Some of the most common services sought after by early stage healthcare and life science companies are the following:

1. CMC Regulatory Consultants  2. Accounting Services including Tax prep and tax credits 3. Reimbursement Consultants for your Product How should you go about choosing these providers? What is the best way to vet their qualifications and reputation? What are the most common mistakes made in choosing these vendors? How can startups protect themselves from partners who are not performing up to “best practices” standards? Are their tax incentives that you might be missing? 

Come to the November 21st meeting of the National Capital Chapter of the Society of Physician Entrepreneurs and learn from our panel of experts!

Johns Hopkins is getting involved with the vast and swiftly growing field of psychedelic research.

The prestigious university is throwing down $17 million from a group of private donors on its Center for Psychedelic and Consciousness Research. It’s the first of its kind the United States and the largest in the world — intended to expand our knowledge and our minds through psychedelic research.

Hopkins Medicine will explore use of psilocybin to treat diseases such as opioid addiction, Alzheimer’s disease, eating disorders, depression and chronic Lyme disease.

CEO Pascal Soriot knows what’s at stake for AstraZeneca’s business. It is whether China, now the British drugmaker’s second-largest market, can sustain double-digit growth—and some investments that support the Chinese government’s goals are necessary.

In a slew of news coming out of Shanghai on Wednesday, AstraZeneca is teaming up with investment shop China International Capital Corporation to launch a $1 billion fund focused on healthcare, upgrading its Shanghai R&D operations to a global center, establishing a new artificial intelligence innovation center, and partnering up with Sun Pharma to market some oncology drugs in China.

Just a year after I arrived at UMBC as a young vice provost in 1987, what we now know today as the University System of Maryland (USM) was formed through the merger of the five University of Maryland campuses and the six campuses in the State University and College System. The late John S. Toll, a renowned physicist who devoted the prime of his career to public higher education, served as the first Chancellor and quickly established a system that optimized the varied strengths of eleven institutions to give families and employers throughout the state access to outstanding academic programs and research discoveries, and talent.

Image: Baltimore Sun photo by Barbara Haddock Taylor

A pediatric gastroenterologist who is the veteran president of the University of Maryland at Baltimore was named Thursday to become the chancellor of the state’s public university system.

Jay A. Perman will be the fifth chancellor of the University System of Maryland, which encompasses the state flagship campus in College Park and 11 other public institutions serving 176,000 students. Perman will succeed Chancellor Robert L. Caret when the incumbent steps down in coming months. Perman’s start date has not been determined, a system spokesman said.

Image: Scene from the campus of the University of Maryland at College Park. (MARVIN JOSEPH/Washington Post)

Keynote: Rebecca Canino of Johns Hopkins Office of Telemedicine

Digital Health inventors and innovators are invited to discover novel technologies with the potential to transform medicine. Digital Health Day centers around a healthcare technology expo featuring inspiring technologies offered by regional start-ups, industry, and Johns Hopkins innovators.

Image: https://www.eventbrite.com

The New Haven area has become a hub for thriving and growing young bioscience companies like Arvinas and Cybrexa Therapeutics, which are working to develop potentially game-changing cancer cures.

The region’s biotechs are developing treatments for a range of ailments, from Alzheimer’s disease to spinal-cord injuries.

But just as a growing infant can’t stay in an incubator for long, many New Haven-born bioscience companies need room to grow — and fast.

Image: PHOTO | NEW HAVEN BIZ - John Keogh, senior broke with Colliers International, in lab space at 5 Science Park on Winchester Avenue in New Haven.

AstraZeneca said today it will create new R&D centers focused on drug development and artificial intelligence (AI) in Shanghai, as well as partner with state-run China International Capital Corporation Limited (CICC) to launch a potentially $1 billion fund whose investments will aim to advance innovation in China’s healthcare system.

Image: AstraZeneca’s China headquarters at Shanghai Zhangjiang Hi-Tech Park - https://www.genengnews.com

Gaithersburg, MD, November 5, 2019 – Cartesian Therapeutics, a fully integrated, clinical-stage biopharmaceutical company developing cell and gene therapies for cancer and autoimmune diseases, today announced that it has initiated a Phase 1/2 clinical trial (NCT04146051) of its lead CAR-T candidate, Descartes-08, in patients with generalized myasthenia gravis (GMG).  To the company’s knowledge, the program is the first CAR-T investigational candidate to enter clinical development for an autoimmune disease.

“Patients with severe GMG have limited treatment options and are often dependent on nonselective, chronic immunosuppressive therapies (ISTs) that have long-term toxicities,” said Volkan Granit, MD, the trial’s principal investigator and Assistant Professor of Neurology at the University of Miami Miller School of Medicine. “Cartesian’s CAR-T technology selectively targets the primary culprit in the disease:  antibody-producing plasma cells.  Such selective targeting would be a first in GMG and could help patients discontinue use of chronic ISTs.”

For those that lived through the devastation and horror of the HIV/AIDS epidemic of the early 1980s, effective treatment, let alone a cure for Human Immunodeficiency Virus (HIV), seemed unimaginable. 

Some three decades later, a host of Maryland life science companies and research organizations are getting closer to making what was once unthinkable, real.

So little was known about this devastating immune disorder in the early phases of the HIV/AIDS epidemic. 

COLUMBIA, Md., Nov. 7, 2019 /PRNewswire/ -- The Maryland Stem Cell Research Commission (Commission) issued a Request for Applications (RFAs) for its second round of funding for fiscal year 2020 and is looking to continue funding cutting-edge research and accelerating cures through the Maryland Stem Cell Research Fund (MSCRF).

Established under the Maryland Stem Cell Research Act of 2006, the MSCRF is currently budgeted to commit up to $8.2 million, in aggregate, in FY2020 to fund grants under all of its RFAs. These RFAs include: Launch Grants, Discovery Grants, Validation Grants, Commercialization Grants, Clinical Trial Grants and Post-Doctoral Fellowships. Under this funding cycle, all research proposals must pertain to human stem cell-based therapy and regenerative medicine.

RADNOR, Pa. and DUBLIN, Nov. 6, 2019 /PRNewswire/ -- Avantor, Inc. (NYSE: AVTR) and the National Institute of Bioprocessing Research and Training (NIBRT) today announced they are teaming up to address downstream bottlenecks in buffer preparation when producing monoclonal antibodies (mAbs). As part of the joint effort, Avantor® is providing in-line dilution systems for hands-on experience at NIBRT's prestigious training and research facility dedicated to supporting the global bioprocessing industry. Avantor's technology adds to NIBRT's full complement of bioprocessing capabilities.

The growth of the BioHealth Capital Region (BHCR) and its position as a global biohealth cluster is a hot topic of discussion—often filtered through a broad, conceptual lens focused on big-picture trends, GEN publication rankings and widely discussed areas of industry need.

The development and growth of the BHCR is also a story that supports the life science boom in the region and is steeped in real estate development, communities of innovation, bricks and mortar, architectural plans, and construction management, as well as facility and lab design innovation.

Image: https://biobuzz.io

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.

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.

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.

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

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.

“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.

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.

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 

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."

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.”

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.

To cap off the TEDCO Entrepreneur Expo, there was a special ribbon cutting ceremony to welcome the Association of University Research Parks (AURP) to the state of Maryland.

Maryland Department of Commerce Secretary Kelly Schulz did the honors of conferring the Secretary's Citation to the Association of University Research Parks (AURP) on behalf of the citizens of the state for selecting College Park as the home of its HQ2.

We are excited to welcome back Brian Darmody and grateful to have the of Association of University Research Parks (AURP)'s HQ2. in the University of Maryland's very own research park, the Discovery District.

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.