August 2017 Life Sciences Lunch

August 28, 2017

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The Indiana Health Industry Forum and Barnes & Thornburg LLP partner to present a monthly seminar series on critical issues in the life sciences. Each month, at lunch, a policymaker or a panel in the field of life science will be available to answer questions concerning the major challenges and opportunities in the industry. We hope you will join us.

 

Tech Transfer Driving Indiana’s Innovation Ecosystem

The Technology Transfer Offices at Indiana’s leading research universities are churning out new technologies and start-up companies like never before.  Finding new ways to support and develop early stage innovations and then matching those with the right development partners takes time, creativity, and a network of partnerships with industry and funders.  Please join us as we hear from a panel of research university representatives highlighting some of their latest life science technologies and explore how they are gearing up to smooth out the translational process!

Moderator:
Deborah Pollack-Milgate, Partner
Barnes & Thornburg LLP

Panelists:
Brooke Beier, Ph.D.
Purdue Research Foundation
Executive Director of Purdue’s Office of Technology Commercialization.

Karen Imgrund Deak, Ph.D.
Commercialization Specialist
IDEA Center
University of Notre Dame

Simon Atkinson, Ph.D.
IUPUI Interim Vice Chancellor for Research, Biology
IUPUI

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CRI Celebrates 30 Years in the Medical Device Industry

August 18, 2017
Celebrating 30 Years
8/15/17

For Immediate Release

CRI Medical Devices is proudly celebrating its 30th year in business this September 17, 2017.

Established on September 17, 1987, CRI built its foundation through the development of technology that enabled catheters to better navigate the inner passages of the body during surgery. This technology was based upon the use of nitinol wire; an industry standard material still to this day.

Over the past 30 years, CRI has continued to focus on the development and manufacturing of catheters and other custom medical devices. Specialties include high-volume assembly, extrusion, domestic and international regulatory services as well as marketing and sales of its Thomas Medical branded, proprietary women’s health
products.

In 2008, owner John Steen, PhD converted CRI to an employee-owned company. In 2010, CRI became 100% employee-owned and is still an ESOP today. This business model has created an environment where its highly dedicated employee-stock holders have a vested interest in the success of CRI. Dr. Steen has been with CRI since 1991 and currently serves as Chairman of The Board and assists with export activities for Thomas Medical.

Today, CRI is still headquartered in Indianapolis, IN with locations in Minnesota, Ireland and Costa Rica. CRI has expanded its capabilities and services globally, but has not forgotten the importance of local customer service and quality manufacturing practices. “After 30 years of continued growth, the future for CRI is bright.” stated Dr. Steen.

Full post and CRI Website

Pearl IRB becomes a SMART IRB participating institution

August 18, 2017

August 16, 2017

 FOR IMMEDIATE RELEASE

 Contact: Waylon Wright

Pearl IRB

Business: (317) 602-5479

Cell: (832) 942-4152

contact@pearlirb.com

www.pearlirb.com

 

pearl-irb-logo

 

INDIANAPOLIS, INDIANA – August 16, 2017 — Pearl IRB is pleased to announce that we have joined SMART IRB, a platform to ease common challenges and burdens associated with initiating multisite research. SMART IRB is a collaborative initiative supported by the National Center for Advancing Translational Sciences (NCATS) and led by Harvard Catalyst, University of Wisconsin-Madison ICTR, and Dartmouth Synergy.

Through a flexible master IRB reliance agreement, standard operating procedures, and complementary tools and resources, SMART IRB supports and encourages collaboration and harmonization across a national consortium of institutions. Together with SMART IRB, we will shape the future of multisite research across the nation, creating a network that will foster and enhance collaboration.

Pearl IRB strives to deliver superior independent review board services to improve the clinical research process thereby delivering new therapeutics and diagnostics to patients sooner.

The goal of SMART IRB is to streamline the IRB review process in multisite research, help investigators obtain trial results faster and, ultimately, advance the development of new diagnostics, treatments, and preventative measures for patients, while maintaining strong human research protections, oversight, and regulatory compliance.

Under the SMART IRB Agreement, investigators conducting multisite research may request that participating institutions rely on the review of a single IRB, and institutions may elect to do so on a study-by-study basis.

 

A full list of participating institutions and more information may be found at www.smartirb.org.

For information about how you can leverage SMART IRB for your research, please contact us today.

About Pearl IRB

Pearl IRB is an independent institutional review board, fully accredited by the Association for the Accreditation of Human Research Protection Program Inc. (AAHRPP).  Pearl IRB manages the local and central IRB needs for large and small institutions, principal investigators, CROs, and sponsors. Our vision is to improve the clinical research process which will lead to delivering therapeutics and diagnostics to patients sooner. Whether the research is a small single site project or a complex multi-center study, we can help.

Pearl IRB is part of Pearl Pathways, a comprehensive life science product development services company. Pearl Pathways supports biopharmaceutical, medical device, and diagnostic companies as well as life science service providers with clinical, regulatory, and quality compliance needs. Whether you are small startup, still in the pre-commercialization stage, or a large multinational company with several products on the market, Pearl Pathways is equipped to serve you. Learn more at www.pearlpathways.com.

To learn more, please visit us at www.pearlirb.com, call us at (317) 899-9341, or email contact@pearlirb.com. Pearl IRB is located in Indianapolis, Indiana, and is AAHRPP accredited and a WBENC certified woman owned business. For media inquiries, contact contact@pearlirb.com.

 

New ShareVault White Paper: What’s the role of Non-Immuno Oncology in an Immuno Oncology World?

August 10, 2017

“New ShareVault White Paper:  ” What’s the role of Non-Immuno Oncology in an Immuno Oncology World?”

This white paper discusses the role of non-immuno-oncology therapies for cancer in a world where immuno-oncology is playing a greater role.

 

The clinical success of checkpoint inhibitors has made Immuno-Oncology an amazingly “hot” area for pharmaceutical and biotech deal making.  With checkpoint antibodies seen as backbones for combination therapy in cancer, many in Oncology are asking:

• What is the role of non-IO in an IO world and can you partner a non-IO opportunity?

• Is there still room for new anticancer agents that are not working in IO models?

• Are drug candidates evaluated with the assumption that everything will eventually be used in combination with IO agents?  Or are there indications or mechanisms for which IO will never be important?  Should I pursue combinations with IO?

• What kinds of mechanisms are attractive in non-IO?  What data and models will big pharma want to see?   Do I need to run experiments with their molecule?  Are there certain tumor types that are particularly attractive?

• Is it too late to try to compete in the crowded space of combination with PD1 antibodies?  What other IO agents are likely to backbones of oncology franchises?

• What will make my non-IO drug candidate compelling for partners and investors?

Download the white paper at this link.

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