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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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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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State Institution With National Rankings

Posted By Jeff Gallagher, Wednesday, October 29, 2014
Updated: Tuesday, October 28, 2014
Members and friends of Virginia Bio,

It’s 7th in the nation among its peers for awards of federal research dollars, and 6th in the nation for private/industry support. It’s focus is an industry which is, according to some measures, Virginia’s largest private industry. That would be the College of Agriculture and Life Sciences at Virginia Tech (CALS).

I had the privilege of visiting CALS last week with Assistant Secretary of Agriculture and Forestry Carrie Chenery. The Assistant Secretary was moving ahead on Secretary Todd Haymore’s intention to prioritize support for the opportunities presented by biotechnology in the Ag sector. Secretary Haymore’s interest was formed when he accompanied Governor McAuliffe, Secretary of Commerce and Trade Maurice Jones and VEDP CEO Martin Briley to the BIO Convention in San Diego last summer and is driven by a recent announcement of an export deal between China and a Virginia ag bio company.

Our long time friends at Virginia Tech and leaders of the College arranged an all-day lightning round of presentations on research, commercialization and industrial collaborations, with a tour of the fascinating new Human and Agricultural Biosciences Building 1. HABB1 is home to the Department of Biological Systems Engineering and the Department of Food Science and Technology. We heard bright and enthusiastic faculty researchers and entrepreneurs on such topics as: industrial scale production of plant extracts as inputs for advanced composite materials; biofuel feedstock optimization and process innovations; animal and human drug development from plant sourced molecules; the integration of traditional breeding with new genomics to produce better commercial cultivars; and in vitro enzyme systems based on plant metabolism to create bioenergy, leading to the battery that runs on sugar!

I was struck with the excellence and passion, and with a heightened sense of the commonality of research, tools, methods, obstacles, opportunities, contacts between the “Ag and Industrial” bio worlds and the classic biopharmaceutical/biomedical. There’s new significance to me now of big BIO’s tag line “Healing, fueling and feeding the world.”

The exciting promise of ag bio is headline news, as the therapeutic antibodies administered to two recovered ebola infected American health workers were produced by a tobacco plant. The world is indeed facing extraordinary challenges and opportunities in human health and biomedicine. So, too, we have enormous challenges and opportunities for feeding the human family, and for providing the means to affordable, practical, sustainable power across the globe and across the generations.

In the months and years ahead I hope to work in new ways with our universities and researchers in the Ag and Industrial areas, as well as with large company partners and small spinout startups, and our state policy makers to better interweave the fields in our community, providing additional resources and new opportunities to all.


Best Regards,



Jeff Gallagher
CEO

Tags:  CALS  Carrie Chenery  College of Agriculture and Life Sciences  Martin Briley  Maurice Jones  Todd Haymore  Virginia Tech 

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