Have you register for this year’s Women Building Bio event? The third Annual Women Building Bio Conference is taking place October 17 at the Inova Center for Personalized Health. This is a one-day regional conference converging extraordinary men and women, industry and academia, researchers and innovators, professionals and decision-makers gathering together to cultivate relationships and making an impact. Click here for the agenda and more information. (For a discount code, email This email address is being protected from spambots. You need JavaScript enabled to view it. and register by 3 p.m., Tuesday, October 16th.)

Emergent BioSolutions Inc. (NYSE: EBS) announced today that it has completed its acquisition of PaxVax, a company focused on developing, manufacturing, and commercializing specialty vaccines that protect against existing and emerging infectious diseases. With the closing of this transaction, Emergent acquires two marketed vaccines – Vivotif® (Typhoid Vaccine Live Oral Ty21a), the only oral vaccine licensed by the U.S. Food and Drug Administration (FDA) for the prevention of typhoid fever, and Vaxchora® (Cholera Vaccine, Live, Oral), the only FDA-licensed vaccine for the prevention of cholera, a potentially serious intestinal disease, caused by Vibrio cholerae serogroup O1. The acquisition broadens the company’s development pipeline with vaccines that address adenovirus types 4 and 7, which are common causes of acute respiratory disease, and chikungunya, a viral disease spread to humans by infected mosquitoes that can cause severely debilitating joint pain. The acquisition also expands the company’s sales capabilities with a global specialty salesforce and marketing and distribution partners focused on the travelers’ market and establishes an international manufacturing footprint with European-based cGMP biologics facilities.

Pharma major Lupin announced that it has received tentative approval for its Lurasidone Hydrochloride Tablets, 20 mg, 40 mg, 60 mg, 80 mg and 120 mg from the United States Food and Drug Administration (FDA) to market a generic version of Sunovion Pharmaceuticals Inc.’s (Sunovion) Latuda Tablets, 20 mg, 40 mg, 60 mg, 80 mg and 120 mg.

Lupin’s Lurasidone Hydrochloride Tablets, 20 mg, 40 mg, 60 mg, 80 mg and 120 mg is the generic version of Sunovion’s Latuda Tablets, 20 mg, 40 mg, 60 mg, 80 mg and 120 mg.

The Food and Drug Administration approved or tentatively approved a record-setting 971 generic drugs in fiscal year 2018 that ended last month, the agency announced on Thursday.

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, 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 U.S., and the only CERSI to receive continuous funding from the FDA since it first launched in 2011. This latest renewal, which allows for up to $5 million per year over five years, will allow M-CERSI to continue its mission to contribute to modernizing and improving the ways in which drugs and medical devices are reviewed and evaluated.

Montgomery County is proving to be a premium address for the growing biotechnology sector. 

The BioHealth Capital Region, which includes Maryland, Virginia and Washington D.C., is ranked No. 4 on the 2018 list of top biopharma centers by Genetic Engineering & Biotechnology News (GEN). The cluster moves up from a No. 5 ranking in 2017.

GEN ranks regions nationally based on several factors, including National Institutes of Health (NIH) funding, venture capital investment, patents, lab space and jobs in biotech. 

Five consecutive quarters—and counting—of declining deal counts in pre-seed and seed-level investments for health technology startups in the U.S.

We're thrilled to announce Molly McCartin, Partner, Drive Capital, will be a featured speaker at the Fall 2018 Inova Discovery Series!

Molly McCartin is an investing partner with a focus on healthcare at Drive Capital, a venture capital firm based in Columbus, OH founded by two former Sequoia partners. Molly started her career at JP Morgan Chase in Equity Research. She then moved to 7Wire Ventures investing in healthcare companies that empower the health consumer. Molly spent the last four years at Livongo Health, helping the company grow from 6 employees to over 150 and over 200 customers. Molly graduated from MIT with a degree in Applied Math and Economics.

It’s cybersecurity month at Technical.ly and this new accelerator program is here to heat up the discussion.

There are lessons for other industries in the way pharma companies use mergers to innovate, work more efficiently, and bolster product portfolios.

Baltimore-based AgeneBio announced a pair of grants from the National Institutes of Health that will assist with clinical trials of a treatment to combat the progression of Alzheimer’s disease.

MaxCyte announced the first patient has been dosed in its Phase I dose-escalation clinical trial in the United States with the company's lead wholly-owned chimeric antigen receptor (CAR) therapeutic candidate, MCY-M11. The study is designed to evaluate MCY-M11, a mesothelin targeting CAR, in individuals with relapsed/refractory ovarian cancer and peritoneal mesothelioma.

However long a business has operated, investors will look for three big things if they are going to invest.

U.S. healthcare companies have collected $23.4 billion in venture capital funding this year — already surpassing the amount the sector obtained in all of 2017, according to a recent report from Pitchbook, which tracks VC investments.

The number of open innovation challenges in pharma grows by the day. But what’s driving them? That’s what Luminary Labs wanted to know. So the consultancy, which works with pharma and other industries to design and execute those kind of challenges, surveyed the executives at companies that run the contests and asked why and how they do it.

The first Biohealth Capital Region Investment Conference kicks off this week in Montgomery County. The conference marks an important inflection point for a region whose entrepreneurs have been calling for more active investment resources for years.  The event also fulfills a promise made by organizers at past BioHealth Capital Region Forums to bring more investment activity to the region.

Europe’s biotech industry recently celebrated its growth and progress with more than 120 events taking place across 18 European countries September 24 –30, in what organizers call “European Biotech Week.”

Biopharma venture capital activity maintained its red-hot pace during the third quarter of 2018, driven by a handful of deals exceeding $200 million, according to a report released this week.

This has been a year marked by many notable biotech deals, especially in the immunotherapy market.  One deal, in particular, has generated more local excitement in the BioHealth Capital Region than any other; that is the BeneVir acquisition by Janssen, a JNJ company.  Likewise, of the many startup stories and local entrepreneurs we’ve highlighted this past year, none is as unique and interesting as that of BeneVir Co-Founder and COO, Katherine (Katie) Sacksteder, PhD.

Johns Hopkins Center for Health Security authors recommend dedicated attention to and investment in 'potentially transformative' technologies to complement traditional approaches to prevention, preparedness, and response

The Center for Innovative Technology (CIT) announced today the Commonwealth Research Commercialization Fund (CRCF) Request for Proposals (RFP) for FY2019.

Some big cities could see shortages of cancer specialists in the coming decade, according to a new analysis by Doximity, a social network for more than a million physicians. Researchers at the company delved into the data on oncologists and found there’s an imminent wave of retiring physicians. The areas most likely to see shortages: Miami, Virginia Beach, and Tampa. But other cities could also see large portions of the cancer physician workforce retire relatively soon. In half of the 50 metropolitan areas surveyed, more than 20 percent of practicing oncologists are over age 65.

The local funding environment is mirroring the gangbusters national funding situation.

Valneva USA, the U.S. subsidiary of global vaccine biotech company Valneva SE, today announced U.S. Food and Drug Administration (FDA) approval of an accelerated dosing regimen for IXIARO® (Japanese Encephalitis Vaccine, Inactivated, Adsorbed), the only vaccine approved in the United States indicated for protection against disease caused by Japanese encephalitis (JE) virus.

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.)

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

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..

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.

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.

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

A 450-person gathering in Detroit’s Eastern Market this week made it clear Michigan sits at the intersection of development in the mobility space, Midwestern affordability and investor interest.

Alexandria Real Estate Equities chairman and co-founder Joel Marcus sit down with Bloomberg's Rebecca Spalding in Cambridge, Massachusetts.

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.

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.