Archive for the ‘Uncategorized’ Category

BIO Action

June 6, 2017

IHIF members are encouraged to learn about a new effort that the Biotechnology Innovation Organization (BIO) has launched as part of its state and federal advocacy efforts – called BIO ACTION.  In 2017 the potential of biotechnology to heal, fuel, and feed the world has never been more promising – yet some policymakers are proposing ideas that could grind innovation to a halt.

That is why BIO is launching a new grassroots advocacy initiative called BIO ACTION.  This advocacy program will keep you informed of emerging policy issues and threats to biotechnology innovation.  BIO ACTION will ask for your voice when needed to encourage lawmakers to enact policies to further innovation and stop harmful policies from passing.

We know you care about the future of biotechnology from your past support of IHIF.  But now we need your help – and your voice – more than ever before.

To learn about some of the issues BIO ACTION will be actively working on, please visit the BIO ACTION advocacy portal at https://www.bio.org/become-advocate-biotechnology.  Here you can also find the new BIO ACTION online tool that makes it easy for you to contact your federal, state and local public officials.  Our voices must be HEARD – lend yours to help biotechnology heal, fuel, and feed the world!

Please take a moment and help make the biotech industry’s voice heard –  join BIO ACTION!

BioAction block

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.

Trade Mission to 2017 Zhejiang Medical Expo

May 25, 2017

Turnpike Trade Mission
Zhejiang Medical Equipment Expo/Health Services Promotion Expo
Zhejiang Province, China
September 10-17, 2017

Hangzhou ExpoThe Hangzhou International Expo Center will be the main venue for the 2017 Health Expo in Hangzhou, the capital of Zhejiang province.(Photo/Xinhua)

The state trade association members of the Turnpike Partnership and their members are invited to participate in a trade mission to Zhejiang Province, China. Coordinated by the Indiana Health Industry Forum (IHIF) and their agent in China, Pacific World Trade (PWT), the mission will attend the “2017 Health Expo”, a joint meeting of the Zhejiang Medical Equipment Expo and the Health Services Promotion Expo. The exhibition and conference will be held in the newly appointed G-20 conference center in Hangzhou, Zhejiang, China.

Mission Focus

Expo 2

The Medical Products Exhibition provides procurement units across many different hospital and healthcare facility levels with an efficient and convenient platform
for viewing new devices and technologies.

This mission will focus on making introductions and developing commercial partnerships in China for U.S. companies engaged in the design, development, appointment/outfitting of hospitals and healthcare facilities, and related training and services.

  • Facility design and operation
  • Digital technologies
  • Hospital Equipment and Supplies
  • Training (healthcare and equipment)
  • Services

Mission Services
Companies participating in the mission will be provided with 1:1 meetings coordinated by PWT and the Zhejiang Health Services Promotion Council, a presentation opportunity to conference attendees, and participation in a Turnpike booth at the Expo.

Agenda*
September 10 – Depart US
September 11 – Arrive in Hangzhou, Zhejiang Province.
September 12 – Briefing/reception, potential for pre-arranged meetings/tours
September 13 – 16 – 2017 Healthcare Expo: exhibition, presentations, meetings
September 17 – Return to U.S.
*subject to change depending on availability

Mission fees and registration
Delegates are responsible for their own travel/accommodation arrangements. There will be a reserved block of hotel rooms for the mission, near the exhibition center. PWT will provide assistance with letters of invitation for visas, and have staff available on the ground in China. Other anticipated costs may include in-country transportation and translation services.

Mission participation fee: $2,995/organization*
*Mission fee subject to change. Rate includes shared costs for a 3mX3m Turnpike exhibition booth and rental of facilities for company presentations. Requires a minimum of four company participants.

Registration Deadline: August 1, 2017
For more information or to register for the mission, please contact the Indiana Health Industry Forum at info@ihif.org.  Download Mission Brochure.  Download 2017 ZIHIE Brochure.

About Zhejiang: Zhejiang province is located on the southeast coast of China, to the south of Shanghai. It is divided into eleven prefecture-level divisions, nine prefecture level cities and two sub-provincial cities (the capital city of Hangzhou and city of Ningbo). Zhejiang is considered a relatively wealthy province and has been consistently in the top 5 out of 34 provinces in terms of nominal total GDP and GDP per capita. In 2015, it contributed 7% of China’s total GDP. Zhejiang has a population of 55 million people with 1,049 hospitals across the province.

Zhejiang province is the largest consumer of medical devices in China and serves as a “showcase” for the total market. 30,000 professionals will attend the Expo. The annual transaction value at the Expo is over $175 million or about 20% of the total market value.

About the Conference: After two successful ZIHIE Expos, in September 2017, a more comprehensive and innovative Expo will be held at the new Hangzhou International Expo Center. With hundreds of exhibitors and thousands of their products and services from across the world, ZIHIE has become the largest health brand exposition for Zhejiang province. 800 hospitals will be represented by executive staff as part of the provincial Hospital Association annual meeting.

About IHIF/PWT: The Indiana Health Industry Forum and Pacific World Trade work together to help Indiana health science companies explore market opportunities in China and specifically work with governmental and private organizations in Zhejiang Province, Indiana’s sister-state. Leveraging the 30+ year relationship PWT has fostered on behalf of Indiana, combined with export guidance and counseling, member companies of IHIF can be assured of a well-researched and supported introduction to the Chinese market.

About the Turnpike Partnership: The Turnpike Partnership is an international network of health science industry associations focused on patient-driven public policy and innovation services. The Turnpike Partnership brings together health science associations and their members with industry leaders, research universities, startup companies, mentors, and related national trade associations. The Turnpike model erases geo-political boundaries and focuses on getting innovation in front of the people who can connect it most quickly to patients. Organized and led at the state/grassroots level, the Partnership provides a collaborative, viable, sustainable business model and support system.

Pitch at INX3 – $100,000 prize

May 19, 2017

Pitch at INX3. The grand prize is $100,000 in cash and services.

INX3 is a five-day conference in Indianapolis that focuses on entrepreneurship, startups, and venture capital. You can find more here: http://www.inx3.org/

In order to pitch at INX3, you need to qualify at one of the regional pitch qualification events (Bloomington).   This event is being organized by Pat East (Hannapin Marketing), The City of Bloomington, and the BEDC.

Step 1: Apply via this form: https://hanapinmarketing.formstack.com/forms/bloomington_pitch_qualification_for_inx3

Step 2: Hannapin will schedule a 10-minute introduction phone call. The purpose is both informational and for screening purposes.

Step 3: Hannapin will email invited applicants the rubric the judges will use. These criteria are set by INX3 and will be the same criteria in other regional pitch qualifications.

Step 4: Invited startups will pitch in the Bloomington finals at the Dimension Mill on Thursday, June 8 at 5:30 pm. You’ll receive feedback and be notified that night whether you advance to INX3.

You can find more info on the conference here: http://www.inx3.org/ (do *not* apply via the form here, apply via https://hanapinmarketing.formstack.com/forms/bloomington_pitch_qualification_for_inx3 or by emailing me directly at pat.east@cofoundventures.com.)

IHIF Signs Partnership Agreement With Scottish Lifesciences Association

May 17, 2017

 Builds New Market Opportunities for State Industry Members

Contact: Kristin Jones, IHIF, kjones@ihif.org +1-317-752-9809

(Indianapolis,IN USA and Edinburgh, Scotland UK- May 16, 2017) — The Indiana Health Industry Forum (IHIF) and the Scottish Lifesciences Association (SLA) have signed a Memorandum of Understanding to share member benefits between the two organizations.  IHIF and SLA share the same essential vision with regards to creation and maintenance of an environment that nurtures and supports life sciences companies.  The objectives are to foster innovation and valuable, dynamic links between US-based member companies of IHIF and Scotland-based member companies of SLA.

 

According to Scott Johnstone, CEO of the SLA, “IHIF and SLA intend to represent the USA and EU to each other as practical for the mutual benefit of our organizations and our member companies.  Through this relationship, we intend to increase the visibility, sales, investment, regulation, and innovation prospects for our member companies”.

 

Both organizations are members of the multi-state Turnpike Partnership, an innovation-driven network of resources and organizations built to support and enhance the life sciences industry. Scotland is a key international partner with a life sciences cluster of similar size and scope to Indiana’s.

 

Building on an already strong trade relationship, “IHIF and SLA were able to come together through the Turnpike Partnership and build an alliance that will directly benefit our members”, said Kristin Jones, President and CEO of IHIF.  “The partnership with SLA is a further expansion of our international network and will give our members strategic access to UK and European markets at a time of dynamic change.  We also look forward to working with members of SLA as they build their business networks and explore opportunities in the U.S.”

 

The MOU was signed at the 2017 Derby Summit, an annual event for the Kentucky Life Sciences Council.  The Scottish delegation also visited Boston and IHIF representatives attended the May 11 Spring Members Meeting for the SLA in Glasgow, Scotland.

 

About SLA

With 135 member companies and organisations, the SLA is the voice of Scotland’s vibrant life sciences industries to investors, NHSScotland, the Scottish and UK Governments, and the wider community.  The SLA is driven by and network with its members through 14 Special Interest Groups and 4 sub-groups.  The SLA helps to grow members’ businesses, and engage with the NHS and Government to grow the life sciences sector in Scotland.

 

For more information: http://www.scottishlifesciencesassociation.org.uk

 

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.

 

For more information: http://www.ihif.org

SLA Mou

Kristin Jones (IHIF) and Scott Johnstone (SLA) sign agreement to trade member services.

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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

April 2017 Life Sciences Lunch – Digital Wellness – Managing Your Personal Health Portfolio

May 3, 2017

The scope of health information has evolved considerably from just describing the clinical information stored in your electronic health record to now encompassing the myriad data points and tools people use to manage their personal health and conditions. All of that data has clinical usefulness but organizing it, protecting it, and ultimately using it to drive long-term wellness and lifestyle changes is the key.

PANELISTS

Dr. Sanjay Parikh, Chief Medical Officer, Green Circle Health
Mr. Dinesh Sheth, CEO, Green Circle Health
Laura Hoag, National Health Promotion Director at Activate Healthcare
Craig Wilhite, CTO, Brightlamp LLC

MODERATOR
Kristin Jones, President and CEO, Indiana Health Industry Forum

 

The Indiana Health Industry Forum and Barnes & Thornburg LLP partner to present a monthly seminar series on critical issues in life science. 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 life science industry. We hope you will join us.

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

March 2017 Life Sciences Lunch – How Secure Are Your Patents?

April 12, 2017

LSL Banner

The last run at patent reform fell flat in the fall of 2015. With no real legislative appetite to tackle the reform process, you might think that things would have calmed down but in this age of uncertainty, nothing stays quiet for long. Whether it is regulatory reform coming from the Patent Office and Congress, addressing the continued issues of inter partes review (IPR) and managing patent trolls, or exploring potential changes in patent protection due to the renegotiation of trade agreements, it is important to plan ahead and be aware of where there may be future disruptions. Please join us as our panel discusses the current patent landscape for life sciences products, delves into the key players and constituencies shaping the process, and see what it might mean for protection of your intellectual property.

PANELISTS
Deborah Pollack-Milgate, Partner, Barnes & Thornburg LLP
Angela Freeman, Associate, Barnes & Thornburg LLP
Jennifer Finefield, Senior Technology Manager, Indiana University Research and Technology Corporation
MODERATOR
Chris Felts, Partner, Barnes & Thornburg LLP

The Indiana Health Industry Forum and Barnes & Thornburg LLP partner to present a monthly seminar series on critical issues in life science. 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 life science industry. We hope you will join us.

February 2017 Lunch – “One Health – It’s All Connected”

March 22, 2017

“One Health – It’s All Connected”

The One Health concept recognizes that the health of people is connected to the health of animals and the environment. The goal of One Health is to encourage the collaborative efforts of multiple disciplines-working locally, nationally, and globally-to achieve the best health for people, animals, and our environment.  Sixty percent of infectious diseases in people are spread from animals and the interactions between the points of this triad are changing more rapidly and dynamically than ever before.  Our panel will discuss how looking at the bigger picture will shape drug development and impact innovation and research efforts going forward.

Panelists:

Josh Johnson

 General Manager

Benchmark Biolabs

Reza J. Rasoulpour, Ph.D.

 Global Predictive Safety Center LeaderRegulatory Sciences, R&D

Dow AgroSciences, LLC

 Kristin Bloink

Senior Director

 Global Research and External Innovation 

 Elanco Animal Health

Moderator:


Deborah Pollack-Milgate 

Partner

Barnes & Thornburg LLP

The Indiana Health Industry Forum and Barnes & Thornburg LLP partner to present a monthly seminar series on critical issues in life science. 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 life science industry. We hope you will join us.