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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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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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Virginia Higher Education Research Summit Recap

Posted By Jeff Gallagher, Thursday, June 19, 2014
Updated: Wednesday, June 18, 2014
Members and Friends of Virginia Bio,

What can be done to optimize the extraordinary  potential of the state’s great research universities, to increase extramural research funding, and accelerate discovery, development and commercialization of their innovations?   

This important and timely question was the focus of the Virginia Higher Education Research Summit held in Richmond on June 9.  The Summit was hosted by the State Council of Higher Education of Virginia, in cooperation with the Center for Excellence in Education, Center for Innovative Technology, Virginia Chamber of Commerce, Virginia Business Higher Education Council, and the Virginia Economic Development Partnership.  The Summit brought together some 250 leaders and stakeholders committed to supporting and growing Virginia’s research enterprise, including representatives from executive and legislative branches of state and federal government, Virginia’s public and private higher education institutions, large and small businesses. Presenters showcased exemplary private/public partnerships between universities and the private sector, challenges and opportunities for acquiring capital to drive an idea to market, advice from university researchers to young investigators, and corporate thoughts about future fields that will be required to address the multi-dimensional challenges in health, cyber, manufacturing, energy, agriculture and the environment.   Research and development of the bioscience and medicine featured prominently.  

This day-long event featured Governor Terry McAuliffe and Secretary of Education Ann Holton, among others, and two panels of experts, one from the academic side and the other from industry.  The morning panel featured eminently successful academic researchers speaking about “Public Private Partnerships:  Exemplary Models”. The panelists were Donald Brown, UVa, Paul Fisher, VCU, Michael Friedlander, Virginia Tech Carillion Research Institute, Richard Heller, ODU and Duminda Wijesekera, George Mason, and I was privileged to moderate. The afternoon panel furnished a funder and industry perspective on a “Forecast of Future Market Demand and Trends” and featured James Ellenbogen, MITRE Corporation, Donald Hamadyk, Newport News Shipbuilding, Sean Kanuck, Office of the Director of National Intelligence, and Christopher Yochim, AstraZeneca, and was moderated by Bobbie Kilberg, CEO of  NVTechCouncil.  The program with slides is at:  http://www.schev.edu/VAResearchSummit.asp

Virginia is home to a number of extraordinary research universities with strengths in varied fields, and they serve as the engine for much of the Commonwealth’s innovation in the biosciences.  Both new and established university researchers hold enormous potential to make and develop discoveries that will save lives and improve health and well-being worldwide, while creating jobs and economic development in the Commonwealth.

It is widely believed that traditional federal sources of science research funding such as NIH will remain level at best in the foreseeable future, and thus to increase research funding our universities need to increase collaboration with industry and foundations.  At the same time, competition for these funding sources will increase, and thus to be successful our universities must find new ways to become more valuable and more competitive. One obvious response is to improve collaborations within the state universities; however, our great institutions are geographically widely dispersed and structurally not as tightly coordinated as in some other states.  SCHEV CEO Peter Blakely and Board members summed up the discussions at the end of the day and sketched next steps, declaring  the Summit a call to action - the beginning for an informed and purposeful statewide effort to encourage and support private and public research collaborations and extramural funding.  

Virginia Bio pledges its support of this important effort going forward, and will be involved in follow through.  If this is a subject of particular interest to you as a member, please let me know and I will keep you  apprised of developments and tap your energy and time as opportunities arise.    


Best Regards,

Jeff Gallagher
CEO

Tags:  Biological  DARPA  federal  funding  Governor  Research  STEM 

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DARPAs New Biological Technologies Office (“BTO”)

Posted By Jeff Gallagher, Wednesday, April 30, 2014
Updated: Tuesday, April 29, 2014
Members and friends of Virginia Bio,

The purpose of this monthly post is to highlight extraordinary people, activities and assets in this broad, deep and diverse Virginia bioscience community.

DARPA is the Defense Advanced Research Agency Program, headquarteredin Arlington, Virginia and it awards grants to fund breakthrough R&D.

DARPA recently formed a Biological Technologies Office (“BTO”) to consolidate and expand DARPA’s funding of the biosciences. “Starting today,” DARPA officials proclaimed when announcing the formation of the BTO, “biology takes its place among the core sciences that represent the future of defense technology”.

The BTO is tasked is to merge biology, engineering, and computer science to harness the power of natural systems for national security, to explore the increasingly dynamic intersection of biology and the physical sciences, to harness the power of biological systems, and to design next-generation technologies that are inspired by insights gained from the life sciences.

“Biology is nature’s ultimate innovator, and any agency that hangs its hat on innovation would be foolish not to look to this master of networked complexity for inspiration and solutions,” said DARPA Director Arati Prabhakar in testimony to Congress this Spring.

BTO programs push the leading edge of science. For example, DARPA recently announced a Hand Proprioception & Touch Interfaces (HAPTIX) program, expanding on the work of DARPA’s Revolutionizing Prosthetics and Reliable Neural-Interface technology programs.

BTO establishes research priority areas. Future programs will be created from ideas brought to the agency by program managers and through conversations with the research community. BTO soon will release a Broad Agency Announcement (BAA) that will define research areas of interest and welcome solicitations from industry and academia to meet defined goals, and the BTO hosts forum in Arlington for academic and corporate R&D visits and discussions. The BTO’s new Director is Dr. Geoffrey Ling, a neuroscientist.

Take a look at http://www.darpa.mil/Our_Work/BTO/

Virginia Bio will seek to help Virginia’s researchers and companies become aware and take full advantage of DARPA and other federal defense sources of bioscience funding, many in our own backyard. Look for webinars, events, and other opportunities in the months to come.

Best Regards,



Jeff Gallagher

Tags:  agency  Biological  DARPA  federal  funding  government  Research 

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