Archive for the ‘Member Press Releases’ Category

IHIF Welcomes CRI Medical Devices as New Member!

March 14, 2016

CRI - Full logo

CRI is a global full service medical device manufacturer specializing in class I, II & III single-use medical devices, concept development and product life cycle management. With three decades of experience, CRI® has a dedicated staff focused on customer needs to ensure a high level of satisfaction.

Learn more at

Anagin Lands Health Grant

March 11, 2016

Posted: Mar 10, 2016 6:18 PM

Updated: Mar 11, 2016 9:15 AM


Eric Messner (photo courtesy of IU)
Eric Messner (photo courtesy of IU)
INDIANAPOLIS –An Indianapolis-based startup that uses technology from Indiana University has received a large grant. The National Institute of Neurological Disorders and Stroke awarded Anagin LLC a $267,000 grant to test benefits of a compound to treat damage caused by traumatic brain injury.

IU says Xiao-Ming Xu, scientific director of the Spinal Cord and Brain Injury Research Group in the Stark Neurosciences Research Institute, is a sub-awardee for the grant. Anagin CEO Eric Messner says Xu will conduct the most important portions of the research at the IU School of Medicine.

“There is a critical need to understand the molecular mechanisms underlying functional deficits after traumatic brain injury,” said Messner. “There is also a need to translate this knowledge into the development of new treatments.”

Xu says the research will investigate an optimal dose of the compound and whether it retains its efficacy “when administered in a delayed reaction.”

Anagin has previously been awarded similar grants to test its compounds to treat post-traumatic stress disorder. It also won the BioCrossroads New Venture Competition in 2014.

CRI Medical Devices Facility Move is Now Complete

March 2, 2016

For Immediate Release
CRI Medical Devices Facility Move is Now Complete
Indianapolis, Indiana

February 25, 2016

CRI is pleased to announce the move to its new facility has been completed. The new facility is located at 6102 Victory Way Indianapolis, IN 46278 in Park 100. It can be seen from Interstate 465 just before 71st Street.

Over the past 6 months, CRI has been preparing for a facility move which would significantly increase production and warehouse capacity while accommodating the growing global support teams such as finance, quality, engineering and business development. “We were fortunate to find such a nice space so close to our former facility. We really wanted to limit the impact that relocation could have on our customers and our employees; I don’t think we could have found a better location for our team. Our new location, with enhanced operational capacity, allows us to scale and meet the needs of an ever demanding medical device marketplace, while providing exceptional product quality along the way,” said Mike Andrus, CRI’s EVP of Commercial Operations.


About CRI
CRI is a global full service medical device manufacturer specializing in class I, II & III single-use medical devices, concept development and product life cycle management. With three decades of experience, CRI has a dedicated staff focused on customer needs to ensure a high level of satisfaction.

For more information please visit or email

Marketing Team CRI®

IHIF Welcomes Alzheimer’s Association of Greater Indiana as New Member!

February 8, 2016

Alzheimers Assoc Logo

The Alzheimer’s Association Greater Indiana Chapter provides education, care and support o 73 counties across the sate of Indiana. We raise funds and awareness about the disease for the more than 110,000 Hooisers living with Alzheimer’s disease and their 332,000 caregivers. Our local advocates work with Indiana legislators to make Alzheimer’s disease a priority in policy making. Additionally, we help nearly 300,000 people annually by offering support, information and referrals though (800.272.3900) staffed by specialists and master’s level clinicians.

Learn more at

BIO Releases First-Ever Industry Principles on Value of Biopharmaceuticals

February 5, 2016

BIO Logo Horizontal RGB

News Release

1201 Maryland Avenue, SW l Ste. 900

Washington, D.C. l 20024 l 202-962-9200



Twitter: @IAmBiotech

For Immediate Release

Contact:Daniel Seaton

BIO Releases First-Ever Industry Principles on Value of Biopharmaceuticals

Innovative biopharmaceutical industry focused on value, advocating for needed reforms

Washington, D.C. (February 3, 2016) – The Biotechnology Innovation Organization (BIO) today released new Principles on the Value of Biopharmaceuticals. These voluntary Principles represent the first-ever systemic, industry-endorsed set of commitments by research-based biopharmaceutical companies to support comprehensive and sustainable solutions to improve patient access to and affordability of innovative medicines that are transforming how we treat and cure patients with once-devastating diseases.

The following statement may be attributed to BIO President and CEO Jim Greenwood:

“America’s innovative biopharmaceutical companies exist to advance the health and well-being of patients by tackling head-on the unrelenting scientific challenges inherent in the discovery, development and delivery of new, high-value cures and treatments. These Principles represent a commitment by our industry to do our part to improve the ability of patients to access those medicines on a sustainable and affordable basis, while also continuing to take the big risks and make the enormous investments required to fulfill the promise of the next generation of cures.”

Among other principles, BIO members are committed to open dialogue with patients, healthcare providers, and payers on the value of their biopharmaceutical innovations and to take these stakeholders’ views into account in the development and delivery of such cures and treatments.  In addition, BIO and its members will work with such stakeholders, as well as policymakers, to explore a broad range of novel delivery approaches to maximize the value of these innovations for patients and the overall healthcare system, including by seeking to remove legal barriers that currently limit the ability to engage in value-based contracting and communications.

“As evidenced by these Principles, the research-based biopharmaceutical industry welcomes the vigorous public debate about the cost and value of our medical innovations,” Greenwood said.  “BIO members already are doing their part to find sustainable patient-centered solutions, and as an industry we are committed to doing even more.  To effectively accomplish these goals, it is essential that other stakeholders in the healthcare system do their part, as well. To that end, we call upon payers, healthcare providers and policymakers to join with us in designing and implementing comprehensive solutions that will ensure patients continue to benefit from the tremendous medical advances biotechnology has made possible.”

The full Principles on the Value of Biopharmaceuticals are available here. To learn more about the value of innovation, please visit here.

About BIO

BIO is the world’s largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products. BIO also produces the BIO International Convention, the world’s largest gathering of the biotechnology industry, along with industry-leading investor and partnering meetings held around the world. BIOtechNOW is BIO’s blog chronicling “innovations transforming our world” and the BIO Newsletter is the organization’s bi-weekly email newsletter. Subscribe to the BIO Newsletter.

IHIF Welcomes Johnson Co. EDC as new Member!!

January 26, 2016

jcdc logo

A non-profit public/private partnership that provides economic development services to municipalities and companies throughout Johnson County.


Learn more at

Pearl Pathways participates in program to drive second-stage growth

January 11, 2016

January 7, 2016

Contact: Diana Caldwell
Pearl Pathways
Business: (317) 899-9341
Cell: (317) 490-0511

Life sciences consulting company selected for prestigious Purdue Economic Gardening Program

INDIANAPOLIS, INDIANA – January 7, 2016 — Pearl Pathways, a comprehensive life science product development services company, is excited to announce its’ participation in the Purdue Economic Gardening Program.

The Economic Gardening program is managed by the Purdue Center for Regional Development with funding provided from a gift from the Lilly Endowment Inc.

Using an entrepreneurial approach to promote business growth, the Purdue Economic Gardening Program provides tailored assistance to second-stage companies. The program states that economic gardening “is about leveraging information using sophisticated business intelligence tools and databases that growth companies either aren’t aware of or cannot afford.”1 Four focus areas of the program include providing information that helps companies define core business strategies, delivering market intelligence, assisting in efforts to identify qualified leads, and contributing to the company’s leadership development. Purdue collaborates with the businesses to work through barriers and develop new methods.

Purdue and Pearl Pathways will focus on market intelligence analysis, geographical mapping, search engine optimization, and analyzing key industry trends. Diana Caldwell, CEO & President, states, “We are thrilled to have been selected for the program. This will allow us access to data and experts that can provide great insights into our business and the marketplace. The highly-skilled Economic Gardening team has been a pleasure to work with, and we are confident that the information they can provide will impact our business planning priorities and day to day efforts with our clients.”PearlPathways

BioStorage Technologies:Innovative Sample Management Partnership is Advancing Precision Medicine to Find Cure for IBD

November 19, 2015

INDIANAPOLIS – As the global leader in comprehensive sample management solutions, BioStorage Technologies has entered into a strategic partnership with the Crohn’s & Colitis Foundation of America (CCFA) to provide innovative sample management and transformative technology servicers across the entire sample lifecycle including logistics, kitting, bioprocessing, storage and distribution of samples for its new IBD Plexus initiative.


Earlier this year, CCFA was awarded a grant from The Leona M. and Harry B. Helmsley Charitable Trust to establish an integrated knowledge platform designed to centralize and aggregate patient information – with linked biosamples – across multiple research efforts. The new initiative, called IBD Plexus, is designed to speed progress toward precision medicine through novel research, leading to better diagnostics, treatments and, ultimately cures for Crohn’s disease and ulcerative colitis, also known as inflammatory bowel diseases (IBD).


IBD Plexus will enable academic and industry researchers, clinicians, and other healthcare providers to study IBD in patients of all ages. The initiative will nurture collaboration among stakeholders and is powered by a common goal of supporting better care, improving treatments, and finding a cure.


The IBD Plexus research project includes a biobank; registries to capture clinical, patient-reported, and biosample data (genetic, genomic, microbiomic, etc.); and a large data management platform to house, organize, aggregate, and disseminate data to support research decisions. Within three years, databases will be combined or built with clinical information on more than 40,000 Crohn’s and colitis patients, along with genomic and microbial profiles from 7,000 patients who will be followed over time.


IBD Plexus’s sample management and technology services platform will be provided by BioStorage Technologies. In addition, BioStorage will be relocating a sample collection and performing DNA extraction through its BioProcessing Solutions Alliance with RUCDR Infinite Biologics.


“We are honored to collaborate with CCFA’s IBD Plexus to support their delivery of personalized medicine to patients with IBD and the advancement of the search for the cure,” said Greg Swanberg, CEO, BioStorage Technologies.


“IBD Plexus will provide the infrastructure and capacities to dramatically shift the paradigm and accelerate IBD research. We are pleased to be working with BioStorage Technologies as a partner in this important initiative,” said Dr. Caren Heller, Chief Scientific Officer for CCFA.


“This project embodies the Helmsley Charitable Trust’s commitment to establishing close and productive partnerships with the organizations that offer the greatest potential to impact the areas that we support,” said Helmsley Charitable Trust trustee Sandor Frankel. “We are thrilled at the prospects of what this important new research platform can achieve in advancing therapies, care and the path to a cure for those with IBD with the support of best-in-class partners.”


About Biostorage Technologies 

BioStorage BioStorage Technologies, Inc. is the premier, global provider of comprehensive sample management solutions for the bioscience industry. Offering flexible onsite, offsite and hybrid models for the smartsourcing of research assets, BioStorage Technologies provides a complete life-cycle of sample management solutions. With an expert team of global sample consultants, industry-leading temperature-controlled storage facilities, innovative bioprocessing solutions and state-of-the-art technology solutions to support sample inventory and data virtualization, the company supports its customers in maximizing opportunities, minimizing risk and reducing costs. BioStorage Technologies, Inc. is a privately held, global corporation. For more information, visit or call +1 866 697 2675 for North America, +49 6155 898 1011 for Europe or +65 31576199 for Singapore or +86 10 8587 2390 for China.


About CCFA

The Crohn’s & Colitis Foundation of America (CCFA) is the largest non-profit voluntary health agency dedicated to finding cures for inflammatory bowel diseases (IBD). CCFA’s mission is to cure Crohn’s disease and ulcerative colitis, and to improve the quality of life of children and adults who suffer from these diseases. The Foundation works to fulfill its mission by funding research, providing educational resources for patients and their families, medical professionals, and the public, and furnishing supportive services for those afflicted with IBD. For more information, visit or call 888-694-8872.


About CCFA

The Leona M. and Harry B. Helmsley Charitable Trust aspires to improve lives by supporting exceptional nonprofits and other mission-aligned organizations in the U.S. and around the world in health, selected place-based initiatives, and education and human services. Through its IBD and Crohn’s Disease Program, the Trust has allocated nearly $160 million to institutions in the United States, Canada, Europe, and Israel. Across the program, nearly 100 Helmsley-funded investigators are working to understand both how human genetics and the gut microbiome can cause and exacerbate IBD and bring those insights into the development of new treatments and a cure. For more information, please visit


Acquisition expands Novo Nordisk’s portfolio of projects within diabetes and obesity

August 27, 2015

Bagsværd, Denmark, 27 August 2015 – Novo Nordisk today announced that it has entered into a definitive agreement under which Novo Nordisk will acquire Calibrium LLC and MB2 LLC, two privately held biopharmaceutical research companies based in Indiana, US.


Formed in 2013 and 2014, respectively, Calibrium and MB2 are focused on developing a portfolio of novel drug candidates for the treatment of diabetes and related metabolic diseases. The acquisition will expand Novo Nordisk’s portfolio of projects and intellectual property rights within diabetes and obesity and provide a basis for expanding Novo Nordisk’s research presence in the US.


Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk says: “We are always on the lookout for ways to strengthen our leadership position within therapeutic proteins. This research team has demonstrated world-class capabilities in protein design and created a project portfolio of innovative product leads that fit very well with our aspirations within diabetes and obesity.”


Dr Richard DiMarchi, chief scientific officer and co-founder of Calibrium and MB2 says: “It’s an honour to join the global Novo Nordisk research community. Their intense focus on metabolic diseases, which over the years has led to numerous breakthrough protein-based medicines, aligns perfectly with my career-long priorities. I’m optimistic that together we can create novel, transformative therapies in the fight against the global epidemic of diabetes and obesity.”


The parties have agreed not to disclose the financial details of the transactions.


The closing of the transaction is subject to US regulatory approval and is expected to occur during the third quarter of 2015.


About Calibrium and MB2

Calibrium is an emerging biopharmaceutical company focused on the discovery and early development of novel peptides for the treatment of diabetes and related metabolic diseases. Calibrium was co-founded by Fritz French, chief executive officer, and Richard DiMarchi, PhD, chief scientific officer.


MB2 is a clinical-stage biopharmaceutical company advancing a pipeline of first-in-class, mixed agonist drugs for the treatment of diabetes and obesity. MB2 was co-founded by Kent Hawryluk, chief executive officer and Richard DiMarchi, PhD, chief scientific officer.


Both companies are privately held and located in Carmel, IN, US.



Further information

Katrine Sperling +45 3079 6718
Ken Inchausti (US) +1 609 514 8316


Peter Hugreffe Ankersen +45 3075 7085
Daniel Bohsen +45 3079 6376
Melanie Raouzeos +45 3075 3479
Frank Daniel Mersebach (US) +1 609 235 8567


Pearl IRB Granted AAHRPP Accreditation

March 1, 2015

February 17, 2015

Contact: Diana Caldwell
Pearl IRB
Business: (317) 899-9341
Cell: (317) 490-0511

Pearl IRB Granted AAHRPP Accreditation
Further distinguishing the uniqueness of Pearl IRB

INDIANAPOLIS, INDIANA – February 17, 2015 — Pearl IRB, LLC a provider of superior central IRB review services, is proud to announce its recent accreditation by the Association for the Accreditation of Human Research Protection Programs (AAHRPP). Pearl IRB earned this distinction in December 2014 by demonstrating extensive safeguards in all levels of the research operations and abiding by high standards of excellence for all research.

Pearl IRB now joins an elite group of 23 commercial-independent IRB’s who hold this prestigious designation. Additionally, Pearl IRB joins Indiana University as just the second AAHRPP accredited organization in the state of Indiana.1

“We are extremely proud to have earned AAHRPP accreditation. This accreditation validates our commitment to high quality research processes and organizational excellence,” shares Pearl IRB’s President and CEO, Diana Caldwell. Pearl IRB is further differentiated by being one of only five AAHRPP accredited, commercial-independent IRB’s to also receive WBENC (Women’s Business Enterprise National Council) certification as a Women’s Business Enterprise (WBE). Caldwell highlights, “Our clients want to work first and foremost with an IRB that demonstrates excellence, but many also have the business objective of engaging with diverse suppliers in the clinical research space. With Pearl IRB, they get both.”

To date, there are more than 200 AAHRPP accredited organizations in 46 states and 10 different countries. 1 AAHRPP promotes high-quality research through an accreditation process that helps organizations worldwide strengthen their human research protection programs (HRPPs). To earn AAHRPP accreditation Pearl IRB completed a voluntary, peer-driven process and provided tangible evidence through policies, procedures, and practices of its commitment to scientifically and ethically sound research and to continuous improvement. Historically, this process can take years to complete – Pearl IRB moved from Phase 1 submission to accredited in just 6 months.

As the “gold seal,” AAHRPP accreditation offers assurances that Pearl IRB demonstrates its value in providing excellence and following high standards for quality, ethics, and protection to research participants, researchers, sponsors, government regulators, and the general public.

To learn more about Pearl IRB, visit or email

About Pearl IRB
Pearl IRB was founded in 2010 by Diana Caldwell and Gretchen Miller Bowker, who have both been involved in drug, device or diagnostic research, development, and commercialization for over 45 years. Pearl IRB’s team is comprised of experts in the fields of medical practice, science, ethics and clinical research and understands the need for efficient and high quality reviews for human subject research. Protecting human subjects and driving improved value and efficiency in protocol reviews and implementation shapes the behaviors of Pearl IRB’s team.

Pearl IRB is part of a family of life science companies. Learn more about Pearl Pathways.
Pearl Pathways is a comprehensive life science product development services company. Our experienced team is obsessed with expediting life science product development regulatory pathways. We have three business units to serve you:
Pearl IRB is a full service commercial Independent Review Board that provides human research IRB reviews, IRB exemptions and waivers, and also offers support for research protocol/ICF medical writing, site assessments, and monitoring services.
Pearl ReGXP is a regulatory and quality compliance consulting practice that provides regulatory filing guidance, conducts global health authority negotiations, develops/improves quality systems, and delivers GMP/GLP/GCP auditing services.Pearl IDEAS provides strategic product development assistance, third party vendor selection and management strategies, due diligence services, and sales and marketing services for drug, biologic and device companies.

To learn more, please visit us at, call us at 317.899.9341, or email Pearl IRB is located in Indianapolis, Indiana, and is a WBENC certified woman owned business. For media inquiries, contact Diana Caldwell at


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