Monthly Archives

March 2019

Interview: Viela Bio Eyes BLA for Lead Asset Only One Year After Launch

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One year after spinning out from AstraZeneca’s MedImmuneViela Bio is already anticipating filing a Biologics License Application with the U.S. Food and Drug Administration (FDA) for its lead asset, inebilizumab.

Chief Executive Officer Bing Yao told BioSpace that the company plans to file the BLA in the middle of 2019 based off results from its Phase IIb pivotal trial of inebilizumab in neuromyelitis optica spectrum disorder (NMOSD). In January, the company reported positive results from the Phase IIb trial that patients who received inebilizumab in the trial saw a 77 percent decrease in the risk of developing NMOSD attack in patients receiving inebilizumab monotherapy compared to placebo. Secondary analysis showed a decrease in worsening of disability in patients receiving the drug, the company said. Safety and tolerability were acceptable and consistent with previous data.

Viela’s inebilizumab is a humanized monoclonal antibody that binds with high affinity to CD19, a protein expressed on a broad range of B cells, which includes antibody-secreting plasmablasts and plasma cells. After binding to CD19, these cells are rapidly depleted from the circulation, the company said.

NMOSD is a rare condition that affects the optic nerve and spinal cord in approximately five in 100,000 people. About 80 percent of patients with NMOSD have autoantibodies to a water channel protein dubbed aquaporin-4. Following the Phase IIb results, Jorn Drapa, Viela’s chief medical officer and head of R&D, said the study supported the hypothesis that CD19 expressing B cells including plasmablasts and plasma cells play a key role in the pathogenesis of NMOSD.

Click here to read more via Biospace

Takeda and HemoShear Therapeutics Extend Exclusive Drug Discovery Partnership in Liver Diseases

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HemoShear Therapeutics, LLC, a privately held biotechnology company, today announced an extension of its partnership with Takeda Pharmaceutical Company Limited to discover and develop additional novel therapeutics for liver diseases, including nonalcoholic steatohepatitis (NASH).

“We are excited that Takeda recognizes our unique ability to identify novel therapeutic approaches for liver fibrosis and NASH,” said Jim Powers, HemoShear’s CEO.  “We have an incredibly strong and productive relationship with Takeda and are happy to see our science drive their decision to expand our partnership.”

Under the terms of the original agreement, HemoShear received upfront payments and R&D funding, and Takeda received exclusive access to HemoShear’s proprietary disease modeling platform to discover and develop best-in-class therapeutics for specific liver diseases.  HemoShear was eligible to receive milestone payments of potentially $470 million and royalties. Further additional financial terms related to the extension of the partnership were not disclosed.

HemoShear’s partnership with Takeda has already generated several early drug discovery therapeutic targets.  These targets were shown in the HemoShear REVEAL-Tx™ platform to inhibit biological processes associated with inflammation and fibrosis that can lead to nonalcoholic steatohepatitis (NASH), cirrhosis, and liver cancer.  Furthermore, analysis using REVEAL-Tx™ suggests that inhibition of these targets demonstrates disease responses that are superior to established mechanisms of fibrosis currently being targeted by other companies in clinical trials.

“Our partnership with HemoShear has already borne fruit and we are enthusiastic about expanding the relationship,” said Gareth Hicks, Ph.D., head of GI Drug Discovery at Takeda.  “We are planning to advance novel drug targets identified and validated by HemoShear into our discovery pipeline and look forward to bringing new therapies to the clinic.”

Click here to read the entire press release

We’re not doing enough for our kids | Kurt Newman | TEDxTysons – YouTube

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It all begins at birth. That’s the starting point for Kurt Newman as he shares his poignant journey as a pediatric surgeon. Newman offers a new perspective for approaching the most chronic and debilitating health conditions. Against a backdrop of personal challenges and patients who overcame impossible odds, we learn to appreciate the importance of treating every child with early customized care, and an eye for the future.

 

2019’s Most & Least Innovative States – Maryland Ranked 4th

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Innovation is a principal driver of U.S. economic growth. In 2019, the U.S. will spend an estimated $581 billion on research and development — more than any other country in the world and about 25% of the world’s total — helping the nation rank No. 6 on the Global Innovation Index. According to the results of the ranking, knowledge and technology outputs are America’s particular strengths.

But certain states deserve more credit than others for America’s dominance in the tech era. These states continue to grow innovation through investments in education, research and business creation, especially in highly specialized industries.

In order to recognize the nation’s biggest contributors, WalletHub compared the 50 states and the District of Columbia across 24 key indicators of innovation-friendliness. Our data set ranges from share of STEM professionals to R&D spending per capita to tech-company density. Read on for our findings, commentary from a panel of experts and a full description of our methodology.

Click here to read the entire article via wallethub.

Be Bold. Cutting-edge Lab Space Available at the Gateway of the NIH. Delivering Summer 2021.

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Cutting Edge Lab Space Available

The NIH is the cornerstone to the world scientific community and is the largest life sciences engine in the US.

Bethesda Bio gives life science companies the ability to be on the doorstep of this invaluable wealth of resources, community, talent, technology, intellectual property, clinical studies. The existing Bethesda central business district provides a vibrant live, work and play environment to recruit and retain the best scientific minds. Over the past two decades, Bethesda has been the center of Montgomery County and the hub of innovation.

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BHI Entrepreneur-in-Residence Feedback Session – March 20th

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Are you a start-up in Maryland, DC or Virginia seeking feedback on your biohealth business idea, pitch deck, or commercialization plan?  Sign up by noon 3/19 to schedule your feedback session with BHI Entrepreneurs-in-Residence (who have industry experience in therapeutics, Dx, medtech and more) next Wednesday, March 20th.  (The next session is scheduled for 3/20 and 5/22.)  Pre-registration is required; sign up here(“EIR resource” at BHI).  For questions/more information, contact BHI.

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Strong interest in Non-Dilutive Funding Programs

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More than 120 people registered for last week’s SBIR Workshop organized by BioHealth Innovation in partnership with Launch Workplaces and support from TEDCO and NIH FCU.  

The event featured program overviews, “how to” sessions regarding specific aspects of proposal development and 1:1 partnering meetings with the program managers.  

Speakers included:  Todd Haim,  Ph.D., Chief, Office of Small Business Research NIA;  Mike Pieck, Ph.D., Small Business Coordinator, NHLBI; Maureen (Cusick) Thomas, Outreach Coordinator, NIA;Victor Prikhodko, Business Advisor, NIDA; Amir Rahbar, PhD, MBA, Program Director, NCI;  Vladimir M. Popov, PhD, Business Dev. Manager, NCI-FNL;Amir Rahbar, PhD, MBA, Program Director, NCI; Henry Ahn, Program Director SBIR/STTR, NSF; and Colleen Gibney, SBIR Deputy Project Mgr, USAMRMC.  

44% of the attendees had applied for SBIR funding before with half of these innovators receiving a Phase 1.  Only 16% had received a Phase II award.  The majority of attendees were from Montgomery and Frederick Counties and the City of Baltimore.  However, registrants also traveled from Virginia, DC, Illinois and Pennsylvania.

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Anne Lindblad, Ph.D., President, and CEO of Emmes, joins Rich Bendis for BioTalk

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BioTalk Host Rich Bendis sits down with Anne Lindblad, Ph.D., President, and CEO of Emmes, to discuss her view of the region, her history with the company, and their mission, vision, and values.

Anne Lindblad, Ph.D., joined Emmes in 1982 as a Biostatistician and is currently the President and CEO. She has supported clinical research throughout her career, serving as Principal Investigator of projects spanning diverse disease areas, including neurology, ophthalmology, oncology, dialysis, transplantation, speech and hearing, and dentistry. Dr. Lindblad has been an NIH reviewer on multiple project applications for NINDS, NEI, NICHD, NIDCR, NIDDK, and NCCAM and has served as a member or chair of several Data and Safety Monitoring Committees for NEI, NIAAA, NIDDK, and NINDS. She was a member of an Advisory Committee charged with drafting policy to shape the appropriate planning and conduct of intramural studies at NIH. She was elected to the Board of Directors for the Society for Clinical Trials (2003-2006) and served as Program Chair (2002), as an Officer (2006-2014), and as President (2012-2013). Dr. Lindblad was selected to serve on NIH’s National Advisory Dental and Craniofacial Research Council from 2004 through 2008. She has taught courses in best practices in clinical trial design and conduct for ophthalmologists, neurologists, and immunologists. She has published and presented over 100 manuscripts in peer-reviewed journals and conferences. Dr. Lindblad joined the Board of BioHealth Innovation in 2018.  Emmes has grown from 15 employees in 1982 to over 650 globally. In 2019 Emmes announced a significant investment by Behrman Capital which will allow Emmes to gain access to new tools, talent, service offerings, and expanded footprint faster than what Emmes might otherwise have accomplished.

Listen now on iTunesGoogle Play, and TuneIn.

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