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AstraZeneca and BioHealth Innovations, Inc is hosting the semi-annual Bio Networking event on November 6th from 3pm-5pm at the AstraZeneca Campus in Gaithersburg, MD. Come to this FREE event, which will bring together biotech professionals from Maryland, DC, and Virginia (the BioHealth Capital Region). You never know who you will meet and what you can achieve together!

Please register to confirm your attendance. Although the event is free, registration is REQUIRED. Please contact This email address is being protected from spambots. You need JavaScript enabled to view it. with any questions.

 

Neximmune Logo

GAITHERSBURG, Md., Oct. 31, 2019 (GLOBE NEWSWIRE) — NexImmune, a clinical stage immunotherapy company developing novel T cell therapies, received Investigational New Drug (IND) clearance for the company’s first cellular therapy product. NEXI-001 is being developed for the treatment of acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) patients with relapsed disease after an allogeneic hematopoietic cellular transplant (allo-HCT).

Scott Carmer, NexImmune’s President and CEO, commented “we are excited to initiate clinical trials with NEXI-001, and to provide these patients with a promising new treatment option. NEXI-001 is a product that is meaningfully differentiated from other cellular therapies in that it contains multiple populations of antigen specific endogenous T cells with enhanced anti-tumor properties. Because of this, we are hopeful NEXI-001 will address key limitations observed with other cellular immunotherapies; specifically, tumor escape through single target down-regulation and tumor relapse due to diminished T cell persistence.”

 

Neo Progen Logo

The biotech company is developing a cell therapy that could help patients who have suffered a heart attack. It’s the latest company led by medtech entrepreneur Bill Niland. NeoProgen, a Baltimore-based company led by medtech entrepreneur Bill Niland, raised $1.5 million in seed funding as it develops a cell therapy for patients following a heart attack.

The round featured an all-Maryland lineup of investors: The University System of Maryland’s Momentum Fund, which contributed $245,000; TEDCO; and UM Ventures, which is the commercialization arm of the University of Maryland.

Like his earlier venture, Harpoon Medical, NeoProgen has origins in research at the University of Maryland, Baltimore. That’s where Dr. Sunjay Kaushal, a leading pediatric cardiac surgeon, found that a specific kind of stem cells are extremely effective in regenerating muscle tissue in the heart.

 

Illumina Sequencing and array based solutions for genetic research

BALTIMORE, Oct. 29, 2019 /PRNewswire/ -- Illumina, Inc., a leading developer, manufacturer, and marketer of life science tools and integrated systems, celebrated today the grand opening of its new training facility in the University of Maryland (UM) BioPark.

The 13,000-square-foot Illumina Solutions Center provides training lab capabilities and office space for customers and commercial teams. It is the company's first commercial location on the East Coast and will host hundreds of employees and customers annually.

 

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The Chesapeake Bay Area Chapter of ISPE has partnered with the Regional Manufacturing Institute of Maryland and the Montgomery County Executive’s Office to bring some vital state and local resources to our industry at a trade-show like event on November 8 at the Washington DC/Rockville Hilton Hotel from 7:30-11:00 a.m.  The event is targeted at manufacturing executives, HR, CFOs and Engineering & Facility managers from leading biotech, pharma, IT, defense, printing and other industry executives from Montgomery County.  Please join us and find out how you can access thousands of dollars of state and local resources and meet the experts for those programs to address your workforce needs, reduce energy expenses and find grant funding, access financing/tax credit programs and more….all in one place.

 

TEDCO s Entrepreneur Expo Energizes Maryland s Startup Ecosystem with Record Attendance BioBuzz

The Maryland Technology Development Corporation (TEDCO) held its inaugural Entrepreneur Expo in 2011. The first Expo attracted approximately 300 attendees. Three times that number descended on The Hotel at the University of Maryland for its 9th annual Entrepreneur Expo on October 29th.

Entrepreneurs, thought leaders, small business owners, angel and venture investors, federal and state economic development teams and university leaders from across Maryland, the Biohealth Capital Region (BHCR) and beyond gathered at the event to network, share ideas and showcase their programs, technologies and companies.

 

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Former Howard County Executive Ken Ulman is known for his work with the University of Maryland, which hired him in 2014 to boost economic development in College Park.

Now, Montgomery County officials are hiring Ulman for a different task — luring the University System of Maryland and its flagship campus at College Park.

“We’ve had a lot of conversations with folks in the county about the desire to drive more higher education investment,” Ulman said in a phone interview on Tuesday. “Essentially, you have Montgomery County — an engine of innovation, a strong business community, but lacking a traditional four-year university.”

Image: Ken Ulman, a former Howard County executive and founder of the consulting firm Margrave Strategies. PHOTO VIA MARGRAVE STRATEGIES

Ex FDA chief Gottlieb sees investment opportunity in unloved antibiotics Reuters

NEW YORK (Reuters) - As a private investor, former U.S. Food and Drug Administration Commissioner Scott Gottlieb is focused on an area where few have found success in recent years: developing new antibiotics.

Since leaving the FDA in April, Gottlieb has revealed little about what types of investments he would make in his new role at New Enterprise Associates, one of the country’s largest venture capital firms where he worked prior to his time in government.

Image: FILE PHOTO: FDA Commissioner Scott Gottlieb speaks during an interview with Reuters in New York City, U.S., November 26, 2018. REUTERS/Brendan McDermid/File Photo -https://www.reuters.com 

healthcare

The Centers for Medicare and Medicare Services this week announced the 25 participants selected to move on to the next round of its Artificial Intelligence Health Outcomes Challenge.

WHY IT MATTERS

Launched this past March by the CMS Innovation Center, in collaboration with the American Academy of Family Physicians and the Laura and John Arnold Foundation, the AI Health Outcomes Challenge aims to give innovators a showcase for how they're developing AI and machine learning technologies, deep learning tools and neural networks.

 

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The former commissioner of the US Food and Drug Administration, Scott Gottlieb, tells Reuters that in his new role as a venture capitalist, he is interested in supporting companies examining new antibiotics.

"I'm very interested in finding opportunities in the anti-infective space, particularly around multi-drug resistant organisms," Gottlieb tells Reuters. "Anti-infectives have been unloved for a very long time. There's a huge clinical need."

 

top innovators

“The Biggest Biotech Bombshell in Years,” declared The Motley Fool of Biogen’s market-moving announcement October 22 that it was planning to file for FDA approval of the Alzheimer’s disease (AD) candidate aducanumab, being co-developed with Eisai, despite halting two failed Phase III studies of the drug in March. Investors flocked to Biogen stock, sending the company’s stock price surging 40% before the start of trading that day. When the market closed, Biogen shares finished the day 26% higher at $281.87.

 

san francisco

Earlier this year, Crunchbase, a database that tracks startup companies and their investors, noted that biotech venture funding has been increasing in recent years, with corporate venture investors significantly increasing their funding into biotechs in 2018. Recently, The San Francisco Business Times pulled together a list of the Bay Area’s top-funded biotech companies from July 1, 2018 through June 30, 2019. Here’s a look at the top 10.

 

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GAITHERSBURG, Md., Oct. 24, 2019 /PRNewswire/ -- MaxCyte, the global cell-based therapies and life sciences company, announces today that, having completed dosing of the second cohort of patients, clinical investigators have initiated dosing in the third cohort of patients of MaxCyte's Phase I clinical trial with the next higher cell dose of MCY-M11. This lead, wholly-owned, non-viral mRNA-based cell therapy candidate from MaxCyte's CARMA platform is a mesothelin-targeting chimeric antigen receptor (CAR) therapy being tested in individuals with relapsed/refractory ovarian cancer and peritoneal mesothelioma.

 

BioTalk Skyscraper Bashi

Super Angel Investor, Faz Bashi, MD, guests on BioTalk from the BioHealth Capital Region Investor Conference to talk about his background in Immunology/Virology, Venture Investing, and coming to the BioHealth Capital Region.

Listen on Google Podcasts bit.ly/2qR2cRE, Apple Podcasts apple.co/32Ta8A3, and TuneIn bit.ly/2Nip5VJ.

Dr. Faz Bashi, M.D., has a background in Immunology and Virology from UCSF. Faz is the Chair of the Medical Device Screening Committee of Life Science Angels and is an active member of the LSA screening committee for Biotechnology and Pharmaceuticals. He is also the Chair of the Angel Capital Association’s Life Sciences Syndication Group, is a member of the Berkeley Angel Network, and was one of the founding members of Healthtech Capital, where he served two years on the Board of Directors.

He is an adjunct professor in the Integrative Health Studies program at the California Institute of Integral Studies. Faz is an active advisor to the UCSF Clinical and Translational Science Institute. He had worked previously at San Mateo Medical Center developing and implementing special clinical projects targeted towards helping those who are under-served, which included projects focused on TeleDermatology, Diabetic Retinopathy, Screening, and advancements in electronic medical records. Faz is an active consultant to Coleman Associates as a Deep Dive expert, and he coaches public health clinics and safety net organizations on improving their workflow processes. He currently serves as an External Advisory Board Member at The Johns Hopkins University’s Center for Bioengineering Innovation and Design.

 
BioTalk SkyScraper Kalayoglu

Cartesian Therapeutics’ President & CEO Murat Kalayoglu, MD, Ph.D., guests on BioTalk from the BioHealth Capital Region Investor Conference to talk about developing novel cell and gene therapies, building his company in the region, and also being an investor.

Listen now on Apple Podcasts https://apple.co/2pNSKhr, Google Podcasts http://bit.ly/2qCatIU, and TuneIn http://bit.ly/2Wb14DP

Dr. Kalayoglu is co-founder and CEO of Cartesian Therapeutics, a fully-integrated, clinical-stage biopharmaceutical company developing novel cell and gene therapies to treat cancer and autoimmune diseases. Before Cartesian, he was co-founder and CEO of Topokine, which he led from concept to late-stage clinical trials, followed by a successful sale to Allergan (NYSE:AGN). Prior to Topokine, he was co-founder and COO of HealthHonors Corporation, which he led from concept to commercialization, followed by a successful sale to Healthways (NASDAQ:HWAY). Dr. Kalayoglu is a board-certified ophthalmologist who completed his residency and research fellowship at Harvard, MD/Ph.D. in immunology at the University of Wisconsin-Madison, and MBA from the MIT Sloan School of Management.

Founded in 2016, Cartesian is a fully-integrated, clinical-stage biopharmaceutical company developing novel cell and gene therapies to treat cancer and autoimmune diseases. All of the company’s products are manufactured internally at the company’s wholly-owned cGMP manufacturing facility in Gaithersburg, MD. Cartesian has three programs in clinical development. The lead product, Descartes-08, is a CD8+ CAR T-cell therapy with a defined and predictable half-life, enabling repeat dosing to maximize potency while minimizing risk of toxicity. Descartes-08 is currently in Phase I/II clinical trials to treat patients with multiple myeloma.

 
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NeoProgen, a Baltimore-based company led by medtech entrepreneur Bill Niland, raised $1.5 million in seed funding as it develops a cell therapy for patients following a heart attack.

The round featured an all-Maryland lineup of investors: The University System of Maryland’s Momentum Fund, which contributed $245,000; TEDCO; and UM Ventures, which is the commercialization arm of the University of Maryland.

Like his earlier venture, Harpoon Medical, NeoProgen h

 

johns hopkins

NEW YORK, Oct. 22, 2019 /PRNewswire/ -- Bloomberg Philanthropies, Johns Hopkins University School of Medicine (JHUSOM), and The New York Stem Cell Foundation (NYSCF) Research Institute today announced an initiative to fundamentally advance and expand the science of precision medicine, in which diagnostic disease markers are defined with pinpoint accuracy to help researchers understand disease pathways and customize therapeutic approaches. The collaboration will combine the renowned clinical and medical expertise of Johns Hopkins with the unique stem cell technologies and research capabilities of the NYSCF Research Institute to accelerate Hopkins' pioneering Precision Medicine Initiatives.

 

Francis Collins - From Wikipedia

Our world has never witnessed a time of greater promise for improving human health. Many of today’s health advances have stemmed from a long arc of discovery that begins with strong, steady support for basic science. In large part because of fundamental research funded by the National Institutes of Health (NIH), which traces its roots to 1887, Americans are living longer, healthier lives.

 

Joseph Allen

Next year marks the 40th anniversary of the passage of the Bayh-Dole Act. With election day looming, 2020 is likely to be the most politically contentious year of our lifetime. The country is divided right down the middle on many fundamental issues. Rather than debate, the opposing sides often descend into personal attacks, even questioning one another’s patriotism. This isn’t the time you want issues you care about dragged into the public arena, but patent rights and the Bayh-Dole Act have been summoned into the gladiator pit. Happy birthday, indeed.

 

gene

Although touted as having potential to cure some of the most intractable of human illnesses, gene therapies also carry some eye-popping price tags that have threatened to limit their availability to wealthy countries. However, a new public-private partnership aims to make them available to people around the world, including in developing countries.

 

Meet With Johnson Johnson Innovation

On Thursday, November 7, join JLABS @ Washington, DC as representatives from Johnson & Johnson Innovation provide an overview of goals and mission, highlighting how Johnson & Johnson Innovation interacts with the entrepreneurial community through JLABS, JJDC, the Innovation Centers and Janssen Business & Development.

Click here for more information.

 
Robert L. Caret

The Montgomery County Business Hall of Fame (MCBHOF) is excited to announce Dr. Robert Caret as the keynote speaker for its annual luncheon and induction ceremony on October 29.

Dr. Caret is the Chancellor of the University System of Maryland. He has held this position since 2015 where he established the priorities of access and affordability, college completion, academic and research excellence, and workforce development. Under his leadership, the USM has expanded partnerships with the business community and embraced a more entrepreneurial approach, positioning the system as vital economic and workforce engine for Maryland.

 

healthcare

Pocket-size ultrasound devices that cost 50 times less than the machines in hospitals (and connect to your phone). Virtual reality that speeds healing in rehab. Artificial intelligence that’s better than medical experts at spotting lung tumors. These are just some of the innovations now transforming medicine at a remarkable pace.

 

seattle

In March 2019, BioSpace wrote about how the BioForest Hotbed area was the fastest-growing life sciences market in the top 10 from 2014 to 2017. Although relatively small compared to the top areas such as California and Massachusetts, Washington state and Seattle are growing at faster than 17%. One of the life sciences’ heavy hitters in real estate development, Alexandria Real Estate Equities, is showing its increasing interest in the region.

 

The Galien Foundation Honors 2019 Prix Galien Award Recipients

NEW YORK, Oct. 25, 2019 /PRNewswire/ -- The Prix Galien USA Committee last night honored excellence in the biopharmaceutical and medical industry for research, development and innovation at its 13th annual Prix Galien Awards Gala, held at the American Museum of Natural History in New York City. In recognition of the development and discovery of products that improve the human condition, a committee of highly accomplished scientific leaders, inclusive of four Nobel Laureates, recognized winners in three categories: "Best Pharmaceutical Product," "Best Biotechnology Product," and "Best Medical Technology."

Image: “Best Pharmaceutical Product:” GlaxoSmithKline, SHINGRIX

asia

A year after transactions involving “research and development in biotechnology” and 26 other “critical technology” industries were made subject to review by the Committee on Foreign Investment in the United States (CFIUS), President Donald Trump’s Administration has signaled a desire to keep an even closer eye on such deals. The new rules could further reduce foreign direct investment in the United States by overseas investors, including Asian firms and wealthy individuals increasingly flush with capital as biopharma has grown in Asia.

 

Hilja Biotalk Skyscraper

Gentian’s CEO Dr. Hilja Ibert, Ph.D., guests on BioTalk from the BioHealth Capital Region Investor Conference to talk about their presence in the US market, Biomarkers, and Innovate Diagnostic Efficiency.

Listen now on Google Podcasts http://bit.ly/2MwE0w8, Apple Podcasts https://apple.co/2P7e5Nw, and TuneIn http://bit.ly/2oZkv6x

Dr. Hilja Ibert has over 25 years’ experience from the international diagnostic industry, from which she also has extensive leadership experience. She is a hands-on CEO, driving development and commercialization of product solutions for the clinical diagnostics market.

Gentian is a research-driven company that Dr. Ibert knows to appreciate, as she has gained experience with the development and market introduction of innovative technology throughout her career. Gentian develops and manufactures immunoassays based on unique and proprietary technologies, which enables these products to run on a wide range of high-throughput clinical chemistry analyzers. This results in significant workflow advantages for the laboratories. Through Dr. Ibert’s leadership, the company innovates and focuses on diagnostic efficiency through development and production of accurate and high throughput immunoassays that save time and costs for the laboratories and which provide relevant information earlier to clinicians. By doing so, Gentian contributes to improved patient outcomes. Gentian’s current products and pipeline cover kidney, infectious, inflammatory and cardiovascular diseases.

 
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Gentian’s subsidiary in the US, Gentian USA, Inc. collaborates with BioHealth Innovation (BHI) in order to expand Gentian’s presence in the USA.

BHI, with its established healthcare market and business expertise, addresses Gentian’s needs at this early market entry stage. BHI’s market analysis expertise will allow Gentian to gain valuable market insight to market both their existing products and their pipeline product developments to the US market. In addition, it will also support launches of newly developed, innovative products.

 

MockV Solutions Biotechnology company developing a series of analytical kits

Rockville, MD – October 16, 2019 – MockV Solutions, Inc. (MockV or the Company), a company developing innovative products to analyze viral clearance during process development, announced today that it has signed a test and study agreement with REGENXBIO Inc. (REGENXBIO), Thermo Fisher Scientific Inc. (Thermo Fisher) and Texcell-North America, Inc. (Texcell NA) to evaluate MockV’s MVM-MVP Kit for predicting Minute Virus of Mice (MVM) clearance during adeno-associated virus (AAV) bioprocessing.

 

emergent biosolutions

GAITHERSBURG, Md., Oct. 21, 2019 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE: EBS) today announced that the company will host an analyst and investor day on November 21, 2019 in New York City. This event, which is designed for sellside research analysts and institutional investors, will begin at 8:00 AM EST and end at 2:00 PM EST.

Institutional and analyst attendees who choose to participate onsite must register, as space is limited. To register for onsite participation at the event or for more information, please contact Robert Burrows, IRO for Emergent BioSolutions at This email address is being protected from spambots. You need JavaScript enabled to view it. or (240) 631-3280.