Orgenesis Inc. (OTCQB: ORGS), a fully-integrated cell therapy and contract development and manufacturing company, announced that its Belgian subsidiary, Orgenesis SPRL, has received the formal approval from the Walloon Region, Belgium (Service Public of Wallonia, DGO6) for a budget of EUR 12.3 million ($12.8 million) support program for the GMP production of AIP cells for two clinical trials that will be performed in Germany and Belgium. The project support will be for a period of three years commencing on January 1, 2017.

Of the approved amount, a total of EUR 3.3 million is budgeted for a development work at our Belgian-based subsidiary, MaSTherCell S.A.

In labs testing how brain implants could help people with physical disabilities, tales of success can be bittersweet.

Experiments like those that let a paralyzed person swig coffee using a robotic arm, or that let blind people “see” spots of light, have proven the huge potential of computers that interface with the brain. But the implanted electrodes used in such trials eventually become useless, as scar tissue forms that degrades their electrical connection to brain cells (see “The Thought Experiment”).

Which state has the nation’s most research-intensive economy? California? Massachusetts? North Carolina?

Actually it’s Maryland. A greater portion of Maryland’s economy comes from private, federal, and university research spending than any state (with the exception of rural New Mexico with its two large federal labs).  But not enough of us recognize that.

Funding and Research Opportunities

The following funding opportunity announcements from the NHLBI or other components of the National Institutes of Health, might be of interest:

Notices:

• Impact of Washington, DC Area Federal Office Operating Status on NIH Grant Application Due Dates 
• (NOT-OD-17-041) 
• National Institutes of Health
• Notice of NIA's Participation in PA-17-101 "Research on the Health of Women of Underrepresented, Understudied and Underreported (U3) Populations - An ORWH FY17 Administrative Supplement (Admin Supp)"
• (NOT-AG-17-004)
• National Institute on Aging
• NHLBI Priorities for HIV Research and Funding 
• (NOT-HL-17-486)
• National Heart, Lung, and Blood Institute
• Notice of NLM's Participation in PA-17-101 "Research on the Health of Women of Underrepresented, Understudied and Underreported (U3) Populations An ORWH FY17 Administrative Supplement (Admin Supp)"
• (NOT-LM-17-004)
• National Library of Medicine

Hot off the (online) presses: the first annual Year-End Market Report produced by MCEDC. How does the employment rate in Montgomery County compare to the state? What are the biggest business highlights from last year? How does the future look for the county? Find these answers, and more.

Emergent BioSolutions Inc. (NYSE:EBS) today announced that it has received a task order from the Biomedical Advanced Research and Development Authority (BARDA) valued at up to $30.5 million to develop monoclonal antibody therapeutics for viral hemorrhagic fever. This task order will utilize the company’s Center for Innovation in Advanced Development and Manufacturing (CIADM) facility located in Baltimore, Maryland. Using monoclonal antibodies from Mapp Biopharmaceutical Inc., the company will conduct technology transfer of process materials and information, perform process and analytical method development, execute small-scale production runs, and perform cGMP cell banking leading to cGMP manufacture of bulk drug substance. The task order consists of a 36-month period of performance with a base task order valued at $7.4 million and options that, if executed, will bring the total task order value over three years to up to $30.5 million.

Scientists are no strangers to having their work questioned by lawmakers, and now they are fighting back.

On April 22, scientists and their supporters will hold a March for Science to advocate for science and evidence-based research in policies. The main march will be held in Washington, D.C., and satellite marches will be held in other cities, as they were with the Women’s March the day after the inauguration. And the march’s organizers say they aren’t just fighting for more funding for science, or more influence in policy, but also to raise awareness about the type of research they’re doing.

The recent flurry of activity around the Affordable Care Act (ACA) has many people confused about where it stands, and what the employer's obligations are. The following summarizes the activity so far.

Legislative Repeal Activity

A popular meme suggests that the Senate voted to eliminate virtually all of the provisions of the ACA, including the ability to obtain insurance in spite of pre-existing conditions, the requirement to cover adult children up to the age of 26, etc. This is not the case.

President Donald Trump’s new health secretary took office Friday after becoming the latest Cabinet nominee to eke out a confirmation victory in the bitterly divided Senate.

Vice President Mike Pence administered the oath of office to Tom Price, of Georgia, at the White House hours after the Senate confirmed him 52-47 in a party-line vote. That roll call came in the dead of night, thanks to Democrats’ tactic of forcing prolonged debates to broadcast their opposition to Trump and his team.

Researchers from the University of Maryland College Park (UMD) and Baltimore (UMB) campuses have developed a blood test that could help doctors more quickly diagnose schizophrenia and other disorders. Their study, "Redox Probing for Chemical Information of Oxidative Stress," was recently published in the journal Analytical Chemistry.

"We hope our new technique will allow a more rapid detection and intervention for schizophrenia, and ultimately lead to better outcomes," said Gregory Payne, one of the authors and a joint professor with UMD's Fischell Department of Bioengineering (BIOE) and the Institute for Bioscience and Biotechnology Research (IBBR).

Gynecological surgery device developer SurgiGyn said today it inked an exclusive license arrangement with the University of Maryland, Baltimore for laparoscopic surgical device technology developed at the University.

The Baltimore, Md.-based company said it also closed a seed round of funding from UM Ventures and a private investor, with funds slated to support accelerated development of its uterine electrosurgical device

The Biotechnology Innovation Organization (BIO) issued the following statement regarding President Trump’s comments today supporting biopharmaceutical innovation:

"We look forward to working with President Trump and his team to enact policies that ensure better access to and affordability of today’s medicines and the vision the President laid out in his inaugural address ‘….to free the earth from the miseries of disease, and to harness the energies, industries and technologies of tomorrow.’ The ideas the President laid out in his meeting today--policies that would cut unnecessary regulation, enforce fair trade, increase competition, support small companies' ability to attract capital and strengthen and promote market-based solutions--are ideas that BIO has been advocating for and working to build consensus on with others in the healthcare system.  They will go a long way toward ensuring that patients have affordable access to today's innovative medicines and that our companies have the policy and regulatory environment they need to bring a new generation of breakthrough medicines to our children and grandchildren.

Thursday, February 23, 2017 6:00 p.m. – 8:00 p.m. EST

Johns Hopkins University – Montgomery Campus 106-110 A&R Building 9601 Medical Center Drive Rockville, MD 20850

Washington DC/Baltimore Chapter of Women In Bio is presenting a program to learn about how bioscience discoveries move from the bench to the market. The route from discovery to market is not linear. Our panelists will relay their experiences with clinical trials, manufacturing, and marketing and will discuss how each of these aspects interacts along the way. Whether you are looking to enter the world of bench to market or are just curious about the process, this will be an informative and fun event. Moderated by Lynn Johnson Langer, Program Director, Sr. Lecturer, Johns Hopkins University, our panel includes the following individuals:

• Neta Nelson - Associate Director, Clinical Operations & Project Management, Technical Resources International, Inc.
• Maura Kahn - Vice President, Business Development and Marketing, Noxilizer, Inc.
• Kathy Webb - Senior Director GMP Operations, Paragon Bioservices, Inc.

On the first two days of February, I testified before Maryland legislative committees in support of Governor Larry Hogan's FY 2018 budget proposal for the University System of Maryland (USM).

Governor Hogan has proposed state support for USM of $1.35 billion. This is an increase of $26.6 million --- or approximately 2 percent --- over the final FY 2017 budget, which includes the November Board of Public Works reduction of $14.2 million.

Thursday February 16, 2017 from 5:00 PM to 7:00 PM EST 

Join BioBuzz and founding sponsor The Johns Hopkins University Montgomery County Campus at Growlers in Gaithersburg on February 16th for our 1st networking event of 2017. The Johns Hopkins University Montgomery County Campus offers part-time graduate courses in several disciplines, including education, biotechnology and liberal arts. Students attend classes in the evenings and on Saturdays, enabling them to hold full-time jobs during the day. Depending on the degree area, students can fully complete their coursework in Montgomery County. Other students take some courses in Baltimore and/ or online.

Understanding how mechanics complement bio-signaling in defining patterns during morphogenesis is an outstanding challenge. Here, we utilize the multicellular polyp Hydra to investigate the role of the actomyosin cytoskeleton in morphogenesis. We find that the supra-cellular actin fiber organization is inherited from the parent Hydra and determines the body axis in regenerating tissue segments. This form of structural inheritance is non-trivial because of the tissue folding and dynamic actin reorganization involved. We further show that the emergence of multiple body axes can be traced to discrepancies in actin fiber alignment at early stages of the regeneration process. Mechanical constraints induced by anchoring regenerating Hydra on stiff wires suppressed the emergence of multiple body axes, highlighting the importance of mechanical feedbacks in defining and stabilizing the body axis. Together, these results constitute an important step toward the development of an integrated view of morphogenesis that incorporates mechanics.

To the Editor:

We the undersigned, founders and leaders of biotech companies, write to express our deep concern and opposition to the executive order signed by President Donald Trump on January 27, 2017, barring the entry of citizens from seven countries into the United States1.

The United States is the world’s greatest developer of medicines and new inventions to ameliorate and cure intractable diseases, a status achieved through massive investment in private and public companies, academia and R&D. Most importantly, our success has been founded on the creativity and dedication of our most precious resource—our people.

Tuesday, March 7th 8:00am—5:00pm

This one-day event will highlight the latest trends in medical devices and technologies and feature resources in the state that help bring products from invention to market. Topics include bioelectronics, cybersecurity for medical devices, convergence of devices and drugs, big data, robotic prosthetics, and additive manufacturing applications. Organizations representing Maryland innovation, entrepreneurial, funding, regulatory, and product scale-up resources will be there to discuss ways that they work with the medical device community.

This event is sponsored by the University of Maryland Robert E. Fischell Institute for Biomedical Devices, Maryland Manufacturing Extension Partnership, the Maryland Department of Commerce, Federal Laboratory Consortium (FLC), FLC Mid-Atlantic Region, National Institute for Standards and Technology Manufacturing Extension Partnership , and TEDCO.

Cuddles, kisses, and caring conversations. These are key ingredients of our close relationships. Scientists are finding that our links to others can have powerful effects on our health. Whether with romantic partners, family, friends, neighbors, or others, social connections can influence our biology and well-being.

Nestlé announced last week it is moving its US headquarters from California to Arlington, Virginia. We see similarities to other recent headquarters moves, yielding lessons for communities seeking to attract or retain these high profile activities.

The black sports bra and matching leggings that Under Armour began selling Monday don’t look particularly distinctive from the rest of the workout attire on its website.

But, in fact, the garments are different in a key way: They were made in the United States, marking a key milestone in the company’s ambitious bid to significantly rethink its manufacturing strategy.

Build the MoCo STEM community by attending this free event for educators from pre-K to college, business leaders and employers, County Councilmembers, county government leaders and service providers, industry practitioners, interested parents and students. We are showcasing best practices, laying out a vision and asking for input on an effective STEM engagement strategy for Montgomery County.

12:30pm - 1pm: Networking and STEM Demonstrations

1pm - 4pm: Panels and Discussion

MCPS Superintendent Jack Smith to speak at 1:15pm

The Federal Laboratory Consortium for Technology Transfer congratulates the winners of its 2017 Awards. With over 90 nominations submitted this year’s competition was fierce, which made our judges’ task of selecting winners an unenviable one. We thank our winners, and their competitors, for a great job in realizing the technology transfer potential within their laboratories. 

The awards will be presented on Wednesday, April 26, 2017 at the FLC National Meeting in San Antonio, Texas. To register for the meeting and/or awards ceremony, visit meeting.federallabs.org.

The volume of startups says a lot about an area’s viability.

But as that number keeps growing, it’s worth considering which of those companies are “real.” It helps people who track startups (like, say, journalists) keep tabs on the next big companies coming out of Baltimore.

Men whose prostate cancer comes back after surgery are more likely to survive if, along with the usual radiation, they also take drugs to block male hormones.

The finding, published Wednesday in The New England Journal of Medicine, comes from a long-running study that experts say will help clarify treatment for many patients.

Chronic graft-versus-host disease (cGVHD) is a prevalent and highly lethal condition affecting stem cell transplant recipients. Unfortunately, biopsies are a painful, invasive and slow procedure that cause discomfort to patients and does not yield rapid results. The National Cancer Institute seeks licensees to commercialize this improved method for detection of diseases that are characterized by the presence of rapidly-dividing cells using deuterated water as a label for dynamic measurement of in vivo cellular kinetics.

Date: February 22, 2017

Time: 7:30 a.m. - 8:00 a.m. Registration and Networking 8:00 a.m. - 9:30 a.m. Program

Curious about Lean Startup? What does it really mean and why is everyone talking about it? Lean is a way of thinking that can shorten cycles for developing products and business startups. It is a logical, scientific approach that helps businesses and entrepreneurs draw distinct lines between the fuzzy dream in their head and the reality on the ground. Best of all it teaches us how to create a deep, lasting relationship with the most important person our business will ever know: our customers.

Come join moderator Bob Smith, a serial entrepreneur and Lean Startup instructor and a panel of experienced Lean practitioners as they provide an overview of the process and how it can be used during any phase of the business life cycle; startup to new product development.

As part of REDI's 20th Anniversary, we've created a new retention program aimed at solidifying relationships with the City's leading businesses: Rockville Key Visits, or RKVs for short.

REDI is joined on the monthly visits by representatives of the Mayor & City Council, our Board of Directors, and partner economic development organizations.

RKVs are arranged with businesses that are major employers, operating in a priority industry, and/or exhibiting fast growth potential. The program creates an open line of communication to discuss the opportunities and challenges facing the local business community, which benefits all parties through a regular exchange of information and resources.

The first RKV took us to Supernus Pharmaceuticals, which focuses on developing and commercializing products for the treatment of central nervous system disorders and employs over 160 in its Rockville headquarters. As a major employer operating in the region's important biotech cluster with strong potential for growth, Supernus was a great visit to kick off RKV!

President Donald Trump wants to remake the Food and Drug Administration. And he happens to have a “fantastic person” in mind to do it, he said Tuesday — someone who will turn the agency into an industry-friendly shop that cranks out new cures on the double.

With over 75 scientific ventures to its name, Flagship’s startup network has now generated 16 IPOs and $19 billion in aggregate value over 17 years.

Things were going well, but Flagship Pioneering (formerly Flagship Ventures) still felt the need for a name change in December of last year.

When: Thursday February 16, 2017 from 5:00 PM to 7:00 PM EST

Location: Growlers 227 E Diamond Ave Gaithersburg, MD 20877

Johns Hopkins Montgomery County Campus is also a site for the popular Osher Lifelong Learning Institute. Geared toward retirees, these non-credit classes cover topics including opera, literature, history, politics and more.

The campus is home to approximately 35 research companies and entrepreneurs. Scientists on campus are studying cervical cancer, Alzheimer's disease, cell therapy, proteins and other health issues. Other companies focus on technology, medical devices and consulting services. The Rockville Science Center's administrative offices are located here. Start-up companies, second-stage businesses and more established companies are welcome.

Supernus Pharmaceuticals, Inc. (NASDAQ:SUPN), a specialty pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system diseases, today announced the issuance on January 24, 2017 of a seventh patent (number 9,549,940) by the United States Patent and Trademark Office (USPTO) covering Trokendi XR®, its novel once-daily extended-release topiramate product. The patent provides protection for the product with expiration that is no earlier than 2027.

In a unique collaboration, a concurrent degree program featuring Penn State Harrisburg’s master of business administration and the Penn State College of Medicine’s doctorate in biomedical sciences allows students to get on a fast track to jobs that combine scientific research with positions of management responsibility. The concurrent program gives students an edge in a highly competitive field by providing them with a foundation in management in addition to specialization in biomedical science.

The coming $1.1 billion acquisition of CoverMyMeds LLC – Ohio's first tech startup " unicorn" – is a huge win for the Ohio Third Frontier program.

McKesson Corp., one of the three biggest U.S. health-care products distributors, announced Wednesday it would acquire the fast-growing Columbus software maker in a deal that could grow to $1.37 billion depending on its financial performance over the next two years.