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Biotech startup seeking up to $4M in financing

Baltimore biotech firm Ocular Proteomics LLC is seeking its first round of financing within the next six months, for $3 million to $4 million in venture capital. While a closing date for the round has not been determined, the decision follows a $1.2 million federal grant the biotechnology startup recently won to begin clinical trials on macular degeneration diagnosis and treatment. The startup last month moved from Towson to UMB BioPark for larger laboratory facilities.

The venture capital financing will be used for clinical trials, marketing and new hires, according to director of business development Joshua Hines.

The $1.2 million grant comes from the National Eye Institute and National Institutes of Health, and runs for  two years, from May 2013 to May 2015. Next year, the company will apply to renew the grant and, if successful, would receive $1.5 million per year for up to five years.

The $1.2 million grant enables Ocular to start clinical trials for ophthalmic diagnosis based on the company’s discovery of biochemical markers in the vitreous of the human eye. The trials will be held at three locations -- Baltimore, Chicago and Cleveland – and will involve 200 patients with macular degeneration.

Dr. Bert M. Glaser, Ocular’s chief scientific Institutes of Health officer, founded the company in 2009. Dr. Glaser heads the National Retina Institute, of which Ocular is a spinoff.
 
Age-related macular degeneration is the leading cause of blindness among adults. An estimated 15 million Americans have macular degeneration, of whom 2.5 million have the advanced form that threatens their eyesight. If not treated, the disease inevitably leads to blindness.
 
There is no cure for macular degeneration but there is an injectible medication that stops the progression of the disease in about one-third of the patients on whom it is used. However, a patient must wait six months to a year before knowing if the medication is effective. Based on the biomarkers, the company’s focus is to determine if the patient will respond to the medication before then.
 
The privately-financed Ocular has two full-time employees. It is looking to hire two laboratory technicians within the year, and is also seeking up to three college students who are interested in unpaid internships doing eye research.
 
Source: Joshua Hines, Ocular Proteomics LLC
Writer: Barbara Pash

Biomedical startup OptiCul seeking $5M in funding for new product

OptiCul Diagnostics Ltd. this month submitted an application to the U.S. Food and Drug Administration for approval of its first product, a device that tests for bacterial presence and promises to shorten hospital stays. Upon regulatory approval, which is expected this year, the Rockville biomedical startup with ties to Baltimore plans to market the device next year.
 
The startup is also seeking $5 million in funding from angel and venture capital investors this year, says CEO and Co-founder Israel Gannot. His wife Gallya Gannot is president and co-founder. Last year, the company raised $400,000 from angel investors.

The startup has eight full- and part-time employees. It plans to hire an additional eight employees, in engineering, marketing and sales, this year in preparation for selling the device in 2014.

Called an Optidet, the device OptiCul is developing can determine if a patient is carrying bacteria and if so which kind within three minutes. 

“The device helps with diagnosis and allows you to treat patients quicker, resulting in shorter hospital stays,” says Gannot, professor of biomedical engineering at Johns Hopkins University and a professor at Tel Aviv University.
 
The Maryland Department of Business and Economic Development awarded grants totaling $300,000 for research, which OptiCul conducted with the University of Maryland microbiology and chemistry departments.  
 
OptiCul Diagnostics was founded in Israel in 2008 with seed money from the Israeli government. In 2010, it opened its American headquarters and main laboratory to the William E. Hanna Jr. Innovation Center, an incubator in Montgomery County, where it is still located.
 
Gannot says the device, about the size of a small box, is designed to be placed in a hospital laboratory and used multiple times. The samples, about the size of business cards, are disposable. The device is priced at $10,000 and the samples at $3 each.
 
The initial marketing focus will be the I-95 corridor, Boston to Washington, D.C.,  where, by Gannot’s count, there are 2,500 hospitals with laboratory facilities.
 

Source: Israel Gannot, OptiCul Diagnostics Inc.
Writer: Barbara Pash
 
 
 
 
 
 

UMd. researcher makes breakthrough discovery about life on Mars

A University of Maryland research team led by Shiladitya DasSarma last month revealed a type of organism that may survive on Mars and other extreme environments. The discovery is a breakthrough in methods of survival under the cold and dry conditions found in Antarctica -- and Mars.

DasSarma’s research for NASA focuses on Halorubrum lacusprofundi, a microbe that was discovered in Deep Lake, a very salty lake in Antarctica.

“It’s a good model for surviving in conditions like Mars,” he says of the microbe whose adaptations allow it to live in a cold, salty environment that is considered similar to some environments on Mars.

The National Space and Atmospheric Administration is funding the research, which was published in a professional journal, with an ongoing multi-year grant for nearly $500,000.                     

DasSarma says there is so much interest in the question of life on Mars because Mars and Earth are sister planets. Both are within the “habitable zone,” close enough to the Sun to sustain life if liquid water is present.

“Mars is much drier and colder than Earth,” he says, but photographs show seasonal flows of brine, or salty water, down the sides of a crater on Mars. “There are probably pools of brine under the surface of Mars.”

DasSarma says the NASA grant is intended to answer basic biotechnology questions.

“NASA is asking, could any organism survive under Mars’ conditions? What molecular adaptations are necessary for survival? Our research determined that certain organisms can survive,” says DasSarma, a professor at the University of Maryland School of Medicine, in downtown Baltimore. DasSarma is also a research scientist with the university’s Institute of Marine and Environmental Technology at the Inner Harbor.

DasSarma and his team have long studied organisms that grow in unusual environments. “Our specialty is understanding how they are able to survive in very dry and salty conditions,” says DasSarma, the key finding being that they have adaptations that allow them to hold onto water.

DasSarma says the microbe he is studying for NASA won't  be found on Mars necessarily. But if life is one day discovered on Mars, “they will be a salt-loving type of organism,” he says, “possibly something like it.”

DasSarma says his research may lead to the development of novel biotechnological applications for use on Earth.

Source: Shiladitya DasSamra, University of Maryland School of Medicine and Institute of Marine and Environmental Technology
Writer: Barbara Pash
 
 
 
 
 
 

Life sciences company developing device to prevent blindness caused by diabetes

Early-stage medical device company Vasoptic Medical Inc. is conducting tests on a device to detect and prevent a progressively worsening eye condition that leads to blindness.

The tests, being held at the Johns Hopkins Wilmer Eye Institute, are required for federal Food and Drug Administration approval. When done in 2014, the Columbia company will seek FDA clearance to market and sell the device.

CEO and general counsel M. Jason Brooke estimates it will cost $7.5 million to bring the device to market. The federal National Institute of Health last year awarded the team a $225,000 development grant. The company next month will apply for a $1 million to $1.5 million NIH Small Business Innovation grant, which is intended to help speed commercialization of promising technology.
 
Johns Hopkins has a $180,000 multi-year grant from the Wallace H. Coulter Foundation, part of which goes to Vasoptic for commercialization. Vasoptic has received a $75,000 grant from Maryland Technology Development Corp., or TEDCO, for commercialization. It is also one of 33 finalists in the state’s InvestMaryland Challenge, the winners and cash prizes to be announced next month.
 
Brooke says the company is considering an angel financing round this year for $500,000.

“We are starting to get recognition of the value of technology among investors,” he says.
 
Brooke and Chief Technology Officer Abhishek Rege are Vasoptic’s current staff. Depending on grants, the company will hire two to four research engineers this year. The company is located in Howard County incubator, the Maryland Center for Entrepreneurship.
 
The so-far unnamed device is intended for the early detection of diabetic retinopathy, a condition caused by both Type I and Type II diabetes. One in nearly three diabetics, or six-to-eight million people, has some form of diabetic retinopathy. Another eye implant invented by Hopkins scientists and manufactured by a California company recently received FDA approval. 
 
In the US, 25 million people have diabetes, seven million people are undiagnosed diabetics and another 80 million people are pre-diabetic. The condition causes reduced blood flow to the tissue of the retina that leads to severe visual impairment and eventually blindness.
 
Brooke says the recommended treatment is regular eye exams to detect the condition and better management of one’s diabetes to slow its progression.
 
Vasoptic is not the only technology to screen for the condition. But other technologies require an ophthalmologist to analyze the images, says Brooke. Vasoptic’s technology is designed to be used by the primary care physician.
 
Vasoptic’s hand-held device captures anatomical images and physiological information like blood vessel flow that its accompanying software analyzes. The device not only detects the existence of the condition but predicts the risk of the diabetic developing it as well.
 
“It’s not hard for an ophthalmologist to detect the condition in its early stage but half of diabetics don’t receive the recommended eye exams” because of the expense and inconvenience, Brooke says . “Our focus is the primary care facility and keeping the device low cost,” likely under $10,000 each.
 
Rege developed the technology while working at the Johns Hopkins department of biomedical engineering. Hopkins filed patent papers and entered into a licensing agreement with Vasoptic to commercialize the device.
 

Source: M. Jason Brooke, Vasoptic Medical, Inc.
Writer: Barbara Pash
 
 

Hunt Valley life sciences firm makes push into Latin America

Baltimore County life sciences firm Sterilex Corp. is tapping into the Latin American market this year.

The Hunt Valley company will launch in Mexico by mid-2013, followed by a rollout in other countries, including Costa Rica and Chile. It made its first international foray last year with a launch in Canada.
 
Sterilex manufactures proprietary and microbiological agents to solve contanimation problems, says Alex Josowitz, director of business development. Put in layman’s terms, the company makes different substances that kill organisms that form a protective biofilm, such as plaque on the teeth or pink streaks in grout. 
 
“Once the biofilm is formed, it’s difficult to get to the organisms. It becomes an issue in health care and industrial applications,” says Josowitz, whose company makes several different agents, liquid and powder, for different customers.
 
Most of Sterilex customers are food and beverage manufacturers, including meat, poultry, dairy, wineries and breweries. It also has clients in the dental industry as it has an agent to disinfect dental water lines where biofilm tends to build up.
 
To make the agents, Sterilex has several manufacturing plants across the country, including one in Baltimore City.  The company sells mainly through distributors. Josowitz estimates that over 5,000 companies use its products but almost all are sold through full-service chemical distributors.
 
Josowitz says the entry into international markets came at the request of its American distributors, many of whom have international operations. “They asked if we had the ability to sell abroad. We felt it would help our business here,” he says.
 
To do so, the company obtained an export grant from the state, met federal Environmental Protection Agency regulations and fulfilled the application process in each of the foreign countries. There were patent and trademark issues.
 
“It was convoluted and costly, and can take over 12 months to get approvals,” says Josowitz.
 
Sterilex was founded in 1995. It shares an office with its sister company, Global EPI Research. The privately held company pulls in about $10 million in annual sales, which are growing about 30 percent a year.
 
The woman-owned business has a staff of 11.  It is not currently hiring but Josowitz says there’s a “good chance” it will do so in the future.
 
Source: Alex Josowitz, Sterilex Corp.
Writer: Barbara Pash

Johns Hopkins awarded $3.5M for robot research project

Johns Hopkins University Whiting School of Engineering is collaborating with universities around the country on a project to create robots that work more efficiently with people. The National Science Foundation has funded the four-year, $3.5-million human-robot interaction research project, part of the National Robotics Initiative, a federal effort. 
 
“In the world of robotics, there are two natural extremes: the completely autonomous robot and the fully technically-operated robot,” says Gregory Hager, chair of the computer science department at the engineering school.
 
“The idea is to create a more holistic robot,” he says of the project. “As more and more robots interact with people in different ways, that’s the middle stage we’re in now.”
 
Hager is the co-principal investigator of a team that includes researchers from Stanford University, University of California at Berkeley and Santa Cruz, and the University of Washington.
 
The project will focus on the manufacturing and medical industries, the two areas where humans and robots are most involved. Researchers' challenge is to improve human-robot teamwork and communication.
 
Hager says the researchers will examine the manufacturing process at two companies that make specialized products, like wire baskets, and require quick turnover. “Robots may be a way to enhance productivity at a reasonable cost,” he says, as well as reduce workers’ repetitive motion injuries.
 
For the medical industry, the team will work with Silicon Valley company Intuitive Surgical Inc., maker of the daVinci surgical robot, to improve speed, accuracy and precision. With over 2,000 daVinci robots in use, the company is the dominant player in the robotic surgery field.
 
“We hope to come up with methods that apply to a wide set of problems,” says Hager.
 
Source: Gregory Hager, Johns Hopkins University Whiting School of Engineering
Writer: Barbara Pash

Baltimore nonprofit may launch new health care accelerator

BioHealth Innovation Inc., a nonprofit that seeks to commercialize technology in the biotech and healthcare fields, could open an accelerator for health information technology startups this year.

Co-located in Rockville and in Baltimore, BioHealth wants the accelerator to serve entrepreneurs and small businesses in central Maryland. Upon board approval, the organization plans to identify a location by the first quarter of this year and have it operational by the fourth quarter.
 
“We are evaluating it. We believe there is a need for one. We know there is interest,” BioHealth President and CEO Richard Bendis says. 
 
Also in the works for 2013 is an angel fund, a for-profit investment fund for high net-worth individuals to invest in early-stage biohealth companies, says Bendis, who is anticipating a first close for the fund by the end of 2013.

"We are bridging the gap between Montgomery County and Baltimore, where most of the biohealth assets reside in Maryland," says Bendis. "We are interested in things that have the potential to be commecially relevant -- not only that it works but you can build a product or business around it."

Bendis defines biohealth broadly. It encompasses traditional therapeutics and pharmaceuticals as well as diagnostics, medical diagnostics, health care services, electronic medical records, mobile health and biohealth cybersecurity.

"We see a convergence between technology and devices and pharmaceuticals and biotechnology. All those companies depend on data statistics and analytics," he says.
 
BioHealth Innovation was founded last year as a private-public partnership with the goal of accelerating the commercialization of technology and science affiliated with the biohealth industry in central Maryland.
 
"We work with scientists and entrepreneurs beyond the technology transfer phase. We get involved once they get past the transfer office in the university," says Bendis.

"We have the expertise that can help them do that [commercialize research]. We have investors on our board. We have a person who started and ran a biotech company. We connect people to the resources they need," he says.

To that end, BioHealth Innovation is initiating a program to provide free proposal and review assistance to small businesses that apply for Small Business Innovation Research (SBIR) grants. The SBIR requires federal agencies to set aside 2-1/2 percent of their research budgets, a total of $2.5 billion annually, for grants to small businesses. The goal is to speed commercialization of early-stage projects.
 
Bendis contends that while Maryland’s reputation in science is exceptional and the state is recognized as a leader in life sciences, it has not been as successful as other states in competing for the SBIR grants. Phase 1 grants run about $100,000 to $150,000; phase 2, $1 million and up.
 
At the National Institutes of Health, according to Bendis, Maryland small businesses submitted the third highest number of applications for its SBIR grants. But the state ranked 34th in winning phase 1 grants and 36th in winning phase 2 grants.
 
BioHealth Innovation’s assistance is available to anyone, private or academic, who is eligible to apply for an SBIR grant, with a particular emphasis on the National Institutes of Health grants.

BioHealth also offers what it calls "client agreements," and has already signed up a few bioheath start-ups in Baltimore. Bendis says the goal of the client agreements is "to help them move their business plans forward, to help them get clients and identify investors and local technology talent. They have a business but it is pre-revenue."
 
Source: Richard Bendis, BioHealth Innovation Inc.
Writer: Barbara Pash

Baltimore Staffing Firm Technisource Gets New Name

Baltimore Region for Randstad Technologies is the new name for Technisource, a long-time IT staffing company in Baltimore that is expanding its services and hiring new employees early this year.
 
Randstad, an international staffing company, acquired Technisource in 2011. However, because of the change in systems and processes, Technisource wasn’t renamed until this week. The newly rebranded company will continue to occupy its office in downtown Baltimore.
 
Technisource had specialized in providing IT staffing, on either a permanent, contractual or temporary basis, for data centers and project management. Anthony Petrelli, managing director of Baltimore Region for Randstad Technologies, says the Randstad acquistion allows Technisource to expand its services to the integration of talent and application development.
 
Petrelli says there will be no layoffs because of the rebranding. The newly named company is hiring an additional three to four staffers, including account executives, IT recruiters and sales people. The company recently moved into expanded office space that accommodates 22, for existing employees and future hires. Last year, Technisource added three people to its staff of 10. 
 
Randstad is publicly traded on the European stock exchange and is headquartered in The Netherlands. Founded in 1960, it is a market leader in offering human resources services in administration-clerical, accounting and finance, IT, pharma, life sciences, industrial and engineering industries.
 
Randstad has offices throughout the US. Its US headquarters is in Atlanta, Ga. The company’s Baltimore region covers Delaware and the Baltimore metropolitan area. There is also a Randstad Washington, D.C., office that covers the Bethesda and Rockville area.
 
 
Source: Anthony Petrelli, Baltimore Region for Randstad Technologies
Writer: Barbara Pash
 

UMBC Life Sciences Startup Launching First Product

Life sciences company Plasmonix will begin selling its first product, QuantArray, early this year. The Baltimore County startup plans to commercialize two other products later in 2013, the QuantaWell 100 and the Quanta NP, and will seek $2 million to $3 million for another round of financing, CEO William Gjust says.

Plasmonix develops support tools to detect cells in medical research and clinical diagnostics by enhancing luminescent and fluorescent signals using metal nanoparticles. QuantArray, its latest product, has various applications in performing assays, a test that analyzes components, and enhances luminescent signals hundred-fold over conventional methods. The technology can be be applied not only in the life sciences, but also apparel, paint and cosmetics. 
 
QuantaWell 100 also enhances signals hundred-fold but in a different format than QuantArray. Quanta NP is a supplementary solution that is used to improve the efficiency and sensitivity of commercially available assays.
 
“It’s a rarefied field. There is no direct competition that we are aware of,” says Gust of Plasmonix’ products. 
 
Gust says potential customers are any company or institution that performs assays, from pharmaceutical and biotechnology companies to academic facilities. Market research showed that the average price for standard assays is $25 per substrate microscope slide. Gust says he has not determined a price for QuantArray but it is likely to be slightly higher than the standard assay.
 
In 2011, Plasmonix received $1.5 million from venture capitalists in its initial round of financing. It has also received $200,000 from the Maryland Biotechnology Center and $100,000 from the Maryland Industrial Partnership, to be used by its academic collaborators.
 
Plasmonix grew out academic research, primarily at the University of Maryland Center for Fluorescence Spectroscopy. The company was formed in 2009. In 2011, it moved into the incubator, bwtech@UMBC Research and Technology Park, where it occupies a 1,500-square-foot office. The company employs four.
 
“We are translating academic research into robust, reproducible commercial techniques,” says Gust.
 
Source: William Gust, Plasmonix
Writer: Barbara Pash

Noxilizer Expands Medical Device Production

Noxilizer Inc. expects to more than double its manufacturing capacity of its proprietary sterlization units for medical devices, thanks to its recent move to a larger production facility.
 
Maura Kahn, vice president business development and marketing, says Noxilizer’s relocation from the incubator at University of Maryland, Baltimore County to the University of Maryland, BioPark in downtown Baltimore allows the company to manufacture five to six units, rather than one to two, per year. Kahn says customers include medical device manufacturers, biotechnology and pharmaceutical companies, such as the Catheter Research Center in Indianapolis.
 
“We have roughly the same amount of office space but double the laboratory space. Moving to a larger lab facility allows us to expand our microbiology operations and to build our sterilization units,” Kahn says.
 
Noxilizer’s manufactures its RTS 360 Sterilization Unit on premise, with subcontractors in Maryland completing the assembly. The first units went on sale in 2011. The units employ a gas-based, room temperature process that allows them to be used for new medical devices that can’t be sterilized by the traditional method.
 
Noxilizer’s sterilization units cost $250,000 each. The company offers a three-year service contract for $40,000.  To run the unit, customers purchase sterilants from Noxilizer at a typical cost of $2000 to $2500 per month.
 
Noxilizer, a privately-held company, was founded in 2004. It originally had offices in both Bethesda and Baltimore. In 2010, the two offices were combined into one and moved into the incubator bwtech@UMBC.
 
The company employs 19 full-time and two part-time workers. Last year, it added six new employees and is currently looking to hire a director of quality. The company also employs four-to-six paid interns per year, usually from the University of Maryland Baltimore County and Stevenson University, who are often hired as full-time employees after graduation.
 
Noxilizer recently raised $3.5 million in a financing round via the Maryland Biotechnology Investment Tax Credit program. It also received $500,000 from The Abell Foundation. Last year, the company was named Maryland Incubator Company of the Year in the life sciences category.
 
Source: Maura Kahn, Noxilizer Inc.
Writer: Barbara Pash

Johns Hopkins Spinoff Readies Medical Device For Sale

Clear Guide Medical LLC is readying its first product, a medical device used in minimally invasive ultrasound surgeries that will be for sale in early 2014. Federal and state grants received this year aided the commercialization process for the Johns Hopkins spinoff, which hopes to receive another state grant early next year. 
 
The Baltimore life sciences company received a total of $550,000 from the federal National Institutes of Health and National Science Foundation, in 2011 and 2012, and $125,000 from the Maryland Technology Development Corp. in 2010 and 2012. It is waiting to hear about another grant from the latter, for $100,000.
 
“We are developing a medical device that will lower health care costs by allowing [procedures] to be done quickly and at less cost,” COO Dorothee Heisenberg says. The device clips onto an ultrasound probe and provides guidance to surgeons before and during minimally invasive procedures like needle biopsies, needle nerve blocks and vein catherizations. The device provides such information as the angle to hold the needle and how far to push to reach the nerve or vein.

Heisenberg says the advantage of the device is that it makes it easier for surgeons to learn how to use ultrasound, for which they need special training. She also sees a benefit for rural areas or areas where there aren’t a lot of medical facilities. Local physicians and clinics may be able to do a biopsy, and then consult with medical experts for a diagnosis.
 
Heisenberg expects Clear Guidance’s device to cost in the $12,000 to $15,000 price range. 

Clear Guide Medical was founded in 2010, a spinoff from the Johns Hopkins Department of Computer Science and the Johns Hopkins School of Medicine’s radiology department. In 2012, it was the first company to move into the Johns Hopkins accelerator, located on the Homewood campus, Heisenberg says.
 
The company has five employees. It is in the midst of applying for a worldwide patent that covers the US, nations in Europe, Japan, Canada and Israel – countries that are most likely to develop competing devices. Johns Hopkins is paying the patent filing and application expenses, about $80,000, for which Clear Guidance will pay back in time.
 
“We want to sell our product without complications,” Heisenberg says.
 
Source: Dorothee Heisenberg, Clear Guide Medical LLC
Writer: Barbara Pash

Baltimore Life Sciences Startup To Develop Animal Health Test

InstantLabs Medical Diagnostics Corp. is entering the animal health/veterinary medicine field next year, with plans to develop a variety of tests for the detection and diagnosis of dangerous pathogens in animals.
 
CEO Steven Guterman says the tests will be based on its general purpose molecular diagnostic test kits, which can be refined for different markets. Located at the University of Maryland BioPark, InstantLabs commercialized its first test kit this year for the food safety market and currently is developing a test kit for the human health/hospital market.
 
“Our goal is to change the way people do food testing," Guterman says. "We spent a lot of time building a device with the power of molecular testing that is small, affordable and easy to use.”
 
Food companies typically send samples to an outside laboratory for testing, a process that can take three to five days for results. InstantLab’s test, for both extraction and identification, can be done on-site, with test results within 12 to 24 hours.
 
Customers include poultry processors, fish farmers and nutritional companies that use the kits to detect different and dangerous bacteria like salmonella, listeria and e-coli.
 
The food safety kits were first sold commercially in spring of 2012. So far, more than a dozen have been sold, half in the US and half overseas. By early 2013, the company will also have a test for the bacteria Vibrio.
 
In human health/hospitals, InstantLab is developing a test kit for MSRA, an antibiotic-resistant staphylococcus infection. It received a $100,000 award from the Maryland Industrial Partnerships to develop a test kit for the detection of MSRA.
 
The company is working with Jennifer Johnson, an assistant professor at the University of Maryland School of Medicine, on the test. It should be ready by the end of 2013, after which the company will begin human trials and seek US Food and Drug Administration approval.
 
InstantLabs was formed in 2008. In 2010, it moved to the University of Maryland BioPark in order to grow internally and have its own laboratory. In 2011, it moved to a larger space in the BioPark, doubling the size of its office.
 
The company has five employees in Maryland. Guterman says it is looking to hire a senior molecular biologist in 2013 for its entry into the veterinary field.
 
Source: Steven Guterman, InstantLabs Medical Diagnostics Corp.
Writer: Barbara Pash

Meridian Helps Baltimore Biotech Firm Meet FDA Standards

Frederick biotech firm Meridian Biogroup has completed a four-year project for Baltimore contract research and manufacturing firm Paragon Bioservices so its laboratory equipment and programs meet US Food and Drug Administration regulations.

“Our projects are not like construction projects with a definite end. Some are long-term,” says Thomas Blake, Meridian’s Principal and Co-Founder with Alison Demarest.
 
Meridian offers validation and compliance services for biotechnology and pharmaceutical companies. These include testing facilities’ utility systems, developing higher-quality programs and providing extra staff for specific tasks.
 
Meridian’s 37 clients range from large companies like Human Genome Sciences and Osiris Therapeutic to small- and mid-range companies like Paragon Bioservices and startups that want to launch a product and need to comply with FDA regulations. Paragon moved to the University of Maryland, Baltimore BioPark in 2008.
 
Blake says that for MedImmune, another client, Meridian is engaged in more than 30 new and ongoing projects at the company’s sites in Frederick and Gaithersburg in Maryland, and in Pennsylvania and Liverpool, England. Projects for MedImmune include quality assurance, regulatory affairs and FDA inspection.
 
Meridian, a privately held company, has been located at the Frederick Innovation Technology Center since its founding in 2007. It has grown from the two co-founders to a staff of 26.
 
The company was the recipient of the 2012 Incubator of the Year Award in the technology services company category. The Maryland Technology Development Corp. (TEDCO) and the Maryland Department of Business and Economic Development sponsor the annual award.
 
Last spring, the Board of County Commissioners of Frederick County officially recognized the company for its contributions to a variety of charitable and community causes, among them Believe in Tomorrow, Frederick Head Start, Smile Train, Hope Alive and the Frederick Community Action Agency.
 
“We feel it’s important to give back,” says Blake. “Frederick county and city have supported our efforts since we started. We’re pleased to be recognized.”
 
Source: Thomas Blake, Meridian Biogroup
Writer: Barbara Pash

Biotech Firm Fyodor to Begin Trials for Malaria Test

Fyodor Biotechnology Inc. expects to complete human trials on its product to detect malaria next year, with commercial production to begin in 2014. The Baltimore biotech firm is also in the planning stages for a second product, a variation of the first, that should be ready for production by 2015. The tests are significant for diagnosis and treatment of an illness that is endemic in developing countries around the world. 

"The tests will be revolutionary in malaria circles," says Eddy Agbo, CEO and chairman of the board of Fyodor, which has established a global network of malaria health professionals.

Fyodor Biotechnology is working with partners who will manufacture and distribute the tests, which will be sold to government and non-government organizations like the World Health Organization, travelers and the military. The tests are for citizens and visitors to countries in the "frontier" market, aka developing countries.

The University of Maryland School of Medicine is conducting the human trials on the first product in Nigeria and Mali. The Urine Malaria Test is the first urine-based test geared to the type of malaria seen in Africa, the Caribbean and South America. The second product will detect the malaria strain found in Asia, China and India. It, too, is the first urine-based test for this malarial type and human trials will also be conducted.  
 
The human trials are required to obtain approval from the US. Food and Drug Administration. While FDA approval is not necessary to sell the products in other countries, it validates them, Agbo says. 
 
Agbo says the tests resulted from Johns Hopkins University’s global health initiative. Using technology that came out of the initiative, Fyodor created a one-step test that is accurate, easy to use, and quick. Test results are available within 20 minutes.
 
Founded in 2008, Fyodor was initially housed in the University of Maryland BioInnovation Center. It subsequently moved to the University of Maryland BioPark where, in July, it relocated from a 700-square foot space to a 2,000-square foot space.
 
The company is doubling its staff, from its current three full-time employees to hiring another three full-time employees by 2013 with expertise in chemistry and recumbent DNA technology. It is also looking for several part-time employees and interns who are familiar with biology, chemistry and laboratory procedures.
 
So far, Fyodor has attracted a total of $2 million in state and federal grants and from private investors, including Maryland Technology Development Corp. and the National Science Foundation (NSF). In August, NSF awarded the company a grant of $476,000 to continue its research.
 
Source: Eddy Agbo, Fyodor Biotechnology
Writer: Barbara Pash

Tech Networking Group Startup Grind Launches in Baltimore

Start Up Grind, an international community of entrepreneurs and investors, makes its debut this month in Baltimore. Loyola University of Maryland and Wasabi Venture are inaugurating the group here for monthly meetings, open to everyone interested in technology and startups.
 
The first local Start Up Grind will take place Sept. 18 from 6 to 9 p.m. at Loyola University, 4501 North Charles St., in the Student Center’s fourth floor programming room. Brian Razzaque, CEO and inventor of SocialToaster, is the guest speaker.
 
“We were interested in the concept of getting entrepreneurs together, and Start Up Grind is also a way for us to be involved in that community,” said Kendall Ryan, director of events and outreach for Wasabi Ventures. The group serves as an outlet for entprepreneurs who want to network, brainstorm and offer feedback with one another. 
 
Start Up Grind began last year in Silicon Valley and has grown into an organization with chapters in more than a dozen cities in the U.S. and in countries ranging from Australia to the Union of South Africa. Ryan says that Start Up Grind Baltimore will host a monthly event although an October date has not yet been chosen.
 
Fee ranges from $10 (with early-bird registration) to $20 per person. The event is free to Loyola University undergraduates and graduates. Ryan says the reception so far has been enthusiastic and she expects at least 150 people at the first event.
 
Start Up Grind Baltimore joins another group that gives local entrepreneurs an opportunity to get together. Baltimore Tech Breakfast began last year as a casual get-together for about a dozen people and has since grown to a list of 1,000.
 
Ron Schmelzer, president of the tech company, Bizelo and founder of Baltimore Tech Breakfast, says about 250 people usually attend the monthly event. Meetings are held the last Wednesday of the month except for this month, when the meeting will be on Sept. 27. Meetings are free but pre-registration is required. 
 
Schmelzer says he started Baltimore Tech Breakfast as a way “to help increase the momentum of technology in Baltimore.” The group is not associated with any organization. Participants are invited to give short, three-minute talks about their companies.
 
Sources: Kendall Ryan, Wasabi Ventures; Ron Schmelzer, Bizelo
Writer: Barbara Pash
 
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