Creatv MicroTech, a biotechnology company developing noninvasive diagnostics for cancer, has received a $250,000 Small Business Innovation Research (SBIR) grant from the National Institutes of Health/National Cancer Institute (NIH/NCI) to test the company's CellSieveTM system for determination of residual disease in lung cancer patients after chemoradiation therapy, and for early detection of lung cancer recurrence. Creatv MicroTech's discovery of a very large cell, the cancer associated macrophagelike cell (CAML), in patient blood has enabled more informative and reliable blood based cancer diagnostics. The presence of the CAML biomarker indicates the presence of cancer. Creatv developed CellSieveTM technology to capture and analyze CAMLs. In collaboration with The University of Texas MD Anderson Cancer Center in Houston, Creatv will assess the use of CAMLs in lung cancer patients to determine residual disease following treatment. Lung cancer is the leading cause of cancer death, with an estimated 158,040 deaths (86,380 men and 71,660 women) from this disease in 2015. Ideally, treatment should be continued as long as necessary and stopped only after the cancer has been eradicated. The problem is that standard imaging techniques, CT and MRI, cannot detect small residual cancers, and thus treatment regimens may be insufficient for a patient's individual need. The goal of Creatv's study is to determine the point at which chemoradiation should be stopped, reducing the likelihood of recurrence. "We are honored to be recognized for the progress we have made in developing precision blood-based cancer diagnostics," said Cha-Mei Tang PhD, President and CEO of Creatv MicroTech. "Our collaboration with the world renowned MD Anderson Cancer Center and support from the NIH will further demonstrate the value and utility of the CellSieveTM system and CAMLs in the battle against cancer and will ultimately save lives."

Join us on Thursday, August 24 for the 2017-18 Fall Term FAES Graduate School Open House to meet and mingle with FAES faculty. Bring yourself, a friend, and your questions about registering for the Fall 2017 courses. The event will be held in the FAES Academic Center, Building 10, NIH, Bethesda, MD, 4:00 - 6:00 PM. Light refreshments will be served!

Once considered a potential Democratic challenger to Maryland Gov. Larry Hogan next year, John Delaney has set his sights higher — much higher. The three-term representative of Maryland’s 6th Congressional District is aiming to unseat President Trump with a promise to jump-start the U.S. economy by bringing innovation and entrepreneurship to Washington.

Job Summary: BioFactura is seeking highly motivated applicants with an entrepreneurial spirit for an open position in our biosimilar development programs. We are looking for qualified candidates with a masters or doctoral degree in the life sciences with highly relevant skills and bench experience. The selected candidate will participate in the development and validation of various biosimilar product assays. In this position, the candidate will be responsible for planning, conducting, execution and analysis of experiments using various techniques in protein analysis. Relevant skills include HPLC/U-HPLC (HILIC, RP, SEC, CEX, AEX, affinity), capillary electrophoresis (CE), mass spec, SDS-PAGE, IEF, ELISA, qPCR. Knowledge of protein purification methods and process development/scale-up is a plus. Knowledge of Good Laboratory Practices (GLP) including analytical method qualification/validation and current Good Manufacturing Practices (cGMP) are desired. Experience in the preparation and delivery of oral and written presentations as well as participation in the preparation and submission of grants and/or manuscripts for publication are a plus. Excellent communication skills and the ability to analyze and interpret data, design appropriately controlled experiments independently, and maintain up-to-date laboratory notebooks are a must. This is an excellent opportunity to gain valuable experience with an innovative, small, young Biotech company and build a career in the biopharmaceutical industry. Candidates should feel comfortable working in a high risk/potential high reward environment and able to work overtime and weekends as project needs are determined.

Wed, October 25, 2017

PITCH. NETWORK. LEARN. BE INSPIRED.

TEDCO’s 7th Annual Entrepreneur Expo will bring together all of Maryland’s entrepreneurial resources from across the state into one place, at one time.

You can expect to see 700+ of the region’s top entrepreneurs, small and large business executives, angel and venture capital investors, federal and state economic development officials, university leaders and legislators.

Pharma major Lupin Limited (Lupin) and Natco announced the final ANDA approval of Lanthanum Carbonate Chewable Tablets 500 mg (base), 750 mg (base), and 1000 mg (base) from the United States Food and Drug Administration (FDA). The product, as the first generic, will be launched shortly.

Natco’s Lanthanum Carbonate Chewable Tablets 500 mg (base), 750 mg (base), and 1000 mg (base) are generic equivalents of Shire Development LLC’s Fosrenol Chewable Tablets 500 mg, 750 mg and 1000 mg. Lanthanum Carbonate Chewable Tablets 500 mg (base), 750 mg (base), and 1000 mg (base) are indicated to reduce serum phosphate in patients with end stage renal disease (ESRD).

CEL-SCI Corporation (NYSE American: CVM) today announced it has received a letter from the U.S. Food and Drug Administration (FDA) stating that the clinical hold that had been imposed on the Company's Phase 3 cancer study with Multikine* (Leukocyte Interleukin, Inj.) has been removed and that all clinical trial activities under this Investigational New Drug application (IND) may resume.

Sucampo Pharmaceuticals, Inc. (Sucampo) (Nasdaq:SCMP), a global biopharmaceutical company, today announced the publication of results from a Phase 1/2a study of intrathecal administration of VTS-270, a 2-hydoxypropyl-β-cyclodextrin (HPβCD) under investigation for treatment of Niemann-Pick Disease Type C1 (NPC-1). The results of the study were published in the August 10, 2017 issue of The Lancet and can be found at http://www.thelancet.com/pdfs/journals/lancet/PIIS0140-6736(17)31465-4.pdf.

25-year biopharma industry veteran joins the Company to drive further growth of its innovative high-performance cell engineering platform for use in commercial drug development

MaxCyte, a US-based global company dedicated to driving the acceleration of the discovery, development, manufacturing and commercialization of next-generation, cell-based medicines, announced today that it has appointed Brad Calvin, a 25-year veteran within the drug development and biotechnology industries, as Executive Vice President of Global Marketing. In his role, Mr. Calvin is responsible for leading MaxCyte’s marketing function to drive growth of the Company’s drug discovery and cell therapy business.

Doug Doerfler, Chief Executive Officer, said, “We are delighted to have someone of Brad’s caliber join MaxCyte to lead our marketing and market development efforts. Brad’s broad biopharmaceutical industry experience has provided him with an in-depth understanding of working across global markets and supporting all phases of product life cycles. His appointment comes at an opportune time for the Company, as we continue to develop new offerings based on our Flow Electroporation® Technology.”

From companies created to work in best in today's new value-based healthcare system to precision medicine, data analytics and interoperability, you can count on a healthcare IT landscape that is always in flux, thanks to new approaches driven by entrepreneurs who are adept at shaking things up.

This gallery highlights some of the most promising new companies and the founders and CEOs who are making news in 2017. Healthcare IT News is keeping tabs on the most exciting and promising new ventures.

U.S. Sen. Benjamin L. Cardin, JD ‘67, returned to his alma mater, the University of Maryland, Baltimore (UMB), to tour the UM BioPark and host a roundtable discussion with university leaders and biomedical innovators, highlighting such topics as bipartisan solutions to health care policy and ways to encourage small business innovation.

“I always get excited being here,” said Cardin as he kicked off the discussion Aug. 10. “It does energize me. After what I’ve just gone through this month in the United States Senate, it’s good to be here, to realize there is real life going on in our communities.”

You don't have to go to Johns Hopkins University to make a lot of money. In fact, you can make more money by going elsewhere in Maryland. The U.S. Department of Education offers a College Scorecard that provides would-be attendees many of the resources they need in deciding where to apply and, ultimately, where to attend.

The Trump administration is pushing for dramatic cutbacks at the National Institutes of Health. The proposed $5.8 billion cut from the agency's annual $32 billion budget would translate into 5,000 to 8,000 fewer grants per year for basic medical research.

But the impact of such cuts would actually be much broader, totaling $15 billion in lost economic activity and 90,000 jobs lost nationwide.

Women Building Bio: the XX factor is a day long conference to recognize and learn from leading women in the bioscience industry as pioneers paving the path to success. These women have faced their own unique challenges and carved out lasting legacies.

This day will catalyze the formation of a diverse network. It is a convergence of academia and industry, men and women, researchers and innovators, professionals and decision-makers gathering together to build relationships. This day long conference provides extraordinary opportunities to exchange new ideas, highlight areas of bioscience and research opportunities, and find partners for future collaboration.

In a striking advance that helps open the door to organ transplants from animals, researchers have created gene-edited piglets cleansed of viruses that might cause disease in humans.

Every metro area in the U.S. has strong industry clusters that are readily identifiable and reflect the unique competitive advantages of the region—Oil and Gas in Houston, Automotive in Detroit, and Financial Services in New York City are just a few examples. These clusters represent the backbone of their metro economies. The importance of clusters to regional competitiveness and economic performance was first established in the 1990s. Since then, research has shown that the co-location of businesses in clusters increases the productivity of companies and job creation, drives innovation, stimulates the formation of new businesses, and supports the survival and growth of small businesses.

Senseonics Holdings, Inc. (NYSE-MKT: SENS), a medical technology company focused on the development and commercialization of a long-term, implantable continuous glucose monitoring (CGM) system for people with diabetes, today reported financial results for the second quarter ended June 30, 2017.

BioGenerator’s largest investment in any single company is paying off for St. Louis.  Confluence Life Sciences, Inc. has been acquired by Aclaris Therapeutics, Inc. for the St. Louis company’s world-class research team, intellectual property and drug discovery assets.

At Illumina, we’re committed to unlocking the power of the genome, and we know we can’t do it alone. Illumina Accelerator is our way of accelerating innovation in the entrepreneurial community. With extensive mentorship, financial support, and access to sequencing systems, reagents, and lab space, we are building a dynamic ecosystem to help genomics startups launch in the San Francisco Bay Area. Together, we'll advance breakthrough applications in genomics, including therapeutics, diagnostics, agriculture, synthetic biology, forensics, and direct-to-consumer applications.

Join the Greater Baltimore Committee for its annual Economic Outlook Conference, which this year will focus on Washington uncertainties and what does it mean for Maryland’s economy. Hear from Paul Heckley, Health Economist and Leading Expert on U.S. Health Industry Trends and Reform, and Dean Zerbe, Former Senior Counsel to U.S. Senate Finance Committee, AlliantGroup National, Managing Director.

When: Thursday, September 14, 2017; 7:30 a.m. registration, 8 a.m. program

Where: Renaissance Baltimore Harborplace Hotel, 202 East Pratt Street, Baltimore, MD 21202

September 25th - 27th, 2017 - San Jose, California

The MedTech Conference is your opportunity to connect with thousands of medical technology professionals this September. Join us in San Jose for business development, innovative technology, and networking with policymakers, business executives and industry leaders.

Calling all medical device innovators! This year’s symposium will host the National Capital Consortium for Pediatric Device Innovation (NCC-PDI) competition. Up to six innovations will be awarded up to $50,000 each during the “Make Your Medical Device Pitch for Kids!” competition.

At the John's Hopkins Kimmel Cancer Center, researchers have been working for years to figure out how prostate cancer cells are able to move from one infected organ and spread to other parts of the body.

“Because we know that's the type of cancer that eventually will kill a man with prostate cancer," said Johns Hopkins Associate Professor of Oncology and Pathology. Dr. Srinivasan Yegnasubramanian.

AstraZeneca and its global biologics research and development arm MedImmune, has appointed Dr Geoffrey Kim and Dr Jean-Charles Soria, respectively. Kim and his team will focus on the development of the company’s late-stage immuno-oncology combinations programme, aiming to develop combination regimens that will deliver innovative medicines to patients.

It figures a personalized health accelerator would want to personalize the experience for its companies.

When Virginia health system Inova Health closed on the 117-acre former Exxon-Mobil campus in Fairfax back in 2015, it was clear there was plenty of space to do something bold. (It was called the real estate deal of the year.) And from the start personalized medicine was going to be the focus.

The company alleges the U.S. Food and Drug Administration isn't honoring a drug designation program Congress passed in 1983.

You are invited to travel with County Executive Ike Leggett, MCEDC, other county officials and select area business leaders on an exclusive Business Development trip to South Korea and China, October 20-29, 2017. Our delegation will visit some of the most forward-thinking technology hubs and global commerce destinations of East Asia including Seoul, Daejeon, Xi’an and Shanghai.

Between now and 2020, we can expect to see a wave of innovation in pharma. But how will the coming drug launches fare in today’s challenging market? Consider these facts: the number of drugs per indication has risen by 37 percent since 2006, while the top company in an indication still commands at least half of the market. At the same time, restrictions to market access are rising in Europe, the United States, and emerging economies as advances in analytics and multichannel engagement open new opportunities to differentiate products.

Gilead Sciences, under intense investor pressure to do a significant M&A deal, may have found a target it likes. It is said to be evaluating United Therapeutics, although it finds itself in competition with GlaxoSmithKline and perhaps others.

The Evening Standard, citing unnamed sources, said that Gilead Sciences is considered the most likely candidate to win a bid for United Therapeutics. But the newspaper also said that GSK has Citi and Lazard helping it assess the United, a company founded in 1996 on a pulmonary arterial hypertension (PAH) drug that had been discarded by GSK.

WellDoc® and the American Association of Diabetes Educators (AADE) announce the collaborative launch of “The Diabetes Digital Health Learning Network” at the AADE17 conference. The goal of this Learning Network is to assist diabetes educators in gaining next-generation skills in using digital health therapeutics to improve clinical care and outcomes cost-effectively. “As a digital health leader, WellDoc is proud to launch ‘The Diabetes Digital Health Learning Network’ in collaboration with AADE to support its members who are on the front lines of diabetes care and management,” said WellDoc President and CEO Kevin McRaith. “This is a natural progression of our already-established partnership with AADE that began with our collaboration to incorporate The AADE Diabetes Education Curriculum into our FDA-cleared digital therapeutic platform, BlueStar®.”

As far as healthcare goes, Boston has historically focused on biotechnology, life sciences, and pharmaceuticals. Until a few years ago, digital health wasn’t a big talking point in the Boston healthcare scene. After a multilateral initiative launched in 2016, however, Boston wants to be regarded as a national leader in digital healthcare investment and activity.

With a focus on improving health, driving economic growth, and expanding the country’s research capacity, the National Institutes of Health (NIH) within the U.S. Department of Health and Human Services is the largest public funder of biomedical research in the world. Because of NIH’s central role in supporting science, technology, and innovation, a better understanding of the agency’s footprint may be helpful to the technology-based economic development practitioner community. This edition of Useful Stats utilizes data from NIH’s Research Portfolio Online Reporting Tool (RePORT) and covers each year from 2007 to 2016. The data does not include projects funded by the American Recovery and Reinvestment Act of 2009.

Tuesday, September 26, 2017 9:00AM-5:00PM

Women of the Virginia bioscience community from across the state will lead this full day event offering examples of working together to build a stronger bioscience industry, stronger companies and institutions, stronger teams and networks, and stronger individuals.

New this year, we’re co-locating our event with The MedTech Conference powered by AdvaMed, to San Jose, CA!

Join us for this important program that dives into the changing landscape and the issues facing our pathway to greater innovation. This year’s theme is “Partnering for Breakthroughs in Pediatric Surgery and Care.”