B2S Life Sciences Plans Long-Term Growth, R&D in Central Indiana

March 7, 2018

FRANKLIN, Ind. (March 7, 2018) – B2S Life Sciences, a biotherapeutic drug development company, announced plans today to expand its operations in Johnson County, creating up to 23 new, high-wage jobs by 2020.

“Indiana has earned a reputation as a global leader in life sciences, ranking second in the nation for worldwide exports,” said Elaine Bedel, president of the Indiana Economic Development Corporation (IEDC). “At its new facility, B2S can continue to advance new technologies and life-saving research, while simultaneously investing in Indiana’s future workforce, propelling other entrepreneurs and creating good jobs for Hoosiers. We’re excited to witness B2S’ continued growth alongside our life sciences sector here in Indiana.”

The company, which develops pharmaceutical and diagnostic biological reagents, is investing $1.5 million to expand and renovate its nearly 3,000-square foot facility at 97 E. Monroe St. in Franklin, adding 9,000 square feet of laboratory space. The new building, which is scheduled to be operational in the summer of 2018, will allow B2S to grow its client base, which includes large contract research organizations (CROs), pharmaceutical companies, and smaller biotech businesses and startups. The company also plans to scale its reagent manufacturing to meet export demands and expand its services in biotherapeutic drug development.

B2S currently has 16 full-time employees and plans to begin hiring this year for scientists, project managers, statisticians, and business development and management associates. New positions are expected to offer average salaries above the state and county average wage. Interested applicants may learn more about the company’s career opportunities online or submit a resume at info@B2SLifeSciences.com.

“Recruiting and hiring local talent in the area is a priority for us,” said Dr. Ron Bowsher, chief scientific officer at B2S. “From the onset, we have worked together to enhance the local area where we live and work. This priority is reinforced by the fact that many of our lab staff reside in the southern portion of Marion County or Johnson County and by our close partnership with Franklin College. We look forward to continuing to grow the life sciences and biotech presence in central Indiana.”

Founded in 2015, the company specializes in drug development support with products and analytical services that facilitate drug research. Through its collaborative efforts, B2S scientists are contributing to advance treatments for cancer, diabetes and other chronic diseases. Along with its planned growth, the additional lab space will help propel biotech startups and other small operations. The company is also investing in central Indiana’s workforce by partnering with Franklin College to give Hoosier students the opportunity to receive hands-on experience through internships in applied biotechnology.

“Franklin is pleased to have B2S in our dynamic downtown. We look forward to seeing them expand and bring more economic diversity to our city,” said Franklin Mayor Steve Barnett.

The IEDC offered B2S up to $250,000 in conditional tax credits based on the company’s job creation plans. These tax credits are performance-based, meaning until Hoosiers are hired, the company is not eligible to claim incentives. This project was supported by the Johnson County Development Corporation and received grant funding and other tax incentives from the Franklin Development Corporation and Franklin Redevelopment Commission.

“This project gives B2S the opportunity to invest in highly skilled talent and jobs quicker than we would be able to achieve otherwise. Together, the state of Indiana, IEDC and city of Franklin have created an environment where small businesses can grow and prosper, allowing for quality of life improvements and business diversification in the region,” said Aleks Davis, chief executive officer at B2S.

Biotech companies like B2S are choosing to locate and grow their operations here because of Indiana’s reputation as a global leader in the life sciences industry. According to BioCrossroads and the Indiana Business Research Center, Indiana is the second largest exporter of life sciences products in the U.S. at $8.2 billion in total exports. More than 1,600 life science companies operate in the state, supporting more than 55,000 Hoosier jobs with average wages of nearly $95,000 annually.

About B2S Life Sciences
B2S Life Sciences LLC is a customer-focused biotherapeutic enablement company located in Franklin, Ind. The company sepecializes in bioanalytical consulting, immunoassay development, custom biological reagent generation and life-cycle management (LCM), immunogenicity cut point analysis, PK/TK statistics and advanced analytics. For more information about B2S, visit www.b2slifesciences.com.

About IEDC
The Indiana Economic Development Corporation (IEDC) leads the state of Indiana’s economic development efforts, helping businesses launch, grow and locate in the state. Governed by a 15-member board chaired by Governor Eric J. Holcomb, the IEDC manages many initiatives, including performance-based tax credits, workforce training grants, innovation and entrepreneurship resources, public infrastructure assistance, and talent attraction and retention efforts. For more information about the IEDC, visit www.iedc.in.gov
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Media Contacts: 
Garrett Sheets (B2S Life Sciences) – 317.787.2213 or pr@B2SLifeSciences.com
Abby Gras (IEDC) – 317.232.8845 or agras@iedc.in.gov


February 2018 Life Sciences Luncheon – 2018 Public Policy Overview

February 27, 2018

Public policies are impacting the life sciences sector dynamically, with many changes at the state and federal levels targeting manufacturers. Please join us as we hear the latest on the 2018 session of the Indiana General Assembly and delve into current public policy issues for the medical device and bio-pharmaceutical sectors. This month’s program will feature an Indiana legislative leader sharing thoughts on the current session and the direction state policy makers are heading in support of innovation. This will be followed by a moderated discussion featuring local industry leaders. This is a great time to reach out – please invite your legislators to attend with you!



Anne HathawayExecutive Director, Indiana Medical Device Manufacturers’ Council (IMDMC)
Michael O’ConnorSenior Director, State Government Affairs, Eli Lilly and Company
Kristin JonesPresident and CEO, IHIF


About the Series: 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.


To learn about upcoming lunch programs, please visit us on-line.

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.”





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

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
BBS 2012
Let us show you how to start
the New Year off with savings!
Your first step in 2018 can be accessing deep savings on business and lab essentials through BIO Business Solutions®. Request a FREE cost savings program analysis and we’ll review which programs and benefits would be the best fit for your company!
As the largest cost-savings purchasing program for the life sciences industry, BIO Business Solutions® aggregates the purchasing power of over 3,400 life science companies to deliver savings from more than a dozen leading suppliers-at no charge to you.

You also don’t have to change the way you do business to enjoy the BIO discounts and other benefits. The individual cost-savings programs do not restrict your purchasing selection to a short list of obscure “close out” items. In most cases, the full selection of products and services offered by a BIO Business Solutions® supplier are available to you at a discounted price.

Enrollment is quick and easy!
Visit bio.org/bbs/programs to learn more about the savings and services available to you.
Learn More
IHIF Members have access to a wide range of savings and discount programs offered exclusively through BIO Business Solutions and BIO’s state affiliate network.  Learn more here
About BBS

Apexian Pharmaceuticals Opens Phase 1 Clinical Study of APX3330 in Patients with Solid Tumors

January 24, 2018

Apexian Logo Font



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


Contact: Waylon Wright
Pearl Pathways
Business: (317) 602-5479

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


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.


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


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.