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A Word from Jeff Gallagher, CEO, Virginia Bio It’s my privilege to travel the state and meet hundreds of companies, research institutions, and individuals who are doing fascinating innovative work and making valuable contributions to our economy and to the health and well-being of people around the globe. Every month in this blog I’ll take a short look at an outstanding member of Virginia’s bioscience community, or update you on important information that impacts the community.

 

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Lawmaking is in bloom in Richmond

Posted By Administration, Thursday, January 25, 2018
Updated: Thursday, January 25, 2018

Dear Members and Friends,

Let’s talk Public Policy.

Virginia.

The Virginia General Assembly has convened, and lawmaking is in bloom in Richmond.  The GA has a different balance and feel, after the startling results of the November election.  At this early point things feel more fluid, and we’ve not been shelled by volleys of polarizing bills from either side.   In one of the areas Virginia Bio prioritizes - economic development and the innovation and entrepreneurship agenda, there’s a sense of steadiness.  VEDP reform has rebuilt the confidence of policymakers, and there are many bills to strengthen that organization.  There appears to be agreement that the Governor’s consolidation of functions and organizations under the Secretary of Commerce and Trade is a wise direction.  Perhaps the parties are appraising their opponents.  Perhaps we are trying to lead the nation to a less confrontational public politics and policy.

In our close watch and work at the GA we are helped greatly by Scott Johnson and the team at First Choice Consulting.  We also draw on the expertise of public policy pros among our members, and the public policy staffs at our ally organizations BIO, PhRMA, AdvaMed, MDMA and We Work for Health.

Now for some specifics.  Last Friday was the deadline for filing new bills.  We’ve combed the 3,000+ bills introduced in House and Senate, and sifted to the ones we may track.  On our website you’ll find a table of those and our position to date.  Last week was the deadline for budget amendments, and relevant ones also are included on the table.

This Friday, January 25 at 10:30 am, we’ll have a webinar/open call on these bills and issues, and you are all welcome to join and provide your feedback.  Scott Johnson and I will lead the discussion, and we’ll look to hear from our members your opinions and priorities.

So far, on the priorities we track year to year, this seems like a level-flight session. 

Tax credits have been continued in Governor’s introduced budget at as-is levels, and we’ve seen no budget amendments nor legislation, introduced to reduce or impair them.  This includes the refundable R&D Tax credit; the (new) major R&D tax credit; and the Angel investor tax credit.  Similarly, funding for the Catalyst (Virginia Bioscience Health Research Corporation) was included in the Governor’s introduced budget at $3.75M/yr. for both years, and no budget amendments nor bills have been introduced to reduce that unique and effective grant program.  Nor is there any change to the authority or funding for the GGBRI (Global Genomics and Bioinformatics Research Institute).    

The wild card in all funding decisions, however, is the final determination, to be made late in the Session, of the amount of revenue in the budget. Under state law  this strictly limits the expenditures.  The Governor’s introduced budget includes significant revenue from Medicaid expansion, though it is uncertain that will become law. Moreover, this year projections of revenue based on tax receipts are especially difficult to make because of the significant recent changes in the federal tax law.

The two major new economic development programs created together two years ago, VRIC and GoVirginia, have developed cautiously and retain solid support of the Administration and in the General Assembly.  VRIC (Virginia Research Investment Committee) funding is continued at same level, and without significant legislative change, with a mission of accelerating and commercializing research at our research universities.  VRIC engaged outside consultants who just delivered a strategic report which suggested sharp changes in the state’s strategy, so look for changes in program priorities and operations to be considered, decided and implemented this Spring.  GoVirginia funding remains steady and attention is being directed at how to refine and improve the program, which aims to incentivize local economic development systems to work collaboratively with one another and industry to recruit and grow companies and high paying jobs.  

There have been a number of bills introduced to regulate in miscellaneous ways our industry.  These are usually unpredictable and unique, and we meet them as they come.  Bills we are tracking and speaking to at the GA now include (among many others) proposals:  to create a state “right to repair” digital electronic equipment, including medical devices; to legislate state level drug pricing data disclosure; to extend the statute of limitations on personal injury claims arising from drugs, and imposing state level cold chain requirements for prescribed drugs.   On our website we keep an updated table of these and other bills we are tracking, sponsors, issues, our position and status in the General Assembly, so that you can stay as informed as you like.

Federal

In Washington, a two-year extension of the suspension of the medical device tax was included in the tax package that ended the government shutdown earlier this week.  This is great news for our medical device members, and we were happy to add our voice to many hundreds from across the country to remind our Congressional Representatives of the horrible impact of the tax on US innovation and jobs.

For those of you interested in helping up present the case of the industry to our Congressional delegation and their staffs, there will be two opportunities in the coming months, when like minded people from across the US fly in and a coordinated day of lobbying.  We and our national ally organizations set up the meetings and provide briefings.   Visit our website for how to join me and others from around Virginia and the US on these important days:

                  AdvaMed Fly-In, February 27-28, for the medical device portion of our industry

                  BIO Fly-In, April 17-18, centered on the biological and pharmaceutical part of the industry, but extending to innovation and entrepreneurship

 

Please give me a call with any questions, or if you would like to become more involved

 

Best Regards,

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Appreciation

Posted By Administration, Wednesday, December 20, 2017
Updated: Tuesday, December 19, 2017

Dear Members and Friends,

 

Let’s pause to appreciate the hard and good work of members of our community across the state last year by taking a quick look at some 2017 headlines.  We celebrate the headlines, but appreciate the extraordinarily difficult, demanding, dedicated, important work that goes on every day in countless places to make such headlines possible.  Let’s share in the joy of the accomplishments of the people behind these headlines, and commit ourselves to help one another write more headlines for next year.  

 

AgroSpheres receives $750,000 Seed Funding; partners with Milenia Labs to expand international outreach. 

 

AMPEL BioSolutions creates multiple collaborations developing innovative approaches to assess and treat Lupus.

 

Aperiomics Raises $512k in Seed Funding to expand pathogen testing services.

 

             ATCC and One Codex partner to Address Microbiome Research.

 

Canon Virginia Inc Receives ISO Certification and Launches Medical Device Contract Manufacturing Services in Newport News.

 

Cavion Raises $26.1 MM Series A Financing and launches clinical trial in Essential Tremor.

 

CEL-SCI Announces $1.5 Million Offering of Shares, and fully enrolls pivotal Phase 3 head and neck cancer study. 

 

Ceres Nanosciences raises $3 Million in Series A Funding; receives DARPA award to adapt Nanotrap® and, with GMU, Tasso & USAMRIID receives $4.25M from DTRA.

 

             Contraline’s Kevin Eisenfrats makes Forbes’ “30 under 30”.

 

Cupron’s copper infused materials use widely expanded by Sentara HealthCare hospitals to reduce risk of infection.

 

Diffusion Pharmaceuticals moves towards Phase 3 Clinical Trial for lead compound for inoperable GBM brain cancer.

 

Focused Ultrasound Foundation Receives Transformative $10M Contribution.

 

  George Mason University scientists develop test to detect TB early.

 

  Granules Pharmaceuticals Inc. to expand manufacturing in Fairfax County.

 

Hemoshear Therapeutics and Takeda Pharmaceutical Company announce a multimillion dollar partnership to discover and develop novel therapeutics for liver diseases, including nonalcoholic steatohepatitis (NASH).

 

             HemoSonics is acquired by Stago Group for point point-of-care blood diagnostics platform.

 

IALR expands one of a kind library of endophytes in the plant microbiome; first license to Indigo Ag.

 

Iggbo to open health care locations in 40 major markets nationally.

 

             Illuminia Ventures raises $230M in First Fund.

 

             Indivior wins FDA approval for drug to fight opioid addiction.

 

Inova Personalized Health Accelerator accepts first company, Hememetics Biotechnologies, into investment portfolio.

 

ivWatch raises $14.8M; receives FDA 510 (k) clearance on device advancing the safety of IV therapy for pediatric patients.

 

Kaleo wins FDA approval of AUVI-Q® auto-injector for life-threatening allergic reactions in infants and small children; and donates epinephrine injectors to all U.S. public elementary schools

 

Landos Biopharma Raises $10 Million in Series A Financing.

 

LifeNet Health to Invest $12.25 million, create 321 new jobs in Virginia Beach.

 

Medicines for All Institute created with additional $25M Gates Foundation Grant to VCU School of Engineering to increase global access to life saving medicines.

 

Nutriati raises $10M for Chickpea protein product development.

 

             Owens & Minor acquires Halyard Health’s Surgical and & Infection Prevention Business.

 

             Perthera collaborates with Novartis on Clinical Trials for Breast and Lung Cancer.

 

             PPD expanding Vaccines lab in Richmond.

 

             Tear Solutions raises $8.5M series B financing co-led by VTC Innovation Fund.

 

             TechLab Receives FDA Clearance to Market Tri-Combo Parasite Screen.

 

The Virginia Catalyst (VBHRC) announces 7 Virginia research universities sign groundbreaking agreement to share resources to enhance collaborative research; and also makes + $3M grants to collaborative commercialization projects. 

 

  TypeZero partners with Senseonics and Roche on ‘Artificial Pancreas’.

 

  University of Virginia and Inova Health System fund first 9 joint research projects in their long term partnership.

 

  UVA Health System Plays Role in Cancer Moonshot Program

 

  VeneBio Launches Tool to Help Reduce Opioid Overdoses.

 

  Vibrent Health’s Precision Medicine SaaS Platform granted Authority to Operate (ATO) by NIH.

 

Virginia Beach Innovation Challenge launches with mission to seed 25 companies focusing on biomedical innovation impacting Veterans’ health.

 

Virginia Institute of Neuropsychiatry develops NeuroGage software to measure brain volume of high school athletes to detect injury.

 

             Virginia Tech Carilion Biomedical Research Institute Expansion holds ground breaking on $90M Project.

 

             Virginia Tech Carilion Innovation Fund formed and makes first investment.

 

             William and Mary iGEM team wins 1st runner up in global competition in synthetic biology.

 

At Virginia Bio, the staff and Board of Directors, led by the Executive Committee, have worked hard, too, this year, honored to play a part in helping this community accomplish its important work.  Together with collaborating organizations and financial sponsors, we conducted valuable programs and advanced strategic objectives.   Here’s a quick look.


Our invitation-only Virginia Reception at JPMorgan last January was a hit, battling snow and rain, and featured industry champion and BIO Governor of the year Terry McAuliffe.  Our members-only complimentary meeting rooms at the Clift Hotel provided just the right spot for special meetings. Darden Executive Education, UVA Licensing and Ventures, Cherry Bekaert and the Catalyst led the support for this showcase event. 


We held our statewide conference THRIVE 2017 in Virginia Beach in April, co-hosted by LifeNet Health, Williams Mullen, Sentara Health Care and Virginia Beach Economic Development.  The community gathered 350 strong to meet new sources of private funding across Virginia, and national leaders of research and development for Veterans and military personnel, and the EVMS/Sentara collaboration with IBM Watson.

Women Building Bio grew in its second year, led by outstanding women in the industry and academia in Virginia, and supported by top sponsors GMU, VCU, UVA Health System and Virginia Bio + Tech Park.  We gathered hundreds of outstanding women and men again at Inova Center for Personalized Health to inspire, inform and weave a network of relationships to build the state and regional ecosystem. 


Bringing Data to Life was the Innovate conference we co-hosted with Dulles Regional Chamber of Commerce, Vibrent Health and Inova Center for Personalized Health.  We gathered for the first time the rapidly expanding and diverse community of companies and researchers in the region working in digital health to take the first steps in forming a network of excellence around critical common problems and significant opportunities. 


The BioHealth Capital Region Forum once again brought together nearly 1,000 leaders from industry, academia, government, investment and health in Virginia, Maryland and DC to encourage our development into one of the nation’s “top 3 by 2023” bio regions.  We again co-hosted this important event with BioHealth Innovation, Paragon Bioservices, University System of Maryland and Inova, under the extraordinary leadership of co-host MedImmune at its Gaithersburg, MD headquarters.

In the Insights series we brought national leaders to Charlottesville to meet industry and university leaders, students and community members on Grounds at our co-host the i.Lab, and with the support of the Virginia Catalyst, CSC Leasing, Cherry Bekaert and Finnegan.  
 

The two webinar series we produced were greatly appreciated by the audiences, for practical information easily within reach - one on Intellectual Property Protection and, more recently, on Cybersecurity for bioscience companies.  These are archived for members on the Virginia Bio website.

The BioPurchasing program saved Virginia Bio members $9.6M over the last 12 months. 

We arranged for the consulting firm G2G to provide at no cost to our members insightful comprehensive monthly bulletins on recently announced opportunities for nondilutive federal funding. Many members identified valuable opportunities of which they were otherwise unaware.  

Networking and education events were produced across the state -  at the monthly Biotech Commercialization luncheons in Richmond, the Southwest Virginia LifeScience Forum, “Biotech and Beer” networking events at many spots, and bioscience executive luncheons throughout Northern Virginia.

Finally, Virginia Bio and the lobbyist we engaged, First Choice Consulting, worked hard to represent the industry before policymakers in Virginia year round and during the General Assembly, and Virginia Bio worked with our national partners BIO, AdvaMed, MDMA, PhRMA and We Work for Health, to represent our interests before the US Congress and federal policymakers

Special thanks to our Premium Sponsors.  They provide an elevated level of support throughout the year, which enables us to do everything we do, and to do it better.  They are:  Cooley LLP, Piascik CPA, Lilly, Pfizer, VWR, Xenith Bank, Prince William County Economic Development, Medimmune, the Virginia Bio+Tech Park, the Institute for Advanced Learning and Research, Cherry Bekaert, Vibrent Health and the Virginia Catalyst.  

Thanks, too, to our Board of Directors and Executive Committee, and to our terrific staff.  For the first time in seven years we added a position this year, when Cassandra Isley joined us as Director of Business Development and Strategy.  With Sherri Halloran and Caron Trumbo, and our part time bookkeeper Stephone Jones, the team gets an awful lot done.  They bring a passion for the ultimate mission, and great affection for the people we get to deal with on a daily basis. 

As I travel across the region and the country and return home, I am reminded again and again of the spirit of collaboration, the goodwill and the sense of purpose which animates the community of people in our industry in the Commonwealth.  Over time I have come to appreciate that these are our strongest winds, pushing us to make the best headway we can each on our important journeys, to help patients, customers and folks across Virginia and around the world who are waiting for the fruits of our labors.    


Merry Christmas, Happy Holidays and Happy New Year.

 


 

Tags:  #biotech #2017inreview 

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Hitting the pavement for our members

Posted By Administration, Thursday, November 16, 2017

Dear Members and Friends,

One of the missions of Virginia Bio is to lead, and sometimes that means identifying big opportunities for our members and the state and put our shoulder to the wheel.   Let me share a few.

Last week, it was my treat to serve as MC for the VCU School of Engineering’s first Medicines for All Summit, bringing together industry, academic researchers, global public health experts from across the nation and world to Richmond, to spark the collaborative work of the M4All Institute, recently formed with the support of the Bill and Melinda Gates Foundation.  By re-engineering the chemistries and manufacturing processes by which small molecule pharmaceuticals are made, M4All is already making an impact on the price and distribution of one major global public health drug – an antiretroviral, with more in the pipeline, and also holds the promise of significantly reducing the cost and barriers to entry to the generic drug industry, improving access to medicines for all.  The technology opens the possibility for entirely new modes of manufacture, and could seed a cluster of innovative companies in the region.

This Wednesday, we were honored to co-host a conference on Digital Health “Bringing Data to Life” along with Vibrent Health, Inova Center for Personalized Health and Dulles Region Chamber of Commerce.  150 attendees heard from a wide variety of companies and university researchers, as well as NIH and NSF funders working in this emerging area. It was the first small step toward a vision of gathering all the considerable strengths in Virginia, DC and Maryland in this hot space, and perhaps creating a Center or Network of Excellence to work together on solving the toughest challenges and pursing opportunities no one company or university can pursue alone.    

Several weeks ago, at the invitation of Virginia Beach Economic Development, I gave remarks at a symposium at the Oxford Biotech Network on the occasion of their Annual Dinner, “Doing (Bioscience) Business to the United States”.  My conversations during my visit opened my eyes to a commonality of strategies among English companies - if not European companies broadly:  they all plan on crossing the pond at some point to establish a US presence to access the US market, and that provides opportunities to Virginia. I applaud the Virginia Beach team for their vision, and the relationship they’ve built with OBN.        

Switching gears to state economic development policy, I’ve lent a hand over the last six months on the Region 4 GoVirginia Foundation Board and the Virginia Research Investment Fund project evaluation team to help build up the systems and processes for these new and significant economic development programs impacting our industry, and to help connect them throughout our community.  Lesson learned:  its’ not easy to stand up a new state program.  I am hopeful these two programs will thrive.  Further reflecting on this fact gives me renewed gratitude for the accomplishments of VBHRC over four short years.

Finally, in a different vein, Cassandra Isley on our team has been working closely with our new member Canon Virginia, Inc., which is undertaking a large expansion of its medical device CMO work in Newport News, to help them connect to members across the state.  We wish them the best, as the realization of their plans will be a strong addition to that region, and to the medical device industry across the state.

If you see major opportunities to grow bioscience R&D and commercialization in Virginia that you don’t think we are aware of, please let us know and we will do our best to help in any way we can.


Best regards,

 

 

 

Jeff 

Tags:  #biotech #m4all #innovateconference #vabeachbio 

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Reasons to Celebrate

Posted By Administration, Monday, October 23, 2017

Dear members and friends,

“Life should not only be lived, it should be celebrated.” Especially in our industry, perhaps, where so many people work so hard, so well and so long to move ahead our communal progress in fighting disease, promoting health, feeding and fueling the world.

If you followed our news stories this past month you would have read some great reasons for celebration of all kinds of bioscience companies across the state. The news was great for these drug and device development companies themselves, also for the many suppliers, professionals, CROs who work with them, for the people they will hire, and of course for the patients and customers we all serve. And as it takes success to build success, these stories help build the momentum and the story of the vibrancy and diversity of bioscience R&D and commercialization in Virginia to the benefit of our entire community.

Landos BioPharma in Blacksburg closed a $10M Series A funding, led by a NY life science investment firm. It’s focusing its unique technology on autoimmune diseases, beginning with a unique — and potentially more effective — way to treat Crohn’s disease. The technology has roots at Virginia Tech, as does CEO Dr. Josep Bassaganya-Riera.

Ceres Nanosciences several months ago closed an $8M Series A investment round, and in the last weeks announced it is part of a team including George Mason University (and its National Center for Biodefense and Infectious Diseases), which received an award of $8M from Defense Threat Reduction Agency (DTRA) to extend Ceres’ NanoTrap technology platform to develop an effective disease surveillance platform that can be rapidly deployed in the field, operated by untrained users, and improve early response. This technology, too, has roots at a Virginia university - George Mason University.

Aperiomics, Ashburn, Virginia, announced the close of a half-million-dollar seed funding round led by Pipeline Angels, a national network of new and seasoned women angel investors. Aperiomics, a biotechnology company that saves lives by harnessing the power of deep next-generation sequencing to identify all known pathogens (bacteria, virus, fungi or parasite) in a single test. Technology and talent at George Washington University’s Virginia Science and Technology Campus was the seed for this company, led by CEO Crystal Icenhour.

Finally, Hemoshear Therapeutics in Charlottesville announced a partnership with Takeda Pharmaceutical to discover and develop novel therapeutics for liver diseases, including nonalcoholic steatohepatitis (NASH). HemoShear will receive upfront payments and R&D funding and Takeda will receive exclusive access to HemoShear’s proprietary disease modeling platform to discover and develop best-in-class therapeutics for specific liver diseases. Yes, this technology originated at UVA.

We are privileged at Virginia Bio to know the people who comprise and lead these companies, proud they are Virginia Bio members and delighted to be able to help them in their important work. We’ve watched them over the years and have seen their perseverance, good will, the ability to evolve strategy - even to pivot if needs be, a bedrock pursuit of great science, a distinguishing technology, continual awareness of the ultimate need for and beneficiaries of their work, perseverance (but I repeat myself), and 101% commitment.

“Celebrate what you’ve accomplished, but raise the bar a little higher each time you succeed,” advised another quote.

Let’s go!



Jeff

Tags:  #biotech #landos #ceres #aperiomics #hemoshear 

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Women Building Bio Conference Next Week

Posted By Administration, Thursday, September 21, 2017
Updated: Thursday, September 21, 2017

Dear Members and Friends,

The Women Building Bio: the XX Factor conference is like no other, and it’s upon us: next Tuesday, September 26, all day at the Inova Center for Personalized Health in Fairfax, VA. Register now!

We expect 300 women and men to attend and participate. For those of you who attended last year’s inaugural event, you know the special vibe. Attendees from across the state and region are eager to meet and learn about one another. Come make many new contacts, and plant the seed for friendships and future collaborations. There’s plenty of time built in to network.

Download the App now, and learn about the 40 outstanding women featured on the program, and see who else is already registered to attend.
Hear outstanding leaders in science, business, government, philanthropy engage in insightful discussions on recent developments and trends, and share tips on personal professional development.

A new program element this year, features several presenters whose organizations and programs enable you to plug in, get training and take action all year round. We’re featuring experts at training women for the boardroom, mentoring and accelerating your startup, making your voice known via automated mobile technology when it counts on issues that matter to you to policymakers, and designing with sex and gender in mind.

The program also features inspiring pairs of mentors/mentees share their journey, illustrating the grace and vision of the mentor and the talent of the younger generation just waiting to be nurtured and unleashed. You will be amazed.


Have some fun with us that day, too. We’ll end the day with two-hour reception in the lovely atrium. And share the event on social media as it unfolds. Last year we trended as the number two topic in Greater Washington, DC. This year let’s make it to the top! We’ve got a prize to the number one tweeter. Please use #XXfactor2017 for all your posts!

Many thanks to our host Inova, and our sponsors George Mason University, Virginia Commonwealth University, Activation Capital, University of Virginia Health System, AstraZeneca/MedImmune, BIO, Pfizer, Vibrent Health, Virginia Tech University, Silverline Communications, William & Mary, Cherry Bekaert, Greenberg Traurig, LifeNet Health, HHMI Janelia Research Campus, Merck, Sanofi, UVA Licensing and Ventures, iGIANT and Prince William County.

 

Best Regards,

 

 

Jeff

 

Tags:  inova  virginia bio  women in science  womenbuildingbio  xxfactor 

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Cybersecurity for Biomedical Companies

Posted By Administration, Thursday, August 17, 2017
Updated: Wednesday, August 16, 2017

Dear members and friends,

The biomedical industry is increasingly taking note of the risks and costs of cyberattacks. In late June, a number of biopharma companies, including a global industry giant, were hit by a well-publicized worldwide hack. The companies were denied access to data as ransomware demands flashed on their screens, and they were exposed to the risk of exposure of proprietary and competitive scientific and commercial information.

Closer to home, some of you may remember that last Spring my own email address list was hacked, despite protection on my office computer, and certain addresses used as the basis of a phishing scheme.

We asked around, received recommendations, interviewed folks, and ultimately engaged BlueStone Analytics of Charlottesville to provide a cybersecurity assessment and implementation plan to Virginia Bio. The firm has similar work for some of our member companies.

The firm undertook a series of interviews with staff, inspected our hardware and work patterns, preformed a dark web threat intelligence collection, a vulnerability scan of networks and a security architecture review, launched a simulated attack on our system, and finally prepared and delivered to us a Cybersecurity Assessment Report on the first of August.

Most importantly, the firm’s report contains a Security Action plan, which lists nine specific recommendations and additional options to improve our security, encompassing not only the computers and network in our office, but also our mobile devices and cloud based support.

The first seven items were highly recommended, and I am pleased to report all seven recommendations we have completed or are underway. We have implemented universal two-factor authentication (2FA) for all staff, we have changed the passwords on printers and other peripherals which are an attractive opening for cyberattacks; we have installed uniform end-point protection for all devices, we have resumed a practice of regular and systematic data backup; we have turned on device encryption on our mobile devices, and all staff have begun use of Virtual Private Network (VPN). All staff also have started a course of cybersecurity training which will span several months.

The above recommendations have been implemented for all devices used by all four Virginia Bio employees. In the FY 2017/18 budget recently approved by the Board we budgeted for these and other improvements. We believe we owe this to our member companies and to the industry at large. If you have questions about the tools or software we’ve used and our experience with them, please contact Sherri Halloran.

We’ve asked BlueStone Analytics to help us put on a series of webinars in the Fall focused on cybersecurity for startup and scale-up bioscience companies, and access to the webinars will be made available to members free of charge. We will invite you to join the webinars, become aware of the risks and learn about steps you can take to significantly reduce the risk, so watch for an invitation in the coming weeks.

Best regards,

 

 


Jeff

Tags:  bluestone analytics  cybersecurity  hacking  intelligence  phishing  virginia bio 

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Virginia Bio Sets Plan and Goals for the New Term

Posted By Administration, Thursday, July 20, 2017
Updated: Thursday, July 20, 2017

Dear members and friends,

I’m writing from a hotel room in DC, about to spend the day on Capitol Hill visiting Virginia Members of Congress or their staffs to lend our voice in support of timely passage of the FDA Reauthorization Act, including PDUFA and MDUFA, BSUFA and GUFA, to put in place continued funding and continuing improvements in FDA before current authorizations expire. The FDA Reauthorization Act passed the House last week, and the Senate is considering whether to take it up.

Please write our senators urging them to take the FDA Reauthorization bill up quickly and pass it as is. The Senators’ health legislative assistants are: Marvin Figueroa (Senator Warner)  and Kristen Malloy (Senator Kaine).

July brings a new year to Virginia Bio, embodied in a plan and budget forged by staff and our Board of Directors in which we set priorities and goals, and plan our programs and events for the year ahead.

One area of change in the year ahead will be in our public policy efforts, state and federal, and is designed to enable greater engagement by our members directly and through Virginia Bio, thus greater effectiveness in representing our industry.

We are excited to be implementing a tech-enabled way for our members to interact with their elected representatives in a quick, timely and informed way on issues. This is the BioAction policy messaging system developed by BIO and provided to us for the use of our members at no cost. It’s an integrated mobile and social media tool, which allows individuals who choose to sign up to receive updates on federal policy issues, to access background information, and to quickly and easily message their representatives via text, tweet or email their position on the issue. In May we sent Members an email with information on how (it’s easy) to get involved, and we will be working with BIO to incorporate into the BioAction platform coverage and support of pertinent Virginia state policy issues as well. For those of you who want to be engaged, this will be an extraordinary tool. Join this effort now!  

We also will be revamping our Virginia Bio state public policy web pages to make them an up-to-date and ready source of concise information on key policy matters impacting the industry. We will draw from a wealth of information from our federal allies BIO, PhRMA, AdvaMed and MDMA and We Work for Health. A very talented University of Richmond senior will intern with us for the year to help collect and summarize and keep the website concise, informative and up-to-date, and issue alerts when needed.

In Virginia, we’ll provide new and purposeful opportunities for our members to interact with members of the General Assembly. During the Session, we’ll hold a series of Bioscience Caucus coffees at the General Assembly during the day. Each event will be themed, and leaders of companies and members of the industry from, for example, a geographic region or an industry sector, will be featured. Legislators and staff, and administration staff, will be invited to drop by; we’ve learned this is far more practical for them and creates a greater impression of presence. We’ll also schedule one or more days during the Session to invite members to Richmond and help them schedule visits with their delegates and Senators, creating a “Capitol Hill Day” for the industry. And we’ll forego our traditional reception and dinners in Richmond because changes in gift laws over the past several years have caused legislators to avoid such events.

Finally, the Virginia gubernatorial election occurs November 7. We have invited the two major candidates Ed Gillespie (Republican) and Lt. Governor Ralph Northam (Democrat) to meet and hear from our members and the bioscience community in a number of different forums over the next several months, and will send out alerts and invites as they are scheduled.

Please contact me if you’d like to be specially involved in our public policy work.

Best regards,



Jeff

Tags:  bioaction  gubernatorial election  virginia bioscience 

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Healing our heroes – getting down to work

Posted By Administration, Wednesday, June 21, 2017

Dear Members and Friends,

 

Just a few feet in front of me, a highly articulated gleaming metal hand and wrist was mounted on a busy workbench, and moving fluidly through a series of strikingly natural gestures. My eyes were drawn to two thin wire leads issuing from it, snaking across the bench and affixed by skin patches to the forearm of a young man, and then i realized - as he moved his hand of flesh and bone, the prosthetic hand on the bench moved as one.

I was midway through a tour of several of the many research labs at McGuire Veterans Administration Medical Center in Richmond, one of the top tier of the many hundreds of Veterans Health Administration facilities nationwide. The tour was graciously arranged by the Director of McGuire VAMC, John Brandecker.

In a flash, I understood in a way that I had not before the depth and breadth of research at McGuire VAMC, and by McGuire researchers at nearby Virginia Commonwealth University where most have joint faculty appointments. Hundreds of clinical trials are underway, both intramural and with external partners, and innovations are being generated in labs and clinics. In one lab, researchers are undertaking funded studies advancing new developments in restoring movement after spinal cord injury using exoskeletons muscular manipulation and electrostimulation of the spinal cord. In another lab, they’re developing Bluetooth enabled control of prosthetics with brainwaves. They’re developing innovations in surgical procedures and cancer therapy.

VA clinicians and researchers tackle biomedical issues unique to Veterans, but they also push advance research and care in health and wellness which their 9 million patients share with the rest of us - cardiac, diabetes, cancer and neurological disease, to name a few.

As I hope you know, Virginia Bio has made a commitment to help our companies and researchers understand the needs and ongoing work in research in the Veterans Administration, with the goal of creating new opportunities for growing our industry and helping our heroes. To do this right, one needs to know not only VA leadership and the exciting national programs and opportunities, but also what’s going on at the facilities across the country. That’s why I was touring McGuire VAMC.

And that’s why we are planning new and different ways to introduce the researchers and leaders at the VA system in Virginia and nationally to companies, scientists and clinicians around Virginia. Already our Medical Device CEO roundtable is exploring a quarterly meeting at McGuire, and we are planning ways to move this ahead. Look for more opportunities ahead.

We are moving ahead on our commitment in other ways, as well. On September 26 at our Women Building Bio conference, hosted at the Inova Center for Personalized Health in Fairfax, Dr. Rachel Ramoni, Chief Research and Development Officer (CRADO) of the Veterans Health Administration will be featured on the program. Dr. Ramoni oversees the VHA’s $1.6B research enterprise, encompassing groundbreaking national programs like the Million Veteran Study, as well as multicenter trials for industry. Women Building Bio will provide the opportunity to 350 leaders, women and men, from across Virginia and the near abroad of DC and Maryland, to understand and become engaged in that important work.

I’m writing this from a sidewalk table outside a Subway restaurant in (humidity free) San Diego at the BIO convention. Yesterday, I attended a press conference here at BIO announcing the Virginia Beach Innovation Challenge to this international gathering. The City of Virginia Beach has partnered with the Center for Advancing Innovation to create a long-term program to identify technologies, assemble startup teams and plant 20 startup companies focused on breakthroughs impacting Veterans’ health. We look forward to helping this great and novel way to harness the power of biomedical science and innovation for focused economic development and helping our heroes.

Lastly, remember that Virginia BIO has engaged a consultant expert in federal nondilutive funding for bioscience. Early each month, we post on our website for members only a report containing dozens of new opportunities issued by the National Institutes of Health, NSF and DARPA, among others, and importantly including DOD and the VA. I encourage our members to calendar a 15-minute date with the new list early every month to quickly determine if any opportunities align with your work, and if you are not a member to join now and enjoy access this valuable member benefit.

We’ve made a commitment, and now we’re working it. It’s a great opportunity for growth and development for biomedical science and industry in Virginia, and a great opportunity to make a difference in the lives of our military and Veterans and their families. Please let me know of your ideas to move this ahead successfully.

Best regards,

 

Jeff

Tags:  #veterans #vamedicalcenter #g2gconsulting #biotech 

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Remembering a Great Man and Great Biotech Leader with Virginia Roots

Posted By Administration, Wednesday, May 17, 2017
Updated: Wednesday, May 17, 2017

Dear Members and Friends of Virginia Bio,

 

Today I mourn the loss of Henri Termeer –  a mentor and a friend for over twenty years.  Henri was a passionate advocate for patients and the industry he helped to create. He inspired hundreds – if not thousands – of entrepreneurs with his drive and enthusiasm. That sparkle in his eye that caught your attention and that famous grin that drew you to him, made him eminently likable and inspired you to be your best.  Simply put, Henri Termeer changed the world.

 

While we often group Henri Termeer, Genzyme, and Cambridge in the same sentence, the roots of Henri’s business success were actually formed in Virginia.  In 1971 Henri arrived in Charlottesville from his native Netherlands to attend the University of Virginia’s Darden Business School. Like many immigrants, Henri came to America to learn business and to participate in Teddy Roosevelt’s great narrative of “the arena” of men working to make the world a better place. Termeer’s growth into one of the greatest biotech leaders in the industry started in the classrooms of UVA and with a relationship he later formed with another UVA graduate, Sheridan Snyder. Snyder had formed Genzyme a mere 18 months prior to Henri’s joining as President in 1983.  From a small shop in a warehouse next to Tufts, Termeer created a company that helped dying children, employed thousands, and eventually created fabulous wealth for its employees and shareholders when it was sold for $20 billion in 2011.

 

Henri was kind and generous with both his time and money. I will never forget the day I told him 12 years ago that I was leaving UVA to set up a pharma company. He was genuinely excited for me. We were fishing off the coast of Nantucket with his son Nick when he said to me, “Building a company that truly helps people is like running a marathon – it is hard, it takes discipline, and it takes time. It is not a sprint, Andrew. So, you now have just picked out a pair of sneakers!” Over the years, he encouraged me during my marathon. He would always take my calls or make time to see me at JP Morgan or on his many trips to Charlottesville for a Darden Board meeting. He was unfailingly generous with his resources; he introduced me to his team at Genzyme and helped me secure my first partnership to screen compounds.  On another occasion, he told me something I needed to hear and that I'll never forget, to “focus relentlessly on the patient, and that will make everything clear"  this was not a suggestion, but a commandment. I also saw his generosity displayed in remarkable philanthropic gifts.  In a world of big venture capital, staggering IPOs, huge acquisition deals and other remarkable liquidity events, but not always advancements of remedies for patients, I have tried to follow Henri’s words and actions to take the time to build my company properly by focusing first on helping patients and letting the financial piece come second.

A great hallmark of Henri’s success was his persistence and sound judgement.  A few years ago, I was struggling with raising capital and trying to figure out what I was going to do to keep the company moving forward. It was hard as I contemplated the company’s strategy: should I give up on my work in the orphan-indicated brain cancer space or stay the course?  Henri reminded me, with a hearty chuckle, of the time he was nearly out of money and desperately flying around in a small plane with a very pregnant researcher who was also the mother of a Gaucher’s Disease patient trying to get the next raise closed. Or the time when the data from a Gaucher’s Disease clinical trial said enzyme replacement therapy did not work as a therapy.  Henri’s solution was to gather 8 MIT professors to figure out if it was a dosing problem. Having heard their response to give up, Henri ended up ignoring their advice and went back and re-ran the trial –  properly – and it worked. Like Churchill, Termeer never, never gave up!

Thank you, Henri for your generous spirit and friendship. And thank you for instilling confidence in me that I am the only person who could change the course of a disease’s history. He would say, “Andrew, if not Cavion, who will do this? Who then?”  As Henri took his valuable time to help and encourage me, I learned from him what a big difference a conversation can make.  We all model ourselves after great leaders and the thing I took from Henri was to make it a point to be open to answer calls and share thoughts with starting-out, startup CEOs and colleagues. In fact, this is why I love my involvement with Virginia Bio: there are so many people who are willing to work with their colleagues (and the next generation) and to remind them to always put patients first. To all the Virginia CEO’s and entrepreneurs, Henri would be thrilled with your work and would encourage you to figure out how to make your science and company work for the benefit of patients.

 

May Henri’s soul rest in God’s tender mercy and may his legacy continue to inspire the next generation of entrepreneurs here in Virginia and beyond.

 

If you would like to read an oral history of Henri Termeer, please click here.

 

Best,

 

 

Andrew Krouse
President and CEO of Cavion, Vice Chairman of Virginia Bio.

Tags:  #biotech #genzyme 

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Thank you!

Posted By Caron Trumbo, Thursday, April 20, 2017
Updated: Wednesday, April 19, 2017

Dear Members and Friends,

 

From all of us, thank you for making THRiVE 2017 a huge success.   Wow and Phew! 

 

It was a great team effort – and our team is way bigger than the four of us on staff.  We had five terrific co-hosts anchoring us firmly in Virginia Beach / Hampton Roads.  We had more than 20 sponsors and exhibitors, 37 different experts and leaders from across Virginia and beyond on the program, and 250 in attendance.  Heartfelt thanks to all.

Not storm, nor tornado warnings, nor hotel evacuation alarm, could deter this group! We even ended the day with a beautiful rainbow over the oceanfront.   

 

Presentations of the day and lots of photos are available on our website and through the event app

 

Throughout the day, there were several exciting announcements. During his welcoming remarks, Virginia Beach Mayor Will Sessoms, announced the launch of the VABeachBIO Innovation Challenge, the first of it's kind in the country. The challenge will center around inventions to improve Veteran healthcare.

 

The Virginia Bioscience Health Research Corporation, aka The Catalyst also announced that applications are open for Round 7 of grants to fund the development, validation and application of new approaches to diagnosing, preventing and treating neurological conditions, including brain injuries, brain developmental disorders, neurodegenerative disorders, neuropsychiatric and behavioral disorders, as well as addiction and substance abuse.

 

 

We thought you’d enjoy a few comments we’ve received from attendees.

 

“Thrive 2017 was one of the more valuable and productive conferences I’ve attended in the past year. The quality and relevance of the panel speakers was very well matched to the needs of the VaBio community. The accessibility of the conference speakers was great – the format of the conference allowed for meaningful conversations with the speakers and it allowed me to uncover new opportunities and identify new collaborators and potential funding sources. Of course, the enthusiasm and camaraderie from the other VABio members was the best part – a really great forum for reconnecting and discussing collaborations with other members. Finally, the quality and comfort of the venue, the accommodations, the food, the receptions, etc. was exceptional. Overall, a very big return on investment of time and expense to attend.” 

 

“One high-powered conference….”

 

“Thank you, so much, for a fabulous event this last week!  Thrive was a huge success and I benefited on many levels.  This was my first Virginia Bio event.  I have a number of new contacts and my plate is full making sure that I follow up expeditiously.  I look forward to the next event and appreciate your efforts to ensure the healthy growth of Virginia as a bio-tech hub for the nation.  You all are a great team and I am glad to know you.”

 

“Great balance of science and business and fun….”

 

“Thrive 2017 achieved the vision Virginia Bio talked about: an event to celebrate, connect and educate our community of entrepreneurs, academic researchers, companies, investors and healthcare providers.  The evolution of Virginia-based funding sources and the inclusion of the VA/VHA and USAMRMC signify strategic options for companies to build partnerships and secure capital.  The chance to celebrate the ongoing success of our peers in this community was fantastic.  I am reminded of the power of the people in this community and our ability to help each other in many ways.  Wow.  Thank you!!”

 

If you were there with us, thanks!  If not, become involved and experience the power of the people in this community to help and to lift up one other. Building the time into your busy schedules to make one of our upcoming events, like Women Building Bio; the XX Factor conference on September 26 in Fairfax.

 

 

Best regards,

 

Sherri Halloran

Cassandra Isley

Stephone Jones

Caron Trumbo

Jeff Gallagher

Tags:  #biotech #thriveinva #thankyou 

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