Archive for the ‘Member Press Releases’ Category

Pearl Pathways Hires Masheka Fuqua

May 25, 2017

May 25, 2017

 

FOR IMMEDIATE RELEASE

 

Contact: Waylon Wright

Pearl Pathways

Business: (317) 602-5479

Cell: (832) 942-4152

contact@pearlpathways.com 

www.pearlpathways.com

 

 

Pearl Pathways Hires Masheka Fuqua

 

Experienced clinical research associate joins Pearl Pathways

 

INDIANAPOLIS, INDIANA – May 18, 2017 — Pearl Pathways announces the hiring Masheka Fuqua as a Clinical Research Associate serving biopharmaceutical, medical device, and diagnostic life science companies.

Fuqua brings over a decade of clinical research experience to Pearl Pathways, including the coordination, management, and submissions of clinical trial activity across many therapeutic areas of research. Her decade of industry experience involves roles within clinical and healthcare market research at other organizations, including direct work with sponsors, sites, and clinical research organizations (CROs). Fuqua’s in-depth understanding of FDA, ICH, and Good Clinical Practice regulations coupled with her strong clinical background and acumen in auditing and monitoring various regulatory documents make her a strong addition to the team. Masheka holds an MS in Health Science from Indiana State University, a B.S. in Business Management from Indiana Wesleyan University, and an A.A.S. in Funeral Service from Mid-America College of Funeral Service.

Diana Caldwell, President and CEO shares, “Masheka delivers strong, balanced, and uncompromising research administration skills with integrity and credibility. She deeply understands clinical study regulatory processes including IRB submissions. Our clients will benefit from her broad industry experience that encompasses all aspects of clinical research, from site to sponsor to CRO. We are thrilled to have Masheka join the team.”

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 www.pearlpathways.com, call us at (317) 899-9341, or email contact@pearlpathways.com. Pearl Pathways is located in Indianapolis, Indiana, and is AAHRPP accredited and a WBENC certified woman owned business. For media inquiries, contact contact@pearlpathways.com.

FAST BioMedical Raises $8 Million as part of Series A2 Financing Round

May 3, 2017

Carmel, Indiana – May 3, 2017 – FAST BioMedical, Inc. today announced it has secured $8 million of additional financing.  $5 million comes from a Series A2 Financing led by one new investor, F&M Investment Office.  This financing augments $3 million of grant funding received as a competing renewal award from the National Institute of Diabetes and Digestive and Kidney Diseases at the National Institutes of Health.  The proceeds will primarily be used to advance clinical trials of the company’s technology as well as to hire additional talent and advance the company’s global patent portfolio.

“This financing is an important and validating step to continue our progress,” said Joe Muldoon, FAST BioMedical Chief Executive Officer.  “We have already begun adding talent to the team, and are excited about their ability to immediately add value”

“FAST BioMedical has enormous potential to serve large unmet medical needs with its innovative technology,” said Mr. McClure, President of F&M Investment Office.  “We are delighted to partner with them, and see great promise in the ability to favorably impact critical patient care. ”

About FAST BioMedical

FAST BioMedical is a private, clinical-stage medical technology company in Carmel, Indiana.  The company’s globally patented first-in-class technologies directly measure blood volume and kidney function in a clinically viable way.  This has the potential for profound impact on care of congestive heart failure, major surgery, sepsis, critical care, and kidney disease patients.   The company has been financially supported by the NIH, Elevate Ventures, the Indiana 21st Century Fund, Rose-Hulman Ventures, BioCrossroads, Indiana University Medical Group, The Purdue Foundry Fund, Ellipsis Ventures, StepStone Partners, and private family office investors. The FDA has determined the company’s technology met the requirements for an Expedited Review.

These products are investigational and not yet approved for human use.

For more information, please visit www.FASTBioMedical.com

Iotron Industries USA Announces Strategic New Hire

April 25, 2017

 

PRESS RELEASE:

Mon, 24 Apr 2017, 07:59:30 EST

COLUMBIA CITY, Indiana, Apr. 24, 2017 – Iotron Industries USA is carefully adhering to its strategic growth plan in the area of geographic expansion of its electron beam processing services. This week it announced a new hire, Brandon Glock, Business Development Manager for the Columbia City, IN location.

Brandon brings with him experience in project management and technical marketing as it applies to the medical device manufacturing community. Prior to joining Iotron, he was account manager at a Warsaw, IN based orthopedics manufacturing firm.

In his new role at Iotron, he will work to build upon the foundation of customer partnerships developed within the region, and begin to lay the groundwork for new opportunities in the medical
device industry as demand continues to increase for Iotron’s contract sterilization and radiation crosslinking services.

“Brandon shares the same passion and values for the medical device industry as Iotron when it comes to market development and customer service,” says Aaron Starkey, Commercial Director of Iotron Industries CANADA/USA. “Customer service is paramount in our work. Brandon’s knowledge in med device and his methodic approach to brand promotion will be key to executing our strategic growth plan in Indiana and throughout North America.”

Iotron Industries provides sterilization, bio-reduction and materials modification services for the orthopedic, medical device, and specialty plastics markets. Iotron offers a team of dedicated experts to facilitate material processing requirements utilizing Electron Beam irradiation technology. For over 25 years, Iotron’s highly experienced staff has been providing a knowledgeable approach to the development of unique processes associated with a broad array of products and materials, earning Iotron recognition as a global leader in radiation processing.

About Glock:
Brandon Glock brings to Iotron a diverse background in the medical device and orthopedics industries, with previous roles in Project Management and Sales & Marketing at both Instrumedical Technologies (Warsaw, IN) and Zimmer-Biomet (Warsaw, IN). He holds a Bachelor’s Degree from Grace College with a Double Major in Communications and Sports Management.

4394 East Park 30 Drive, Columbia City, IN 46725 USA Tel: 260 338-0046 Fax: 260 338-0448
Web Site: www.iotron.com email: iotron@iotron.com

Ivy Tech Bloomington led development of national educational skill standard for medical device careers

August 9, 2016

 

FOR IMMEDIATE RELEASE

August 9, 2016

 

Contact:  Amanda Billings

Executive Director, Marketing/Communications

Ivy Tech Community College – Bloomington

(812) 330-6222   |   abillings7@ivytech.edu

 

BLOOMINGTON – Ivy Tech Community College’s Bloomington campus led a consortium of 12 other community colleges and 72 medical device industry partners nationwide to develop the nation’s first skill set standards for entry-level medical device jobs in the U.S. The Community College Consortium for Bioscience Credentials (c3bc) published “Medical Device Skill Standards,” a manual of educational guidelines to ensure educators and trainers develop and teach the skills needed in entry level medical device jobs in the U.S. The project was funded by a $15 million dollar grant from the U.S. Department of Labor.

 

Sengyong Lee, Ph.D., professor and Ivy Tech Bloomington biotechnology program chair, is c3bc’s medical device hub leader. Dr. Lee and his team at Ivy Tech Bloomington led the nationwide collaboration. “The advancement of medical technology and growing health care needs for elderly populations around the globe have accelerated the growth of companies like Cook Medical in recent decades,” Dr. Lee said. “The medical device industry is in need of a continuous pipeline of skilled workers to meet their growth demands. Our partners and educators who developed the skill standards manual hope for a long-term return on investment in the form of graduates from community colleges who will fill those jobs.”

 

Local employers, including Chapman Lake Instrument Corp., Cook Medical, Cook Polymer Technology, and Boston Scientific Corporation, participated as industry partners. Employers outlined skills needed in entry-level medical device positions, which educators used to create skill standards for teaching and testing students.

 

Educators nationwide have already begun to use the skill standards manual to create new and revise educational courses, certificates, and degrees to align with industry needs. For example, Ivy Tech Bloomington developed a new medical device quality certificate that counts toward the biotechnology associate degree and leads to a career in the industry. Ivy Tech Bloomington also has a plastics program and regulatory affairs certificate to meet local employer needs.

 

In addition to publishing the manual, c3bc also developed ‘Courses in a Box’ which educators nationwide can use to develop curriculum. The downloadable, digital materials outline exactly what should be taught, and includes everything a credentialed instructor would need to teach the course online or in person.

 

“The courses in a box project will be especially valuable to educators and trainers who are new in the field. Of course, the main beneficiaries of the project are the students and trainees who will receive valuable education,” Dr. Lee said.

 

The c3bc’s Medical Device Skill Standards manual and Courses in a Box are now published and are free and available to download. The standards manual can be found online at

https://www.skillscommons.org/handle/taaccct/8777 and the Courses in a Box can be found at

https://www.skillscommons.org/handle/taaccct/442.

 

For information about Bloomington programs in medical device manufacturing, plastics, and biotechnology, visit ivytech.edu/biotechnology and click Bloomington. Fall classes begin August 22 but students should enroll by August 12 in order to be prepared on the first day of classes. To enroll, visit www.ivytech.edu/applynow, stop into Ivy Tech Bloomington located at 200 Daniels Way, or call (812) 330-6013.

 

About Ivy Tech Community College
Ivy Tech Community College (www.ivytech.edu) is the state’s largest public postsecondary institution and the nation’s largest singly accredited statewide community college system.  Ivy Tech has campuses throughout Indiana. It serves as the state’s engine of workforce development, offering affordable degree programs and training that are aligned with the needs of its community along with courses and programs that transfer to other colleges and universities in Indiana. It is accredited by the Higher Learning Commission and a member of the North Central Association.

 

###

 

Interview contacts:

 

Dr. Sengyong Lee
812-330-6036

slee@ivytech.edu

 

Chris Kilander

Global Product Manager/Team Leader – Peripheral Intervention

Cook Incorporated

750 Daniels Way

Bloomington, IN 47404

1-800-468-1379 ext. 10-1978

Mobile: 812-322-8097

Chris.Kilander@CookMedical.com

 

Kathy Heuer,

Executive Director, Indiana Medical Device Manufacturing Council, Inc.

Kathy Heuer

Executive Director, IMDMC, Inc.

PO Box 441385

Indianapolis, IN 46244

(260) 609-2802

imdmc@imdmc.org

 

IHIF Welcomes New Members

August 3, 2016

Quality Connection

Quality Connection is a labor management partnership comprised of 100 union electrical contractors and nearly 3,000 International Brotherhood of Electrical Workers (IBEW) #481 electrical workers. Together labor and management provide the needed expertise, highly trained workforce, safety and dedication to help build many of Central Indiana’s premiere education, health care, utility sites and logistics projects. The unique business relationship spans more than 50 years and represents a strong tradition of quality electrical construction, progressive labor negotiations and community service. With an unprecedented commitment to workforce training, job safety and worker standards. Quality Connection . . .Quality Work, Customer Connected. Learn more at www.qcindy.com

NeRX Biosciences

One of the most effective chemotherapeutics used in the treatment of cancer continues to be the DNA damaging agent cisplatin. Pioneered by our Medical Advisor, Dr. Larry Einhorn at the Indiana University School of Medicine for the treatment of testicular cancer, cure rates now exceed 90% for this cancer. This represents one of the few shining stories since the “War on Cancer” was initiated in the early 1970’s. Unfortunately, cisplatin is considerably less effective in treating other cancers but remain first-line treatment for lung and ovarian cancer. NERx Biosciences co-founder and CSO, Dr. John Turchi has been studying the biology and biochemistry of cisplatin for 25 years and in 2005 was recruited to the Indiana University Cancer Center where advances in his laboratory have paved the way for recapitulating the successes of platinum treatment for testicular cancer in lung and ovarian cancer.

NĒRx Biosciences was established in 2009 to capitalize on these advances and discoveries to develop novel therapeutics to enable the effective treatment of highly prevalent and difficult to treat cancers including lung and ovarian. Learn more at www.nerxbiosciences.com.

 

Azenix/Futago Corporation

 Researching and developing advanced process technology and design manufacturing plan cooperated with Futago LLC.

KinaSense

KinaSense is developing cell-based assays used in preclinical drug discovery to identify and characeterize new compounds for oncology. Our assays are faster, less expensive, and have more physiological relevance than traditional methods used in target validation and potency studies, allowing earlier decision making fro progressing compounds into animal studies.Learn more at www.kinasense.com.

MorNuCo

MorNuCo, Inc. is a biotech company focused on age related diseases with an emphasis on cancer detection. Learn more at www.mornuco.com.

Phytoption LLC

Phytoption LLC is an innovation company developing propriatory ingredients to improve drug bioavailability, food quality, and cosmetics functionality. It offers patented technology and ingredients to pharmaceutical, food, or cosmetic industrial partners.

Safekeeping (2)

Safekeeping is a moblie application that delivers health and lifestyle information to family members of patients in care facilities.Learn more at www.safekeepingapp.com.

Pearl Pathways’ CEO completes Goldman Sachs 10,000 Small Businesses entrepreneurship program

July 6, 2016

PearlPathways

July 6, 2016

 

FOR IMMEDIATE RELEASE

 

Contact: Michele Taylor

Pearl Pathways

Business: (317) 899-9341 (ext. 112)

 

contact@pearlpathways.com 

www.pearlpathways.com

 

 

Indiana Life Science Executive completes Goldman Sachs 10,000 Small Businesses entrepreneurship program

 

Pearl Pathways’ Diana Caldwell welcomed into elite alumni group of the Babson College Cohort of Goldman Sachs’ 10,000 Small Business program

 

 

INDIANAPOLIS, INDIANA – July 6, 2016 — Pearl Pathways is pleased to announce that its President and CEO, Diana Caldwell recently completed an elite entrepreneurship training program in the Babson College Cohort of Goldman Sachs’ 10,000 Small Business program.  She is among 137 entrepreneurs who graduated in May 2016 representing 34 states, Washington D.C, and Puerto Rico.  Goldman Sachs 10,000 Small Businesses is a national program created to help entrepreneurs create jobs and economic opportunity by providing greater access to education, capital, and business support services. The graduates of the program this spring completed the blended online and face-to-face program that delivers intensive practical entrepreneurship training from Babson’s business experts and peers, alongside educational teams who teach the 10,000 Small Businesses program at community colleges across the country.

“We’re proud of our graduates of the Goldman Sachs 10,000 Small Businesses Initiative. These entrepreneurs put forth incredible effort to complete this program and we are confident their efforts will continue in growing their businesses. We are excited to watch their many successes,” said Kerry Healey, President of Babson College.

Pearl’s President and CEO, Diana Caldwell shares “The 10,000 Small Business program offered training for entrepreneurs that I was able to immediately implement in the business, and allowed me to network and learn from impressive CEOs across the country. I would recommend this program to fellow CEO’s who want to take their company to the next stage.”

Babson has been partnering with Goldman Sachs and others on the 10,000 Small Businesses program since 2010, and has helped train over 200 faculty and staff who deliver the program. The small businesses in this group represent a total of $240M in revenues and over 3,000 jobs from a broad range of industries.

Starting in March 2016, for 11 weeks, these small business owners connected with peers and worked together through practical business education delivered through a blend of online and in-person sessions.

“The program is designed to be highly participative, focusing on peer and experiential types of learning – just Babson’s style,” said Babson Professor Patricia Greene, National Academic Director of Goldman Sachs 10,000 Small Businesses and 10,000 Women. “Babson is proud to see these business owners applying what they have learned to take their next steps in growing their revenues, creating jobs, and supporting our economy.”

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 www.pearlpathways.com, call us at (317) 899 – 9341, or email contact@pearlpathways.com. Pearl Pathways is located in Indianapolis, Indiana, and is AAHRPP accredited and a WBENC certified woman owned business. For media inquiries, contact contact@pearlpathways.com.

 

About Goldman Sachs 10,000 Small Businesses

Goldman Sachs 10,000 Small Businesses is based on the broadly held view of leading experts that greater access to this combination of education, capital and support services best addresses barriers to growth for small businesses. 10,000 Small Businesses is guided by an Advisory Council on which Babson President Kerry Healey serves and is co-chaired by Goldman Sachs chairman and CEO Lloyd C. Blankfein, Bloomberg L.P. founder, president and CEO, and 108th Mayor of the City of New York Michael R. Bloomberg, Berkshire Hathaway chairman and CEO Warren Buffett, and the Initiative for a Competitive Inner City’s Dr. Michael Porter.  The National Urban League and the U.S. Hispanic Chamber of Commerce are also represented on the Advisory Council, among other groups.

10,000 Small Businesses offers qualified business owners:

  • Guidance in creating a customized growth plan that includes opportunity identification and feasibility analysis, financial management, leadership, negotiations, and marketing.
  • One-on-one business counseling and a network of peer support from other small business owners, as well as leaders in the business world.

To apply for the 10,000 Small Businesses business and management education program, please visit www.10KSBapply.com.

About Babson College

Babson College is the educator, convener, and thought leader for Entrepreneurship of All Kinds®. The top-ranked college for entrepreneurship education, Babson is a dynamic living and learning laboratory where students, faculty, and staff work together to address the real-world problems of business and society. We prepare the entrepreneurial leaders our world needs most: those with strong functional knowledge and the skills and vision to navigate change, accommodate ambiguity, surmount complexity, and motivate teams in a common purpose to make a difference in the world, and have an impact on organizations of all sizes and types. As we have for nearly a half-century, Babson continues to advance Entrepreneurial Thought & Action® as the most positive force on the planet for generating sustainable economic and social value.

 

Thomas Medical Receives Indy Chamber GoGlobal Grant to Support Export Growth

June 3, 2016

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[Indianapolis] — Thomas Medical has been awarded one of the Indy Chamber’s first GoGlobal grants, a new program in partnership with JPMorgan Chase to recognize and support the efforts of local employers to begin or expand exporting activity. To earn the competitive grant, Thomas Medical shared specific, practical plans to increase international sales over the next year.

“Thomas Medical is thrilled to be awarded a GoGlobal Grant from the Indy Chamber,” said Ben Ovenden, Sales Manager for Thomas Medical. “The incremental expenses associated with export growth can be prohibitive for smaller companies, so reaping the benefits of exporting, such as job growth, can seem daunting. Support like the Indy Chamber’s Global Indy Initiative goes a long way to keeping local companies on the global market.”

 
The grant announcement was made at the Indy Chamber’s 2016 World Trade Day, an annual event highlighting the impact of global trade and investment in the Indianapolis region. Exports and foreign investment support more than 100,000 local jobs, with Indianapolis companies selling nearly $15 billion in goods and services outside the U.S. last year.

 
“Indy ranks 23rd out of the 100 largest metro areas in total exports, but the successful exporters in our community are far outnumbered by companies who aren’t taking advantage of global opportunities,” said Michael Huber, president and CEO of the Indy Chamber. “With the support of JPMorgan Chase, the GoGlobal grant program will help businesses explore new markets and find new customers around the world – and inspire others to follow suit.”

 

Thomas Medical will use the grant funds to participate in the annual meeting of the European Society of Human Reproduction and Embryology (ESHRE), July 3-6 in Helsinki, Finland.

 
The GoGlobal Grant awards are part of the Indy Chamber’s Global Indy initiative, which exists to encourage the Indy metro’s companies to engage in global opportunities through export support and facilitating foreign direct investment activity.

 
For more information about the GoGlobal Grant awards, visit IndyChamber.com/GoGlobalGrant.

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 http://www.cri-devices.com/en

Anagin Lands Health Grant

March 11, 2016

Posted: Mar 10, 2016 6:18 PM

Updated: Mar 11, 2016 9:15 AM

Source:http://www.insideindianabusiness.com/story/31441356/iu-startup-lands-health-grant 

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.

CRI
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 www.cri-devices.com or email info@cri-devices.com.

Marketing Team CRI®

marketing@cri-devices.com