CHARLOTTESVILLE, Va., Jan. 31, 2023 /PRNewswire/ -- AMPEL BioSolutions today announces a breakthrough in precision and personalized medicine that could revolutionize the way doctors treat chronic pain syndromes, such as fibromyalgia. Revealed in the peer-reviewed journal Lupus Science and Medicine, the paper details AMPEL's breakthrough approach to characterize the underlying disease activity from gene expression data obtained from patient blood samples.

The FibroGENE^® lab test, only a concept for the last few years, is now ready for development for practical use as a decision support biomarker test that could greatly impact health care by allowing physicians to identify the cause of patient disease symptoms and select appropriate treatment more precisely.  AMPEL's initial focus is fibromyalgia that affects Lupus patients, but the test can be used for millions of Americans diagnosed with fibromyalgia every year.

GERMANTOWN, Md., Jan. 30, 2023 /PRNewswire/ -- Deka Biosciences ("Deka"), a biotech company focused on developing novel cytokine therapies to treat cancer and inflammatory diseases, today announced that the U.S. Food and Drug Administration (FDA) has completed its review of the investigational new drug (IND) application for DK210 (EGFR) and concluded that Deka may proceed with a Phase 1 clinical trial in the United States. The Phase 1, first-in-human, multicenter clinical study seeks to characterize the safety, and biomarkers for response of DK210 (EGFR) in patients with advanced solid cancer who are overexpressing epidermal growth factor receptors (EGFR) (NCT05704985).

Germantown’s Precigen Inc. (NASDAQ: PGEN) has raised $75 million in a public offering that closed Friday and intends to use the proceeds to speed development of its experimental treatments for multiple rare diseases.

The clinical-stage biotech, which is developing gene and cell therapies for cancers, autoimmune disorders and infectious diseases, sold 42.86 million shares of common stock for $1.75 each. The company also gave the underwriters an option to buy up to 6.43 million additional shares in the 30 days after it filed an updated prospectus Jan. 26 with the Securities and Exchange Commission.

This free 1:1 virtual session is an opportunity to discuss your company with experts in diagnostics, therapeutics, digital health and medical devices.

If you’re a growth-stage biohealth company looking for unbiased advice on your pitch deck, commercialization strategy, evidence development or entrepreneurial challenges, our EIRs can help.

To request a feedback session, please send a non-confidential pitch deck, and a short description of the input you’re seeking from the EIRs, to Sarah Miller   This email address is being protected from spambots. You need JavaScript enabled to view it.,this)" rel="noreferrer">This email address is being protected from spambots. You need JavaScript enabled to view it.  

The requested information should be received by our office at least 2 weeks in advance, so that we can schedule the appropriate experts. 

By Cho KyooHong

On Jan. 9, the Ministry of Health and Welfare reported to President Yoon Suk Yeol concerning its 2023 plan, of which the main tasks include leaping forward as a leading country in the field of biohealth through human resource cultivation, deregulation and export support.

Noting that a large number of quality jobs can be created as the biohealth industry grows, President Yoon called for strong support from the government for domestic enterprises to be up to global standards, which requires a tax benefit corresponding to that of the semiconductor sector, capacity development and a solid industrial ecosystem.

Image: Minister of Health and Welfare Cho Kyoo-hong

BHI Life Science Business Strategists Monique Bennett and Kelly Murphy join host Rich Bendis to talk about BioHealth Commercialization, Proposal Assistance, and Submissions for Entrepreneurs and Start-Ups

Listen now via Apple https://apple.co/3RoZb35, Google https://bit.ly/3JqvzQN, and Spotify https://spoti.fi/3WPibcj.

Novavax Announces Plan to Deliver Updated Protein-based Vaccine Consistent with FDA Recommendations for 2023/2024 Vaccination Season at VRBPAC Meeting

Jan 27, 2023

FDA Advisory Committee votes to harmonize vaccine strain composition of primary series and booster doses Novavax’ protein-based option remains an important part of the current U.S. vaccine portfolio

Novavax participated in yesterday’s U.S. Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee’s (VRBPAC) meeting, which resulted in a unanimous vote recommending harmonizing vaccine strain composition of primary series and booster doses. During the meeting, Novavax shared data demonstrating that the Novavax COVID-19 Vaccine, Adjuvanted (NVX-CoV2373), when used as a booster induces a broad functional immune response, including against forward drift variants.

It's the largest pool of capital the company has raised in its 46-year history.

Image: Workday Inc. is among the more than 270 companies New Enterprises Associates has invested in that later went public. TODD JOHNSON | SAN FRANCISCO BUSINESS TIMES

Pennovation Works, the 23-acre University of Pennsylvania property just across the Schuylkill River from the core campus, has long been a site for innovation. Home to a ferry business in the 18th century, a paint company in the 19th century, and a DuPont chemical research facility for much of the 20th century, the space underwent a further transformation in 2016 with the establishment of the Pennovation Center, an incubator for science and technology startups, many of which have their origins within the University. Last year, the 65,000 square foot Pennovation Lab opened, offering larger lab spaces for companies outgrowing their previous locations.

Image: A view of the new research, development, and biomanufacturing facility from the intersection of Grays Ferry Avenue and 34th Street on the Pennovation Works property. (Image: Longfellow Real Estate Partners)

In conversation with Mathias Alder, CEO of Gain Therapeutics discussing his personal life insights and professional achievements in the field of Computational Drug Discovery. Matt Pillar:  A few months ago, I set out to learn as much about computational biology and as myriad applications in Biotech as I could. And on more than one occasion, that effort led me to a Zoom call with Matthias Alder. That my inquiry resulted in multiple opportunities to talk with Matthias made me happy. One, because he’s a really great guy, and two, because while his company’s drug discovery model leans heavily into proprietary structure based computational methods, he’s not one of these bombastic, over the top futurists who’s all in on relinquishing science to the algorithms. Just the opposite, he’s pragmatic and practical about the advantages and the limitations of deploying computational tools in an industry whose mission it is to save lives by injecting things into living human bodies.

As many of us were winding down our work over the winter holidays, my colleagues at the University System of Maryland were putting the finishing touches on our 2022 Annual Report. And while the new year compels us to look ahead with purpose, the report gives us a chance to look back at what's brought us to our place of strength.

The annual report breaks down progress on our five strategic priorities: Innovate the education we provide our students. Make that education accessible to all. Prepare students for jobs that will write Maryland's future. Conduct and commercialize research that changes the world. Center equity and justice in everything we do.

At first glance, it seems like a rough time for venture capital, especially in the healthcare industry. Overall, venture investments in 2022 were down 35% from 2021, according to CB Insights, with digital health investments down over 50%. Biopharma investment beat the trend a little bit, according to Evaluate Vantage, down only 23% from the year before.

Image: Dimension founders Zavian Dar, Adam Goulburn and Nan LiDIMENSION

The biotechnology industry is one of the riskiest and the most challenging—but it is also one of the few that makes the difference between life and death.

In recent years, biotech has given us major breakthroughs: vaccines that provide protection from lethal viruses; a lupus treatment approved for use in children with the first new mechanism of action in more than 50 years; and significant progress in hematology with the approval of a bispecific antibody for multiple myeloma.

Image: Dinesh Patel, PhD, CEO of Protagonist Therapeutics (PTGX)

ROCKVILLE, Md., Jan. 24, 2023 /PRNewswire/ -- Montgomery County companies had a record year of investment in 2022, with more than $29.9 billion in combined initial public offering (IPO), merger and acquisition, private investment and venture capital deals. That is an increase from $4 billion in 2020 and more than $18 billion in 2021. In all, Montgomery County had 144 deals across 126 companies in 2022.

"The record investment in Montgomery County companies is a testament to the region's remarkable climate of business growth and innovation," said Bill Tompkins, President and CEO of the Montgomery County Economic Development Corporation. "We are a premier destination with a powerful network of existing businesses across a wide range of industries. Our deep talent pool, diverse and vibrant communities, and proximity to the federal agencies including the Departments of Transportation and Energy, FDA, and NIH position the County's companies for success."

QuartzBio, a Part of Precision for Medicine, Acquires SolveBio and Expands Software-as-a-Service (SaaS) Data Management Solutions for Clinical Research & Development (R&D)

QuartzBio’s suite of end-to-end SaaS solutions provides pharmaceutical and biotech clients with a fully connected data ecosystem linking sample, biomarker, and clinical data to improve collaboration, planning, and R&D productivity.

Frederick, MD – January 24, 2023 – Precision for Medicine, the first global, precision medicine clinical research services organization, today announced the strategic acquisition of SolveBio by QuartzBio.

SolveBio’s intelligent technologies and enterprise data management platform has integrated into QuartzBio’s suite of SaaS solutions, providing a single, scalable solution supporting clinical sample inventory management and biomarker data management for the biotech and pharmaceutical sectors.

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

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

This Spring 2023 course (SMB035) will take place starting February 8^th  on the Montgomery College Rockville Campus each Wednesday from 6-8:40 p.m. For more details on the course see here .

By Alex Keown
January 24, 2023

BioHealth Innovation’s lofty goal of the BioHealth Capital Region (BHCR) achievement of “Top 3 by 2023” is not likely to be reached this year due to inflation and uncertain economic conditions.

That’s the assessment of Rich Bendis, President and Chief Executive Officer of BHI, who has championed the region’s transition into a top four biopharma hub in the United States. However, given the state of the economy and the amount of money being invested, Bendis said it is unrealistic to expect the region to move up the ranking of the top 10 life sciences regions compiled by Genetic Engineering & Biotechnology News (GEN).

The Bear Institute, a pediatric health IT collaboration between Washington, D.C.-based Children's National Hospital and Oracle Health, has named four startup companies as the winners of its second annual pediatric digital health innovation competition.

The competition, dubbed the Bear Institute Pediatric Accelerator Challenge for Kids, allows startups to share their innovations and receive feedback from judges while competing for a chance to win an on-site pilot and software development support, according to a Jan. 17 release from Children's National.

TEDCO, Maryland’s economic engine for technology companies, unveiled a legislatively mandated Maryland Innovation Competitiveness Study—one that could lead to a 5-year, $250 million down payment for an Equitech Growth Fund and the establishment of a major Kirwan-type commission. The new commission would map out an in-depth strategic plan focused on ensuring Maryland becomes a national model for a thriving, inclusive tech sector and innovation economy.

Luis Gutiérrez and John K. Hsu join the growing collaboration being BHI and NIH in 2023

ROCKVILLE, MARYLAND, January 23, 2021 – BioHealth Innovation Inc. (BHI) announces the addition of Luis Gutiérrez and John K. Hsu, Ph.D., J.D., to the growing Entrepreneurs-in-Residence (EIR) team. Luis will work with the NIH Office of Extramural Research (OER), while John will work with The National Heart, Lung, and Blood Institute (NHLBI).

The OER manages the NIH’s extramural research program, providing guidance and support to staff, grantees, and the public on funding opportunities, policies, and regulations. It also oversees the review, award, and administration of grants and contracts for biomedical and behavioral research conducted outside of the NIH. In addition, the NHLBI conducts and supports research on the causes, prevention, diagnosis, and treatment of heart, blood vessel, lung, and blood diseases. It also works to improve the health of individuals and populations through education and public health initiatives.

BioHealth Innovation, Inc. (BHI) and Montgomery County are pleased to announce the selection of Kevin Heller, MD as a part-time “Executive in Residence”—a position dedicated to providing 1:1 technical assistance to Montgomery County-based biotech and medtech startups.

Heller will join two previously announced “MoCo” Executives in Residence, Jen Butler and Luis Guitierrez, who have been working closely with local entrepreneurs since November.

“​I am eager to join Jen and Luis as we strengthen our community’s biohealth cluster,” said Heller. “Starting and growing a successful biotech company takes patience, perseverance, and resources. Supporting the next generation of life sciences entrepreneurs is critical from a long-term public health perspective and from a local economic development standpoint.”

BioHealth Innovation (BHI) is an innovation intermediary that facilitates the commercialization of emerging technologies in the BioHealth Capital Region (Maryland, DC and Virginia).  We are seeking a Life Sciences Business Strategist to join our team remotely.

The right candidate will be an energetic and continuous learner who is passionate about accelerating the adoption of new technologies to improve lives. The position is geared toward an early-career scientist who wants to engage with the biohealth industry in new ways.

Our Strategists support selected growth-stage businesses beyond commercialization plans and federal grant proposals—they cultivate important relationships with client entrepreneurs and innovators. The Strategists’ work also includes collaborating with expert Entrepreneurs-In-Residence from around the country and other professionals in BHI’s network who have built careers at the intersection of business and science.

John C. Jacobs joined Novavax as president and chief executive officer, and a member of the board of directors, in January 2023. He is a seasoned industry leader who has more than 25 years of commercial, operations, business and leadership experience across multiple therapeutic areas. Previously, Mr. Jacobs served as president and chief executive officer and a member of the board of directors at Harmony Biosciences from June 2018 to January 2023, and executive vice president and chief commercial officer from October 2017 to June 2018, leading the company through a successful IPO and taking its first product through FDA review, approval and commercialization. Prior to joining Harmony, Mr. Jacobs held leadership roles at Teva Pharmaceuticals beginning in 2014, including senior vice president and general manager of the Respiratory Business Unit, senior vice president of Commercial Operations in North America and general manager of Teva in Canada. Mr. Jacobs has also held positions of increasing scope and responsibility at major pharmaceutical companies including Cephalon, Wyeth and Pfizer. Mr. Jacobs has a proven track record in developing market-leading commercial strategies, major product launches and building and leading highly effective teams and organizations. He received bachelor’s degree in business from State University of New York College at Plattsburgh and a master of business administration from The State University of New York at Binghamton.

• Company has initiated Phase I/II AFFINITY DUCHENNE™ trial of RGX-202
• Company also enrolling newly active observational screening study, AFFINITY BEYOND, evaluating AAV8 antibody prevalence in boys with Duchenne
• Commercial-scale cGMP material from the REGENXBIO Manufacturing Innovation Center to be used in the clinical trial
• 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

ROCKVILLE, Md., Jan. 23, 2023 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced that the Phase I/II AFFINITY DUCHENNE™ trial of RGX-202 for the treatment of Duchenne muscular dystrophy (Duchenne) is now active and recruiting patients. RGX-202 is designed to deliver a transgene for a novel microdystrophin protein that includes the functional elements of the C-Terminal (CT) domain found in naturally occurring dystrophin. RGX-202 uses REGENXBIO's proprietary NAV® AAV8 vector.

AFFINITY DUCHENNE is a multicenter, open-label dose evaluation and dose expansion clinical trial to evaluate the safety, tolerability and clinical efficacy of a one-time intravenous (IV) dose of RGX-202 in patients with Duchenne.

The University of Virginia will build a biotechnology institute funded with a $100 million donation from Charlottesville investor Paul Manning and his wife, Diane, the university announced Friday.

Along with the Mannings’ gift, U.Va. will contribute $150 million, and the state has allocated $50 million in initial investments for the institute in its 2022-24 budget, according to the announcement.

Image: Paul Manning. Photo courtesy the University of Virginia

Ahead of his swearing-in on Wednesday, Gov.-elect Wes Moore’s Cabinet is nearly complete. Moore announced his picks for nine additional cabinet positions on Tuesday, filling out key roles including the heads of the departments of Housing, Environment, Planning and Commerce.

The latest appointments include two Maryland mayors — Jake Day of Salisbury and Emily Keller of Hagerstown — meaning a change of leadership elsewhere in the state.

Image: The Great Seal of the State of Maryland on the front of the Maryland State House. Photo by Danielle E. Gaines.

On December 19, 2022, the Department of Defense ("DOD") issued a proposed rule seeking to amend the Defense Federal Acquisition Regulation Supplement (“DFARS”) to implement the data rights portions of recent Small Business Innovation Research Program and Small Business Technology Transfer Program Policy Directive, which emphasizes the need to protect the intellectual property interests of small businesses. In addition to addressing the small business directives, the proposed rule seeks to update markings requirements related to (1) small business data rights and (2) concerns raised by the Federal Circuit’s decision in The Boeing Co. v. Secretary of the Air Force, 983 F.3d 1321 (Fed. Cir. 2020).

Federal innovation and entrepreneurship initiatives would receive substantial new funding under the text of the omnibus spending bill shared on the morning of Dec. 20 by the Senate Committee on Appropriations. The legislation, which totals $1.7 trillion and covers both regular FY 2023 appropriations and supplement funding, provides a total of $1.8 billion for programs authorized by this year’s CHIPS and Science Act and increases funding for multiple long-standing efforts — including each of the SSTI Innovation Advocacy Council’s priority programs. The legislation is expected to pass Congress this week, before the current funding agreement expires on Dec. 23.

Organizations across the globe are pivoting their workplace technology strategy and many employers are grappling with big questions about which tools are needed to create a thriving hybrid environment in 2023.

Based on a JLL survey of over 1,000 companies worldwide, a vast majority expect to make significant changes to their tech stack over the next three years. Download the infographic highlighting the workplace technologies that were consistently mentioned by employers as top priorities and discover why those technologies are prioritized and how they change workplace.

The BioHealth Capital Region (BHCR) and its life science ecosystem have a rich and deep history of pioneering scientific innovation, research, development, and commercialization. The region’s history has been written by life science anchor companies, scientific research universities, government research organizations, rich startup culture, and serial entrepreneurs, all of whom have played critical roles in transforming the BHCR into one of the most innovative and productive biocluster in the world.

Image: https://biobuzz.io/

A new year means new opportunities to grow your business. If you're one of the millions of resolution makers who are using the new year to take their ventures to new heights, Maryland SBDC has the expertise to turn your goals into gains.

Whether your goal is to start a business, grow a business, or just learn something new, Maryland SBDC will jump-start your year with no-cost confidential, one-on-one consulting and low-cost training on topics ranging from business planning and financing to marketing and more.

Norfolk biotech company Embody has racked up a bevy of accomplishments since it was founded in 2014 with just two employees.

It has attracted millions of dollars in grant funding from the Department of Defense, and millions more from local and national stakeholders. Last April, the company announced plans to spend $5 million to expand its lab space by 10,000 feet and add 92 new jobs.

And now a bigger milestone can be added to the list: Embody’s sale to a major sports medicine company.

Zimmer Biomet, a Fortune 500 medical technology company based in Warsaw, Indiana, has signed a deal to acquire Embody for $155 million at closing and an additional $120 million subject to achieving other milestones over a three-year period.

Sanofi has thrown its financial weight behind its venture capital unit, making a $750 million, multi-year commitment to enable the financier to build on a year in which it backed 10 companies globally.

Sanofi Ventures is a well-established player in the biotech VC space, with its roots dating back to the formation of Sanofi-Genzyme BioVentures in 2011 and beyond that to the establishment of Genzyme Ventures a decade earlier. But Sanofi has largely stayed in the shadows, leaving its venture unit to build out a portfolio without publicly disclosing the details of how it supports the fund.

Happy New Year! Maryland is coming off of a busy and successful year of business attraction and expansion. Continue reading to see the companies that committed to Maryland in the 4th quarter of 2022.

Our momentum continues into 2023, with many exciting new projects on the horizon. We look forward to connecting with industry colleagues at events this spring, and as always, we’re standing by to help you make your next project a success.

Total research spending at American universities reached nearly $90 billion in 2021,1 2 and university licensing revenue has climbed to almost $3 billion a year.3 From robotics to agriculture to medicine, useful discoveries constantly emerge from academic labs. Yet policymakers often fail to recognize the critical role of intellectual property in driving all that spending, income, and innovation. Standing up for strong IP rights must be a priority for American universities.

Click here to read the full PDF Briefing.