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

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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

December 2017 Life Sciences Lunch – Perspectives on the FDA

January 10, 2018

Perspectives on the FDA

With a new administration at the helm and a new set of User Fee Agreements recently approved by Congress, the U.S. Food and Drug Administration (FDA) is taking a fresh approach to regulation. In an effort to keep pace with technological and scientific change, the FDA has issued and updated a number of guidance documents for industry – drugs, devices, and IT. Please join us as our panel explores some of the new procedures, shares tips on tapping under-utilized data sources, and offers a look at ahead at 2018.

PANELISTS

Gretchen BowkerCo-Founder and COO, Pearl Pathways
Howard CooperPresident, EQACT, Inc.
Lynn Tyler, Partner, Barnes & Thornburg LLP

MODERATOR

Deborah Pollack-MilgatePartner, Barnes & Thornburg LLP

 

 

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. We hope you will join us.

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.

Singota Solutions announces partnership with Slope.io

October 19, 2017

Singota Solutions, a pharmaceutical contract development and manufacturing organization, expands service offerings through partnership with Slope.io, a clinical trial logistics automation service.

graphs on tablet shutterstock_105421988Bloomington, IN (October 18, 2017)–Singota Solutions announced its partnership with Slope.io to enhance outsourced management of clinical trial supplies. The partnership will benefit pharmaceutical firms in the clinical trial stage looking to streamline the tedious process of reordering and managing supplies.

Slope.io’s Clinical Trial Logistical Planning platform adapts, predicts, and responds to any clinical trial logistics scenario. The technology integrates directly into clinical trial data sources, reducing administrative burden to keep study sites provisioned with fresh supplies by utilizing automated supply ordering, resupply, and predictive forecasting.

Singota provides storage and materials management in its GMP warehouse that contains a range of storage conditions including 15-25°C, 2-8°C, -20°C, -80°C. Singota’s supply chain services include inventory management, expedited shipping services, and technical expertise in cold chain processes. In addition, Singota provides the pharmaceutical industry with state-of-the-art robotic aseptic manufacturing, formulation development, analytical testing, and labeling and kitting operations.

Singota’s ERP System is tightly integrated with Slope.io’s technology platform. Once needs are established with the trial specific replenishment algorithms created by Slope.io, Singota prepares materials and kits as necessary, and ships to trial sites as directed by Slope.io’s technologies. The combined expertise of Singota and Slope.io enables a breakthrough in clinical trial material operations proven to reduce delivery times, supply waste, and material costs, driving overall trial efficiency.

For more information, please contact Singota – info@singota.com or 812.961.1700.
About Singota Solutions
Singota Solutions is a service provider to the pharmaceutical, animal health, and medical device industries. Founded in 2006 as BioConvergence, the company is a woman-owned business operating in a 72,000-square foot facility in Bloomington, Indiana. The company’s service lines include aseptic manufacturing, supply chain operations, drug formulation development, analytical methods development & testing activities, and labeling & kitting operations. For more information, please visit www.singota.com.

About Slope.io
Slope.io is a clinical trial logistics automation service. The company uses a modern, data-driven technology platform with predictive analytics to enable patient-centered, automated, and end-to-end integrated services for clinical trial supplies. Trial data powers automated, just-in-time delivery of drugs and ancillary clinical supplies to study sites across the globe. For more information, please visit www.slope.io.

September 2017 Life Sciences Lunch

October 18, 2017

Women in Leadership in Life Sciences

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. We hope you will join us.

 

 

Women In Leadership In Life Sciences

Join us as we highlight and recognize the success and influence of women in the life sciences industry. There are as many stories as there are paths to the top and each woman’s individual contribution helps pave the way for those coming up through the ranks. Whether it is about following your passion, finding your niche or growing your team, please join us as we hear from a panel of women leaders sharing their stories and acknowledging those who have helped and inspired them.

PANELISTS

Catherine Ann Cassidy,

Senior Director of Strategy and Operations for Early Phase Development, Eli Lilly and Company

 

Natalie Sutton, 

Chapter Executive, Alzheimer’s Association, Greater Indiana Chapter

 

Yvonne Lai,

Director of Research & Development, Indiana University

 

MODERATOR

Deborah Pollack-Milgate, Partner, Barnes & Thornburg LLP

B-Start Selects 2017 Startups

October 18, 2017

FOR IMMEDIATE RELEASE

Media Contact:                                                                               

Anne McCombe

Project Manager, BEDC

(812) 335-7346

amccombe@bloomingtonedc.com

 

 

B-Start Selects 2017 Startups

Bloomington, IN (October 18, 2017) – B-Start, a pre-accelerator program for early-stage startups in Bloomington, announced its 2017 cohort today. Eleven startups were selected to participate in the 22-week program during which they will attend workshops in lean business concepts, customer acquisition, fundraising, marketing and more.

 

The program was opened to all Bloomington residents this year, including students from Indiana University and Ivy Tech Community College as in past years. B-Start has ushered 18 startups through the program since it was launched in 2015, with 7 still actively working on their businesses. In total, B-Starters have hired 5 new employees, and 3 have gone on to successfully participate in local business pitch competitions.

 

The newest group of B-Start participants focuses on a wide variety of industries. The eleven participants include:

  • Adventure Field Guides: Marketplace of trip guides made by a community of outdoor influencers
  • Be-u-tiful: Online marketplace that helps review and sell hair care products
  • Bot Maven: Software that creates bots for event promotions
  • Codemoji: Coding platform for kids using emojis
  • Community Carbon Exchange: Platform that facilities the financial exchange of personal carbon offsets between producers and consumers
  • Elephants on Mars: Virtual reality arcade to explore immersive VR and develop new technology
  • Eqlsr: Blockchain platform to share, curate, collaborate and listen to music
  • Nomad Chest: Platform for renting clothing to travelers
  • Rent My Window: Auction platform for brick-and-mortar businesses and advertisers
  • Sharon: Auction platform for brick-and-mortar businesses and advertisers
  • Thumb: Long-distance ride sharing platform for college students

 

“We are now in the third year of our B-start program, and are really excited to have non-students participating this year alongside students” said Anne McCombe, Project Manager of the BEDC. “Creating new businesses and plugging them in to the startup ecosystem in Bloomington is the goal of the B-Start program and this new cohort looks like one of our strongest yet.”

 

B-Start hosted a kickoff reception with the startups and business community on Wednesday, October 18th. Each of the B-Start participants will be paired with a local Bloomington entrepreneur who will serve as a mentor. The program culminates in a final Demo Day in March 2018 where the startups will deliver a 5-minute pitch with the chance to win cash prizes based on a panel of judges.

 

Founding sponsors for B-Start are Cook Group, Inc., Indiana University Office of the Vice President for Engagement, and The Gayle & Bill Cook Center for Entrepreneurship at Ivy Tech Community College Bloomington. For a full list of mentors, startups, and sponsors visit www.b-start.org.

 

About B-Start

B-Start is a pre-accelerator program of the Bloomington Economic Development Corporation (BEDC) to help launch for-profit innovation-driven businesses in Bloomington, Indiana. B-Start participants are at the earliest stage of their business development and are coached through a comprehensive process of cohort activities and individualized mentorship over the course of the program to build a foundation for acceleration. For more information, visit www.b-start.org.

 

About the BEDC

The BEDC is a not-for-profit organization dedicated to the retention, development and attraction of quality jobs in Monroe County. The BEDC is led by a partnership of private industry leaders, the City of Bloomington, Monroe County, Indiana University and Ivy Tech Community College–Bloomington. For more information, visit www.bloomingtonedc.com.

 

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