David Block, MD, MBA, CEO of Gliknik
David Block, MD, MBA, CEO of Gliknik. Dr. Block is a serial entrepreneur and the founder of Ruxton Pharmaceuticals and Gliknik. He has been in the bioscience industry for 17 years, 12 of which were in a series of commercial positions at DuPont Merck and DuPont Pharmaceuticals including sales management, licensing, portfolio planning, market development and product launch. He was executive vice president of International Operations at the time of the sale of DuPont Pharmaceuticals to Bristol-Myers Squibb. From 2002 to 2004 Dr. Block was the chief operating officer of Celera Genomics.
Members: Membership in the Bioscience Committee is by invitation only. This is to keep a constant ratio of largely company CEOs and service providers. Members include: Dr. Blake Paterson, CEO, Cerecor; Trudy Burke, Senior Director, Baltimore and Gliadel Operations, Eisai; Marco Chacon, CEO, Paragon Bioservices; and Julie Garner, Government Affairs Manager, MedImmune.
What does the committee do:
- Actively advocates for legislation at both the state and federal level that will support the industry and help it grow. This includes annual efforts to increase the amount of the Maryland Biotech Tax Credit and working with the federal delegation to increase the percentage of funding that goes to commercial companies when SBIRs are awarded.
- Helped establish the Maryland Biotechnology Center.
- Conducted a comprehensive survey of all 400 bioscience companies in Maryland to find out how they would like to see state resources utilized.
- Created and ran the Maryland Bioscience Awards for seven years.
- Created a long-term strategy for growing the bioscience industry in Baltimore and is now writing a report on that research.
- Sponsored creation of a new business model for translational medicine.
- Worked with DBED and other industry advocates to produce regulations favorable to the industry in the administration of the Biotech Tax Credit.
What is the value in joining: The Bioscience Committee is recognized as an effective advocacy and informational resource. Through this committee, the GBC partners with other bioscience industry groups to ensure that the industry is always well represented. The committee draws its strength from the input of its members and from the strength of its voice which is directly connected to the number and caliber of companies that join. This is also an excellent way to meet other members of the bioscience business community and to interface with our research universities.
2016 Bioscience Committee news:
At its April 20, 2016 meeting the Bioscience Committee reviewed legislation affecting the industry from the 2016 Maryland General Assembly legislative session and then met with John Wasilisin, President and CEO of TEDCO, to gain a better understanding of how TEDCO plans to handle the Maryland Venture Fund and its vision for the future.
The Bioscience Committee continued its discussion about how it can help to support the growth of the medical device community in Greater Baltimore and how the industry can attract and retain talented management at its February 11, 2016 meeting.
The committee heard from Neil Veloso, Executive Director, Technology Transfer for Johns Hopkins Technology Ventures, the university’s intellectual property administration center.
Veloso and committee members discussed possible incentives to attract talented management to the Greater Baltimore region to help grow the industry.
At the Jan. 7, 2016 Bioscience Committee meeting the committee heard from Michael Tangrea, Ph.D. and Kaushika Prakash of LifeBridge Health. Tangrea and Prakash made a presentation about LifeBridge Health’s new BioIncubator at Sinai Hospital.
The committee also heard from Bioscience Committee member Martha Connolly of the University of Maryland. Her presentation was about “Building and Supporting the Emerging Medtech Industry in the Greater Baltimore Region.”
Following Connolly’s presentation the committee discussed ways in which it can support the growth of the medical device industry in the Greater Baltimore region. The committee is working to identify, specifically, how to support the industry’s growth.
2015 Bioscience Committee news:
The Bioscience Committee has identified keeping bio startups in Baltimore and giving them the support they need to succeed as its project for the year. The committee is considering numerous initiatives to support this project, both hands-on and legislative. Among these are: commercialization as part of a tenure track in Maryland universities; educating would-be entrepreneurs among local higher education faculty; enhancing existing funding sources for startups; finding ways to provide follow on investing; working with major companies such as Johnson and Johnson for funding; creating a program similar to Dreamit but for bios only; net operating loss legislation; and working with state pension fund to carve out more investment dollars for venture funding.
The Bioscience Committee heard from Jarrod Borkat of MedImmune at its June 9, 2015 meeting and facilitated a discussion about how to grow Baltimore’s biotech industry. The group also focused on how Maryland, Washington, D.C., and Northern Virginia can work together to bolster the region’s role in the industry. Committee members told Borkat, a senior director at MedImmune, that his company’s leadership can help the Baltimore region attract industry talent and become a biotech hub.
At its April 23, 2015 meeting, the Bioscience Committee further discussed how to keep bio startups in Baltimore and give them the support they need to succeed. Committee members are honing in which initiatives they want to pursue. The committee also heard from three entrepreneurs: Carolyn Yarina, CEO and co-founder of SISU Global Health, and Joshua Budman and Kevin Keenahan, the co-founders, CTO (Chief Technology Officer) and CEO, respectively, of Tissue Analytics. The entrepreneurs told committee members about their companies, why they chose Baltimore for their corporate headquarters and what their companies need in terms of mentorship and funding.
The Life Science Investment Fund (LSIF) exists to meet the needs of Maryland companies developing products addressing human health that require approval from the U.S. Food and Drug Administration (FDA) for commercialization. The LSIF program helps to move products along this pathway by making investments that will enable companies to reach critical milestones early in their product development efforts, to increase the company’s valuation, and to better position the company for follow-on investment, product commercialization, and job creation.
There are three main eligibility requirements for a LSIF investment. It is critical to check with the Request for Applications (RFA) prior to initiating an application.
1. The company must be a for-profit entity located in Maryland with fewer than 16 FTE (Full-Time Equivalent) employees.
2. The company is pre-revenue or has received less than an aggregate of $1,000,000 in equity investments from ‘Accredited’ investors (as defined in Rule 501 Reg. D).
3. The company is developing a product (i) that requires FDA approval through the New Drug Application (NDA) or Biologic License Application (BLA) pathway, e.g., drugs, vaccines, biologics, etc., or (ii) that is defined by the FDA as a Class II or Class III medical device requiring approval through the 510(k) or Pre-Market Approval (PMA) pathways, e.g., medical devices, diagnostics, etc. (hereinafter a “Medical Product”).
TEDCO will make investments of up to $200,000 for a period of 1 year through the LSIF program to support milestone-based projects that advance a Medical Product toward commercialization. Investments are made in the form of a five-year, convertible note to the company. Interest will accrue on the note at a rate of 8% per annum (see RFA for details). The LSIF program requires a minimum 50% match for each TEDCO dollar invested in the First Investment. This match must be provided in the form of cash. The Company Match description must include information on the source and availability of the matching funds.
Applications for LSIF investment can be submitted to TEDCO two times each year. Application deadlines for 2016 are 5 p.m. on October 14. Prior to submitting an application through TEDCO’s web portal, companies must set-up an account in the system.
Sisu Global Health is looking to create a blood transfusion device that has an impact in areas that lack medical facilities around the globe. But when it comes to design and manufacturing of their device, called the hemafuse, CEO Carolyn Yarina said keeping it local has allowed the process to move along faster than it would with an out-of-town — or overseas — firm.
Harbor Design and Manufacturing has been that local source for Sisu, and a number of other local companies.
“Production does not need to happen in other states, it can — and will — happen right here in Baltimore,” said CEOKevin Barnes.
Harbor is planning for future growth to make that happen. The firm has new space in the Wicomico Building on the outskirts of Pigtown. (That building is also home to Zest Tea.) On the current trajectory, Harbor intends to have a 45,000 square feet and 200 employees.
As Sisu illustrates, one big growth area is medical devices. In addition to the Hemafuse, Harbor is also working on medicine flavoring for Columbia-based Flavorx, and a portable sterilizer for D.C.-based Eniware. Flavorx CEO Stu Amos said putting design and manufacturing under one roof was appealing for his company.
Medical devices are also a natural strength for Baltimore given the research coming out of Johns Hopkins andUMB, and that has helped lead to support from the Abell Foundation and TEDCO. Harbor recently received certifications known as ISO 9001 and ISO 13485 that are specifically for such devices.
They also have capabilities across a range of projects. A motorized longboard for Thor and golf training aid Core Putters are also client projects.
Beyond making cool stuff, though, Harbor is tapping into another natural Baltimore strength. Bringing manufacturing jobs back to the town is a big reason for excitement around the project. It’s an issue Kevin Plank discussed with Under Armour’s effort to bring some its own processes stateside. Harbor’s growth is an example of how that can play out in other areas.
Harbor’s headquarters is located in a HUB — or historically underutilized business — zone, which Barnes said can help spur local hiring.
“We want to create good-paying and stable jobs in an environment that offers career paths throughout the manufacturing process,” said Barnes.
Source: Techical.ly Baltimore, May 18, 2016
Harbor Designs and Manufacturing, a Baltimore-based contract design and manufacturing shop, cut the ribbon on its new 45,000 sq. ft. facility Tuesday, accompanied by officials from the Maryland Department of Commerce, the Abell Foundation, the Baltimore Development Corporation, the Economic Alliance of Greater Baltimore, the Regional Manufacturers Institute and others.
Located in the heart of a Baltimore City Economic Empowerment Zone, HDM is leading Baltimore’s resurging manufacturing economy, serving local, regional and national companies that require high quality, cost-effective product design and contract manufacturing services.
“Baltimore has a long history of manufacturing, and we’re proud to be working to bring it back,” Harbor Designs CEO Kevin Barnes said. “We are putting people to work in a manufacturing environment that offers career paths that haven’t flourished in the region for quite some time. We believe our growth will have a lasting impact on the neighborhood, Baltimore and the Maryland region.”
The new HDM facility is dedicated to engineering and mass production of cutting-edge technologies built with local labor. In what’s anticipated to be a 200-person engineering and technical assembly facility, engineering and manufacturing projects range from advanced bioreactors already in use aboard the International Space Station, to ground-breaking lifesaving medical devices funded by NIH, as well as advanced defense, rail and consumer products. Harbor Designs & Manufacturing is helping inventors, startups, universities and Fortune 500 companies turn their ideas into products, while leading a resurging manufacturing economy right in the heart of Baltimore.
This ribbon cutting ceremony celebrated manufacturing in the region, spotlighting the amazing technologies being developed and produced at HDM. With its recent award of ISO 9001 and ISO 13485 GMP manufacturing certifications, HDM is working to make Baltimore City a manufacturing hub, not only to meet the needs of the region’s bio-medical technology sector, but also the needs of diverse industries and companies across the country and around the world.
Harbor Designs and Manufacturing serves clients in the bio-production, medical device, rail, government and consumer products industries. HDM works with innovative companies and individuals to develop new products, and has brought countless products to life. As a result, HDM’s associates have developed a deep knowledgeable about a diverse number of industries, markets, and cutting edge technologies. The firm provides industrial design, mechanical engineering and production engineering services, along with contract manufacturing, and is one of the only contract manufacturers to be ISO 9001 and ISO 13485 certified, which allows it to provide high-end bio-production services.
Source: The Daily Record, May 17, 2016
Baltimore vaccine research firm Pharos Biologicals hopes to begin clinical trials for a Zika virus vaccine this fall.
Pharos has been awarded exclusive worldwide licenses for DNA vaccine technology and other nanotechnologies from the Johns Hopkins School of Medicine. The licenses are a crucial step for Pharos, a fledgling company with big plans for changing the way we think about vaccines.
In addition to Zika, plans to pursue vaccines for influenza and flaviviruses.
Pharos intends to specialize in the research and development stage of drug development, and will license the drugs to a larger pharmaceutical company once they are ready to be manufactured and sold, said CEO David Wise.
Pharos was founded in December 2015 by Dr. J. Thomas August, a professor of pharmacology, molecular sciences and oncology at Hopkins, whose research is the basis for the company’s work.
Traditional live virus vaccines use a small, weakened dose of the virus itself to prompt the immune system to develop antibodies to protect against it. August developed a method to instead use virus DNA to stimulate an immune response. Vaccines can be developed more quickly with this approach and could generate a stronger immune response.
Pharos hopes to begin this fall clinical trials of its first vaccine using this technology, a Zika vaccine.
Zika is a mosquito-borne virus that, until recently, was found primarily in Africa and Southeast Asia. The virus began spreading last year and leading health organizations, U.S. Centers for Disease Control and Prevention, warn that it will continue to spread. The virus’ symptoms are similar to those of a cold or flu and typically go away in a week, but can cause birth defects among babies born to infected women.
The danger the virus poses to pregnant women and discovery that it can be sexually transmitted have elevated public concern about its spread.
For this reason, Pharos hopes to move through its clinical trials and regulatory approvals as quickly as possible. is in the process of hiring an adviser to help with the U.S. Food and Drug Administration approval process that regulates drug development. Pharos is also working to raise money and identify partners to help move through the regulatory process.
Wise said it is too soon to say when the Zika vaccine may complete its clinical trials, obtain FDA approval and be available commercially.
Source: Baltimore Business Journal, May 4, 2016
While Central Maryland isn’t a major hub for the biohealth industry like Boston or San Francisco, it has key assets that can be enhanced to compete with some of the giants.
That’s one of the takeaways from a new report published by the Economic Alliance of Greater Baltimore and BioHealth Innovation Inc., a nonprofit dedicated to growing the state’s entrepreneurial ecosystem and supporting biohealth startups.
The report establishes the Central Maryland BioHealth Innovation Index, a numerical score that shows how the region stacks up against its peers.
The authors used data from the U.S. Census Bureau, the Association of University Technology Managers and other sources to compare Maryland to Boston, New York, Philadelphia, Pittsburgh, San Diego, San Francisco and the Raleigh-Durham are of North Carolina.
Each market was ranked according to criteria such as the number of residents with a bachelor’s degree or higher, the number of patents awarded at universities, and the number of initial public offerings. Those rankings were averaged to provide scores in four categories — talent, capital, entrepreneurship and research — as well as an overall score.
Maryland earned high marks for talent, tying with New York for the top score, largely due to the “constant stream of BioHealth workers” that cycle through institutions such as the National Institutes of Health, the University of Maryland, Baltimore and Johns Hopkins University, according to the report.
“That’s a great launch point for us,” said Tom Sadowski, president and CEO of the economic alliance.
General Electric’s recent decision to move its headquarters to the Boston area was motivated by the desire to tap into a similar talent pool in that region, Sadowski said.
“If you don’t have the students that are well-educated and a workforce that’s well-educated, you can’t build any major industry,” said Rich Bendis, president and CEO of BioHealth Innovation. “We have the knowledge base with our workers, students and scientists that we can build on.”
But Maryland ranked sixth out of eight overall, beating only Pittsburgh and Philadelphia; New York ranked first and San Francisco second.
With more access to risk capital, new technology and a general culture of entrepreneurship, Central Maryland can become one of the country’s top three biotech hubs by 2023, according to the report.
Commercialization is a key area where the Free State falls behind, because few of the region’s research projects enter the commercial marketplace, according to the report.
“We have a great deal of research and development that comes into the state every year,” Bendis said. While more effort has been made to translate that into startup companies, licenses and royalties, there’s still room for improvement, he said.
Key institutions, such as the University System of Maryland and Johns Hopkins University, are taking steps to address that need by beefing up their research commercialization – often called tech transfer – operations, Sadowski said.
While organizations like the Maryland Technology Development Corp., or TEDCO, exist to provide seed funding to emerging companies, Maryland still needs to enhance access to early-stage venture capital, according to the report.
“That’s one thing we want to work on in the future,” Bendis said. “How do we create more Maryland-based funds?”
Source: The Daily Record, April 20, 2016
The Abell Foundation has invested $200,000 in Sisu Global Health, a Baltimore-based company that’s developing medical devices for doctors in the developing world.
“Sisu’s business of providing cost-effective medical devices for developing countries and its network of support within its target markets and with international NGOs is compelling,” said Eileen O’Rourke, the Abell Foundation’s chief financial officer, in a statement.
The company’s first device, the Hemafuse, allows doctors to recycle blood from patients with internal bleeding, reducing the need for donor blood.
Sisu is working to raise $1 million as it scales up to production. The company garnered a $100,000 investment from former AOL CEO Steve Case in September after winning the live pitch competition in Baltimore during his “Rise of the Rest Road Trip.”
The company moved to Baltimore from Michigan in 2015 after securing an investment from DreamIt Health, a joint venture of Johns Hopkins University and the Abell Foundation.
“The energy and support around entrepreneurship has made Baltimore a great place for us to build our company,” Sisu CEO Carolyn Yarina said in a statement.
Source: The Baltimore Sun, April 20, 2016
Johns Hopkins University is launching a new Ph.D program that will offer students hands-on work experience in the biopharmaceutical field, where they’ll learn about the process of discovering and developing new drugs.
Officials say the partnership between the university and MedImmune, a company that focuses on biologics – prescription medicines developed from biological sources – is the first of its kind in the United States.
Students from the university’s medical and engineering schools can apply to the program, which will combine the standard Hopkins curriculum with courses co-taught by MedImmune scientists and a possible yearlong internship with the company.
MedImmune, which has facilities in Gaithersburg as well as California and the United Kingdom, is the biologics research arm of the London-based AstraZeneca, which reported $24.7 billion in revenue in fiscal 2015.
Scientists often spend years getting their doctoral degrees but don’t really know what awaits them outside of academia, MedImmune Executive Vice President Bahija Jallal told The Daily Record, adding that she didn’t know much about the industry until she was doing her postdoctoral research.
“One of the major challenges for the future of the biomedical workforce is how to prepare the next generation of scientists for diverse careers inside and outside of academia,” JHU President Ronald J. Daniels, said in a statement. “As the nation’s first research university, it is fitting that Johns Hopkins is at the forefront of creating innovative training opportunities for our students.”The new program is about opening the doors to students and showing them what MedImmune does and how they do it, Jallal said.“It’s our obligation to give back to society,” she said. “This is a way to give back.”One of the most important things that the program can convey to students is that collaboration is crucial to science, Jallal said. “If we do nothing but plant that seed [in their minds],” she said, “we will have succeeded already.”Students will work with MedImmune principal investigators on some projects, and the company will open its laboratories to students “if the project permits,” she said.
The first cohort of up to five students will begin its studies in the spring of 2017, Jallal said.
Both Hopkins and MedImmune say they want to duplicate the program with other partners in the future.
While this is this is the first partnership the company has established with an American university, MedImmune launched a similar Ph.D program with the University of Cambridge in England in October 2015 and has collaborated with the school on various other programs dating back 25 years, Jallal said.
In 2013, MedImmune and Johns Hopkins launched a five-year, $6.5 million joint research initiative with areas of focus that included oncology, neuroscience and infectious disease.
Source: The Daily Record, March 2, 2016
Just like last summer, the nonprofit invested $250,000 in the medical device startup.
“Expanding our investment in Vasoptic Medical Inc. is a win-win for Baltimore,” said a joint statement released by the Abell Foundation board. “Vasoptic is growing Baltimore’s innovative tech industry and is poised to improve access to affordable healthcare for low-income populations.”
Vasoptic Medical, which moved from Columbia into an office in Mindgrub’s space near McHenry Row in Locust Point last year, is developing a device that allows primary-care doctors to give eye exams to diabetes patients. Since all diabetes patients are at risk for a condition that could cause blindness called diabetic retinopathy, eye exams have become a part of medical care. Vasoptic’s device would eliminate the need for an eye doctor to be present during those exams.
Vasoptic CEO M. Jason Brooke said the investment dollars will fund clinical studies and R&D activities. The company is currently conducting an early feasibility study at University of Maryland Baltimore in conjunction with the Department of Ophthalmology and Visual Sciences. Since making the move to Baltimore, the company also added a scientist and engineer to the team.
Source: Technical.ly Baltimore, February 24, 2016
University College London (UCL), a leading UK university, is going to invest £50 million in what it hopes will be the next generation of university spin out companies over the next five years.
The fund, which was launched today, is designed to help academics and student entrepreneurs commercialise their research.
UCL said it will enable scientists to develop a proof of concept, fund licensing projects and create new spinout startups.
Academics working in life sciences, engineering, and information communication technology will be able to apply for investment out of the fund.
Several other universities in the UK have launched their own venture funds in recent years as they look to piggyback on the success of their academics’ work and cash in at the same time.
Last May, the University of Oxford launched the £300 million Oxford Sciences Innovation fund. Imperial Innovations (a fund set up by Imperial College London) has raised £346 million since going public on the London Stock Exchange in 2006.
Imperial Innovations is contributing £24.75 million to UCL’s new fund. The European Investment Fund, which is part of the European Union’s European Investment Bank, is contributing the same amount. The remaining £500,000 is coming from Albion Ventures, a London-based venture capital firm that will manage the fund.
UCL also runs a technology transfer company called UCL Business (UCLB). The university said UCLB has launched over 60 spin-out companies to commercialise intellectual property developed by UCL researchers. Recent UCLB spinouts include Freeline, which is developing gene therapies for blood disorders and Autolus, which is developing cancer immunotherapy treatment.
Source: Business Insider, Jan. 18, 2016