323rd Edition – October 2, 2018

Jeff Gallagher, CEO of Virginia Bio sits down with BioTalk host Rich Bendis to discuss accomplishments, challenges, and initiatives in his state and the BioHealth Capital Region.

Jeff is responsible for leading the premier statewide trade group that promotes the considerable scientific and economic impact of the life sciences industry in the Commonwealth of Virginia. Prior to taking on the leadership of Virginia Bio in May 2012, Jeff was a co-founder and served as VP & General Counsel for Lyotropic Therapeutics. This small specialty pharma company used its proprietary formulation technology to create new drug products based on both NCIs and already approved API for license, further development and commercialization by mid and large pharma. Previously he practiced corporate law in Richmond, focusing on new technology company formation, international business and intellectual property transactions. He was a co-founder and longtime Chairman of the Richmond based nonprofit World Pediatric Project. He holds an A.B. in Government from Harvard, a J.D. from the University of Wisconsin Law School, and an LL.M in Public International Law from the University of Virginia School of Law. He resides with his family in the Ginter Park area of Richmond, VA.

Listen now on iTunes , Google Play , and TuneIn. 

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Last week to register for BioBowl…only a few spots left…and it’s free!

Join us for the 5th Annual BioBowl! You and your company team will be competing against other biotech firms to win the coveted BioBowl Trophy! But first you have to RSVP to claim your spot in the competition.

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BioHealth Innovation, Inc. (BHI), is a Montgomery County innovation intermediary which translates market-relevant research into commercial success by bringing together management, funding, and markets.  BHI is seeking an experienced life science professional with entrepreneurial and investment experience to join the BHI EIR team and serve as an Entrepreneur-in-Residence (EIR) at the National Institutes of Health (NIH). This position will report to and work closely with our lead at the NIH Office of the Director, Office of Extramural Research (OER) at the Bethesda, MD campus. The EIR will provide product, corporate and private investment strategy for companies which have SBIR/STTR awards and are ready for the next step towards commercial success.

The NIH is the world’s largest early stage biomedical investor providing nondilutive funding for US companies in the form of grants and contracts through the SBIR/STTR program. In FY19 the Congressional funds set aside for company funding exceeds $1B USD. The EIR program supports NIH interests in commercial success of its SBIR/STTR portfolio companies. 

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Montgomery County has awarded a total of $425,000 in matching grants to 12 small companies who applied for the County’s new Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Matching Grant Program.

In order to qualify, eligible companies must have been awarded a SBIR or STTR Phase 1 or Phase II grant during the current calendar year by the National Institutes of Health (NIH), and 51 percent of research and development operations must be conducted in Montgomery County.

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BHI and Launch Workplaces are co-hosting a series informational programs on topics of interest to early stage companies in Montgomery County’s innovation network. Geared toward biohealth and technology startups, these sessions are open to all start-ups in the BioHealth Capital Region (with priority on 1:1 office hours given to Montgomery County Innovation Center tenants).

Each program begins with an overview of issues related to the day’s topic with lessons learned and best practices from experts in the field and companies which have been through the process. Attendees can sign up for 1:1 meetings with the experts after the overview session to discuss their specific scenarios more in depth. Mark your calendars (more details to follow):

10/24 – CMS Reimbursement

11/28 – Legal Issues for Early Stage Companies

1/24 – Tax Implications for Startups

1/29 – Fundraising (SBIR)

2/27 – Fundraising (nonSBIR nondilutive and dilutive)

3/27 – Successful Marketing & PR Strategies

4/24 – Selling to the Government

5/15 – Pricing Factors

6/12 – Staff Recruitment and Retention

For more information/to hold your spot for one of the dates now, email BHI.

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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?  Schedule your feedback session with BHI Entrepreneurs-in-Residence on one of the following dates: 10/31, 12/5, 2/13, 3/20, 5/22. (30 minute blocks of time beginning at 9:00 in the morning. If the morning slots are filled, more time will be allotted beginning at 1 p.m.)  Pre-registration is required; sign up here (“EIR resource”at BHI).  For questions/more information, contact BHI.

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Viral clearance is not a new challenge for the biopharmaceutical industry. However, regulatory demand for better data combined with the growing recognition of the shortcomings of current virus removal and inactivation methods are fostering innovation, according to industry experts.

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ReveraGen BioPharma, Inc. recently announced the initiation and first patient enrollment in a double-blind, placebo- and prednisone-controlled clinical trial (VBP15-004) of vamorolone, a first-in-class dissociative steroidal anti-inflammatory, in Duchenne muscular dystrophy.

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The National Institutes of Health (NIH) Office of Extramural Research (OER) provides the corporate framework for NIH research administration, ensuring scientific integrity, public accountability, and effective stewardship of the NIH extramural research portfolio. The OER is seeking a Supervisory Medical Officer (Research) or Pharm.D. or Ph.D. Clinical Research Nurse to serve as the Director of a new division with oversight for human subjects research and clinical trial policy and process implementation.

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BioHealth Innovation sponsors quarterly office hours in Montgomery County and at Johns Hopkins Fast Forward (Fast Forward hours are for JHU innovators only).

BioHealth Capital Region innovators not located at Fast Forward can register for SBIR office hours on the following dates.

• Tuesday – Nov 6, 8:00 a.m. – 12:00 p.m. – Germantown Innovation Center
• Wednesday – Nov 7, 1:00 – 5:00 p.m. – Rockville Innovation Center
• Tuesday – Feb 12, 8:00 a.m. – 12:00 p.m. – Germantown Innovation Center
• Wednesday –Feb 13, 1:00 – 5:00 p.m. – Rockville Innovation Cente
• Wednesday – May 8, 8:00 a.m. – 12:00 p.m.- Germantown Innovation Center
• Thursday — May 9, 1:00 – 5:00 p.m. – Rockville Innovation Center

To register for the open sessions, click here. (BHI also will be hosting a more general SBIR overview with office hours on January 29, 2019. Mark your calendar; more details to follow.)

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If you and your team are located in the BioHealth Capital Region, BHI may prepay for experts to help you improve your SBIR and other non-dilutive funding applications for biohealth related projects. Your only obligation is that if you win the award, you reimburse BHI for the consulting fees (typically $1500 or $3000) and a minimal program management fee (ten % of the prepaid consulting fee i.e. $150 or $300).

For more information contact BHI.

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Summer 2018 may have brought more rain than sun, but when it comes to funding at Maryland startups, things have been hot, hot, hot. With top-notch research institutions, an unparalleled technical workforce, and a network of accelerators, Maryland is a hotbed for innovation, so it’s no wonder venture capitalists want Maryland startups in their portfolio. Here’s a snapshot of companies that have recently received VC investments.

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Baltimore-based Cerecor announced the acquisition of Ichorion Therapeutics, a New York–based biopharmaceutical company.

The deal includes an all-stock transaction worth up to $26.6 million, with potential for an additional $15 million in milestones, which could be paid in cash or stock.

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Qiagen announced today that the US Food and Drug Administration has approved the expanded use of the company’s Therascreen EGFR RGQ PCR Kit to allow its use as a companion diagnostic for Pfizer’s Vizimpro (dacomitinib) for first-line treatment of patients with non-small cell lung cancer with EGFR exon 19 deletions or exon 21 L858R mutation.

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CASI Pharmaceuticals, Inc. (CASI), a biopharmaceutical company dedicated to the development and delivery of high quality, cost-effective pharmaceutical products and innovative therapeutics to patients in the U.S., China and throughout the world, announces the appointment of George Chi to the position of Chief Financial Officer. Dr. Wei-Wu He, Executive Chairman of CASI Pharmaceuticals, commented, “I’m very pleased to announce George’s appointment and welcome him to CASI. George joins us at an opportune time as our company prepares for the marketing and sales of our first oncology product in China. He will be integral to help transition the Company’s financial operations to commercial stage as we launch EVOMELA® and other additional products from our pipeline.”

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New cases of sexually transmitted diseases are on the rise worldwide, and some strains have become resistant to the antibiotics commonly used to treat them.

With the support of a $5.1 million grant from the National Institutes of Health, Jeff Wang a professor in the Whiting School of Engineering’s Department of Mechanical Engineering and member of the school’s Institute for NanoBioTechnology, is leading a team that is creating a device that not only rapidly tests for gonorrhea, but detects if a particular bacterial strain is resistant to antibiotics.

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UM Ventures – College Park, part of the University of Maryland Division of Research, is pleased to announce the addition of new talent to its innovation and commercialization efforts: Ken Porter, director of the Office of Technology Commercialization (OTC) and Stan Smith, venture investment manager. These new hires build on UM Ventures’ strategic goal of unleashing innovation.

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Innovating medical technologies in emerging markets Medical device company with the potential to save up to 2.6M newborn lives a year

In developing countries, many hospitals are overcrowded, understaffed, and lack standard medical equipment, leading to preventable newborn deaths. Neopenda is a for-profit public benefit corporation that is developing technologies to prevent these deaths, including a wearable that captures newborn vital signs so nurses in resource-constrained hospitals can attend to babies in distress.

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When: Thursday, October 11, 20184:30 – 7:30 PM EST Where: UM BioPark801 West Baltimore StBaltimore, MD 21201

bwtech @UMBC Cyber Incubator and Anchor Ventures will co-host a special event celebrating the cybersecurity industry in Maryland. The first part of the event will include an Anchor Ventures Panel discussing “Cybersecurity Issues in Healthcare” from 4:00 PM to 5:30 PM, immediately followed by the renowned CyberTini Networking Reception from 5:30 PM to 7:30 PM. This double feature event will attract C-Level Executives and cybersecurity practitioners and will include comments by the “movers and shakers” in the cybersecurity world.

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Fina Biosolutions announces that the United States Patent and Trademark Office has issued a patent for expression and purification of the conjugate vaccine protein CRM197 in E. coli. CRM197 is a key component of many vaccine formulations utilized worldwide.

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The Biotechnology Innovation Organization applauds the House and Senate’s bipartisan passage of the Small Business Innovation Protection Act. The bill directs increased cooperation between the Small Business Administration (SBA) and the U.S. Patent and Trademark Office (PTO) to improve intellectual property protections for small businesses.

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We are pleased to announce a pitch event will be hosted by MITRE Corporation at the Tysons, VA campus in the Metro DC area on Wednesday, October 10th from 9am-6pm EST.

Join us to hear 10 new startups present their innovations to our ecosystem of industry experts. This will be Starburst’s annual east coast selection committee, so don’t miss out! It’s a great way to make the most of your trip for those of you who plan to be in the DC area for the AUSA conference Oct 7-10.

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Swiss-based Roche announced it is buying UK-based Tusk Therapeutics in a deal that could hit $758 million (U.S.).

Under the terms of the acquisition, Roche is paying $81 million upfront with another possible $677 million in various milestone payments.

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A report released this week at the annual conference of the trade association for medical device and diagnostics companies had a stark message to deliver: invest in customer-centric capabilities and digital collaborations to build personalized health solutions or die.

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Across the state, nearly 120,000 scientists are developing biologically advanced materials with the potential to change the course of our health, environment and even the foods we eat. It’s expanding New Jersey’s reputation from the “medicine chest of the world” to a hub for the life sciences.

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The Collegiate Inventors Competition®, an annual competition that rewards innovations, discoveries and research by college and university students and their faculty advisors, announced today its 2018 Finalists.

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The 2018 Nobel Prize in Physiology or Medicine was awarded on Monday to James P. Allison of the United States and Tasuku Honjo of Japan for their work on unleashing the immune system’s ability to attack cancer, a breakthrough in developing new cancer treatments.

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