Biohealth Innovation
Kelly Chu stands at the front of the room and explains a complex spreadsheet displayed on a projector.
With precision she describes the discounted free cash-flow model she built of a food-services and construction company, and walks through its revenue-growth assumptions before making a recommendation on whether or not to invest.
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There is nothing like the sight of children to inspire hope, so it was only fitting that University of Maryland, Baltimore (UMB) President Jay A. Perman, MD, began his second annual State of the University Address on May 7 with a performance by the sixth-grade dancers from Southwest Baltimore Charter School.
But there was deeper meaning as well to their presence at his optimistic address “Renew the State. Repair the World” before an overflow crowd at the School of Nursing.
Funding and Research Opportunities The following funding opportunity announcements from the NHLBI or other components of the National Institutes of Health, might be of interest: Notices:
Program Announcements:
Please note that most links to RFAs, PAs, and Guide Notices will take you to the NIH Web site. RFPs will take you to FedBizOpps. Links to RFPs will not work past their proposal receipt date. Archived versions of RFPs posted on FedBizOpps can be found on the FedBizOpps site using the FedBizOpps search function. Under “Document to Search,” select Archived Documents.
Symbiomix Therapeutics today announced multiple milestones, including the closing of the third and final tranche of a $41 million Series A financing and positive results from a multi-center, randomized Phase 2 trial testing a single oral dose of SYM-1219 for the treatment of bacterial vaginosis (BV). Based on discussions with the U.S. Food and Drug Administration (FDA) at an End-of-Phase 2 meeting, the Company now is planning to submit the Phase 2 trial as one of two pivotal studies for a New Drug Application (NDA) filing in 2016. Simultaneously, the Company announced that the FDA recently designated SYM-1219 as a Qualified Infectious Disease Product (QIDP). SYM-1219 is a novel drug candidate that contains secnidazole, an antibiotic with favorable pharmacokinetics that facilitate administration as a single-dose oral therapy.
University of Maryland (UM) Ventures and Biomecite Diagnostics, LLC announced today the signing of an exclusive option by Biomecite Diagnostics for the rights from University of Maryland, Baltimore (UMB) to develop diagnostics to detect inflammatory bowel diseases (IBD), such as ulcerative colitis (UC) and Crohn's disease (CD). Drs. Florian Fricke and James White developed the licensed technology while both were with the University of Maryland School of Medicine's Institute for Genome Sciences (IGS). The technology explores distinctive genomic variances in the populations of bacteria or microbiome found in the human gut to diagnose the closely related but differing gastrointestinal diseases, UC and CD.
Presenter:
Rana Gupta
President, Kwydk, LLC
Moderator:
Gary Robinson, Ph.D.
National Heart, Lung, and Blood Institute
The landscape of potential customers for biomedical products can be complicated, with patients, providers and payers assigning different values to new technologies. Companies must navigate this landscape to find the individuals who will actually make the decision to purchase their products. In this webinar, entrepreneur and educator Rana Gupta will talk about how customers can not only help biomedical innovators to define the value proposition for their products, but can also guide and fund their product development.
Since it seems that 1776 can’t go a week without making news, they just announced an Innovation Opportunity Program that they are launching with General Assembly. DC’s Mayor Muriel Bowser along with representatives from TDF Foundation, THEARC, Capital One, MedStar Health, and Microsoft were also on hand for the announcement.
Emergent BioSolutions of Gaithersburg has won approval from the U.S. Food and Drug Administration for its hemophilia drug Ixinity.
The treatment, administered intravenously, helps control and prevent bleeding episodes and also is approved for use during surgery in adults and children 12 and older with hemophilia B, according to a company news release. Hemophilia B is a bleeding disorder caused by a mutation on the factor IX gene resulting in a deficiency of clotting factor IX in the blood, which controls bleeding.
On Tuesday, the Senate Health committee held a hearing on the promise of precision medicine. Last week, the House released draft legislation to support biomedical innovation. And following President Obama's State of the Union in January, the White House unveiled the Precision Medicine Initiative, meant to provide funding to accelerate biomedical research.
What none of these things do directly is to curb the price of speciality drugs—including precision drugs—which cost Americans more than $80 billion in 2013, according to the Campaign for Sustainable Rx Pricing.
The Montgomery County Business Hall of Fame will add four new members later this year, including a former space issues attorney turned health company CEO, a bank chairman, a barbecue expert and the chief executive of a hospital.
The following people have been named to the business hall of fame and are scheduled to be honored at an Oct. 27 event:
Photo Credit: Fortune Live Media - Flickr
Drug testing on humans and animals will be a thing of the past within two decades, United Therapeutics CEO Martine Rothblatt said Monday.
Soon, companies will test pharmaceuticals on silicon versions of the human body, entering drugs as code, she said.
Photo Credit: Fortune Live Media - Flickr
The advent of connected devices and M2M is offering a tremendous opportunity for healthcare professionals. Near-ubiquitous mobile networks are allowing carers to diagnose, monitor, and communicate with patients with unprecedented speed and efficacy.
Every venture firm’s looking for many multiples when it comes to returns – but in reality, they expect things to shake out a little differently. Seth DeGroot, a managing partner at boutique Minneapolis investment firm Brightstone Venture Capital, spoke on what the firm’s expectations in potential investment targets – and how startups can avoid pesky problems like, say, overinflated valuations.
NextGen Angels recently announced plans to bring its brand of under-40, entrepreneur-friendly angel investors to 12 more U.S. cities, with plans for international expansion down the line.
I caught up with CEO Dan Mindus, who founded the group in 2012, about both the expansion and the venture market in the Greater Washington area. Based on our conversation, there are two important things about the local funding market that every entrepreneur should probably know:
Gaithersburg-based molecular diagnostics company OpGen Inc. went public Tuesday, and saw its shares drop more than 20 percent during the day before closing at $4.85, down nearly 19 percent.
CEO Evan Jones said he's not concerned. In the world of biotech, making money can take time.
Each time 81-year-old Bill Dworsky or his 80-year-old wife Dorothy opens the refrigerator, closes the bathroom door or lifts the lid on a pill container, tiny sensors in their San Francisco home make notes on a digital logbook.
The couple's 53-year-old son, Phil, checks it daily on his smartphone. If there's no activity during a designated time, the younger Dworsky gets an automated email, so he can decide whether to call or stop by. "This is peace of mind, really," he says of the system he installed last year.
Dr. Patrick Soon-Shiong has some big ideas in healthcare, like a vision of a fully connected ecosystem that truly empowers patients to make informed choices about their own care, aided by supercomputers to crunch all the data, including highly complex genomic information. And he’s not afraid to toot his own horn every once in a while.
“We’ve created the Google of genome mapping,” Soon-Shiong, the multibillionaire entrepreneur behind the still-somewhat-mysterious NantHealth and parent company NantWorks, said Monday at the American Telemedicine Association annual meeting in Los Angeles.
QIAGEN N.V. (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) announced today that it has expanded its relationship with BGI, the world's largest genomics organization, to provide QIAGEN's Ingenuity® Variant Analysis™ in integrated bioinformatics for all customers of BGI's sequencing services.
Under the reseller agreement, BGI customers will receive sequencing data generated from their samples through Ingenuity Variant Analysis' secure, cloud-based environment and gain access to its leading comprehensive gene variant data and genomic interpretation applications. BGI will provide Ingenuity Variant Analysis to customers in China, Hong Kong and Taiwan, with plans to expand to other regions throughout the year. BGI collaborates with more than 10,000 organizations and 30,000 partners worldwide, providing sequencing services for thousands of research projects, including large-scale genome initiatives.
Metro areas with strong startup ecosystems depend on success stories and market conditions that converge over time. In the best of circumstances, a regional community can become stronger than the sum of its parts, moving the needle for industries nationally – or even worldwide.
On Wednesday, big names from D.C.'s tech and business circles will come together at DC Inno's State of Innovation event at Artisphere to discuss the area's future for young startups. One of the hot topics for the evening will be exactly how an innovation ecosystem comes together. Tackling the question will be local leaders from Eastern Foundry, Video Blocks, Arlington Economic Development and Springboard Enterprises.
Fresh from unveiling a $3.1B fund, New Enterprise Associates is the sole investor in a $3 million Series A round by MORE Health. The health IT startup wants to connect Chinese doctors and their patients with U.S. specialists across areas such as oncology, neurology, cardiology and pediatrics.
As part of its investment, Xiaodong Jiang, managing director for NEA China, will take a seat on the company’s board of directors. NEA has been in the China market for 12 years and has invested about $400 million in 20 companies there.
The Company: Noble Life Sciences (Gaithersburg, MD) is a rapidly growing contract research organization (CRO) that provides a continuum of preclinical drug, vaccine and medical device development services, from discovery to GLP-compliant studies for regulatory submissions. The company offers in vitro and in vivo services, including cellular and animal disease model development and experimental design, non-GLP and GLP animal efficacy, toxicity, biodistribution and product release studies in both small and large animals, and vivarium services. The company also offers custom antibody production services and research animal and tissue products.
The Company operates out of two Maryland-based facilities – in Gaithersburg and Woodbine where it operates as Spring Valley Laboratories, a unit of Noble Life Sciences, offering a range of GLP and non- GLP studies with a primary focus on GLP and large animal testing. Noble is AAALACi accredited, USDA licensed, OLAW compliant, FDA inspected and successfully audited by numerous clients.
The Position: The Director Account Development is a key position within the organization with significant prospects for career growth as the company continues to increase the breadth and scope of its business. This position reports directly to the President and is a member of the management team.
At DC Inno we are constantly on the look out for the next innovative local company. Over the past several months, one of the most interesting industries we have had the opportunity to cover is the virtual reality (VR) sector. Virtual reality is immensely cool and as a medium, it offers a host of exciting applications and uses. In the past, the technology was so expensive that it offered little to many consumers, but that is now changing. With the proliferation of new, consumer-targeted devices—like the Oculus Rift, Samsung Gear and Google Cardboard—more people are finally getting the opportunity to experience VR.
How well do you understand science?
Jon D. Miller, director of the International Center for the Advancement of Scientific Literacy at the University of Michigan at Ann Arbor, has been asking people in the United States and abroad that question since 1988.
The American Telemedicine Association (ATA) today released an update to two critical state policy reports which identified gaps in coverage and reimbursement, and physician practice standards and licensure.
“After ATA issued the State Telemedicine Gaps Reports last September, many state regulating bodies responded by looking at how their laws and regulations impact healthcare delivery in their state,” said Jonathan Linkous, CEO of ATA. “As a result of state actions across the nation, ATA reevaluated the indicators for each state and issued new reports. As before, we anticipate that these reports will serve as an incentive to increase the utilization of telemedicine to improve the accessibility, affordability and quality of healthcare.”
With molecular diagnostics projected to grow to a $7.6 billion industry by 2017 (Kalorama) and surpass $8 billion by 2020 (Grand View Research), the field is seeing growing interest from both corporate giants and smaller specialized companies.
On the corporate side, the largest players include such familiar names as Roche, Qiagen, Becton Dickinson, and Abbott, as well as more recent arrivals such as Hologic, Grifols, and bioMérieux. Yet the past few years has also seen a growing number of smaller companies devoted to MDx by focusing on specific technologies or disease areas (especially cancer).
U.S approval of GlaxoSmithKline’s newest respiratory inhaler continues the global drugmaker’s shift from the blockbuster drug Advair to a suite of drugs that will be assembled at the British company’s Zebulon manufacturing site.
GSK said Thursday the company and business partner Theravance won approval from the Food and Drug Administration to market Breo Ellipta for asthma. The drug had been approved in 2013 for chronic obstructive pulmonary disease, but it failed to win approval for sale to minors as GSK officials had hoped.
Emergent BioSolutions Inc. (EBS) today announced that the U.S. Food and Drug Administration (FDA) has approved IXINITY(R) [coagulation factor IX (recombinant)], an intravenous recombinant human coagulation factor IX therapeutic for the control and prevention of bleeding episodes and for perioperative management in adults and children, >=12 years of age, with Hemophilia B. Hemophilia B is a bleeding disorder caused by a mutation on the factor IX gene resulting in a deficiency of clotting factor IX in the blood, which controls bleeding.
Teachers' unions provided a lot of the muscle to get the Affordable Care Act passed, but now they're working to overturn one portion of the law that stands to affect their members: the law's excise tax.
The National Education Association on April 29 signaled its support for a bill introduced by Rep. Joe Courtney, D-Conn., that would repeal the tax, which goes into effect in 2018.
Having secured a funding boost for the National Institutes of Health in the 21st Century Cures legislation, House Democrats now say the Food and Drug Administration would be ill-equipped to handle the new burdens under the bill without more resources.
Rep. Frank Pallone (D-N.J.), the ranking member of the House Energy and Commerce Committee, raised the matter during a hearing Wednesday on the latest iteration of the legislative package, which is intended to accelerate the pace of innovation in medical drug and device development.
U.S. legislators recently released a discussion draft of the medical innovation bill known as the 21st Century Cures Initiative. The legislation aims to hasten the discovery, development, and delivery of new medical devices and drugs, particularly for the treatment of thousands of diseases for which there are no cures.
The proposals in the draft include ways to revamp how agencies such as the National Institutes of Health (NIH) and the Food and Drug Administration (FDA) foster and regulate medical innovation in the U.S.
District investor group NextGen Angels has raised $1 million from 24 of its members to finance expanding to two more cities.
The local angel group, which currently boasts 85 members, has a similar presence in New York City and very recently set up a Boston location. CEO Dan Mindus told me Austin and Chicago are the next two cities on the list, with 10 more cities slated in the next 12 to 18 months. Those include Atlanta, Philadelphia, Seattle, Portland and San Diego.
Gaithersburg company to use funds to add staff and upgrade equipment to meet demand
Angela Graham, President and CEO, accepts check from DED's Valerie Fremont and Gene Smith Quality Biological, Inc., an industry leader in manufactured ready-to-use biological research tools, has been awarded an EDF Grant by the Montgomery County Department of Economic Development (DED) to support the expansion of their fulfillment operations. The award, funded from the Montgomery County Economic Development Fund (EDF), will be used to upgrade and modernize equipment needed to meet requirements from local and regional customers. The company, headquartered in Gaithersburg, plans to add 10 new jobs as part of the expansion.
Bungalow Insurance won the $30,000 Perlman Grand Prize of the 2015 Wharton Business Plan Competition. The prize was awarded at the Wharton School’s annual Venture Finals on April 30, 2015, where student finalists received more than $128,000 in combined cash prizes and in-kind legal/accounting services.
Twenty-four Maryland executives were named Maryland regional finalists for EY’s Entrepreneur of the Year.
The annual award program recognizes entrepreneurs who demonstrate excellence in innovation, financial performance and commitment to their businesses. Winners will be announced June 25 at a gala at the Baltimore Marriott Waterfront.
OrderUp Inc. CEO Chris Jeffery, Medifast CEO Michael MacDonald and Goodwill Industries of the Chesapeake Inc. CEO Lisa Rusyniak are among the Baltimore-area business leaders named as finalists.