Archive for the ‘Uncategorized’ Category

One person’s efforts could fund work that saves thousands of lives.

April 10, 2019
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ResearchHERS
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Congressman Hollingsworth Honored as Innovator in Biotechnology

April 9, 2019

Hollingsworth award

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 9th 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

April 9, 2019

Young Award 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

February 14, 2019

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

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, 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: 

2019 Indiana Session Bill Watch

January 16, 2019

House

House Public Health Committee

House Committee on Commerce, Small Business and Economic Development

1001

1029

1179

1228

1246

1249

1307

1334

1351

1354

1414

1570

1593

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

133

154

157

166

176

233

242

298

312

386

415

444

563

584

585

The Indiana Health Industry Forum Announces 2018 Legislator of the Year

December 17, 2018

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.

Trey Hollingsworth“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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Apexian Presents at ASCO Palliative Care Meeting

December 5, 2018

Apexian Logo Font

FOR IMMEDIATE RELEASE – 

Apexian Pharmaceuticals presents data on their lead drug for anti-chemotherapy-induced peripheral neuropathy (CIPN), APX3330, at ASCO Palliative Care and Symptom Management meeting

 

Indianapolis, IN – December 5, 2018 – Chemotherapy causes chemotherapy-induced peripheral neuropathy (CIPN) in a significant number of patients, yet the pharmaceutical landscape is completely devoid of treatments to prevent CIPN. The tingling, burning, pain or numbness in the extremities can limit or stop cancer treatment. And, in half the patients affected, CIPN’s symptoms persist five years or more after treatment ends. Apexian Pharmaceuticals aims to change that with their lead compound, APX3330.

 

Data presented at the meeting showed continued preclinical support for APX3330 as a potential anti-CIPN treatment, particularly for patients treated with cisplatin or oxaliplatin. Preclinical results presented show APX3330 can block tumor growth while protecting nerve cells.

 

APX3330, an oral treatment, is currently in a Phase I oncology trial for safety. A Phase II trial is planned in 2019 for anti-tumor and anti-CIPN.

 

Apexian’s founder and Chief Science Officer, Mark Kelley, PhD, presented the trial’s results in ASCO’s Symptom Management Meeting in San Diego, November 16-18, 2018.

 

Currently ASCO does not recommend any drug for preventing or treating CIPN.

 

“CIPN is a disease with high unmet need and it is exciting to see that APX3330 may have a role to play in addressing the need, says Steve Carchedi, President & CEO of Apexian”. “We are committed to developing a portfolio of novel APE1/Ref-1 compounds that will enhance the lives of patients”.

 

The success of APX3330 builds upon three decades of research by Kelley and his colleagues in modulating a key DNA repair protein, APE1/Ref-1. APX3330 tweaks the protein’s activity to prevent or repair neuronal damage without stimulating cancerous tumors.

 

APX3330 is Apexian’s lead compound in its growing drug development pipeline.

 

About Apexian Pharmaceuticals

Apexian Pharmaceuticals is a patient-centered biotechnology company dedicated to developing novel anti-cancer compounds that target the multiple functions of the APE1 protein. Apexian’s research is grounded and driven by the belief that “better is always possible.” Please visit www.ApexianPharma.com for more information.

 

Media Contact:

Email: PR@Apexianpharma.com

Roger D. Miller, COO

Telephone: 844-463-3330 x100

IHIF Statement on U.S.-Mexico-Canada Agreement

October 11, 2018

INDIANAPOLIS (October 11, 2018) – Indiana Health Industry Forum President and CEO Kristin Jones released the following statement on the recent United States-Mexico-Canada Agreement:

“The new United States-Mexico-Canada Agreement (USMCA) is a positive step forward for America’s innovative health care sector. For decades, biotechnology pioneers from Indiana and across the country have been responsible for groundbreaking discoveries that have improved the lives of patients across the globe. The new business standards in this agreement will help continue this leadership by providing incentives for companies to continue to innovate, discover and grow.”

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Related Statements from IHIF Partners:

AdvaMed Statement from Scott Whittaker

PhRMA Statement from Stephen Ubl

BIO Statement from Jim Greenwood

Waters has acquired DESI 2D from Prosolia

September 6, 2018

Today, July 23, 2018, Waters Corporation (NYSE: WAT), Prosolia, Inc. and the Purdue Research Foundation (PRF) announced that Waters® acquired exclusive rights to Desorption Electrospray Ionization (DESI) technology for all mass spectrometry applications from Prosolia and PRF.

“The acquisition of DESI technology bolsters Waters’ portfolio of mass spectrometry imaging innovations, a rapidly expanding MS technique for biomedical research and related applications,” said Chris O’Connell, Chairman and Chief Executive Officer, Waters Corporation. “DESI mass spectrometry imaging provides complementary and actionable data when compared to classical histopathology imaging technologies with major advantages in analyzing the molecular fingerprint within a sample, thus delivering deeper biological insights. Ultimately, these insights will lead to better understanding of disease and enable the development of new, more effective medical therapies.”

“We at Prosolia are proud of our role in developing and commercializing DESI technology,” said Justin Wiseman, Chief Executive Officer, Prosolia. “The potential for MSI analysis using DESI technology is significant because of the quality of the data, the minimal sample preparation required, and the non-destructive nature of the technique allowing for multimodal analysis on a single sample.”

Waters will continue to support its customers who are already realizing the benefits of DESI technology with their Xevo™ and Synapt time-of-flight mass spectrometers. As the technology transitions from Prosolia to Waters, Prosolia will also continue to supply the DESI 2D technology for certain Thermo Scientific and Agilent mass spectrometer configurations until September 30, 2019. Prosolia will be responsible for and will continue to honor its warranty commitments made prior to Waters’ acquisition of the DESI technology to those scientists and organizations who currently have a DESI 2D source unit on any non-Waters mass spectrometer.

Read the full press release here.

FAST BioMedical’s Phase 2 Clinical Trial Results Published in the Prestigious Journal of the American Society of Nephrology

August 9, 2018

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Posted 7:32 PM

Carmel, IN — May 18, 2018 — FAST BioMedical announced today the recent publication of their Phase 2 clinical trial data on kidney function measurement in the Journal of the American Society of Nephrology. The results were presented in an article entitled “A Novel Method for Rapid Bedside Measurement of GFR”.

The Phase 2 clinical trial assessed the safety and performance of the FAST technology. Performance was determined by comparing the FAST technology’s kidney function measurement (Measured Glomerular Filtration Rate or mGFR) to an iohexol clearance measurement methodology in patients with varying degrees of kidney function. Iohexol is a research methodology for accurate kidney function measurement. Iohexol is not FDA approved and is considered too cumbersome, with results too delayed, to be commercially viable.

The FAST technology demonstrated impressive accuracy via a high correlation to iohexol clearance. The per patient linear correlation to iohexol was greater than 99%. The FAST technology also demonstrated a strong safety profile and excellent repeatability.

“The results in this publication demonstrate that an accurate, safe, and clinically meaningful kidney function measurement is a major step closer to the patient.” said Dr. Bruce Molitoris, FAST BioMedical Medical Director and Co-Founder. “This technology has the potential to move us past the current poor estimations, to a clinically actionable answer for the individual patient.”

“The FAST technology was easy to use and can be comfortably translated to routine hospital protocols. It was well tolerated, and there were no serious adverse events,” said Dr. Dana Rizk, a nephrologist at University of Alabama at Birmingham Hospital, and one of the lead investigators for the trial. “This new technology has the potential to allow physicians to detect early kidney function loss and renal reserve, thus enabling earlier therapeutic interventions. In short, it opens the door to exciting new endeavors in the world of Nephrology.”

About FAST BioMedical

FAST BioMedical is a privately held, clinical-stage medical technology company 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 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.

For more information, please visit www.FASTBioMedical.com