Are you a start-up in Maryland, DC or Virginia seeking feedback on your biohealth business idea, pitch deck, or commercialization plan? business/commercialization plan, pitch deck, or idea?

Schedule your feedback session with BHI EIRs 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 This email address is being protected from spambots. You need JavaScript enabled to view it..

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The University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) has been renewed for funding under a cooperative agreement grant from the U.S. Food and Drug Administration (FDA).

A collaborative partnership led by James Polli, PhD, the Shangraw/Noxell Endowed Chair in Industrial Pharmacy and Pharmaceutics at the University of Maryland School of Pharmacy (UMSOP), and William E. Bentley, PhD, the Robert E. Fischell Distinguished Chair of Engineering at the University of Maryland, College Park (UMCP), M-CERSI is one of only four FDA-funded CERSIs in the United States and the only CERSI to receive continuous funding from the FDA since it launched in 2011.

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Led by Joel Marcus, Founder of Alexandria Real Estate Equities

October 9th at 4:20pm

One MedImmune Way, Gaithersburg, MD 20878

Networking Reception to follow

RSVP by 2 p.m. 10/8 to:  This email address is being protected from spambots. You need JavaScript enabled to view it.

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In this episode of BioTalk, Rich Bendis and guest Brian Darmody discuss growth across the region, the battle for talent and the upcoming AURP International Conference hosted in College Park.

Brian Darmody is responsible for developing projects, funding opportunities, and policies to support partnerships with the private sector. Previously he was the University's  Associate Vice President for Research and Development, Director of the University of Maryland Center for Applied Policy Studies, Director of State and Federal Relations in the UMD President's Office, and served in the  University's legal counsel's office. He serves on national and state boards, including Maryland Technology Council Executive Board, Fraunhofer USA, the Maryland Economic Development Association and is past President of the Association of University Research Parks.He has served on the staff for the U.S. House of Representatives, the U.S. Health Care Financing Administration Office of Attorney-Advisor, and the Maryland General Assembly. He holds an undergraduate degree from the University of Maryland and Juris Doctor from the University of Baltimore.

Listen now on iTunes Google Play , and TuneIn

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Dear Friend:

On Wednesday, October 17th, I will be hosting a follow up discussion to a Biotech forum held earlier this year that addressed ways to help the biotechnology sector thrive in Montgomery County. I will be joined at this discussion by Congressman Jamie Raskin, Dr. Anthony Saleh, CEO, miRecule Inc. and Dr. Chris Austin, Director of the National Center for Advance Translational Sciences (NCATS), NIH.

The topic will be whether federal ethics and conflict of interest restrictions on NIH (intramural) scientists impede the competitiveness of our region’s biotechnology enterprise by limiting incentives for starting new commercial ventures.

This meeting will be held at Johns Hopkins University Montgomery County Campus, Room 121 in the 9605 Building, which is located at Medical Center Drive in Rockville. Parking on campus is available; however, a parking permit is required. Please park in the lot adjacent to the building located at the corner of Key West Avenue and Broschart Road. To ensure you receive a parking permit you must RSVP to this event. The event begins at noon and is scheduled to end at 1:30pm. A light lunch will be provided. Please email your RSVP to Walton Harris at This email address is being protected from spambots. You need JavaScript enabled to view it. or 240-777-7945.

Best,

George L. Leventhal
Montgomery County Councilmember

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Biotechnology Innovation Organization (BIO) President & CEO James C. Greenwood today issued the following statement on the United States-Mexico-Canada Agreement (USMCA):

BIO supports the USMCA and appreciates the Administrations efforts to prioritize biotechnology innovation, including provisions that update intellectual property protections and agricultural market access to 21st century standards.

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Anqoinette Crosby hosts County Report This Week. On this episode: Members of Governor Larry Hogan’s cabinet visited the county to discuss transportation and other topics with the Montgomery County Planning department, Artspace broke ground in Silver Spring, Biohealth Innovation will take part in an upcoming conference, Aspen Hill residents voice their opinions about cell towers, and the World of Montgomery Festival takes place on October 21 from 12-4p at Montgomery College in Rockville.

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When: Thursday, October 18, 2018 from 5:00 PM to 7:30 PM EDT

Where: CRB Office 1801 Research Blvd #620 Rockville, MD 20850

It's harvest time again and we're continuing our Fall Oktoberfest tradition with a special Open House event at CRB's Rockville office; featuring local microbrewery, Brookville Beer Farm.  Join us on Oktober 18th to help celebrate a year of tremendous growth within our region with a firm who is responsible for designing and building the facilities that many local companies are expanding into. 

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DATE AND TIME: Mon, October 22, 2018 8:00 AM – 1:00 PM EDT

LOCATION: Montgomery College Germantown Bioscience Education Center, 20200 Observation Drive, Bioscience Education Center, Room 151/152, Germantown, MD 20876

Montgomery County Government requests that you join County Executive Isiah Leggett and Council President Hans Riemer at the Commercial Buildings Broadband Summit, Monday October 22, 2018, 8 am to 1 pm.

The purpose of the Summit is to bring together select business leaders in commercial real estate development and leasing, gigabit fiber networks and wireless 5G and IoT, and leading business sectors to discuss how broadband-ready commercial buildings can support today’s business needs and what strategic direction the County should take to prepare for tomorrow’s business growth. There is no charge to attend, but space is limited and reservations are required.

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When the Danaher Corporation announced in May 2015 that it would split into two separate enterprises in 2016, it seemed at first like a reversal of the company’s history. Danaher had built itself into a remarkably successful business over four decades by acquiring and integrating new companies into a unified whole, improving them through a group of distinctive management practices known as the Danaher Business System (DBS), then holding onto them.

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Altimmune, Inc. (Nasdaq: ALT), a clinical-stage immunotherapeutics company, today announced the pricing of an underwritten public offering of common units and pre-funded units for a combined total of 2,400,000 units. Each common unit is being sold at a public offering price of $5.00 and consists of a share of its common stock and a warrant to purchase one share of common stock at an exercise price of $6.00. Each warrant will be exercisable immediately and will expire five years from the date of issuance. Each pre-funded unit consists of a pre-funded warrant to purchase one share of our common stock at an exercise price of $0.01 per share and a warrant. The purchase price of each Pre-funded Unit is equal to the price per common unit being sold to the public in this offering, minus $0.01. The pre-funded warrants will be immediately exercisable and may be exercised at any time until all of the pre-funded warrants are exercised in full

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Maryland Tech Council (MTC) announced today that, with the support of the Maryland Department of Commerce, the Maryland Tech Council Venture Mentoring Services (MTC VMS), will expand beyond Montgomery County to serve entrepreneurs throughout Maryland. The MTC VMS, which started just two years ago, has trained more than 60 mentors. The program uses a unique team approach to mentoring and is focused on technology and life sciences companies that are preparing to raise their first or second round of venture capital or institutional financing.

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CASI Pharmaceuticals, Inc. (Nasdaq: 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 Larry Zhang to the position of President of CASI (Beijing) Pharmaceuticals Co., Ltd., the China operating subsidiary of CASI Pharmaceuticals, Inc. headquartered in Rockville, Maryland. 

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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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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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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 This email address is being protected from spambots. You need JavaScript enabled to view it..

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ReveraGen BioPharma, Inc. today 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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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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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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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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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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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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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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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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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.