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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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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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What’s up with “Nano”?

Posted By Administration, Wednesday, December 16, 2015
Updated: Wednesday, December 16, 2015
Members and friends of Virginia Bio,

I loved the book “Don’t Sweat the Small Stuff.” But in bioscience innovation and commercialization, don’t diss the really small stuff. It’s called “Nano” - Nanoparticles, nanotubes, nanosurfaces. And it’s big.

What’s up with “Nano”? First of all, materials can have very different properties and function in unique ways when structured at the nanoscale. When particles are created with dimensions of about 1–100 nanometers (where the particles can be “seen” only with scanning electron and atomic force microscopes and the like) the materials’ properties change significantly from those at larger scales.

Quantum effects rule the behavior and properties of particles, and in this size range properties such as melting point, fluorescence, electrical conductivity, magnetic permeability, and chemical reactivity change as a function of the size of the particle. Nanoscale gold particles, for example, change significantly from those at larger scale, and that can be put to practical use: nanoscale gold particles selectively accumulate in tumors, where they can enable both precise imaging and targeted laser destruction of the tumor by means that avoid harming healthy cells.

Nanoscale materials have enormously larger surface areas than similar masses of larger-scale materials. A cubic centimeter solid has a surface area of 6 square centimeters. Fill that same volume with 1-nanometer-sized cubes—1021 of them, each with an area of 6 square nanometers, and their total surface area comes to 6,000 square meters - bigger than a football field.

Now add in the observation that nature has perfected nanotechnology - most biological processes occur at the nanoscale. The diameter of hemoglobin is 5.5 nanometers, and a strand of DNA about 2 nanometers.

With this, one can begin to imagine why there’s excitement that nanowires, Bucky balls, gold nanoparticles, even nanobots can make unprecedented contributions not only to medicine, in the design of tools, the discovery and development of treatments and therapies, but also to environmental and agricultural challenges the facing the world in the coming decades.

The federal agencies of public sciences are on to it. NIH has a Nanomedicine Program and an NIH/NCI Alliance for Nanotechnology in Cancer, and its website provides a good overview of the science and biomedical applications. NIST has a separate Center for Nanoscale Science and Technology (CNST), and NSF, too, has a Nanoscience Project.

In our state, the Virginia Nanotechnology Initiative (VNI) is a statewide consortium of Virginia's universities, federal labs, state agencies, and industrial partners, dedicated to promoting collaborative nanotechnology research, workforce development, technology transfer and commercialization. Established through seed funding from Virginia's Center for Innovative Technology (CIT), VNI goals include building a "nanotechnology community" in Virginia and placing the state in the forefront of nanotechnology research and innovation. 

A quick (and incomplete) tour around the programs and centers at our universities and colleges includes the following:

• College of William and Mary – The Department of Applied Science works in Nanostructures & Thinfilms, and has the Nanomaterials and Imaging Lab.

• George Mason University - The Mason Nanotechnology Forum has developed a Graduate Certificate in Nanotechnology and Nanoscience, and the Mason Nanotechnology Initiative opens a space for discussion and planning to nanoscience and nanotechnology across the university.

• Old Dominion University – The Xu Group performs cutting-edge research on bio- and nano- technologies and ultrasensitive analytical methodologies to address fundamental and practical questions in chemical, biochemical and biomedical research.

• University of Virginia - multiple resources and centers dot the grounds. The Institute for Nanoscale and Quantum Scientific and Technological Advanced Research (nanoSTAR) is a dedicated, multi-disciplinary team striving to advance research & development at the nanoscale, working in nanomedicine, nano and quantum electronics, and energy/environment through partnerships with academia, industry, and national laboratories. NanoSTAR programs, including Seed Grants and the Spring Symposium. Researchers are spinning out companies, including CIT grant recipients. The Center for Nanoscopic Materials Design (MRSEC) and the Nanoscale Materials Characterization Facility provide important and cutting edge resources for the university and collaborators. UVA School of Engineering and Applied Science’s departments of Materials Science and Engineering and Biomedical Engineering have formed a program in nanomedicine.

• Virginia Commonwealth University – offers a Ph.D. in Nanoscience and Nanotechnology in Departments of Chemistry and Physics, and at the School of Engineering the Biomedical Engineering Program includes the NanoMedicine Lab and the Nanomaterials Core Characterization Facility.

• Virginia Tech - Core resources on campus include the Micro and Nano Fabrication Laboratory and the Nanoscale Characterization and Fabrication Lab (NCFL). Other foci are the Advanced Materials Group, Center for Sustainable Nanotechnology, the Nano2Earth Project and NanoBioEarth Research Group. Virginia Tech recently won a spot in the National Nanotechnology Coordinated Infrastructure (NNCI) a five year National Science Foundation award to focus on the interactions of nanomaterials the soil, water, air, and biological systems. Translational Nanomedicine is explored by the Fralin Life Sciences Institute, ICTAS and Virginia Tech Carilion Research Institute (VTCRI). At the Wake Forest Virginia Tech School of Biomedical Engineering and Sciences, Nanomedicine & Nanobioengineering provides a center of bioresearch at the nano level. Virginia Tech also offers a B.S. in nanoscience.

• Virginia’s Community Colleges offer a half dozen courses in nanotechnology and nanomaterials. And Virginia public schools have nanotechnology in their sights as well. October is “Techtober” in Virginia, and this year the National Nano Initiative, MathScience Innovation Center, and Virginia Department of Education partnered to offer a Web meeting for teachers to explore “Nanotechnology: Applications, Educational Pathways & Resources. Click here to see a nice video from the meeting.


Statewide an increasing number of companies, big and small, are putting nanoscale discoveries to use in areas from therapeutics to diagnostics, biosensors, synthetic biology, regenerative medicine, medical devices, environmental resource remediation and treatment, and agricultural use.

It’s hard to say “think big” with Nano; perhaps it’s think differently, use your imagination and be open to big improvements in bioscience innovation and commercialization.

Best Regards,



Jeff Gallagher
CEO

Tags:  nanoparticles  nanotechnology  ODU  University of virginia  UVA  VCU  Virginia bio  virginia bioscience  Virginia Tech  William and Mary 

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Family Funds Investing in Bioscience Innovation

Posted By Administration, Thursday, November 19, 2015
Updated: Monday, November 16, 2015

Members and friends of Virginia Bio,

It was a family fund that fifteen years ago provided my startup specialty pharma company with its first capital. The scion of a wealthy East Coast family some years prior had received an experimental drug in a clinical trial that halted the progression of a deadly disease after approved therapeutics had not. From then on a percent of the fund’s investments were directed to bioscience startups with a compelling business plan to provide new treatments and cures. The investment had a financial objective, to be sure. But the investor was focused on the clinical outcome as well, and his board designee was patient and helpful in many ways as we ran the crooked road of drug discovery, development and commercialization.

 

Today, family funds – sometimes called “family offices”, or “home offices”, or “high net worth (HNW) individuals” worldwide are increasingly a significant direct source of funding for startups, emerging and mature bioscience companies, bypassing traditional private equity funds and snapping up opportunities left by the great VC migration. The number of funds and the dollars at their disposal are staggering.


Last Thursday we brought together experts deeply engaged in the family fund sector at our monthly Virginia Bioscience Commercialization Panel Series. If you missed this eye-opening discussion, remember we livestream these events and archive the video for Virginia Bio members to watch at their convenience at the News and Events, Video Library section of our website.


Our three panelists occupy very different vantage points. Peter Harris is a Vice President & Managing Director at Axel Johnson, the investment fund of a prominent European family. He is involved with cultivating and evaluating new investment opportunities and providing strategic and operational support to existing portfolio companies. While the family is European, the Fund has a significant investment in a Virginia medical device company and Peter and colleagues operate the funds’ investments in the US out of NYC and Charlottesville. Tom McKenzie is Senior Vice President, Membership, of Cavendish Global, as well as a principal with Capital Partners LLC, a private equity advisory firm. Cavendish Global is an innovative and relatively new organization - a community of global family funds intent on making impact investments in new and emerging biomedical companies. Tom scouts the country for companies to bring to the attention of the community. Paul Romness is Senior Advisor to McKenna & Associates in the Life Sciences and issue advocacy campaigns. McKenna is a versatile DC strategic consulting firm specializing in management and fundraising, and assists family funds with investment opportunities.


Some key points from the panel. Family funds have more flexibility than institutional private equity and VCs because they answer to themselves, not to recruited investors. This allows them greater freedom from strict investment criteria like asset grade, deal structure, sector or geography. They tend to have a longer time horizon, looking to build capital not harvest a rapid return. They may accept greater risk, in terms of sector, stage of investment and even deal structure, to accomplish other goals. And other goals they do have: perhaps a sweet spot based on family history and values, such as interest in funding solutions to a particular disease. The result – family funds operate in many different ways. Still, it’s an investment, not a philanthropic gift. The bioscience company has to evidence a strong business case to reach returns, as well as impact. And while the role of family funds making direct investments is relatively new, it’s unlikely to be a mere fad. No matter how many years pass, wealth will be accumulated, the wealthy will seek investments, families’ happiness will be bound to sickness and health of their members, the urge to impact the spread of medicine and human health will continue to call good souls, and the potential returns of innovation in the biomedical sector will draw good looks from savvy investors.


No discussion of capital formation can end without reminding you of JP Morgan Health Care Conference Week in San Francisco on January 10 - 15, 2016. There’s an exciting new development this year, and one could say it has to do with “Families”. This year we are greatly expanding our Sunday evening reception. The Virginia Reception, co-hosted with University of Virginia Darden School of Business, will be held at 5:00pm on January 10 in the Velvet Room of the Clift Hotel.


Just two weeks ago Darden was rated by The Economist as the #2 MBA school in the world. Darden is inviting its extensive family of alumni in the biotech and health care industry, and Virginia Bio is inviting the leaders of our member companies who are seeking capital and strategic deals. In San Francisco in January, these Type A Virginians act more like family, sharing connections and talking one another up to help one another succeed on the tough but important journey they walk along together.


We’re also expanding the number of slots we will make available free to Virginia Bio members in our hotel room overlooking Union Square for private and semi-private meetings. See you there!

If your organization is not a member of Virginia Bio yet, give us a call.

Best Regards,



Jeff Gallagher
CEO

Tags:  Axel Johnson  Cavendish Global  Darden  Family Funding  funding  JP Morgan Healthcare Conference  McKenna & Associates  Virginia bio  virginia bioscience 

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Help Drive Virginia’s Economy

Posted By Administration, Monday, October 19, 2015
Updated: Monday, October 19, 2015
Members and friends of Virginia Bio,

Virginia faces an urgent need to diversify and grow its economy. This need has made economic development a rare potential area of cooperation between the General Assembly and the Governor, Republicans and Democrats.

Bioscience commercialization presents a unique opportunity to Virginia to meet this need and solve this crisis. The state has all the pieces to base significant long term growth and to grow into a leading state economy. We need to focus and align, make some investments and incentivize private sector activity.

For these reasons, I have been working for over a year with policymakers in the Administration and General Assembly to gather facts on bioscience commercialization policies and results within Virginia and in other states. We have collected data on demonstrated return on investment. We have helped to mount three statewide gatherings of Virginia bioscience leaders. We helped coordinate statewide working groups commissioned by the Governor and brought their reports back to an audience of state leaders, setting out principles for a plan that would take Virginia from where it is today to a greatly expanded and mature bioscience economy. At Virginia Bio's April strategic Board retreat, the organization set our top priority to prepare, propose and fight for a plan to enact in budget and legislation during the 2016 General Assembly, which begins in January.

This week, on Tuesday, October 20 at 12pm we will conduct a webinar for our members to present the plan that has been developed, answer questions, and enlist your active support in making the plan reality. Click here for the webinar link.


I will share the plan one on one with policymakers and present it to gatherings of stakeholders statewide from now until January.

We also will enlist your help starting immediately and continuing over the coming months to socialize the plan. We need members to meet with their legislators and with the members of the Administration and urge them to support the plan, support the industry and do something significant to make a significant difference in the future of Virginia's economy.

This is a topic in which virtually every elected legislator and public official agrees, and declares publicly its importance. It is our task to assure these people make it a priority against the many competing claims of legacy programs and louder voices. The Governor has famously and repeatedly announced bioscience is a top priority. We need to work to assure that in his proposed budget and legislative agenda that is indeed the case. Legislators have declared their support for economic development. We need to be in repeated contact with them to explain the importance of the bioscience initiative and monitor the response in the progress of legislation and the decisions of the money committees in each chamber whether that is in fact the case.

I would love to hear from those of you who would be willing to help us by visiting, making calls or writing emails to your legislators, sending letters to the editor, or hosting legislators for a tour of your facility to communicate the importance of bioscience commercialization and your support of Virginia Bio's plan firsthand.

Please join us for the webinar, and then help us convert this historic opportunity to a real and significant achievement for the state.

We can create many thousands of new high paying jobs, while helping to heal, feed and fuel the world.


Best Regards,



Jeff Gallagher
CEO

Tags:  Economic Development  funding  government  Governor  Virginia bio  virginia bioscience 

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Accelerating Progress in Virginia Bioscience Commercialization

Posted By Administration, Wednesday, September 23, 2015
Updated: Tuesday, September 22, 2015
Members and friends of Virginia Bio,

A sage cautioned “don’t confuse familiarity with understanding.”

Many of us are familiar with the research and commercialization parks and accelerators which are available for biotech commercialization around the state. But don’t blink, and don’t stop asking questions, because the facilities we know are evolving, and new resources are developing across the state to meet the great opportunity bioscience commercialization presents for the Commonwealth.

Let’s start with an update on the Prince William County Science Accelerator at Innovation Park. This space, opened in June 2014, offers leading life science and biotechnology companies 9 wet labs to grow their business at an intersection of university research and commercialization. This accelerator is the only public-private, commercially available wet laboratory space in Northern Virginia, located less than an hour away from key government buildings such as the National Institute of Health and the FDA.

Already, the accelerator is moving fast. ISOThrive LLC, a leader in nutritional ingredients that benefit the gut microbiome, expanded into larger lab space within the accelerator this past April. Since then, it has partnered with George Mason University’s MicroBiome Analysis Center to push along their research into the commercialization process. In addition to ISOThrive, two other companies, Ceres Nanosciences and Virongy, make use of the county’s accelerator. Ceres endeavors to seize the future of diagnostics by researching and commercializing novel sample processing techniques. Virongy, a virological reagent and tool company, provides cutting-edge services that catalyze scientific discoveries, enhance disease treatments, and more.

In Richmond, the Virginia Biotechnology Research Park, to strengthen its role in leading bioscience commercial innovation, has transitioned the Virginia Biotechnology Research Park Corporation Board to The Innovation Council. With an emphasis on innovation and entrepreneurship, the Council, a 501-c(3) entity with 19 members, will seek to leverage individuals and organizations doing groundbreaking work in order to ensure commercial success and benefit the state economy at large. The Council boasts leaders in business, education, and other fields as part of their membership, and also received a helping hand from Dr. Rao, President of Virginia Commonwealth University in the form of a $1.2 million dollar commitment to be matched with other sources of funding.

In Danville, the Institute for Advanced Learning and Research recently completed a strategic reevaluation, and a focus on translational research and support of entrepreneurs and commercialization rose to the top. Its top notch research facilities, leaseholds and common facilities are a great home for the right bio business. IALR’s mix of labs, office and meeting facilities was a perfect spot to host the highly successful statewide Governor’s Forum on Agriculture and Industrial Bio earlier this month.

In Virginia Beach, an impressive year long, community wide economic development planning process, led by the city’s Mayor and top corporate leaders, has recommended an emphasis on biomedical industry development, and designated a 150+ acre tract adjacent to LifeNet Health and Sentara Princess Anne to set aside as biomedical research and commercialization park. Early steps in the plan call for the development thereof a bioscience accelerator.

Back to Northern Virginia, the plans for Inova’s Center for Personalized Health on the massive campus formerly the home to ExxonMobil continue to take shape. The public announcements and interviews are exciting, and it’s clear that an integral element of the campus will be facilities and services to house and support biomedical and biotech startups.

Another new, and very different, player on the scene is the new LiftOff Health, in Arlington, that is accelerating commercial expansion and networking by functioning as a digital platform of collaboration/incubation, with dreams of serving and attracting any entrepreneur around the world. This approach appears at first glance to fit companies in mobile health and e-health - involved in the “creative destruction of medicine”, as Eric Topol, director of the Scripps Translational Science Institute, puts the impact of wireless and Internet on medicine and research. Awarables, for example, is a company using LiftOff Health which provides men and women who suffer from chronic sleep disorders an app that tracks details about their sleep patterns.

Check out other parks and accelerators you may be familiar with across the state, and equip yourself with up to date information: Virginia Tech’s impressive Corporate Research Center “CRC” in Blacksburg, UVA Research Park in Charlottesville, Innovation Research Park at ODU, and Innovation Village @ Rockingham by SRI Shenandoah Valley among others. In fact, click here to view our VA Life Sciences Map. On the top row of the map window, choose the Snapshots button, then select Research Park or Accelerator Organization Types to view all together.

We are picking up the pace and getting smarter about creating on the “Virginia Common” the physical and expert resources needed by researchers and entrepreneurs to succeed in commercializing bioscience innovations. The accelerators, incubators and parks are diversifying and providing more value, helping to propel the biotechnology industry into the future, which is looking bright. That means more jobs, more cures and more health for the commonwealth.

Best Regards,



Jeff Gallagher
CEO

Tags:  accelerator  Ceres  commercialization  Economic Development  IALR  Innovation council  Inova  Institute for Advanced Learning and Research  ISOThrive  LifeNet  LiftOff  MicroBiome  prince william  Research  Scripps  Sentara  SRI Shenandoah  Virginia bio  virginia bioscience  virginia biotech  Virongy 

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Ag/Bio - Rapidly Growing High Value Sector

Posted By Administration, Thursday, August 27, 2015
Updated: Wednesday, August 26, 2015

Members and friends of Virginia Bio,

On Wednesday, September 9, we are helping to mount the Governor’s Conference on Agricultural and Industrial Bio, in Danville at the impressive Institute for Advanced Learning and Research.

For the first time ever in Virginia, we’ll gather the companies, researchers and members of the agricultural community working in this rapidly growing high value sector where hi-tech meets Virginia’s largest private industry.

Agricultural and Industrial biotechnology is enabling the world to feed its growing populations and supply fuel and materials to its growing economies in an affordable, sustainable and environmentally sound manner. At the end of this letter, I provide a snapshot of field for those who are unaware.

This rapidly growing sector provides an opportunity to add new hi-tech strength to a pillar of Virginia’s economy. In turn this will strengthen the state’s traditional biomedical biotech industry because of the commonality of skills, talents, resources, supplies, equipment and services required to succeed in R&D and commercialization.
Thanks to generous sponsors, the event is free of charge.

It’s a great agenda on September 9, which will enable attendees to learn in one day, in one place what’s going on in the industry in Virginia, to meet the key players, to better understand the opportunities, to assess public policy and start to think about moving forward.

 

- In a morning and afternoon lightning round, we’ll hear from ten companies, large to small from all across Virginia working across many different areas of ag/ind bio, and we’ll hear from ten researchers from universities and private institutions doing exciting and promising work across the field.

- We’ll hear from Paul Ulanch, Ph.D., MBA, Executive Director, Biotechnology Crop Commercialization Center, with our friends at the North Carolina Biotechnology Center some of the steps they’ve taken in the last five years to become one of the top ag bio centers in the US, and opportunities to collaborate.

- A panel of federal, state and private funders will explore opportunities to fund commercial efforts in this field.

- We’ll hear from Shawn Semones Ph.D., Director of Applied Discovery Research & Development, Salem Virginia Site Lead, Novozymes North America, Inc., one of the world’s leading ag bio companies, on the company’s work, outlook and trends.

- Top state policy makers, including Governor Terry McAuliffe, Secretary of Agriculture and Forestry Todd Haymore, and Delegate Steve Landes will share ideas on the state’s role in supporting the development of the industry.


I look forward to seeing you there! Click here to register now for this important event.


Best Regards,



Jeff Gallagher
CEO

 

Agricultural biotechnology is a rapidly expanding, broad and dynamic industry that applies a range of advanced biotechnology tools, such as genetic engineering, to improve plants and animals, to develop microorganisms for specific agricultural uses, to make agriculture more efficient, sustainable and profitable, and to improve food quality and safety.

Biotechnology can engineer crops to tolerate specific herbicides, making weed control simpler and more efficient, and to be resistant to specific diseases and pests, improving control and decreasing the use of synthetic herbicides and pesticides. Crops with the ability to grow in salty soils or better withstand drought conditions are entering the marketplace. These require less fuel, labor, fertilizer, and water, decreasing pressures on land and wildlife habitats.

Biotechnology creates improved foods, by increasing certain components such as vitamins and other nutrients, and reducing levels of others, such as naturally occurring toxicants, allergens, or saturated fats.

US farmers have rapidly adopted many of these new varieties: 88% of the corn, 94% of the cotton and 93% of the soybeans planted in the U.S. were varieties produced through genetic engineering. Use is spreading globally as well, helping countries keep pace with demand for food while reducing costs.

Genetically engineered bacteria and yeasts produce vitamins and nutritional supplements for human food, and improve the production of fermented beverages and foods.

Biotechnology advances improve animal food, and enable animals to more effectively use nutrients present in feed, and produce new vaccines, diagnostics and treatments for animal disease, and additional markets for animal products.

Biotechnology provides a wealth of tools improving the safety of our food supply chain.

Industrial biotechnology applies biotechnology tools to traditional industrial processes (“bioprocessing”) and the manufacturing of products (such as fuels, chemicals and plastics) from bio-based renewable feedstocks.

New and more valuable sources of biomass, and new more efficient methods of bioprocessing, are being developed continually. Current commercial products include bio-based plastics with applications ranging from cosmetics, home cleaning products and antifreeze to food packaging and car parts, and chemicals used in the production of detergents, textiles, pulp and paper, leather, metals, fuels and minerals.

There is rapid innovation in renewable chemicals, frequently co-produced as side streams of biofuels and bioenergy, providing new intermediates, novel products, or direct replacements for petroleum products.

Genetically engineered crops can serve as factories for the production of a wide array of chemicals, including new medicines.

Tags:  agriculture  funding  government  Governor  IALR  industrial biotechnology  Institute for Advanced Learning and Research  mcauliffe  Novozymes  Paul Ulanch  Shawn Semones  steve landes  Todd Haymore  Virginia bio  virginia bioscience 

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Federal Lawmakers Focus on Bio

Posted By Administration, Wednesday, July 22, 2015
Updated: Tuesday, July 21, 2015

Members and friends of Virginia Bio,

 

After several years of relative inactivity, federal lawmakers are in gear again. And so are we at Virginia Bio.

 

The 21st Century Cures Act (H.R.6) was passed in the House of Representatives on July 10 by an impressive vote of 344 to 77. This bill was bipartisan in its creation and authorizes several changes to the approval process for drugs and medical devices.

 

The bill also authorizes an increase of $8.7 billion for the NIH and a $550 million increase for the FDA over 5 years. The bill amends the Federal Food, Drug, and Cosmetic Act to revise the drug approval process by allowing patient experience data to be considered in the risk-benefit assessment of new drugs; requiring the FDA to qualify drug development tools; allowing the FDA to rely on data previously submitted for a different purpose to expedite the development of certain drugs; and establishing a streamlined data review program for approval of drugs for additional indications. The bill requires the FDA to establish a program for priority review of breakthrough medical devices, identify types of devices that do not require a report preceding introduction, and rely on a third party to determine the safety and effectiveness of changes to medical devices. The bill requires manufacturers and distributors of investigational drugs for serious conditions to publish their policies on compassionate requests; revises and extends the priority review voucher program for rare pediatric diseases; and requires a pharmaceutical and technology ombudsman within the CMS to respond to complaints from manufacturers of medical products. The bill allows Medicare prescription drug plan sponsors to limit certain beneficiaries’ access to frequently abused drugs and mandates interoperability and certification of electronic health records. The House overturned a last-minute amendment that threatened the bill’s passage by proposing to make the new NIH and FDA spending discretionary, rather than mandatory.

 

The Senate is working up and is expected to consider its own version of the bill in the Fall.


Intellectual property protection is at issue on a couple of fronts. Reform of the US Patent system is the work of H.R. 9, the Innovation Act, which has been captained by Chairman Bob Goodlatte (VA). The bill was poised to reach the floor any day, before being slowed down for additional consideration until after the August recess. The bill offers multiple procedural changes to the patent process, many of which are inspired by the scourge of patent trolls famously impacting the IT industry. Virginia Bio has joined voices with BIO, PhRMA, MDMA, the American Association of Universities, the National Small Business Administration and the National Venture Capital Association, among others, to push back against several proposals and urge other important changes. Inter partes review proceedings at the Patent Trial and Appeal Board at the PTO is effectively changing the legal standard and disrupting the certainty of patent validity. While true trolls in the IT space must be deterred, the bioscience innovation sector is so different than IT that these fixes are extremely harmful, and threaten the affordable access to dependable patents on which all investment in our sector depends. The Senate has its own version of the legislation under development. If you are interested and willing to speak with your federal lawmakers about these issues, please do so, or contact me for further information and assistance.


A very different legislative venue for IP issues, is consideration of the merits of the Trans Pacific Partnership trade agreement, now in final stages of negotiation among the Administration and counterparts from foreign nations around the Pacific Rim. Congress will have the opportunity to vote the agreement up or down when reported by the President under fast track authority. At issue is the protection of biological drugs. US law recognizes the special character of biological drugs and protects them with a 12 year period of data (or “regulatory”) exclusivity: that is, data prepared and submitted to FDA by the innovator as a condition of approval may not be used by competitors to support applications of other (usually biosimilar) drugs. The 12 year period is set by statute in the US, and balances the goal of enabling innovators to benefit from their research investment and risk taking without competitors taking a free ride, while creating a time certain after which reference is allowed to ease the entry of biosimilars into the marketplace.


Medical Device Tax Repeal. After several tries over as many years, the House on June 15 passed H.R. 160, the “Protect Medical Innovation Act of 2015.” The bill would repeal the 2.3 percent medical device excise tax on manufacturing and importing medical devices, which was implemented through the Affordable Care Act and has proven to be highly unpopular. The tax is expected to bring in less than $3.2 billion in tax revenue each year over the next 10 years to help fund Obamacare. According to the Advanced Medical Technology Association, the tax is expected to cost medical device manufacturers approximately $194 million per month and the loss of up to 43,000 jobs in the medical device industry. The Senate is now in the final stages of finishing its consideration of an equivalent bill. President Obama has promised to veto the bill if it passes the Senate as well, though some observers believe there may be enough bipartisan support in Congress to secure the two-thirds majority needed to override the president and pass it into law without his signature.

 

User Fee Acts. Recently we have seen the various FDA regulated bioscience industries gearing up for the every five year process between industry and FDA to reauthorize PDUFA, GDUFA and MDUFA. Over the course of more than a year, in hearings and by written comment, the will review whether past improvements have achieved intended results, set the amounts and distribution for the voluntary industry user fee payments, and consider improvements to FDA standards and procedures going forth.

 

Recent visits. I recently visited various Congressional offices with a delegation of members of the coalition We Work for Health to point out the above issues and thank them for their support. This is a coalition of small and large companies in the biopharmaceutical industry, patient groups, large employers and chambers of commerce, united to highlight the importance of the industry, not only for individual health but for our nation’s economic health as well. Virginia Bio was a founder of the coalition, and I serve as co-chair. Members of the coalition held a series of meetings on Capitol Hill last week: Senator Tim Kaine’s Chief of Staff, Mike Henry; Senator Mark Warner’s Legislative Director Elizabeth Falcone and Health Legislative Assistant Marvin Figueroa; Congressman Dave Brat and his Legislative Director Kurt Couchman; Congresswoman Barbara Comstock and her Chief of Staff Susan Falconer; Congressman Morgan Griffith and his legislative aid Adam Harbison; and finally Congressman Don Beyer’s Chief of Staff Ann O’Hanlon.

 

If you’re interested in getting involved, to discuss or want more information, please let us know. We work closely with BIO, PhRMA, MDMA and AdvaMed to watch out for and act on the federal issues which impact our industries and our companies.

 

Best Regards,




Jeff Gallagher
CEO

Tags:  21st century cure  federal  funding  government  Todd Haymore  Virginia bio  virginia bioscience 

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Better Access to Capital

Posted By Administration, Thursday, June 25, 2015
Updated: Thursday, June 25, 2015
Members and friends of Virginia Bio,

Access to capital is one of the most important and pressing needs of bioscience innovation companies. The need for capital starts even before the moment of creation of the company, and continues and evolves throughout all stages of a company’s life cycle.

Virginia Bio is continually seeking ways to help our member companies access capital, and in the year ahead we will provide increased emphasis, and new programs and projects.

To jump start this effort, Virginia Bio recently entered into a one year agreement with CB Insights to provide access for select members to CB Insight’s proprietary comprehensive database of private investment data on current and historic deals and investors.

CB Insights is a national Science Foundation-backed data and technology company that exclusively focuses on private company financing and exit information. The database tracks any private company that has received financing including government grants angel investment, VC, growth equity, or had an exit via M&A, an IPO or other, and captures extensive information on the financings and the investors.

Please watch in the coming days for our announcements describing this exciting new program, the content of the database, the capabilities of the search, analytic and visualization tools, a date for a live webinar training how to use the database for your needs, and terms of use.

A handful of Virginia Bio member companies and investment advisors who helped us evaluate the database service were impressed that this will be a valuable tool. It will help our startup, early stage and growing companies analyze industry trends, identify target investors and acquirers, conduct reverse due diligence on investors prior to meeting them, understand comparable transactions and competitors, and track and research relevant life science and health care deals.

In addition to this new service, in January we’ll continue to build on our support of companies during JP Morgan week, with a second private meeting room and a much expanded networking reception Sunday night.

Please let me and members of our Board know additional ideas for supporting our companies’ efforts to gain access to the capital they need to thrive.

Best Regards,




Jeff Gallagher
CEO

Tags:  capital  cb insights  Economic Development  funding  government  Virginia bio  virginia bioscience 

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THRIVE 2015: Where We Go From Here

Posted By Administration, Thursday, May 21, 2015
Updated: Thursday, May 21, 2015
Members and friends of Virginia Bio,

Thanks to each and every one of you who supported or attended THRiVE 2015, making our statewide conference a tremendous success by every measure.

Over 350 people attended throughout the day, both members and future members. You can enjoy scores of photos, plus press coverage plus most of the power point presentations of the day on our THRiVE conference webpage.

We networked morning, noon and night.

We made valuable contacts and heard from experts in a wide variety of fields.

We spoke in one voice to the Governor, Secretaries and legislators about transformationally improving how the state supports bioscience commercialization in Virginia. Thanks to the many industry and university members of the Governor’s Working Groups and public servants who made that unique event possible.

Together, we assembled and celebrated the largest gathering ever of Virginians, harnessing the power of data science for the biomedical enterprise.

And we provided a forum for the leaders of the Northern Virginia bioscience community to come together, at this time of so much growth by individual organizations and companies.

Most importantly, by doing this well, we further developed opportunities to work together to create the future of bioscience in Virginia.

So we will be busy.

In state public policy, over the next nine months we will be informing, counselling and advocating to the Administration and General Assembly a coherent package of policies and programs that will make a dramatic impact on biosciences in Virginia. We will need your help.

Starting immediately, we will be working with companies, universities, the state and other organizations to weave our strengths together and accelerate the momentum in the big data space. This is uncharted territory, with great upside. We will need your help.

And going forward, we will continue to increase our programming in Northern Virginia, to help our members and partners their reach their enormous potential and weave them together with the rich opportunities across the Commonwealth. We will need your help.

The explosion of scientific knowledge, the transformation of the delivery of health care on account of reimbursement, big data and mobile technology, the globalization of knowledge …. We live in interesting times. And we will be measured, individually and collectively, by how we respond to these extraordinary challenges and opportunities.

Virginia Bio looks forward to this wonderful challenge, because we are part of wonderful community of members and friends, and the work we are about is of such critical value to the Common wealth.

Best Regards,




Jeff Gallagher
CEO

Tags:  commercialization  Economic Development  government  Governor  policy  Thrive  Virginia bio  virginia bioscience 

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