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Hollingsworth Passes Bill to Cut Red Tape, Help Hoosier Companies Making Life-Saving Breakthroughs

February 15, 2018
FOR IMMEDIATE RELEASE Contact: Katie Webster
February 14, 2018 (202) 225-5315
 

 

WASHINGTON, D.C. – Today, the U.S. House of Representatives passed H.R. 1645, the Fostering Innovation Act, introduced by Rep. Trey Hollingsworth (R-IN) and Rep. Krysten Sinema (D-AZ), as part of a bipartisan legislative package to provide financial regulatory relief to Americans. H.R. 1645 helps ensure that costly regulations don’t stand in the way of successful biopharmaceutical research.

 

“This country has led the world in biotechnology innovation, successfully pushing limits to find cures for some of the deadliest diseases,” said Representative Hollingsworth. “The Fostering Innovation Act will right-size the regulatory environment that detracts from advancements, enabling America to develop the next generation of cures to combat illnesses that plague Hoosiers.”

 

Read the full text of the legislation, here.

 

The bioscience and biotechnology sector in Indiana has expressed strong support of the Fostering Innovation Act:

 

Kristin Jones, President and CEO, Indiana Health Industry Forum: “While the Fostering Innovation Act will be of broad benefit to companies in the bioscience sector across the country, Hoosier companies and patients also stand to benefit.  By eliminating a costly administrative burden, pre-revenue biotech companies will be able to focus more of their scarce investment funding on developing new therapies and adding high-wage jobs, instead of paying for expensive internal audits.  As more Indiana bioscience companies mature and look to IPOs as a viable fundraising option, we expect the benefits of the Act to accrue quickly.  We commend Rep. Hollingsworth for his leadership on this issue.”

 

Jeff Schwegman, Ph.D., Founder & CEO of AB BioTechnologies, Inc. (Bloomington, IN): “The Fostering Innovation Act eliminates the costly burdens of extensive audits to many of our clients, allowing them to invest further in drug development in Indiana. Ultimately these savings will be passed on to patients which benefits the community as a whole. Thanks to Representative Hollingsworth’s depth of understanding of the life sciences sector in Indiana, he was able to pass meaningful legislation that will provide a benefit to Hoosiers at all levels.”

 

 

Background

 

Currently, emerging growth companies (EGCs) are exempt from certain regulatory requirements for the first five years after their IPO.  One of the requirements EGCs are exempt from is Sarbanes-Oxley Section 404 (b) – which requires public companies to obtain an external audit on the effectiveness of their internal controls for financial reporting.  This reporting requirement is both costly and unnecessary because management is still required to assess internal controls, and these EGCs have limited public exposure.

 

H.R. 1645 is a narrowly-tailored fix that temporarily extends the Sarbanes-Oxley Section 404(b) exemption for an additional five years for a small subset of EGCs with annual revenue of less than $50 million and less than $700 million in public float. This legislation does not prohibit an external audit if the company or the majority of shareholders determine an audit is benefit.

 

 

 

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Office of Representative Trey Hollingsworth  |  1641 Longworth House Office Building, Washington, DC 20515

P: (202) 225-5315 |  www.hollingsworth.house.gov

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Announcing Genes in Space 2018

February 5, 2018
Design and Launch your DNA Experiment to Space!

 

Calling all students in grades 7 through 12: Pioneer research on the International Space Station by designing your DNA experiment for space. Genes in Space is a science contest that challenges students to design original DNA experiments that address real-life challenges and opportunities of space exploration. The contest is free, and does not require equipment. Proposals will be judged solely on their creative and scientific merit. The winning experiment is conducted in space, and samples are returned to Earth for you to analyze!

Submission deadline is April 20th, 2018

Genes in Space is a collaboration between miniPCR and Boeing with generous support from CASIS, Math for America, and New England Biolabs, Inc.
Learn More

For IHIF Members: Request a FREE cost savings program analysis

February 5, 2018
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Apexian Pharmaceuticals Opens Phase 1 Clinical Study of APX3330 in Patients with Solid Tumors

January 24, 2018

Apexian Logo Font

 

FOR IMMEDIATE RELEASE

Indianapolis, IN – January 24, 2018 – Apexian Pharmaceuticals, a clinical-stage biopharmaceutical company, has announced the opening of a clinical trial for patients with advanced solid tumors. The study involves APX3330, a first in class orally administered inhibitor of APE1/Ref 1, a dual-function protein that plays a critical role in promoting and maintaining a broad variety of cancers. Details of the study, including eligibility criteria, the location of participating clinical centers and referral contact information can be found at www.ClinicalTrials.gov, a website maintained by the National Institutes of Health.

 

The APE1/Ref-1 protein regulates the activity of other cancer-associated proteins, including transcription factors HIF-1-alpha, AP-1, NF-kappa B, and STAT3; proteins that control the aggressiveness of many cancers. Data indicates that Apexian’s drug APX3330 inhibits the cancer-promoting activity of APE1/Ref-1 without causing the side effects normally associated with many types of chemotherapy. Additionally, in a variety of pre-clinical studies APX3330 has been shown to not only have an anti-cancer effect, but to also prevent, and reverse the nerve damage caused by certain forms of chemotherapy.

 

The clinical study is the first to explore APX3330 use in patients with advanced cancer, and is the culmination of extensive research on APE1/Ref-1 and APX3330 conducted by Dr. Mark Kelley, Professor of Pediatrics and Associate Director of Basic Science Research at Indiana University’s Simon Cancer Center as well as other scientists worldwide. Dr. Kelley’s work on APE1/Ref-1 and APX3330 has previously resulted in significant research grants provided through the National Cancer Institute in order to explore APX3330’s potential to benefit cancer patients.

 

According to Dr. Richard Messmann, Apexian’s Chief Medical Officer, “Apexian’s research has provided us with a clear path to understanding, and an ability to measure, the clinical benefit that may be obtained when cancer patients are treated with APX3330. It also lays the foundation for determining whether patients with chemotherapy-induced peripheral neuropathy (CIPN) may benefit when receiving APX3330. The clinicians involved in the study, including those at the Simon Cancer Center and at START SA (San Antonio, TX) and START Midwest (Grand Rapids, MI) have uniformly expressed excitement regarding their participation in the study.”

 

“The initiation of the APX3330 study is a significant step forward in Apexian’s mission to develop safe and effective treatments for cancer patients,” said Steve Carchedi, President and CEO of Apexian Pharmaceuticals. “Despite recent advancements in cancer treatments, there continues to be a need for treatments that improve the survival of cancer patients. Apexian is committed to ‘moving mountains’ to help these patients.”

 

 

About Apexian Pharmaceuticals

Apexian Pharmaceutical’s mission is to develop safe and effective therapy for patients with high unmet medical needs.  Apexian’s lead drug candidate is APX3330, with additional promising agents in their drug-development pipeline. To learn more about Apexian Pharmaceuticals, please visit the company’s website at http://www.ApexianPharma.com

 

Media Contact:  Steve Carchedi

Email: PR@Apexianpharma.com, Telephone: 844-463-3330 x113

Former FDA regulatory scientist joins Pearl Pathways

January 20, 2018

PearlPathways

FOR IMMEDIATE RELEASE
Contact: Waylon Wright
Pearl Pathways
Business: (317) 602-5479
wwright@pearlpathways.com
http://www.pearlpathways.com

INDIANAPOLIS, INDIANA – January 18, 2018— Pearl Pathways announces the hiring of Robert Seevers, PhD as Senior Advisor to serve biopharmaceutical companies.

Seevers brings over 40 years of experience in pharmaceutical research and development for both large and small molecules. His expertise includes CMC regulatory, cold chain shipping, setting global specifications, quality by design (QbD), global regulatory submissions, and interactions with global regulatory agencies. His knowledge spans all major therapeutic areas with specific expertise in CNS, Endocrine, Metabolism, Autoimmune, Oncology, Radiopharmaceuticals, and drug delivery systems. Seevers’ robust clinical research experience includes acting as a primary investigator, Vice-Chair of an Institutional Review Board, FDA Reviewer/Team Leader, and medical writer.

Seevers’ career includes eight years at the United States Food and Drug Administration (FDA). At FDA, Seevers served as a Team Leader responsible for managing a team of reviewers for the evaluation of CMC sections of INDs, NDAs and BLAs. Prior to joining Pearl Pathways, Seevers spent 16 years with Eli Lilly and Company in Regulatory Affairs, where he led the regulatory CMC submission strategy for drugs in preclinical development through their NDA/MAA submission and the approval process for both small and large molecules.

As Senior Advisor at Pearl Pathways, Seevers is responsible for the development of the regulatory strategy for early through late stage regulatory filings of both large and small molecules, interactions with global regulatory agencies, leading cross-functional CMC development teams, helping clients identify product development vendors (e.g. CROs, CMOs, contract laboratories), and will serve on Pearl IRB, an AAHRPP accredited Independent Review Board.

Seevers is a member of the United States Pharmacopeia Packaging, Storing, and Distribution Expert Committee, acts as a Stability Consultant for the World Health Organization (WHO), speaks regularly at nation and international life science conferences, and continues to be an active writer of industry publications.

Diana Caldwell, President and CEO shares, “Our clients will benefit from Robert’s unique life science portfolio as an ex-FDA regulator coupled with extensive leadership experience within the biopharmaceutical industry. His dual-sided industry experience will be invaluable for our clients to navigate a variety of regulatory compliance challenges in both large multi-national companies and small startups. He brings expert technical knowledge of CMC development, drug substance synthetic processes, cold-chain shipping, radiopharmaceuticals, and global regulatory submissions including INDs, NDAs, and BLAs. We are thrilled to have Robert join our team.”

About Pearl Pathways
Pearl Pathways is a comprehensive life science product development services company. Every day we strive to provide our customers top quality service, unyielding ethics, and efficient services through our team of experts. Pearl Pathways supports biopharmaceutical, medical device, and diagnostic companies as well as life science service providers with clinical, regulatory, and quality compliance needs. Our AAHRPP accredited central IRB, Pearl IRB, supports all aspects of human research.
To learn more, please visit us at https://www.pearlpathways.com, call us at (317) 899-9341, or email contact@pearlpathways.com. Pearl Pathways is headquartered in Indianapolis, Indiana, with a regional office in Houston, Texas, and is AAHRPP accredited and a WBENC certified woman owned business.

For media inquiries, contact contact@pearlpathways.com

Senator Joe Donnelly Recognized as IHIF 2017 Legislator of the Year

January 16, 2018

September 14, 2017 – (Indianapolis, IN) –  The Indiana Health Industry Forum (IHIF) presented Senator Joe Donnelly with its 2017 Legislator of the Year Award at the group’s Annual Meeting held in Indianapolis in September.  As the Senate was in session, he accepted the award via a video shown to the attendees and was later presented with the award plaque at a meeting in Washington, D.C.. The recognition is given annually to state and federal legislators who demonstrate a commitment to excellence in public health policy and service to Indiana’s health science business community.

 

“Since being elected to the Senate in 2012, Senator Donnelly has been an outstanding advocate for patients and their right to access innovative medicines and therapies”, said Kristin Jones, president and CEO of IHIF.  “He understands the impact that this industry makes both economically to the state and to the lives of Hoosiers”.

 

In a year that saw a tremendous volume of healthcare policy negotiations and votes, Senator Donnelly stood by Hoosier veterans and Medicare recipients, sought ways to proactively address the nation’s opioid crisis, showed intense interest in learning how new medicines and devices are developed and brought to market, and strongly supported Indiana’s bioscience industry.

 

“Senator Donnelly joins a long line of previous award recipients at the state and federal levels,” said Jones. “While many legislators understand the importance of the bioscience industry to Indiana’s economy, we are delighted to be able to recognize those special champions who go the extra mile to help Hoosier patients.  It is a privilege to be able to include Senator Donnelly among our honorees”.

 

About IHIF

IHIF is a statewide trade association representing Indiana’s health science 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.

Letter to the Editor – 1/14/18

January 16, 2018

The following letter was published in the Sunday edition of the Indianapolis Star (1/14/18)

Protect Medicare Prescription Drug Program

The Medicare prescription drug program has been a remarkable success for seniors and taxpayers, despite what a Jan. 4 op-ed claims. Ninety percent of seniors are satisfied with the program and it has cost $349 billion less than originally expected. The program also helped reduce seniors’ hospital admissions and premiums are going down.

The success of the program is market-based competition — not government price controls. The private insurers who administer the Medicare drug program negotiate aggressively with drugmakers for discounts and rebates, often securing better deals than what’s available in the private market.

Dismantling the program would be detrimental to seniors and do nothing to lower drug costs. In fact, more than 200 patient-advocacy groups urged Congress to reject government interference in Medicare because it could “jeopardize beneficiaries’ access to comprehensive, affordable” medicines.

To get health care costs under control, policymakers should take a close look at the entire system. Hospital and physician services make up 42% and 43% of all Medicare spending, respectively, and they are expected to grow by $552 billion over the next decade. Let’s tackle the real drivers of health care spending and preserve a prescription drug program that is working well for everyone.

 

-Kristin Jones

Indianapolis

Apexian Pharmaceuticals is Closing a Series A Round to Initiate Phase 1 Trial

December 4, 2017

Apexian Logo Font

FOR IMMEDIATE RELEASE

Indianapolis, IN – November 29, 2017 – Apexian Pharmaceuticals, an Indiana-based clinical stage biotechnology company developing novel compounds to treat cancer, announced today that they are closing their Series A round. This financing follows previous investments as well as numerous grants and awards by the company since its founding. Proceeds will be used to initiate their phase 1 clinical study for APX3330 a novel first in class oral treatment for patients with cancer.

 

APX3330, the lead molecule for Apexian has a unique dual biological role targeting the APE1/Ref-1 protein.  The APE1 protein is a critical molecular “switch” controlling the activity of cancer regulatory proteins, including transcription factors HIF-1-alpha, STAT3, NF-kappa B, and AP-1. The Investigational New Drug application was issued based on robust non-clinical data and a safety database of over 422 patients in non-cancer studies. In addition, the data identified APE1/Ref-1 protein also plays a critical role in the repair of neuronal DNA that has been damaged through oxidative mechanisms which are common with platinum-containing chemotherapy agents. Apexian has developed robust non-clinical data demonstrating APX3330 prevents and/or reverses such damage and is the basis for pursuing an indication for Chemotherapy Induced Peripheral Neuropathy (CIPN).

 

Elevate Ventures, a venture development organization based in Indiana, committed funding through their Indiana 21st Century Research & Technology Fund, a direct investment vehicle overseen by the Indiana Economic Development Corporation positioned to support early-stage high-growth companies. “Apexian Pharmaceuticals has an impressive body of preclinical work in an exciting new target to treat cancer,” said Elevate Ventures Chief Executive Officer Chris LaMothe. “We look forward to joining other sophisticated investors to see this molecule tested in the clinical setting.”

 

Apexian Pharmaceuticals President and Chief Executive Officer Steve Carchedi commented: “We are very pleased to have an Indiana group, like Elevate Ventures join with others to enable this key data to be generated for our lead molecule. Developing a first-in-class oral molecule to treat pancreatic, colon and other difficult to treat cancers, is at the core of our mission. Cancer patients are truly waiting for novel treatments to attack these deadly diseases.”

 

About Elevate Ventures
Elevate Ventures nurtures and develops emerging and existing high-potential businesses into high-performing, Indiana-based companies. Elevate Ventures accomplishes this by providing access to capital, rigorous business analysis and robust advisory services that connect companies with the right mix of resources businesses need to succeed long-term. To learn more about its team and funds under management, visit www.elevateventures.com.

 

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 APX3330, is an oral first in class novel inhibitor of the APE1 protein, a critical node in cancer cell signaling. To learn more about Apexian Pharmaceuticals, please visit the company’s website at www.ApexianPharma.com

 

Media Contact:

Email: PR@Apexianpharma.com

Telephone: 844-463-3330 x113

Inscope Medical Solutions Launches First Laryngoscope with Integrated Suction

November 6, 2017

Available for demo at ACEP17, Inscope Direct cuts airway intubation time nearly in half when secretions are present

WASHINGTON–(BUSINESS WIRE)–Inscope Medical Solutions, an innovative medical device company, today announces the first laryngoscope with integrated, controllable suction. The Inscope Direct is a disposable laryngoscope that allows clinicians to maintain a clear view of the airway. Designed to be the best choice for trauma intubations, the device eliminates the need to juggle between yankauer suction and the endotracheal tube while securing the airway. The device is available for demo during the American College of Emergency Physicians Scientific Assembly (ACEP), at booth #2411, Oct. 29 – Nov. 1, 2017.

“Using the Inscope Direct is addicting. It’s easy to use and the controllable suction in the mouth throughout procedures keeps the right hand free to focus on passing the endotracheal tube”

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Inscope Direct’s integrated suction removes secretions allowing a clear view of vocal cords for easy placement of the endotracheal tube. The device features a built-in LED light source and an anti-clog design with two controllable suction inlets eliminating the need for a yankauer suction catheter as it easily removes existing and re-accumulating secretions. Inscope Direct connects to standard suction tubing and is compatible with wall suction and powered portable suction. The convenient MAC 3.5 blade size fits most adults and each device is disposable to eliminate the risk of cross contamination.

“Using the Inscope Direct is addicting. It’s easy to use and the controllable suction in the mouth throughout procedures keeps the right hand free to focus on passing the endotracheal tube,” said Co-founder and Chief Medical Officer, Dr. Mary Nan Mallory. “Being able to easily suction while starting and throughout the intubation process is a game changer – it makes the first view a clear view, simplifying direct laryngoscopy every time.”

“Inscope Direct was born out of a real-life need following an incident where a founding physician had to treat a patient with life-threatening injuries, but struggled through the intubation process by juggling multiple pieces of equipment to clear the airway and pass the breathing tube. Every second is critical in emergency situations, and we knew there just had to be a better way,” said Co-founder and CEO Maggie Galloway. “We are thrilled to bring the Inscope Direct to market – not only for emergency intubations, but also planned intubations when secretions can unexpectedly become an issue. Now with the Inscope Direct, clinicians have at their disposal a tool that makes the intubation process more efficient and can improve outcomes for patients.”

In addition to the Inscope Direct, Inscope Medical plans to leverage its existing integrated suction technology in a forthcoming video laryngoscope.

To learn more, visit Inscope Medical Solutions at ACEP17 in booth 2411 in the main expo or at the Innovation Playground in innovateED for a hands-on demo. For more information on Inscope Direct visit www.inscopemedical.com.

About Inscope Medical Solutions

Inscope Medical Solutions is an innovative medical device company located in Jeffersonville, IN. Their first product, the Inscope Direct, is the first laryngoscope to integrate controllable suction to quickly remove secretions for a clear view of vocal cords allowing easy placement of the endotracheal tube. The company has won multiple awards for the Inscope Direct, including, JEMS 2017 Hot Product award at EMS Today Conference, Indiana Innovation Showcase winner, and a finalist for the 2017 Indiana Life Sciences Summit New Venture Competition. To learn more, please visit http://inscopemedical.com/ and follow us on LinkedIn, Twitter @inscopemedical, or Facebook.

Contacts

BLASTmedia for Inscope Medical Solutions
Emily Darr, 317-806-1900 ext. 121
emily@blastmedia.com

October 2017 Life Sciences Lunch

November 1, 2017

LSL Banner

The Best Ideas Start on Napkins: 
Medical Product Development Pathways, Pitfalls and Predictions

Tuesday, October 17

There’s not much time from the AHA! moment to a pencil and scratch pad, but from there, the process of bringing a medical device to market can take a lot of twists and turns. Whether making decisions on design elements, quality systems, finding suppliers, or actually manufacturing an approved piece of medical equipment, CEOs need expert guidance and supportive teams. Please join us as we hear from a panel that includes experts in product design, development, and precision manufacturing.

PANELISTS

Elizabeth HagermanVice President of Corporate Engagement, Rose-Hulman Ventures
Greg OttingerVice President of Business Development, GMI Corporation
Jake Flagle, President and Founder, 316 Product Development

MODERATOR

Kristin JonesPresident/CEO, Indiana Health Industry Forum

 

The Indiana Health Industry Forum and Barnes & Thornburg LLP partner to present a monthly seminar series on critical issues in the life sciences. 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 industry.