Archive for the ‘BIO’ Category

Drug Cost Facts: Your comprehensive guide to the drug cost ecosystem

March 6, 2017

March 3, 2017

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The Biotechnology Innovation Organization (BIO) today launched DrugCostFacts.org, a new interactive web tool designed to help healthcare stakeholders gain a better understanding of the true facts surrounding drug costs, spending and value.

 

The site features a series of commonly asked questions—ranging from “Why are some drugs expensive?” to “What role do PBMs, insurance companies and wholesalers play in determining what patients pay for their drugs?”—and then answers these questions using infographics, videos and interactive tools. The site also has additional research and reading materials for those who want to dive deeper into these issues. The tool is mobile responsive, allowing users to access information on their phones and tablets.

 

The goal of the site is to provide information—drawn from independent studies, news articles and outside research—that policymakers, the media and the public can rely on when writing or engaging in discussions about issues relating to drug costs and spending. The site also features a “Follow the Debate” section, where users can get more information on topics ranging from drug importation to government negotiations in Medicare that are making headlines and that are part of the current policy and public debate.

 

Below are highlights of some of the elements of the site:

 

(Note: The interactive tools were developed based on publically-available data and each tool includes an explanation of how the calculations were determined.)

 

Understanding Your Drug Costs: Follow the Pill

 

Understanding Your Drug Costs: Follow the Pill is designed to give users a better understanding of how prescription drug costs are really determined and where the pharmaceutical dollar actually goes. The whiteboard video begins with a typical transaction at your local pharmacy. It then traces that purchase back through a series of complex transactions that occur throughout the pharmaceutical distribution and insurance chain. The video breaks down the differences between the list price and the net price of a medicine, explains how the various actors (e.g., pharmacy benefit managers (PBMs), wholesalers, insurance companies, etc.) in the health care ecosystem operate to deliver medicines to patients and at what cost, and demonstrates why it is that a biopharmaceutical company has very little power to determine what a patient ultimately pays for his or her medicine.

Insurance Calculator

The Insurance Calculator is an interactive tool that allows you to explore how changes on the front end of insurance benefit design (e.g., to your deductible or required cost-sharing for drugs) ultimately impact what you pay each month for premiums and other out-of-pocket costs.

 

The calculator allows you to get a better understanding of how insurance design impacts patient out-of-pocket costs. The tool starts you off with two pre-set plans (i.e., an Affordable Care Act Silver Family Plan and a Large Corporate Individual Plan) to give you examples of what common deductible and co-payment amounts can be. Once you gain more familiarity with how to use the tool, choose the “customize” option to explore all of the various elements of a plan benefit. Users are encouraged to experiment with the different parameters, keeping a close eye on “Total Monthly Out-Of-Pocket Costs” on the left-hand side to see just what elements of your insurance plan’s structure impact the costs you bear the most.

 

For example, increasing deductibles may not have as much of an impact on your premiums as you may think. In addition, you’ll see that increasing brand drug cost-sharing by patients does little to lower your premium, but has a major impact on your out-of-pocket costs.

 

Like the tool discussed below, this insurance calculator is not meant to provide exact data on your individual plan or an individual patient’s costs—instead, it uses real-world data to map the relationship between insurance benefit design of a plan like yours and out-of-pocket costs to demonstrate the effect that one has on the other.

 

How Much Does the Cost of an Innovative New Drug Impact Overall Health Care Costs?

 

When an innovative new medicine becomes available on the market, insurance companies often raise concerns that covering the drug will put upward pressure on health care costs. To take a deeper look at this issue, BIO developed an interactive tool that simulates the impact of adding a new innovative drug on average health care costs across a hypothetical insurance market. The site allows you to enter the monthly cost of a new medicine and the number of people who would take the drug to determine what an approximate monthly impact would be on health care costs if the cost were distributed equally nationwide. What you will see is that, even in the case of more expensive drugs, the incremental cost across all insured individuals is modest. This is important information to know when the alternative is restricting access to these new medicines, and in turn, restricting the potential benefits they would have for patients.

 

Here are a few scenarios you can try: Take your typical statin, which would cost about $10 per month. The population taking this drug would be about two million people. As the calculator shows, the incremental impact on each individual’s health care costs would be about $0.11 a month. Remember, these numbers are not meant to be exact for any particular plan or individual, but instead to demonstrate the magnitude of the impact of covering medicines on health care costs.

 

Another scenario would be a novel therapy costing $1,000 per month and taken by 100,000 patients, which could be the case for a new medicine that treats a certain type of cancer or a specific form of cardiovascular disease. Ensuring coverage of this drug for all patients that need it would have a monthly impact of just $0.56. Or, for example, if a more expensive rare disease drug cost $25,000 per month, and is utilized by 2,000 patients, the monthly impact would be $0.28.

 

Try it out yourself to see how both common and rarer medicines impact the insurance system. We think you’ll quickly see how easy it is for insurance plans to provide robust drug coverage for patients who need new medicines without fear of significant cost increases.

 

Additional Tools

 

In addition to these tools, the site includes an animated video that follows a molecule from the lab through the drug development process, and it features a range of downloadable infographics on topics – from where new drugs are being developed to the role of private sector R&D in drug development.

 

With this resource, BIO has created a one-stop shop for factual information and answers to some of the most hotly debated questions regarding the role of drugs in our nation’s health care system.

January 2017 -Understanding 21st Century Cures for Drugs and Devices

February 1, 2017

This month we’ll discuss the 21st Century Cures Act – a $6.3 billion, nearly 1,000-page, comprehensive legislation package that passed the U.S. House and Senate in late December 2016. 21st Century Cures overhauls the way drugs and devices will be coming to market; the legislation offers grant funding to states to help fight the opioid epidemic and addresses mental health laws and resources. It also places a big emphasis on research funding – especially for cancer and neurodegenerative diseases – and patient rights. All of these factors are expected to change the research-to-commercialization pathway. Please join us as we learn more about the act and its impact on patients, regulators, and large and small companies.

Presenters:

Jeanne Haggerty, Senior Vice President, Federal Government Relations
BIO

Lynn Tyler, Partner
Barnes & Thornburg LLP

Moderator:

Kristin Jones
Indiana Health Industry Forum

The Indiana Health Industry Forum and Barnes & Thornburg LLP partner to present a monthly seminar series on critical issues in life science. Each month, at lunch, a policymaker or a panel in the field of life science will be available to answer questions concerning the major challenges and opportunities in the life science industry. We hope you will join us.

For more information on upcoming programs, please visit www.ihif.org/pages/lifescience

Follow us on Twitter @IHIF1 #LifeScienceLunch @BTLawNews

BIO Press Release: National Bioscience Report Shows Industry Creating Jobs and Driving Innovation

June 7, 2016
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NEWS RELEASE
1201 Maryland Avenue, SW l Ste. 900 l Washington, D.C. l 20024 l 202-962-9200
Web: www.bio.org       Blog: www.biotech-now.org  Twitter: @IAmBiotech
 
For Immediate Release  
   
Contact:      George Goodno 202-962666       Ryan Helwing 800-832-1296

National Bioscience Report Shows Industry Creating Jobs and Driving Innovation

Bioscience industry contributing to U.S. economic growth and improving quality of life for patients
Indiana Maintains Recognition for Being a Large, Diverse Cluster

 

San Francisco, CA (June 7, 2016)-A study released today at the BIO International Convention shows increased employment within the U.S. bioscience industry for the last four consecutive years.  The report also shows impressive bioscience industry strength and resilience, with employment growth of nearly 10 percent since 2001. Among technology sectors the bioscience industry has been a leading performer over this period.

The report, The Value of Bioscience Innovation in Growing Jobs and Improving Quality of Life 2016, finds U.S. bioscience firms employ 1.66 million people, a figure that includes nearly 147,000 high-paying jobs created since 2001. The average annual wage for a U.S. bioscience worker reached $94,543 in 2014. These earnings are $43,000 greater, on average, than the overall U.S. private sector wage of $51,148.

The report further shows that since 2012, the bioscience industry has grown by 2.2 percent with four of its five major subsectors contributing to this overall job gain.  Two of these subsectors-research, testing, and medical labs and drugs and pharmaceuticals-have led growth during the 2-year period with both increasing employment by more than 3 percent.

Indiana’s bioscience industry is recognized again for being large, highly specialized, and standing out in its diversity.  In keeping with findings from recent studies and reports from BioCrossroads, Indiana’s industry has grown by 1.4 percent since 2012 with especially large job gains in drugs and pharmaceuticals. Indiana’s research universities combine to conduct nearly $582 million in bioscience-related R&D. Indiana has been increasing its bioscience patents, which reflect the diversity of the industry with medical devices, agricultural biosciences, biochemistry, and drugs and pharmaceuticals all represented as areas of focus.  Indianapolis-Carmel-Anderson and Lafayette-West Lafayette, IN Metropolitan Statistical Areas are recognized as being specialized in four of the five bioscience subsectors, with Bloomington and South Bend-Mishawaka Metropolitan Statistical Areas recognized as being specialized in three subsectors.

The report also takes the pulse of the broader U.S. innovation ecosystem for bioscience companies and finds this ecosystem rebounding but with mixed results.  The U.S. is experiencing strong gains in bioscience venture capital funding and patents, but a slowdown in bioscience-related university R&D expenditures and declining research funding from the National Institutes of Health (NIH).

In addition to examining the economic value of bioscience innovation, the report takes a focused look at the value of this innovation to patients illustrated via two case studies for patients with lung cancer and Type 2 diabetes.  The value of bioscience innovation is evident in quality of life improvements achieved over the last three decades, but there is more to be done.

“This report highlights the long-term expansion of our industry and the significant impact of the high-paying jobs that come with developing the innovative technologies that are helping to heal, fuel and feed the world. These biotech jobs are a critical economic component to states and local communities across the nation,” said Jim Greenwood, President and CEO of the Biotechnology Innovation Organization. “While the bioscience industry has continued to grow, our analysis shows it is not immune to market realties. State-level legislative and regulatory policies directly impact the innovation that brings research from the lab to the marketplace, and BIO will continue to advocate for effective public policy at every level of government.”

“The bioscience industry continues to prove its economic value by driving U.S. economic growth through innovation, but beyond this economic value, the industry is contributing value to patients every day through improvements to their quality of life,” said Ryan Helwig, Principal and Project Director with TEConomy Partners.

The state-by-state industry assessment is the seventh in a biennial series, developed in partnership by  TEConomy and  BIO, presenting data on national, state, and metropolitan area bioscience industry employment and recent trends.

Additional highlights from the industry economic analysis include:
  • Overall industry employment has increased for four consecutive years, and in 2014 all five of the major industry subsectors grew.
  • The industry continues to create and sustain high-wage jobs, reflecting the high skills and education requirements of an innovative workforce, with the average U.S. bioscience worker earning nearly 85 percent more than the private sector average. Bioscience wages have grown substantially faster than overall private sector wages.
  • The industry is a major economic driver and is well distributed across U.S. states and cities:
    • From 2012 through 2014, 35 states experienced net job growth in the biosciences.
    • Thirty-two states and Puerto Rico have an employment specialization in at least one bioscience subsector (at least 20 percent more concentrated than the nation).
    • For U.S. metropolitan areas, 222 of 381 have at least one bioscience specialization.
  • Through strong economic multiplier impacts, each bioscience industry job generates an additional 4.5 jobs in the U.S. economy. The broader employment impact of the 1.66 million U.S. bioscience jobs is an additional 7.53 million jobs throughout the rest of the economy.
Highlights from the analysis of the innovation ecosystem for the bioscience industry include:
  • TEConomy/BIO see strength in recent venture capital and patenting trends:
    • Venture capital investments in bioscience-related companies have increased significantly from a $10.0 billion per year average in 2012-13 to a $14.4 billion per year average in 2014-15.  The investment levels reached in the last two years represent new highs for bioscience-related venture capital.
    • Innovation continues to drive the biosciences, with more than 100,000 U.S. bioscience patents awarded from 2012 through 2015.  During this period, patent volumes continue to trend upward.
  • Signs of stress remain in metrics of federal research funding and academic R&D activity:
    • Overall funding from NIH has declined by 3 percent from 2012 through 2015, despite an uptick in this latest year.  It should be noted that concerns over this stagnate level of NIH funding led Congress to approve a nearly 6 percent increase for NIH in FY 2016.
    • Across America’s colleges and universities, the pace of R&D spending in bioscience-related research areas has slowed considerably.  From 2012 through 2014, the average annual increase in bioscience-related university R&D was 0.6 percent, while during the preceding 10-year period annual increases averaged 7 percent.
The TEConomy/BIO report includes individual profiles for all 50 states, the District of Columbia and Puerto Rico, and can be found on the BIO website at bio.org/jobs2016.  Indiana’s report is availablehere.

About BIO

BIO is the world’s largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products. BIO also produces the BIO International Convention, the world’s largest gathering of the biotechnology industry, along with industry-leading investor and partnering meetings held around the world. BIOtechNOW is BIO’s blog chronicling “innovations transforming our world” and the BIO Newsletter is the organization’s bi-weekly email newsletter.  Subscribe to the BIO Newsletter.

About TEConomy
TEConomy Partners, LLC is a global leader in research, analysis, and strategy for innovation-based economic development. Today we’re helping nations, states, regions, universities, and industries blueprint their future and translate knowledge into prosperity.  The Principals of TEConomy Partners include the authors of the prior Battelle/BIO State Bioscience Development reports, published since 2004.  For more information, please visit http://www.teconomypartners.com.

About IHIF

The Indiana Health Industry Forum is the state affiliate of the Biotechnology Innovation Organization (BIO).  IHIF is a statewide trade association representing members of Indiana’s health science business community.  Our mission is the connect key stakeholders to: enhance business networks, advocate for member interests, develop workforce skills, and provide strategic vision in the interest of growing the state’s health industry economy and reputation.  For more information or to become a member, please visit www.ihif.org.

News Release: Senator Donnelly Honored as BIO Legislator of the Year

April 13, 2016

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1201 Maryland Avenue, SW l Ste. 900 l Washington, D.C. l 20024 l 202-962-9200

Web: www.bio.org  Blog: www.biotech-now.org  Twitter: @IAmBiotech

For Immediate Release Contact: George Goodno
202-962-9660

Senator Donnelly Honored as BIO Legislator of the Year

Washington, D.C. (April 12, 2016) – The Biotechnology Innovation Organization (BIO) announced today its selection of Senator Joe Donnelly (D-IN) as a Legislator of the Year for 2016. Senator Donnelly receives the award in conjunction with BIO’s Legislative Day Fly-In.

“Senator Donnelly has been a steadfast champion on the issues that matter to our industry. BIO thanks Senator Donnelly for his support of biotechnology in human and animal health, in food and agricultural production, and in generating renewable fuels and bio-based products,” said BIO President and CEO Jim Greenwood. “Through his seats on the Senate Committee on Agriculture, Nutrition and Forestry, the Senate Special Committee on Aging and the Senate Committee on Armed Services, the Senator is a strong and effective leader for the innovation community. We thank him in particular this year for his efforts to find a bipartisan federal solution to prevent a state-by-state patchwork of bioengineered food labeling laws that would upend the American food value chain.”

“As a champion for the thousands of Hoosiers working in the biotechnology industry, Senator Donnelly has demonstrated leadership on issues vitally important to our state and the nation,” said Kristin Jones, President and CEO of the Indiana Health Industry Forum. “The life science industry in Indiana provides an enormous economic impact and provides jobs, both directly and indirectly, for over 57,000 people. We thank Senator Donnelly for his engagement and dedication to the innovative capacity and job creating potential of life science companies, and congratulate him on receiving this award.”

More than 200 biotechnology industry representatives from over 40 states, representing hundreds of thousands of American workers, will participate in hundreds of meetings with Members of the House and Senate during the BIO Legislative Day Fly-In. Participants will discuss issues critical to the biotechnology industry including, drug development, discovery and delivery reforms, targeting abuses of the U.S. patent system while protecting innovation, providing adequate reimbursement for vital therapies under Medicare, FDA funding, tax policy, support for science-based GMO food labeling solutions and capital formation issues relevant to biotechnology companies.

Photos of the award presentation are available upon request.

About BIO

BIO is the world’s largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products. BIO also produces the BIO International Convention, the world’s largest gathering of the biotechnology industry, along with industry-leading investor and partnering meetings held around the world. BIOtechNOW is BIO’s blog chronicling “innovations transforming our world” and the BIO Newsletter is the organization’s bi-weekly email newsletter. Subscribe to the BIO Newsletter.

Upcoming BIO Events 

BIO International Convention
June 6-9, 2016
San Francisco, CA

World Congress on Industrial Biotechnology
April 17-20, 2016
San Diego, CA

BIO Investor Forum
October 18-19, 2016
San Francisco, CA

 

 

 

February 2016 Life Science Lunch

February 16, 2016

Clinical Trials from a Study Site Perspective

The conduct of clinical research requires effective working relationships between the study sites that execute clinical trials and the sponsors that design the trials and provide product for testing. With much riding on study outcomes, understanding what happens behind the scenes may help you design more effective trials.  This month’s discussion will explore some of the bigger technical challenges to running a clinical research site, including:
•    Types of clinical trials, sponsors and study sites
•    Staffing/Workforce requirements,  needs, and challenges
•    Managing study site and sponsor expectations
•    Role of an IRB
•    Subject recruitment, screening, informed consent and enrollment
•    Managing costs

Moderator:

Deborah Pollack-Milgate, Partner

Barnes & Thornburg, LLP

Panelists:

Diana Caldwell

President and Founder

Pearl Pathways

Jenna Sallee

Executive Director

Orthopedic Research Foundation, Inc.

Dr. Scott Denne

Director

CTSI Clinical Research Center at IUPUI

About the Series

The Indiana Health Industry Forum and Barnes & Thornburg LLP partner to present a monthly seminar series on critical issues in life science. Each month, at lunch, a policymaker or a panel in the field of life science will be available to answer questions concerning the major challenges and opportunities in the life science industry. We hope you will join us.

There is no charge to attend, but please register so we know how many lunches to order. Please see registration page for details. Some of the discussion questions will be submitted to the speakers in advance.

For information on upcoming programs, please visit the Life Science Lunch website – http://www.ihif.org/pages/lifescience

Supporting Materials Mentioned in Today’s Discussion

New “Time Is Precious” Video from BIO

TIPIntro

Learn more at TimeIsPrecious.Life

“Research in Your Backyard: Developing Cures, Creating Jobs” PhRMA Report on Clinical Research in Indiana

Introducing New IHIF Member Benefit Program for Workwear and Facilities Services

February 15, 2016

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We are excited to announce that the Indiana Health Industry Forum (IHIF) and BIO Business Solutions are now offering our members a new benefit program through UniFirst Corporation. This program can help you save on a wide selection of uniforms, lab coats, and other clothing items for rental programs or for direct purchase. The UniFirst partnership will also extend to program offerings from UniClean, a single-source provider for all cleanroom and controlled environment garment-related needs. Similar rental programs are also in place for facility service products and microfiber cleaning supplies.

This savings program is the result of collaboration between Indiana Health Industry Forum and the Biotechnology Innovation Organization (BIO), the world’s largest biotechnology trade association.

Member companies of IHIF can realize the benefits from UniFirst’s services through this program, which include:

  •  Uniform and facility service savings of 30-50%
  •  Hygienically clean garments
  •  Dedicated customer service team
  •  3-year fixed pricing
  •  Free lab coat pressing included with rental program
  •  Free company and name emblems on initial installation
  •  No upfront program investment
  •  1 week complimentary service upon new agreement

Want to learn more?

Please click here to complete a brief survey to help assess your company’s needs and interest in UniClean/UniFirst.

For more information about the UniClean/UniFirst programs or to enroll for member savings, please visit bio.org/bbs/unifirst or bio.org/bbs/uniclean.
Learn more about other Savings Solutions and special offers available to you exclusively through your membership in IHIF.  Click here

BIO Releases First-Ever Industry Principles on Value of Biopharmaceuticals

February 5, 2016

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News Release

1201 Maryland Avenue, SW l Ste. 900

Washington, D.C. l 20024 l 202-962-9200

Web: www.bio.org

Blog: www.biotech-now.org

Twitter: @IAmBiotech

For Immediate Release

Contact:Daniel Seaton
202-470-5207

BIO Releases First-Ever Industry Principles on Value of Biopharmaceuticals

Innovative biopharmaceutical industry focused on value, advocating for needed reforms

Washington, D.C. (February 3, 2016) – The Biotechnology Innovation Organization (BIO) today released new Principles on the Value of Biopharmaceuticals. These voluntary Principles represent the first-ever systemic, industry-endorsed set of commitments by research-based biopharmaceutical companies to support comprehensive and sustainable solutions to improve patient access to and affordability of innovative medicines that are transforming how we treat and cure patients with once-devastating diseases.

The following statement may be attributed to BIO President and CEO Jim Greenwood:

“America’s innovative biopharmaceutical companies exist to advance the health and well-being of patients by tackling head-on the unrelenting scientific challenges inherent in the discovery, development and delivery of new, high-value cures and treatments. These Principles represent a commitment by our industry to do our part to improve the ability of patients to access those medicines on a sustainable and affordable basis, while also continuing to take the big risks and make the enormous investments required to fulfill the promise of the next generation of cures.”

Among other principles, BIO members are committed to open dialogue with patients, healthcare providers, and payers on the value of their biopharmaceutical innovations and to take these stakeholders’ views into account in the development and delivery of such cures and treatments.  In addition, BIO and its members will work with such stakeholders, as well as policymakers, to explore a broad range of novel delivery approaches to maximize the value of these innovations for patients and the overall healthcare system, including by seeking to remove legal barriers that currently limit the ability to engage in value-based contracting and communications.

“As evidenced by these Principles, the research-based biopharmaceutical industry welcomes the vigorous public debate about the cost and value of our medical innovations,” Greenwood said.  “BIO members already are doing their part to find sustainable patient-centered solutions, and as an industry we are committed to doing even more.  To effectively accomplish these goals, it is essential that other stakeholders in the healthcare system do their part, as well. To that end, we call upon payers, healthcare providers and policymakers to join with us in designing and implementing comprehensive solutions that will ensure patients continue to benefit from the tremendous medical advances biotechnology has made possible.”

The full Principles on the Value of Biopharmaceuticals are available here. To learn more about the value of innovation, please visit here.

About BIO

BIO is the world’s largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products. BIO also produces the BIO International Convention, the world’s largest gathering of the biotechnology industry, along with industry-leading investor and partnering meetings held around the world. BIOtechNOW is BIO’s blog chronicling “innovations transforming our world” and the BIO Newsletter is the organization’s bi-weekly email newsletter. Subscribe to the BIO Newsletter.

BIO Statement on Senate Judiciary Committee Passage of PATENT Act

June 10, 2015

Washington, D.C. (June 5, 2015) – The Biotechnology Industry Organization (BIO) today issued the following statement regarding the mark-up of The Protecting American Talent and Entrepreneurship (PATENT) Act, championed by Senate Judiciary Committee Chairman Chuck Grassley and Ranking Member Patrick Leahy, along with committee members Sens. John Cornyn, Chuck Schumer, Orrin Hatch, Amy Klobuchar, and Mike Lee:

“BIO appreciates the efforts of members of the Senate Judiciary Committee to include needed reforms to the PTO’s inter partes review (IPR) and post-grant review (PGR) proceedings, aimed at addressing our concerns about the basic fairness of these proceedings to patent owners.

“We remain committed to working with all Senators engaged in the process to include further IPR improvements necessary to ensure that the PATENT Act reflects an appropriate balance between the interests of those who seek to enforce patent rights and those who are accused of infringement.

“Biotechnology companies rely upon the strength of their patents to raise and invest the hundreds of millions of dollars needed to develop and bring to market the next generation of innovations. Without strong patent protections, revenue streams will dry up, degrading our industry’s ability to provide solutions to the most pressing medical, agricultural, industrial and environmental challenges the world faces.”

For additional information:
BIO’s Letter to Senate Judiciary Committee on Managers Amendment to PATENT Act

About BIO

BIO is the world’s largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products. BIO also produces the BIO International Convention, the world’s largest gathering of the biotechnology industry, along with industry-leading investor and partnering meetings held around the world. BIOtechNOW is BIO’s blog chronicling “innovations transforming our world” and the BIO Newsletter is the organization’s bi-weekly email newsletter.” Subscribe to the BIO Newsletter.

NCATS SBIR & STTR Funding to Advance Translational Research & Small Business Innovation

October 14, 2014

Free Webinar for IHIF and BIO Members
Monday, October 27, 2014 – 12:00 pm (EDT)

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Are you interested in learning more about how you can leverage non-dilutive funding to advance your research and technology development? Through its SBIR and STTR funding opportunities, the National Center for Advancing Translational Sciences (NCATS) can help.

Register today to join NCATS and BIO on October 27 for a webinar on how NCATS can support small businesses and technology transfer organizations as they develop and discover new therapies and diagnostics to help move bench research to clinical practice and commercialization.

The webinar is free and open to BIO members and other interested small businesses, research organizations, and venture-backed companies. Leaders from BIO and the NIH SBIR and STTR programs will discuss:

    • Program overviews
    • Benefits of NCATS funding
    • Tips for submitting a successful application
    • Key NCATS focus areas to advance clinical research and patient care
    • Upcoming opportunities and deadlines
    • Other resources and programs, including the Therapeutics for Rare and Neglected Diseases (TRND) and Bridging Interventional Development Gaps (BrIDGs) programs

Register today to take advantage of this exciting opportunity!

Featured speakers:

Cartier Esham, Ph.D.
Executive Vice President for Emerging Companies
Biotechnology Industry Organization
Lili M. Portilla, M.P.A.
Director, Strategic Alliances, NCATS, NIH, U.S. Department of Health and Human Services
Matthew Portnoy, Ph.D.
SBIR and STTR Program Coordinator, NIH, U.S. Department of Health and Human Services

 

Join us on October 27 by registering HERE.

BIO Launches Survey on FDA/Sponsor Interactions During Drug Development

August 8, 2014

Survey responses will help inform Prescription Drug User Fee Act VI negotiations

For Immediate Release Contact:

Daniel Seaton
202-470-5207

Washington, D.C. (August 6, 2014) – The Biotechnology Industry Organization (BIO) today announces a first-of-its-kind survey tool on FDA/Sponsor Interactions During Drug Development to better inform policy initiatives designed to improve FDA and drug sponsor coordination and communication during drug development.  This will serve to inform the next reauthorization of the Prescription Drug User Fee Act (PDUFA VI), which will begin in late 2015 with final enactment expected in 2017.

 
“Sponsor input is critically important for BIO and the entire industry to understand the real challenges associated with the regulatory process to help guide our discussions with FDA and ultimately work with Congress to establish new and effective measures to implement under PDUFA VI,” said John Maraganore, PhD, CEO of Alnylam Pharmaceuticals and Chair of BIO’s Emerging Companies Section Governing Board.

Survey responses will help assess FDA-sponsor interactions during drug development and address problems, particularly those that result  from inconsistencies between review divisions.

The survey will focus on individual clinical programs for products that are in the pre-clinical testing phase through the clinical testing phase, prior to submission of an initial NDA/BLA, and responses will be held strictly confidential, blinded, and aggregated.

Sponsor input will help identify areas where policies, regulations, and practices are working well and should not be changed; and identify areas where policies, regulations, and practices need improvement in order to make the process more efficient and effective.

Participants will have access to the survey tool 24 hours a day, seven days a week so that responses can be updated on a continual basis. The survey is open to all biopharmaceutical representatives regardless of membership within BIO. Participants will be provided with an annual report on the survey results and invited to join exclusive BIO webinars to discuss survey results with industry leaders and regulatory experts.

 

The survey can be accessed at https://fdasurvey.bio.org. Maraganore discussed the upcoming PDUFA VI reauthorization in a recent BIO Buzz Center video interview that can be accessed here.

 
About BIO

BIO is the world’s largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products. BIO also produces the BIO International Convention, the world’s largest gathering of the biotechnology industry, along with industry-leading investor and partnering meetings held around the world. BIOtechNOW is BIO’s blog chronicling “innovations transforming our world” and the BIO Newsletter is the organization’s bi-weekly email newsletter.” Subscribe to the BIO Newsletter.