Archive for the ‘Member Press Releases’ Category

Safis clients win market clearance!

November 12, 2013

Contact:
Thomas (Tom) Stergar II
FOR IMMEDIATE RELEASE
Office: 317-777-6203
Cell:317-697-9988
tstergar@safis-solutions.com
October 29, 2013

Safis Solutions is announcing that two of its clients, Stereotaxis, Inc. (Nasdaq:STXS) and Dermal Life LLC, are cleared to market four products by 510(k) approval from the Food and Drug Administration (FDA). Stereotaxis, St. Louis, MO., is marketing its Vdrive™ Robotic Navigation System with V-Sono™ Intracardiac Echocardiography (ICE) catheter manipulator to help improve the efficiency of cardiac catheterization procedures. This represents the first FDA clearance for the Vdrive family of products, which has been utilized in Europe since 2011. Karen Duros, Senior Vice President & General Counsel, said, “Safis helped lead us through this crucial regulatory hurdle. They are a trusted partner and valued member of the Stereotaxis Team, and we are grateful for their involvement.” The Safis team was led by John Nadelin, Vice President of Regulatory & Compliance. Nadelin expressed, “We are very happy for Stereotaxis. It is very gratifying to be part of the Stereotaxis team whose work is important to improving the lives of not only thousands of cardiac patients, but the physicians that perform these delicate procedures.” Stereotaxis is a healthcare technology and innovation leader in the development of robotic cardiology instrument navigation systems designed to enhance the treatment of arrhythmias and coronary disease, as well as information management solutions for the interventional lab.

Dermal Life LLC, a Florida company founded in 2010 and also a Safis client, has a mission to develop advanced skin care products that maximize skin health. In May 2013, Dermal Life received FDA 501(k) clearance for Hydropermeate™ Topical Emulsion (Rx) with indications for full-thickness wounds, pressure sores, dermal ulcers, including lower leg ulcers; superficial wounds; 1st and 2nd degree burns, including sunburns; dermal donor and graft site management; radiation dermatitis; and minor abrasions. Additionally, Dermal Life received FDA clearance for Answer2Skin™ Sunburn Relief Cream (OTC) for minor burns, including minor sunburns, and Answer2Skin™ First Aid Cream (OTC) for minor superficial wounds and minor abrasions, including cuts and scrapes. Randy Hitchens, Senior Vice President Business Development, reports that “Dermal Life leveraged the regulatory and quality skills of Safis Solutions to select our CMO partner, develop our formulation, create lab-validation-stability batches, pass required-FDA toxicology testing, successfully complete stability testing, file our FDA 510(k) application, respond to FDA requests for additional information and achieve FDA clearance in a 2.5 year period. Our team was highly impressed with the Safis Solutions team of Ping Poulsen, John Nadelin, John Lockwood and John Steichen. Dermal Life has actively recommended Safis Solutions to other health care companies.

Safis Solutions provides consulting services in the areas of regulatory affairs, quality compliance (cGxP), audits, computer system validation, and IT services for pharmaceutical, medical device and biotechnology clients worldwide. Services successfully executed by Safis have helped more than 150 clients over the past 11 years meet regulatory compliance and quality standards and gain government agency approvals for their products, manufacturing systems, clinical and laboratory systems. Safis originated at the Indiana University Emerging Technologies Center (IUETC), and has been certified as WBE by WBENC, MBE by MSDC, both MBE and WBE by the state of Indiana and the city of Indianapolis.

For more information, contact Thomas (Tom) Stergar II at 317-777-6203.

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ASH Consulting Goes After Chase Mission Main Street Grant

November 5, 2013

Please vote for ASH Consulting to win a Chase Mission Main Street Grant!

The $250,000 grant will allow David Woll and Aleta Hodge to collaborate to present seminars for college students on early stage funding opportunities in 2014 and 2015! Our target population will consist of women and under-served small business owners.

 

You can vote by either using Facebook or the ASH Consulting Web page

  1. https://facebook.com/ashconsult5

(In lower right hand corner, click on Chase Mission Main Street Grants)

 

  1. http://www.ashconsult5.com

(links to Chase site & then click on Vote Now button, you must vote

via your Facebook account)

 

Voting period runs until Nov. 15th!

Ivy Tech Fall Life Science Classes Now Available

August 26, 2013

Ivy Tech Corporate College just released its fall catalog. Two courses may be of particular interest to companies and individuals in the life science sector.

Regulatory Affairs Overview

This 9-contact hour course will provide an overview of the laws and regulations that govern the life sciences industry. This course will provide a brief introduction to the regulatory environment for employees in the biosciences sector who do not work in the Regulatory department of your company. The course is scheduled to run on 3 Wednesday afternoons in September.

Biomanufacturing Overview. This 9-contact hour course is intended to provide an overview of the biotechnology industry. This course is designed for more of a general audience, such as your friends and neighbors who may be curious about the industry and who might wonder if a career in it is right for them. This course is scheduled to run on 3 Thursday evenings in October.

 

These courses are listed on page 6 of the catalog, which you can click here to download. There is a registration form in the front of each catalog or you can register at www.ivytech.edu/bloomington/corporate-college.

 

Please contact Clint Merkel, Director, Indiana Center for Life Sciences, Ivy Tech Bloomington  or call 812-330-6065 if you have any questions.

 

 

 

Purdue Technology Road Show

August 21, 2013

Presented by the

Purdue Office of Technology Commercialization and

Purdue Research Park of Northwest Indiana

You are cordially invited to the

Purdue Technology Road Show

featuring new innovations developed at Purdue University

September 18, 2013 12:30 p.m. to 3:30 p.m.

Purdue Technology Center of Northwest Indiana

9800 Connecticut Drive Crown Point, Indiana

Event is free and includes lunch. Please RSVP by September 11

to Sally Ross at (765) 588-3490, saross@prf.org. Seating is limited.

DuPont and IQLP Ink Deal to Develop High-Speed Circuit Technology

August 8, 2013

Liquid Crystal Polymer to Target High-Frequency Film Market 

 

DuPont Circuit & Packaging Materials (DuPont) and IQLP, LLC, a division of Interplex Industries, Inc., announced their ongoing efforts to further develop and refine liquid crystal polymer (LCP) thin-film technology for use in high-speed circuit applications.

Read the full Dupont press release here

Click here for more info on IQLP

www.interplex.com

Notre Dame Announces Biomedical Imaging Partnership – Newsroom – Inside INdiana Business with Gerry Dick

July 26, 2013

Notre Dame Announces Biomedical Imaging Partnership – Newsroom – Inside INdiana Business with Gerry Dick.

 

SOUTH BEND, Ind. – The University of Notre Dame has established a formal partnership with Bruker Corp., a world leader in scientific instrumentation. The partnership will develop one of the Midwest’s top imaging facilities at Notre Dame. The arrangement, called Bruker at Notre Dame (BAND), will allow the Notre Dame Integrated Imaging Facility (NDIIF) and Bruker to collaborate on research, training and new application development.

Congratulations to iGEM Competitors

July 2, 2013

MCITlogo

 

IHIF is so proud to have been a sponsor of a high school team competing in this year’s International Genetically Engineered Machine (iGEM) competition.  The student team from the McKenzie Center for Innovation and Technology, in Indianapolis (a Lawrence township school) competed last week at the international Jamboree in Boston.  The students had a great experience and learned so much about synthetic biology and experimental design.  Their project involved the development of a bioreactive cream for the detection of melanoma.  For more on the project, please visit their site – http://2013hs.igem.org/Team:MCIT_Indianapolis

Abstract

According to the World Health Organization, 132,000 people are diagnosed with melanoma skin cancer each year and 48,000 deaths occur from this diagnosis. The development of a yeast based early detection system has the potential to save thousands of lives. Team MCIT Indianapolis is working on a topical cream that will detect the early onset of malignant melanoma. The biosensor system will be developed within a Saccharomyces cerevisiae chassis, using a plasmid containing Firefly Luciferase and Renilla coding that will enable fluorescence in the presence of precancerous cells.  The bioengineered yeast will express the receptor protein FGFR-1 on its surface allowing the device to detect increased levels of Basic Fibroblast Growth Factor (FGF2) commonly expressed by precancerous melanocytes. Detection of bFGF will initiate the production of Firefly Luciferase and Renilla proteins, which will cause the yeast to fluoresce showing the patient where potential malignant melanoma cells may be located.

If you would like to be a sponsor or provide support for next year’s team, please let us know!

 

Algaeon Inc. Closes on $770,000 Investment Round

June 4, 2013

June 3, 2013 News Release

INDIANAPOLIS, Ind. – Algaeon Inc., an Indianapolis-based biotech company that has developed algae cultivation technology for use in the nutraceutical and micronutrient markets, announced today that it has closed a $770,000 investment round of funding from early-stage growth company investors. The investment group included City Securities Corporation and multiple individual Angel investors. The funding will support the addition of capacity for sample qualification and animal testing for 3 prospective customers and the design of a commercial scale facility. This sets the ground work for the Company to expand operations and to produce products used as food supplements to promote health and disease prevention for humans and animals.
Algaeon is an early stage company entering its early growth phase. Founded in 2008, the company completed 2 rounds of funding in 2012 for $1.2 Million. The Company has currently completed technology scale-up and is working with 3 customers to secure long-term supply contracts. The company will be seeking additional funds for construction of commercial scale capacity. The first commercial scale capacity will begin operation in late 2013. Capacity will continue to be expanded thereafter to fulfill purchase contracts with industry leading companies. Algaeon’s patent-pending production technology sets a new standard in the industry for efficiency and overcomes the common industry challenges of contamination control and cost containment. Growing demand for over-the-counter health solutions is driving the need for innovative large volume supplies of nutritional supplements. Similarly, there is growing demand for improving animal production efficiency by improving survivability, health and weight gain without the use for antibiotics. Demands in these markets are growing and the industry is having difficulty obtaining sufficient supply. “The markets for our high-value algae derivative products have been growing at significant rates, and the investment will advance our entry into these high-demand areas,” said Paul DeLacey, President and CEO, Algaeon, Inc.

About Algaeon Inc.

Algaeon Inc. is an Indianapolis-based biotech company that has developed a breakthrough patent pending industrial scale microalgae cultivation technology. Unique high value products are currently being grown for leading companies in the Nutraceutical and Animal Micronutrient markets. Algaeon is developing its own cultivation capacity, as well as, licensing the technology for algae farms. For more information about Algaeon visit www.algaeon-inc.com Source: Algaeon Inc.

New Report Shows Over 3,200 Clinical Trials of Medicines Conducted by Indiana Research Institutions Since 1999

June 4, 2013

FOR IMMEDIATE RELEASE
Contact: Jeff Trewhitt
(202) 835-3460

Research Supported by Biopharmaceutical Companies Boosts Indiana Economy, Benefits Local Patients

WASHINGTON, D.C. (June 4, 2013) – Working in collaboration with Indiana clinicians and research institutions, America’s biopharmaceutical research companies have conducted 3,266 clinical trials of new medicines in Indiana over the last 13 years, according to a new report by the Pharmaceutical Research and Manufacturers of America (PhRMA). The report – “Research in Your Backyard: Pharmaceutical Clinical Trials in Indiana” – was released today at a news conference with Indiana Governor Mike Pence at Covance, a clinical research facility and biopharmaceutical services company in Greenfield.
Governor Pence, Chester “Chip” Davis, PhRMA Executive Vice President for Advocacy, and Andrew Dahlem, Ph.D., Lilly Research Laboratories Vice President and Chief Operations Officer, shared their perspectives on the importance of biopharmaceutical research and life sciences in the state.
“Indiana’s life sciences industry has tremendous potential for growth,” said Governor Pence. “We are actively working to expand the partnership among life sciences and biopharmaceutical companies and our state’s universities and hospitals to grow the economy, to attract and retain talent, and to address the critical health issues we face today.”
The economic impact of the biopharmaceutical sector extends far beyond direct jobs. Pharmaceuticals accounted for nearly $5 billion of the $7.4 billion in Indiana exports in 2009. A BioCrossroads report shows that the primary life sciences industries supported about 155,000 jobs in Indiana in 2009, including more than 64,000 pharmaceutical sector positions. Nearly 17,800 of the pharmaceutical jobs involved direct employment and about 46,500 were jobs supported by biopharmaceutical companies through statewide business arrangements. Life sciences product exports nearly tripled from $2.5 billion to $7.4 billion from 2002 to 2009, ranking Indiana as third-highest among the states, behind only California and Texas, according to BioCrossroads. Additionally, We Work for Health data released last fall revealed the businesses biopharmaceutical companies engage with in Indiana, showing that the 17 companies surveyed worked with over 3,500 vendors in 2011 alone, spending more than $1.8 billion.
“In addition to the economy, patients have been the beneficiaries of the research our companies have conducted in Indiana,” said Davis. “Working with local research institutions across the state, our companies have conducted over 1,750 clinical trials since 1999 just on the most debilitating chronic diseases – cancer, diabetes, heart disease, stroke, mental illnesses and asthma.”
Increasingly, medicines clinically tested in Indiana and across the country are cutting-edge biotechnology treatments.
“Our growing understanding of the molecular underpinnings of disease, coupled with new scientific approaches to developing medicines, gives us the capacity to create safer and more effective medications and improves our ability to predict and even prevent disease,” said Davis. “It’s impressive that a great deal of that research is underway here in Indiana.”
The report highlights how clinical trials are addressing the serious challenges of chronic disease:
• In 2011, more than 10 percent of the state’s adults had diabetes, according to the state Department of Health. Currently, 33 clinical trials of potential new treatments for diabetes are recruiting patients in the Hoosier State.
• In 2010, nearly 13,000 residents died from some form of heart disease and 3,077 died from a stroke, according to the Indiana Department of Health. Twenty heart disease and seven stroke clinical trials are seeking Indiana patients.
• Nearly 227,000 adults live with serious mental illness in the state and about 71,000 children live with serious mental health conditions, according to the National Alliance on Mental Illness. Thirty mental illness clinical trials are recruiting patients.
The findings also show that research institutions in Indiana are conducting clinical trials of new medicines in collaboration with biopharmaceutical companies, including:
• Cancer Care Center Inc., New Albany
• Central Indiana Cancer Centers, Carmel, Fishers, Indianapolis
• Children’s Center for Cancer and Blood Diseases, Indianapolis
• Indiana University Hospital, Indianapolis
• Indiana University School of Medicine, Indianapolis
• Oncology Hematology Associates of Southwest Indiana, Evansville, Newburgh
• Lafayette Regional Vein and Laser Center, Lafayette
• Deaconess Hospital-The Heart Group, Evansville
• Premier Healthcare, Bloomington

For a listing of all clinical trials recruiting patients and their locations in Indiana, consult the appendix of the “Research in Your Backyard” report, which can be found at http://www.phrma.org/innovation/research-in-your-backyard. Indiana clinical trial information can also be found at http://www.clinicaltrials.gov, the trials data base of the National Institutes of Health.

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The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the country’s leading innovative biopharmaceutical research and biotechnology companies, which are devoted to discovering and developing medicines that enable patients to live longer, healthier, and more productive lives. Since 2000, PhRMA member companies have invested over $500 billion in the search for new treatments and cures, including an estimated $48.5 billion in 2012 alone.
Find PhRMA Online:
• Website – http://www.phrma.org
• Facebook – http://www.facebook.com/PhRMA
• Blog – http://www.phrma.org/catalyst
• Twitter – http://www.Twitter.com/PhRMA and http://www.Twitter.com/PhRMApress
• YouTube – http://www.youtube.com/PhRMApress
For information on how innovative medicines save lives, visit: http://www.innovation.org
For information on the Partnership for Prescription Assistance, visit: http://www.pparx.org
For information on ensuring the flow of medicines during public health emergencies, visit http://www.rxresponse.org

Thousands of Clinical Trials Boosting Hoosier Economy – Newsroom – Inside INdiana Business with Gerry Dick

June 4, 2013

Thousands of Clinical Trials Boosting Hoosier Economy – Newsroom – Inside INdiana Business with Gerry Dick.

A new report from the Pharmaceutical Research and Manufacturers of America suggests Indiana has hosted more than 3,200 clinical research trials over the last 13 years for biopharmaceutical companies throughout the country. Governor Mike Pence says the state is working to expand partnerships between life science companies and local universities to benefit patients and the Indiana economy.


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