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.

Michael Lenardo, M.D., Chief, Molecular Development of the Immune System Section NIAID/DIR, joins Rich Bendis on BioTalk to discuss his work at NIH, his recent election to the National Academy of Medicine, and advice for fellow scientists

Listen now on Google Podcasts http://bit.ly/2Ws6L0v, Apple Podcasts https://apple.co/2WupsAq, and TuneIn http://bit.ly/2Pve2ex

Michael Lenardo attended the Johns Hopkins University and graduated with a Bachelor of Arts in Natural Sciences in 1977. He then attended Washington University in St. Louis, Mo. and obtained his Doctor of Medicine (M.D.) in 1981. He carried out clinical and research training at the University of Iowa from 1981-1985. He was then a Research Fellow at the Whitehead Institute for Biomedical Research at Massachusetts Institute of Technology with an adjunct appointment at Harvard Medical School. During this time, he carried out molecular biology research under the mentorship of Nobel laureates David Baltimore and Philip Sharp. He was then appointed Section Chief in the National Institute of Allergy and Infectious Diseases, National Institutes of Health from 1989 to the present, directing research on T-lymphocyte regulation, HIV-1, and genetic diseases of the immune system. He has served on the editorial boards for the European Journal of Immunology, the Journal of Experimental Medicine, Science magazine, and Biology Direct. He is an Adjunct Professor of Pathology at the University of Pennsylvania School of Medicine, and a Visiting Fellow at Cambridge University. He has founded or co-founded several joint research programs including the NIH-Oxford-Cambridge Biomedical Research Scholars, the NIH-University of Pennsylvania Immunology Program, the NIH-Marshall Scholars, the NIH-Rhodes Scholars, the National M.D./Ph.D. partnership program, and the NIH-Institut Pasteur Infectious Disease and Immunology Program.

Dr. Lenardo has published over 200 scholarly works and holds a number of medical patents. He discovered the propriocidal mechanism of immune regulation and his work has defined several genetic diseases of the immune system including the Autoimmune Lymphoproliferative Syndrome, Caspase-8 deficiency syndrome, and X-linked magnesium deficiency with EBV and neoplasia (XMEN) disease. He is currently the Director of the Clinical Genomics Program and Chief of the Molecular Development of the Immune System Section, National Institute of Allergy and Infectious Diseases, National Institutes of Health. Among his honors and awards, he is Officer of the Most Excellent Order of the British Empire (O.B.E.), conferred by Queen Elizabeth II, March, 2006 and a Fellow of the American Association for the Advancement of Science, the American Academy of Arts and Sciences, National Academy of Science and the National Academy of Medicine.

He is married to Lesley-Anne Furlong, M.D. and has two sons, Brian and Timothy.

The National Institute of Allergy and Infectious Diseases (NIAID) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

NIAID has "intramural" (in-house) laboratories in Maryland and Montana, and funds research conducted by scientists at institutions in the United States and throughout the world. NIAID also works closely with partners in academia, industry, government, and non-governmental organizations in multifaceted and multidisciplinary efforts to address emerging health challenges such as the pandemic H1N1/09 virus.

The second annual Biohealth Capital Region Investment Conference attracted 108 companies and 47 participating investors—both conference records—and has already resulted in an investment deal for Gaithersburg’s MiRecule, an early-stage biotech focused on microRNA-based cancer therapy development.

The conference, which was held at AstraZeneca in Gaithersburg on October 15 and 16, was designed to increase the concentration of venture capital opportunities within the region’s ecosystem. BioHealth Innovation (BHI), J.P. Morgan, Wilson Sonsini Goodrich & Rosati (WSGR), Deloitte, AstraZeneca, NIST and The Maryland Department of Commerce all played critical roles in the conference’s success. 

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.

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.

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.

Drones are being taught to deliver food and medical supplies to customers. Now, doctors and scientists at the University of Maryland at College Park are creating special, custom-made drones that can literally save lives. Alexey Gorbachev has the story narrated by Anna Rice. 

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.

The United States continues to fall further behind world leaders in funding for university research. To reverse course, it should increase support by $45 billion per year and provide stronger incentives for businesses to increase their investments.

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.

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

Many of the region’s successful life science startups are built on technologies that were licensed from The National Institutes of Health (NIH), The National Cancer Institute (NCI), other government biomedical research institutions and Biohealth Capital Region (BHCR) research universities like Johns Hopkins and the University of Maryland. 

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.

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.

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.

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.

With its world-class institutions, talent and collaboration, now is the time for Maryland to take the next steps in becoming the nation’s premier science and tech-based innovation and entrepreneurial corridor.

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.

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.

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.

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

BALTIMORE, Md., Oct. 21, 2019 (GLOBE NEWSWIRE) -- CoapTech LLC announced today that the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) within the National Institutes of Health (NIH) awarded the company a two-year, $1.2M R44 Small Business Innovation Research (SBIR) Phase II grant on August 29, 2019. This builds on a $225,000 Phase I SBIR R43 grant and a $200,000 Maryland Industrial Partnerships (MIPS) grant awarded to the company last year.  

The new $1.2M grant will support a 40-patient clinical trial at the University of Maryland Medical Center (UMMC) evaluating safety and cost-effectiveness characteristics of a novel medical procedure known as percutaneous ultrasound gastrostomy (PUG), which is enabled by CoapTech’s PUMA-G device.  

ROCKVILLE, Md., Oct. 18, 2019 /PRNewswire/ -- American Gene Technologies (AGT) announced today the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for AGT's lead HIV program, AGT103-T, which is potentially a single-dose, lentiviral vector-based gene therapy developed for the purpose of eliminating HIV from people infected with the disease. 

Image: https://www.prnewswire.com

The General Assembly of Maryland has enacted Senate Bill 137 (the "General Corporate Legislation"), which makes several changes to the Maryland General Corporation Law (the "MGCL") and the Maryland REIT Law (the "MRL"). The General Assembly has also enacted Senate Bill 136 to explicitly permit the use of distributed electronic networks or databases (sometimes referred to as "blockchain" technology) in corporate record keeping (the "Distributed Ledger Legislation"). Finally, the General Assembly enacted House Bill 1116 and the identical Senate Bill 911 regarding annual reporting on the composition of the boards of directors of certain Maryland corporations (the "Annual Report Legislation"). The new legislation was signed by Governor Hogan and became effective on October 1, 2019. Unless otherwise noted, all section references below are to the MGCL.

Why do startups fail?

Image: https://www.linkedin.com

SILVER SPRING, Md. and RESEARCH TRIANGLE PARK, N.C., Oct. 21, 2019 /PRNewswire/ -- United Therapeutics Corporation (Nasdaq: UTHR) today announced that the U.S. Food and Drug Administration (FDA) has approved a supplement to the New Drug Application for Orenitram® (treprostinil) Extended-Release Tablets reflecting data from the FREEDOM-EV study in patients with pulmonary arterial hypertension (PAH).  

The FDA-approved labeling has now been updated to indicate that Orenitram delays disease progression when used in conjunction with an approved oral background PAH therapy. The primary efficacy endpoint of the FREEDOM-EV study was time to first clinical worsening (morbidity or mortality) event. The new label notes that treatment with Orenitram resulted in a significant increase in the time to first clinical worsening event compared with patients who received placebo, which was associated with a reduction in the risk of an event. The treatment effect on time to first clinical worsening due to disease progression was consistent across subgroups.

(Reuters) - GlaxoSmithKline will sell two travel vaccines to Bavarian Nordic for up to 955 million euros ($1.1 billion), the British firm said on Monday, as it looks to bolster its push into the lucrative cancer drug market.

The sale of anti-rabies treatment Rabipur and Encepur, used for the prevention of tick-borne encephalitis, to the Denmark-based biotechnology firm includes an upfront payment of 301 million euros and milestone payments of up to 495 million euros.

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.

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.

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.

CareFirst BlueCross BlueShield's corporate investment and innovation organization, Healthworx, has partnered with the Washington, D.C.-based Halcyon incubator program to provide funding and support for healthcare entrepreneurs.

Through the partnership, Healthworx will allot up to $200,000 to support innovative healthcare ventures in the incubator. Additionally, a Healthworx team member will join the Halcyon selection committee, tasked with ensuring that at least one slot in each of the next four program cohorts will go to a healthcare entrepreneur or startup developing solutions to improve outcomes and reduce the cost of care.

Virginia Tech plans to launch a cancer research initiative to promote collaboration among engineers, veterinarians, biomedical researchers and other scientists.

“We are going to create a sense of intellectual community of common interest for people. That takes money, resources and creating things they are interested in,” said Michael Friedlander, Tech’s vice president of health sciences and technology. “We are going to make available instrumentation and facilities for cancer researchers to use from all over the campus, some of which will be here, some of which will be new things we haven’t gotten yet. And we’re going to survey people: What do you need that you don’t have at Virginia Tech for leading-edge research?”

Image: Michael Friedlander

Silicon Valley Bank (SVB) recently conducted a survey called, “Women in Technology Leadership 2019”, which examined tech and healthcare company startup data and demographics. Respondents were from the U.S., UK, Canada and China.

SVB’s survey found that only 56% of responding startups have at least one woman in an executive position and only 40% have at least one woman on the board of directors. 28% of surveyed startups had at least one female founder. 

Image: https://biobuzz.io

Cerecor Announces $43 Million Deal with AYTU BioScience to Sell Pediatric Portfolio and Advance Towards NDA

It was announced today that Rockville, Maryland-based Cerecor Inc. (NASDAQ: CERC) has entered into an asset purchase agreement with AYTU BioScience, Inc. (“AYTU”) to sell Cerecor’s Pediatric Portfolio in a deal valued in excess of $32 million.

Cerecor is a biopharmaceutical company focused on becoming a leader in the development and commercialization of treatments for pediatric rare diseases. Earlier this year the company received Fast Track Designation for its lead product candidate, CERC-801 and expects to receive its first FDA approval within the next 18 months.

Visit https://lnkd.in/e8zm7df to read more.