Hoosiers Work for Health Partners Promote Indiana Innovation on Capitol Hill

July, 2019 – During a recent visit to Washington, D.C., Hoosiers Work for Health partners met with the members of Indiana’s congressional delegation to provide updates on the state’s growing health and life sciences sector which now supports more than 165,000 Hoosier jobs. Partners Eli Lilly and Company, Indiana Biosciences Research Institute, Indiana Health Industry Forum and Quality Connection spoke to members of Congress and their staffs about collaboration within Indiana’s life sciences ecosystem along with the latest research happening in Indiana to address conditions such as diabetes and Alzheimer’s Disease. They also discussed key policy issues including ways to lower costs for seniors enrolled in Medicare.

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  Rep. Greg Pence (IN-6)

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  Rep. Jackie Walorski (IN-2)

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  Rep. Susan Brooks (IN-5)

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  Senator Todd Young

Source: Hoosiers Work for Health

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McAdams and Hollingsworth offer bipartisan bill to ease red tape on promising start-ups

July 24 , 2019 – Washington DC—Congressman Ben McAdams (D-UT) and Congressman Trey Hollingsworth (R-IN) have introduced bipartisan legislation to provide commonsense regulatory relief for America’s growing companies, including many in the bioscience sector.  The Fostering Innovation Act is a narrow fix that allows small emerging growth companies to keep public capital working to fund business needs, such as innovative medical research, rather than expensive regulatory filings.

“The initial years after a company goes public are a critical time for that company’s success and every penny counts.  This bill narrowly targets a subset of public companies that would receive an additional five years of cost-savings through an exemption from an expensive regulatory requirement. That money can then be plowed back into product-testing and development and move them towards becoming more stable and sustainable businesses,” said McAdams.

“America has always been a leader in scientific and medical innovation,” said Rep. Trey Hollingsworth (IN-09). “The Fostering Innovation Act will update our federal regulations, ensuring they do not get in the way of allowing America to develop the next generation of cures.”

The bill extends a Securities and Exchange Commission (SEC) exemption from an external audit requirement for an additional five years for a small subset of emerging growth companies with annual revenue of less than $50 million and less than $700 million in public float. The legislation would be particularly important for Utah’s life science industry, as most biotechnology companies lack revenue for at least a decade as they work towards their first product approval.

“For emerging biotech companies, one-size-fits-all compliance burdens present a costly roadblock to growth and medical progress,” said Biotechnology Innovation Organization (BIO) President and CEO Jim Greenwood. “These companies typically operate for many years without product revenue, meaning that funds needed to comply with unduly burdensome regulations are diverted from their intended purpose – scientific advancement for the benefit of patients and consumers. The Fostering Innovation Act would reduce the cost of Sarbanes-Oxley compliance for these companies – without undermining important investor protections – allowing them to utilize investment capital to spur job creation and advance their potentially life-saving research.”

BioUtah President & CEO Kelvyn H. Cullimore said the legislation will allow capital provided from public financing to more effectively sustain promising companies.

“I commend Representatives Ben McAdams and Trey Hollingsworth for championing the Fostering Innovation Act. Many of Utah’s emerging biotech companies are small start-ups and do not yet generate product revenue. Accessing capital through public financings can be a key tool in sustaining the efforts of these companies in developing technologies that extend and save lives. This pro-business bill will enable those companies to focus critical resources in the lab and not on unnecessary regulatory burdens,” Cullimore said.

“The Fostering Innovation Act makes good business sense for Indiana and our state’s emerging biotech companies by reducing the cost of burdensome regulations,” said Kristin Jones, President and CEO of the Indiana Health Industry Forum. “This bill builds upon the success of the JOBS Act and will enable emerging biotechnology innovators to devote more of their limited resources to potentially lifesaving research and development activities. On behalf of Indiana’s innovative biotechnology companies, I commend Representatives Trey Hollingsworth and Ben McAdams for their leadership.” 

A bipartisan companion bill has been introduced in the Senate.

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AdvaMed Statement on Medical Device Tax Repeal Bill

FOR IMMEDIATE RELEASE                                                              

April 10, 2019

House Bill Targets Looming $20 Billion Tax On MedTech Industry

WASHINGTON, D.C. – Scott Whitaker, president and CEO of the Advanced Medical Technology Association (AdvaMed), issued the following statement on introduction of bipartisan legislation (H.R. 2207) in the U.S. House of Representatives to permanently repeal the medical device excise tax:

“America’s medical technology industry is facing a $20 billion tax increase at year-end, when the current medical device tax suspension expires. Urgent action is essential to protect future medtech innovations that benefit patients and to avoid putting good-paying U.S. jobs at risk.

“House introduction today of the ‘Protect Medical Innovation Act of 2019’ in the 116^th Congress brings us one step closer to ensuring this innovation-stifling burden on the medtech industry never returns, supporting continued American leadership of this vital industry.

“We thank the bill’s lead sponsors, Reps. Ron Kind (D-Wis.), Jackie Walorski (R-Ind.), Scott Peters (D-Calif.), and Richard Hudson (R-N.C.) for their leadership on this issue. This bill – and the strong bipartisan support they have gathered – reflect the high priority this Congress places on patients, jobs, and future investment.

“While past suspensions of the medical device tax have enabled manufacturers to invest in R&D, infrastructure and new hiring – which in turn benefits patients and the U.S. economy – these benefits are at risk. Now that bipartisan legislation to permanently repeal the device tax has been introduced in both the House and Senate, AdvaMed will urge Congress and the administration to act as expeditiously as possible to get rid of the tax once and for all this year.”

# # #

AdvaMed member companies produce the medical devices, diagnostic products and health information systems that are transforming health care through earlier disease detection, less invasive procedures and more effective treatments. AdvaMed members range from the largest to the smallest medical technology innovators and companies. For more information, visit www.advamed.org.

FAST BIOMEDICAL COMPLETES SUCCESSFUL PHASE II TRIAL; RESEARCH FEATURED IN PEER-REVIEWED PUBLICATION CARDIORENAL MEDICINE

Carmel, IN, March 26, 2019 — FAST BioMedical announced today the recent publication of their Phase II clinical trial data on Plasma Volume (PV) measurements in CardioRenal Medicine.

The company’s globally-patented, first-in-class technology directly measures blood volume and kidney function in a clinically-actionable way, which has the potential for profound impact on the care of heart failure, cardio-renal, major surgery, sepsis, critical care, and kidney disease patients. Each year more than 35 million hospitalizations worldwide would benefit from a plasma volume measurement.

The study was conducted at two sites in the U.S. in healthy subjects and patients with varying levels of chronic kidney disease. Included in the study was a measurement of how healthy subjects handled the administration of a volume challenge as evaluated by FAST’s Plasma Volume technology. The primary and the secondary endpoints of pharmacokinetics, safety and accuracy were achieved.

Highlights of the Phase 2 Trial results:
 The FAST injectable proved to be safe and well tolerated.
 The FAST PV technology delivered clinically meaningful results as demonstrated by its ability to stratify patients into the appropriate clinical group.
 The FAST injectable distributes in a manner consistent with the vascular volume and the PV marker remains stable in the vasculature for a period of at least 6 hours, allowing repeat measurements of PV during that time period without re-dosing.
 The FAST PV technology responded precisely and proportionally to a volume challenge given in healthy subjects.
 The technology displayed excellent reproducibility

“I am very pleased with the excellent accuracy and repeatability the FAST BioMedical technique to quantify plasma volume has shown. The demonstrated ability to closely track a fluid challenge is especially compelling. This technology can allow the clinician to have new understanding for both diagnosis and therapy. Congestive heart failure, sepsis and acute kidney injury are conditions where the value of an accurate PV is critical to understand. However, other difficult to diagnose and manage diseases such as hyponatremia, hypertension and chronic kidney disease also will benefit from the test,” stated Bruce A. Molitoris, M.D., FASN, FAST BioMedical’s medical director and co-founder and professor of medicine at Indiana University, and a lead author of the report.

FAST BioMedical’s Plasma Volume measurement technology is being developed to address the shortcomings of the current clinical standard of care for patients with volume instability. In patients presenting with the potential of volume abnormalities, an accurate determination of volume status is critical for appropriate diagnosis and management. Unfortunately, volume assessment is challenging. Current misdiagnosis rates are high and existing standard of care methodologies lack an accurate quantitative measurement. Less accurate indications of volume status have potential negative impact on medical outcomes.

FAST BioMedical’s technology has the potential to provide a clinician with a PV measurement as quickly as 30 to 45 minutes, and provide updated measurements for up to six hours. This allows for the
evaluation of volume changes impacted by clinical treatment, throughout that time. The technology uses a patented fluorescent injectable that works in concert with a patented measurement device.

“There is currently no technology in clinical care that can quickly and easily provide an accurate plasma volume measurement. The FAST BioMedical Technology has the potential to provide this, and, is an advantage for all types of patient care. For example, the management of congestive heart failure patients could be greatly improved by having such a tool,” said Co-author, FAST BioMedical Medical Advisory Board Member and Associate Chief of Emergency Medicine Research at Baylor College of Medicine Dr. Frank Peacock.

CardioRenal Medicine, a peer-reviewed medical journal, recently published a research article on FAST’s Plasma Volume technology. The full article can be found via https://www.karger.com/Article/FullText/496480

FAST BioMedical also had an additional peer-reviewed paper published in the Journal of the American Society of Nephrology (JASN). The publication highlighted FAST’s kidney function data from a successful Phase 2 clinical study. The FAST technology demonstrated impressive measurement accuracy via a high correlation (99%) to the research gold standard. The full article can be found via https://jasn.asnjournals.org/content/29/6/1609.abstract

In January 2019, FAST BioMedical was highlighted in the American Association of Kidney Patients (AAKP), RENALIFE Magazine as its featured Innovation.

About FAST BioMedical
FAST BioMedical is a privately held, late clinical-stage medical technology company based in Carmel, Indiana. The company’s globally-patented, first-in-class technology directly measures blood volume and kidney function in a clinically-actionable way. This has the potential for profound impact on the care of heart failure, cardio-renal, major surgery, sepsis, critical care, and kidney disease patients. The company has been financially supported by the NIH, Elevate Ventures, the Indiana 21st Century Fund, Rose-Hulman Ventures, BioCrossroads, Indiana University Medical Group, The Purdue Foundry Fund, Ellipsis Ventures, VisionTech Partners, and private single family office investors. The FDA has determined the company’s technology met the requirements for an Expedited Review. These products are investigational and not yet approved for human use.

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Congressman Hollingsworth Honored as Innovator in Biotechnology

Pictured above: Amy Walker, BIO, Kristin Jones, IHIF, Rep. Trey Hollingsworth (IN-9), and Chris Wilson, Hoosiers Work for Health

 

Washington, D.C. (April 4, 2019) – Congressman Trey Hollingsworth was recognized today by the Biotechnology Innovation Organization (BIO) for his leadership as an Innovator in Biotechnology. Congressman Hollingsworth received the award in conjunction with today’s BIO Legislative Day Fly-In.

 

BIO’s Innovator in Biotechnology award recognizes Members of Congress who have been collaborative partners, advocates, and champions of the biotechnology and life sciences industries.

 

“The life sciences industry in Indiana provides jobs for over 58,000 people. Congressman Hollingsworth has been an invaluable advocate for the biotechnology community – both in Indiana’s 9^th District and the nation at large,” said Kristin Jones, President & CEO of the Indiana Health Industry Forum. “On behalf of the Indiana life science industry, we thank him for outstanding leadership and dedication to supporting the innovative capacity and job-creating potential of American life science companies.”

 

“Congressman Hollingsworth has been a stalwart advocate for sound public policies that advance the jobs creating potential of America’s biotechnology industry as we address the most pressing medical, agricultural, industrial and environmental challenges facing our nation and the world,” said BIO President and CEO Jim Greenwood. “His commitment to support the needs of America’s innovative life science companies allows them to focus on what matters – delivering life-saving and life-enhancing products.”

 

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, trade, tax policy, Farm Bill Implementation, protecting the Renewable Fuel Standard and capital formation issues relevant to biotechnology companies.

Senator Young Honored as Innovator in Biotechnology

Washington, D.C. (April 4, 2019) – Senator Todd Young was recognized today by the Biotechnology Innovation Organization (BIO) for his leadership as an Innovator in Biotechnology. Senator Young received the award in conjunction with today’s BIO Legislative Day Fly-In.

 

BIO’s Innovator in Biotechnology award recognizes Members of Congress who have been collaborative partners, advocates, and champions of the biotechnology and life sciences industries.

 

“The life sciences industry in Indiana provides jobs for over 58,000 people. Senator Young has been an invaluable advocate for the biotechnology community – both in Indiana and the nation at large,” said Kristin Jones, President & CEO of the Indiana Health Industry Forum. “On behalf of the Indiana life science industry, we thank him for outstanding leadership and dedication to supporting the innovative capacity and job-creating potential of American life science companies.”

 

“Senator Young has been a stalwart advocate for sound public policies that advance the jobs creating potential of America’s biotechnology industry as we address the most pressing medical, agricultural, industrial and environmental challenges facing our nation and the world,” said BIO President and CEO Jim Greenwood. “His commitment to support the needs of America’s innovative life science companies allows them to focus on what matters – delivering life-saving and life-enhancing products.”

 

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, trade, tax policy, Farm Bill Implementation, protecting the Renewable Fuel Standard and capital formation issues relevant to biotechnology companies.

 

 

 

Patented drug therapy for lung condition has been exclusively optioned to Theratome Bio

Proteins from adult stem cells might reduce inflammation caused by Acute Respiratory Distress Syndrome

FOR IMMEDIATE RELEASE

Feb. 11, 2019

 

INDIANAPOLIS — A patented Indiana University School of Medicine discovery that uses proteins, lipids and nucleic acids secreted by adult stem cells to treat Acute Respiratory Distress Syndrome, or ARDS, has been optioned to Theratome Bio, an Indianapolis-based life sciences company.

One of the symptoms of ARDS is a buildup of fluid and severe inflammation in the lungs, which impairs their ability to exchange oxygen and carbon dioxide. More than 200,000 people in the U.S. are affected by ARDS each year, and the mortality rate is approximately 40 percent.

The patented IU discovery uses the secretome from the stem cells as a biologic therapeutic to reduce the inflammation and buildup of fluid in the lungs. The IU Innovation and Commercialization Office exclusively optioned the treatment to Theratome Bio, which is building a portfolio of therapeutics based on the secretome of stem cells.

Michael Coleman

Michael Coleman, president and CEO of Theratome Bio, said: “There is no effective pharmacotherapy for ARDS. Mechanical ventilation is the standard of care, and innovation aimed at improving effectiveness and reducing ventilator-induced lung injury is ongoing. But mechanical ventilation does not address the underlying physiologic causes of ARDS.

“The IU School of Medicine innovation, discovered by Dr. Keith March — who serves as Theratome Bio’s chief medical officer — has the potential to treat ARDS by reducing inflammation, enhancing bacterial clearance and restoring capillary barrier function.”

Coleman said the cell-free therapy is easier to manufacture and store than using cells, which have shown benefit in early-stage clinical trials. The cell-free approach also offers defined potency and immediate bioavailability. It presents a therapeutic more consistent with a traditional pharmaceutical model than does using live cells.

“Developing this ARDS therapy aligns with Theratome Bio’s development plan to target acute treatments with a high medical need,” Coleman said. “Our next step to develop the work is performing further studies to confirm dosing levels and manufacturing needs for clinical trials.”

About Indiana University Innovation and Commercialization Office

Indiana University ICO is tasked with the protection and commercialization of technology emanating from innovations by IU researchers. Since 1997, IU research has generated almost 3,200 inventions resulting in more than 4,800 global patent applications. These discoveries have generated more than $145 million in licensing and royalty income, including more than $115 million in funding for IU departments, labs and inventors.

 

Media Contact

Steve Martin

IU Communications

Phone: 317-278-1505 | Email: stgmart@iu.edu

2019 Indiana Session Bill Watch

House

House Public Health Committee

House Committee on Commerce, Small Business and Economic Development

1001

• HB 1001: State budget.

1029

• HB 1029: Prescription drug pricing study committee.

1179

• HB 1179: Prior authorization of prescription drugs.

1228

• HB 1228: Prescription drug importation study.

1246

• HB 1246: Pharmacy matters.

1249

• HB 1249: Medicaid prescription drug program.

1307

• HB 1307: Health care service cost sharing.

1334

• HB 1334: Provider diagnostic information release.

1351

• HB 1351: Strategic plan on dementia.

1354

• HB 1354: Sickle cell disease grant program.

1414

• HB 1414: Labeling of food products.

1570

• HB 1570: Prescription price.

1593

• HB 1593: Certified technology park funding.

Senate

Senate Health and Provider Service Committee

Commerce and Technology

Tax and Fiscal Policy

SR 26

• Patient Records Confidentiality
  • Urges Congress to amend federal law concerning confidentiality of patient records

33

• SB 33: Comprehensive addiction recovery centers.

133

• SB 133: Prescription drug listed as an opioid on label.

154

• SB 154: Small business council.

157

• SB 157: Economic development incentive accountability.

166

• SB 166: Treatment of Lyme disease.

176

• SB 176: Transfer of prescription drugs.

233

• SB 233: Business personal property tax exemption.

242

• SB 242: Telemedicine and medical devices.

298

• SB 298: Small business job creation tax credit.

312

• SB 312: Mandatory electronic prescriptions.

386

• SB 386: Health care comparison information and program.

415

• SB 415: Essential off-patent or generic drugs.

444

• SB 444: Medicaid based statewide health plan.

563

• SB 563: Economic development.

584

• SB 584: Fetal cell research.

585

• SB 585: Continuous prescription drug coverage.

The Indiana Health Industry Forum Announces 2018 Legislator of the Year

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December 17, 2018 – INDIANAPOLIS, IN – The Indiana Health Industry Forum (IHIF) today announced Indiana Congressional Representative Trey Hollingsworth (IN-9) as the group’s 2018 Legislator of the Year. The award is presented annually to legislative leaders who demonstrate a strong commitment to public health policy and service to Indiana’s health science business community.

“Representative Hollingsworth has been a strong proponent of Indiana’s bioscience industry”, said Kristin Jones, President and CEO of IHIF. “We applaud his support of the Fostering Innovation Act which provides financial management tools that can considerably aid young bioscience companies here in Indiana and nationwide. He has also actively connected with life science companies in his district and shown a deep understanding of the challenges facing companies in the industry.”

“The availability and effectiveness of a cure is what stands between life and death. For generations, the United States has led the world in biotechnology innovation, successfully pushing limits to find cures for some of the deadliest diseases,” said Representative Trey Hollingsworth. “Our country’s laws should allow for continued innovation and research for these cures, not prevent new ideas from potentially saving lives.”

Representative Hollingsworth was also recognized earlier this year as one of the Biotechnology Innovation Organization (BIO)’s “Innovators in Biotechnology” in recognition of his efforts to embrace the value of biotechnology and promote public policies to unleash the potential of life-saving innovations. BIO gives this award to Members of Congress who have been collaborative partners, advocates, and champions for the biotechnology and life sciences industries.

Previous IHIF Legislator of the Year award recipients include: Senator Joe Donnelly (2017), Representative Larry Bucshon and State Senator Patricia Miller (2016), Representative Susan W. Brooks (2015), and State Representative Ed Clere (2014) and State Senator Brandt Herschman (2014).

 

About IHIF:

IHIF is a statewide trade association representing Indiana’s bioscience business community. The diverse members of the Indiana Health Industry Forum generate the collective voice of the state’s health and life science industry. Our mission is to 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. To learn more, please visit www.ihif.org.

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