable, but detecting these hazards can support the safety of everyone in the area,” said Abhishek Motayed, Ph.D., CEO of N5 Sensors. “I’m thankful for TEDCO’s interest and support—with this additional funding, we can continue our research and find new ways to help provide safety to everyone.”

N5 Sensors, based in Rockville, Md., is a startup company with a mission to keep people safe form environmental hazards. This process is done using a cloud-connected ecosystem of smart sensors that utilize and leverage the endless possibilities of shared data and artificial intelligence. Through this approach, the company has developed a variety of products and solutions, each with the goal of helping individuals stay safe from various environmental hazards.

Baltimore’s Flavocure Biotech Announces FDA Clearance of IND Application for Caflanone (FBL-03G), for Clinical Trials in Pancreatic Cancer Patients.

Baltimore, Maryland–(Newsfile Corp. – May 17, 2023) – Flavocure Biotech, Inc. (“Flavocure”), today announced that it has received clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) to initiate a Phase I, first-in-human clinical study of Caflanone (FBL-03G) for the treatment of pancreatic cancer. Pancreatic Ductal Adenocarcinoma (PDAC) accounts for about 2% of all cancers and is associated with 5% of cancer‐related deaths. Caflanone treatment is combined with radiotherapy (RT) for enhanced efficacy against cancer cells.

“We are thrilled to obtain clearance to advance Caflanone (FBL-03G) into clinical trials and are excited about the prospects of what this new class of therapeutic agent may mean for cancer patients,” said Dr. David G. Brooks, MD, Ph.D., Interim Chief Medical Officer of Flavocure Biotech, Inc. “This is an important milestone for our company, representing our first program to receive FDA clearance to proceed into a clinical trial. This new approach combining radiotherapy with our lead drug candidate, caflanone, leverages our groundbreaking science and has broad potential applicability in many therapeutic areas,” said Dr. Ngeh J. Toyang, Ph.D., Chief Executive Officer and co-Founder of Flavocure Biotech, Inc.

PQE Group US Earns 2023 Great Place To Work Certification™

PQE Group receives certification in the U.S. as a work environment where “you trust the people you work for, take pride in what you do, and have fun with the people you work with.”

May 18, 2023, Washington DC — PQE Group US is proud to be Certified™ by Great Place To Work® for the second year in a row. This esteemed recognition is solely based on the feedback of our present employees regarding their work experience at PQE Group. This year, a remarkable 91% of our employees expressed their satisfaction with their workplace, which is 34 points higher than the average U.S. Company.

Great Place To Work® is the global authority on workplace culture, employee experience, and the leadership behaviors proven to deliver market-leading revenue, employee retention and increased innovation. “Great Place to Work Certification is a highly coveted achievement that requires consistent and intentional dedication to the overall employee experience,” says Sarah Lewis-Kulin, the Vice President of Global Recognition at Great Place To Work. She emphasizes that Certification is the sole official recognition earned by the real-time feedback of employees regarding their company culture. “By successfully earning this recognition, it is evident that PQE Group stands out as one of the top companies to work for, providing a great workplace environment for its employees.”

JLL Life Sciences Observations Suburban Maryland Q1 2023

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

Click here to read the entire report.

REGENXBIO Announces NAV® Technology Platform Will Support Bespoke Gene Therapy Consortium’s First Rare Disease Clinical Portfolio

ROCKVILLE, Md., May 16, 2023 /PRNewswire/ — REGENXBIO Inc. (Nasdaq: RGNX) today announced that preclinical research in Mucopolysaccharidosis type IVA (MPS IVA), also known as Morquio syndrome, was selected for inclusion in the Foundation for the National Institutes of Health Accelerating Medicines Partnership® Bespoke Gene Therapy Consortium (AMP® BGTC), clinical trial portfolio. The Consortium brings together partners such as NIH and FDA, as well as partners from private and non-profit sectors.

Sponsored by Nemours Children’s Hospital, MPS IVA is one of eight programs selected as part of AMP® BGTC’s first clinical portfolio to help accelerate the development of bespoke gene therapies, with the goal of streamlining the regulatory approval process. MPS IVA is a metabolic condition that primarily affects the skeleton, and is estimated to impact 1 in 200,000 to 300,000 individuals.

Harsha Rajasimha, PhD, founder and CEO of Jeeva Informatics discusses current challenges leading to clinical trial delays, such as the “valley of death.”

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.

May 16 2023

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558th Edition, May 16, 2023

By admin BHI Weekly Newsletter Archives

Navigating the Challenges of Rare Disease Research with Dr. Harsha Rajasimha on BioTalk

Join us for an enlightening episode of BioTalk with Rich Bendis as we explore the pivotal role of patient registries in rare disease research and treatment. Our guest, Harsha Rajasimha, MS, Ph.D., CEO of Jeeva Informatics Solutions and Founder and Executive Chairman of IndoUSrare, shares his extensive experience in clinical genomics data science and precision medicine.

In this episode, Dr. Rajasimha introduces Jeeva Informatics Solutions and IndoUSrare, his non-profit organization. He discusses the importance of patient registries in accelerating rare disease research, the current obstacles in the field, and the potential solutions.

We discuss the role of governments in rare disease research and treatment and the potential for collaboration with non-profits in clinical trials. Finally, Dr. Rajasimha shares the goals of the upcoming Indo-US Rare Summit at the GMU Campus in Arlington, VA.

Tune in for valuable insights from a leader in rare disease research and patient advocacy.

Listen now via your favorite podcast platform

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BHI EIR Renée JG Arnold Shares Expertise at the 28th Annual International ISPOR Meeting

Renée JG Arnold, PharmD, RPh, who serves as an Entrepreneur-in-Residence at BHI NHLBI EIR, recently moderated and participated in a panel discussion at the 28th Annual International meeting of ISPOR, which was held on May 8, 2023 in Boston. The panel, titled “Blazing the Trail for Digital Health Innovation: Resources and an Example Based on a Digital Health Application for Dementia Family Caregivers,” was attended by 75 delegates and focused on various aspects of digital health application development. Topics included the challenges and opportunities associated with the development of digital health applications, available NIH grants and product development resources, real-world experience in developing digital health solutions, and emerging regulations in the US for digital health.

After the panel discussion, Arnold and the other panelists continued the conversation with 15 attendees in a separate venue, where they further explored various aspects of digital health applications. Other panelists included Kathleen Rousche, PhD, Director of the Innovation & Commercialization Office at NHLBI; Eric Jutkowitz, PhD, an Associate Professor at Brown University; and Anindita (Annie) Saha, the Assistant Director of the Digital Health Center of Excellence at the US Food and Drug Administration.

BHI’s EIR Ethel Rubin, Ph.D., Joins JLABS @ NYC Roundtable

Ethel Rubin, Ph.D., an Entrepreneur-in-Residence at BioHealth Innovation, Inc. (BHI), recently participated in a “CEO Roundtable” for JLABS @ NYC. The discussion revolved around various financing strategies for biotech companies. In addition to Dr. Rubin, the roundtable also featured Sally Allain, MBA, M.S., Head of JLABS @ Washington, DC, and Board Member of BHI. Her participation added further depth to the discussion, bringing in her unique insights and experiences in the biotech sector.

The roundtable brought together CEOs from the biotech sector to discuss various topics. These included the different types of investors in the biotech space and strategies for identifying and engaging with them. The participants also delved into the concept of an investment thesis, a guiding principle that dictates the kind of opportunities investors seek.

The conversation also touched on the current environment for biotech financing. The CEOs discussed the importance of preparedness in this dynamic and competitive landscape, including having a solid business plan, a clear value proposition, and a strong management team.

Non-dilutive funding, which includes grants, contracts, and other forms of funding that do not require giving up equity, was also discussed. The role of such funding as part of a comprehensive financing strategy was explored.

The roundtable participants also examined the role of corporate venture capital (VC) and pharma partners in biotech financing. They discussed the potential benefits and challenges of partnering with these entities, which can provide funding, strategic support, and resources.

The CEOs shared their perspectives on securing deals, current trends, and factors influencing the landscape. They also touched on the role of brokers/dealers, intermediaries in the securities market, in a biotech company’s financing strategy. The roundtable offered a comprehensive exploration of biotech financing strategies, with Dr. Rubin and other CEOs sharing their insights and experiences.

BHI/NIH EIR Anna Zornosa Moderates Panel of Experts: Unlocking Reimbursement for Innovators in Maternal Health Solutions

Reimbursement is key to the success of innovators who have products, therapies, and new modes of service for expectant and new mothers. Not only is it key to have the codes and contracts that are critical to billing, the payors themselves (both commercial and Medicaid) open the door to meeting the moms and babies for whom the products are intended.

Anna Zornosa (seated on the right), EIR with both BHI and the NIH, moderated a panel featuring three OB GYNS who represent key sectors of the reimbursement ecosystem: Dr. John Keats (first on the left), a maternal health expert with Cigna, represented the commercial insurer viewpoint; Dr. Barbara Levy, vice-chair of the AMA’s CPT panel, represented the view of how codes are established; and Dr. Miguel Fernandez (third from the left), spoke of his experience with Medicaid programs as Chief Medical Officer of Aetna Better Health of Florida. The three concurred that innovators need to lead with data showing the impact of their innovations on patients’ outcomes as the basis of initial conversations. The lively panel brought to life examples of successful innovator-reimbursement partnerships and responded to dozens of audience questions.

Rockville’s MaximBio Inks Contract with National Institutes of Health (RADx) Centered on a new Rapid Platform

ROCKVILLE, Md. , May 9, 2023 /PRNewswire/ — MaximBio® is proud to announce it has signed a new agreement with the National Institutes of Health (NIH) through the Rapid Acceleration of Diagnostics (RADx® ) initiative, continuing a relationship fostered during the height of the COVID-19 pandemic. Building on their previous collaboration which resulted in the successful launch of the MaximBio ClearDetect® COVID-19 Antigen Home Test, the new partnership is centered around development of a COVID-19 and Influenza A/B combo test employing novel Lateral-Flow Technology. This technology, paired with the innovative FiarFly™ analyzer platform, and MaximBio’s proprietary manufacturing techniques, results in class-leading assay performance.

The FiarFly™ platform is a flexible, low-cost solution designed to bring diagnostic testing closer to the patient, providing lab-comparable performance in the home at an affordable cost. The pocket-sized, battery powered reader, created for maximum accessibility and ease of use, can produce results at a higher performance (sensitivity) and at a cost comparable to visually read home-use tests. The platform allows for an expanded menu of tests on a single device and includes HIPAA-compliant connectivity for EMR results reporting.

In a recent interview, Jonathan Maa, MaximBio Inc. COO, pointed to the company’s previous success and experience with RADx and expanded U.S. manufacturing capabilities as some of the primary factors leading to the new collaboration. “Our upgraded infrastructure allows us to produce in excess of 100 million tests annually, right here in the United States,” he pointed out. He went on to say, “We are looking forward to working again with the NIH on this exciting new project and the opportunity to offer the market an innovative, yet affordable, diagnostic platform to transform the future of at-home testing solutions.”

This project has been funded in part with Federal funds from the National Institute of Biomedical Imaging and Bioengineering (NIBIB), National Institutes of Health, Department of Health and Human Services, under Contract No. 75N92023D00001.

USP to Host the 2023 BioHealth Capital Region Forum, Investment Conference, & Crab Trap Competition on September 19, 20 & 21

BioHealth Innovation, Inc. (BHI) is proud to announce that US Pharmacopeia (USP) will be hosting the 9th Annual BioHealth Capital Region Forum for the second year in a row on September 19th and 20th, 2023. In addition to this flagship event, USP will also host the 8th Annual BioHealth Capital Region Crab Trap Competition on September 20th and the 6th Annual BioHealth Capital Region Investment Conference on September 21st.

“We are looking forward to once again hosting the BioHealth Capital Region Forum. As an integral part of this dynamic region, USP is deeply committed to fostering innovation and collaboration across the BioHealth space. USP eagerly anticipates bringing together leading minds and stakeholders to advance our shared vision for the future.” said Anthony Lakavage, J.D., SVP of Global External Affairs at USP.

President Biden Announces Intent to Nominate Dr. Monica Bertagnolli as Director of the National Institutes of Health

Today (May 15, 2023), President Biden announced his intent to nominate Dr. Monica Bertagnolli as Director of the National Institutes of Health (NIH), the world’s preeminent biomedical research organization. Dr. Bertagnolli is a world-renowned surgical oncologist, cancer researcher, educator, and physician-leader who has the vision and leadership needed to deliver on NIH’s mission to seek fundamental knowledge and promote human health.

Statement from President Biden: “Dr. Bertagnolli has spent her career pioneering scientific discovery and pushing the boundaries of what is possible to improve cancer prevention and treatment for patients, and ensuring that patients in every community have access to quality care.

As Director of the National Cancer Institute, Dr. Bertagnolli has advanced my Cancer Moonshot to end cancer as we know it. She has brought together partners and resources from different sectors to launch groundbreaking efforts in cancer prevention and early detection, a national navigation program for childhood cancers, and additional programs to bring clinical trials to more Americans.

Women In Bio announces appointment of Gina Ford as Executive Director

Women In Bio is proud to announce that Gina Ford has joined our team as Executive Director. Gina brings a wealth of experience, having worked in the life science and non-profit industries for years. She is a champion of women in the sciences, and we are thrilled to have her guide WIB into the future.

As WIB nears the conclusion of its latest 3-year Strategic Plan and looks ahead to the future, we are thrilled to have Gina at the helm. Her leadership will continue to drive positive changes that will elevate our operational excellence, enrich our existing programming, and reinforce WIB’s position as a premier organization for women impacting the life sciences and beyond.

“After an extensive search with hundreds of candidates, I am thrilled for Gina Ford to serve as the WIB Executive Director.” WIB President Azurii K. Collier, Ph.D. shared. “As a pharmacist by training, prior association Executive Director, and a formidable corporate executive, we believe Gina will identify and deliver on big audacious ideas. Gina is the right leader for WIB’s growth phase, and I look forward to all we will achieve together in a One WIB spirit.”

Gina Ford is a highly experienced professional with 20 years of expertise in life sciences, biotech, and pharmaceutical industries. Throughout her career, she has held leadership roles in Corporate Strategy, Commercial, Portfolio Management, Business Development and Patient Advocacy.

As the new Executive Director of Women In Bio, I am honored to lead an organization comprised of some of the most talented and accomplished women in the life science industry. Women In Bio has established itself as the premier organization dedicated to advancing women in our industry, and I am excited to work with our members and partners to continue this legacy. Together, we will drive progress toward greater gender diversity and equity and ensure that women have equal opportunities to thrive and succeed in the life sciences and beyond. – Gina Ford, WIB Executive Director

Join AURP in Boston for a Deep Dive into Building Communities of “Biotech Innovation”!

Before the 2022 BIO International Conference begins in San Diego join AURP for an in-person conference focused on building research space supporting communities of bio innovations. Developers, A/E firms, researchers, economic development reps, VC firms, and bio innovation district managers will want to attend.

Wet Lab Incubator and Flex Space: What Every Community Wants
Diversifying Your Talent Pool Though University Real Estate Programs
The Future of Labs: Will Digital Bio Lesson Demand for Wet Labs?
Where is Lab Space Being Developed?
New Federal Funding Programs for Bio Research and Bio Clusters
Patents in Your Park: The Role of IP Protection

https://www.aurp.net/bio-health-caucus

Raising Awareness: Indo US Bridging RARE Summit 2023 to Shine a Spotlight on Rare Diseases

Scheduled for October 29-30, 2023, at the George Mason University Campus in Arlington, VA, the Indo US Bridging RARE Summit 2023 aims to unite the global rare disease community and raise awareness about these conditions. While rare diseases are increasingly understood in the United States and Europe, there remains a lack of awareness in other parts of the world, including India. By addressing this gap, the summit aims to make a positive impact on the lives of 1.5 billion people in India and the global population of 8 billion.

Bringing together leaders representing diverse stakeholders in rare diseases, the summit serves as a platform for knowledge-sharing, exchanging experiences, and fostering collaborations to address the challenges faced by rare disease patients and their families. The event covers crucial themes such as cross-border patient engagement, care pathways encompassing screening, diagnosis, and treatment options, digitization of rare diseases including registries and emerging markets, diversity, equity, and inclusion in the globalization of orphan drugs, orphan drug clinical trials, and regulatory pathways.

IndoUSrare, the organizing body behind the summit, is committed to connecting rare disease patients worldwide and prioritizing education, research, and engagement to enhance their quality of life.

For sponsorship opportunities and event information, interested individuals can contact summit@indousrare.or and visit https://www.indousrare.org/summit/. The Indo US Bridging RARE Summit 2023 is an important platform for collaboration and knowledge exchange to make a positive impact on the rare disease community worldwide.

The summit planning committee includes prominent individuals representing various organizations and institutions involved in rare disease research and advocacy. Some of the committee

May 09 2023

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557th Edition, May 09, 2023

By admin BHI Weekly Newsletter Archives

TEDCO Announces Investment into Rise Therapeutics

Biotech company receives follow-on funding to accelerate ongoing clinical development efforts

COLUMBIA, Md. (May 8, 2023) – TEDCO, Maryland’s economic engine for technology companies, announced a recent Seed Funds investment of $200,000 into Rise Therapeutics, a Maryland-based biotechnology company. TEDCO’s Seed Funds invest in early-stage, technology and life sciences companies and provides access to gap financing.

“We are thrilled to receive this follow-on investment from TEDCO,” said Gary Fanger, Ph.D, president and CEO of Rise Therapeutics. “This funding will allow us to accelerate our ongoing clinical development efforts and move closer to bringing our synthetic biology-based immunotherapy drugs to market; we are grateful to TEDCO for their support.”

US FDA approves GSK’s Arexvy, the world’s first respiratory syncytial virus (RSV) vaccine for older adults

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.”

MaxCyte Signs Strategic Platform License with Walking Fish Therapeutics to Support the Development of its Innovative B Cell Platform

Walking Fish to use MaxCyte’s Flow Electroporation® technology and ExPERT™ platform to engineer novel B-cell based medicines for the treatment of serious diseases

ROCKVILLE, Md., May 04, 2023 (GLOBE NEWSWIRE) — MaxCyte, Inc., (Nasdaq: MXCT; LSE: MXCT), a leading, cell-engineering focused company providing enabling platform technologies to advance the discovery, development and commercialization of next-generation cell-based therapeutics and to support innovative, cell-based research, today announced the signing of a strategic platform license (SPL) with Walking Fish Therapeutics, Inc. a biotechnology company that is rapidly advancing B cell-based therapeutics.

Under the terms of the agreement, Walking Fish obtains non-exclusive clinical and commercial rights to use MaxCyte’s Flow Electroporation® technology and ExPERT™ platform. In return, MaxCyte is entitled to receive platform licensing fees, clinical milestone payments and sales-based payments.

Gain Therapeutics Awarded CHF 2.5 million Innosuisse Grant to Advance Lead Program in GBA1 Parkinson’s Disease

BETHESDA, Md., May 03, 2023 (GLOBE NEWSWIRE) — Gain Therapeutics, Inc. (Nasdaq: GANX), a biotechnology company leading the discovery and development of allosteric small molecule therapies, today announced that Innosuisse, the Swiss Innovation Agency, supports GT Gain Therapeutics SA with the amount of CHF 2.5 million (~$2.8 million) to develop GT-02287, Gain’s lead program for GBA1 Parkinson’s disease.

The Company’s Swiss Accelerator innovation project supported by Innosuisse entitled “Harnessing Structurally Targeted Allosteric Regulators to treat Parkinson’s Disease” includes clinical pharmacology and preclinical studies with the Company’s drug candidate GT-02287, which will be conducted as the lead program progresses through Phase 1 and Phase 2 clinical studies in GBA1 Parkinson’s disease.

Discover the Future of Pediatric Healthcare: Register Now for the 2023 Children’s National Innovation Day & Showcase

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.

USP to Host the 2023 BioHealth Capital Region Forum, Investment Conference, & Crab Trap Competition on September 19, 20 & 21

BioTalk: Ensuring Quality and Compliance with Gaurav Walia – Mastering the Art of CSV in Life Sciences

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

May 02 2023

Love0

556th Edition, May 02, 2023

By admin BHI Weekly Newsletter Archives

BioTalk: Ensuring Quality and Compliance with Gaurav Walia – Mastering the Art of CSV in Life Sciences

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

USP to Host the 2023 BioHealth Capital Region Forum, Investment Conference, & Crab Trap Competition on September 19, 20 & 21

Virginiabusiness.com: Betting on biotech, U.Va. institute may lead to research boom

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.

Emmes Applauded by Frost & Sullivan for Streamlining Clinical Trials and for Its Competitive Strategies

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.

Germantown’s Seraxis Presents Successful Results Using Synthetic Replacement Endocrine Clusters for Type 1 Diabetes

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.

NanoFCM Partners with Frederick,MD’s RoosterBio as an Approved Service Provider for Exosome Analysis

PR Newswire Wed, April 26, 2023 at 3:05 PM EDT

In this strategic partnership, RoosterBio becomes the first US-based service provider approved by NanoFCM to perform contract analytical services using the NanoAnalyzer platform.

FREDERICK, Md., April 26, 2023 /PRNewswire-PRWeb/ — NanoFCM Co., Ltd today announced that RoosterBio, Inc. a leading supplier of human mesenchymal stem/stromal cells (hMSCs), highly engineered media, development services, cell engineering, and advanced therapy bioprocess solutions, is approved to provide analytical services worldwide using NanoFCM’s NanoAnalyzer.

In this strategic partnership, RoosterBio becomes the first US-based service provider approved by NanoFCM to perform contract analytical services using the NanoAnalyzer platform. RoosterBio has leveraged the NanoAnalyzer in its exosome / extracellular vesicle (EV) analytics workflows for over a year and offers this technology as a stand-alone service as well as integrated within broader exosome process development programs.

NoVa Renewable Chemical Innovator Capra Biosciences to Build a Green Biochemical Production Facility in Manassas, VA

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.”

Discover the Future of Pediatric Healthcare: Register Now for the 2023 Children’s National Innovation Day & Showcase

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

JLABS Event to Explore Breakthroughs in Vaccinations: Overcoming Seasonal Dependencies

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.

Biggest Risk Factors for Emerging and Mid-market Biopharma Companies, Costly Clinical Trial Delays

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

Apr 25 2023

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555th Edition, April 25, 2023

By admin BHI Weekly Newsletter Archives

Rich Bendis to Discuss U.S. Capital Region’s Role in APEC Dialogue on Medical Product Supply Chain on April 25th at USP

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

Mason engineers and partners receive $3M award to build new technology for personalized musculoskeletal injury rehabilitation to support troop readiness

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.

USP to Host the 2023 BioHealth Capital Region Forum, Investment Conference, and Crab Trap Competition

The BioHealth Capital Region (BHCR) stands as one of the largest and most vibrant biohubs in the United States, boasting a unique and unparalleled concentration of assets in the life sciences and biotechnology sectors. Situated within the dynamic corridor that encompasses Washington, D.C., Maryland, and Virginia, the BHCR is home to key federal agencies such as the Food and Drug Administration (FDA) and the National Institutes of Health (NIH), which contribute to the region’s stature as a center of cutting-edge research and regulatory expertise. In addition to these government entities, the BHCR is also home to world-class BioHealth companies that drive innovation and development in the field. Complementing this ecosystem is the presence of top-tier educational institutions that foster a highly skilled workforce and provide research and collaboration opportunities. Collectively, these one-of-a-kind assets establish the BioHealth Capital Region as a premier destination for biotech innovation, collaboration, and growth.

“We are thrilled to embark on another year of fostering innovation and collaboration within the biohealth industry. The upcoming BioHealth Capital Region Forum, the Investment Conference, and the Crab Trap competition represent exciting opportunities to engage with industry leaders, showcase groundbreaking ideas, and foster valuable partnerships. I want to extend my heartfelt thanks to The United States Pharmacopeial Convention (USP) for graciously hosting these events for the second year in a row in 2023. Their dedication to advancing global health and their support for this region is commendable. Together, we will continue to drive forward the vision of a healthier and brighter future for all.” — Rich Bendis, President, and CEO, BioHealth Innovation

Gain Therapeutics Revolutionary Drug Discovery: Combining Physics, Biochemistry, and Supercomputing

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.

REGENXBIO Receives FDA Fast Track Designation for RGX-202, a Novel Gene Therapy Candidate for the Treatment of Duchenne Muscular Dystrophy

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.

CBRE – 2023 Life Sciences Reports

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:

Maryland Life Sciences Q1 2023 ReportLife Sciences Q1 2023 Report

2023 U.S. Life Sciences Outlook

Maryland General Assembly passes legislation to create TEDCO Equitech fund – BizJournals

By Matt Hooke – Reporter

April 20, 2023, 03:04pm EDT

The Maryland General Assembly passed a bill that would establish a Maryland Technology Development Corp. (TEDCO) fund to promote job growth and minority inclusion in the sciences.

Both chambers passed House Bill 781 earlier this month, which establishes the Equitech Growth Fund to send state funding to projects that expand the economy through infrastructure investment and create a diverse workforce through job training programs. The bill, which is awaiting Gov. Wes Moore‘s signature, would require $5 million annually in the state budget from 2025 through 2033 to pay for the fund. A spokesperson for the governor did not immediately say whether Moore would sign the bill when contacted Thursday.

The fund would invest in public, nonprofit and private entities to attempt to stimulate employment opportunities in the technology industry. The specific mechanics of the fund, such as what stage of companies it will focus on, and whether the fund will give out money in a specific ratio of loans, grants and/or equity investments, is still undecided, TEDCO CEO Troy LeMaile-Stovall said.

A 2023 report by TEDCO found that Maryland’s job growth in the high tech industry lags behind other states, ranking 28th in the country in annual job growth rate in the sector at 1.6% annually over the past 10 years. The report says that, while Maryland is the country’s 15th largest economy by gross domestic product (GDP), the state’s GDP growth is below the national average and “Maryland’s high-tech industry will need to grow much faster to increase Maryland’s real GDP growth rate over the next 10 years.”

“The governor has said it best: We are asset-rich, but strategy-poor,” LeMaile-Stovall said.

JLABS Event to Explore Breakthroughs in Vaccinations: Overcoming Seasonal Dependencies

Maryland Tech Council Announces 2023 ICON Awards Finalists

Winners will be revealed at the celebration on April 27th

The Maryland Tech Council (MTC) is proud to announce the ICON awards finalists for its annual Industry Awards Celebration. The event honors individuals and companies in the life sciences, technology, and government contracting industries that have made a significant impact in their respective fields. This year there were ninety-three nominations in eleven categories. Two new award categories have been added this year: Investor of the Year and C-Suite of the Year. The winners will be announced live on April 27^th at the Bethesda North Marriott Hotel & Conference Center. Click here to learn more about the event.

“The Maryland Tech Council is excited to present this year’s ICON Awards. The finalists highlight the best and brightest in the fields of life sciences, technology and government contracting. We are looking forward to hosting Maryland’s greatest night of networking and celebrating the winners,” said IAC committee Co-Chair and Corporate M&A Partner at Pillsbury Winthrop Shaw Pittman, Nicole Islinger.

Apr 18 2023

Love0

554th Edition, April 18, 2023

By admin BHI Weekly Newsletter Archives

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April 18, 2023

FOUNDING MEMBER OF

USP to Host the 2023 BioHealth Capital Region Forum, Investment Conference, and Crab Trap Competition

"We are looking forward to once again hosting the BioHealth Capital Region Forum. As an integral part of this dynamic region, USP is deeply committed to fostering innovation and collaboration across the BioHealth space. USP eagerly anticipates bringing together leading minds and stakeholders to advance our shared vision for the future." said Anthony Lakavage, J.D., SVP of Global External Affairs at USP.

BHI Entrepreneur-in-Residence with NIH/NHLBI, Renée Arnold, Leads Trailblazing Discussion on Digital Health Innovation and Regulation for Dementia Caregiver Apps at ISPOR 2023 Conference

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.

Charlotte’s Tanner Pharma Group and Rockville’s ExeGi Pharma Announce Partnership to Distribute High Potency Probiotic

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.

Altimmune Completes Enrollment In Phase 2 Clinical Trial Of HepTcell™, An Immunotherapeutic For Chronic Hepatitis B

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.

REGENXBIO Receives FDA Fast Track Designation for RGX-202, a Novel Gene Therapy Candidate for the Treatment of Duchenne Muscular Dystrophy

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).

Maryland Industrial Partnerships (MIPS) – Proposals are due May 1!

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.

BizJournals – Baltimore digital health startup Scene Health raises $17.7 million in funding

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

BioBuzz: Here Are Several BioHealth Capital Region Life Science Companies Hiring Right Now: Q2 2023

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.

Sr. Director, Head of Quality Control

The senior director, head of quality control will be responsible for leading a commercial manufacturing site Quality Control organization, including analytical, microbial, technical services and sample management groups and activities for cell therapy products. The position also calls for the director to advance technology integration in the labs and methods to cultivate COGM reduction. A qualified candidate will possess an advanced scientific degree, such as an MD, PhD or PharmD, and 12+ years’ experience in Quality Control Biopharmaceuticals or a master’s degree and 12+ years’ experience in Quality Control Biopharmaceuticals.

White House amps up COVID vaccine development with Project NextGen

he 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

TRUiC: 19 Best Angel Investor Groups for Startups

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

The decision to seek angel investment to launch your startup is the first step, the second step is finding the top angel investors to secure startup capital from. Fortunately, we have a list of the best angel investor groups for startups here.

1. Tech Coast Angels

About

One of the most popular angel investment groups for startups, Southern California-based Tech Coast Angels provides startup capital in addition to mentoring, connections, and business assistance for entrepreneurs. TCA has over 400 accredited investors across five networks, and invests in a variety of industries including medtech, SaaS, IoT, and more.

Best For

Seed-stage and early-stage startups
Tech startups (fintech, medtech, martech, etc.)
Life sciences startup

Montgomery County Economic Development Corporation Adds New Board Members

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.”

Apr 11 2023

Love0

553rd Edition, April 11, 2023

By admin BHI Weekly Newsletter Archives

The BioTalk Podcast Welcomes Dr. Leroy Hood and Dr. Nathan Price, Co-Authors of “The Age of Scientific Wellness”

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

Gov. Moore to sign bill incentivizing creation of wet lab space, other tech infrastructure – Maryland Inno

Maryland should see a boost in direct public funding toward manufacturing and lab space later this year as Gov. Wes Moore said he plans to sign a bill that will help build out the state’s science and technology industries through a new fund.

Image: Wes Moore spoke about several of his plans to boost Maryland’s innovation infrastructure at the TechStars Equitech Demo Day on April 4, 2023. Photo by Matt Hooke/Baltimore Business Journal

Phlow Announces over $35M in Series B Funding to Improve the U.S. Medicine Supply Chain

Richmond, VA, April 05, 2023 (GLOBE NEWSWIRE) — Phlow Corp., a U.S.-based public benefit corporation and contract development and manufacturing organization (CDMO), today announced that it has closed a $36 million Series B capital raise as part of its mission to protect America’s medicine cabinet. Since its launch in 2020, Phlow has been working to leverage advanced development and manufacturing processes to re-imagine the domestic production of key starting materials (KSM), active pharmaceutical ingredients (API), and finished pharmaceutical products that are critical to U.S. healthcare.

Deka Biosciences Announces First-in-Human Dose in Phase 1 Clinical Trial of DK210 (EGFR)

GERMANTOWN, Md., April 5, 2023 /PRNewswire/ — Deka Biosciences (“Deka”), a clinical-stage biotechnology company focused on developing novel cytokine therapies to treat cancer and inflammatory diseases, announced today that the first subject has been dosed in a Phase 1 clinical trial of DK210 (EGFR) at NEXT Oncology in Fairfax, Virginia. The Phase 1, first-in-human, multicenter clinical study seeks to characterize the safety, potential efficacy and evaluate possible biomarkers of response to DK210 (EGFR) in patients with advanced solid cancer(s) who are expressing epidermal growth factor receptors (EGFR) (NCT05704985).

“We are beyond thrilled to begin the clinical trial of DK210 (EGFR), marking our first program to enter clinical development,” said John Mumm, Ph.D., President and CEO of Deka. “Importantly, we anticipate that the results of the study will confirm the clinical safety, pharmacokinetics, exploratory efficacy and correlative biomarker responses to our first DiakineTM, establishing a solid foundation for the expanded use of this treatment in cancer patients.”

Precigen Regains Exclusive Rights to Proven CAR-T Targets, CD19 and BCMA, to Enable Unencumbered Development and Commercialization of UltraCAR-T®

GERMANTOWN, Md., April 3, 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 the amendment of its exclusive license agreement with Alaunos Therapeutics, Inc. (Alaunos).

With this amendment, Precigen has the unique ability to utilize the clinically validated UltraCAR-T platform for unencumbered development and commercialization of two proven CAR-T targets, CD19 and B-cell maturation antigen (BCMA). These targets enhance Precigen’s UltraCAR-T library approach, which is designed to transform the personalized cell therapy landscape for cancer patients through the development and validation of a library of non-viral plasmids to target various hematological and solid tumor-associated antigens. Enabled by the design and manufacturing advantages of UltraCAR-T, coupled with the capabilities of the UltraPorator® system, Precigen is working to empower cancer centers to deliver personalized, autologous CAR-T treatment with overnight manufacturing for cancer patients. The addition of CD19 and BCMA targets positions Precigen as a front runner in the CAR-T space.

Commission Appoints Ruchika Nijhara as Executive Director of the Maryland Stem Cell Research Fund (MSCRF) | TEDCO

COLUMBIA, Md. (April 4, 2023) – The Maryland Stem Cell Research Commission announces the appointment of Ruchika Nijhara, Ph.D., MBA, as executive director of the Maryland Stem Cell Research Fund (MSCRF). As executive director, Nijhara oversees all MSCRF activities and seven programs accelerating stem cell research, commercialization and cures.

The Maryland Stem Cell Research Commission (Commission), which oversees the fund, was established as an independent unit within the Maryland Technology Development Corporation (TEDCO). It leads the way in identifying and supporting the most promising stem cell technologies in our region.

USP/BioPhorum Joint Workshop on Continuous Manufacturing of Biologics

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

Maryland Governor to sign bill incentivizing creation of wet lab space, other tech infrastructure – BizJournals

Prior to his keynote speech at the TechStars Equitech Demo Day this week, Moore said he planned to sign Senate Bill 549, or House Bill 552, “as soon as it’s on my desk,” which would authorize the creation of the “Build Our Future” grant program to fund infrastructure projects in a variety of technological fields.

SBIR and STTR Applicants: Notice of Upcoming Changes Around Disclosures of Foreign Investments and Affiliations or Relationships | Fenwick & West LLP – JDSupra

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.

National Cancer Institute WebEx Enterprise Site – Register Meeting

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.

Start-Up Challenge | National Institute on Aging

Through this Challenge, NIA is seeking researchers and entrepreneurs with a demonstrated need who have innovative ideas for science-driven technologies and products with the potential to increase the diversity of NIA-funded small business research and development. Entrepreneurs from groups underrepresented in health-related sciences are strongly encouraged to apply.

Machine learning experts from around the world compete to improve cancer immunotherapy | Broad Institute

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)

A SELL-OUT crowd is anticipated for the AURP Bio Health Caucus in Boston, planned prior to the BIO International Convention.

Focusing on building research space supporting communities of bio innovations, we invite developers, A/E firms, researchers, economic development reps, VC firms, and bio innovation district managers to attend.

Click here to learn more.

BHI Weekly Newsletter Archives

Walking Fish to use MaxCyte’s Flow Electroporation® technology and ExPERT™ platform to engineer novel B-cell based medicines for the treatment of serious diseases

What is Gain Therapeutics approach to drug discovery?

Winners will be revealed at the celebration on April 27th

Kite Pharma