2019 Indiana Session Bill Watch

January 16, 2019

House

House Public Health Committee

House Committee on Commerce, Small Business and Economic Development

1029

1179

1228

1249

1334

1351

1354

1414

1570

1593

Senate

Senate Health and Provider Service Committee

Commerce and Technology

Tax and Fiscal Policy

33

133

154

157

166

176

233

242

298

312

386

415

444

563

584

585

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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

Indigo BioAutomation, Inc. Receives ISO 13485:2016 Certificate

July 30, 2018

Indigo Bioautomation

Indigo’s Quality Management System demonstrates excellence by obtaining an ISO 13485:2016 certificate

Friday July 20th, 2018

Carmel, IN – Indigo BioAutomation, Inc. (Indigo), a leading provider of software solutions for laboratory automation, announced today that it has received an ISO 13485:2016 certificate from British Standards Institute (BSI) Group. This certificate demonstrates the organization’s ongoing commitment to providing the highest quality medical device solutions, products, and services to its customers. Indigo previously held ISO 9001:2008 certification.

 

The International Organization for Standardization (ISO) is the world’s largest developer and publisher of international standards for the implementation of quality management systems. ISO 13485:2016 identifies the requirements for a medical device focused quality management system to ensure an organization has the ability to consistently meet both regulatory and customer requirements.

 

“This certification is a testament to the high level of performance and quality control we expect at Indigo BioAutomation during the development, production and support of our software,” commented Randall Julian, President, Founder and CEO of Indigo. “This level of rigor is important to ensuring our software continues to provide accurate, reliable, and reproducible results for our customers.”

 

Indigo registered with FDA and listed their flagship product, ASCENT, as a class I exempt medical device in September of 2017.

 

“Receiving this ISO13485:2016 certificate strongly reflects Indigo’s commitment to quality as well as our ability to bring safe and effective products to the market,” said Brian Huff, Director of QA/RA for Indigo. “This certificate also demonstrates Indigo’s drive to raise the level of quality throughout the organization and satisfy a very rigorous standard for medical device quality systems in an innovative manner.”

 

BASi and Seventh Wave Laboratories Combine Operations to Provide Broader Solutions and Greater Scientific Expertise to Clients

July 2, 2018

WEST LAFAYETTE, Ind., July 02, 2018 (GLOBE NEWSWIRE) — Bioanalytical Systems, Inc. (NASDAQ:BASI) and Seventh Wave Laboratories, LLC, today announced that they have signed an asset purchase agreement (APA) joining operations to provide broader solutions and greater scientific expertise to clients.

BASi provides contract research services and niche instrumentation to the life sciences industry, primarily in drug research, discovery, and development in commercial and academic settings. The company’s non-clinical toxicology laboratory provides clients with drug safety and general toxicology services, including carcinogenicity studies, DART and juvenile toxicology studies. The company offers regulated bioanalytical method development and analysis. In addition, the company provides non-clinical PK/PD from a purpose-built in vivo discovery center that includes a dedicated vivarium utilizing BASi’s proprietary Culex® Automated Sampling Systems.

Seventh Wave Laboratories provides consultative integrated services to assess safety and efficacy of pharmaceuticals and devices. Bioanalysis, pharmacokinetics, and histopathology services cover discovery through regulatory approval, and are fully GLP compliant. The company’s in vivo services focus on discovery stage support. Unique pharmacology model development and special pharmacology models are also offered, with emphasis on hepatitis B virus pharmacology using liver humanized chimeric models.

By combining offerings, the two companies expect to capitalize on their collective skill sets, expertise, and assets to create a comprehensive portfolio highlighting:

  • Lead optimization and candidate selection
  • BASi Culex® Automated Sampling Systems
  • In vivo toxicology and pharmacology
  • GLP in vivo services
  • GLP and non-GLP bioanalysis
  • Histopathology including immunohistochemistry and image analysis
  • Pharmacokinetics
  • In vitro and in vivo bioequivalence testing

Established in 2003, Seventh Wave Laboratories has a proud history and in 2017 generated annual revenues of approximately $11 million.

“For both BASi and Seventh Wave Laboratories, our success has been built on a solid foundation of quality, on-time delivery and a commitment to providing personalized and responsive service to our clients,” said Philip Downing, senior vice president of preclinical services at BASi. “We believe Seventh Wave’s scientific depth and expertise in histopathology, pharmacokinetics, investigative toxicology and pharmacology model development perfectly complement BASi’s offerings and make this combination an excellent strategic fit. By bringing our companies together, we intend to provide the same dedication and focus our clients have come to expect, while delivering expanded options and more comprehensive solutions. We are proud and very excited to begin this new venture with Seventh Wave.”

John Sagartz, DVM, PhD, DACVP, president and founder of Seventh Wave Laboratories, added, “We’re so thrilled to be able to bring together these two organizations. Over the past 15 years, we’ve engaged hundreds of clients to facilitate their discovery and development needs. With BASi, we add capabilities that have often been requested, but have not been available through Seventh Wave alone. Through extensive collaborations over the past several years, it is apparent that the two organizations share a focus on delivering quality and timely services. We expect the enhanced capabilities and shared core values to facilitate enriched client interactions and further growth.”

Transaction Summary

Pursuant to the terms of the APA, Seventh Wave Laboratories received 1,500,000 Common Shares of BASI and approximately $7 million in cash (a portion of which remains in escrow) in exchange for substantially all of its assets. In order to finance the cash component of the consideration, BASi entered into a new term loan with First Internet Bank for $5.5 million and increased the borrowing availability under its existing line of credit from $2.0 million to $3.5 million. As of the closing of the transaction, Seventh Wave Laboratories held approximately 17% of BASi’s issued and outstanding Common Shares.

A Current Report on Form 8-K containing further details regarding the APA and the transaction will be filed by BASi.

About Bioanalytical Systems, Inc.

BASi is a pharmaceutical development company providing contract research services and monitoring instruments to the world’s leading drug development companies and medical research organizations. The Company focuses on developing innovative services and products that increase efficiency and reduce the cost of taking a new drug to market. Visit www.BASinc.com for more information about BASi.

About Seventh Wave Laboratories, LLC.

Seventh Wave Laboratories is a consulting-based contract research laboratory located in Maryland Heights, Missouri that provides integrated services for discovery and preclinical drug development. By integrating PK/ADME, bioanalysis, toxicology and pathology, the company provides local, national and international clients a multidisciplinary environment that accelerates their program and goals with focused strategy and execution. For more information, visit www.7thwavelabs.com.

This release may contain forward-looking statements that are subject to risks and uncertainties including, but not limited to, risks and uncertainties related to changes in the market and demand for our products and services, the development, marketing and sales of products and services, changes in technology, industry standards and regulatory standards, and various market and operating risks detailed in the company’s filings with the Securities and Exchange Commission.

Company Contact:
Jill Blumhoff
Chief Financial Officer &
Vice President of Finance
Phone: 765.497.8381
jblumhoff@BASinc.com

A photo accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/9af55093-8993-43ce-888d-c3308d3af4e5

Indiana MSA’s Highlighted in National Bioscience Economic Impact Report

July 2, 2018

June 5, 2018

Contact: Kristin Jones, IHIF

kjones@ihif.org or 317-752-9809

BOSTON, MA and INDIANAPOLIS, IN – The Biotechnology Innovation Organization (BIO),  TEConomy Partners LLC, and PMP Public Affairs Consulting today released the 2018 report, “Investment, Innovation and Job Creation in a Growing U.S. Bioscience Industry”.  This eighth, biennial report focuses on the economic progress and footprint of the industry geographically including the performance, positioning and latest trends in the bioscience industry for the nation, states, and metropolitan areas.

BIO’s latest report shows that the U.S. bioscience industry has reached record setting annual economic impact, venture capital investment and job growth numbers. Among U.S. technology sectors, the bioscience industry is a leading economic driver and job generator across the U.S., with job growth in 41 states.  The U.S. bioscience industry directly employed 1.74 million people in 2016 in more than 85,000 establishments.  Industry wages are consistently higher and growing faster, on average, than those for the overall economy with the average bioscience worker earning nearly $99,000 in 2016.  Combined, the industry accounts for $2 Trillion in national economic output.

The report shows that Indiana is well-positioned.  The state is considered large with specialized employment concentrations in three of the five bioscience subsectors, excelling in: Agricultural Feedstocks and Industrial Biosciences, Drugs and Pharmaceuticals, and Medical Devices and Equipment.  While still considered a strong player, Indiana did not appear as large and specialized in the category of Bioscience-Related Distribution.  The Indianapolis metropolitan area however, ranked 23rd in areas with the largest related employment levels in 2016, with 4,341 people directly employed.

The report’s focus on metropolitan areas also shows that the bioscience industry’s impact is statewide, with the communities of Indianapolis – Carmel – Anderson, Lafayette -West Lafayette, Bloomington, Terre Haute, South Bend – Mishawaka, Louisville – Jefferson Co, IN-KY, Chicago – Naperville – Elgin, IL – IN – WI, and Evansville, IN-KY being recognized for their strengths across all five of the subsectors.  In the U.S., only twenty-six metro regions have a specialized concentration in at least three bioscience subsectors,  Indiana communities claim three of those spots (Indianapolis, West Lafayette, and Bloomington).

“This report affirms that Indiana’s bioscience sector is both geographically broad and community-driven with regional centers of excellence that combine to create a strong industry presence”, said Kristin Jones, President and CEO of the Indiana Health Industry Forum (IHIF).   “Local officials may want to consider using this data to help further their economic development strategies and we stand ready to assist”.

IHIF is participating in the 2018 BIO International Convention taking place this week in Boston, Massachusetts. For more information about the report, state-specific highlights, and the Convention, please visit https://www.bio.org/insights.

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.

About IHIF

The Indiana Health Industry Forum (IHIF) is the state affiliate of the Biotechnology Innovation Organization (BIO).  IHIF is a statewide trade association representing members of Indiana’s bioscience 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.

 

Apexian Pharmaceuticals’ Dr. Mark Kelley recognized as an outstanding researcher at Indiana University/Purdue University IUPUI

April 26, 2018

Apexian Logo Font

Indianapolis, IN – Apexian Pharmaceuticals, a clinical-stage biotechnology company focused on developing safe and effective therapy for patients with high unmet medical needs, is pleased to announce that its Chief Scientific Officer, Mark Kelley, PhD, was recognized as an outstanding scholar and researcher during the annual IUPUI Chancellor’s Academic Honors Convocation on April 20. Dr. Kelley was named the recipient of the Glenn W. Irwin Jr., M.D. Research Scholar Award for his high level of achievement in research, scholarship, or creative activity that stands as a visible representative of excellence for the entire campus.  The award recognizes the outstanding achievements of Dr. Glenn W. Irwin Jr., who was a professor, dean of IU School of Medicine, chancellor of the Indianapolis campus and vice president of IU.

The convocation, hosted by IUPUI Chancellor Nasser H. Paydar, celebrated excellence across all areas of IUPUI’s mission: teaching and learning; research, scholarship and creative activity; civic engagement; and diversity.

Steve Carchedi, Apexian’s CEO, said, “Dr. Kelley is a dedicated researcher whose work is making a significant impact in the lives of patients. This is a well-deserved recognition and we are honored that he is leading the way for Apexian.”

Dr. Kelley’s work has focused on translational research in DNA damage and repair to determine how those activities can be exploited therapeutically to treat cancers and protect normal cells from DNA damage. He has focused specifically on the enzyme called APE1 as a therapeutic target in cancers and other diseases. Dr. Kelley discovered and has been developing a specific inhibitor of APE1, called APX3330, which is now being studied in a Phase I clinical trial. The drug has potential uses in a number of cancers including ovarian, colon, bladder, pancreatic, leukemia, and other adult and pediatric cancers.

Dr. Kelley is the Betty and Earl Herr Professor of Pediatric Oncology Research and professor of pediatrics and of biochemistry and molecular biology at IU School of Medicine and associate director of basic science research at the Indiana University Melvin and Bren Simon Cancer Center.

About Apexian Pharmaceuticals
Apexian Pharmaceuticals is a clinical-stage biotechnology company focused on developing safe and effective therapy for patients with high unmet medical needs.  Apexian’s lead drug candidate is named APX3330. To learn more about Apexian Pharmaceuticals, please visit the company’s website at www.ApexianPharma.com

Media Contact: Roger D. Miller
Email: PR@Apexianpharma.com
Telephone:  844-463-3330 x113