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What is a pre-IND? Why have a pre-IND? What goes into preparing for a pre-IND? And, what documents are required? All of these questions and more will be answered in this webinar presented by Dr. Carmella Moody, a regulatory affairs specialist at RTI International. Dr. Carmella Moody brings her expertise in regulatory affairs and the development of small molecules to the Catalyze program, where she serves as a technical project lead. In this 1-hour webinar, Dr. Moody will explain the process of preparing and approaching an effective pre-IND meeting, but also what to expect from FDA feedback and how to incorporate it into your project to ultimately save time and money.

 

RichandDoug

Vita Therapeutics CEO & Co-founder Douglas Falk chats with Rich Bendis to discuss his career, their platforms, and moving into the University of Maryland BioPark.

Listen now on Apple https://apple.co/3wwzX8N, Google https://bit.ly/3wxbQag, Spotify https://spoti.fi/3sCZH2t, Amazon https://amzn.to/3G3DLDb, and TuneIn https://bit.ly/3FStLfF.

Douglas Falk, MS is the Co-founder and CEO of Vita Therapeutics, a biotechnology company generating state-of-the-art cellular therapeutics for the treatment of muscular dystrophies and solid tumors. He has experience in healthcare equity research investing as a former Principal at Brown Advisory. He has led direct investment into more than 30 biotechnology companies and is a Board Member of Johns Hopkins University’s Biotech Investment Group.

Click here for the transcript.

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GAITHERSBURG, Md., May 16, 2022 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE: EBS) announced today that it has entered into a definitive agreement with Chimerix, Inc. (NASDAQ: CMRX), to acquire Chimerix’s exclusive worldwide rights to TEMBEXA® (brincidofovir), the first antiviral approved by the U.S. Food and Drug Administration (FDA) for all age groups for the treatment of smallpox. TEMBEXA was approved in June 2021 and is indicated for the treatment of human smallpox disease in adult and pediatric patients, including neonates.

 

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ROCKVILLE, Md., May 16, 2022 /PRNewswire/ -- Emmes, a global, full-service clinical research organization (CRO) dedicated to supporting the advancement of public health and biopharmaceutical innovation, today announced that it is providing data, statistical analysis, and project management support for new research that will test the Moderna mRNA vaccine at more than 50 sites in South and East Africa.

The clinical trial, which will include about 15,600 participants, seeks to better understand infection and disease in immunocompromised populations in order to prevent severe COVID-19 and chronic SARS-CoV-2 infections and minimize the risk of transmission.  The study will also address the COVID-19 mRNA vaccine's resistance to the variants that have been detected in South Africa and surrounding countries.

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No question about it—2021 was a banner year for initial public offerings.

Nasdaq data indicates 1,033 IPOs last year, more than double 2020’s 471.  As we move further into 2022, the market has slowed considerably. In the first quarter, only 95 companies filed initial public offerings as opposed to 419 in the first quarter of 2021.

Image: https://www.crainsnewyork.com/

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MIMETAS, a global leader in Organ-on-a-Chip models and technology and headquartered in the Netherlands (Europe), announces  that it has expanded its license to the HUB Organoid Technology to include all organs. The license covers organoid technology developed by Professor Hans Clevers, a pioneer in adult stem cells.

 

IndyGeneUS AI

IndyGeneUS plans to use the grant funding from Johnson & Johnson Innovation to Scale Blockchain-secured Genomic Data Marketplace and Proprietary GenēUS™ Discovery Platform

WASHINGTON, May 12, 2022 /PRNewswire/ -- Today, IndyGeneUS AI was named an awardee of the Johnson & Johnson Innovation Veterans Lead QuickFire Challenge: Innovations by Vets.

Johnson & Johnson Innovation, together with Bunker Labs, a national nonprofit organization that aims to equip the military-connected community with the network, tools, and opportunities needed to launch and grow successful businesses, invited U.S. Veteran innovators and military spouses/legal partners to submit potentially ground-breaking ideas in all aspects of human healthcare.

The black-owned and Service-Disabled Veteran-owned Small Business (SDVOSB), IndyGeneUS AI, pitched their cutting-edge blockchain-encrypted and machine learning-powered bioinformatics "GenēUS™ Discovery Platform" to a panel of judges, which included both Johnson & Johnson Innovation and Bunker Labs executives.

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By: Brian Darmody, Chief Strategy Officer, AURP: Building Communities of Innovation

May 10, 2022

Sometime this September, the US Economic and Development Agency (EDA) will announce its Phase 2 awardees for the $1 billion Build Back Better Regional Challenge award winners.

Thirty or so lucky jurisdictions from across the U.S will receive between $25M -$100 M in EDA funding, although actual funding levels will be smaller to support projects on a regional basis for an industry cluster. These programs will develop or scale regional economies and devote funding to workforce training and support equitable development, including science parks and accelerators.

Thirty other finalists though will not be winners though as EDA only has funds to support thirty awards, much less the hundreds of jurisdictions from across the U.S. that applied for the program. (Five hundred and twenty-nine applicants were received by the EDA.)

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HILDEN, Germany & GERMANTOWN, Md.--(BUSINESS WIRE)--QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) announced today that it has signed agreements to acquire a 96% majority ownership stake in BLIRT SA (Polish Stock Exchange: BLR), a manufacturer of recombinant enzymes for the life science industry based in Gdansk, Poland.

BLIRT develops, manufactures and commercializes standardized and customized solutions for proteins and enzymes as well as molecular biology reagents. Its offering includes proteins and enzymes that are critical to the life sciences industry and diagnostic kit manufacturers, especially for non-COVID-19 applications. BLIRT, founded in 1994 in Gdansk, Poland, has approximately 90 employees and generated 2021 sales of less than $10 million.

QIAGEN Logo

HILDEN, Germany & GERMANTOWN, Md.--(BUSINESS WIRE)-- QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) announced today that it has signed agreements to acquire a 96% majority ownership stake in BLIRT S.A. (Polish Stock Exchange: BLR), a manufacturer of recombinant enzymes for the life science industry based in Gdansk, Poland.

BLIRT develops, manufactures and commercializes standardized and customized solutions for proteins and enzymes as well as molecular biology reagents. Its offering includes proteins and enzymes that are critical to the life sciences industry and diagnostic kit manufacturers, especially for non-COVID-19 applications. BLIRT, founded in 1994 in Gdansk, Poland, has approximately 90 employees and generated 2021 sales of less than $10 million.

 

Cartesian Therapeutics

- Data Presentation Today at 14th Myasthenia Gravis Foundation of America International Conference on Myasthenia and Related Disorders in Miami -

GAITHERSBURG, Md., May 10, 2022 /PRNewswire/ -- Cartesian Therapeutics, a fully integrated clinical-stage biotechnology company pioneering RNA cell therapy in and beyond oncology, will present late-breaking interim data from its Phase 1/2a clinical trial of Descartes-08 in patients with generalized Myasthenia Gravis (MG) today at the 14th Myasthenia Gravis Foundation of America (MGFA) International Conference on Myasthenia and Related Disorders.  The conference is in Miami, May 10–12, 2022.

The oral presentation, "RNA CAR T-cell Therapy for Myasthenia Gravis," will be delivered today, Tuesday, May 10 at 10:50 a.m. ET by principal investigator Volkan Granit, M.D., of the University of Miami. A poster, "Phase 1b/2a Study of Autologous mRNA-Engineered Anti- B-cell Maturation Antigen Chimeric Antigen Receptor T-cells for Treatment of Severe Generalized Myasthenia Gravis," will be presented at the conference today and tomorrow.

Emmes-Logo

The cloud platform will empower biotech companies and CROs with an integrated solution for clinical data management and is supported by Emmes specialist data management teams

ROCKVILLE, Md., May 11, 2022 /PRNewswire/ -- Emmes – a global, full-service Contract Research Organization (CRO) dedicated to supporting the advancement of public health and biopharmaceutical innovation, announces that it will introduce to market its third generation version of Advantage eClinical at Society for Clinical Trials (SCT) in San Diego, May 15th – 18th. The cloud platform of Advantage eClinical will be available as a standalone software product after undergoing more than two years of development. The system has been specifically designed to provide fast study builds, greater flexibility, and insights to clinical trial sponsors of all sizes.

 

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New blockchain talent marketplace seeks to solve hiring and diversity challenges in the rapidly growing biotech industry.

BALTIMORE, MD (May 10, 2022) – BioBuzz Media, the go-to community platform for biotech job seekers and industry professionals looking to access employers and plug into regional biotech communities, today announced its completion of the inaugural University of Maryland Blockchain Accelerator program. BioBuzz and other participating companies pitched to more than 70 attendees, including investors, mentors and industry leaders at Demo Day on May 4, 2022.

Selected from over 60 applicants to be one of eight startups in the inaugural cohort, BioBuzz is building a blockchain-based next-generation talent marketplace to de-risk hires and equitably expand the life sciences workforce. The new solution promises to provide employers with a more efficient recruiting process while providing job seekers with control of their data through a federated layer and enabling them to earn rewards for learning, training and contributing to the marketplace.

The University of Maryland Adds $67M IDEA Factory To Its Innovation Ecosystem

COLLEGE PARK, Md., May 10, 2022 /PRNewswire/ -- The University of Maryland today dedicated the new E.A. Fernandez IDEA (Innovate, Design and Engineer for America) Factory. Designed to foster technology innovations and advances through collaboration across engineering, the arts, business and science, the A. James Clark School of Engineering's new 60,000-square-foot building is the university's only facility funded entirely by private philanthropy.

Image: The University of Maryland Adds $67M IDEA Factory To Its Innovation Ecosystem - https://www.prnewswire.com

Cursor and ISPOR 2022

We are very excited for this year’s conference theme!  Our theme will be a “green thread” that is woven throughout our many sessions to bring a fresh and holistic view into the future of HEOR in patient-driven digital healthcare systems.

The last two years have seen a rapid rise of real-time solutions, digital healthcare interactions and an accelerated expansion of mobile healthcare. As digital systems mature and incorporate a broader array of patient-reported outcomes and preference measures, the trajectory of adoption of new services will be influenced by better information on how they are affecting patients’ lives. Such as:

Image: https://www.ispor.org

Cartesian Therapeutics to Present Late Breaking Data from Phase 1 2a Trial of RNA CAR T cell Therapy in Patients with Generalized Myasthenia Gravis Cartesian

GAITHERSBURG, Md., May 10, 2022  – Cartesian Therapeutics, a fully integrated clinical-stage biotechnology company pioneering RNA cell therapy in and beyond oncology, will present late-breaking interim data from its Phase 1/2a clinical trial of Descartes-08 in patients with generalized Myasthenia Gravis (MG) today at the 14th Myasthenia Gravis Foundation of America (MGFA) International Conference on Myasthenia and Related Disorders.  The conference is in Miami, May 10–12, 2022.

The oral presentation, “RNA CAR T-cell Therapy for Myasthenia Gravis,” will be delivered today, Tuesday, May 10 at 10:50 a.m. ET by principal investigator Volkan Granit, M.D., of the University of Miami. A poster, “Phase 1b/2a Study of Autologous mRNA-Engineered Anti- B-cell Maturation Antigen Chimeric Antigen Receptor T-cells for Treatment of Severe Generalized Myasthenia Gravis,” will be presented at the conference today and tomorrow.

 

Virginia

There is no doubt that Virginia is open for business to the life sciences industry. Over the past several years, the state has seen significant growth in pocket ecosystems across the land, particularly in areas like Charlottesville, Richmond, and Blacksburg.

Some of the growth has been fueled by an infusion of federal monies related to the government’s efforts to mitigate the COVID-19 pandemic, while other growth has been driven by old-fashioned scientific innovation. Across the Old Dominion state, companies are driving research and development of novel therapies and more as they all combine their forces to bolster the life sciences ecosystem.

 

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The Labs at Belward, located at the Belward Campus of The Johns Hopkins University, will Initially Provide 757,000 SF of Trophy Lab and R&D Facilities and Community Serving Amenities

Trammell Crow Company (TCC), a global commercial real estate developer, today unveiled plans to develop The Labs at Belward, a world-class life science campus, in the Shady Grove area of Montgomery County, Md. The Labs at Belward, located at the Belward Campus of The Johns Hopkins University, will initially include 757,000 square feet of trophy lab and research and discovery space across three buildings. The project has the potential to grow to approximately 1.6 million square feet across seven buildings. Construction of the initial 757,000 square feet will begin June 2023 and is slated to be completed in early 2025.

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These free 1:1 virtual sessions are 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 sign-up for any of the EIR dates in 2022, please follow this link.

Image by - Nigel Sussman

The pace at which venture capitalists are deploying funding across the globe slowed yet again in April.

Venture capital dollar volume, as tracked by Crunchbase News in a new report, peaked in November 2021. Since that apogee, the value of venture investments has ticked lower in most months before dropping another $5 billion from March to April.

Image: Nigel Sussman

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COLLEGE PARK, Md. (PRWEB) May 05, 2022

Ultrasound data displayed directly on a patient via augmented reality headsets. Immersive "grand rounds" for medical students and faculty even when they're in different locations. Virtual reality landscapes matched with classical opera to transport people with painful injuries outside of themselves, reducing the need for potentially addictive opioids.

These medical examples of extended reality (XR)--the umbrella term used for technology based in virtual and augmented reality or other immersive media--are already being prototyped or tested in clinical trials. But its widespread use in hospitals and other health care settings is currently hampered by technical challenges and sparse regulatory guidelines.

Scheer partners

It’s been a big few years in the Biohealth Capital Region, especially big for commercial real estate firm Scheer Partners. After the success of buildings like 704 Quince Orchard, a 77,000-square-foot office building converted to lab space, Scheer Partners has continued to bring new buildings to market with both spec suites and build-to-suit space available for tenants of all sizes.

“Speed to market has been the tagline for the last year or so,” said Aaron Gambini, Assistant Vice President at Scheer Partners. “So it’s sort of creating move-in ready options for the market. It seems to be the way to go to start getting activity. And it’s really the next building that delivers that is the next building to lease.”

Image: https://biobuzz.io/

DaveandRich

Dave Saunders, CTO & Co-Founder of Galen Robotics, joins Rich Bendis before their 5/6/2022 Open House in Baltimore. (RSVP to This email address is being protected from spambots. You need JavaScript enabled to view it. to attend) Also, view a demo of their technology at https://bit.ly/GalenRobotics. Rich and Dave and I discuss Digital Surgery, Choosing Baltimore, and their Design Philosophy.

Listen now via Google https://bit.ly/3w7lIr7, Apple https://apple.co/3MQRj6S, Spotify https://spoti.fi/3MNYfBH, Amazon https://amzn.to/3s7PTgj, and TuneIn https://bit.ly/3823iQo.

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CHARLOTTESVILLE, Va., May 3, 2022 — AMPEL BioSolutions today announces a breakthrough in precision and personalized medicine that could revolutionize the way doctors treat inflammatory skin diseases, such as Lupus, Psoriasis, Atopic Dermatitis and Scleroderma. Revealed in the peer-reviewed journal Science Advances, the paper details AMPEL’s breakthrough machine learning approach to characterize disease activity from gene expression data obtained from patient skin biopsies. The lab test, only a concept for the last few years, is now ready for development for practical use. AMPEL's initial focus was Lupus, but the test can be used for many autoimmune or inflammatory skin diseases that affect more than 35 million Americans.

AMPEL's innovative machine learning approach, which is now ready to be developed as a decision support biomarker test, could greatly impact health care by allowing physicians to identify the cause of patient disease symptoms and select appropriate treatment more precisely.  AMPEL’s approach is sufficiently sensitive to detect changes in clinically uninvolved skin so that early intervention may prevent systemic flares and skin damage apparent in lesions.  The application of AMPEL’s machine learning approach could also assist pharmaceutical companies in drug development and clinical trials.

Patients with chronic skin diseases often suffer from unpredictable disease activity that impacts daily activities like work and family life. Since unpredictable symptoms often result in trips to the Emergency Room, the ability to predict worsening disease and systemic involvement with routine skin biopsies has important health care and health economics implications. 

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Thursday, April 28, 2022

The HOPE Initiative will utilize federal funds to create new lab space, technology advancement & new services

(Washington, DC) Today, Mayor Muriel Bowser and the Office of the Deputy Mayor for Planning and Economic Development (DMPED), announced the Helping Our People Endure (HOPE) initiative, which intends to invest $92 million in the life sciences, to catalyze health innovation and address disparities in the District of Columbia. The participants will be part of the District of Columbia's application to the U.S. Department of Treasury's Capital Project Fund.

Vita Therapeutics Logo

From its new headquarters and lab space, the biotech company aims to generate state-of-the-art cellular therapeutics for the treatment of debilitating neuromuscular diseases and cancers

BALTIMORE, May 2, 2022 /PRNewswire/ -- The University of Maryland (UM) BioPark announced today that Vita Therapeutics, a cell engineering company harnessing the power of genetics to develop cellular therapies to treat muscular dystrophies and solid tumors, has established offices and laboratory space within approximately 10,000 square feet of leased space in the BioPark. Vita Therapeutics will leverage the new space to bring together its 25+-person team under one roof for the first time with the goal of progressing its co-lead programs, VTA-100 and VTA-300. The company uses induced pluripotent stem cell (iPSC) technology to engineer specific cell types designed to replace those that are defective in patients.

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These free 1:1 virtual sessions are 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 sign-up for any of the EIR dates in 2022, please follow this link.

Supernus pharmaceuticals
  • First novel, nonstimulant option for adults with ADHD in 20 years
  • ADHD affects an estimated 10 million adults in the U.S.

ROCKVILLE, Md., April 29, 2022 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, announced today that the U.S. Food and Drug Administration (FDA) approved an expanded indication for Qelbree (viloxazine extended-release capsules) for the treatment of attention deficit hyperactivity disorder (ADHD) in adult patients aged 18 and older. The FDA has now approved Qelbree for the treatment of ADHD in children (starting at age 6), adolescents and adults.

Approximately 16 million children, adolescents, and adults have ADHD in the U.S. While many children with ADHD outgrow it, up to 90% of those diagnosed with ADHD in childhood continue to have ADHD as adults.

MikeAndRich

Mike Gill, Maryland Commerce Secretary, visits BioTalk to discuss Life Sciences in the State, growing the economy, and how we can continue building on our successes.

#Apple https://apple.co/3y8gVbA, #Google https://bit.ly/3vWZo3g, #Spotify https://spoti.fi/3w4uoP0, #Amazon https://amzn.to/3kz1uBc, #TuneIn https://bit.ly/3kxWZa0, or #YouTube https://bit.ly/39pFfLv.

Secretary Mike Gill is a business leader with four decades of experience as an entrepreneur, technology executive, investment banker, and public servant. He was tapped by Governor Larry Hogan in 2014 to lead the Maryland Department of Commerce as its first-ever Secretary and was asked by the Governor to again lead the Department in December 2021.

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Biotechnology innovation is a team sport.

While we often credit the discovery of a promising new therapy to a single scientist or research team, turning that discovery into a viable product patients can access requires a vast network of players. There are manufacturing platforms capable of producing new cell and gene therapies, teams to support preclinical and clinical trials, real estate developers that offer cutting-edge laboratory space and experts across a wide range of fields who all contribute to bringing a product to market.

 

Being part of the industry that delivers building solutions to help scientists do their work is what drives Pat Larrabee, CEO of Facility Logix.

Montgomery County is well known for many transformative firsts in life sciences. First to sequence the human genome; first gene therapy for sickle cell, first cell therapy for COVID-19 — and that’s just the start.* Montgomery County is an epicenter for translating knowledge into life-changing treatment and cures, with gene and cell therapies representing some of the most promising advancements in human health.

Image: Being part of the industry that delivers building solutions to help scientists do their work is what drives Pat Larrabee, CEO of Facility Logix. - https://www.bizjournals.com

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In biotechnology, speed matters.

Emerging technology has opened a new world of possibilities for treating — and potentially curing — diseases. Scientists are developing cell and gene therapies designed to help patients with cancer, heart disease, liver disease, Parkinson’s disease, Alzheimer’s and many other conditions. The faster they can get these therapies from the laboratory through clinical trials and into production, the sooner people will be able to benefit.

 

Cursor and 6 life sciences leaders see Montgomery County as partner in success Washington Business Journal

Home to nearly 18 federal agency headquarters, 36 federal labs, and more than 300 life science companies, it’s no surprise Maryland’s Montgomery County is a leader in the life sciences industry.

The six life sciences companies highlighted here consider Montgomery County critical to their success.

MaxCyte, Inc.

“The Montgomery County community has an expansive amount of experience and a perpetual abundance of innovative ideas based on excellent science,” says Doug Doerfler, CEO of MaxCyte, Inc. MaxCyte provides technologies to advance innovative cell-based research and next-generation cell therapeutics. The company’s Flow Electroporation® platform facilitates complex engineering of a wide variety of cells, currently focusing on immuno-oncology and gene editing.

Image: https://www.bizjournals.com

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Deputy Mayor John Falcicchio speaks during a panel at Bisnow's The Future of Downtown D.C. & The Golden Triangle event on March 31, 2022.

The D.C. government is hoping to receive significant federal funding to bring more of the region's booming life sciences industry within District borders.

The District plans to apply for $92M to add research and innovation facilities to four major health institutions, Mayor Muriel Bowser and the Office of the Deputy Mayor for Planning and Economic Development announced Thursday

Image: Bisnow/Jacob Wallace Deputy Mayor John Falcicchio speaks during a panel at Bisnow's The Future of Downtown D.C. & The Golden Triangle event on March 31, 2022.