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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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THRIVE: Creating the future of bioscience in Virginia

Posted By Administration, Thursday, March 19, 2015
Updated: Thursday, March 19, 2015
Members and friends of Virginia Bio,

“A committee meeting is not necessarily the same as doing something,” a mentor once said to me.

Neither is a conference. But it can do something, something of enduring significance - if you start from Day One with that goal. That’s the goal that the Board and the Conference Steering Committee led by Dan Gonzalez set six months ago, and that’s what staff has been up to.

It’s a rare opportunity when the statewide leaders of industry, translational research, public policy and supporting firms and businesses come together in one place for our statewide conference. Two years ago in Charlottesville we looked back, told the story, honored outstanding contributions, and celebrated.

This year in Northern Virginia we will look ahead, and we will move ahead. That’s why we call the conference THRIVE: Creating the future of bioscience in Virginia.

Placing the conference in NoVa helps that community come together and show off, and gives us a chance to introduce the great bio activity there to the rest of Virginia. It also enables great programs throughout the day.

In the morning and in all one place for your convenience, we are bringing together the directors of SBIR programs at four of the highest funding NIH Institutes, plus NSF, DARPA and DOD. They’ll present in series on their programs, and hold one on one meetings. We’ll complement that extraordinary resource with a panel of a variety of different types of private funders to share insights about conditions, trends and opportunities.

We’ll bring to the conference key federal policy makers and experts to help us take an up close look at changing federal laws and regulations that make or break our companies and our industry. Congressman Morgan Griffith (VA–9) and staff, along with policy experts from BIO and ADVAMED will explain and take comments on the 380 page discussion draft legislation recently released from the Congressman’s Subcommittee on Health of the Energy and Commerce Committee, on the 21st Century Cures Initiative to reform FDA and NIH with today’s technology for tomorrow’s needs.

Economic development professionals from around the state will gather to roundtable best practices, strategies for success, learn about one another’s progress. We will unveil a new interactive web based map of the state with all biobusinesses and members pinned, sortable by type, with key word search, that will live on the Virginia Bio website and be open to all.

Governor McAuliffe will spend the day with us, and a number of key state legislators will participate as well. Starting late morning working groups that were formed at the Governor’s December 4 Summit will report findings and recommendations for state policies to move the needle for our companies, universities and industry. We hope this will provide the information and insights that will enable members of the different branches and parties to begin to work together over the coming months to formulate policies for the Governor’s first Budget and the next General Assembly to make real advances in how the state supports and enables the biosciences, which is a widely shared goal.

All afternoon the Governor will preside over The Governor’s Summit on Bio and Big Data / Analytics. Given our Northern Virginia location, the strengths around the state and the accelerating role of data science in bioscience, biomedicine and health care, this Forum has caught great momentum. The Forum will run from 1:30 – 5:00 pm. Thought leaders from around the country will start us off, describing current exciting work, and painting a picture of the fantastic opportunities ahead for those who reach for them. Then we’ll have a lighting round of Virginia companies, institutions and translational researchers doing extraordinary work in the space already, from startups to health care systems to global data companies. If you’re a bioscience company or researcher not quite sure how big data /analytics will directly impact or lead your work, if you’re into bio and big data / analytics already but you are continuously searching for new technology and techniques to push you ahead, or for collaborators, suppliers and clients, or if you’re big data but not big bio then come check out what all the excitement is about and spot your niche.

Every exhilarating day ends better with a two hour reception with heavy hors d’oeuvres, so we’ll have that for you immediately following the Forum. Hunt down the new contacts you spotted during the day, and renew your old ties from around the state. We’ll pause for a while during the reception to honor our two most recent winners of Virginians who have made Outstanding Contribution to Biosciences, joining the 20 we honored at our 20th Celebration in Charlottesville two years ago.

Looking forward. Moving forward. Together creating the future of biosciences in Virginia.

We need you to be there, to create it together.

See you at the Westfields Marriott Washington-Dulles Conference Center in Chantilly, VA on Thursday, April 23. Visit the THRiVE 2015 webpage to register.  And thanks to our Conference Committee and our sponsors who make it all possible.


Best Regards,




Jeff Gallagher
CEO

Tags:  21st century cure  big data  convention  Economic Development  funding  government  Governor  policy  Thrive  Virginia bio  virginia bioscience 

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Discussion Draft Released For 21st Century Cures initiative

Posted By Administration, Wednesday, February 25, 2015
Updated: Wednesday, February 25, 2015
Members and friends of Virginia Bio,

Recently the U.S. House of Representatives Energy and Commerce Committee released a discussion draft related to its 21st Century Cures initiative.

The 21st Century Cures initiative is a bi-partisan effort to take a coherent look at the whole system, from drug and device discovery, to development to delivery, and the impact of the Food and Drug Administration, National Institutes of Health and other federal agencies. The driving idea is that as a nation we created and for the last 75 years have enjoyed the world’s greatest system for turning biomedical innovation into practice. To remain the global leader, to retain and grow research, companies and jobs, and to bring health and therapies to more people more quickly and efficiently, we must improve.

This discussion draft document reflects the work and industry input from 27 public hearings and roundtables and 5 white papers over 10 months dating back to April of 2014.

One of those public roundtables occurred in Blacksburg last October. Virginia Bio was pleased to be able to help organize the event with Rep. Morgan Griffith (VA-7), a member of the Committee’s Subcommittee on Health. The Roanoke Times published their coverage of the roundtable here and later published an Op-Ed with our comments found here.

The Committee has characterized this draft as "far from perfect" but as you will see, this legislative draft includes provisions authored by both Republicans and Democrats that would: (1) incorporate patient perspectives into the regulatory process and help address their unmet medical needs; (2) build the foundation for 21st Century Medicine; (3) streamline clinical trials; (4) accelerate the discovery, development, and delivery cycle and support continued innovation at our Federal public health agencies; and (5) modernize medical product regulation.

Here, you can find an initial analysis of sections of the 393 page legislative draft that would have an impact on the life sciences in Virginia. I tip my hat here to our friends at Pennsylvania Bio who compiled much of this summary.

The full legislative draft document for the 21st Century Cures initiative can be found here.

I encourage you to read through the legislative draft and reach out to us with comments or additional areas of concern. If you prefer to send your comments straight to the House Energy and Commerce Committee, you can do so via email at cures@mail.house.gov. Or to Rep. Griffith, via his staff member on this initiative, Adam Harbison at Adam.Harbison@mail.house.gov.

You have a chance to meet with Congressman Griffith, to hear his comments on the 21st Century Cures Initiative and to discuss the Discussion Draft at our statewide conference April 23 at the Westfields Marriot Dulles Conference Center, THRIVE: Creating the future of bioscience in Virginia. Congressional staff members and other federal policy experts will be present on a panel with Rep. Griffith to provide additional resources and viewpoints for the discussion. I invite you to attend, learn and provide your comments. Register to attend THRIVE here.

Thank you for your ongoing support.

Best Regards,




Jeff Gallagher
CEO

Tags:  21st century cure  government  virginia bioscience 

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