October 2017 Life Sciences Lunch

November 1, 2017

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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.


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


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.


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



Deborah Pollack-Milgate, Partner, Barnes & Thornburg LLP

B-Start Selects 2017 Startups

October 18, 2017


Media Contact:                                                                               

Anne McCombe

Project Manager, BEDC

(812) 335-7346




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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VisionTech Partners, Pearl Pathways Form Alliance to Fuel Growth in Indiana’s Life Sciences Startup Community

September 27, 2017

For Immediate Release

INDIANAPOLIS, Indiana (August 30, 2017) – – VisionTech Partners, the parent of Indiana’s most active angel investing group, and Pearl Pathways, a provider of life sciences product development services, have joined forces to fuel Indiana’s life sciences startup community, which includes biopharmaceutical, medical device and diagnostics technology.


The VisionTech Partners-Pearl Pathways alliance will focus on three essential goals. First, identify the most promising early stage/early growth companies for potential investment by VisionTech’s statewide network of angel investors. Second, connect entrepreneurs with individuals who have already achieved success in the life sciences and are willing to serve as mentors and business advisors. And finally, provide entrepreneurs with access to the highly specialized services required to negotiate the FDA approval process.


VisionTech Partners Executive Director Ben Pidgeon said both companies are eager to leverage their respective strengths through the alliance, which will formally launch Thursday, August 31, at VisionTech Angels’ “Pitch Night” in Indianapolis, featuring two life sciences startups.


“VisionTech Partners is extremely committed to growing Indiana’s life sciences industry and we’ve proven ourselves to be a valuable contributor to this effort as a source of financial and human capital. Of the 24 portfolio companies our angel network has invested in, 10 are in the life sciences and healthcare space; it’s definitely a sweet spot,” said Pidgeon.


“The alliance with Pearl Pathways will not only ensure a high quality deal flow, it will also help us make better investment decisions. Most of these companies must secure FDA approval in order to commercialize their drug, device or diagnostic tool. Pearl Pathways will, in effect, be VisionTech Partners’ resident expert on all things FDA,” he added.


Based in Indianapolis, Pearl Pathways is a life science product development services company that provides clinical research, regulatory, quality compliance, and independent review board services to life sciences companies. Among Pearl Pathways’ clientele are five of the top 20 medical device companies and six of the top 11 pharmaceutical companies in the world.


The balance of their business, said President and CEO Diana Caldwell, is startup companies with pre-commercialization technology that need access to early stage or “seed” funding provided by groups like VisionTech Partners.


“VisionTech Partners is unique in the angel investing space. Yes, they are a source of capital, but more importantly, they have deep experience and success in the life sciences industry. They also have a chapter composed entirely of physicians. These are the people who are around medical technology on a daily basis and have knowledge and insight few investors have. Partnering with VisionTech will not only open doors for our clients, startup companies across Indiana will benefit from the combined talents and resources of our two companies,” Caldwell said.


About VisionTech Partners I VisionTech Angels

Founded in 2008, VisionTech Partners is a privately held company focused on linking investors to high-potential early-stage companies. Headquartered in Indianapolis, among the nation’s most vibrant innovation regions, VisionTech is where inventors, entrepreneurs, investors, universities, and strategic partners convene to share, fund, and launch novel technologies. VisionTech Angels has chapters in Bloomington, Fort Wayne, Indianapolis, Lafayette, and an Affinity chapter, AngelBom.


About Pearl Pathways.

Founded in 2010, Pearl Pathways is a comprehensive life science product development consulting services company with expertise in regulatory, quality compliance, and clinical trial services including an AAHRPP accredited commercial IRB, Pearl IRB. Pearl Pathways works with clients’ clinical teams, in-house regulatory experts, the quality compliance specialists, quality auditors, and the senior leadership team to get life saving diagnostics and therapeutics on the market sooner.

Contact: Melanie Lux, mlux@luxandassociates.com, 803.331.4794

Contact: Waylon Wright, wwright@pearlpathways.com, 317.602.5479

National Cancer Institute selects Apexian Pharmaceuticals to participate in the Small Business Innovation Research (SBIR) Initiative program

September 26, 2017

 Apexian Logo Font



National Cancer Institute selects Apexian Pharmaceuticals to participate in the Small Business Innovation Research (SBIR) Initiative program


Indianapolis, IN – September 25, 2017 –Apexian Pharmaceuticals is pleased to announce that the National Cancer Institute (NCI) has selected the company to participate in its highly competitive Small Business Innovation Research (SBIR) Investor Initiatives program, that encourages domestic small businesses to engage in Research and Development (R&D) that has the potential for commercialization. Through a competitive awards-based program, SBIR enables small businesses to explore their technological potential and provides the incentive to profit from its commercialization. As part of this program, Apexian Pharmaceuticals was selected to present at the BioNetwork Partnering Summit, being held in Laguna Niguel, California on October 23-25 2017. This work was supported by NCI SBIR grant 11196090.  Apexian’s Chief Medical Officer, Dr. Rich Messmann, will be speaking about the development of the company’s lead molecule APX3330, and its effect upon APE1/Ref 1, a dual function protein that is a critical signaling node in cancer cells that also facilitates repair of oxidative damage to DNA.


In extensive preclinical testing, much of it conducted by Dr. Mark Kelley, Apexian’s Chief Scientific Officer, and Associate Director of Basic Science Research at the Indiana University Simon Cancer Center, and as summarized in a recent Nature Precision Oncology article (Shah et al. 2017 npj Precision Oncology), APX3330 provided robust anti-cancer effect by inhibiting the activation of cancer regulatory proteins, including transcription factors HIF-1-alpha, AP-1, NF-kappa B, and STAT3, as well as an ability to prevent and reverse the oxidative damage -called chemotherapy induced peripheral neuropathy or CIPN- caused by platinum-containing chemotherapy agents such as oxaliplatin and cisplatin.  The U.S. Food and Drug Administration has issued an Investigational New Drug license to Apexian to commence human testing of APX3330 and accrual into the initial study will begin in the near future. Details of the trial, including contact information on participating centers, will be found at www.clinicaltrials.gov.


Steve Carchedi, President and Chief Executive Officer of Apexian Pharmaceuticals, commented:  “We are very honored by the NCI’s decision and excited to tell the Apexian story at the BioNetwork event. Cancer patients need additional safe and effective therapy, and the prospect that APX3330 not only provides anti-cancer effect, but may also prevent or reverse the debilitating effects of CIPN could fundamentally change the manner in which certain cancers are treated. We are looking forward to initiating our clinical study in an area with such high unmet need.”


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 http://www.ApexianPharma.com


Media Contact:

Email: PR@Apexianpharma.com

Telephone: 844-463-3330 x113

August 2017 Life Sciences Lunch

August 28, 2017

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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.


Tech Transfer Driving Indiana’s Innovation Ecosystem

The Technology Transfer Offices at Indiana’s leading research universities are churning out new technologies and start-up companies like never before.  Finding new ways to support and develop early stage innovations and then matching those with the right development partners takes time, creativity, and a network of partnerships with industry and funders.  Please join us as we hear from a panel of research university representatives highlighting some of their latest life science technologies and explore how they are gearing up to smooth out the translational process!

Deborah Pollack-Milgate, Partner
Barnes & Thornburg LLP

Brooke Beier, Ph.D.
Purdue Research Foundation
Executive Director of Purdue’s Office of Technology Commercialization.

Karen Imgrund Deak, Ph.D.
Commercialization Specialist
IDEA Center
University of Notre Dame

Simon Atkinson, Ph.D.
IUPUI Interim Vice Chancellor for Research, Biology

CRI Celebrates 30 Years in the Medical Device Industry

August 18, 2017
Celebrating 30 Years

For Immediate Release

CRI Medical Devices is proudly celebrating its 30th year in business this September 17, 2017.

Established on September 17, 1987, CRI built its foundation through the development of technology that enabled catheters to better navigate the inner passages of the body during surgery. This technology was based upon the use of nitinol wire; an industry standard material still to this day.

Over the past 30 years, CRI has continued to focus on the development and manufacturing of catheters and other custom medical devices. Specialties include high-volume assembly, extrusion, domestic and international regulatory services as well as marketing and sales of its Thomas Medical branded, proprietary women’s health

In 2008, owner John Steen, PhD converted CRI to an employee-owned company. In 2010, CRI became 100% employee-owned and is still an ESOP today. This business model has created an environment where its highly dedicated employee-stock holders have a vested interest in the success of CRI. Dr. Steen has been with CRI since 1991 and currently serves as Chairman of The Board and assists with export activities for Thomas Medical.

Today, CRI is still headquartered in Indianapolis, IN with locations in Minnesota, Ireland and Costa Rica. CRI has expanded its capabilities and services globally, but has not forgotten the importance of local customer service and quality manufacturing practices. “After 30 years of continued growth, the future for CRI is bright.” stated Dr. Steen.

Full post and CRI Website

Pearl IRB becomes a SMART IRB participating institution

August 18, 2017

August 16, 2017


 Contact: Waylon Wright

Pearl IRB

Business: (317) 602-5479

Cell: (832) 942-4152






INDIANAPOLIS, INDIANA – August 16, 2017 — Pearl IRB is pleased to announce that we have joined SMART IRB, a platform to ease common challenges and burdens associated with initiating multisite research. SMART IRB is a collaborative initiative supported by the National Center for Advancing Translational Sciences (NCATS) and led by Harvard Catalyst, University of Wisconsin-Madison ICTR, and Dartmouth Synergy.

Through a flexible master IRB reliance agreement, standard operating procedures, and complementary tools and resources, SMART IRB supports and encourages collaboration and harmonization across a national consortium of institutions. Together with SMART IRB, we will shape the future of multisite research across the nation, creating a network that will foster and enhance collaboration.

Pearl IRB strives to deliver superior independent review board services to improve the clinical research process thereby delivering new therapeutics and diagnostics to patients sooner.

The goal of SMART IRB is to streamline the IRB review process in multisite research, help investigators obtain trial results faster and, ultimately, advance the development of new diagnostics, treatments, and preventative measures for patients, while maintaining strong human research protections, oversight, and regulatory compliance.

Under the SMART IRB Agreement, investigators conducting multisite research may request that participating institutions rely on the review of a single IRB, and institutions may elect to do so on a study-by-study basis.


A full list of participating institutions and more information may be found at www.smartirb.org.

For information about how you can leverage SMART IRB for your research, please contact us today.

About Pearl IRB

Pearl IRB is an independent institutional review board, fully accredited by the Association for the Accreditation of Human Research Protection Program Inc. (AAHRPP).  Pearl IRB manages the local and central IRB needs for large and small institutions, principal investigators, CROs, and sponsors. Our vision is to improve the clinical research process which will lead to delivering therapeutics and diagnostics to patients sooner. Whether the research is a small single site project or a complex multi-center study, we can help.

Pearl IRB is part of Pearl Pathways, a comprehensive life science product development services company. Pearl Pathways supports biopharmaceutical, medical device, and diagnostic companies as well as life science service providers with clinical, regulatory, and quality compliance needs. Whether you are small startup, still in the pre-commercialization stage, or a large multinational company with several products on the market, Pearl Pathways is equipped to serve you. Learn more at www.pearlpathways.com.

To learn more, please visit us at www.pearlirb.com, call us at (317) 899-9341, or email contact@pearlirb.com. Pearl IRB is located in Indianapolis, Indiana, and is AAHRPP accredited and a WBENC certified woman owned business. For media inquiries, contact contact@pearlirb.com.


New ShareVault White Paper: What’s the role of Non-Immuno Oncology in an Immuno Oncology World?

August 10, 2017

“New ShareVault White Paper:  ” What’s the role of Non-Immuno Oncology in an Immuno Oncology World?”

This white paper discusses the role of non-immuno-oncology therapies for cancer in a world where immuno-oncology is playing a greater role.


The clinical success of checkpoint inhibitors has made Immuno-Oncology an amazingly “hot” area for pharmaceutical and biotech deal making.  With checkpoint antibodies seen as backbones for combination therapy in cancer, many in Oncology are asking:

• What is the role of non-IO in an IO world and can you partner a non-IO opportunity?

• Is there still room for new anticancer agents that are not working in IO models?

• Are drug candidates evaluated with the assumption that everything will eventually be used in combination with IO agents?  Or are there indications or mechanisms for which IO will never be important?  Should I pursue combinations with IO?

• What kinds of mechanisms are attractive in non-IO?  What data and models will big pharma want to see?   Do I need to run experiments with their molecule?  Are there certain tumor types that are particularly attractive?

• Is it too late to try to compete in the crowded space of combination with PD1 antibodies?  What other IO agents are likely to backbones of oncology franchises?

• What will make my non-IO drug candidate compelling for partners and investors?

Download the white paper at this link.